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Cannabis Packaging Regulations and Labeling Guidelines for 2024

The rules and regulations around cannabis packaging are ever-changing and can vary widely depending on where you reside and/or operate from. To make your life a little easier as you head into your 2024 business operations, we’ve compiled all of the relevant information here when it comes to packaging and labeling cannabis products throughout the U.S. 

Note: Regulations can change. For the most current regulations in your market, we recommend reaching out to your respective regulating body. 

  1. A Processor must properly package its approved medical cannabis products as follows:
      1. Packaging and containers must be child-resistant.
      2. Packaging and containers must be tamper-evident.
      3. Packaging and containers (or labels, see below) must identify the Processor and type of product.
      4. Packaging and containers must not be attractive to minors. 
      5. Packaging and containers must be designed to minimize appeal to children.
      6. Packaging and containers must not contain any false statement or statement that advertises health benefits or therapeutic benefits of medical cannabis.
  2. A Processor must properly label its packages of medical cannabis as follows:
      1. Labels must be securely attached to or imprinted on the accompanying packaging. 
      2. Labels must be clear and contain print of a size and quality so as to be legible to the average patient or caregiver with a sixth-grade education. 
      3. Labels must identify the type of product (pills, tinctures, transdermal patches, etc.).
      4. Labels must contain lot and batch numbers. 
      5. Labels must contain the name of and a license identification number for the Cultivator.
      6. Labels must contain the name of and a license identification number for the Processor.
      7. Labels must identify the cannabinoids content and potency of the product. 
      8. Labels must identify the amount, number or count of the product in the package on which they are attached.
      9. Labels must contain the universal state symbol approved by the Commission, printed in color at least one-half inch by one-half inch in size.
      10. Labels must contain the words “Keep out of reach of children.”
      11. Labels must contain a digital image or QR Code for purposes of tracking medical cannabis products and must interface with the Statewide Seed-to-Sale Tracking System.
      12. Labels, or if space is not available, a package insert, must contain the following: “WARNING: This product may make you drowsy or dizzy. Do not drink alcohol with this product. Use care when operating a vehicle or other machinery. Taking this product with medication may lead to harmful side effects or complications. Consult your physician before taking this product with any medication. Women who are breastfeeding, pregnant, or plan to become pregnant should discuss medical cannabis use with their physicians.” 
      13. Labels must not be attractive to minors.
      14. Labels must not contain any false statement or statement that advertises health benefits or therapeutic benefits of medical cannabis.
  1. A retail marijuana store shall assure that
      1. Marijuana sold on its licensed premises is packaged and labeled in compliance with 3 AAC 306.470 and 3 AAC 306.475
      2. Any marijuana product sold on its licensed premises is packaged and labeled in compliance with 3 AAC 306.565 and 3 AAC 306.570
      3. At the point of sale, marijuana or a marijuana product sold is packaged in, resealable, child-resistant packaging designed or constructed to be significantly difficult for children under five years of age to open, but not normally difficult for adults to use properly
      4. Unless already packaged by the cultivation facility or the manufacturing facility in an opaque package for final retail sale, any marijuana or marijuana product purchased by the consumer is placed in an opaque package by the retail marijuana store or the consumer before the consumer exits the retail marijuana store
  2. In addition to labeling requirements provided in (1) of this section, a retail marijuana store shall affix a label to each package of marijuana or marijuana product that
      1. Identifies the retail marijuana store selling the marijuana product by name or distinctive logo and marijuana establishment license number
      2. States the estimated amount of THC in the labeled product; and
      3. Contains each of the following statements
          1. “Marijuana has intoxicating effects and may be habit forming and addictive.”
          2. “Marijuana impairs concentration, coordination, and judgment. Do not operate a vehicle or machinery under its influence.”
          3. “There are health risks associated with consumption of marijuana.”
          4. “For use only by adults twenty-one and older. Keep out of the reach of children.”
          5. “Marijuana should not be used by women who are pregnant or breastfeeding.”
  3. In this section, “paque” means a packaging material that does not allow the contents of the package to be seen without opening the package.
  1. A marijuana establishment shall ensure that marijuana or a marijuana product provided by the marijuana establishment’s retail site to a consumer:
      1. Complies with packaging and labeling requirements in A.R.S. §§ 36-2854.01 and 36-2860(A)
      2. Is labeled with:
          1. The marijuana establishment license number
          2. The amount, strain, and batch number of the marijuana or marijuana product
          3. The form of the marijuana or marijuana product
          4. As applicable, the weight of the marijuana or marijuana product
          5. In compliance with Table 3.1, the potency of the marijuana or marijuana product, based on the results of testing by a marijuana testing facility, including the number of milligrams per designated unit or percentage of:
            1. Total tetrahydrocannabinol, reported according to R9-18-408(F)(2)(a)
            2. Total cannabidiol, reported according to R9-18-408(F)(2)(b)
            3. Any other cannabinoid for which the marijuana establishment is making a claim related to the effect of the cannabinoid on the human body
          6. The following statement: “ARIZONA DEPARTMENT OF HEALTH SERVICES’ WARNING: Marijuana use can be addictive and can impair an individual’s ability to drive a motor vehicle or operate heavy machinery. Marijuana smoke contains carcinogens and can lead to an increased risk for cancer, tachycardia, hypertension, heart attack, and lung infection. Marijuana use may affect the health of a pregnant woman and the unborn child. KEEP OUT OF REACH OF CHILDREN”?
          7. For a marijuana product, the ingredients in order of abundance; and
          8. As required by A.R.S. § 36-2854.01 and not later than December 31, 2023, a quick response code linking to a webpage that contains the following:
            1. The strain of the marijuana
            2. The following statement: Using marijuana during pregnancy could cause birth defects or other health issues to your unborn child
            3. Distribution chain information, including:
                1. The name of the marijuana establishment;
                2. If not cultivated by the marijuana establishment, the name and the license number or registry identification number, as applicable, of the marijuana establishment or dispensary that cultivated the marijuana; and
                3. If not infused or prepared for sale by the marijuana establishment, the name and the license number or registry identification number, as applicable, of the marijuana establishment or dispensary that infused or prepared the marijuana product for sale;
                4. A link to the final report of testing marijuana or a marijuana product, specified in R9-18-410(B)(3), from a marijuana testing facility.
                5. If applicable, the method used to extract tetrahydrocannabinol from the marijuana; and
                6. The date of:
                    1. Harvest of the marijuana; and
                    2. If applicable, manufacture of the marijuana product; and
                    3. Is placed in child-resistant packaging on exit from the marijuana establishment.
  2. If a marijuana establishment provides marijuana cultivated, or a marijuana product infused or prepared for sale, by the marijuana establishment to another marijuana establishment or to a dispensary, the marijuana establishment shall ensure that:
      1. The marijuana or marijuana product is labeled with:
          1. The marijuana establishment license number;
          2. The amount, strain, and batch number of the marijuana or marijuana product; and
          3. The dates of:
            1. Harvest or sale; and
            2. If applicable, manufacture; and
      2. A copy of results of testing by a marijuana testing facility for the marijuana or marijuana product is provided to the receiving marijuana establishment or dispensary.
  1. A hemp-derived product distributed or offered for sale in this state shall include the following information on the product label or product packaging:
      1. The name of the hemp-derived product manufacturer, whether in-state or out-of-state, and distributor, whether in-state or out-of-state;
      2. Product labeling clearly showing that the product contains material derived from hemp and not marijuana or medical marijuana; and
      3. Any other marking, words, statement, or symbol as required by Arkansas Tobacco Control through rules.
  2. A person shall not advertise, market, or offer for sale in this state any hemp-derived product by using, in the labeling or design of the product, its packaging, or in its advertising or marketing materials, trade dress, trademarks, branding, or other related imagery that:
      1. Imitates or replicates those of food brands or other related products that are marketed to or are commonly associated with children or minors, including without limitation breakfast cereal, cookies, juice drinks, soft drinks, frozen drinks, ice creams, sorbets, sherbets, and frozen pops;
      2. Depicts or signifies characters or symbols that are known to a reasonable person to appeal primarily to or are commonly associated with children or minors, including without limitation superheroes, cartoons or cartoon characters, including anime characters, comic book characters, video game characters, television show characters, movie characters, mythical creatures, unicorns, or that otherwise incorporates related imagery or scenery; or
      3. Uses the terms “candy”, “candies”, “cake”,” “cakes”, “pies”, or “cupcakes” or any variant of these terms, or any other term referencing a type or brand of candy, cakes, pastries, or pies, including types or brands of candy, cakes, pastries, or pies that do not include the words “candy”, “candies”, “cake”, “cakes”, “pies”, or “cupcakes” in their names, labels, or slogans.
  1. Packaging requirements
      1. Cannabis goods are required to be in packaging that is:
          1. Child-resistant
          2. Tamper-evident
          3. Resealable (if more than one serving)
          4. Opaque (if an edible cannabis product)
DCC has guides to help you understand the requirements: Child-resistant packaging (CRP) Packaging requirements: final form cannabis goods        2. Labeling requirements
      1. Labels have two parts:
          1. Primary panel – the portion of the label most likely to be displayed to the consumer at retail
          2. Informational panel – any other part of the label
  DCC has labeling checklists to help you make sure all required information is on your label: Labeling requirements: non-manufactured products in final form Labeling requirements: manufactured cannabis products in final form  

3. Download the universal symbol

      1. The universal symbol for cannabis alerts people that the product contains cannabis. It must be on the primary panel of all cannabis goods sold in California. Do not alter the symbol, other than changing the size. It must be at least ½ inch by ½ inch in size.
      2. Download the universal symbol to use on your package

4. What cannot be on a label

      1. Consumers use the information on labels to decide what products they buy and use. That’s why it’s important that labels do not include anything that is false or misleading. Do not:
          1. Use the name of a California county, unless 100% of the cannabis was grown there
          2. Use designs attractive to children, including:
              1. Cartoons
              2. Images popularly used to advertise to children
              3. Imitations of candy labeling
              4. The words “candy,” “candies” or anything similar
          3. Make unproven health claims
          4. Use the words “organic” or “OCal” unless you are registered with the California Department of Food and Agriculture or California Department of Public Health
          5. Market the cannabis good as an alcoholic beverage
          6. Include a picture of the product (edibles)

5. Report non-compliant product

      1. Tell us if you see cannabis goods being sold that do not meet the packaging or labeling standards. Report non-compliant product through our online complaint form.

6. Other requirements for cannabis goods

      1. A complete list of requirements for cannabis and cannabis products is in the DCC regulations.
The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(a), 44-10-202(1)(c), 44-10-202(6), 44-10-203(2)(d)(IV)(A) -(C), 44-10-203(2)(f), 44-10-203(2)(w), 44-10-203(1)(a), 44-10-601(2)(a), 44-10-603(4)(a), and 44-10-603(8), C.R.S. The purpose of this rule is to define additional labeling requirements for Regulated Marijuana, Regulated Marijuana Concentrate, and/or Regulated Marijuana Product (except Regulated Marijuana seeds and Immature Plants) based on its intended use. These labeling requirements are in addition to, not in lieu of, the labeling requirements in Rule 3-1010. This Rule 3-1015 was previously Rules M and R 1003-1, 1 CCR 212-1 and 1 CCR 212-2. The Division and State Licensing Authority intend to monitor data regarding Regulated Marijuana use-by dates following implementation of these rules, and will make any necessary changes, including but not limited to, reducing the nine months use-by date if Licensees choose not to conduct stabilization studies.
  1. Applicability. This Rule establishes additional labeling requirements for Regulated Marijuana (except seeds and Immature Plants), Regulated Marijuana Concentrate, and Regulated Marijuana Product prior to Transfer to a patient or consumer. The labeling requirements in this Rule apply to all Containers immediately containing Regulated Marijuana, Regulated Marijuana Concentrate, and Regulated Marijuana Product. These labeling requirements based on intended use are in addition to, not in lieu of, the requirements in Rule 3-1010.
      1. Exemption for Transfers to Consumers by a Retail Marijuana Hospitality and Sales Business. Unless otherwise provided by these rules, a Retail Marijuana Hospitality and Sales Business Transferring Retail Marijuana to consumers in compliance with the packaging and labeling requirements of Rule 3-1020 is exempt from the requirements of this Rule.
  2. Additional Information Required on Every Container (Except Seeds and Immature Plants) Prior to Transfer to a Patient or Consumer. Prior to Transfer to a patient or consumer, every Container of Regulated Marijuana (except seeds and Immature Plants), Regulated Marijuana Concentrate, or Regulated Marijuana Product and any Marketing Layer must have a label that includes at least the following additional information.
      1. Statement of Intended Use. The Container and any Marketing Layer shall identify one or more intended use(s) for Medical Marijuana, Retail Marijuana, Medical Marijuana Concentrate, Retail Marijuana Concentrate, Medical Marijuana Product, and Retail Marijuana Product from the following exclusive list:
          1. Inhaled Product:
            1. Flower, shake, or trim;
            2. Pre-Rolled Marijuana and Infused-Pre-Rolled Marijuana;
            3. Solvent-Based Medical Marijuana Concentrate;
            4. Solvent-Based Retail Marijuana Concentrate;
            5. Physical Separation-Based Medical Marijuana Concentrate;
            6. Physical Separation-Based Retail Marijuana Concentrate;
            7. Heat/Pressure-Based Medical Marijuana Concentrate;
            8. Heat/Pressure-Based Retail Marijuana Concentrate;
            9. Vaporizer Delivery Device;
            10. Pressurized Metered Dose Inhaler.
          2. For Oral Consumption:
            1. Food or drink infused with Regulated Marijuana;
            2. Regulated Marijuana Concentrate intended to be consumed orally;
            3. Pills and capsules;
            4. Tinctures.
          3. Skin and Body Products:
            1. Topical;
            2. Transdermal.
          4. Audited Product:
            1. Metered Dose Nasal Spray;
            2. Vaginal Administration;
            3. Rectal Administration.
      2. Inhaled Product. The “Inhaled Product” intended use may be used only for products intended for consumption by smoking or Vaporizer Delivery Device where the product is heated or burned prior to consumption, or through use of a Pressurized Metered Dose Inhaler. The label(s) on all inhaled product intended use shall also include:
          1. The potency statement required by Rule 3-1010 for:
              1. flower, shake, or trim,
              2. Pre-Rolled Marijuana,
              3. Infused-Pre-Rolled Marijuana,
              4. Solvent-Based Medical Marijuana Concentrate,
              5. Solvent-Based Retail Marijuana Concentrate,
              6. Physical Separation-Based Medical Marijuana Concentrate,
              7. Physical Separation-Based Retail Marijuana Concentrate,
              8. Heat/Pressure-Based Medical Marijuana Concentrate,
              9. Heat/Pressure-Based Retail Marijuana Concentrate shall be stated as the percentage of Total THC and CBD. If CBD is not detected, then total CBD potency is not required.
          2. Use-By Date. Effective January 1, 2024, a product use-by date, upon which the Regulated Marijuana, Regulated Marijuana Concentrate, or Regulated Marijuana Product will no longer be fit for consumption, or upon which the Regulated Marijuana, Regulated Marijuana Concentrate, or Regulated Marijuana Product will no longer be optimally fresh. Once a label with a use-by date has been affixed to a Container containing Regulated Marijuana, Regulated Marijuana Concentrate, or Regulated Marijuana Product and any Marketing Layer, a Licensee shall not alter that use-by date or affix a new label with a later use-by date. The use-by date shall not be longer than nine months from the harvest or production date, unless shelf stability testing, including but not limited to potency, microbial, and water activity testing, supports a longer shelf life. All use-by dates must be entered into the Inventory Tracking System prior to Transfer. Prior to Transfer to a patient or consumer, a Regulated Marijuana Store or Accelerator Store must inform the patient or consumer if the Regulated Marijuana, Regulated Marijuana Concentrate, or Regulated Marijuana Product is past its use-by date.
          3. The potency statement required by Rule 3-1010 for Vaporizer Delivery Devices and Pressurized Metered Dose Inhalers shall be stated as either the percentage of Total THC and CBD, or the number of milligrams of Total THC and CBD, per cartridge, pen, or inhaler. If the potency value for Total THC or CBD of the Vaporizer Delivery Devices or Pressurized Metered Dose Inhalers is less than one milligram, the potency may be expressed as “<1 mg.” If CBD is not detected in the Vaporizer Delivery Device or Pressurized Metered Dose Inhaler, then total CBD potency is not required.
          4. Additional Labeling Requirement for Regulated Marijuana Concentrate to Promote Consumer Health and Awareness: Effective January 1, 2023, if a Regulated Marijuana Concentrate that is an Inhaled Product cannot easily be measured or separable to the recommended serving size established under Rule 3-335(D)(3)(d) and (4)(f), the Regulated Marijuana Manufacturer that manufacturers the Regulated Marijuana Concentrate must:
              1. Affix the Container of Regulated Marijuana Concentrate with a measuring device that permits the patient or consumer to measure each serving in a manner consistent with the recommended serving established under Rule 3-335(D); or
              2. Include a label on the Container of Regulated Marijuana Concentrate that provides instructions to allow the patient or consumer to measure each recommended serving pursuant to Rule 3-335(D).
      3. For Oral Consumption. The label(s) on all Edible Medical Marijuana Products and Edible Retail Marijuana Products, including but not limited to confections, liquids, pills, capsules and tinctures, shall also include:
          1. Potency Statement. The potency statement required by Rule 3-1010 shall be stated as:
            1. milligrams of active THC and CBD per serving and
            2. milligrams of active THC and CBD per Container where the Container contains more than one serving. The Target Potency may be used to fulfill the requirement of this Rule. If CBD is not detected, then active CBD potency is not required.
              1. If the Edible Medical Marijuana Product’s or Edible Retail Marijuana Product’s Target Potency or potency value of active THC or CBD is less than one milligram per serving, the potency may be expressed as “<1 mg.” If “<1 mg” was used to display the active THC or CBD per serving, then a corresponding statement regarding the total THC or CBD content for the entire Container shall be included on the Container. For example, if there are five servings in the Container, “<5 mg” should be displayed for the active THC or CBD statement that was represented as “<1 mg” per serving.
          2. Additional Warning Statement Required. The following additional warning statement shall be included on the label on the Container or Marketing Layer for all Edible Medical Marijuana Product and Edible Retail Marijuana Product: “The intoxicating effects of this product may be delayed by up to 4 hours.”
          3. Expiration/Use-By Date. A product expiration date, upon which the Edible Medical Marijuana Product or Edible Retail Marijuana Product will no longer be fit for consumption, or a use-by-date, upon which the Edible Medical Marijuana Product or Edible Retail Marijuana Product will no longer be optimally fresh. Once a label with an expiration or use-by date has been affixed to a Container containing an Edible Medical Marijuana Product or Edible Retail Marijuana Product and any Marketing Layer, a Licensee shall not alter that expiration or use-by date or affix a new label with a later expiration or use-by date. All expiration or use-by dates must be entered into the Inventory Tracking System prior to Transfer. Prior to Transfer to a patient or consumer, a Regulated Marijuana Store or Accelerator Store must inform the patient or consumer if the Edible Medical Marijuana Product or Edible Retail Marijuana Product is past its expiration or use-by date.
          4. Production Date. The date on which the Edible Medical Marijuana Product or Edible Retail Marijuana Product was produced which may be included in the Batch Number required by Rule 3-1010.
              1. Statement Regarding Refrigeration. If an Edible Medical Marijuana Product or Edible Retail Marijuana Product is perishable, a statement that the product must be refrigerated.
          5. Skin and Body Products (Topical and Transdermal). The “Skin and Body Products” intended use may be used only for products intended for consumption by topical or transdermal application, and must be intended for external use only. The label(s) on all skin and body products shall also include:
              1. Topical Product Potency Statement. For topical product the potency statement required by Rule 3-1010 shall be stated as the number of milligrams of active THC and CBD per Container. The Target Potency may be used to fulfill the requirement of this Rule. If CBD is not detected, then active CBD potency is not required. If the THC or CBD comprises less than one percent of the total cannabinoids, the potency may be expressed as less than one percent of the total cannabinoids.
              2. Transdermal Product Potency Statement. For transdermal products, the potency statement required by Rule 3-1010 shall be stated as the number of milligrams of active THC and CBD per transdermal product, and the total number of milligrams of active THC and CBD per Container. The Target Potency may be used to fulfill the requirement of this Rule. If CBD is not detected, then active CBD potency is not required.
                1. If the transdermal product’s Target Potency or potency value of active THC or CBD is less than one milligram per transdermal product, the potency may be expressed as “<1 mg.” If “<1 mg” was used to display the active THC or CBD per transdermal product, then a corresponding statement regarding the total THC or CBD content for the entire Container shall be included on the Container. For example, if there are five servings in the Container, “<5 mg” should be displayed for the active THC or CBD statement that was represented as “<1 mg” per serving.
              3. Expiration/Use-By Date. A product expiration or use-by date, after which the skin and body product will no longer be fit for use. Once a label with an expiration or use-by date has been affixed to any Container holding a skin and body product and any Marketing Layer, a Licensee shall not alter that expiration or use-by date or affix a new label with a later expiration or use-by date. All expiration or use-by dates must be entered into the Inventory Tracking System prior to Transfer. Prior to Transfer to a patient or consumer, a Regulated Marijuana Store or Accelerator Store must inform the patient or consumer if the skin and body product is past its expiration or use-by date.
              4. Production Date. The date on which the skin and body product was produced which may be included in the Batch Number required by Rule 3-1010.
              5. Audited Product. Packaging and labeling for all Audited Products:
                  1. metered dose nasal spray,
                  2. vaginal administration, or
                  3. rectal administration shall include:
                    1. All packaging and labeling requirements required by this 3-1000 Series for Regulated Marijuana Products; except Rules 5-325 and 6-325 control where the context otherwise clearly requires.
                    2. Audited Product shall be packaged and labeled for Transfer to a patient or consumer prior to Transfer from a Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer.
                    3. Expiration/Use-By Date. A product expiration date that is appropriate for the Audited Product when stored at room temperature as verified by testing required by Rules 5-325 and 6-325. Once a label with an expiration date has been affixed to a Container containing an Audited Product, a Licensee shall not alter that expiration date, or affix a new label with a later expiration date. All expiration or use-by dates must be entered into the Inventory Tracking System prior to Transfer. Prior to Transfer to a patient or consumer, a Regulated Marijuana Store or Accelerator Store must inform the patient or consumer if the Audited Product is past its expiration or use-by date.
                    4. Production Date. The date on which the Audited Product was produced, which may be included in the Batch Number required by Rule 3-1010.
  3. No Other Intended Use Permitted. No intended use other than those identified in this Rule shall be identified on any label, except as permitted by an Alternative Use Designation approved by the State Licensing Authority pursuant to Rules 5-325 and 6-325. Licensees shall accurately identify all intended use(s) from the exclusive list of intended uses in this Rule, or as required by the Alternative Use Designation, on the label.
      1. Alternative Use Product. No Regulated Marijuana Business shall Transfer or accept an Alternative Use Product unless the Alternative Use Product received an Alternative Use Designation in accordance with Rules 5-325 and 6-325 and complied with all the requirements of Rules 5-325, 6-325, and 3-1005 through 3-1015, and with any additional packaging and labeling requirements identified in the Alternative Use Designation. At a minimum the label(s) on all Alternative Use Products shall include:
          1. All packaging and labeling requirements applicable to the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer by these 3-1000 Series Rules unless inconsistent with the Alternative Use Designation in which case the Alternative Use Designation shall control.
          2. Expiration/Use-By Date. A product expiration date that is appropriate for the Alternative Use Product when stored at room temperature as verified by a Regulated Marijuana Testing Facility. Once a label with an expiration date has been affixed to a Container containing Alternative Use Product, a Licensee shall not alter that expiration date, or affix a new label with a later expiration date.
          3. Production Date. The date on which the Alternative Use Product was produced, which may be included in the Batch Number required by Rule 3-1010.
          4. All other requirements identified by the Alternative Use Designation.

