NACB NATIONAL STANDARDS

NACB Packaging and Labeling Standard

Standard Last Updated: May 17, 2018

After accounting for the input of the public and various experts, the NACB’s members voted to adopt the NACB Packaging and Labeling Standards on May 17, 2018.

ARTICLE 2. PACKAGING AND LABELING.

Standard 2.01.  Compliance.

1. Before selling or transferring Cannabis or a Cannabis Product to a Cannabis Retailer, a Cannabis Cultivator or Cannabis Processor shall ensure that the Cannabis or Cannabis Product meets the requirements of this Article.
2. Before selling or transferring Cannabis or a Cannabis Product to a consumer or another Cannabis Retailer, a Cannabis Retailer shall ensure that the Cannabis or Cannabis Product meets the requirements of this Article. A Cannabis Retailer may not knowingly purchase, take possession of, or sell or transfer to a consumer Cannabis or a Cannabis Product that does not meet the requirements of this Article.
3. Notwithstanding Subsection (b) of this Standard, a Cannabis Retailer is not required to open and inspect any tamper-evident layer of packaging that is external to the Container, as described by Standard 2.08.

Standard 2.02. Child-Resistant Packaging.

1. In this Article, “Child- Resistant” means special packaging that is opaque and designed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
2. A Container or exit package is considered “Child-Resistant” if it:
   1. is certified as “special packaging” in accordance with 16 C.F.R. Part 1700 (Poison Prevention Packaging Act of 1970 Regulations);
   2. is certified as “special packaging” in accordance with 16 C.F.R. 1700.15 and 1700.20 (Poison Prevention Packaging Act of 1970 Regulations), as those sections existed on January 1, 1997;
   3. is packaged in plastic at least four mils thick and is heat-sealed with no easy-open tab, dimple, corner, or flap;
   4. for liquid Edible Cannabis Product Containers, is packaged in plastic at least four mils thick and is sealed using a metal crown cork-style bottle cap; or
   5. otherwise satisfies the requirements of Subsection (a) of this Standard.
3. A Child-Resistant Container or exit package containing the following products must maintain its Child-Resistant effectiveness for multiple openings:
   
   1. Cannabis;
   2. Cannabis Products, other than topical Cannabis Products, that contain more than one Standard Serving of active THC; and
   3. topical Cannabis Products
4. If, in order to accommodate elderly or handicapped persons, a state law or regulation provides an exception to the state’s requirement that a Container or exit package be Child-Resistant, a Cannabis Establishment operating in that state is exempt from the Child-Resistant requirements of this Article to the extent of the state’s exception.

Notes, Standard 2.02: These Standards do not prohibit Cannabis Retailers from displaying products that are not for sale in packaging that is not opaque or child-resistant (i.e., display products). However, under these Standards, the sale of such display products is prohibited unless such display products are packaged in a manner that meets the requirements of this Article prior to sale.

Standard 2.03. Certificate of Conformance; Child-Resistant Packaging.

1. A Cannabis Establishment that is required to transfer Cannabis or Cannabis Products in Child-Resistant Containers or exit packages shall, with each shipment of Child-Resistant Containers or exit packages, obtain from the manufacturer of the Containers or exit packages a certificate of conformance that:
   1. certifies that the Containers or exit packages being delivered meet the standards for which the Containers or exit packages were certified as Child-Resistant; and
   2. identifies the batch and lot numbers assigned by the manufacturer of the Child-Resistant Containers or exit packages.
2. A Cannabis Establishment that is required to transfer Cannabis or Cannabis Products in any Containers shall, with each shipment of containers, obtain from the manufacturer of the Containers or exit packages a certificate of conformance that:
   1. certifies that the Containers or exit packages being delivered meet the standards for which the Containers were certified as meeting the requirements for package integrity in Standard 2.24; and
   2. identifies the batch and lot numbers assigned by the manufacturer of the Containers.

Standard 2.04. Packaging of Cannabis.

1. A Cannabis Retailer shall ensure that Cannabis Flower and Trim are placed in a Container prior to sale or transfer to a consumer. The Container may be, but is not required to be, Child-Resistant.

2. If the Cannabis Flower or Trim Container is not Child-Resistant, the Cannabis Retailer shall place the Container in a Child-Resistant exit package at the point of sale to a consumer.

Notes, Standard 2.04: Unlike for other products, the new Colorado regulations (effective 1/1/18) do not require cannabis flower or trim to be packaged in a Child- Resistant Container prior to being placed in a Child-Resistant exit package. Rather, flower and trim may be given to the consumer in a Child-Resistant exit package.

