New York Cannabis Packaging and Labeling & Marketing and Advertising Guidance for Medical & Adult-Use Licensees

New York recently received one of the most significant expansions of its legal cannabis market since the legalization of the substance. Marijuana regulators in the state have approved a package of ordinances that will lay the groundwork for expanding the state’s emerging cannabis industry. With the approval, numerous individuals and businesses will be able to apply for cultivator, processor, distributor, microbusiness, and retail dispensary licenses from October this year.

The updated guidelines were approved by the Cannabis Control Board (CCB) and outline licensing and operation procedures for different marijuana businesses. Let’s explore these new laws to uncover how they’ll affect new and existing cannabis businesses within the state.

Medical Cannabis

New York legalized medical marijuana back in 2016. However, with the advent of the recreational market in 2021 and the recent approval of new market regulations, the state’s medical cannabis sector has received some changes. The new laws for medical cannabis include everything from the proper use of child-resistant and tamper-evident containers to the types of exit packaging marijuana brands can use. It also highlights the correct use of cannabis labelsand other elements of packaging for cannabis. Here’s a detailed look at the approved package of ordinances for medical cannabis in New York.

New York – Medical

New York has separated its regulations for medical cannabis from adult use. New York has implemented the following minimum standards for medical cannabis packages. Each medical cannabis product package shall be:

• Packaged and labeled in its final form at the manufacturing facility;
• Easily readable and firmly affixed to the package;
• Child-resistant (meaning that it’s a resealable package intended for more than one use or containing multiple doses, that is designed to be significantly difficult for children under 5 years old to open, and not difficult for adults to use, as defined by specified federal regulations (see full rules for details));
• Tamper-evident (meaning that it bears a seal, label or marking that makes unauthorized access or tampering with the package easily detectable);
• Fully enclosing the product, minimizing oxygen exposure and prevent contamination and degradation.

No retail packaging shall impart toxic or deleterious substances onto the cannabis product.

Exit packages, which are receptacles into which medical cannabis products are placed at the point of sale, are optional and are not required to be labeled, and may include only the registered organization’s name or logo, provided that such name or logo is compliant with all regulations.

Registered organizations are required to implement recycling programs for medical cannabis product packaging. Claims about recyclable or recycled content packaging shall comply with Title 16 of the Code of Federal Regulations relating to Commercial Practices, Part 260 regarding Guides for the Use of Environmental Marketing Claims.

The state has a long list of restrictions on medical cannabis product packaging, including:

• The packaging cannot be opened or the original seal be broken, except for at or after the point of sale to a patient or caregiver, or under other circumstances, such as for quality testing, adverse event investigations, by authorized research license holders, or by the registered organization for quality control or disposal purposes;
• The packaging cannot contain any features that emit scent or sound;
• The packaging can’t contain pictures, images, or graphics, other than what may be required by the Cannabis Control Board (the “Board”);
• The packaging cannot contain any features that change or alter a package’s appearance through technology, such as holographs (with an exception for anti-counterfeiting purposes);
• It can’t be made attractive to persons under 21 years of age;
• It can’t use any term or variants in the spelling of any term describing a medical condition;
• It can’t be made of single-use plastic, unless the plastic is made of minimum 25% post-consumer recycled material (“PCR”); and
  • PCR includes 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; but does not include post-industrial material, or material generated by means of combustion, incineration, pyrolysis, gasification, solvolysis, chemical recycling and any high-heat or conversion process.);
• Finally, the packaging must comply with any additional requirements as set forth by the Office of Cannabis Regulation.

What makes packaging “attractive to individuals under 21”? In New York, this means labeling, packaging, advertising and marketing that uses or includes, among other things:

• Cartoons;
• Bubble-like or cartoon-like font;
• Bright neon colors;
• 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 those under 21. For example, this would include imitations of food, candy, soda, drinks, cookies, or cereal;
• The term “candy,” “candies,” or spelling variations thereof;
• Symbols, images, characters, public figures, phrases, toys, or games that are commonly used to market products to those under 21; and
• Images of individuals who reasonably appear to be under 21.