4. Multiple Intended Uses. Any Regulated Marijuana having more than one intended use shall identify every intended use on the label and shall comply with all labeling requirements for each intended use. If there is any conflict between the labeling requirements for multiple intended uses, the most restrictive labeling requirements shall be followed. Licensees shall not counsel or advise any patient or consumer to use Regulated Marijuana other than in accordance with the intended use(s) identified on the label.

5. Decontaminated Product. Effective July 1, 2025, if a Licensee chooses to Decontaminate Regulated Marijuana following a failed test result, the Licensee must have the Division-established label on every Container of the Decontaminated Regulated Marijuana flower, shake, trim, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana.

  1. Being packaged, presented or advertised in a manner that is likely to mislead a consumer by:
      1. Bearing a resemblance to trademarked or characteristic packaging of, either
          1. Cannabis offered for sale in this state or on tribal land; or,
          2. A commercially available non-cannabis product.
      2. Implies that the product either; 
          1. Is a cannabis product;
          2. Contains a total THC concentration greater than 0.3% on a dry-weight basis; or,
          3. Is a high-THC hemp product.
  2. Manufacturer hemp products that are a food, beverage, oil or other product intended for human ingestion must be packaged or labeled in packaging that includes:
      1. A scannable barcode, web address or QR Code that links to the product’s Certificate of Analysis that includes:
          1. The name of the product;
          2. The name, address and telephone number of the product’s manufacturer, packer and distributor, as applicable;
          3. The batch number, which shall match the batch number on such package or label; and
          4. The concentration of cannabinoids present in the product, including, but not limited to, total THC and any cannabinoids or active ingredients comprising at least one per cent of such product.
      2. An expiration or best by date, if applicable;
      3. A statement disclosing:
          1. Children, or those who are pregnant or breastfeeding, should avoid using such product prior to consulting with a healthcare professional concerning such product’s safety;
          2. Products containing cannabinoids should be kept out of reach of children; and,
          3. The federal Food and Drug Administration has not evaluated such products for safety or efficacy.
      4. For products intended for inhalation a warning statement disclosing that smoking or vaporizing is hazardous to human health.
  3. Manufacturer hemp products that are a topical, soap or cosmetic must be packaged or labeled in packaging that includes:
      1. A scannable barcode, web address or QR Code that links to the product’s Certificate of Analysis that includes:
          1. The name of the product;
          2. The name, address and telephone number of the product’s manufacturer, packer and distributor, as applicable;
          3. The batch number, which shall match the batch number on such package or label; and,
          4. The concentration of cannabinoids present in the product, including, but not limited to, total THC and any marketed cannabinoids.
      2. An expiration or best buy date, if applicable; and,
      3. A statement disclosing that the federal Food and Drug Administration has not evaluated such product for safety or efficacy.
  1. Requirements for marijuana and marijuana products sold or distributed by marijuana establishments, including information for consumers and labeling requirements for marijuana products that include all of the following:
      1. The length of time it typically takes for a product to take effect.
      2. The amount of marijuana in the product using the standard established in this section, not to exceed 10 mg per serving.
      3. The serving size and the number of servings in each package, not to exceed 10 servings.
      4. Ingredients and possible allergens.
      5. A nutritional fact panel.
      6. The requirement that information on the packaging may not mislead consumers.
      7. The specific batch number of the product.
      8. Educational information for consumers to educate consumers, including evidence-based information about how to interpret the information on the label, health effects, and potential interactions with prescription and nonprescription medications.
      9. Opaque, resealable, and continually child-resistant packaging, which must be designed or constructed to be significantly difficult for children under 5 years of age to open and not difficult for an adult to use properly as defined by 16 C.F.R. § 1700.20.
      10. A standard symbol indicating edible marijuana products contain marijuana so that marijuana products are clearly identifiable.
      11. A warning label that explains evidence-based harms from consuming marijuana, including the impact on developing brains, the impact on an individual’s ability to operate machinery, the impact on pregnant and breastfeeding women, and any interference with prescription drugs.
      12. A label that indicates the product is not for children.
      13. All required information must be in typed, legible font that is easy to read, is unobstructed and conspicuous, and contrasts sufficiently with the background. The information must be in English, but may also include translations in additional languages.
  2. Health and safety regulations and standards for the manufacture of marijuana products by marijuana establishments consistent with other Delaware requirements for food, including all of the following:
      1. Prohibition of the manufacture of products that look like candy or cartoon characters.
      2. Restrictions or prohibitions on additives to marijuana and marijuana-infused products, including additives that are toxic, designed to make the product more addictive, or designed to make the product more appealing to children, but not including common baking and cooking items.
      3. Standards for the safe manufacture of marijuana extracts and concentrates.
      4. Requirements for random sample testing, including the manner and frequency of testing, to ensure quality control, including by ensuring that marijuana and marijuana-infused products are accurately labeled for potency. The testing analysis must include testing for: residual solvents, poisons, or toxins; harmful chemicals; dangerous molds or mildew; filth; harmful microbials such as E. coli or salmonella; and pesticides.
  3. Restrictions on the advertising, marketing, and signage of marijuana and marijuana products, including a prohibition on mass-market campaigns that have a high likelihood of reaching minors.
  4. Restrictions on the display of marijuana and marijuana products, including requirements that marijuana and marijuana products may not be displayed in a manner that is visible to the general public from a public right-of-way.
  5. Requirements governing visits to cultivation facilities and product manufacturers, including the requirement that these marijuana establishment log visitors.
  6. Requirements that educational materials be disseminated to consumers who purchase marijuana-infused products.
  7. Standards for the operation of marijuana testing facilities, including requirements for equipment and qualifications for personnel, which shall be based upon international standard ISO/IEC 17025. Marijuana testing facilities shall achieve and maintain accreditation to ISO/IEC 17025 by an International Laboratory Accreditation Corporation recognized accreditation body. The marijuana testing facilities shall achieve and maintain accreditation within the first applicable licensing period.
  8. Civil penalties for the failure to comply with regulations made under this chapter.
  9. Procedures for receiving and processing consumer complaints about marijuana establishments.
  1. No medical marijuana shall be dispensed or distributed to a qualifying patient or caregiver unless the container in which it is distributed bears a legible label, firmly affixed, stating:
      1. The name of the cultivation center where the medical marijuana was produced and the manufacture date;
      2. The name of the dispensary where the medical marijuana was dispensed;
      3. The quantity of medical marijuana contained within;
      4. The cannabinoid profile of the medical marijuana contained within, including the THC level;
      5. Any other ingredient or ingredients besides medical marijuana contained within;
      6. The name of the recommending physician;
      7. The dispensing date that the medical marijuana was transferred to the qualified patient or caregiver;
      8. The qualifying patient’s name and registration card number; and
          1. A statement that the product is for medical use, not for resale or transfer to another person, containing the following language: “Contains Marijuana. Keep out of the reach of children.”
  2. All medical marijuana sold or otherwise distributed by a cultivation center shall be packaged and labeled in a manner that advises the purchaser that it contains marijuana, specifies the amount of marijuana in the product, and that the marijuana is intended for medical use solely by the patient to whom it is sold, and that any re-sale or re-distribution of the medical marijuana to a third person is prohibited.
  3. The label shall include all ingredients contained in the product, in order from most abundant to least abundant. The label for ingestible items shall identify potential food allergy ingredients, including milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans. The product shall be packaged in a sealed container that cannot be opened without obvious damage to the packaging.
  4. The label shall contain the following warning: “There may be health risks associated with the ingestion or use of this product.” Please consult your physician if you have any questions or concerns.
  5. All medical marijuana shall be labeled with a list of all chemical additives, including but not limited to non-organic and organic pesticides, herbicides and fertilizers that were used in the cultivation and production of the medical marijuana.
  6. A cultivation center may place a trade or product name on the medical marijuana container prior to transporting it to a dispensary.
  7. The label shall not contain any of the following information:
      1. Any false or misleading statement or design; or
      2. Any seal, flag, crest, coat of arms, or other insignia likely to mislead the qualified patient to believe that the product has been endorsed, made, or used by the District government.
  8. A cultivation center or dispensary shall not alter, obliterate, or destroy any label attached to a medical marijuana container.
  9. A dispensary shall place for transport purposes packaged and labeled medical marijuana in a separate sealed container prior to dispensing medical marijuana to a qualified patient or caregiver. This separate sealed container shall comply with these regulations and include a label containing the following required information contained in
      1. The dispensing date the medical marijuana was transferred to the qualifying patient or caregiver; and
      2. The qualifying patient’s name and registration card number.
  10. A cultivation center or dispensary shall not use the word(s) “candy” or “candies” on the product, packaging, or labeling of any medical marijuana product.
  11. A cultivation center or dispensary shall not place any content, image, or labeling that specifically targets individuals under the age of twenty-one (21), including but not limited to, cartoon characters or similar images, on the product, packaging, or a container holding medical marijuana.
  12. A cultivation center that produces edible marijuana products or marijuana- infused products shall ensure that all edible marijuana products or marijuana- infused products offered for sale:
      1. Are labeled clearly and unambiguously as medical marijuana;
      2. Are not presented in packaging or with labeling that is appealing to children; and
      3. Have packaging designed or constructed to be significantly difficult for children under five (5) years of age to open, but not normally difficult for adults to use properly.
  13. A cultivation center or dispensary shall not use or allow the use of any content, image, or labeling on a medical marijuana product that is offered for sale if the container does not precisely and clearly indicate the nature of the contents or that in any way may deceive a customer as to the nature, composition, quantity, age, or quality of the product.
  14. Packaging of edible medical marijuana products or medical marijuana- infused products shall not bear any:
      1. Resemblance to the trademarked, characteristic or product-specialized packaging of any commercially available candy, snack, baked good or beverage;
      2. Statement, artwork or design that could reasonably mislead any person to believe that the package contains anything other an edible medical marijuana product or medical marijuana- infused products; or
      3. Seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any person to believe that the product has been endorsed, manufactured, or used by any state, county or municipality or any agency thereof.
  15. The Director may prohibit a cultivation center or dispensary from selling any medical marijuana product upon a finding by the Director that the product is deceptively labeled or branded in a manner which is misleading about its content or that contains injurious or adulterated ingredients.
  16. In addition to the other labeling requirements of this section, all edible marijuana products, and marijuana- infused products shall be labeled in accordance with 16 C.F.R. Part 1700 (2016), Poison prevention packaging; 21 C.F.R. Part 101 (2016), Food Labeling, as specified in Section 1102 of the District Food Code Regulations (Title 25-A DCMR).
  17. A dispensary shall submit its labeling to the Mayor for approval and record. The Mayor shall transmit the final dispensary labeling designs to MPD.

Package the marijuana in compliance with the United States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.

Package the marijuana in a receptacle that has a firmly affixed and legible label stating the following information:

  1. The marijuana or low-THC cannabis meets the requirements of sub-subparagraph d.
  2. The name of the medical marijuana treatment center from which the marijuana originates.
  3. The batch number and harvest number from which the marijuana originates and the date dispensed.
  4. The name of the physician who issued the physician certification.
  5. The name of the patient.
  6. The product name, if applicable, and dosage form, including concentration of tetrahydrocannabinol and cannabidiol. The product name may not contain wording commonly associated with products marketed by or to children.
  7. The recommended dose.
  8. A warning that it is illegal to transfer medical marijuana to another person.
  9. A marijuana universal symbol developed by the department.
  10. The medical marijuana treatment center shall include in each package a patient package insert with information on the specific product dispensed related to:
      1. Clinical pharmacology.
      2. Indications and use.
      3. Dosage and administration.
      4. Dosage forms and strengths.
      5. Contraindications.
      6. Warnings and precautions.
      7. Adverse reactions.
  11. In addition to the packaging and labeling requirements specified in subparagraphs 11. and 12., marijuana in a form for smoking must be packaged in a sealed receptacle with a legible and prominent warning to keep away from children and a warning that states marijuana smoke contains carcinogens and may negatively affect health. Such receptacles for marijuana in a form for smoking must be plain, opaque, and white without depictions of the product or images other than the medical marijuana treatment center’s department-approved logo and the marijuana universal symbol.
  12. The department shall adopt rules to regulate the types, appearance, and labeling of marijuana delivery devices dispensed from a medical marijuana treatment center. The rules must require marijuana delivery devices to have an appearance consistent with medical use.
  13. Each edible shall be individually sealed in plain, opaque wrapping marked only with the marijuana universal symbol. Where practical, each edible shall be marked with the marijuana universal symbol. In addition to the packaging and labeling requirements in subparagraphs 11. and 12., edible receptacles must be plain, opaque, and white without depictions of the product or images other than the medical marijuana treatment center’s department-approved logo and the marijuana universal symbol. The receptacle must also include a list of all the edible’s ingredients, storage instructions, an expiration date, a legible and prominent warning to keep away from children and pets, and a warning that the edible has not been produced or inspected pursuant to federal food safety laws.
  1. A production licensee shall submit drafts of the packaging and labeling designs to the Commission for approval prior to using such designs for the product. The Commission hereby delegates the authority and responsibility to review packaging and labeling designs as set forth in Code Section 16-12-203(6), and determine whether such designs shall be approved to the GMCC Executive Director. The licensee shall not use such designs unless they have been approved by the GMCC Executive Director.
  2. A production licensee shall package product in final packaged form on such licensee’s premises. Packaging used to contain product shall:
      1. Protect the product from contamination and shall not expose the product to any toxic or harmful substance;
      2. Be tamper-evident or have tamper-evident features applied to such packaging;
      3. Be opaque;
      4. Not imitate any packaging used for goods that are publicly known to be marketed to minors;
      5. Not include the following so as to attract or market to minors:
          1. Any cartoon, comic drawing, a series of drawings, or animation;
          2. Words such as “candy” or “candies” or any alternative spelling of such words; and3. Depictions of people or animals.
          3. Use only Commission-approved trademarks, logos, or imagery;
          4. Be a child-resistant package; and
          5. Be resealable if the product has more than one (1) dose.
  3. A production licensee shall label product in final packaged form on such licensee’s premises. Labeling used shall be weather resistant, unobstructed, and legible, and include the following:
      1. The name and license number of the production licensee;
      2. The brand name of the product;
      3. The unique identifying manufactured batch number of the product;
      4. The registration number of the independent laboratory who completed the required testing;
      5. The expiration date;
      6. The quantity contained therein;
      7. The weight of the product in grams;
      8. A list of all active ingredients, including:
          1. Tetrahydrocannabinol (THC);
          2. Tetrahydrocannabinol acid (THCA);
          3. Cannabidiol (CBD);
          4. Cannabidiolic acid (CBDA); and
          5. Any other active ingredient that constitutes at least one percent (1%) of the cannabis used in the product.
      9. The American Society for Testing and Materials International Intoxicating Cannabinoid Product Symbol standard (D8441/D8441M) universal symbol, or other symbol requirements for labeling, if designated by the Commission, indicating that products contain intoxicating cannabinoids; and
      10. A statement that the product, in final packaged form, has been tested by an independent laboratory.
  4. Before any product is transported to a dispensary or pharmacy, a production licensee shall package and label such product in accordance with this rule.
  1. Except as provided in subsection (4), every hemp product shall be labeled with the following information displayed prominently and conspicuously, but in no case may the letters or numbers be less than one-sixteenth inch in height:
      1. Product name;
      2. Product net weight;
      3. The total quantity (in milligrams) of the following cannabinoids contained in the packaged hemp product:
          1. Total tetrahydrocannabinol;
          2. Delta-9-tetrahydrocannabinol;
          3. Cannabidiol (CBD); and
          4. Any other cannabinoid specifically listed, described, or advertised in the label or packaging of the hemp product, including but not limited to cannabigerol (CBG) and cannabinol (CBN);
      4. An ingredient statement that meets the requirements of section 11-37-31;
      5. A responsibility statement that meets the requirements of section 11-37-32;
      6. Batch number;
      7. Directions for use;
      8. The statement “Use this product under the guidance of a physician if you have a medical condition or are pregnant or lactating.” or words of similar meaning;
      9. The statement “Keep out of the reach of children. nor words of similar meaning;
      10. The statement “This product has been tested pursuant to chapter 11-37 subchapter 2, Hawaii Administrative Rules.”; and
      11. A QR code or website that displays test results as required by section 11-37-24.
  2. Except as provided in subsection (4), every hemp product intended to be consumed shall be labeled with the following information displayed prominently and conspicuously, but in no case may the letters or numbers be less than one-sixteenth inch in height:
      1. The statement “This product is not intended to diagnose, treat, cure, or prevent any disease.” or words of similar meaning;
      2. The net quantity (in terms of weight, measure, or numerical count) of each serving;
      3. The content (in milligrams) per serving of the following cannabinoids:
          1. Total tetrahydrocannabinol;
          2. Cannabidiol (CBD); and
          3. Any other cannabinoid specifically listed, described, or advertised in the label or packaging of the hemp product, including but not limited to cannabigerol (CBG) and cannabinol (CBN); and
      4. A statement of the major food allergens the product contains or has protein derived from, to include:
          1. Milk;
          2. Egg;
          3. Fish;
          4. Crustacean shellfish;
          5. Tree nuts;
          6. Wheat;
          7. Peanuts; and
          8. Soybeans.

Highly refined oils derived from any of the eight major food allergens and any ingredient derived from such highly refined oils are exempt from this requirement.

3. Every hemp product intended for topical application to the skin or hair shall be labeled with the following information displayed prominently and conspicuously, but in no case may the letters or numbers be less than one-sixteenth inch in height: the statement “For external use only.” or words of similar meaning.

4. Allowed exceptions.

      1. If the container of any hemp product is too small to accommodate a label containing all of the information required by subsection (1) and (2), the information in paragraph (2) (a) may be included on labeling attached to or inserted into the package using a type size no smaller than one-sixteenth inch in height.
      2. In lieu of being included on the product label, the information may be included on labeling attached to or inserted into the package using a type size no smaller than one sixteenth inch in height.