Standard 2.05.Packaging of Cannabis Concentrates and Cannabis Products for Retail; Generally.

A Cannabis Establishment shall ensure that Cannabis Concentrates and Cannabis Products are placed in a Child-Resistant Container prior to sale or transfer to a consumer or another Cannabis Establishment.

Standard 2.06. Packaging of Edible Cannabis Products for Retail.

1. A solid Edible Cannabis Product containing more than one Standard Serving of active THC must either:
   1. be separated into internal Containers of one Standard Serving or less of active THC, with:
      1. the external packaging being Child-Resistant and meeting the labeling requirements of this Article and the internal Containers being labeled with the Warning Symbol described by Standard 2.10 but not being required to be opaque or Child-Resistant; or
      2. the internal Containers being Child-Resistant and being labeled with the Warning Symbol described by Standard 2.10 and the external packaging being subject to the labeling requirements of this Article but not being required to be opaque or Child-Resistant; or
   2. be packaged in a single Child-Resistant Container and demarcated into separate or easily separable Standard Servings or less of active THC.
2. Except as provided by Subsection (d) of this Standard, a Cannabis Processor shall mark, stamp, or otherwise imprint an indication that the solid Edible Cannabis Product contains THC or marijuana or cannabis, such as the Warning Symbol described by Standard 2.10, on:
   1. each solid Edible Cannabis Product containing one Standard Serving or less of active THC; and
   2. each serving, as described by Subsection (a)(1) or (a)(2) of this Standard, of a solid Edible Cannabis Product containing more than one Standard Serving of active THC.
3. The indication described by Subsection (b) of this Standard must be marked, stamped, or otherwise imprinted in a manner to cause the indication to be distinguishable and easily recognizable to consumers.
4. A solid Edible Cannabis Product (such as granola, popcorn, or powder) on which it is impracticable to mark, stamp, or otherwise imprint an indication in the manner described by Subsection (c) of this Standard may contain more than one Standard Serving of active THC only if it complies with Subsection (a)(1) of this Standard.
5. A solid Edible Cannabis Product that is of a type that is impracticable to demarcate into separate or easily separable servings of one Standard Serving or less of active THC as described by Subsection (a)(2) of this Standard may contain more than one Standard Serving of active THC only if it complies with Subsection (a)(1) of this Standard.
6. A liquid Edible Cannabis Product containing more than one Standard Serving of active THC must be placed in a Child-Resistant Container that includes a measuring component that enables a user to pour increments of one Standard Serving or less of active THC. The measuring component must be within the Child-Resistant cap or closure of the bottle and may not be separate from the cap and container. Hash marks on the Container are not sufficient.

Standard 2.07. Exit Packages.

1. A Cannabis Retailer may, but is not required to, place a Container in an exit package at the point of sale to a consumer. Except as required by Standard 2.04(b), the exit package is not required to be opaque or Child-Resistant.

2. An exit package may not contain any statements, claims, or appeals to minors that are prohibited by this Article.

3. The exit package is not required to contain any warnings, statements, symbols, or other information required by this Article.

Standard 2.08. Packaging Layers.

1. A Cannabis Establishment may use additional layers of packaging that are external to the Cannabis’s or Cannabis Product’s Container for display at retail and inclusion in the sale to a consumer.
2. The outermost packaging layer, other than an exit package, of Cannabis or a Cannabis Product must comply with the requirements for Container labels in this Article.
3. Any intermediate layers of packaging that are between the Container and the outermost layer may not contain any statements, claims, or appeals to minors that are prohibited by this Article, but such intermediate layers are not required to contain any warnings, statements, symbols, or other information required by this Article.

Notes, Standard 2.08: The “Container” is the package directly containing the Cannabis or Cannabis Product and is sufficient packaging for sale at retail. Some states have accommodated Cannabis Establishments that wish to include additional external packaging. Called the “marketing layer” in Colorado, the outermost packaging layer will face the consumer at retail and upon sale, so it’s reasonable to require it to convey the same information as is required on Containers. Having a marketing layer does not, however, relieve the Container itself of any labeling obligations, since a consumer is likely to discard a marketing layer soon after purchase.

Standard 2.09. Product Identification.

