Part 128: Packaging & Labeling Guidance

Part 128 regulations outline New York State’s requirements for how cannabis products must be packaged and labeled. These rules require that cannabis products are labeled clearly, packaged more safely, and branded responsibly, while aligning with public health goals and environmental sustainability standards.  

The regulations cover:

• Required label information, including potency, ingredients, warnings, and the universal symbol
• Packaging restrictions on certain features that may be attractive to individuals under 21
• Standards for child-resistant and tamper-evident packaging requirements
• Rules that encourage the use of sustainable materials

Who Should Use This Guidance

This guidance is intended for all cannabis licensees involved in packaging and labeling, including Processors, Microbusinesses, Registered Organizations with Dispensing (RODs), Registered Organizations Non-Dispensing (RONDs) and Cooperative licensees authorized to conduct processing activities.

Additionally, Retail Dispensaries can use the packaging and labeling checklists (below) when accepting a shipment of cannabis products from a distributor to verify that those cannabis products are properly packaged and labeled. Offering mislabeled products for sale is not permitted.

Summary of Updates to Part 128

Key changes to the revised Packaging and Labeling regulations include: 

• Clarification of child-resistant and tamper-evident requirements
• Updates to post-consumer recycled content requirements, including due-diligence documentation and phase-in periods
• Streamlined labeling requirements, including updated warnings, terpene profile disclosure, and processor information
• Technical edits to align rules across both Adult-Use and Medical Cannabis Programs

Annual Reporting Requirements

Licensees who package cannabis products for retail sale must submit an annual report to the Office that includes:

• Total weight of packaging material sold, offered for sale, or distributed in the prior calendar year, by type of material composition
• Total number of cannabis products sold in reusable packaging and number of reusable packages refilled in the prior calendar year
• Total cost of packaging material sold, offered for sale, or distributed in the prior calendar year
• Any other information as required by the Office

VIEW PART 128 & PART 129 REGULATIONS (PDF)

Licensees must keep records showing that every retail package used for cannabis products meets child-resistance standards.

Specifically, packaging must comply with the most current:

• Poison Prevention Packaging Standards as defined in 16 CFR § 1700.15 and
• Testing Procedures for Special Packaging requirements defined in 16 CFR § 1700.20, as updated.

The Office may request this documentation at any time to verify compliance.

Minimum Standards for Retail Packaging

All cannabis retail packages must meet the following standards:

• Be child-resistant for the entire lifespan of the product
• Be tamper-evident, without covering or obscuring any required labeling—even after opening
• Fully enclose the cannabis product
• Be sealed to protect the product from oxygen exposure, contaminants, and degradation of the product
• Does not impart any toxic or harmful substances to the cannabis product
• Be resealable if the package contains multiple servings

These requirements apply even if a product is placed inside another package (for example, a jar inside a box or bag). Every cannabis product must have a compliant retail package. A separate marketing layer is optional.

Packaging Cannot Be Attractive to Individuals Under 21

Cannabis product packaging, including all elements except non-consumer packaging, must not be attractive to individuals under 21 years of age.

Packaging is considered attractive to individuals under 21 if it includes:

• Cartoons or mascots;
• References or visual similarities to products commonly associated with youth (e.g., candy, cookies, soda, cereal, or similar food/drink items)—with the exception of cultivar names;
• Terms “candy” or “candies,” or variants in spelling such as “kandy” or “kandeez” (except as part of a cultivar name);
• Characters, public figures, symbols, phrases, toys, or games commonly used in marketing to those under 21; or
• Images of individuals who could reasonably appear to be under the age of 21, unless the individual is at least 25 years old.

Please Note: The removal of specific examples from the definition of attractive to individuals under 21 (such as references to bright colors, bubble-type or other cartoon-like fonts) should not be interpreted as an endorsement of their use. Licensees remain responsible for ensuring that, based on the totality of the design, packaging, labeling, marketing, and advertising do not appeal to individuals under 21 years of age.

Plastic Packaging Restrictions

Cannabis product packaging cannot be made of plastic unless it contains at least 25% post-consumer recycled content.

This requirement does not apply to:

• Plastic components needed to meet child-resistant packaging requirements (e.g., push buttons or locking mechanisms on boxes or containers);
• Items for which no version containing post-consumer recycled content is available.