5. All words, statements, and other information required by this section shall be prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use. A word, statement, or other required information may lack that prominence and conspicuousness required by reason (among other reasons) of:

      1. The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;
      2. The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;
      3. The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;
      4. Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by this subchapter to appear on the label;
      5. Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or
      6. Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.
  1. Each cannabis product produced for sale shall be registered with the Department of Agriculture on forms provided by the Department of Agriculture. Each product registration shall include a label and the required registration fee at the rate established by the Department of Agriculture for a comparable medical cannabis product, or as established by rule. The registration fee is for the name of the product offered for sale and one fee shall be sufficient for all package sizes.
  2. All harvested cannabis intended for distribution to a cannabis enterprise must be packaged in a sealed, labeled container.
  3. Any product containing cannabis shall be sold in a sealed, odor-proof, and child-resistant cannabis container consistent with current standards, including the Consumer Product Safety Commission standards referenced by the Poison Prevention Act unless the sale is between or among a craft grower, infuser, or cultivation center.
  4. All cannabis-infused products shall be individually wrapped or packaged at the original point of preparation. The packaging of the cannabis-infused product shall conform to the labeling requirements of the Illinois Food, Drug and Cosmetic Act, in addition to the other requirements set forth in this Section.
  5. Each cannabis product shall be labeled before sale and each label shall be securely affixed to the package and shall state in legible English and any languages required by the Department of Agriculture:
      1. The name and post office box of the registered cultivation center or craft grower where the item was manufactured;
      2. the common or usual name of the item and the registered name of the cannabis product that was registered with the Department of Agriculture under subsection (1);
      3. a unique serial number that will match the product with a cultivation center or craft grower batch and lot number to facilitate any warnings or recalls the Department of Agriculture, cultivation center, or craft grower deems appropriate;
      4. the date of final testing and packaging, if sampled, and the identification of the independent testing laboratory;
      5.  the date of harvest and “use by” date;
      6. the quantity (in ounces or grams) of cannabis
      7. contained in the product;
      8. a pass/fail rating based on the laboratory’s
      9. microbiological, mycotoxins, and pesticide and solvent residue analyses, if sampled;
      10. content list.
          1. A list of the following, including the minimum and maximum percentage content by weight for subdivisions (e)(8)(A)(i) through (iv):
              1. delta-9-tetrahydrocannabinol (THC);
              2. tetrahydrocannabinolic acid (THCA);
              3. cannabidiol (CBD);
              4. cannabidiolic acid (CBDA); and
              5. all other ingredients of the item, including any colors, artificial flavors, and preservatives, listed in descending order by predominance of weight shown with common or usual names.
          2. The acceptable tolerances for the minimum percentage printed on the label for any of subdivisions (e)(8)(A)(i) through (iv) shall not be below 85% or above 115% of the labeled amount.
  6. Packaging must not contain information that:
      1. is false or misleading;
      2. promotes excessive consumption;
      3. depicts a person under 21 years of age consuming cannabis;
      4. includes the image of a cannabis leaf;
      5. includes any image designed or likely to appeal to minors, including cartoons, toys, animals, or children, or any other likeness to images, characters, or phrases that are popularly used to advertise to children, or any packaging or labeling that bears reasonable resemblance to any product available for consumption as a commercially available candy, or that promotes consumption of cannabis;
      6. contains any seal, flag, crest, coat of arms, or other insignia likely to mislead the purchaser to believe that the product has been endorsed, made, or used by the State of Illinois or any of its representatives except where authorized by this Act.
  7. Cannabis products produced by concentrating or extracting ingredients from the cannabis plant shall contain the following information, where applicable:
      1. If solvents were used to create the concentrate or extract, a statement that discloses the type of extraction method, including any solvents or gases used to create the concentrate or extract; and
      2. Any other chemicals or compounds used to produce or were added to the concentrate or extract.
  8. All cannabis products must contain warning statements established for purchasers, of a size that is legible and readily visible to a consumer inspecting a package, which may not be covered or obscured in any way. The Department of Public Health shall define and update appropriate health warnings for packages including specific labeling or warning requirements for specific cannabis products.
  9. Unless modified by rule to strengthen or respond to new evidence and science, the following warnings shall apply to all cannabis products unless modified by rule: “This product contains cannabis and is intended for use by adults 21 and over. Its use can impair cognition and may be habit forming. This product should not be used by pregnant or breastfeeding women. It is unlawful to sell or provide this item to any individual, and it may not be transported outside the State of Illinois. It is illegal to operate a motor vehicle while under the influence of cannabis. Possession or use of this product may carry significant legal penalties in some jurisdictions and under federal law.”
      1. Warnings for each of the following product types must be present on labels when offered for sale to a purchaser:
          1. Cannabis that may be smoked must contain a statement that “Smoking is hazardous to your health.”
          2. Cannabis-infused products (other than those intended for topical application) must contain a statement “CAUTION: This product contains cannabis, and intoxication following use may be delayed 2 or more hours. This product was produced in a facility that cultivates cannabis, and that may also process common food allergens.”
          3. Cannabis-infused products intended for topical application must contain a statement “DO NOT EAT” in bold, capital letters.
  10. Each cannabis-infused product intended for consumption must be individually packaged, must include the total milligram content of THC and CBD, and may not include more than a total of 100 milligrams of THC per package. A package may contain multiple servings of 10 milligrams of THC, indicated by scoring, wrapping, or by other indicators designating individual serving sizes. The Department of Agriculture may change the total amount of THC allowed for each package, or the total amount of THC allowed for each serving size, by rule.
  11. No individual other than the purchaser may alter or destroy any labeling affixed to the primary packaging of cannabis or cannabis-infused products.
  12. For each commercial weighing and measuring device used at a facility, the cultivation center or craft grower must:
      1. Ensure that the commercial device is licensed under the Weights and Measures Act and the associated administrative rules (8 Ill. Adm. Code 600);
      2. Maintain documentation of the licensure of the commercial device; and
      3. Provide a copy of the license of the commercial device to the Department of Agriculture for review upon request.
  13. It is the responsibility of the Department to ensure that packaging and labeling requirements, including product warnings, are enforced at all times for products provided to purchasers. Product registration requirements and container requirements may be modified by rule by the Department of Agriculture.
  14. Labeling, including warning labels, may be modified by rule by the Department of Agriculture.
  1. A manufacturer shall ensure that all medical cannabidiol packaging is labeled with the following information:
      1. The name and address of the manufacturer where the medical cannabidiol was manufactured;
      2. The medical cannabidiol’s primary active ingredients, including levels of tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, and cannabidiol acid;
      3. Directions for use of the product, including recommended and maximum amount by age and weight, if applicable;
      4. All ingredients of the product shown with common or usual names, including any colors, artificial flavors, and preservatives, listed in descending order by predominance of weight;
      5. Instructions for storage, including light and temperature requirements, if any;
      6. Date of expiration;
      7. The date of manufacture and lot number;
      8. A notice with the statement, including capitalization: “This product has not been analyzed or approved by the United States Food and Drug Administration. There is limited information on the side effects of using this product, and there may be associated health risks and medication interactions. This product is not recommended for use by pregnant or breastfeeding women. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.”;
      9. The universal warning symbol provided by the department; and
      10. A notice with the statement: “This medical cannabidiol is for therapeutic use only. Use of this product by a person other than the patient listed on the label is unlawful and may result in the cancellation of the patient’s medical cannabidiol registration card. Return unused medical cannabidiol to a dispensary for disposal.”
  2. Labeling text shall not include any false or misleading statements. 
  3. A package may contain multiple labels if the information required by this rule is not obstructed.
  4. Labeling text font size shall be no smaller than 6 point.
  1. Packaging and labeling of any medicinal cannabis or medicinal cannabis product shall not bear:
      1. Any resemblance to the trademarked, characteristic, or product-specialized packaging of any commercially available food or beverage product and not be visually reminiscent of major brands of edible noncannabis products;
      2. Any statement, artwork, or design that could reasonably lead an individual to believe that the package contains anything other than medicinal cannabis;
      3. The logo of the cabinet or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured, or approved for use by any state, county, or municipality or any agency thereof; and
      4. Any cartoon, image, graphic, or feature that may make the package attractive to children or minors.
  2. A cannabis business shall package and label at its facility each form of medicinal cannabis prepared for sale to cardholders. The original seal of a package may not be broken, except:
      1. For testing at a safety compliance facility;
      2. By a dispensary for the purpose of displaying product examples for the benefit of cardholders; or
      3. As needed by the cabinet or its authorized agents as part of an inspection or investigation.

 

Section 2. Packaging of Medicinal Cannabis for Sale to Cardholders.

  1. Pursuant to KRS 218B.140(1)(c)(13), a cannabis business shall comply with 15 U.S.C. secs. 1471 to 1476 when packaging and labeling medicinal cannabis and medicinal cannabis products for sale to cardholders.
  2. When packaging medicinal cannabis and medicinal cannabis products for sale to cardholders, a cannabis business shall ensure each product package:
      1. Is child-resistant and requires at least a two (2) step process of initial opening;
      2. Has a tamper-evident seal;
      3. Minimizes exposure to oxygen;
      4. Contains the following warnings:
          1. The typical length of time for the medicinal cannabis to take effect;
          2. The statements “For medicinal use by cardholders only. KEEP OUT OF REACH OF CHILDREN”; and
          3. For raw plant material packaged for sale to a cardholder, the statement “NOT INTENDED FOR CONSUMPTION BY SMOKING”;
      5. Discloses the strain of medicinal cannabis, form of medicinal cannabis, and standard amount of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) in the medicinal cannabis, including:
          1. If the medicinal cannabis product is intended for oral consumption as an edible, oil, or tincture, potency shall be stated as milligrams per serving for total THC and total CBD, as applicable, and milligrams per package for total THC and total CBD, as applicable; and
          2. For concentrates, total THC and total CBD, as applicable, shall be stated in percentages;
      6. Discloses the amount of medicinal cannabis the product is considered the equivalent to, if applicable;
      7. Discloses any possible allergens;
      8. Is light-resistant and opaque;
      9. Clearly and conspicuously displays the standardized symbol in navy blue provided in Appendix A, which is incorporated by reference, indicating that a product contains medicinal cannabis;
      10. Is resealable, if applicable;
      11. Contains the name, address, and license number of the cannabis business packaging the medicinal cannabis;
      12. Protects the medicinal cannabis from contamination;
      13. Does not impart any toxic or deleterious substance to the medicinal cannabis; and
      14. Provides the telephone number for the National Poison Control Center.

 

Section 3. Labeling of Medicinal Cannabis for Sale to Cardholders.

  1. Medicinal cannabis and medicinal cannabis products prepared for sale to cardholders shall include a label that is firmly affixed to the packaging holding medicinal cannabis or firmly affixed to any outer packaging if used.
  2. The label required by this section may contain a quick response (QR) code that links to some or all of the information required under this section. The QR code shall be:
      1. Labeled as “Specific Product Information” directly above or below the QR code; and
      2. Large enough to be smart-phone readable.
  3. The label required by this section shall:
      1. Be made of weather-resistant and tamper-resistant materials;
      2. Be legible;
      3. List the strain, form, and net weight of the medicinal cannabis included in the package;
      4. List any ingredients;
      5. List the specific amount of THC and CBD in the medicinal cannabis included in the package as stated on the certificate of analysis for the medicinal cannabis’s harvest batch or production batch. The specific amount of THC and CBD may be expressed in milligrams or by percentage, as applicable;
      6. List the percentage of total terpenes and the three (3) most prevalent terpenes expressed in the medicinal cannabis, as applicable;
      7. Provide the name and license number of the cannabis business that cultivated the medicinal cannabis;
      8. Provide the name and license number of the cannabis business that processed the medicinal cannabis, if applicable;
      9. Provide the identifier that is unique to the particular harvest batch or production batch of medicinal cannabis in the package;
      10. List the date the medicinal cannabis was harvested or processed;
      11. List the date the medicinal cannabis was packaged;
      12. List the name and license number of the safety compliance facility that tested the medicinal cannabis and the date the medicinal cannabis was tested;
      13. List the expiration date of the medicinal cannabis; and
      14. If the medicinal cannabis product is intended for oral consumption as an edible, oil, or tincture, provide a nutritional fact panel, the number of individual servings contained within the package, and the amount of THC per serving, which shall not exceed ten (10) milligrams per serving.

 

Section 4. Packaging and Labeling Requirements for Sale or Transfer of Medicinal Cannabis Between Cannabis Businesses.

  1. All medicinal cannabis sold or otherwise transferred between cannabis businesses for the purpose of processing or packaging and labeling for retail sale to cardholders shall:
      1. Regarding packaging:
          1. Fully enclose the medicinal cannabis so that it cannot be seen from outside the packaging;
          2. Protect the medicinal cannabis from contamination; and
          3. Not impart any toxic or deleterious substance to the medicinal cannabis.
      2. A label shall be firmly affixed to the packaging holding medicinal cannabis or firmly affixed to outer packaging if used that, at a minimum, contains the following information:
          1. Name, address, phone number, and license number of the cannabis business that is selling or otherwise transferring the medicinal cannabis to another cannabis business;
          2. Name, address, phone number, and license number of the cannabis business receiving the medicinal cannabis;
          3. The type and amount of medicinal cannabis in the package;
          4. An identifier that is unique to the particular harvest batch or production batch of medicinal cannabis in the package;
          5. The date the medicinal cannabis was harvested and, if applicable, processed;
          6. The date the medicinal cannabis was packaged; and
          7. A statement confirming that the medicinal cannabis in the package has been tested, and:
            1. Affix a QR code to the label that directs the purchaser to the certificate of analysis for the medicinal cannabis harvest batch or production batch contained in the package; or
            2. Provide a hardcopy or electronic copy of the certificate of analysis for the medicinal cannabis harvest batch or production batch contained in the package to the purchaser at the time of sale.
  2. Any sale or transfer of medicinal cannabis between cannabis businesses shall be documented in the Commonwealth’s designated electronic monitoring system and seed to sale tracking system.
  1. Labels must include:
      1. Statement of Identity:
          1. In the case of consumable hemp, “cannabidiol” is not sufficient as a descriptor. If the product is an extract, isolate, or tincture, the Statement of Identity should reflect that.
          2. This clear, distinct statement of the product should appear on the part of the label most likely to be observed by a consumer when the product is sitting on a shelf
      2. Net quantity of contents:
          1. Fluid items should bear a net quantity expressed in terms of volumetric or fluid measure (e.g., fl. oz. and ml) while semisolid or solid items should bear a net quantity statement expressed in terms of weight measure (e.g., grams [g] and ounces [oz.]
          2. Statements should include terms in U.S. AND metric systems
          3. For solid or viscous products, this statement must be preceded by a declaration of “Net”, “net wt.” or “net weight”. This statement is optional for fluid products.
      3. List of ingredients:
          1. Ingredients must be listed in descending weight order; the ingredient you used the most of should appear first in the list, with each following ingredient being the next-most used ingredient until the final ingredient: the ingredient you used the least of
          2. Flavorants need to be listed as artificial, natural, or both
          3. Cannabinoids and phytocannabinoids are insufficient descriptors – specify whether this is an extract/isolate/distillate
          4. Terpenes must be listed individually
      4. Responsible party declaration:
          1. Names/address of manufacturer/distributor
            1. Full street address needed unless the address is listed in a local telephone directory
            2. The zip code is mandatory
          2. The firm name must match the entity name that is registered with the Secretary of State
          3. If your firm changes addresses, you must update your firm’s information on the portal
          4. For firms other than proprietorships, the firm’s full name must be used as the responsible party name. This must be preceded by “Manufactured for” or “Distributed by” if any product is manufactured by another firm than the registrant.
      5. Allergens:
          1. The specific allergen must be named (tree nut allergen will not suffice: please list almond allergen if the product contains almonds) (fish allergen will not suffice: please list flounder if the product contains flounder)
          2. All allergens must be named. If dairy and peanuts are used in the ingredients, the firm must list both in an allergen statement.
      6. Nutrition facts
          1. Only FDA approved nutrients may be listed in the panel. Cannabinoids are not nutrients and should not be listed in the panel
          2. The panel must be separate from the ingredients list
      7. QR code or website URL:
          1. Certificate of Analysis must be directly provided through the URL or the QR code; the QR code or URL may not link to a google drive (or other file displaying program) containing the file
          2. If the URL/QR code takes you to a firm’s website, the COA must be placed so that it is easily seen on the website
      8. Serving Size
          1. If the product contains THC, a statement with the amount of THC per serving is required
          2. A unique UPC code/SKU
          3. Any adult-use consumable hemp product (any consumable hemp product that contains more than 0.5 milligrams of total THC per package) must be identified as such on the label
  2. Labels may not include:
      1. Medical claims
          1. Medical claims include, but are not limited to: “for sleep”, “melatonin”, “for digestion”, “for digestive purposes”, “cure”, “treat”, “heal”, “cancer”, “relieve”, “pain”, “ache”
      2. Any claim that suggests the product is a “dietary supplement”
  1. Labeling requirements.  Adult use cannabis and adult use cannabis products to be sold or offered for sale by a licensee to a consumer in accordance with this chapter must be labeled with the following information, as applicable based on the cannabis or cannabis product to be sold: 
      1. The license numbers of the cultivation facility, the products manufacturing facility and the cannabis store where the adult use cannabis or adult use cannabis product was cultivated, manufactured and offered for sale;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      2. An identity statement and universal symbol;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      3. Health and safety warning labels as required by rules adopted by the department after consultation with the Department of Health and Human Services, Maine Center for Disease Control and Prevention;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      4. The batch number;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      5. A net weight statement;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      6. Information on the THC potency of the cannabis or cannabis product and the potency of such other cannabinoids or other chemicals in the cannabis or cannabis product, including, but not limited to, cannabidiol. For edible cannabis products, the information required pursuant to this paragraph must be consistent with section 703, subsection 1, paragraphs F and F‑1;   [PL 2021, c. 558, §2 (AMD); PL 2021, c. 669, §5 (REV).]
      7. Information on the amount of THC and cannabidiol per serving of the cannabis or cannabis product. For edible cannabis products, the information required pursuant to this paragraph must be consistent with section 703, subsection 1, paragraphs F and F‑1 and contain the number of servings per package;   [PL 2021, c. 558, §3 (AMD); PL 2021, c. 669, §5 (REV).]
      8. Information on gases, solvents and chemicals used in cannabis extraction;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      9. Instructions on usage;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      10. For adult use cannabis products:  
          1. The amount of cannabis concentrate per serving of the product, as measured in grams, and the amount of cannabis concentrate per package of the product, as measured in grams;  
          2. A list of ingredients and possible allergens; and  
          3. A recommended use date or expiration date;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      11. For edible cannabis products, a nutritional fact panel; and   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      12. Any other information required by rule by the department.   [PL 2017, c. 409, Pt. A, §6 (NEW).]

[PL 2021, c. 558, §§2, 3 (AMD); PL 2021, c. 669, §5 (REV).]

2. Packaging requirements.  Adult use cannabis and adult use cannabis products to be sold or offered for sale by a licensee to a consumer in accordance with this chapter must be packaged in the following manner, as applicable based on the cannabis or cannabis product to be sold:  

      1. Adult use cannabis and adult use cannabis products must be prepackaged in child-resistant and tamper-evident packaging or must be placed in child-resistant and tamper-evident packaging at the final point of sale to a consumer;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      2. Adult use cannabis and adult use cannabis products must be prepackaged in opaque packaging or an opaque container or must be placed in opaque packaging or an opaque container at the final point of sale to a consumer;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      3. Packaging for multiserving liquid adult use cannabis products must include an integral measurement component and a child-resistant cap; and   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      4. Packaging must conform to all other applicable requirements and restrictions imposed by rule by the department.   [PL 2017, c. 409, Pt. A, §6 (NEW).]

[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]

3. Other approved labeling and packaging.  Adult use cannabis and adult use cannabis products to be sold or offered for sale by a licensee to a consumer in accordance with this chapter may include on the label or the packaging of the cannabis or cannabis product:  

      1. A statement of compatibility with dietary practices;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      2. Depictions of geometric shapes or cannabis leaves;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      3. Use of the terms “organic,” “organically cultivated” or “organically grown” in accordance with requirements regarding the use of such terms as adopted by rule by the department; and   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      4. Any other information that has been preapproved by the department.   [PL 2017, c. 409, Pt. A, §6 (NEW).]

[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]

4. Labeling and packaging prohibitions.  Adult use cannabis and adult use cannabis products to be sold or offered for sale by a licensee to a consumer in accordance with this chapter:  

      1. May not be labeled or packaged in violation of a federal trademark law or regulation or in a manner that would cause a reasonable consumer confusion as to whether the cannabis or cannabis product was a trademarked product;   [PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
      2. May not be labeled or packaged in a manner that is specifically designed to appeal particularly to a person under 21 years of age;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      3. May not be labeled or packaged in a manner that obscures identifying information on the label or uses a false or deceptive label;   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      4. May not be sold or offered for sale using a label or packaging that depicts a human, animal or fruit; and   [PL 2017, c. 409, Pt. A, §6 (NEW).]
      5. May not be labeled or packaged in violation of any other labeling or packaging requirement or restriction imposed by rule by the department.   [PL 2017, c. 409, Pt. A, §6 (NEW).]
  1. Packaging Requirements:
      1. The Massachusetts Cannabis Control Commission (CCC) requires that all cannabis products be sold in child-resistant packaging. This means that the packaging must be designed or constructed to be significantly difficult for children under five years old to open within a reasonable time and not difficult for normal adults to use properly. Additionally, packaging must be opaque or translucent so that the contents cannot be seen from outside the packaging. 
  2. Labeling Requirements:
      1. Name and Address: The name and address of the registered marijuana dispensary (RMD) or manufacturer must be listed on the label.
      2. Net Weight: The net weight of the product in the container must be listed on the label.
      3. THC and CBD Content: The total amount of THC and CBD contained in the product must be listed on the label. For edible products, the label must also include the amount of THC and CBD per serving.
      4. Date of Harvest: The date of harvest, or manufacture, of the cannabis used to produce the product must be listed on the label.
      5. Testing Results: The label must include information on the testing results of the product, including the date of the test and the name of the testing facility.
      6. Ingredients: A list of ingredients used to make the product must be included on the label.
      7. Serving Size: For edible products, the serving size must be listed on the label.
      8. Warning Labels: All cannabis products must include a warning label stating that the product contains THC and may have psychoactive effects. Additionally, products that contain more than 5 milligrams of THC must include a warning label that states the product may cause impairment and that consumers should not operate machinery or drive after consuming the product.
  1. Before a marihuana product is sold or transferred to or by a marihuana sales location, the container, bag, or product holding the marihuana product must be sealed and labeled with all of the following information:
      1. The name and the state license number of the cultivator or producer, including business or trade name, and package tag as assigned by the statewide monitoring system.
      2. The name and the marihuana license number of the licensee that packaged the product, including business or trade name, if different from the producer of the marihuana product.
      3. Date of harvest, if applicable.
      4. Name of strain, if applicable.
      5. Net weight in United States customary or metric units.
      6. Concentration of Tetrahydrocannabinol (THC) and cannabidiol (CBD) as reported by the laboratory after potency testing along with a statement that the actual value may vary from the reported value by 10%.
      7. Activation time expressed in words or through a pictogram.
      8. Name of the laboratory that performed passing compliance testing on the product in final form and any test analysis date.
      9. The universal symbol for marihuana product published on the agency’s website.
      10. A warning that includes all the following statements:
          1. “It is illegal to drive a motor vehicle while under the influence of marihuana.”
          2. “National Poison Control Center 1-800-222-1222.”
          3. For products being sold by a marihuana facility that exceed the maximum THC levels allowed for products sold under MRTMA, “For use by registered qualifying patients only. Keep out of reach of children.”
          4. For all other products, “For use by individuals 21 years of age or older or registered qualifying patients only. Keep out of reach of children.”
          5. In clearly legible type and surrounded by a continuous heavy line: “WARNING: USE BY PREGNANT OR BREASTFEEDING WOMEN, OR BY WOMEN PLANNING TO BECOME PREGNANT, MAY RESULT IN FETAL INJURY, PRETERM BIRTH, LOW BIRTH WEIGHT, OR DEVELOPMENTAL PROBLEMS FOR THE CHILD.”
  2. An edible marihuana product sold by a marihuana sales location must comply with R 420.403(7) to (10).
  3. An infused marihuana product sold by a marihuana sales location must comply with R 420.403(7).
  4. A marihuana sales location must make available to every customer at the time of sale a pamphlet measuring at least 3.5 inches by 5 inches, that includes, at minimum, the statement “National Poison Control Center Hotline 1-800-222-1222,” and at least two of the following statements:
      1. Marijuana use during adolescence may affect the developing brain negatively by impairing thinking and problem solving.
      2. Marijuana use during adolescence may affect the developing brain negatively by impairing memory and learning.
      3. Marijuana use during adolescence may affect the developing brain negatively by impairing coordination.
      4. Marijuana use during adolescence may affect the developing brain negatively by impairing ability to maintain attention.
      5. Marijuana use during adolescence may impact performance in school.
      6. Marijuana use during adolescence may impact the risk of mental health issues.
      7. Marijuana use during adolescence may impact driving abilities.
      8. Marijuana use during adolescence may impact the potential for addiction.
      9. Any other statement as approved by the agency and published on the agency’s website.
  1. General.
      1. All cannabis flower, cannabis products, lower-potency hemp edibles, and hemp-derived consumer products sold to customers or patients must be packaged as required by this section and rules adopted under this chapter.
  2. Packaging requirements.
      1. Except as provided in paragraph (b), all cannabis flower, cannabis products, lower-potency hemp edibles, and hemp-derived consumer products sold to customers or patients must be:
          1. prepackaged in packaging or a container that is child-resistant, tamper-evident, and opaque; or
          2. placed in packaging or a container that is plain, child-resistant, tamper-evident, and opaque at the final point of sale to a customer.
      2. The requirement that packaging be child-resistant does not apply to a lower-potency hemp edible that is intended to be consumed as a beverage.
      3. If a cannabis product, lower-potency hemp edible, or a hemp-derived consumer product is packaged in a manner that includes more than a single serving, each serving must be indicated by scoring, wrapping, or other indicators designating the individual serving size. If the item is a lower-potency hemp edible, serving indicators must meet the requirements of section 342.46, subdivision 6, paragraph (b).
      4. Edible cannabis products and lower-potency hemp edibles containing more than a single serving must be prepackaged or placed at the final point of sale in packaging or a container that is resealable.
  3. Packaging prohibitions.
      1. Cannabis flower, cannabis products, lower-potency hemp edibles, or hemp-derived consumer products sold to customers or patients must not be packaged in a manner that:
          1. bears a reasonable resemblance to any commercially available product that does not contain cannabinoids, whether the manufacturer of the product holds a registered trademark or has registered the trade dress; or
          2. is designed to appeal to persons under 21 years of age.
      2. Packaging for cannabis flower, cannabis products, lower-potency hemp edibles, and hemp-derived consumer products must not contain or be coated with any perfluoroalkyl substance.
      3. Edible cannabis products and lower-potency hemp edibles must not be packaged in a material that is not approved by the United States Food and Drug Administration for use in packaging food.