1. Before transferring Cannabis or a Cannabis Product to a consumer or another Cannabis Establishment, a Cannabis Establishment shall ensure that the Cannabis or Cannabis Product Container includes a label containing a number that identifies the batch of the Cannabis or Cannabis Product. Units of Cannabis or Cannabis Products are in the same batch if they share:
   
   1. for units of Cannabis, the same strain, standard operating procedures, pesticide and other chemical exposure, and time of harvest;
   2. for Cannabis Concentrates, the same concentrate type, extraction method, standard operating procedures, and Cannabis batch(es) of origin; or
   3. for Cannabis Products, the same product type, ingredients, standard operating procedures, and Cannabis batch(es) of origin.
2. Before transferring Cannabis or a Cannabis Product to a consumer or another Cannabis Establishment:
   
   1. a Cannabis Cultivator shall ensure that the Cannabis or Cannabis Product container includes a label containing the Cannabis Cultivator’s license number;
   2. for Cannabis Concentrates, the same concentrate type, extraction method, standard operating procedures, and Cannabis batch(es) of origin; or
   3. for Cannabis Products, the same product type, ingredients, standard operating procedures, and Cannabis batch(es) of origin.
3. Before transferring Cannabis or a Cannabis Product to a consumer or another Cannabis Establishment:
   1. a Cannabis Cultivator shall ensure that the Cannabis or Cannabis Product Container includes a label containing the Cannabis Cultivator’s license number;
   2. a Cannabis Processor shall ensure that the Cannabis or Cannabis Product Container includes a label containing the Cannabis Processor’s license number and the license number of the Cannabis Cultivator or Cultivators that cultivated the Cannabis or Cannabis Product; and
   3. a Cannabis Retailer shall ensure that the Cannabis or Cannabis Product Container includes a label containing the license number of:
      1. the Cannabis Cultivator or Cultivators that cultivated the Cannabis or Cannabis Product; and
      2. the Cannabis Processor that processed the Cannabis or Cannabis Product, if applicable.

Notes, Standard 2.09: Subsection (a) relates to batch numbers, whereas Subsection (b) addresses license numbers. In the latter, the license numbers of the Cultivator(s) and, as applicable, Processor(s) are required on labels, but not the license number of the Retailer. There are circumstances in which the Retailer’s license number would be useful, however, so that question will be revisited when a Standard regarding recall procedures is drafted. Note also that Standard 2.22 requires the Retailer to provide its contact information on the label, perhaps obviating the need for a license number.

Standard 2.10. Warning Symbol.

1. If the state in which a Cannabis Establishment conducts business requires Container labels to include a standardized symbol indicating that the product contains THC or marijuana or cannabis, the Cannabis Establishment must comply with the state law. The symbol must be located on the label or portion of the label designed to be most prominently displayed at retail.
2. If the state in which a Cannabis Establishment conducts business does not require Container labels to include a standardized symbol indicating that the product contains THC or marijuana or cannabis, the Cannabis Establishment must ensure that each Container label includes a symbol indicating that it contains THC or marijuana or cannabis, such as:
   1. the “Universal Symbol” established by the Marijuana Enforcement Division of the Colorado Department of Revenue (see R 103, 1 C.C.R. 212-2);
   2. the “Universal Symbol” established by the Oregon Health Authority (see O.A.R. 333-007-0020(42)); or
   3. the warning symbol created by the Washington Poison Center (see 314 W.A.C. 55-106).
3. A symbol described by Subsection (b) of this Standard must be located on the label or portion of the label designed to be most prominently displayed at retail and must be clear and legible to consumers.

Standard 2.11. Warning Statements.

1. Each Cannabis or Cannabis Product Container must include, on the label or portion of the label designed to be most prominently displayed at retail, the following:
   
   1. a statement indicating that the product contains THC, marijuana, or cannabis; and
   2. a statement indicating that:
      1. for retail Cannabis or Cannabis Products, the product is for use only by adults age 21 or older; or
      2. for medical Cannabis or Cannabis Products, the product is for use only by authorized patients.
2. Each Cannabis or Cannabis Product Container must include a label containing the following warning statements:
   1. a warning that there may be health risks associated with consumption of the Cannabis or Cannabis Product;
   2. a warning that there may be additional health risks associated with consumption of the Cannabis or Cannabis Product for women who are pregnant or breastfeeding, or that scientific research has not yet established the safety of the use of cannabis by women who are pregnant or breastfeeding;
   3. a warning that the use of Cannabis or Cannabis Products may impair the consumer’s ability to drive or operate heavy machinery, or that the consumer should not drive or operate heavy machinery while using the Cannabis or Cannabis Product;
   4. a warning that the Cannabis or Cannabis Product should be kept out of reach of children;
   5. for Cannabis or Cannabis Products the packaging or labeling of which makes a claim about an intended psychological or physiological effect of the Cannabis or Cannabis Product, as described in Standard 2.16(b)(3), a warning that the claim has not been approved by the Food and Drug Administration; and
   6. for Edible Cannabis Products other than tinctures, a warning that the intoxicating effects of the Edible Cannabis Product may be delayed by two or more hours.

