N.Y. Comp. Codes R. & Regs. tit. 9 § 128.5

Current through Register Vol. 46, No. 25, June 18, 2024

Section 128.5 - Cannabis Product Labeling Minimum Standards

(a) The principal packaging display panel shall contain the following information:

(1) in 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;

(2) if terpenes are marketed, a terpene profile;

(3) in bold, milligrams per package of total THC (THC + [THCA x 0.877]) and total CBD (CBD + [CBDA x 0.877]) content;

(4) 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;

(5) number of servings per package and, if applicable, the recommended size of a serving, except for cannabis flower and other forms of cannabis for vaporization; and

(6) weight of cannabis product.

(b) The retail package or, if it is used, the marketing layer shall contain the following information:

(1) a list of all ingredients in descending order of predominance by weight in the cannabis product - both active and inactive. The ingredient list shall 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 section 343, for misbranded food;

(i) Edibles shall include a nutritional label pursuant to Title 21, as it relates Food and Drugs, of the Codes of Federal Regulations section 101.9(c) for nutrition labeling of food, as amended from time to time; and

(ii) Cannabis products marketed as dietary supplements shall include a supplement fact panel pursuant to Title 21, as it relates to Food and Drugs, of the Codes of Federal Regulations section 101.36 for nutrition labeling of dietary supplements, as amended from time to time;

(2) a list of any solvent used to produce the cannabis product, if applicable;

(3) date of expiration of the unopened cannabis product;

(4) use by date;

(5) proper storage conditions;

(6) name, location (at a minimum, city or zip code) license number, and direct contact information of the processor;

(7) any one of the following three universal symbols at a minimum size of 1.25 inch 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 and its colors cannot be altered unless authorized by the Board and it shall be made conspicuous by printing the symbol on, or outlining the symbol with, a contrasting color;

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(8) clear usage instructions;

(9) lot unique identifier or lot number or bar code;

(10) 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

(11) any other information required by the Board.

(c) Required labeling shall be no smaller than 6-point font size. Labeling text shall be clearly written or printed and in the English language. In addition to the required labeling in English, licensees may include accurate foreign language translation(s) of the labeling text, provided such translation otherwise complies with this Part.

(d) The marketing layer is optional, but if used by a licensee in addition to the required packaging, it shall be labeled according to the requirements in Section 128.6 of this Part.

(e) The information required pursuant to Section 128.5(a) of this Part shall be unobstructed and conspicuous. A licensee may include the information required pursuant to Section 128.5(a) of this Part by printing it directly onto the retail package or by affixing multiple labels with the information to the retail package, provided that none of the information is obstructed.

(f) The retail packaging or, if it is used, the marketing layer shall contain the following warnings, provided however, if the word "warning" is clearly associated with all warnings as a header then the word "warning" does not need to be included in the individual warnings where specifically indicated below:

(1) "This product contains cannabis and THC";

(2) "KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years and older";

(3) " Warning: Do not use if pregnant or nursing";

(4) "Poison Center 1-800-222-1222";

(5) For cannabis products intended to be smoked, inhaled, or vaporized: "Warning: Smoking or vaping is hazardous to health";

(6) For cannabis products intended to be ingested orally: "Warning: Effects of this product may be delayed by 4 or more hours";

(7) For topical products: "Warning: For topical use only. Do not eat or smoke"; and

(8) Any other warning required by the Board.

(g) The warnings required pursuant to Section 128.5(f) of this Part shall be displayed:

(1) in the English language;

(2) in Times New Roman, Calibri, Arial, or Helvetica;

(3) in text no smaller than size six (6) font; and

(4)bolded.

(h) In addition to the required warnings in Section 128.5(f) of this Part, the retail packaging or marketing layer shall include any rotating health warnings as determined by the Office.

(i) To allow for labeling on small packaging, the information required pursuant to sections 128.5(b), (f), and (h) of this Part may appear on labels that are, not by means of limitation: accordion, booklet, dry release, expandable, extendable, or peel-and-reseal. This allowance does not apply to:

(1) The principal packaging display panel minimum standards specified in section 128.5(a) of this Part;

(2) the universal symbol specified in Section 128.5(b)(7) of this Part; and

(3) the following two required warnings:

(i) "This product contains cannabis and THC"; and

(ii) In all capital letters as indicated: "KEEP OUT OF REACH OF CHILDREN AND PETS. For use only by persons 21 years and older".

(j) Any research licensee conducting research approved by the Office involving human subjects shall comply with all packaging and labeling requirements, unless the licensee receives prior written approval for a waiver of specific packaging or labeling requirements in connection with any research approved by the Office. The waiver may extend to a licensee providing cannabis products for an approved research study.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 128.5

Adopted New York State Register March 22, 2023/Volume XLV, Issue 12, eff. 3/22/2023