The following packaging requirements apply to all usable medical cannabis (retail-ready) being transferred to or sold to a medical cannabis dispensary for sale to a qualified patient and/or caregiver. Packaging and labeling, meeting the following requirements, must be in place when transferred or sold to a medical cannabis dispensary:

  • Labels, packages, and containers shall not be attractive to minors and shall not contain any content that reasonably appears to target children, including toys, cartoon characters, or any color scheme, image, graphic, or feature that might reasonably be expected to make the product label, package, or container appealing to children.
  • Packages should be designed to minimize appeal to children and shall not depict images other than the business name and log of the medical cannabis establishment.
  • Packaging must contain a label that reads: “Keep out of reach of children.”
  • All usable medical cannabis and cannabis products must be packaged in child-resistant containers at the point of sale or other transfer o a patient, a patient’s parent, or legal guardian if patient is a minor, or a caregiver.
  • Packages and labels shall not contain product names related to candy or candies (or any spellings thereof e.g., kandy, kandies, etc.)
  • No cannabis and/or cannabis products shall be intentionally or knowingly packaged or labeled to cause a reasonable patient confusion as to whether the medical cannabis or medical cannabis product is a trademarked product or any commercially available candy, snack, baked good or beverage.
  • Packages and labels shall not make any claims or statements that the medical cannabis or medical cannabis products provide health or physical benefits of the patient. Must not contain the log of the Department or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any person to believe the product has been endorsed, manufactured, or used by any state, county, or municipality or any agency thereof.
  • Cannabis products that have a potency of over thirty percent (30%) total THC must be labeled as “extremely potent.”
  • Edible cannabis products must be labeled with a clear determination of how much total THC is in a single serving size and how much THC is in the entire package. The single serving size must also be included on the label.
  • Usable medical cannabis must include the following on the label:
    • Name of the cannabis and/or cannabis product.
    • Batch number of the cannabis and/or cannabis product.
    • Unique identifier number created by the seed of sale system.
    • Net quantity or weight of contents.
    • The length of time it typically takes for the product to take effect.
    • Disclosure of ingredients and possible allergens.
    • A nutritional fact panel.
    • The total amount of THC and CBD in the product as verified by the cannabis testing facility.
    • Terpenoid profile in the product as verified by the cannabis testing facility.
    • A notice of the potential harm caused by consuming medical cannabis; and,
    • For edible cannabis products, when practicable, a standard symbol indicating the product contains cannabis.

All medical marijuana and marijuana-infused products must abide by the following packaging and labeling requirements outlined by the Missouri medical marijuana rules and law.

  1. Clearly and conspicuously labeled with “Marijuana” or “Marijuana-infused Product” in a font size at least as large as the largest other font size used on the package.
      1. “Marijuana” or “Marijuana-infused Product” is required to be the largest text on the packaging regardless of font point size or font type.
      2. A facility’s logo, branding or any other logo or artwork on the package must also comply.  Any words, letters or characters contained within the logos or artwork will be subject to this rule.
      3. Package operating instructions that are part of the package itself may be exempt from font size requirements. Licensees should contact the Department to inquire about such circumstances.
      4. The terms “Marijuana” or “Marijuana-infused Product” must be exact on the package – for example, replacing the term “Product” with the product type (i.e., gummies, cookies, etc.) is not allowed per 19 CSR 30-95.040(4)(K)2.A.  
  2. Contain the following warning statement in a font no smaller than seven (7-) point type:
      1. “Warning: Cognitive and physical impairment may result from the use of Marijuana.”  
  3. At all times, be tagged with traceability information generated by the statewide track and trace system.  
  4. Packaged in opaque, re-sealable packaging designed or constructed to be significantly difficult for children under five (5) years of age to open, but not normally difficult for adults to use properly.
      1. Products not packaged for retail sale before delivery to a dispensary must be compliantly packaged by the dispensary upon sale to a qualifying patient or primary caregiver.  As long as the series of containers/packages (glass jar, box, etc.) covers all areas of the rule, the facility is in compliance.  
          1. Example: the package is compliant if the medical marijuana product is in a clear glass jar with a label, that is placed in an opaque box or opaque re-sealable bag, where one of these containers/packages is also child resistant.
      2. All edible marijuana-infused products must be packaged for retail by the infused products manufacturer before transfer to a dispensary.  
  5. Marijuana and marijuana-infused products must include a label displaying the following information, in the following order:
      1. Total weight of the marijuana included in the package.  
          1. For dried, unprocessed marijuana, weight must be listed in ounces or grams;  
          2. For concentrates, weight must be listed in grams; and   
          3. For infused products, weight must be listed by milligrams of THC.
      2. Dosage amounts, instructions for use, and estimated length of time the dosage will have an effect.
          1. The THC (tetrahydrocannabinol), tetrahydrocannabinol acid, cannabidiol, cannabidiol acid, and cannabinol concentration per dosage.
          2. All active and inactive ingredients, which must not include groupings of ingredients that obscure the actual ingredients, such as “proprietary blend” or “spices”.
          3. In the case of dried, unprocessed marijuana, the legal name, as recorded with the Missouri Secretary of State’s Office and verified by the Department, of the cultivation facility from which the marijuana in the package originated.
          4. In the case of infused products, the legal name, as recorded with the Missouri Secretary of State’s Office and verified by the Department, of the infused product manufacturer from which the product originated.
          5. A “best if used by” date.  
  6. Each package, or packages with or within a package, containing an edible marijuana-infused product with ten or more milligrams of THC, must be stamped with a universal symbol for such products, which must consist of the following:
      1. A diamond containing the letters “THC”;
      2. The letter “M” located under the “THC” within the diamond, to signify the product is for medical use; and
      3. The number of milligrams of THC in the package.
      4. The symbol must be placed on the front of the package in red and white print and must measure one-half inch by one-half inch from point to point.
      5. Example of acceptable symbol:
      6. The intended or approximate milligram amount may be listed with the universal THC symbol.  Facilities may utilize stickers on retail packaging to satisfy this requirement.   
          1. Example: A process lot of brownies bites was formulated for 10 mg of THC per serving/dose and tested at 9.53mg per serving/dose.  There are 10 servings/doses of brownie bites per container, and the total milligrams for the entire package is 95.3mg.  A facility’s packaging would be compliant if the sticker states a rounded amount of 100mg for the entire package.
      7. If an approximate milligram amount is displayed on the package’s primary display panel, the facility must ensure only a reasonable deviation exists between the approximate amount of THC and the final tested amount.   
          1. A reasonable deviation would include an amount of less than 10% above or below the amount listed on the panel.
      8. Advertising used for products may also state an approximate milligram value.  

For additional guidance on packaging and labeling, please reach out to your Compliance Officer or send an email to Complianceinspections@health.mo.gov. 

  1. Labeling requirements apply to marijuana and marijuana products sold from a dispensary to customers. A licensee that sells marijuana or marijuana products to other licensees is not required to comply with labeling requirements.  
  2. All information required on the label of marijuana or a marijuana product shall be:
      1. unobstructed and conspicuous. A licensee may affix multiple labels to a package, or use a booklet, accordion, or other type of label, provided that no required information is completely and permanently obstructed;
      2. displayed in a legible font, such as Times New Roman, Arial, or Helvetica. The lowercase letter “o” must be at least one-sixteenth of an inch in height;
      3. displayed in a color that contrasts conspicuously with the background; and
      4. displayed in English, although a licensee may choose to display required information in additional languages.
  3. All marijuana or marijuana products shall be labeled with the following information:
      1. strain name;
      2. the common or usual name of the marijuana product (e.g., flower, inhaled extract, edible, cookie, or drinkable, topical, transdermal patch);
      3. the name of the marijuana dispensary that sold the product and the license number or numbers of the cultivator and manufacturer, as applicable; 
      4. the unique identification number generated from the seed-to-sale tracking system;
      5. date of harvest for marijuana flower or date of manufacture for marijuana products;
      6. the net quantity of contents of the marijuana product. The statement of quantity shall be:
          1. stated in U.S. Customary Units and Metric (SI) Units, with the latter enclosed in parentheses;
          2. if the product is a liquid:
            1. expressed in terms of fluid measure; and
            2. preceded by the phrase “Net Contents” or “Net”; or
          3. if the product is a solid, semi-solid, or viscous:
            1. expressed in terms of weight; and
            2. preceded by the phrase “Net Weight,” the abbreviation “Nt. Wt.,” or “Net.”
          4. In addition to weight or fluid measure, a licensee shall include the number of servings in the net quantity of contents statement if the product is a multi-serving marijuana product (e.g., Net Weight: 2 oz. (56.7 g) (10 cookies)); 
      7. the following statement: “This product has been tested and meets the requirements of the state of Montana.”
      8. a QR code that links to the product’s certificate of analysis with a statement informing customers they can scan the code to see additional product information;
          1. the universal symbol, available from the department’s website. The universal symbol:
            1. shall be at least .33 inches wide and .33 inches high;
            2. may be downloaded from the department’s website; and
            3. shall be in the following form:

 

cannabis packaging 

  1. All marijuana and marijuana products shall be labeled with the following warnings:
      1. “Keep out of reach of children and pets”;
      2. “This product may be addictive”; and
      3. “This product may have intoxicating effects. Do not drive while under the influence of marijuana.”

5. Marijuana or marijuana product labeling shall not contain any statement or information that is false or misleading.

6. The label of manufactured marijuana products must identify the method of manufacturing (e.g., mechanical, chemical) and for chemical manufacturing must identify the solvent used in the manufacturing process.

7. Marijuana or marijuana products that, because of their size, do not have sufficient space for all of the information required for compliance with the Act and department rules may, if approved by the department pursuant to 16-12-208, MCA, display the information required in (3) in a legible font that does not meet the minimum size requirement established in (2)(b).

8. Marijuana or marijuana products in excess of the THC limits in 16-12-224, MCA, may only be sold to registered cardholders and must contain the following additional information:

          1. “For medical use only”; and
          2. “This product is not approved by the U.S. Food and Drug Administration to treat, cure, or prevent any disease.”

9. Marijuana or marijuana products that do not require heat to administer or consume shall not have a total THC or total potential psychoactive THC value listed on the marijuana facts panel.

12.010 Requirements for single packages.  

 

  1. Unless preparing bulk packages only for delivery to another cannabis establishment and not for sale to a consumer, a cannabis establishment that packages cannabis or cannabis products must individually package, label and seal the cannabis or cannabis products in a single package for sale. A cannabis sales facility shall only sell cannabis or cannabis products in a single package which must not contain:
      1. More than 1 ounce (28.35 grams) of usable cannabis.
      2. For a cannabis product sold as a capsule, more than 100 milligrams of THC per capsule or more than 800 milligrams of THC per package.
      3. For a cannabis product sold as a tincture, more than 800 milligrams of THC.
      4. For a cannabis product sold as an edible cannabis product, more than 100 milligrams of THC.
      5. For a cannabis product sold as a topical product, a concentration of more than 6 percent THC or more than 800 milligrams of THC per package.
      6. For a cannabis product sold as a suppository or transdermal patch, more than 100 milligrams of THC per suppository or transdermal patch or more than 800 milligrams of THC per package.
      7. For any other cannabis product, more than 800 milligrams of THC.
  2. An edible cannabis product must be packaged in a manner which indicates the number of servings of THC in the product, measured in servings of a maximum of 10 milligrams of THC per serving, and include a statement that the edible cannabis product contains cannabis and its potency was tested with an allowable variance of plus or minus 15 percent of the allowable limit.
  3. For cannabis or cannabis products that are intended to be sold to a consumer, the text used on all labeling must be printed in at least 8-point font and may not be in italics.

 

12.015 Requirements for edible cannabis products, products in solid or liquid form, usable cannabis and concentrated cannabis or cannabis products.  

 

  1. Any edible product containing cannabis must:
      1. Be clearly and unambiguously packaged as cannabis with the words “THIS IS A CANNABIS PRODUCT” in bold type that clearly identifies that the product contains cannabis;
      2. Be packaged in a manner which is not modeled after a brand of products primarily consumed by or marketed to children;
      3. Be presented in packaging which does not contain an image of a cartoon character, mascot, action figure, balloon or toy, except that such an item may appear in the logo of the cannabis product manufacturing facility which produced the product; and
      4. Not be packaged or marketed as candy.
  2. When sold at a cannabis sales facility, any cannabis or cannabis product must be packaged in opaque, child-resistant packaging in accordance with 16 C.F.R. Part 1700 and the standards specified in subsection 3 or 4. The child-resistant packaging must maintain its effectiveness for multiple openings before leaving the cannabis sales facility with the consumer.
  3. Except as otherwise provided in subsection 4, cannabis products in solid or liquid form must be packaged in:
      1. Plastic which is 4 mils or more in thickness; or
      2. If the product is in liquid form, a food-grade container.
  4. Edible Cannabis products in liquid form containing more than 10 milligrams THC must be packaged using a resealable cap in a container that:
      1.  Clearly demarks each serving of cannabis in a way that enables a reasonable person to intuitively determine how much of the product constitutes a single serving of THC; and
      2. Includes a device that allows a reasonable person to intuitively measure and serve a single serving of THC. → The portion of such a container that demarks each serving of cannabis need not be opaque.
  5. Any container or packaging containing usable cannabis, concentrated cannabis or cannabis products must protect the contents from contamination and must be of a food grade material. 
  6. An edible cannabis product must be sealed in a container which is not transparent and sold in packaging which is opaque.
  7. Each single serving in a multiple-serving edible cannabis product must be physically demarked in a way that enables a reasonable person to intuitively determine how much of the edible cannabis product constitutes a single serving. Each demarked serving must be easily separable in a manner that allows an average person who is 21 years of age or over to physically separate, with minimal effort, an individual serving of the edible cannabis product.
  8. If an edible cannabis product is of a kind that is impracticable to clearly demark each serving of cannabis or to make each serving easily separable, the edible cannabis product must:
      1. Contain not more than 10 milligrams of THC per unit of sale; or
      2. Be sold in a package that contains more than one individually wrapped single-serving edible cannabis product.  

 

12.020 Stamp or mold required for edible cannabis products; exception. 

 

  1. Except as otherwise provided in subsection 3, each single-serving edible cannabis product and each individual serving containing not more than 10 milligrams of THC of a multiple serving edible cannabis product must be stamped or molded with a symbol approved by the Board to indicate that the product contains cannabis.
  2. An edible cannabis product that is impractical to stamp or mold with a symbol, including, without limitation, bulk goods or powders, each individual serving must be individually wrapped with the warning symbol on the wrapper exemption from stamping or molding product must be requested on a form prescribed by the Board.
  3. An edible cannabis product in liquid form which is packaged as required by NCCR 12.015 need not be stamped or molded as described in this section.  

 

12.025 Requirements for labeling products “organic.” 

  1. A cannabis cultivation facility or cannabis product manufacturing facility shall not label usable cannabis, concentrated cannabis or cannabis products as “organic” unless the cannabis plants and all ingredients used are produced, processed and certified in a manner that is consistent with the national organic standards established by the United States Department of Agriculture in accordance with the Organic Foods Production Act of 1990, 7 U.S.C. §§ 6501 et seq.    

 

12.030 Cannabis cultivation facility: Required labeling before sale of cannabis to another cannabis establishment.

  1. A cannabis cultivation facility shall label all cannabis before it sells the cannabis to another cannabis establishment and shall securely affix to the package a label that includes, without limitation, in legible English:
      1. The name of the cannabis establishment and its license number;
      2. If the cannabis establishment is operated by a dual licensee, the number of the medical cannabis establishment registration certificate of the cultivation facility operated by the dual licensee;
      3. The batch number;
      4. The lot number;
      5. The date of final harvest;
      6. The date of final testing;
      7. The date on which the product was packaged;
      8. The cannabinoid profile and potency levels and terpenoid profile of the top three terpenes as determined by the cannabis testing facility, which may include the potential total THC but must not include any other calculated level of THC;
      9. The quantity of cannabis being sold;
      10. A warning that states: “THIS PRODUCT CONTAINS CANNABIS”; and
      11. A warning that states: “Keep out of Reach of Children.”
  2. The label required by subsection 1 for a container or package containing usable cannabis sold by a cannabis cultivation facility must be in substantially the following form:  T&M NURSERY License Number: 123 456 789 001 0001 Registration Certificate Number: 543 210789 000 0100 (if applicable)  THIS PRODUCT CONTAINS CANNABIS  Keep out of Reach of Children Batch Number: 1234 Lot Number: 1234  Final Harvest Date: 01/01/2020  Final Testing Date: 01/15/2020 Packaged on: 01/17/2020 Best if used by: 03/17/2020  16.7% THC   1.5% CBD   0.3% CBN Myrcene 5.6 mg/g   Limonene 5.1 mg/g   Valencene 3.5 mg/g  Net Weight: 2 lbs.    

 

12.035 Cannabis product manufacturing facility: Required labeling of cannabis products before sale to retail stores.  

 

  1. A cannabis product manufacturing facility shall label all cannabis products before it sells the cannabis products to a cannabis sales facility or another cannabis product manufacturing facility and shall include on the packaging or securely affix to the package a label that includes, without limitation, in legible English and in a manner which must not mislead consumers:
      1. The name of the cannabis establishment and its license number;
      2. If the cannabis establishment is operated by a dual licensee, the number of the medical cannabis establishment registration certificates of the facility for the production of edible cannabis products or cannabis-infused products, as defined in Title 56 of NRS, operated by the dual licensee;
      3. The production run number;
      4. A warning that states: “Keep out of reach of children.”
      5. The date of production;
      6. The date of final testing;
      7. The date on which the product was packaged;
      8. The cannabinoid profile and potency levels and terpenoid profile of the top three terpenes as determined by the cannabis testing facility,
      9. If the product is perishable, the expiration date;
      10. The total amount of THC in the cannabis product, measured in milligrams;
      11. The total amount of THC in each serving of the edible cannabis product and a notice that the actual amount of THC may be within 15 percent of the stated amount;
      12. A list of all ingredients and all major food allergens as identified in 21 U.S.C. § 343;
      13. The net weight of the product;
      14. If concentrated cannabis was added to the product or if the product consists solely of concentrated cannabis, a disclosure of the type of extraction process used and any solvent, gas or other chemical used in the extraction process or any other compound added to the concentrated cannabis;
      15. If the product is an edible cannabis product other than extracts and tinctures, the serving size; and
      16. A warning that states: “THIS PRODUCT CONTAINS CANNABIS.”
  2. The label required by subsection 1 for a container or package containing concentrated cannabis or edible cannabis products sold by a cannabis product manufacturing facility must be in substantially the following form:  TK’s Cannabis Products License Number: 123 456 789 001 0001 Registration Certificate Number: 543 210789 000 0010 (if applicable)  Production Run Number: 1234  THIS PRODUCT CONTAINS CANNABIS  Keep out of Reach of Children  Produced on: 01/01/2020 Final Testing Date: 01/15/2020 Packaged on: 01/17/2020 Best if used by: 03/17/2020 Cannabinoid profile: Terpenoid profile:  Total THC content: THC content per serving +/- 15%: This product contains concentrated cannabis produced with butane.  Ingredients: Wheat, Sugar, Milk Chocolate Allergy Warning: Peanuts, Tree Nuts, Eggs, Wheat, Soy Net Weight: 100mg  

 

12.040 Cannabis sales facility: Required labeling of usable cannabis.

 

  1. A cannabis sales facility must affix to each container or package containing usable cannabis sold at retail, if not already included on the container or package, a label which must include, without limitation:
      1. The business or trade name and the license number of the cannabis cultivation facility that cultivated and sold the usable cannabis;
      2. If the cannabis cultivation facility is operated by a dual licensee, the number of the medical cannabis establishment registration certificate of the cultivation facility operated by the dual licensee;
      3. The batch number;
      4. The lot number;
      5. The date and quantity sold, including the net weight measured in ounces and grams or by volume, as appropriate;
      6. The name and address of the cannabis sales facility;
      7. The cannabinoid profile and potency levels and terpenoid profile as determined by the cannabis testing facility, which may include the potential total THC but must not include any other calculated level of THC;
      8. A warning that states: “This product may have intoxicating effects and may be habit forming;”
      9. The statement: “This product may be unlawful outside of the State of Nevada”;
      10. The date on which the cannabis was harvested;
      11. A warning that states: “THIS PRODUCT CONTAINS CANNABIS”; and
      12. A warning that states: “Keep out of Reach of Children.”
  2. The label required by subsection 1 for a container or package containing usable cannabis sold at retail must be in substantially the following form:  MM’s Plant Emporium License Number: 123 456 789 001 0001 Registration Certificate Number: 543 210789 000 0010 (if applicable)  THIS PRODUCT CONTAINS CANNABIS Keep out of Reach of Children Batch #: 1234 Lot #: 1234 Final harvest: 01/01/2020  by We Care Cannabis sales facility 123 Main Street, Carson City, NV 89701  WARNING: This product may have intoxicating effects and may be habit forming.  16.7% THC   1.5% CBD   0.3% CBN Myrcene 5.6 mg/g   Limonene 5.1 mg/g   Valencene 3.5 mg/g  Net Weight: .25 ounces (7 grams)  This product may be unlawful outside the State of Nevada.  