New York has also established the following minimum standards for its labeling. The principal packaging display panel, meaning the part of the packaging that is displayed at the dispensing site, shall have a white background with black text containing the following information:

• The medical cannabis product form;
• The brand designation;
• List of ingredients, both active and inactive, in descending order of prominence by weight; and a separate list in bold of major allergens as set forth in specified federal code;
• Milligrams per dose, and per package, of total THC (THC + THCA x 0.877), total CBD (CBD + CBDA x 0.877) content;
• Any other marketed phytocannabinoids in milligrams per dose and milligrams per package;
• The amount of total THC (THC + THCA x 0.877) and any other marketed phytocannabinoids as a percentage of volume, unless otherwise exempted by the Office;
• The total quantity or volume included in the package;
• List of solvents used in production, if applicable;
• The product’s lot unique identifier (lot number or bar code);
• Expiration date (based on stability studies)
• Use-by date, if not included on the dispensing label;
• Storage recommendations;
• The registered organization’s name, address and registration number;
• A scannable bar code or QR code linked to a downloadable certificate of analysis (or website where it can be downloaded); and
• Any other information required by the Board.

Medical cannabis packaging must also include the following warning statements:

• “Keep secured at all times.”;
• “May not be resold or transferred to another person.”;
• “This product might impair the ability to drive.”;
• “Medical cannabis products must be kept in the original container in which they were dispensed and removed from the original container only when ready for use by the certified patient.”;
• “KEEP PRODUCT AWAY FROM CHILDREN (unless the medical cannabis product is being given to the child under a practitioner’s care). In case of accidental ingestion or overconsumption, contact the poison control hotline 1-800-222-1222 or call 9-1-1.”
• “This product is for medicinal use only. This product should not be consumed during pregnancy or while nursing except on the advice of the certifying practitioner, and in the case of a nursing parent, including the infant’s pediatrician.”; and
• For topical products: “For external use only”.

All required labeling text must also meet the following minimum requirements:

• Six point font;
• Clearly written or printed and visible to consumers;
• In Times New Roman, Calibri, Arial, or Helvetica;
• In English (however, licensees may include accurate foreign language translations);
• Unobstructed and conspicuous, even after the product has been opened; and
• Printed directly on the package or by affixing labels (multiple labels are permissible; as are accordion, expandable, extendable, or layered).

There are also several enumerated prohibitions that detail what you can’t do with medical cannabis package labeling. Packaging may not display any content or labeled in any manner that:

• Is attractive to persons under 21 years old;
• Includes any false or misleading statements;
• Includes the terms “organic”;
• Includes the term “craft”;
• Cause reasonable consumers confusion as to whether the cannabis product is trademarked, marked or labeled in a manner that violates any federal trademark law or regulation;
• Depicts cannabis, cannabis products, or paraphernalia;
• Promotes overconsumption or consumption contrary to a certifying practitioner or pharmacist’s recommendations;
• Depicts a child or other person reasonably appearing to be under the age of twenty-one (21); and
• Violates any other prohibitions, as may be set forth by the state.

The dispensing site must also add a “patient-specific” label at the time of dispensing. The label must be easily readable and firmly affixed, and include the following information:

• The name and registry identification number of the certified patient and designated caregiver, if any;
• The certifying practitioner’s name;
• The dispensing site name, address and phone number;
• The dosing and administration instructions;
• The quantity and date dispensed;

• Any recommendation or limitation by the practitioner as to the use of medical cannabis; and
• The expiration date of the product once opened (if not already included on the package label).

Adult-Use Marijuana

New York legalized adult-use cannabis in 2021, but the state’s legal recreational weed sector has only recently started to take shape. The new regulations outlined by the CCB establish requirements for the licensing of eight types of recreational marijuana businesses. These include plant nurseries, cultivators, processors, cooperatives, distributors, dispensaries, delivery services, and microbusinesses. 

Similarly, the new laws also touch on several other crucial aspects of adult-use cannabis businesses. These include factors like logo design, licensing, the use of QR codes, and rules governing custom branded packaging. Here’s a closer look at the new regulations for the recreational marijuana industry in New York.