Grace Period for New Licensees

New licensees have 12 months from their date of licensure to comply with the minimum 25% post-consumer recycled content requirement. Licensees may be asked to show proof of compliance at the time of their initial license renewal and upon request by the Office.

Formatting Requirements

Certain information must be on an adult-use cannabis product label. Some information must be on a certain part of the product (called the principal packaging display panel), but other information can be anywhere on the product’s outermost layer.  

Regardless of where a specific piece of information must be, all adult-use cannabis products must meet the following labeling standards:

• Labels must be unobstructed, clearly visible, and remain intact even after the product is opened.
• The label must appear on the outermost layer of packaging—either the retail package or, if used, the marketing layer.
• Labels must be written or printed in English (Foreign language translations are allowed in addition.)  
• All required text must use a font size no smaller than 6-point
• Public health warnings must be in an approved standard font: Times New Roman, Calibri, Arial, or Helvetica.

IMPORTANT: Using the universal symbol or any other required labeling information as a tamper-evident seal is unacceptable. Required labeling cannot be printed on a tamper-evident seal unless that same information also appears elsewhere on the package in a clear and permanent way. If the label would be broken, covered, or removed after opening, it does not meet the requirement.

You’ll find examples below showing compliant labels, including how to properly label both the principal packaging display panel and the retail or marketing layer.

Principal Packaging Display Panel (PPDP) Requirements

The Principal Packaging Display Panel (PPDP) is the single panel of the retail package (or marketing layer, if used) that is intended to face the customer at retail. 

For All Cannabis Products (Except Inhalable Products):

The PPDP must include:

• Milligrams per single serving and per package of total THC
  • Total THC is calculated as: Total THC = THC + (THCA x 0.877)
• Milligrams per single serving and per package of total CBD
  • Total CBD is calculated as: Total CBD = CBD + (CBDA x 0.877)
  • Total CBD is not required to be listed on products which contain <0.01mg CBD per package
• Milligrams per single serving of any other marketed phytocannabinoids
  • Marketed phytocannabinoids are any phytocannabinoids that are mentioned on the cannabis product’s packaging or labeling or otherwise associated with the cannabis product by the processor
• Number of servings per package
• Recommended serving size
• Net quantity of the product
• Brand name of the product

For Inhalable Cannabis Products:

The PPDP must include:

• Total THC as a percentage of weight or volume
• Total CBD as a percentage of weight or volume
• Any other marketed phytocannabinoids as a percentage of weight or volume
• Net quantity of the product
• Brand name of the product

Compliant Labeling Examples:

Example 1: Edible Cannabis Product PPDP

Example 2: Cannabis Flower Product PPDP

Outermost Packaging Layer Requirements

The outermost layer of a cannabis product’s packaging—either the retail package or, if used, a marketing layer—must include:

• A full list of ingredients in the cannabis product
• All other required labeling information
• All required warnings

Ingredient List:

An ingredient list must appear on the outermost packaging (retail package or marketing layer) and must:

• Include all active and inactive ingredients in the product, including but not limited to, single ingredient cannabis products such as whole cannabis flower
• List ingredients in descending order of predominance by weight
• Clearly identify any major allergens, as defined by the Food Allergen Labeling and Consumer Protection Act of 2004 as it relates to Food and Drugs for misbranded food (21 U.S. Code § 343), as updated.

Nutritional/Supplemental Facts:

Most orally ingested products must include either a nutritional facts or supplement facts panel:  

• If an edible (except for tablets/capsules without food ingredients, micronutrient, or herbal supplements) includes a nutritional facts panel that complies with 21 CFR § 101.9(c), as it relates to the labeling of food, as updated; or
• If marketed as dietary supplements (except for tablets/capsules without any micronutrients or herbal supplements) must include a supplement facts panel that complies with 21 CFR § 101.36, as it relates to the labeling of dietary supplements.  

Terpene Profile:

If a cannabis product’s terpene content is marketed, the outermost packaging—either the retail package or, if used, the marketing layer—must include a terpene profile.

VIEW TERPENE PROFILE GUIDANCE (PDF)

Universal Symbol Requirements:

Every cannabis product must include at least one version of the universal symbol on its outermost packaging layer—either the retail package or, if used, the marketing layer.

While the symbol can appear anywhere on the outermost layer, the Office encourages licensees to place it on the PPDP when possible, for better visibility.