 

12.045 Cannabis sales facility: Required labeling of cannabis products.

 

  1. A cannabis sales facility must affix to each container or package containing cannabis products sold at retail and affix to or include with each container or package containing concentrated cannabis or cannabis products sold at retail a label which must not mislead consumers and must include, without limitation:
      1. The business or trade name and the license number of the cannabis product manufacturing facility that extracted and sold the concentrated cannabis or manufactured and sold the product;
      2. If the cannabis product manufacturing facility is operated by a dual licensee, the number of the medical cannabis establishment registration certificate of the facility for the production of edible cannabis products or cannabis-infused products operated by the dual licensee;
      3. The production run number that accounts for all lot numbers of all cannabis used to extract the concentrated cannabis or create the product, as recorded in the inventory control system of the cannabis product manufacturing facility that sold the concentrated cannabis or product;
      4. The name and address of the cannabis sales facility;
      5. The date on which the concentrated cannabis was extracted or the product was manufactured;
      6. The date on which the concentrated cannabis or product was packaged;
      7. If the product is perishable, a suggested use-by date;
      8. The cannabinoid profile and potency levels and terpenoid profile of the product, as determined by the cannabis testing facility that tested the product;
      9. The measurements of THC included on the label must include only the delta-9 tetrahydrocannabinol in the cannabis product, measured in milligrams THC;
      10. The total amount of THC in each serving of the product and a notice that the actual amount of THC in each serving may be within 15 percent of the stated amount;
      11. A list of all ingredients and all major food allergens as identified in 21 U.S.C. § 343.
      12. The concentration of THC in the product, measured in milligrams;
      13. The net weight of the cannabis or cannabis product;
      14. A warning that states: “Caution: When eaten or swallowed, the intoxicating effects of this product may be delayed by 2 or more hours”;
      15. If concentrated cannabis or a cannabis extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process, or any other compound added to the concentrated cannabis or the cannabis  extract;
      16. A warning that states: “This product may have intoxicating effects and may be habit forming”;
      17. A warning that states: “Keep out of Reach of Children”
      18.  A statement that: “This product may be unlawful outside of the State of Nevada”; and
      19. A warning that states: “THIS PRODUCT CONTAINS CANNABIS.”   
  2. The label required by subsection 1 for a container or package containing concentrated cannabis or cannabis products sold at retail must be in substantially the following form:  We Care Cannabis Sales Facility 123 Main Street, Carson City, NV 89701  THIS PRODUCT CONTAINS CANNABIS  Date Sold: 3/27/2020  Cookie Net Weight: 2 ounces (56 grams) Produced on: 1/1/2020 Final Testing Date: 1/15/2020 Packaged on: 1/17/2020 Best if used by: 6/3/2020 Cannabinoid profile: Terpenoid profile: THC content per serving +/- 15%:  CAUTION: When eaten or swallowed the intoxicating effects of this product can be delayed by 2 or more hours. Keep out of Reach of Children  This product may be unlawful outside the State of Nevada.  Manufactured at: KC’s Kitchen License Number: 321654987101 0401 Registration Certificate Number: 543 210789 000 0010 (if applicable)  Production Run #5463  INGREDIENTS: Flour, Butter, Canola Oil, Sugar, Chocolate, Cannabis, Strawberries  CONTAINS ALLERGENS: Milk, Wheat  Contains cannabis extract processed with butane. Contains concentrated cannabis produced with CO2.  WARNING: This product may have intoxicating effects and may be habit forming.  

 

12.050 Cannabis sales facility: Required disclosures and warnings.

 

  1. A cannabis sales facility must provide with all usable cannabis sold at retail accompanying material that discloses any pesticides applied to the cannabis plants and growing medium during production and processing.
  2. A cannabis sales facility must provide with all usable cannabis and cannabis products sold at retail a written notification which contains the following warnings:
      1. That cannabis and cannabis products must be kept out of the reach of children; 
      2. That cannabis and cannabis products can cause severe illness in children;
      3. That allowing children to ingest cannabis or cannabis products or storing cannabis or cannabis products in a location which is accessible to children may result in an investigation by an agency which provides child welfare services or criminal prosecution for child abuse or neglect;
      4. “THE INTOXICATING EFFECTS OF CANNABIS MAY BE DELAYED BY 2 HOURS OR MORE AND USERS OF CANNABIS PRODUCTS SHOULD INITIALLY INGEST A SMALL AMOUNT OF THE PRODUCT CONTAINING NO MORE THAN 10 MILLIGRAMS OF THC, THEN WAIT AT LEAST 2 HOURS BEFORE INGESTING ANY ADDITIONAL AMOUNT OF THE PRODUCT”;
      5. “This product may have intoxicating effects and may be habit forming. Smoking is hazardous to your health”;
      6. “Ingesting cannabis or cannabis products with alcohol or other drugs, including prescription medication, may result in unpredictable levels of impairment and a person should consult with a physician before doing so”;
      7. “There may be health risks associated with consumption of this product”;
      8. “Pregnant women should consult with a physician before ingesting cannabis or cannabis products”;
      9. “Cannabis or cannabis products can impair concentration, coordination and judgment. Do not operate a vehicle or machinery under the influence of cannabis or cannabis products”; and
      10. “Ingestion of any amount of cannabis or cannabis products before driving may result in criminal prosecution for driving under the influence.” 
  3. The text used on all accompanying material and warnings must be printed in at least  12-point font and may not be in italics.  

 

12.055 Cannabis cultivation facility, cannabis product manufacturing facility and cannabis sales facility: Required labeling. Each cannabis cultivation facility, cannabis product manufacturing facility and cannabis sales facility shall: 

 

  1. Use for labeling all cannabis and cannabis products the standard label described in NCCR 12.010 and 12.030 to 12.045, inclusive;
  2. Exercise strict control over labeling materials issued for use in labeling operations for cannabis and cannabis products;
  3. Carefully examine labeling materials issued for a batch for identity and conformity to the labeling specified in the applicable production or control records; and
  4. Have and follow written procedures describing in sufficient detail the control procedures employed for the issuance of labeling.  

 

12.060 Cannabis cultivation facility, cannabis product manufacturing facility and cannabis sales facility: Examination of products during finishing operations; collection of representative samples of units; recording of results. Each cannabis cultivation facility, cannabis product manufacturing facility and cannabis sales facility shall: 

 

  1. Examine packaged and labeled products during finishing operations to provide assurance that the containers and packages have the correct labels;
  2. Collect a representative sample of units at the completion of finishing operations and ensure that the samples are visually examined for correct labeling; and
  3. Record the results of the examinations performed pursuant to subsections 1 and 2 in the applicable production or control records.  

 

12.065 Cannabis treated with radiation. If any cannabis or cannabis product has been treated with radiation at any time, any and all packaging of the irradiated cannabis or cannabis product must include labeling that contains the following statement: “NOTICE: This product contains ingredients that have been treated with irradiation” in bold lettering, along with the Radura symbol as used by the U.S. Food and Drug Administration.

  1. The dispensing of cannabis or CIP shall be prohibited unless the cannabis is placed within a container and labeled in accordance with this section.
  2. All cannabis or CIP to be dispensed shall be packaged as follows:
      1. Cannabis or CIP shall be packaged in plain, opaque, tamper-proof, and child-resistant containers, except that the container shall not require to be child-resistant if the qualifying patient or designated caregiver has affirmed in writing that he or she would have difficulty opening a child-resistant container and that there are no young children living in his or her household;
      2. Cannabis or CIP shall be packaged in a manner that is not attractive to children;
      3. Depictions of the product, cartoons, or images other than the ATC’s logo shall not be permitted on the packaging;
      4. The packaging of edible CIP shall not bear a reasonable resemblance to any commercially available product; and
      5. If the ATC has a second location for cultivation, packaging, including the application of a tamper-proof seal on the package, shall be completed at the cultivation location and not at the dispensing location.
  3. The ATC shall not use any product or strain name that:
      1. Is identical to, or confusingly similar to, the name of an existing non-cannabis product;
      2. Is identical to, or confusingly similar to, the name of an unlawful product or substance;
      3. Is obscene or indecent, such as names that are sexually suggestive, include curse words, or are ethnic, racist, or derogatory in nature;
      4. Might encourage the use of cannabis or CIP for recreational purposes
      5. Might encourage the use of cannabis or CIP for a condition other than a qualifying medical condition;
      6. Is customarily associated with persons under the age of 18; or
      7. Is related to the benefits, safety, or efficacy of the cannabis product unless supported by substantial evidence or substantial clinical data.
  4. All cannabis or CIP dispensed shall meet the following labeling requirements:
      1. The ATC shall place a legible, firmly affixed label on all cannabis or CIP dispensed, which contains, at a minimum, the following information:
          1. The qualifying patient’s registry identification number;
          2. If the cannabis or CIP is being dispensed to a designated caregiver on behalf of a qualifying patient, in addition to a. above, the designated caregiver’s registry identification number;
          3. The qualifying patient’s address;
          4. The name, registration number, address, and phone number of the ATC;
          5. The quantity, in ounces, of usable cannabis dispensed, which, for CIP, shall be as determined by He-C 402.13(i) ;
          6. The date that the ATC dispensed the cannabis or CIP;
          7. The batch number;
          8. The strain of cannabis dispensed or, for CIP that has been produced with more than one strain, terminology that indicates that multiple strains have been used to create the CIP, such as “blend” or “hybrid”;
          9. The cannabinoid profile of the cannabis or CIP dispensed, as follows:
            1. For flower, in percent by weight;
            2. For CIP, in milligrams; and
            3. If the cannabinoid profile testing indicates that the amount of a cannabinoid is undetectable, it shall not be required to be included on the label;
          10. This statement, including capitalization: “This product has not been analyzed or approved by the FDA. It is not certified to be free of contaminants. There is limited information on the side effects of using this product, and there may be associated health risks. Do not drive or operate heavy machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.”; and
          11. This statement: “This cannabis or CIP is for therapeutic use only. Diversion of this product is a class B felony and shall result in the revocation of one’s registry identification card.”;
      2. In addition to (a) above, the ATC shall place a legible, firmly affixed label on all CIP including the following information:
          1. The type of the product;
          2. A list of ingredients;
          3. The net weight of the product;
          4. A warning if nuts or other known allergens are contained in the product;
          5. The date of product creation and the recommended “use by” or expiration date;
          6. A statement that the CIP, if perishable, should be refrigerated;
          7. Directions for use of the product if relevant;
          8. Dosing information regarding the serving size of the product relative to the amount of THC or CBD in the product; and
          9. The estimated time the CIP may take to go into effect;
      3. In addition to (a) and (b) above, for any CIP that contains an ethanol- or isopropanol-based cannabis concentrate with a residual solvent level that exceeds 500 parts per million per gram, the ATC shall add a warning to the label stating the amount of residual solvent, in parts per million per gram, contained in the product;
      4. Labeling text shall not include any false or misleading statements regarding health or physical benefits to the consumer; and
      5. Multiple labels on a container shall be allowed, however, labels shall be unobstructed and conspicuous in that no information required by these rules shall be obstructed.
  1. A cannabis cultivator or cannabis manufacturer, as applicable, shall ensure that each package of unusable or usable cannabis or cannabis product contains all information set forth in this section, whether printed directly on the package, or affixed with a compliant label before transfer to another cannabis business.
  2. Direct printing on the package of, or labels affixed to, unusable cannabis packaged for the purposes of manufacturing of cannabis items shall include the following consumer safety and product information:
      1. The name, address, license number, telephone number of the cannabis cultivator, and cannabis manufacturer that produced the cannabis item, as applicable;
      2. Net weight and quantity of the unusable cannabis or cannabis items contained in the package;
      3. Production or harvest date;
      4. Expiration date, consistent with the requirements at N.J.A.C. 17:30-11.8;
      5. A sequential serial number, batch or lot number, and bar code to identify the batch or lot associated with cultivation or manufacturing;
      6. A list of any other inactive or excipient ingredients besides unusable or usable cannabis or cannabis concentrate used to manufacture a cannabis product or contained within the package;
      7. A list of all potential allergens contained within the cannabis product;
      8. Whether the cannabis item requires refrigeration;
      9. For a finished cannabis item, serving size and the total number of servings contained and the cannabinoid and terpene profile, in milligrams and as a percentage, of the cannabis item and of a single serving size.
          1. For example: “The serving size of active THC in this product is X mg. This product contains X servings of cannabis, and the total amount of active THC in this product is X mg.”
          2. The cannabinoid profile shall reflect for the consumer the total THC, total CBD, and total CBG in the finished cannabis item:
            1. Total THC = (THCA 0.877) + delta-9-THC; and
            2. Total CBD = (CBDA 0.877) + CBD;
          3. The cannabinoid profile may reflect for the consumer the total CBG, total CBN, total CBC, total THCV, total CBDV, or other total cannabinoids in the finished cannabis item:
            1. Total CBG = (CBGA 0.878) + CBG;
            2. Total CBC = (CBCA 0.877) + CBC;
            3. Total THCV = (THCVA 0.867) + THCV; and
            4. Total CBDV = (CBDVA 0.867) + CBDV;
      10. The strain/cultivar name, listed by scientific terms, if available, and generic or “slang” names;
      11. For unusable or usable cannabis, the chemotype, growth method, an indication whether the cannabis was grown using all-organic materials, and a list of any allowable pesticides, fungicides, and herbicides used in cultivation pursuant to N.J.A.C. 17:30-10.9.
          1. Chemotypes shall be displayed as:
            1. “High THC, Low CBD,” where the THC to CBD ratio is greater than 5:1 and the total THC percentage is 15 percent or greater;
            2. “Moderate THC, Moderate CBD,” where the THC to CBD ratio is between 5:1 and 1:5 and the total THC percentage is between five percent and 15 percent;
            3. “Low THC, High CBD,” where the THC to CBD ratio is less than 1:5 and the total THC percentage is less than or equal to five percent; or
            4. Where unusable or usable cannabis does not conform to one of the three chemotypes, it shall be listed as the closest chemotype determined by mathematical analysis of the ratio of THC to CBD.
          2. Growth methods include, but are not limited to:
            1. Indoor;
            2. Outdoor;
            3. Soil-grown;
            4. Hydroponic; or
            5. Aquaponic;
      12. A summary of the written report detailing the results of the testing laboratory testing, including, but not limited to:
          1. Potency of all major cannabinoids detected and listed in the written report; and
          2. A list of major terpenoids detected and listed in the written report;
      13. Directions for inhalable, ingestible, or topical administration, as appliable;
      14. Requirements for proper storage ; and
      15. Optionally, a unique URL or QR code for each batch/lot that links to the complete written report.
  3. Labels affixed to cannabis items shall contain the following consumer warnings, as applicable, in no less than six-point font, unless otherwise noted:
      1. For all finished cannabis items:
          1. “This product contains cannabis”;
          2. “This product is intended for use by adults 21 years of age or older and not for resale. Keep out of the reach of children”;
          3. “There may be health risks associated with the consumption of this product, including for women who are pregnant, breastfeeding, or planning on becoming pregnant”;
          4. “Do not drive a motor vehicle or operate heavy machinery while using this product”; and
          5. The nationwide toll-free telephone number used to access poison control centers that is maintained in accordance with 42 U.S.C. § 300d-71;
      2. For any cannabis item that contains a total THC percentage greater than 40 percent:
          1. “This is a high potency product and may increase your risk for psychosis” printed in no less than 10-point font.
      3. For ingestible products:
          1. “The intoxicating effects of this product may be delayed by two or more hours” printed in no less than 10-point font.
      4. For an electronic smoking device: “This device has not been evaluated or approved by the Food and Drug Administration.”; and
      5. A label containing any statements about the product other than those specified in this chapter shall contain the following statement prominently displayed, and in boldface type: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
  4. The cannabis business shall submit the label and any required form to the Commission for recordkeeping.
      1. The Commission shall provide a copy of the label to authorized employees of State agencies or local law enforcement agencies, as necessary for these agencies to perform their official duties.
  1. Packaging and labels not designed to appeal to children: A package containing usable cannabis shall not display any content that reasonably appears to target minors, including but not limited to, cartoon characters or similar images. A product name or package shall not be modeled after a brand of product that is traditionally marketed toward children.
  2. Labeling requirements: A label shall be securely affixed to all usable cannabis product packages, prior to sale or distribution, that is in the format provided at Table 8, Sample Label for Usable Cannabis Products, that is conspicuous and unobstructed, and that uses a font that is clearly legible, not italicized, and is printed in no smaller than 1/16th of an inch. The cannabinoid content specified on a cannabis derived product label shall be ninety percent or greater in accuracy. The label shall identify the following:
      1. the names of the entities that produced and manufactured the product, respectively;
      2. the name of the strain of cannabis contained in the product;
      3. a manufacture date and an expiration date;
      4. for dried, usable cannabis: the total of THC and CBD per package, which shall be expressed by percentage of weight;
      5. for concentrated cannabis derived product: the total of THC and CBD per package, which shall each be expressed by weight in milligrams and by percentage of total weight;
      6. for non-concentrated cannabis derived product: the totals of THC and CBD per package, which shall each be expressed by weight in milligrams;
      7. total product weight, expressed in milligrams, and if the product is in liquid form, total volume, expressed in milliliters;
      8. the name of the strain;
      9. the name of the department approved laboratories that analyzed the product or cannabis contained in the product in accordance with department rule;
      10. for all products containing THC: the universal New Mexico THC warning symbol, the image file for which can be obtained from the department upon request, which shall be reproduced at a minimum size of 1/2 inch by 1/2 inch;
      11. warnings for use that include at a minimum the statements, “Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development”, “Do not drive a vehicle or operate heavy machinery while under the influence of this product”, and “Keep out of reach of children”;
      12. for all cannabis-derived products that contain THC and that are intended to be consumed by vaporization: a health warning that states in bolded text, “WARNING: Vaping THC has been associated with cases of severe lung injury, leading to difficulty breathing, hospitalization, and even death.”;
      13. a sales barcode that is associated with the product and product batch;
      14. a batch number or code that is associated with the product batch and that is recorded by the non-profit producer or manufacturer in the electronic tracking system specified by the department; and
      15. instructions for use that are specific to the labeled product.
  3. Drug information sheets: A non-profit producer shall generate a drug information sheet for every item of cannabis and cannabis derived product that is sold or distributed to a qualified patient or primary caregiver, and shall provide a copy of the drug information sheet to the qualified patient or primary caregiver at the time of sale or distribution, and upon request. A copy of a drug information sheet shall be provided to the department or its designee upon request. A drug information sheet shall be in the format provided at Table 9, Sample Label for Usable Cannabis Products, and shall use a font that is clearly legible, not italicized, and is printed in no smaller than 10 point type. The drug information sheet shall contain, at a minimum, the following:
      1. all of the content of the associated product label, as specified in this rule and identified in Table 8;
      2. a batch number or code that is associated with the cannabis used for the manufacture of the product, that is recorded by a non-profit producer in the electronic tracking system specified by the department;
      3. pesticide(s) used in the production of the cannabis or cannabis-derived product;
      4. for dried, usable cannabis and edible cannabis products: the total of THC, THCA, CBD, and CBDA per package, which shall be expressed by percentage of weight;
      5. for concentrated cannabis derived product: the totals of THC, THCA, CBD, and CBDA per package, which shall each be expressed by weight in milligrams and by percentage of total weight;
      6. for non-concentrated cannabis derived product: the total of THC, THCA, CBD, and CBDA, both per serving and per package, which shall each be expressed by weight in milligrams;
      7. a “best by” date or freeze date for products capable of supporting the growth of infectious, toxigenic, or spoilage microorganisms;
      8. instructions for appropriate storage;
      9. complete list of product ingredients;
      10. product facts or a nutrition fact panel, a statement that the product is for medical use by qualified patients, and a statement that the product is not for resale; and
      11. allergy warnings, including but not limited to information regarding whether the contents of the package were processed in any facility that also processes nuts.
  4. Expiration date: An expiration date that is identified on a usable cannabis product label shall not be modified, removed, or obscured. In the event that an expiration date specified on a usable cannabis product label has passed, the product shall be wasted in accordance with the terms of this rule and deducted from inventory in the electronic tracking system specified by the department.
  5. Failure to comply with packaging or labeling requirements: If a non-profit producer does not comply with any packaging or labeling requirement of this rule, the department may immediately suspend sales and distribution of any such non-compliant product, may order the recall of any such product, may order the relabeling of any such product, and may pursue disciplinary action in accordance with this rule.
  1. A licensee that packages cannabis products for retail sale shall annually report:
      1. the total amount of packaging material, by weight, sold, offered for sale, or distributed into the State by the licensee in the prior calendar year;
      2. the percentage of all packaging material sold, offered for sale, or distributed for sale in the State;
      3. the total amount of packaging material, by the country of origin where the packaging was manufactured or sourced, sold, offered for sale, or distributed into the State;
      4. the total number of refillable containers reused for cannabis products sold, offered for sale, or distributed for sale in the State; and
      5. the total costs of packaging material.  

 

This information shall be reported through a method authorized by the Board and shall begin one year after the date the license is issued. In anticipation of this reporting requirement, licensees should be tracking this information throughout the year.  

