New York’s Office of Cannabis Management (OCM) recently proposed Adult-Use Packaging and Labeling Rules. The proposed rules will be published in the New York State Register on June 15, 2022, which will trigger the 60-day public comment period. As outlined below, the rules may be restrictive. If these rules go into effect as drafted, New York cannabis licensees may not have much room for creative packaging of their products.
Nothing Attractive to Individuals Under Twenty-One
The proposed rules may be stringent and would be a far departure from what New Yorkers currently see in the unregulated legacy market. Labeling, packaging, advertising, and marketing cannot be attractive to individuals under twenty-one, which OCM defines as “pleasing or appealing to persons under the age of twenty-one by using or including, among other things:
- 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, in labeling, packaging, advertising, or marketing
- Terms ‘candy’ or ‘candies’ or variants in spelling such as ‘kandy’ or ‘kandeez’
- 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.”
Although this definition of the term “attractive to individuals under twenty-one” is detailed, it is not objective, which could be problematic for licensees. For example, it may be difficult to differentiate between bright colors and “neon” colors. A licensee may struggle to determine whether something on a label is commonly used to market something to individuals under the age of twenty-one.
The proposed rules set minimum standards for retail packaging of cannabis products. A retail package shall:
- Be child-resistant (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 §1700.20 for Testing Procedure for Special Packaging, as amended from time to time, and follows the packaging standards set forth in 16 CFR §1700.15 and the testing procedure set forth in 16 CFR §1700.20)
- Be tamper-evident (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).
- Fully enclose the product, minimize oxygen exposure, and prevent the contamination and/or degradation of the cannabis product; and
- Not impart any toxic or deleterious substance onto the cannabis product.
The proposed rules also include packaging prohibitions. A retail package shall not:
- Contain brand elements beyond one brand logo and the brand name (which has size restrictions but can be any font and color as set forth in the proposed rules);
- Contain any pictures, images, or graphics other than what is required by the Office;
- Contain any features that emit scent or sound;
- Contain any features that change or alter a package’s appearance through technology other than for anti-counterfeiting purposes;
- Be made attractive to individuals under twenty-one;
- Be made of single-use plastic, unless containing a minimum 25% post-consumer recycled content; and
- Violate any additional requirements as set out by the OCM.
It appears that OCM wants all cannabis products enclosed in simple packaging that show nothing more than the brand logo and brand name. A cannabis product package could not feature the producers who grew the cannabis contained in those cannabis products. The proposed restrictions could also prohibit licensing agreements in which multiple brands appear on one package.
The proposed rules also encourage sustainable practices. Licensees will submit environmental sustainability programs as part of the application process. The programs may include strategies for collecting reusable cannabis packaging or other sustainable packaging strategies that use non-plastic compostable or recyclable materials. Retail packaging may be reused so long as it has been sanitized and inspected.
Like many other states with adult-use cannabis, the proposed rules impose stringent labeling requirements on all packaging.
First, cannabis products must contain certain information on the principal packaging display panel, which means “the panel of the retail package or the marketing layer that the manufacturer or distributor intends to be displayed at retail.” Principal display panel is a term used by the FDA and usually means the front of the package easily seen by customers. The proposed rules state that the principal packaging display panel “shall have a white background with black text containing the following information:
- Milligrams per single serving of total THC (THC + THCA x 0.877), total CBD (CBD + CBDA x 0.877) content, and any other marketed phytocannabinoids, or terpene profile;
- Milligrams per package of total THC (THC + THCA x 0.877);
- The amount of total THC (THC + THCA x 0.877) and any other marketed phytocannabinoids as a percentage of volume, except if the cannabis product is in the form of an edible;
- Number of servings in total for the cannabis product except for cannabis flower and other forms of cannabis for vaporization;
- Weight of cannabis product; and
- Lot number.”
Many other states require THC serving information on the principal display panel. But it is uncommon for that information to be required on a white background.