Placement and Formatting Rules:

• Use one of the approved symbol formats: square, vertical, or horizontal
• Minimum sizes:
  • Square: 1.25 inches in height
  • Vertical: 0.5 inch in width
  • Horizontal: 0.5 inch in height
• The Universal Symbol cannot be used as a tamper-evident seal or placed on any part of the packaging that may be removed by the consumer.
• The symbol must be clearly visible, using a color or outline that contrasts with the surrounding packaging.
• The design, color, and white background of the Universal Symbol must not be altered unless an outline is needed to make it more visible.

Required Warnings:

Every cannabis product must include the following warnings on the outermost packaging—either the retail packageor, if used, the marketing layer.

All of the following warnings are required:

• “This product contains cannabis and THC”  
• “KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years of age and older
  • (NOTE: This warning must include the capital letters as indicated)
• “Warning: Do not use if pregnant or nursing”
• “Poison Center 1-800-222-1222”
• For smoked, inhaled, or vaporized products: "Warning: Smoking or vaping is hazardous to health”
• For orally ingested products (e.g., edibles, beverages): “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”  

Note: The word "Warning" does not need to be repeated before each warning if a single header clearly indicates that all statements listed are warnings.

Required Rotating Health Warnings:

In addition to the required warnings described above, each product's retail package, or, if used, marketing layer must include one—and only one—rotating health warning as determined by the Office.

Rotation Requirements:

• The same warning cannot appear on all of a licensee's products at the same time.
• Licensees cannot use all rotating warnings at once across all products.
• Warnings must be rotated and randomly distributed to ensure that each warning appears on an approximately equal number of labels over the course of a calendar year. To meet this requirement, licensees may choose to distribute the warnings evenly:
  • Across all stock keeping units (SKUs), or
  • Evenly across labels, regardless of SKU

Approved Rotating Warnings:

One of the following warnings must appear on each package:

• “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.”
• Any other warnings as determined by the Office.  
  • If additional warnings are added, the Office will provide advance notice to licensees in allowance for the time it will take to print new labels.

Other Required Information:

In addition to the ingredient list, the retail package or, if used, the marketing layer must include the following:

• Expiration date of the unopened product
• Lot unique identifier, lot number or bar code
• Proper storage conditions for cannabis products
  • The Office has provided safer storage recommendations to consumers. Licensees are encouraged to include these messages, along with any product-specific storage guidance.
• Processor details, including name, location (at a minimum, city or zip code), license number, and direct contact information. A website alone will not suffice; licensees must include information that allows a consumer to directly contact them in the event of a contaminated product, such as a phone number or email address.
  • The processor listed on the label must have actively manufactured the product, not just labeled or branded the product.
  • If multiple processors are listed, then one of the processors that only labeled or branded the product must be clearly identified as the product’s manufacturer using the word “Manufacturer”.
• Clear usage instructions if product is edible or topically applied
• List of any solvents used to produce the cannabis product, if applicable
• A scannable bar code or QR code that links to a downloadable Certificate of Analysis (CoA) or a website where the CoA can be accessed  

Use of Overlapping Labeling

To permit labeling of small retail packages, certain required information may appear on labels that may be accordion, booklet, dry release, expandable, extendable, peel-and-reseal, or similar, with the exception of:

• The PPDP requirements;
• The three universal symbols; and
• The following two warnings:
  • “This product contains cannabis and THC”  
  • “KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years of age and older” (NOTE: this warning must include the capital letters as indicated)

Cannabis Product Labeling Prohibitions

A cannabis product package, including exit packages, must not display content or be labeled in a way that:

• Appeals to individuals under 21 years of age;
• Contains any false or misleading statements, images, or other content;
• Includes health claims of any kind.
  • For additional details on what constitutes a prohibited health claim, refer to the Health Claims guidance linked below:

VIEW HEALTH CLAIMS (PDF)

A label also must not:

• Use the term “organic” (or similar) unless:
  • The cannabis product’s ingredients are at least 70% certified organic (excluding salt and water), and
  • The use of the term complies with USDA regulations under 7 CFR § 205.600–205.607, regarding the National list of Allowed and Prohibited Substances;
    • Please Note: This does not prohibit cannabis from being cultivated or processed using organic practices or sustainable methods.
• Use the term “craft” (or similar) unless the processor is designated by the Office as producing a craft product under Part 118;
• Use “gluten-free” (or similar), or imply the product is gluten-free, unless the product meets the definition under 21 CFR § 101.91;
• Use “vegan” (or similar) unless the product contains no animal-derived ingredients;
• Use “kosher” (or similar) unless the product complies with Section 201-a of the Agriculture and Markets Law;
• Include imagery or content that falsely implies the cannabis product is authorized under Article 3 (Medical Cannabis) or Article 5 (Cannabinoid Hemp and Hemp Extract) of the Cannabis Law;
• Promote overconsumption;
• Use special branding materials unless the product or licensee is authorized to do so by the Office;
• Use tamper-evident features in a way that:
  • Obstructs required labeling content, or
  • Separates required labeling content from the package when opened by the consumer.

Prohibited Labeling That Appeals to Individuals Under 21

Labeling on a retail package or marketing layer must not be made attractive to individuals under 21. This includes:

• Cartoons or mascots;
• References or visual similarities to products commonly associated with youth (e.g., candy, cookies, soda, cereal, or similar food/drink items)—with the exception of cultivar names;
• Terms “candy” or “candies,” or variants in spelling such as “kandy” or “kandeez” (except as part of a cultivar name);
• Characters, public figures, symbols, phrases, toys, or games commonly used in marketing to those under 21;
• Images of individuals who could reasonably appear to be under the age of 21, unless the individual is at least 25 years old.

Please Note: The removal of specific examples from the definition of attractive to individuals under 21 (such as references to bright colors, bubble-type or other cartoon-like fonts) should not be interpreted as an endorsement of their use. Licensees remain responsible for ensuring that, based on the totality of the design, packaging, labeling, marketing, and advertising do not appeal to individuals 21 years of age. 

Branded Exit Packages

Retail dispensaries may provide customers withs branded exit packages upon completing a sale. Usually, exit packages can only containing the dispensary’s information.

Permitted branding on an exit package that is not a retail advertising specialty is: 

• The retail dispensary’s name;
• The retail dispensary’s logo; and
• Any authorized special branding materials, provided the name or logo complies with Section 128.6 of this Part.

Additionally, stores can accept a small amount of “branded” exit packages from a cannabis product brand. Processors, distributors, or other similar license types can provide exit packages with their cannabis product brand to a retail dispensary licensee, but the supplier license can only provide these items as Retail Advertising Specialties.

There is a limit on retail advertising specialties: a dispensary can only receive $200 of retail advertising specialties for a cannabis product brand in a given calendar year. Many types of cannabis merchandise are considered retail advertising specialties and count towards the $200 limit, and a dispensary should not accept branded exit packages if doing so would cause it to exceed its annual limit for that brand.  

Correcting Noncompliant Packaging and Labeling

If a retail licensee receives a cannabis product that does not meet the packaging or labeling requirements outlined in PLMA rules and guidance—and is notified of this verified noncompliance by the Office, a customer, or the transferring processor or distributor—the licensee must immediately notify the Office by submitting an incident report.

The noncompliant product must be returned to the licensee who transferred it. The retail licensee must document both the return and the specific reason for noncompliance in the inventory tracking system.

If the issue can be corrected by adding a label that contains only the information needed to make the product compliant, the processor who originally packaged the product can affix the corrected label once the product is returned. This allowance does not prevent the Office from pursuing civil penalties or actions—temporary or otherwise—against the processor, particularly in cases that impact public health and safety.

Packaging and Labeling Violations

The Board may suspend, cancel, or revoke a license, registration, or permit—and may impose additional penalties as authorized by Chapter II of this Title, the Cannabis Law, and related regulations—if a licensee:

• Fails to comply with packaging, labeling, marketing, or advertising requirements; or
• Transfers, sells, or attempts to sell a cannabis product to another licensee that is not packaged or labeled in accordance with adult-use regulations or Office guidance.

Yes, all research licensees conducting approved research involving human subjects must comply with all packaging and labeling requirements unless they have received a waiver approved from the Office.

A waiver may be granted by the Office for specific packaging or labeling requirements if those requirements are not practical or necessary in the context of the approved research study. This waiver can also extend to any licensed entity providing cannabis products for that approved research study.

If you are conducting or supporting a research study and believe a waiver is necessary, you must request and receive waiver approval from the Office before using alternative packaging or labeling.