 

Definitions        

       

The Office will be using the following terms in describing requirements from Cannabis Law, and in this guidance document. The definitions below represent the Office’s interpretation of these terms:

  1. Advertising means the process of disseminating advertisements in any manner or by any means.
  2. Advertisement means any publication, video, use of a brand representative, or any other form of media for the purpose of causing, directly or indirectly, the purchase or use of a brand or cannabis product including, but not limited to: websites, social media, print media, broadcast media, TV, radio, streaming media, out of home media, outdoor signs, merchandise, event sponsorship, street art, murals, and digital communications.
  3. Attractive to individuals under twenty-one means labeling, packaging, advertising and marketing that is pleasing or appealing to persons under the age of twenty-one by using or including, among other things: Cartoons; bubble-type or other cartoon-like font; bright colors that are “neon” in appearance; similarities to products or words that refer to products that are commonly associated with or marketed in a manner so as to be attractive to individuals under twenty-one, including, but not limited to, any imitation of food, candy, soda, drinks, cookies, or cereal (with the exception of cultivar names or a licensee’s name) in labeling, packaging, advertising, or marketing; terms “candy” or “candies” or variants in spelling such as “kandy” or “kandeez” (with the exception of cultivar names or a licensee’s name); symbols, images, characters, public figures, phrases, toys, or games that are commonly used to market products to individuals under the age of twenty-one; or images of individuals who could reasonably appear to be under the age of twenty-one (unless the individual is at least twenty-five years of age).  
  4. Board means the Cannabis Control Board of New York State as established by Article 2 of the Cannabis Law.
  5. Brand or Branding means the name, entity name, or doing business as name, registered trademark, logo, symbol, motto, selling message, recognizable pattern of colors, or any other identifiable marker that identifies one adult-use cannabis licensee or adult-use cannabis licensee’s cannabis products as distinct from those cannabis products of other adult-use cannabis licensees and is used in, among other things, any packaging, labeling, advertising or marketing.
  6. Certificate of analysis means a certified report from a cannabis laboratory that meets the requirements of 9 NYCRR Part 130.
  7. Child-resistant means special packaging for sale to a consumer that is:  a. designed or constructed to be significantly difficult for children under five years of age to open and not difficult for adults to use properly as defined by 16 CFR § 1700.15 for Poison Prevention Packaging Standards and 16 CFR § 1700.15 for Testing Procedure for Special Packaging, as amended from time to time, and b. follows the packaging standards set forth and the testing procedure set forth in 16 CFR § 1700.20.*
  8. Date of expiration means the date prior to which an unopened cannabis product meets applicable standards of identity, potency, and quality at time of use, as determined by appropriate stability testing, subject to any storage conditions stated on the labeling.
  9. Edible means a product, containing either cannabis or concentrated cannabis and other ingredients, intended for use or consumption through ingestion, including sublingual or oral absorption.  
  10. Exit package means a receptacle into which cannabis products within a retail package are placed at the retail point of sale. The exit package is optional.
  11. Health claim means any claim made on the retail package or marketing layer or in the marketing or advertising of a cannabis product, that expressly or by implication, including, but not limited to, by “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol, plus ‘+’ sign, caduceus, or other medical symbols indicating it is a health product), or branding, that characterizes the relationship of any cannabis product to a disease or health-related condition or symptom. Implied health claims include those statements, symbols, branding, advertisements, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the cannabis product to a disease or health-related condition or symptom.
  12. Licensee means an individual or an entity who has been granted a license for any activity under Article 4 of the Cannabis Law.
  13. Lot unique identifier or lot number or bar code means any distinctive combination of letters, numbers, or symbols, from which the complete history of cultivation, manufacturing, processing, testing, distribution or recall of a lot of a cannabis product can be determined.
  14. Marketing means the process of identifying consumers’ needs and addressing such needs through advertisements.
  15. Marketing layer means packaging in addition to the retail packaging that is the outermost layer visible to the consumer at the point of sale. The Marketing Layer is optional, but if used it must comply with all adult-use labeling requirements.  
  16. Non-consumer package means any container or wrapping used solely for the transport of cannabis or cannabis products in bulk between licensees and particularly, a package intended solely for wholesale distribution and not final retail sale.  
  17. Office means the Office of Cannabis Management as established by Article 2 of the Cannabis Law. 
  18. Phytocannabinoids means any of the chemical compounds, excluding terpenes or any other compounds determined by the Office, that are the active principles of the cannabis sativa, including but not limited to tetrahydrocannabinol (THC) and cannabidiol (CBD), and does not include synthetic cannabinoids as that term is defined in subdivision (g) of schedule I of section thirty-three hundred six of the Public Health Law.  
  19. Plastic means a synthetic material that is made from linking monomers through a chemical reaction to create a polymer chain that can be molded or extruded at high heat into various solid forms that retain their defined shapes during their life cycle and after disposal. 
  20. Post-consumer recycled content means new material produced using material resulting from the recovery, separation, collection, and reprocessing of material that would otherwise be disposed of or processed as waste and that was originally sold for consumption. It does not include post-industrial content, or material generated by means of combustion, incineration, pyrolysis, gasification, solvolysis, chemical recycling and any high-heat or conversion process.  
  21. Principal packaging display panel means the panel of the retail package or the marketing layer that the processor intends to be displayed for a cannabis product at retail.
  22. Resealable means a package that maintains its child-resistant effectiveness, as well as preserving the integrity of cannabis products for multiple servings. 
  23. Retail package means a sealed, hard or soft-bodied, child-resistant receptacle in which the cannabis product is offered for retail sale. Retail package does not mean:
      1. inner wrapping or lining;
      2. an exit package; or
      3. a non-consumer package used to transfer cannabis from one licensee to another.
  24. Reusable packaging is packaging made from durable material that is designed to be used repeatedly for a number of use cycles, is safe for washing and sanitizing, and is capable of being recycled at the end of use, with the exception of ceramic packaging.  
  25. Special branding material means a visual or audio element which shall only be for use in packaging, labeling, marketing, and advertising by certain licensees or on certain cannabis products including, but not limited to, a designation that a licensee is a social and economic equity licensee. All special branding materials and the brands or products authorized to use such materials shall be defined, made available, and designated for use in guidance. 
  26. Tamper-evident means, with respect to a device or process, bearing a seal, a label or a marking that makes unauthorized access to or tampering with a package, product or container easily detectable. 
  27. Total THC means the sum of the percentage by weight or volume measurement of tetrahydrocannabinolic acid multiplied by 0.877, plus, the percentage by weight or volume measurement of THC.
  28. Universal symbol means an image developed by the Office, and made available to licensees, that indicates that a retail package or the product contains cannabis.
  29. Use by date means the date prior to which an opened cannabis product meets applicable standards of identity, potency, and quality at the time of use, as determined by appropriate data, subject to any storage conditions stated on the labeling. 
  1. A manufacturing facility shall label all usable marijuana in accordance with the following before their sale or transfer to a dispensary:
      1. A container holding dried leaves and flowers must include the following information:
          1. Manufacturers’ business or trade name and registry certification number;
          2. Container identification number;
          3. Batch number;
          4. Date of harvest;
          5. Name of strain;
          6. Net weight in United States customary or metric units;
          7. Concentration of total tetrahydrocannabinol and total cannabidiol as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
          8. Activation time expressed in words or through a pictogram;
          9. Expiration date;
          10. Universal symbol; and
          11. Consumer warnings that state:
            1. “This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease.”
            2. “For use by North Dakota registered qualifying patients only.”
            3. “Keep out of reach of children.”
            4. “It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana.”
      2. A container holding a cannabinoid concentrate must include the following information:
          1. Manufacturing facility’s business or trade name and registry certification number;
          2. Container identification number;
          3. Process lot number;
          4. Product identity;
          5. Date the concentrate was made;
          6. Net weight or volume in United States customary or metric units;
          7. If applicable, serving size and number of servings per container or amount suggested for use by the consumer or patient at any one time;
          8. Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in the container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
          9. Activation time, expressed in words or through a pictogram;
          10. Expiration date;
          11. A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;
          12. Universal symbol;
          13. Pediatric symbol, if applicable; and
          14. Consumer warnings that state:
            1. “This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease.”
            2. “For use by North Dakota registered qualifying patients only.”
            3. “Keep out of reach of children.”
            4. “It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana.”
      3. A container holding a medical cannabinoid product must include the following information:
          1. Manufacturers’ business or trade name and registry certification number;
          2. Container identification number;
          3. Process lot number;
          4. Product identity;
          5. Date the product was made;
          6. Net weight or volume in United States customary or metric units;
          7. If applicable, serving size and number of servings per container;
          8. Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in each serving and in each container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
          9. List of ingredients in descending order or predominance by weight or volume used to process the medical cannabinoid product;
          10. Activation time, expressed in words or through a pictogram;
          11. Expiration date;
          12. A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;
          13. Universal symbol;
          14. Pediatric symbol, if applicable; and
          15. Consumer warnings that state:
            1. “This product is not approved by the Food and Drug Administration to treat, cure, or prevent any disease.”
            2. “For use by North Dakota registered qualifying patients only.”
            3. “Keep out of reach of children.”
            4. “It is illegal to drive or to be in actual physical control of a motor vehicle while under the influence of marijuana.”
  2. Usable marijuana labels required in accordance with this section must be no smaller than eight point, arial or calibri, font. If, due to the size of the container, sufficient space does not exist for a label containing all of the required information, the manufacturing facility may:
      1. Use a peel-back or accordion label if, the peel-back or accordion label is easily identified as containing the required information; or
      2. Reduce the size of the required information to six point font.
  3. Usable marijuana labels may not contain the word “organic”.
  1. A processor distributing medical marijuana to a dispensary shall meet the following requirements:
      1. A processor shall place medical marijuana in a child-proof, tamper-evident, light-resistant package approved by the department prior to distribution to a dispensary. Approved packaging shall maintain the integrity and stability of the medical marijuana, and shall comply with the rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code.
      2. A label shall be affixed to every package and state in legible English:
  2. The name and license number of the cultivator where the packaged plant material was cultivated or the name and license number of the processor where the medical marijuana products were manufactured;
  3. The name and license number of the dispensary facility receiving the shipment;
  4. The product identifier;
  5. The registered name of the medical marijuana plant material strain that was registered with the department or the registered name, form, and dose of the medical marijuana product that was registered with the department;
  6. A unique batch or lot number as defined in paragraph (A) of rule 3796:1-1-01 of the Administrative Code that will match the medical marijuana or medical marijuana products with a batch or lot, in order to facilitate any warnings or recalls the department deems appropriate;
  7. The dates of manufacture, final testing, and packaging;
  8. The total weight in grams of medical marijuana or medical marijuana products in each package;
  9. The name and license number of the independent testing laboratory that performed the required tests on the batch or lot from which the medical marijuana or medical marijuana products in the package were taken;
  10. The laboratory analysis and cannabinoid profile, including the percentage content by weight or total milligrams and milligrams per unit for:
      1. Delta-8-tetrahydrocannabinol;
      2. Delta-8-tetrahydrocannabinolic acid;
      3. Delta-9-tetrahydrocannabinol;
      4. Delta-9-tetrahydrocannabinolic acid;
      5. Cannabidiol (CBD);
      6. Cannabidiolic acid (CBDA);
      7. THC content as defined in rule 3796:1-1-01 of the Administrative Code; and
      8. Any other cannabinoid determined by the department.
  11. The expiration date, which shall not exceed one calendar year from the date of manufacture;
  12. If the product is edible, the following additional information:
      1. A list of all ingredients and subingredients, providing that all ingredients comply with the standards of identity under rule 901:3-1-12 of the Administrative Code;
      2. A list of all major food allergens as identified in 21 USC 343; and
      3. A statement with the following language: “Caution: When eaten or swallowed, the effects and impairment caused by this drug may be delayed.”
  13. If a marijuana extract was used in the manufacture of the product, a disclosure of the type of extraction process and any solvent, gas, or other chemical used in the extraction process or any other compound added to the extract; and
  14. A statement with the following language: “This product is for medical use and not for resale or transfer to another person. This product may cause impairment and may be habit-forming. This product may be unlawful outside the State of Ohio.”
  15. If the product was manufactured using plant material that was acquired from a dispensary pursuant to paragraph (B) of rule 3796:3-2-01 of the Administrative Code, a statement with the following language: “This product was manufactured using medical marijuana that exceeded the expiration date defined in OAC 3796:1-1-01.”
  16. The intended method of administration of the medical marijuana product.
  17. A processor that elects to or is required to determine portions for an edible medical marijuana product under rules promulgated by the state of Ohio board of pharmacy pursuant to Chapter 3796. of the Revised Code shall apply a universal symbol that denotes that the product contains medical marijuana as an ingredient, as determined by the department, to each portion of the medical marijuana product, in accordance with the following:
      1. If the medical marijuana product is presented as separate single portions, the processor shall apply the universal symbol to each single portion;
      2. If the medical marijuana product is presented as a single unit comprised of more than one portion, the processor shall make clearly visible lines of demarcation between portions and apply the universal symbol to each portion; and
      3. The size of the universal symbol marking shall be determined by the size of the portion instead of the overall product size, and shall not be less than one-fourth inch by one- fourth inch.
  18. The label may contain the approval or certification logo of a third-party certifier of manufacturing or cultivation practices if:
      1. The third-party certifier does not have a direct or indirect financial interest in any medical marijuana entity licensed in the state of Ohio; and
      2. The certification protocols used by the third-party certifier have been reviewed and approved by the department.
  19. A label shall not contain:
      1. Any false or misleading statement or design;
      2. Depictions of the product, cartoons, or images that are not registered with the department, which includes any insignia related to a governmental entity;
      3. Any sum totals of cannabinoids or terpenes, except as defined in paragraph (A)(49) of rule 3796:1-1-01 of the Administrative Code; or
      4. Any information that would violate paragraph (E) of rule 3796:5-7-01 of the Administrative Code.
  20. A processor may provide a dispensary free samples of plant material sold at the dispensary. A free sample shall be packaged in a sample jar protected by a plastic or metal mesh screen to allow patients and caregivers to smell the plant material before purchase. A sample jar may not contain more than three grams of a particular strain of plant material. The sample jar and the plant material within may not be sold to a patient or caregiver and shall be destroyed by the dispensary after use by the dispensary. The dispensary shall document the destruction of every free sample in accordance with the rules established pursuant to Chapter 3796. of the Revised Code.
  21. It is prohibited for anyone to knowingly or intentionally alter, obliterate, or otherwise destroy any container or label attached to an approved container. In the event a container or label is altered, obliterated, or otherwise destroyed, the department may act in accordance with rule 3796:5-6-01 of the Administrative Code.
  1. Prohibition on sale or transfer. Commercial licensees shall not sell, distribute, or otherwise transfer medical marijuana and medical marijuana products that are not packaged and labeled in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules.
  2. Nonacceptance or return. A dispensary shall refuse to accept or shall return to the licensee transferring medical marijuana or medical marijuana products to the dispensary, any medical marijuana or medical marijuana products that are not packaged and labeled in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules. The business licensee who sold or otherwise transferred the nonconforming medical marijuana or medical marijuana products shall accept such return. If circumstances are such that the dispensary cannot return or refuse to accept the nonconforming medical marijuana or medical marijuana products, the dispensary shall dispose of the nonconforming medical marijuana and medical marijuana products in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.
  3. Documentation. A dispensary shall document any such return, nonacceptance, or disposal, and such documentation shall include at a minimum:
      1. The license number, name, contact information, and address of the licensee who sold or otherwise transferred the nonconforming medical marijuana or medical marijuana products to the dispensary;
      2. A complete inventory of the medical marijuana and medical marijuana products to be returned or disposed, including the batch number;
      3. The reason for the nonacceptance, return, or disposal; and
      4. The date of the nonacceptance, return, or disposal.
  4. General requirements. The following general label and packaging requirements, prohibitions, and exceptions shall apply to all medical marijuana and medical marijuana products being transferred or sold to a dispensary or by a dispensary:
      1. Labels, packages, and containers shall not be attractive to minors and shall not contain any content that reasonably appears to target children, including toys, cartoon characters, and similar images. Packages should be designed to minimize appeal to children and shall not depict images other than the business name logo of the medical marijuana producer and image of the product.
      2. Packaging must contain a label that reads: “Keep out of reach of children.”
      3. All medical marijuana and medical marijuana products must be packaged in child-resistant containers at the point of sale or other transfer to a patient, a patient’s parent or legal guardian if patient is a minor, or a caregiver.
      4. Label must contain a warning that states “Women should not use marijuana or medical marijuana products during pregnancy because of the risk of birth defects.”
      5. Packages and labels shall not contain any deceptive, false or misleading statements. For purposes of this section, information that is deceptive, false, or misleading includes:
          1. Any indication that the medical marijuana or medical marijuana product is organic, unless the National Organic Program (Section 6517 of the federal Organic Foods Production Act of 1990 (7 U.S.C. Section 6501 et seq.)) authorizes organic certification and designation for marijuana and marijuana products. This includes variants of the word “organic” such as “organix” and “organique.”
          2. Any indication that the medical marijuana or medical marijuana product is “Pesticide-free,” unless the medical marijuana or a medical-marijuana product was grown, harvested, processed, and dispensed without any pesticide.
      6. No medical marijuana or medical marijuana products shall be intentionally or knowingly packaged or labeled so as to cause a reasonable patient confusion as to whether the medical marijuana or medical marijuana product is a trademarked product.
      7. No medical marijuana or medical marijuana products shall be packaged or labeled in a manner that violates any federal trademark law or regulation.
      8. Packages and labels shall not make any claims or statements that the medical marijuana or medical marijuana products provide health or physical benefits to the patient.
      9. Packages and labels shall not contain the logo of the Oklahoma State Department of Health or the Oklahoma Medical Marijuana Authority.
      10. Packages and labels shall not contain any universal symbols from another state, any statements that the medical marijuana was grown in another state, or any depictions, symbols, or other information that could cause a reasonable patient to be confused as to the state of origin of the medical marijuana or medical marijuana product.
      11. Labels shall be designed and applied in a manner that does not cause patient confusion regarding the package’s contents, potency, or other required information. In the event that any package or immediate container of medical marijuana or medical marijuana product is relabeled, all prior labels must be removed in entirety prior to the new label being applied. Covering an initial label with an updated label is prohibited.
      12. All packaging and labeling must contain current and accurate information on file with the Authority, including, but not limited to, the licensee’s legal name, trade name, and license number.
      13. Packages and labels shall be considered inaccurate if the difference in percentage of the cannabinoid and/or total THC claimed to be present on a package or label is plus or minus fifteen percent (15%) of the percentage on the COA. For example, bulk order packaging that identifies a THC amount as 100mg would be inaccurate if the COA for that production batch indicated a THC content of less than 85mg or more than 115mg.
  5. Label requirements for sales to dispensaries or by dispensaries.
      1. Labels on medical marijuana and medical marijuana products being transferred or sold to a dispensary or by a dispensary shall contain, at a minimum, the following information:
          1. The name and license number of the grower, dispensary, or processor who is selling or otherwise transferring the medical marijuana or medical marijuana products to the dispensary;
          2. Name of the medical marijuana or medical marijuana product;
          3. The batch number of the medical marijuana or medical marijuana product;
          4. Net quantity or weight of contents;
          5. Ingredients list;
          6. The Oklahoma Uniform Symbol in the manner and form prescribed by the Department;
          7. THC potency on the COA for that batch;
          8. Total Terpenoid content in the manner prescribed by the Department; and
          9. The statement, “This product has been tested for contaminants.”
      2. Labels for edible medical marijuana products shall also meet the requirements set forth in OAC 310:681-5-8.1.
      3. As applicable, RFID tags shall not obscure required label and packaging requirements.
  6. Label requirements for sales between growers and/or processors. All medical marijuana and medical marijuana products sold or otherwise transferred between growers and/or processors shall be labeled and the label shall contain, at a minimum, the following information:
      1. Name and license number of the grower or processor who is selling or otherwise transferring the medical marijuana or medical marijuana product;
      2. The batch number of the medical marijuana or medical marijuana product;
      3. Date of harvest or production; and
      4. A statement that the medical marijuana or medical marijuana products have passed testing or statement that the medical marijuana failed testing and is being transferred to a processor for purposes of remediation.
  7. Storage requirements for growers and processors.
      1. Growers and processors shall store medical marijuana and medical marijuana products under conditions and in a manner that protects the medical marijuana and medical marijuana products from physical and microbial contamination and deterioration.
      2. When not in use, medical marijuana and medical marijuana products shall be stored in receptacles that are capable of being fully closed and sealed and are kept fully closed and sealed.
  1. A label required by these rules must:
      1. Be printed on or affixed to the container holding the marijuana item or hemp item and printed on or affixed to any outer package or container that is used to display the marijuana item or hemp item for sale or transfer to a consumer, patient, or designated primary caregiver;
      2. Comply with the National Institute of Standards and Technology (NIST) Handbook 130 (2016), Uniform Packaging and Labeling Regulation, incorporated by reference;
      3. Contain all required information in any typed, legible font that is easy to read and contrasts sufficiently with the background and is at least one-sixteenth of an inch in height based on the uppercase “K”;
      4. Be in English, though it can also be in other languages; and
      5. Be unobstructed and conspicuous.
  2.  A label may not:
      1. Contain any untruthful or misleading statements including, but not limited to, a health claim that is not supported by the totality of publicly available scientific evidence, including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles, and for which there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims; or
      2. Be attractive to minors, as that is defined in OAR 845-025-7000.
  3. Principal Display Panel.
      1. Every container that holds a marijuana item or hemp item for sale or transfer to a consumer, patient, or designated primary caregiver must have a principal display panel, as that term is defined in OAR 845-025-7000.
      2. If a container holding the marijuana item or hemp item is placed within another container for sale or transfer to a consumer, patient, or designated primary caregiver, both containers must have a principal display panel as that term is defined in OAR 845-025-7000 in addition to the other labeling requirements provided in these rules.
      3. The principal display panel must contain the product identity, net quantity of contents, and universal symbol or hemp symbol, whichever is applicable.
      4. If the product is a medical grade cannabinoid product, concentrate, or extract processed by a licensee, or medical marijuana processing site, the principal display panel must also include the medical grade symbol.
      5. If the product is a hemp item, the principal display must include the hemp symbol in place of the universal symbol.
      6. On or after July 1, 2022, if the package or container is a jar and is 1.75 inches or less in height and has a lid with a width of two inches or less, then the principal display panel must be on the top of the lid.
  4. Product Identity
      1. The product identity be in bold type, in a size reasonably related to the most prominent printed matter on the principal display panel, and shall be parallel to the base on which the package rests as it is designed and displayed.
      2. The product identity must clearly identify whether the item is derived from marijuana or hemp. An item that contains both industrial hemp and marijuana must identify the item as a marijuana item.
      3. The product identity for cannabinoid and hemp extracts and concentrates must correctly identify whether the product is an extract or a concentrate.
  5. Net Quantity Declaration
      1. The net quantity of contents provided on the principal display panel must be the average net quantity of contents of all of the packages in the batch.
      2. The net quantity declaration shall be in terms of fluid measure if the item is liquid, or in terms of weight if the item is solid, semi-solid, or viscous.
      3. The net quantity declaration shall be a distinct item separated from other printed label information on all sides by at least a space equal to the height of the lettering used in the declaration. The declaration shall be presented in bold type in the bottom 30 percent of the principal display panel and in lines generally parallel with the base of the container.
  6. Potency Labeling. Unless required to be relabeled as described in OAR 845-025-5760, the THC and CBD amounts required to be on a label must be the value calculated by the laboratory that did the testing in accordance with OAR 333-064-0100.
      1. The potency value shall be expressed as an average of the samples taken and tested under OAR 333-007-0360. A label may not have a THC value that exceeds the applicable maximum concentration limit by over 10 percent as specified in OAR 845-026-0200 to 845-026-0220 or 845-025-2760, as applicable.
      2. For products tested on or after February 1, 2020, if the potency value for THC or CBD is reported by the laboratory as less than the limit of quantification, the value on the label must be listed as “<LOQ.”
  7. The universal symbol. The universal symbol must be at least 0.48 inches wide by 0.35 inches high and can be downloaded on the Commission’s website.
  8. Medical grade symbol. The medical grade symbol must be at least 0.35 inches in diameter and can be downloaded at marijuana.oregon.gov.
  9. Hemp symbol. The hemp symbol must be at least 0.48 inches wide by 0.35 high and can be downloaded on the Commission’s website.
  10. A marijuana item or hemp item may have one or more label panels printed on or affixed to the container or packaging.
  11. Small Container Label. A marijuana item or hemp item that is in a container that because of its size does not have sufficient space for a label that contains all the information required for compliance with these rules:
      1. May, in lieu of a label that has all the information required in OAR 845-025-7030 to 845-025-7145, have a label printed on or affixed to the container holding the marijuana item or hemp item that includes at least the following:
          1. A principal display panel containing the net weight or volume, product identity, and universal symbol;
          2. Licensee business or trade name and license number or registrant business or trade name and registrant number;
          3. UID number;
          4. Concentration or amount of THC and CBD in the container; and
          5. Required warnings.
      2. For a retail marijuana item, the following warning is required on the label: “For use only by adults 21 and older. Keep out of reach of children.”