New York - Adult Use

*Note: this summary covers Adult Use and NOT Medical

The following minimum standards are imposed for all retail packages of adult use cannabis. “Retail packages” are sealed, hard or soft-bodied receptacles in which the cannabis product is placed prior to retail sale. It does not include inner wrappers or linings, exit packages, or non-consumer packaging (ie, wholesale level packaging used in transfers between licensees). Each retail package shall be:

• Child-resistant (meaning that it’s significantly difficult for children under 5 years old to open, and not difficult for adults to use, as defined by specified federal regulations, and furthermore follows packaging standards and testing procedures set forth in specified federal regulations (see full rules for details);
• Tamper-evident (meaning that it bears a seal, label or marking that makes unauthorized access or tampering with the package easily detectable);
• Resealable, if multi-serving (meaning that the package maintains child-resistant effectiveness and preserves the integrity of the product within); and
• Fully enclosing the product, minimizing oxygen exposure and prevent contamination and degradation.

No retail packaging shall impart toxic or deleterious substances onto the cannabis product.

A marketing layer is the outermost layer visible to a consumer, which if used, must comply with all labeling requirements as specified herein. Marketing layers are optional.

Exit packages, which are receptacles into which cannabis products within a retail package are placed at the point of sale, are optional and are not required to be labeled, and may include only the dispensary name, logo, and compliant branding materials.

Other restrictions on cannabis product packaging include:

• The packaging cannot contain any features that emit scent or sound;
• The packaging cannot contain any features that change or alter a package’s appearance through technology, such as holographs (with an exception for anti-counterfeiting purposes);
• It can’t be made attractive to persons under 21 years of age;
• It can’t be made of plastic, unless the plastic is made of minimum 25% post-consumer recycled content (“PCR”); and
• Finally, the packaging must comply with any other more stringent packaging requirements set forth in New York state law or regulation.

The state has defined what makes packaging “attractive to individuals under 21”: it 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-like or cartoon-like font;
• Bright neon colors (with saturation value greater than 60%);
• 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 those under 21. For example, this would include imitations of food, candy, soda, drinks, cookies, or cereal;
• The term “candy,” “candies,” or spelling variations thereof;
• Symbols, images, characters, public figures, phrases, toys, or games that are commonly used to market products to those under 21; and
• Images of individuals who reasonably appear to be under 21 (unless the person is actually 25 or older).

As part of the license application process, applicants for certain license types must submit an environmental sustainability program. This program may include, for example, packaging reuse strategies, the use of non-plastic, compostable or recyclable materials, or packaging materials with greater than 25% PCR content. In addition, licensees must submit a plan for the reduction of use of plastic packaging within the first two years of licensure. Licensees must report annually on key metrics of the program. Further details into these strategies are provided:

• Reuse: Retail packages shall be sanitized and disinfected either by a licensee or by a third-party to ensure that they do not contain any harmful residue or contaminants. Retail packages can be reused if, after sanitation and visual inspection, the package is in good working order and doesn’t seem to pose a risk of unintended exposure or ingestion of cannabis products. Inspections shall include looking for brittleness, chips, cracks, or other imperfections that could compromise the package’s child-resistant properties or pose a threat of harm.
• Recyclability. Claims about recyclable or recycled content packaging shall comply with Title 16, as it relates to Commercial Practices, of the Codes of Federal Regulations section Part 260 regarding Guides for the Use of Environmental Marketing Claims.

As for labeling, the state has imposed the following minimum standards.

