N.Y. Comp. Codes R. & Regs. tit. 9 § 114.8

Current through Register Vol. 46, No. 51, December 18, 2024

Section 114.8 - Cannabinoid hemp product requirements

(a) All cannabinoid hemp products distributed or offered for retail sale in New York State shall:

(1) be manufactured in accordance with Parts 101, 111 or 117 of Title 21 of the Code of Federal Regulations, as appropriate for the type of product being manufactured and as otherwise determined appropriate by the office in guidance or future regulation.

(2) contain no more than three-tenths of a percent (0.3%) total [DELTA] 9-Tetrahydrocannabinol concentration;

(3) except for flower products or topical products, contain a ratio of CBD to THC that is 15:1 or higher, provided however, if CBD is not the primary marketed cannabinoid, the sum of cannabinoids excluding THC must have a ratio of 15:1 THC or higher;

(4) not contain liquor, wine, beer, cider or meet the definition of an alcoholic beverage as defined in section 3 of the Alcohol Beverage Control Law;

(5) not contain tobacco or nicotine in the product;

(6) not be in the form of an injectable, inhaler, product including cigarette, cigar or pre-roll, or any other disallowed form as determined by the office;

(7) accurately reflect testing results and not contain less than 80 percent or more than 120 percent of the concentration of total cannabinoid content as listed on the product label;

(8) comply with packaging and labeling standards in section 114.9 of this Part;

(9) be prepackaged and not added to food or any other consumable products at the point of sale;

(10) comply with product testing standards in section 114.10 of this Part; and

(11) not contain synthetic cannabinoids, artificially derived cannabinoids, or cannabinoids created through isomerization, including, but not limited to, [DELTA] 8-tetrahydrocannabinol and [DELTA] 10-tetrahydrocannabinol.

(b) All cannabinoid hemp products distributed or offered for retail sale in New York State shall meet the following additional requirements:

(1) if the cannabinoid hemp product is an orally consumed product it shall not contain more than :

(i) 10 milligrams total THC per package, with no more than 1 milligram total THC per serving; and

(ii) 3,000 milligrams of total cannabinoids per package, with no more than 100 milligrams of total cannabinoids per individual serving, provided however, if the orally consumed product is in the form of a tincture it shall not contain more than:

(a) 100 milligrams of total THC per package; and

(b) 4,000 milligrams of cannabinoids per package.

(2) for cannabinoid hemp products other than flower products, topical products, orally consumed products, or concentrated cannabinoid hemp products, cannabinoid hemp product information must be submitted for review and approval to the office prior to making the product available for sale to retailers and consumers.

(c) If the cannabinoid hemp product contains multiple servings which are not individually wrapped, premeasured, separated or delineated, it shall include a measuring device such as a measuring cap, cup or dropper with the product packaging. Hash marks on the package shall not qualify as a measuring device. This provision shall not apply to flower products, topical products, or concentrated cannabinoid hemp products intended for inhalation or vaporization. Products that consist of more than a single serving shall be:

(1) packaged in a manner such that a single serving is readily identifiable;

(2) packaged in resealable packaging; and

(3) if an orally consumed product in the form of a beverage, packaged in a manner that shall not have more than a single serving per package, provided however, multiple packages of beverage products can be sold together.

(d) All concentrated cannabinoid hemp products intended for inhalation or vaporization shall meet the following additional requirements:

(1) be a closed system with a pre-filled disposable cartridge that attaches to a rechargeable battery, or a single-use product that cannot be recharged;

(2) electronic vaporization devices shall have internal or external temperature controls to prevent combustion and have a heating element made of inert material such as glass, ceramic or stainless steel and not plastic or rubber;

(3) except for hemp-derived terpenes, excipients and ingredients must be pharmaceutical grade unless otherwise approved by the office, and shall not include:

(i) synthetic terpenes;

(ii) polyethylene glycol (PEG);

(iii) vitamin E acetate;

(iv) medium chain triglycerides (MCT oil);

(v) medicinal compounds;

(vi) illegal or controlled substances;

(vii) artificial food coloring;

(viii) benzoic acid;

(ix) diketones; and

(x) any other compound or ingredient as determined by the office in regulation;

(4) not contain any flavors or flavoring agents, except for hemp-derived terpenes; and

(5) include an office approved symbol, as set out in future regulation, in a manner that is clear and conspicuous.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 114.8

Adopted New York State Register November 24, 2021/Volume XLIII, Issue 47, eff. 11/24/2021

Amended New York State Register October 5, 2022/Volume XLIV, Issue 40, eff. 10/5/2022

Amended New York State Register December 13, 2023/Volume XLV, Issue 50, eff. 12/13/2023