      3. For a hemp item, the following warning is required to be on the label: “This product is derived from hemp and could contain THC. Keep out of reach of children.”
      4. For a medical marijuana item, the following warning is required on the label: “For use by OMMP patients only. Keep out of reach of children.”
      5. Must include all required label information on an outer container or other required label information not listed in subsection (1) of this section on a hang tag attached to the marijuana item or hemp item.
      6. May use a peel-back or accordion label with the information required in subsection (b) of this section on the inside of the peel-back or accordion label, if the peel-back or accordion label can be easily identified by a patient or consumer as containing important information.
  12. Tiny Container Label. A marijuana item or hemp item that is in a container that has a complete surface area available for applying a label that is less than two inches squared:
      1. May have a label printed on or affixed to the container that holds the marijuana item or hemp item that includes at least the following:
          1. A principal display panel with the universal symbol and product identity;
          2. UID number;
          3. Concentration or amount of THC and CBD in the container;
          4. Licensee or registrant business or trade name and license or registrant number; and
          5. A warning that reads: “Keep out of reach of children.”
      2. Must include all required label information on an outer container or other required label information not listed in subsection (a) of this section on a hang tag attached to the marijuana item or hemp item.
      3. May use a peel-back or accordion label with the information required in subsection (c) of this section on the inside of the peel-back or accordion label, if the peel-back or accordion label can be easily identified by a patient or consumer as containing important information.
  13. The outer container used to display the marijuana item or hemp item for sale or transfer to a consumer, patient, or designated primary caregiver must comply with the labeling requirements in these rules, even if an inner container qualifies for the exception under section (11) or (12) of this rule.
  14. A marijuana item or hemp item that simultaneously falls within more than one category must comply with the labeling requirements that apply to each category, with the exception of the “DO NOT EAT” warning if the product is intended for human consumption or the “BE CAUTIOUS” warning if the effects of the product are customarily felt immediately. For example, a cannabinoid concentrate that is intended for human consumption must comply with the labeling requirements that apply to both cannabinoid concentrates and cannabinoid edibles.
  15. If a marijuana item or hemp item is placed in a package that is being re-used, the old label must be removed and it must have a new label.
  16. A licensee or registrant must have documentation that demonstrates the validity of the calculation of the amount of sodium, cholesterol, protein, sugar, carbohydrates, and total fat in a cannabinoid edible and must make that documentation available to the Commission or the Authority upon request.
  17. (a) A marijuana item or hemp item that contains an ingredient consisting of two or more sub ingredients must either:
      1. Use the common name of the ingredient followed by a parenthetical listing of all ingredients in a descending order of predominance; or
      2. List all sub ingredients as individual ingredients in descending order of predominance.
      3. The list of ingredients must include any substance used in processing, preparing, manufacturing, packaging, or holding the cannabinoid product or hemp cannabinoid product that is present in the final product, including any cooking or release spray.
      4. The list of ingredients must correctly identify the type of marijuana item or hemp item used to make the product.
  18. A cannabinoid edible or hemp edible that contains only a single serving may omit the servings per container declaration as long as the label clearly states that the package contains a single serving.
  19. A cannabinoid edible or hemp edible shall use one of the nutrition information formats provided by the Commission to display on the label the amount of calories, sodium, protein, added sugars, cholesterol, total carbohydrates, and total fat per serving, the serving size and number of servings per container, and the list of ingredients and potential allergens.
  20. if the container holding the marijuana item or hemp item does not meet the child resistant standards set out in these rules, the outermost label must contain the following statement: “This package is not child resistant.”
  21. Exit packaging must contain a label that reads: “Keep out of the reach of children.”
  22. A cartridge or vaporizing device containing a cannabinoid or hemp concentrate, extract, or product intended for use with an inhalant delivery system as that is defined in ORS 431A.175 is not required to be labeled in accordance with these rules except that the cartridge or device must have a label with the universal symbol or hemp symbol, as appropriate. All the remaining label requirements must be included on the packaging as required by these rules.
  23. The Commission may require that marijuana items and hemp items sold at retail by Commission licensees be labeled with a Universal Product Code.
  24. Once a label is approved by the Commission, the label identification number provided by the Commission must be prominently displayed on the label of the outermost container.
  25. If a cannabinoid concentrate or extract or hemp concentrate or extract contains any added substances, the item shall be considered a cannabinoid product and labeled under OAR 845-025-7120.
  1. A grower/processor shall package and label at its facility each form of medical marijuana products prepared for sale. The original seal of a package may not be broken, except for quality control testing at an approved laboratory, for adverse loss investigations conducted by the Department or by a dispensary that purchased the medical marijuana products.
  2. A grower/processor shall package the medical marijuana products in a package that minimizes exposure to oxygen and that:
      1. Is child-resistant.
      2. Is tamper-proof or tamper-evident.
      3. Is opaque. This requirement does not apply to packages containing dry leaf.
      4. Is resealable.
      5. Clearly distinguishes the contents of the package from the contents of any other package of similar appearance.
      6. Lists all product ingredients and includes a warning for known allergens, such as tree nuts.
  3. A grower/processor shall identify each process lot of medical marijuana with a unique identifier.
  4. A grower/processor shall obtain the prior written approval of the Department of all packaging and the content of any label to be affixed to a medical marijuana product package. Each label must meet all of the following requirements:
      1. Be easily readable.(
      2. Be made of weather-resistant and tamper-resistant materials.
      3. Be conspicuously placed on the package.
      4. Include the name, address and permit number of the grower/processor.
      5. List the form, quantity and weight of medical marijuana included in the package.
      6. List the number of individual doses contained within the package, the species and percentage of THC and CBD and other cannabinoids as enumerated in § 1151a.29 (relating to limit on medical marijuana processing), and the individual terpenes and corresponding percentages, if greater than 0.0%. CAS numbers need not be displayed on the label.
      7. Contain an identifier that is unique to a particular harvest batch of medical marijuana, including the number assigned to each harvest lot or process lot in the harvest batch.
      8. Include the date the medical marijuana product was packaged.
      9. State the employee identification number of the employee preparing the package and packaging the medical marijuana product.
      10. State the employee identification number of the employee shipping the package, if different than the employee described in paragraph (9).
      11. Contain the name and address of the dispensary to which the package is to be sold, except where a clinical registrant sells medical marijuana products to another grower processor and the intended dispensary is not known. In this case, the grower processor selling to a dispensary is required to affix a label bearing the dispensary name and address to the outer packaging, notwithstanding paragraph (17).
      12. List the date of expiration of the medical marijuana product.
      13. Include instructions for proper storage of the medical marijuana product in the package.
      14. Contain the following warning stating: This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant’s pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.
      15. Contain a warning that the medical marijuana product must be kept in the original container in which it was dispensed.
      16. Contain a warning that unauthorized use is unlawful and will subject the purchaser to criminal penalties.
      17. Be firmly affixed to the container directly holding medical marijuana product, except when the product is being used for a blinded research program, and be firmly affixed to outer packaging if used.
      18. List THC as the first number when THC and CBD are listed on a label as a ratio.
  5. Labeling by a grower/processor of any medical marijuana product may not bear:
      1. A resemblance to the trademarked, characteristic or product-specialized packaging of any commercially available food or beverage product.
      2. A statement, artwork or design that could reasonably lead an individual to believe that the package contains anything other than medical marijuana.
      3. A seal, flag, crest, coat of arms or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured or approved for use by any state, county or municipality or any agency thereof.
      4. A cartoon, color scheme, image, graphic or feature that might make the package attractive to children.
  1. Authority and Applicability
      1. These retail-ready medical marijuana product packaging and labeling requirements for compassion centers and licensed cultivators are promulgated pursuant to R.I. Gen. Laws §§ 21-28.6-12(f)(11) and 21-28.6-16(g).
      2. Compassion centers and licensed cultivators shall have ninety (90) calendar days from the effective date of these regulations to comply with these requirements.
      3. The compassion center is responsible for ensuring all medical marijuana products are retail-ready prior to sale to a qualifying patient, registered primary caregiver or authorized purchaser.
  2. General Packaging Requirements
      1. All retail-ready medical marijuana products must be in compliant packaging upon entering the compassion center retail sale space.
      2. In addition to any other requirements pursuant to § 1.5 of this Part, any package containing retail-ready medical marijuana product must:
          1. Be opaque, of a neutral color, and light resistant;
            1. Neutral colors include but are not limited to: black, white, gray, beige, brown, and tan. Neutral colors do not include primary and secondary colors (such as red, orange, yellow, green, blue, or purple) or any variant of primary or secondary colors.
          2. Fully enclose the product;
          3. Protect the product from contamination;
          4. Not impart any toxic or deleterious substance to the medical marijuana product;
          5. Be Child Resistant as defined in § 1.1 of this Part; and
          6. Be able to be resealed in a Child Resistant manner unless the package contains a single-serving medical marijuana edible or ingestible pursuant to §1.5.2(D) and (E) of this Part respectively.
      3. Exit Package
          1. Except for medical marijuana edibles and ingestibles, upon DBR approval, any other retail-ready medical marijuana product placed into a container that is not child-resistant shall be placed into a child-resistant Exit Package at the point of sale.
          2. The Exit Package is not required to be labeled pursuant to § 1.5 of this Part if the package(s) within the Exit Package containing the retail-ready medical marijuana product comply with all labeling requirements pursuant to § 1.5 of this Part.
      4. Additional Packaging Requirements for Retail-Ready Medical Marijuana Edibles1. A single serving unit shall not exceed ten (10) milligrams (“mgs”) of active THC.
          1. A single serving unit, if sold individually, shall be placed into a child-resistant container that may or may not be resealable.
          2. Multiple single serving units may be placed together into a single child resistant and resealable package, so long as the active THC per package does not exceed one hundred (100) mgs.
          3. Multiple packages may be bundled and sold together so long as the:a. Total amount of THC per serving unit does not exceed ten (10) mgs;b. Total amount of THC per package does not exceed one hundred (100) mgs. Total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.
          4. For Medical Marijuana Edibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.
          5. For Medical Marijuana Edibles in liquid form containing multiple serving units, the container must have a resealing cap or closure which maintains child resistance compliance.
          6. Medical Marijuana Edibles in liquid form containing multiple serving units must include a measuring device such as a measuring cap, cup or dropper with the package containing the medical marijuana product. Hash marks on the package do not qualify as a measuring device.
      5. Additional Packaging Requirements for Medical Marijuana Ingestibles
          1. A single serving unit, if sold individually, of a Medical Marijuana Ingestible must be placed into a child-resistant container that may or may not be resealable.
          2. Multiple single serving units may be placed together into a single child resistant and resealable package.
          3. Multiple packages may be bundled and sold together so long as the total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.
          4. For Medical Marijuana Ingestibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.
          5. For Medical Marijuana Ingestibles in liquid form with multiple serving units, the container must have a resealing cap or closure.
          6. Medical Marijuana Ingestibles in liquid form with multiple serving units must include within the package:
            1. A measuring device such as a measuring cap, cup or dropper that is capable of dispensing a ten (10) mg serving unit;
            2. Hash marks on the package do not qualify as a measuring device.
      6. Additional Packaging Requirements for Retail-Ready Medical Concentrates
          1. Cartridges and any other devices, as determined by DBR, shall receive a consumer testing certificate which is subject to DBR review.
          2. Electronic vaporization devices must have internal or external temperature controls to prevent combustion and have a heating element made of inert material.
          3. The total THC per package shall not exceed 500 mgs.
  3. General Labeling Requirements
      1. Each package containing retail-ready medical marijuana products must be labeled with all required information pursuant to § 1.5 of this Part before being sold to a registered patient, registered primary caregiver or authorized purchaser.
      2. Labeling text must be:
          1. No smaller than size 6 font, unless otherwise specified.
          2. In Times New Roman, Calibri, Arial, Helvetica or any other font determined by DBR to be easily read.
          3. In black or white, unless otherwise specified.
          4. Clearly written or printed in the English language.
            1. In addition to the required English label, licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules.
      3. All required information must be unobstructed and conspicuous. Multiple labels may be affixed to the package, provided that none of the information required is obstructed.
      4. Required information may be stated in a peel-back accordion, expandable, or extendable style so long as the label can be easily identified by a consumer as containing important information.
      5. All packages containing retail-ready medical marijuana products must be clearly labeled with the following information:
          1. The business(es) or tradename(s) and license number(s) of the licensee(s) who produced the product;
          2. The business or trade name and license number of the compassion center selling the product;
          3. The unique identifier generated by the Medical Marijuana Program Tracking System;
          4. Total THC and Total CBD as provided by a licensed cannabis testing laboratory;a. Upon request, a compassion center must disclose the name of the licensed cannabis testing lab that conducted the tests and provide the results of all required tests for any medical marijuana or medical marijuana product.
          5. A DBR-selected universal warning symbol must appear on the front or most predominantly displayed area of the package, no smaller than one (1) inch by one (1) inch;a. Vape cartridges sold containing medical marijuana product must include the DBR-approved symbol in a manner that is clear and conspicuous;
          6. If applicable, the recommended expiration date, or “use by” date;
          7. Poison Control Contact Information “American Association of Poison Control Center (800) 222-1222 “; and
          8. For smokable and vapable products, the net weight of the medical marijuana product prior to its placement in the package, using a standard of measure compatible with the tracking system.
      6. Additional Labeling Requirements for Retail-Ready Medical Marijuana Infused Products:
          1. Total contents of THC and CBD must be stated per serving unit in milligrams (mgs), and in font larger than size 6, bolded, underlined and in red, so as to stand from surrounding text to the consumer;
          2. Total contents of THC and CBD must be stated per package, in milligrams (mgs), in font larger than size 6, bolded, underlined and in red, so as to stand out from surrounding text to the consumer;
          3. The serving size; and
          4. The number of servings per package.
      7. The following information may be placed on an insert but must accompany each retail-ready medical marijuana product sold:
          1. A complete list of all nonorganic pesticides, herbicides, and fertilizers that were used in the cultivation and production of the medical marijuana product;
          2. For medical marijuana infused products, the net weight of the medical marijuana or medical marijuana product prior to its placement in a package, using a standard of measure compatible with the tracking system;
          3. For medical marijuana products consisting in whole or in part of marijuana flower or marijuana trim, the date of the harvest batch;
          4. For marijuana products including concentrates and marijuana infused products that were manufactured, the date on which the manufacturing batch was created;
          5. For processed medical marijuana products, the processing technique or solvent(s) used to produce the product;
          6. For processed medical marijuana products, a list of all chemicals, diluents, additives, ingredients and/or excipients used to produce the medical marijuana product or that were added to the medical marijuana product;
          7. For medical marijuana infused products, a list of all ingredients used to manufacture the marijuana infused product, including identification of any major allergens contained in the product in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010), specifically milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans;
          8. For medical marijuana edibles and ingestibles, a nutritional fact panel in accordance with 21 C.F.R. Part 101, incorporated above at §1.1.7(B) of this Part;
          9. For medical marijuana topicals, a list of all ingredients in descending order of predominance by weight or volume as applicable; and
          10. For medical marijuana topicals, the amount recommended for use at any one time.
  4. Imprinting of the Universal Symbol
      1. As directed by DBR, unless deemed impracticable by DBR, each single standardized serving unit of a medical marijuana infused product shall be marked, stamped or otherwise imprinted with a DBR-selected universal symbol directly on at least one side of the medical marijuana infused product in a manner to cause the universal symbol to be distinguishable and easily recognizable. The universal symbol marking shall:
          1. Be centered either horizontally or vertically on each standardized serving of marijuana; and
          2. If only imprinted on one-side, the imprinted side must be the front or most predominantly displayed area of medical marijuana infused product; and
          3. If centered horizontally on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving’s width, but not less than ¼ inch by ¼ inch; or
          4. If centered vertically on a serving, the height and width of the universal symbol shall be of a size that is at least twenty-five percent (25%) of the serving’s height, but not less than ¼ inch by ¼ inch.
      2. Unless determined by DBR to be impractical, the following categories of marijuana infused product are considered to be per se practicable to mark with the universal symbol:
          1. Chocolate;
          2. Soft confections;
          3. Hard confections or lozenges;
          4. Consolidated baked goods (e.g. cookie, brownie, cupcake, granola bar); and
          5. Pressed pills and capsules.
  5. Prohibitions
      1. Medical marijuana products shall not:
          1. Be in the shape of a human, animal, fruit, cartoon character, or any other shape that is especially attractive to children as determined by DBR;
          2. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana;
          3. Be in the shape of a marijuana plant or leaf; and
          4. Cause a reasonable consumer confusion as to whether the medical marijuana product is a trademarked product.
      2. All logos or graphics are prohibited unless prior to use are approved by DBR.1. The logo or graphic submitted to DBR for approval:
          1. Must not be larger than the required universal symbol;
          2. Can be colored; and
          3. Must only be used for the purpose of identifying the compassion center selling and/or the cultivator(s) producing the product.
          4. The logo or graphic submitted to DBR for approval must not:a. Reasonably appear to target individuals under the age of twenty-one (21), including but not limited to, the use of animal characters, toys, cartoon characters or similar images.
            1. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana.c. Include images of children or minors.d. Include images of a marijuana plant, marijuana leaf or marijuana product or any person using or consuming the product.
            2. Include words, a design or brand that resembles a product that is commonly associated with children or minors or marketed to children or minors.f. Include symbols or celebrities that are commonly used to market products to minors.
            3. Include the word or make any reference to “candy” or “candies”.
            4. Include any false or misleading statements, including any statements regarding health or physical benefits to the consumer.
            5. Include any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any reasonably prudent person to believe that the product has been endorsed or manufactured by the State of Rhode Island or any agency or municipality thereof.
            6. Cause a reasonable consumer confusion as to whether the medical marijuana or medical marijuana product is a trademarked product.
            7. Violate any state or federal trademark law or regulation.
  6. Warnings
      1. Warnings on all retail-ready medical marijuana products must:
          1. Be in the English language;
          2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;
          3. Be in text no smaller than size 8 font and bolded;
          4. Not be covered or obscured; and
          5. Be displayed in a bright yellow box as to stand out from other labeling requirements, unless otherwise stated.
      2. The following warnings must be displayed on all medical marijuana products, when applicable;
          1. “Warning: For Medical use ONLY. This product contains marijuana. Store in a securely locked cabinet away from children.”
          2. “Warning: It is unlawful to transport this product outside of Rhode Island.”
          3. “Warning: For medical use by a registered patient only. Not for resale.”
          4. For medical marijuana products intended to be smoked or vaporized:
          5. “Warning: Smoking and Vaping is hazardous to your health.”b. “Warning;
          6. Vaping can expose you to toxic chemicals that may lead to death”.
          7. For all medical marijuana infused products, it must state in slightly larger or bolded font as to stand out from surrounding text, with priority placement,a. “Effects of this product may be delayed by 3 or more hours.”
          8. For all topical products, it must state:a. “For Topical Application – Do Not Eat or Smoke.”C. In addition to the warnings above, rotating warnings must accompany all retail-ready medical marijuana products at the point of sale.
      3. Rotating warnings shall:
          1. Be in the English language;
          2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;
          3. Be in text no smaller than size 10 font and bolded; and
          4. Not cover or obscure any required information pursuant to § 1.5 of this Part.
          5. Accompany all retail-ready medical marijuana products at the point of sale based on a rotating schedule as determined by DBR.
      4. The rotating warnings are:
          1. “Warning: Marijuana has intoxicating effects and may be habit forming and addictive.”
          2. “Warning: Do not operate a vehicle or machinery under the influence of marijuana.”
          3. “Warning: Marijuana should not be used by women that are pregnant or breastfeeding.”
          4. “Warning: Early and frequent cannabis use has been associated with the onset of psychosis.”F. Compassion Centers shall post any additional warnings at the point of sale as determined by DBR.
  1. Before a consumable hemp product that contains or is marketed as containing more than trace amounts of cannabinoids may be distributed or sold, the product must be labeled in the manner provided by this section with the following information:
      1. batch identification number;
      2. batch date;
      3. product name;
      4. a uniform resource locator (URL) that provides or links to a certificate of analysis for the product or each hemp-derived ingredient of the product;
      5. the name of the product’s manufacturer; and
          1. a certification that the delta-9 tetrahydrocannabinol concentration of the product or each hemp-derived ingredient of the product is not more than 0.3 percent.
  2. The label required by Subsection (1) may be in the form of:
      1. a uniform resource locator (URL) for the manufacturer’s Internet website that provides or links to the information required by that subsection; and
      2. a QR code or other bar code that may be scanned and that leads to the information required by that subsection.
  3. The label required by Subsection (1) must appear on each unit of the product intended for individual retail sale. If that unit includes inner and outer packaging, the label may appear on any of that packaging.
      1. This section does not apply to sterilized seeds incapable of beginning germination.
  1. The label of a cannabinoid product shall contain the following information, legibly displayed:
      1. product name or common name, on the front of the label;
      2. brand name, on the front of the label;
      3. the size of the container or net count of individual items, on the front of the label;
      4. net weight;
      5. the suggested use of the product, including serving size if the product is intended for consumption;
      6. list of ingredients, including:
          1. the amount of any advertised cannabinoid listed as present on the COA;
          2. the amount of any primary cannabinoid listed as present on the COA; and
          3. the amount of any THC or any THC analog listed as present on the COA;
      7. list of allergens;
      8. manufacturer, packer, or distributor name and address; and
          1. batch number.
  2. A fact panel may be included on the product label if it is not identified as a Drug Fact Panel or Nutritional Fact Panel.
  3. The label of each product intended for human consumption or intended to be vaporized for inhalation shall include the following text, prominently displayed: “This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
  4. Cannabinoid products containing a cannabinoid other than CBD produced for absorption by humans shall contain the following text, prominently displayed: “Warning – The safety of this product has not been determined.”
  5. Notwithstanding Subsection R68-26-5(1) a cannabinoid product produced for human use that has a National Drug Code issued shall be labeled in accordance with 21 CFR 201.66.
  6. In addition to the requirements of Subsections R68-26-5(1) through R68-26-5(5) a cannabinoid product shall have on the label a scannable barcode, QR code, or web address with an easily located certificate of analysis for the batch identified, containing the information required in Section R68-26-4.
  7. Cannabinoid products may not contain medical claims on the label unless the product has been registered with the FDA and is labeled in accordance with Subsection R68-26-5(5).
  8. Cannabinoid product labeling shall clearly show that the product contains material derived from industrial hemp and not cannabis or medical cannabis.
  9. Cannabinoid product labeling may not:
      1. have any likeness bearing resemblance to a cartoon character or fictional character; or
      2. appear to imitate a food or other product that is typically marketed toward or appealing to children.
  10. A cannabinoid product that is designed to be inhaled shall include a warning on the label regarding the possible health effects of inhaling cannabinoid products.
  11. The label of cannabinoid products intended for oral consumption by animals shall include the amount of cannabinoids per serving determined by weight of the animal.
  12. The label of cannabinoid products intended for consumption by animal may not:
      1. contain any feed claims;
      2. be labeled as food; or
      3. contain any Food and Drug Administration evaluation statement.
  13. A cannabinoid product is considered misbranded if its label is false or misleading in any way.
  • A registered dispensary shall package all marijuana dispensed in an envelope or other container used and intended for sale.
  • A label shall be affixed on the packaging of all marijuana that is dispensed. The label shall identify the particular strain of marijuana and the weight of marijuana contained within the package in gram or ounce units. Marijuana strains shall reflect the properties of the plant.
  • Additionally, the label shall contain a statement to the effect that the State of Vermont does not attest to the medicinal value of cannabis, a statement that this product is not for resale, and clearly identify “marijuana” is contained within the packaging.
  • The dispensary shall verify the amount of all marijuana dispensed.
  • Documentation shall be maintained containing at a minimum the name and registry identification number of the registered dispensary cardholders verifying the amount of marijuana and any errors identified.
  1. Cannabis products produced as a batch shall not be adulterated.
  2. Cannabis products produced as a batch shall be:
      1. Processed, packaged, and labeled according to the U.S. Food and Drug Administration’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 21 CFR Part 111; and
      2. Labeled with:
          1. The name and address of the pharmaceutical processor;
          2. The brand name of the cannabis product that was registered with the board pursuant to 18VAC110-20-285;
          3. A unique serial number that matches the product with the pharmaceutical processor batch and lot number, including the cultivator and manufacturer if produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, so as to facilitate any warnings or recalls the board or pharmaceutical processor deem appropriate;
          4. The date of testing and packaging;
          5. For products produced from bulk cannabis oil, botanical cannabis, or usable cannabis obtained through distribution from another pharmaceutical processor, the name and address of the testing laboratory;
          6. The expiration date, which shall be six months or less from the date of the cannabis product registration approval, unless supported by stability testing;
          7. The quantity of cannabis products contained in the batch;
          8. A terpenes profile and a list of all active ingredients, including:
            1. Tetrahydrocannabinol (THC);
            2. Tetrahydrocannabinol acid (THC-A);
            3. Cannabidiol (CBD); and
            4. Cannabidiolic acid (CBDA).
  3. For botanical cannabis products, only the total cannabidiol (CBD) and total tetrahydrocannabinol (THC) are required;
  4. For cannabis oil products, pass or fail rating based on the laboratory’s microbiological, mycotoxins, heavy metals, residual solvents, and pesticide chemical residue analysis; and
  5. For botanical cannabis products, a pass or fail rating based on the laboratory’s microbiological, mycotoxins, heavy metals, pesticide chemical residue analysis, water activity, and moisture content, and the potency.