Notes, Standard 2.11: These warning statements are required by most or all states. The statements in Subsection (a) are required to be on the principal display panel because they are deemed especially important. To accommodate state variances in phrasing, exact language is not prescribed.

Standard 2.12. False and Misleading Statements Prohibited.

A Cannabis or Cannabis Product Container or label may not contain any false or misleading statements.

Standard 2.13. Appeals to Minors Prohibited.

1. A Cannabis or Cannabis Product Container or label may not be designed to specifically target individuals under 21 years of age, such as by including:

   1. images of cartoon characters, toys, action figures, animals, balloons, or persons under 21 years of age;
   2. the word “candy” or “candies,” except as part of the name of the Cannabis Establishment;
   3. graphics or branding that is similar to commercially available candy; or
   4. symbols or images of celebrities commonly used to market products to persons under 21 years of age.

Standard 2.14. Ingredient List.

Each Cannabis Concentrate or Cannabis Product shall include on a label all ingredients in the Cannabis Concentrate or Cannabis Product, listed by common or usual name in descending order of predominance by weight.

Standard 2.15. Allergen Warnings.

1. The Container or label for an Edible Cannabis Product that contains milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, or soybeans must state that the product “contains” such food allergen(s) and name the food source from which each allergen is derived.

2. If regulations promulgated by the U.S. Food & Drug Administration classify new allergens as “major food allergens,” the requirements of this Standard shall be updated to require that the Container or label for an Edible Cannabis Product state that the product “contains” such food allergen(s) and name the food source from which each allergen is derived.

Notes, Standard 2.15: This Standard is similar to the FDA’s guidance on the Food Allergen Labeling and Consumer Protection Act of 2004, which defines as “major allergens” the allergens listed in Subsection (a) because they account for approximately 90% of all food allergies.

Standard 2.16. Health, Medical, and Disease Claims; Labeling.

1. A Container or label for Cannabis or a Cannabis Product may not:
   
   1. state or imply that the Cannabis or Cannabis Product diagnoses, mitigates, treats, cures, or prevents a disease;
   2. explicitly or implicitly describe the relationship between the Cannabis or Cannabis Product and any health-related condition, except for warning statements;
   3. mimic a brand of over-the-counter or prescription drug; or
   4. use any words, symbols, or images commonly used in or by medical or pharmaceutical professions, including the word “prescription,” the letters “RX,” and a depiction of a caduceus, staff of Asclepius, bowl of Hygeia, or mortar and pestle.
2. Subject to Subsection (a) of this Standard, a Container or label for Cannabis or a Cannabis Product may explicitly describe an intended physical or psychological effect of the Cannabis or Cannabis Product on the consumer only if:
   
   1. the description is a warning statement;
   2. the description is related to a non-cannabis component of a Cannabis Product and is otherwise legally permissible; or
   3. the description:
      1. is substantiated by tests, analyses, research, studies, or other evidence that is based on the expertise of professionals in the relevant area and that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results; and
      2. includes a warning that the effects of the Cannabis or Cannabis Product may vary by consumer.
3. A Cannabis Establishment that includes a description described by Subsection (b)(3) of this Standard on a Container or label for Cannabis or a Cannabis Product shall maintain records substantiating the evidence described by Subsection (b)(3)(A) of this Standard.

Standard 2.17. Health, Medical, and Disease Claims; Retailers.

1. A Cannabis Retailer may not:
   1. state or imply that Cannabis or a Cannabis Product diagnoses, mitigates, treats, cures, or prevents a disease; or
   2. explicitly or implicitly describe the relationship between the Cannabis or Cannabis Product and any health-related condition, except for warning statements.
2. A Cannabis Retailer may describe an intended physical or psychological effect of Cannabis or a Cannabis Product to a consumer only if:
   
   1. the description is substantiated by tests, analyses, research, studies, or other evidence that is based on the expertise of professionals in the relevant area and that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results; and
   2. the Cannabis Retailer notifies the consumer that the effects of the Cannabis or Cannabis Product may vary by consumer.