• Required labeling text shall be, at minimum:
  • Six point font;
  • Clearly written or printed and in English (however, licensees may include accurate foreign language translations);
  • Unobstructed and conspicuous, even after the product has been opened;
  • Printed directly on the package or by affixing labels (multiple labels are permissible); and
  • Warning statements, as further described below, must be in bold and in Times New Roman, Calibri, Arial, or Helvetica.
• The principal packaging display panel, meaning the panel or marketing layer that the processor intends to be displayed at retail (generally including the top, front and sides of a three-dimensional package, but not the bottom or back), shall contain the following information:
  • Milligrams per single serving and per package of total THC (THC + [THCA x 0.877]), total CBD (CBD + [CBDA x 0.877]) content, and any other marketed phytocannabinoids, which must be in bold text;
  • A terpene profile, if terpenes are marketed;
  • The amount of total THC (THC + [THCA x 0.877]) and any other marketed phytocannabinoids as a percentage of volume (not applicable to edibles);
  • Number of servings per package and, if applicable, the recommended size of a serving (not applicable to flower and other forms of cannabis for vaporization); and
  • Weight of cannabis product.
• The retail package, and any marketing layer if used shall contain the following:
  • List of ingredients, both active and inactive, in descending order of prominence by weight; and a separate list in bold of major allergens as set forth in specified federal code;
  • Edibles must include a nutritional label pursuant to specified federal regulations;
  • Products marketed as dietary supplements must have a supplemental fact panel, as specified in certain federal regulations;
  • List of solvents used in production, if applicable;
  • Expiration date and use-by date;
  • Storage recommendations and usage instructions;
  • Processor name and contact information, including location (at minimum, city and zip code) and license number;
  • A state-specified universal symbol, which cannot be altered unless authorized and shall be made conspicuous by printing the symbol on, or outlining the symbol with, a contrasting color, and must meet certain size requirements depending on the shape of the applicable symbol;
  • Lot unique identifiers or lot number or bar code;
  • A scannable bar code or QR code linked to a certificate of analysis or website where the certificate can be downloaded; and
  • Any other information required by the board.
• Retail packaging and marketing layers must also include the following warnings, in bold font:
  • “This product contains cannabis and THC”;
  • “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”;
  • “Poison 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 4 or more hours”;
  • For topical products: “Warning: For topical use only. Do not eat or smoke”; and
  • Any other warning required by the Board, and any rotating health warnings
• Rotating health warnings, as listed below, are to be used by licensees in a manner that ensures the warnings are randomly distributed and that each warning appears on an estimated equal number of labels per year. Licensees cannot use the same rotating warning on all products at once, nor can it display all of the warnings at once on all of its products. Rotating warnings include:
  • “Cannabis can be addictive.”;
  • “Cannabis can impair concentration and coordination. Do not operate a vehicle or machinery under the influence of cannabis.”;
  • “There may be health risks associated with consumption of this product.”; or  
  • Other warnings as determined by the Office.
• To permit for labeling on small packaging, certain information required may appear on labels that are accordion, booklet, dry release, expandable, extendable, or peel-and-reseal. This allowance does not apply to:
  • The principal packaging display panel minimum standards specified above;
  • The universal symbol;
  • The following two warnings: “This product contains cannabis and THC”; and “KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years and older”.

There are also several enumerated prohibitions that detail what you can’t do with cannabis package labeling. Packaging may not display any content or labeled in any manner that:

• Is attractive to persons under 21 years old;
• Includes any false or misleading statements, images, or other content including, but not limited to, any health claims. A health claim is any claim on the retail package or marketing layer that expressly or by implication, including, but not limited to, by third party references, written statements, symbols or branding, 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.
• Includes the terms “organic” or “gluten-free” unless describing the product’s ingredients and in compliance with federal regulations, as specified in the packaging regulations;
• Includes the term “craft” unless the processor is designated by the Office as processing craft products;
• Includes the term “kosher” unless the product meets the term as defined in specified state regulations;
• Includes the term “vegan” unless the product contains no animal products;
• Cause reasonable consumers confusion as to whether the cannabis product is trademarked, marked or labeled in a manner that violates any federal trademark law or regulation;
• Portrays cannabis or cannabis products as being authorized under or part of Article 3 or Article 5 of the Cannabis Law;
• Depicts cannabis products or paraphernalia;
• Promotes overconsumption;
• Promotes price, price reductions, or any other discount, customer loyalty program, or coupon, except as part of an environmental sustainability program;
• Includes a special branding material, unless the use of such special branding material is authorized and complies with all labeling rules; or
• Violates any other prohibitions, as may be set forth by the state.

Final Thoughts

The New York legal marijuana market is on the brink of the most significant expansion in its history. The CCB has greenlit fresh regulations in the region that will oversee numerous facets of the trade, from granting permits to enterprises to rules governing cannabis packaging in New York. This guide provides a detailed overview of what to expect in the state’s marijuana industry to help individuals and prospective licensees better understand the new laws.