(1) The following definitions apply to this section, unless the context clearly indicates otherwise:

(a) “Cartoon” means any drawing or other depiction of an object, person, animal, creature, or any similar caricature that meets any of the following criteria:

(i) The use of comically exaggerated features;

(ii) The attribution of human characteristics to animals, plants, or other objects;

(iii) The attribution of animal, plant, or other object characteristics to humans;

(iv) The attribution of unnatural or extra-human abilities.

(b) “Child resistant packaging” means packaging that is used to reduce the risk of poisoning in persons under the age of 21 through the ingestion of potentially hazardous items including, but not limited to, cannabis concentrates, usable cannabis, and cannabis-infused products.

(c) “Especially appealing to persons under the age of 21” means a product or label that includes, but is not limited to:

(i) The use of cartoons;

(ii) Bubble-type or other cartoon-like font;

(iii) A design, brand, or name that resembles a noncannabis consumer product that is marketed to persons under the age of 21;

(iv) Symbols or celebrities that are commonly used to market products to persons under the age of 21;

(v) Images of persons under the age of 21; or

(vi) Similarities to products or words that refer to products that are commonly associated or marketed to persons under the age of 21.

(d) “Cannabis concentrates” means products consisting wholly or in part of the resin extracted from any part of the plant Cannabis and having a THC concentration greater than 10 percent, consistent with RCW 69.50.101(z).

(e) “Cannabis edible” means a cannabis-infused product as defined in RCW 69.50.101(ff).

(f) “Cannabis topical” or “topical” means any product containing parts of the cannabis plant that is intended for application to the body’s surface including, but not limited to, lotions, ointments, salves, gels, or cream that are not intended for ingestion, inhalation, or insertion by humans or animals.

(g) “Structure and function claims” mean a description of the role of a cannabis product intended to affect normal structure and function in humans, characterized by the means by which a cannabis product acts to maintain such structure or function, or describe the general well-being from consumption of a cannabis product, consistent with the guidance provided in 21 U.S.C. Sec. 343(6).

(h) “Useable cannabis” means dried cannabis flowers consistent with RCW 69.50.101(ww). The term “usable cannabis” does not include either cannabis-infused products or cannabis concentrates.

(2) Cannabis concentrates. The following standards apply to all packaging and labeling of cannabis concentrates:

(a) Containers or packaging containing cannabis concentrates must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the cannabis concentrate.

(b) Cannabis concentrates must be packaged:

(i) In child resistant packaging consistent with 16 C.F.R. Part 1700, Poison Prevention Packaging Act; or

(ii) In plastic that is two mil or greater in thickness, heat sealed without an easy-open tab, dimple, corner, or flap that will protect persons under the age of 21 from accidental exposure to cannabis concentrates.

(c) Cannabis concentrates must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(d) Cannabis concentrate labels must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(e) Cannabis concentrate labels must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the cannabis producer and processor;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) The net weight in ounces and grams or volume as applicable;

(iv) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(v) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use;

(vi) If solvents were used to create concentrate or extract, a statement that discloses the type of extraction method, including in solvents or gases used to create the concentrate; and

(vii) A complete list of any other chemicals, compounds, additives, thickening agents, terpenes, or other substances used to produce or added to the concentrate or extract at any point during production. A copy of the complete list of chemicals, compounds, additives, thickening agents, terpenes, or other substances must be kept and maintained at the facility in which the cannabis concentrates are processed.

(f) Cannabis concentrate labels may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents that the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis; or

(v) Is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(g) The following statements must be included on all cannabis concentrate labels:

(i) “Warning – May be habit forming;”

(ii) “Unlawful outside Washington State;”

(iii) “It is illegal to operate a motor vehicle while under the influence of cannabis;”

(iv) The cannabis universal symbol as provided in WAC 314-55-106; and

(v) “Smoking is hazardous to your health.”

(h) Product labeling for cannabis concentrates identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(i) Where there is one statement made under (h) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product that is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(j) Where there is more than one statement made under (h) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product that is not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(3) Cannabis edibles in solid form. The following standards apply to all packaging and labeling of cannabis edibles in solid form:

(a) Containers or packaging containing cannabis edibles in solid form must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the cannabis edibles in solid form.

(b) Cannabis edibles in solid form must be packaged:

(i) In child resistant packaging consistent with 16 C.F.R. Part 1700, Poison Prevention Packaging Act; or

(ii) In plastic that is two mil or greater in thickness, heat sealed without an easy-open tab, dimple, corner, or flap that will protect persons under the age of 21 from accidental exposure to cannabis edibles in solid form.

(c) Cannabis-infused edibles in solid form, such as capsules, lozenges, and similar products approved by the board on a case-by-case basis may be packaged loosely within a resealing outer package that is child resistant in accordance with Title 16 C.F.R. 1700 of the Poison Prevention Packaging Act.

(d) Cannabis edibles in solid form must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(e) Labels for cannabis edibles in solid form must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(f) Labels for cannabis edibles in solid form must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the licensees that produced and processed the cannabis or cannabis products;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) The serving size and the number of servings contained within the unit. If more than one serving is in a package, the label must prominently display the serving size, the number of servings in the package and the amount of product per serving;

(iv) Net weight in ounces and grams or volume as applicable;

(v) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(vi) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use;

(vii) A list of ingredients in descending order of predominance by weight or volume as applicable and a list of major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004;

(viii) If solvents were used, a statement that discloses the type of extraction method, including any solvents, gases, or other chemicals or compounds used to produce or that were added to the extract.

(g) Labels for cannabis edibles in solid form may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents that the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis, or is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(h) The following warning statements must be included on all labels for all cannabis edibles in solid form. The following warning statements must be legible, unobscured, and visible to the consumer:

(i) “Warning – May be habit forming;”

(ii) “Unlawful outside Washington State;”

(iii) “It is illegal to operate a motor vehicle under the influence of cannabis;”

(iv) The cannabis universal symbol as provided in WAC 314-55-106; and

(v) “Caution: Intoxicating effects may be delayed by 2+ hours.”

(i) Product labeling for cannabis edibles in solid form identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(j) Where there is one statement made under (i) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided it is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(k) Where there is more than one statement made under (h) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided they are not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(4) Cannabis edibles in liquid form. The following standards apply to all packaging and labeling of cannabis edibles in liquid form:

(a) Containers or packaging containing cannabis edibles in liquid form must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the cannabis edibles in liquid form.

(b) Cannabis edibles in liquid form must be packaged:

(i) In child resistant packaging consistent with 16 C.F.R. Part 1700, Poison Prevention Packaging Act; or

(ii) In plastic that is two mil or greater in thickness, heat sealed without an easy-open tab, dimple, corner, or flap that will protect persons under the age of 21 from accidental exposure to cannabis edibles in liquid form.

(iii) Cannabis edibles in liquid form that include more than one serving must be packaged with a resealable closure or cap. Cannabis edibles in liquid form must include a measuring device such as a measuring cup or dropper. Hash marks on the bottle or package qualify as a measuring device.

(c) Cannabis edibles in liquid form must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(d) Labels for cannabis edibles in liquid form must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(e) Labels for cannabis edibles in liquid form must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the licensees that produced and processed the cannabis or cannabis products;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) The serving size and the number of servings contained within the unit. If more than one serving is in a package, the label must prominently display the serving size, the number of servings in the package and the amount of product per serving;

(iv) Net weight in ounces and grams or volume as applicable;

(v) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(vi) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use;

(vii) A list of all ingredients in descending order of predominance by weight or volume as applicable and a list of major food allergens as defined in the Food Allergen Labeling and Protections Act of 2004;

(viii) If solvents were used, a statement that discloses the type of extraction method, including any solvents, gases, or other chemicals or compounds used to produce or added to the extract.

(f) Labels for cannabis edibles in liquid form may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis, or is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(g) The following warning statements must be included on all labels for all cannabis edibles in liquid form. The following warning statements must be legible, unobscured, and visible to the consumer:

(i) “Warning – May be habit forming;”

(ii) “Unlawful outside Washington State;”

(iii) “It is illegal to operate a motor vehicle under the influence of cannabis;”

(iv) The cannabis universal symbol as provided in WAC 314-55-106; and

(v) “Caution: Intoxicating effects may be delayed by 2+ hours.”

(h) Product labeling for cannabis edibles in liquid form identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(i) Where there is one statement made under (h) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided it is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(j) Where there is more than one statement made under (h) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided they are not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(5) Useable cannabis. The following standards apply to all packaging and labeling of useable cannabis:

(a) Containers or packaging containing usable cannabis must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the usable cannabis.

(b) Usable cannabis must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(c) Usable cannabis must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(d) Labels for useable cannabis must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the licensees that produced and processed the cannabis or cannabis products;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) Net weight in ounces and grams or volume as applicable;

(iv) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(v) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use.

(e) Labels for useable cannabis may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis, or is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(f) The following warning statements must be included on all labels for all usable cannabis. The following warning statements must be legible, unobscured, and visible to the consumer:

(i) “Warning – May be habit forming;”

(ii) “Unlawful outside Washington State;”

(iii) “It is illegal to operate a motor vehicle under the influence of cannabis;”

(iv) The cannabis universal symbol as provided in WAC 314-55-106; and

(v) “Smoking is hazardous to your health.”

(g) Product labeling for useable cannabis identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(h) Where there is one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided it is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(i) Where there is more than one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided they are not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(6) Cannabis mix. Cannabis mix is defined in WAC 314-55-010(22) as an intermediate lot that contains multiple strains of usable cannabis and is chopped or ground so no particles are greater than 3 mm. The following standards apply to all packaging and labeling of cannabis mix:

(a) Containers or packaging containing cannabis mix must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the cannabis mix.

(b) Cannabis mix must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(c) Cannabis mix must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(d) Labels for cannabis mix must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the licensees that produced and processed the cannabis or cannabis products;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) Net weight in ounces and grams or volume as applicable;

(iv) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(v) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use;

(vi) If solvents were used, a statement that discloses the type of extraction method, including any solvents, gases, or other chemicals or compounds used to produce or added to the extract;

(vii) Any other chemicals or compounds used to produce or were added to the concentrate or extract.

(e) Labels for cannabis mix form may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis, or is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(f) The following warning statements must be included on all labels for all cannabis mixes. The following warning statements must legible, unobscured, and visible to the consumer:

(i) “Warning – May be habit forming;”

(ii) “Unlawful outside Washington State;”

(iii) “It is illegal to operate a motor vehicle under the influence of cannabis;”

(iv) The cannabis universal symbol as provided in WAC 314-55-106; and

(v) “Smoking is hazardous to your health.”

(g) Product labeling for cannabis mix identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(h) Where there is one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided it is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(i) Where there is more than one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided they are not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(7) Cannabis topicals. The following standards apply to all packaging and labeling of cannabis topicals:

(a) Containers or packaging containing a cannabis topical must protect the product from contamination. Containers or packaging must not impart any toxic or harmful substance to the cannabis topical.

(b) Cannabis topicals must not be labeled as organic unless permitted by the U.S. Department of Agriculture consistent with the Organic Foods Production Act.

(c) Cannabis topicals must comply with the version of NIST Handbook 130, Uniform Packaging and Labeling regulation adopted in chapter 16-662 WAC.

(d) Labels for cannabis topicals must clearly and visibly provide all of the following information:

(i) The business or trade name and the nine digit Washington state unified business identifier (UBI) number of the licensees that produced and processed the cannabis or cannabis products;

(ii) The lot number of the product (the unique identifier number generated by the board’s traceability system). This must be the same number that appears on the transport manifest;

(iii) The label must prominently display the net weight in ounces and grams or volume as applicable, and may not exceed serving and transaction limits as described in WAC 314-55-095;

(iv) Total THC (delta-9-tetrahydrocannabinol) meaning the concentration of THC and THCA, total CBD (cannabidiol) meaning the concentration of CBDA and CBD, using the formulas referenced in WAC 314-55-102;

(v) Medically and scientifically accurate and reliable information about the health and safety risks posed by cannabis use; and

(vi) A list of all ingredients in descending order of predominance by weight or volume as applicable.

(e) Labels for cannabis topicals may not contain any statement, depiction, or illustration that:

(i) Is false or misleading, consistent with guidance provided in 21 C.F.R. Sec. 101.18(a);

(ii) Promotes over consumption;

(iii) Represents the use of cannabis has curative or therapeutic effects;

(iv) Depicts a person under the age of 21 consuming cannabis, or is especially appealing to persons under 21 years of age as defined in subsection (1)(c) of this section.

(f) The following warning statements must be included on all labels for all cannabis topicals. The following warning statements must be legible, unobscured, and visible to the consumer:

(i) “Unlawful outside Washington State;”

(ii) The cannabis universal symbol as provided in WAC 314-55-106; and

(iii) “DO NOT EAT” in bold, capital letters.

(g) Product labeling for cannabis topicals identified as compliant cannabis product under RCW 69.50.375(4) and chapter 246-70 WAC may include:

(i) A structure or function claim describing the intended role of the product to maintain the structure or any function of the body; or

(ii) Characterization of the documented mechanism by which the product acts to maintain such structure or function, provided that the claim is truthful and not misleading.

(iii) Any statement made under this subsection may not claim to diagnose, mitigate, treat, cure, or prevent any disease.

(h) Where there is one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided it is not false or misleading, the disclaimer must state, “This statement has not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(i) Where there is more than one statement made under (g) of this subsection, or there is a warning describing the psychoactive effects of the cannabis product, provided they are not false or misleading, the disclaimer must state, “These statements have not been evaluated by the State of Washington. This product is not intended to diagnose, treat, cure, or prevent any disease.”

(8) Optional label information. Optional label information includes the following: Harvest date, “best by” date, and manufactured dates.

(9) Accompanying materials. Accompanying materials must be provided with a cannabis product or made available to the consumer purchasing cannabis products.

A producer or processor must provide the following product-specific information, for as long as the product is for sale, through an internet link, web address, or QR code on the product label as follows:

(a) A statement disclosing all pesticides applied to the cannabis plants and growing medium during production of the useable cannabis or the base cannabis used to create the concentrate or the extract added to infused products;

(b) A list disclosing all of the chemicals, compounds, additives, thickening agents, terpenes, or other substances added to any cannabis concentrate during or after production.

(10) Upon request materials. A consumer may request the name of the certified lab and quality assurance test results for any cannabis or cannabis product. A retailer must provide the information upon request.

  1. A grower/processor must package and label at its facility each form of medical cannabis prepared for sale. The original seal of a package may not be broken, except for quality control testing at an approved laboratory, for adverse loss investigations conducted by the bureau or by a dispensary that purchased the medical cannabis.
  2. A grower/processor must package the medical cannabis in a package that minimizes exposure to oxygen and that is:
      1. Child-resistant;
      2. Tamper-proof or tamper-evident;
      3. Light-resistant and opaque; and
      4. Resealable.
  3. A grower/processor must identify each process lot of medical cannabis with a unique identifier.
  4. A grower/processor must obtain the prior written approval of the bureau of the content of any label to be affixed to a medical cannabis package. Each label must:
      1. Be easily readable;
      2. Made of weather-resistant and tamper-resistant materials;
      3. Be conspicuously placed on the package;
      4. Include the name, address, and permit number of the grower/processor;
      5. List the form, quantity, and weight of medical cannabis included in the package;
      6. List the number of individual doses contained within the package, and the species and percentage of THC and CBD;
      7. Contain an identifier that is unique to a particular harvest batch of medical cannabis, including the number assigned to each harvest lot or process lot in the harvest batch
      8. Include the date the medical cannabis was packaged;
      9. State the employee identification number of the employee preparing the package and packaging the medical cannabis;
      10. State the employee identification number of the employee shipping the package, if different than the employee described in subdivision
      11. Contain the name and address of the dispensary to which the package is to be sold;
      12. List the date of expiration of the medical cannabis;
      13. Include instructions for proper storage of the medical cannabis in the package;
      14. Contain the following warning stating: “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant’s pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.”;
      15. Contain a warning that the medical cannabis must be kept in the original container in which it was dispensed; and
      16. Contain a warning that unauthorized use is unlawful and will subject the purchaser to criminal penalties.
  5. Labeling by a grower/processor of any medical cannabis may not bear:
      1. Any resemblance to the trademarked, characteristic, or product-specialized packaging of any commercially available food or beverage product;
      2. Any statement, artwork, or design that could reasonably lead an individual to believe that the package contains anything other than medical cannabis;
      3. Any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured, or approved for use by any state, county, or municipality or any agency thereof; or
      4. Any cartoon, color scheme, image, graphic, or feature that might make the package attractive to children.
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