In addition to the panel requirements, the “retail package and any marketing layer shall include the following information:
- A list of all ingredients in descending order of predominance by weight in the cannabis product – both active and inactive. The ingredient list must include and separately list, in bold, any major allergens set forth in the Food Allergen Labeling and Consumer Protection Act of 2004, Title 21, as it relates to Food and Drugs, of the U.S. Code § 343, for misbranded food, as amended from time to time.
- Edible products and beverage products will include a nutritional label pursuant to Title 21, as it relates to Food and Drugs, of the Codes of Federal Regulations §101.9(c) for nutrition labeling of food, as amended from time to time.
- A list of any solvent used to produce the cannabis product, if applicable;
- The date of expiration of the unopened cannabis product;
- Use by date;
- The proper storage conditions;
- Name, address, license number, and contact information of the manufacturer or distributor;
- Any one of the following three universal symbols on the upper left 25% of the marketing layer at a minimum size of 1.25 inches in height for the square symbol, 0.5 inch in width for the vertical symbol, and 0.5 inch in height for the horizontal symbol. The symbol must be made conspicuous by printing the symbol on or outlining the symbol with, a contrasting color.
- Total THC and CBD milligrams in bold on the principal packaging display panel or marketing layer
- Include clear usage instructions;
- A scannable bar code or QR code linked to a downloadable certificate of analysis or linked to a website where the certificate of analysis can be downloaded; and
- Any other information required by the [Cannabis Control] Board [(CCB)].”
Retail packaging must also contain the following warnings in bold and in a bright yellow box on the principal packaging display panel:
- This product contains cannabis and THC;
- In all capital letters as indicated: “KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years and older”;
- Warning: Do not use if pregnant or nursing;
- National Poison Control Center 1-800-222-1222;
- For cannabis products intended to be smoked, inhaled, or vaporized: Warning: Smoking or vaping is hazardous to health;
- For cannabis products intended to be ingested orally: Warning: Effects of this product may be delayed by four or more hours;
- For all topical products: Warning: For topical use only. Do not eat or smoke; and
- Any other warning required by the [CCB].
The labeling on retail packaging must be no smaller than 6-point size font and must be clearly written or printed in English (though licensees may include other languages). The labels must be unobstructed and conspicuous.
Retail packaging shall not display any content or be labeled in any manner that:
- Is made attractive to individuals under twenty-one
- Includes any false or misleading statements including, but not limited to, any health claims;
- Includes the term “organic”;
- Includes the term “craft” unless the processor meets the term as defined [by OCM rule]
- Causes a reasonable consumer confusion as to whether the cannabis product is trademarked, marked, or labeled in a manner that violates any federal trademark law or regulation;
- Contains any illustration or content that falsely portrays cannabis or cannabis products as being authorized under [New York’s medical cannabis or hemp program]
- Depicts cannabis, excluding the universal symbol[,] cannabis products, or paraphernalia
- Promotes overconsumption;
- Promotes price, price reductions, or any other discount or coupon;
- Depicts a child or other person reasonably appearing to be under the age of twenty-one; and
- Violates additional prohibitions as set out by the OCM.
My Two Cents
This could be a restrictive list. Some on the list make sense, for example, cannabis products cannot be labeled “organic” because that term is used by the U.S. Department of Agriculture to designate certain products as organic under federal law, and cannabis remains unlawful under federal. Other proposed restrictions may be overly burdensome, including the complete ban on depictions of cannabis (aside from the required warning images). This requirement is inconsistent with the OCM’s goal of ensuring that cannabis products are not confused with non-cannabis products: wouldn’t it be less likely for a consumer to get confused over whether a product contains cannabis if cannabis were depicted on the packaging? This is especially true of non-English reading consumers. In addition, the highly subjective nature of many of these restrictions appears to give OCM significant discretion in its enforcement of the regulations. What type of labels promote overconsumption or promote price or price reductions?
This post is the first part of a two-part series. Next, we’ll cover the proposed marketing and advertising rules.