Notes, Standards 2.16 and 2.17: These Standards closely track the U.S. Food and Drug Administration’s definitions of “disease claims” and “health claims,” which cannot be made without FDA approval. The FDA has not approved cannabis, so “disease claims” and “health claims” cannot be made about cannabis.

These Standards do, however, leave room for certain claims regarding the effects of cannabis. These claims, which are somewhat analogous to what the FDA calls “structure/function claims,” must be substantiated and accompanied by a disclaimer that the effects of cannabis vary by person.

Standard 2.18. Laboratory Testing.

[RESERVED PENDING ADOPTION OF NACB LABORATORY TESTING STANDARDS]

Standard 2.19. Language.

The statements and information required by this Article must be written or printed clearly and in English. In addition to English, a label may include an accurate translation of the required statements and information in another language.

Standard 2.20. Unobstructed and Conspicuous.

Label text must be unobstructed and conspicuous. A Cannabis Establishment may affix multiple labels to a Container, provided that none of the statements or information required by this Article is obstructed.

Standard 2.21. Text Size.

The statements and information required by this Article must be written or printed in fonts and text sizes that are clear and legible to consumers.

Standard 2.22. Contact Information.

Each Cannabis or Cannabis Product Container or label shall state the name of the licensee that produced the product and the licensee’s phone number.

Standard 2.23. Tamper-Evident Packaging.

1. Before transferring Cannabis or a Cannabis Product to a Cannabis Retailer or consumer, a Cannabis Establishment shall ensure that the Cannabis or Cannabis Product Container has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.
2. The following is a non-exhaustive list of packaging features that, if properly designed and applied, meet the requirements of Subsection (a) of this Standard:
   1. a transparent film wrapped securely around the entire Container that must be cut or torn to open the Container and remove the Cannabis or Cannabis Product;
   2. a band or wrapper that is securely applied to the juncture of the cap and Container and that must be cut or torn to open the Container and remove the Cannabis or Cannabis Product;
   3. foil, paper, or plastic pouches that enclose the Cannabis or Cannabis Product and that must be torn or broken to obtain the Cannabis or Cannabis Product; and
   4. a plastic or metal cap that either breaks away completely when removed from the Container or leaves part of the cap attached to the Container and that must be broken to open the Container and remove the Cannabis or Cannabis Product.
3. A tape seal that relies on an adhesive to bond it to the Container and that can be removed and reapplied with no visible evidence of entry does not meet the requirements of Subsection (a) of this Standard.
4. An indicator or barrier to entry described by Subsection (a) of this Standard must be designed to remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

Standard 2.24. Package Integrity.

A Cannabis Establishment shall ensure that Cannabis and Cannabis Products are packaged only in Containers that:

1. are made of materials that are as generally recognized as safe for use as components of articles that contact articles under 21 C.F.R. Parts 170 through 186 (i.e., FDA Generally Recognized as Safe).
2. protect the Cannabis or Cannabis Product against foreseeable external factors that can cause deterioration or contamination of the Cannabis or Cannabis Product.

Standard 2.25. Serving Size.

1. Each Cannabis Product Container containing one Standard Serving or less of active THC shall be affixed with a label stating the total amount of active THC in the Container.
2. Each Cannabis Product Container containing more than one Standard Serving of active THC shall be affixed with a label stating:
   1. the total number of servings in the Container; and
   2. the amount of active THC per serving.

Notes, Standard 2.25: Note that NACB members may determine serving sizes at their discretion, so long as compliance with state law is maintained.

Standard 2.26. Effective Date.

1. A Cannabis Cultivator or Cannabis Processor shall comply with the requirements of this Article beginning on the 180th day after the date this Article is finally adopted by the National Association of Cannabis Businesses.
2. Except as provided by Subsection (c) of this Standard, a Cannabis Retailer shall comply with the requirements of this Article beginning on the 180th day after the date this Article is finally adopted by the National Association of Cannabis Businesses.
3. If, before the date described by Subsection (b), a Cannabis Retailer takes possession of Cannabis or a Cannabis Product that does not comply with the requirements of this Article, the Cannabis Retailer may sell or transfer the Cannabis or Cannabis Product to a consumer until the 270th day after the date this Article is finally adopted by the National Association of Cannabis Businesses.