N.Y. Comp. Codes R. & Regs. tit. 9 § 114.1

Current through Register Vol. 46, No. 36, September 4, 2024

Section 114.1 - Definitions

For purposes of this Part, the following terms shall have the following meanings:

(a)Attractive to individuals under twenty-one means attractive to individuals under twenty-one as defined in Part 128 of this Title.

(b)Broad spectrum means hemp extract or cannabinoid hemp product containing multiple cannabinoids, but where [DELTA]9-Tetrahydrocannabinol (THC) has been removed to non-detectable levels using a fit-for-purpose method, with a limit of quantification of less than 0.01% THC.

(c)Cannabidiol or CBD means the naturally occurring hemp-derived phytocannabinoid cannabidiol, but does not include synthetic cannabidiol.

(d)Cannabinoids means any hemp-derived phytocannabinoid, including but not limited to, Tetrahydrocannabinol (THC), [DELTA] tetrahydrocannabinolic acid (THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabielsoin (CBE), cannabicitran (CBT). Cannabinoids do not include synthetic cannabinoids, as that term is defined in subdivision (g) of section 3306 of the Public Health Law and section 9-1.1 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York.

(e)Cannabinoid hemp product means hemp or any product manufactured or derived from hemp, including hemp derived terpenes, in its final form, used for human consumption. Cannabinoid hemp product shall not include cosmetics.

(f)Cannabinoid hemp retailer means a person licensed by the office to sell cannabinoid hemp products, including via the internet, to consumers in New York State.

(g)Cannabinoid hemp farm processor means a cannabinoid hemp processor that is licensed to cultivate hemp by the New York State Department of Agriculture & Markets and is permitted to manufacture flower products. A cannabinoid hemp farm processor shall not:

(1) produce more than 1,000 pounds of dried hemp flower annually;

(2) purchase or sell hemp or hemp extract other than those produced from hemp grown on their own farm; or

(3) perform extraction as defined in section 114.1 of this Part.

(h)Cannabinoid hemp processor means a person licensed by the office to extract hemp extract and/or manufacture cannabinoid hemp products in New York State, whether in intermediate or final form, to be used for human consumption.

(i)Certificate of analysis means a certified report from an independent third-party laboratory meeting all of the requirements of section 114.10 of this Part, describing its analytical testing and results.

(j)Concentrated cannabinoid hemp product means:

(1) the separated resin, whether crude or purified, obtained from cannabinoid hemp; or

(2) a material, preparation, mixture, compound or other substance which contains no more than three-tenths of a percent (0.3%) by weight or by volume of total THC.

(k)Corrective action plan means a plan submitted by a licensee and approved by the office under this Part for the licensee to correct a violation or non-compliance with this Part.

(l)Cosmetic means a cosmetic meeting the requirements of section 321 of Title 21 of the United States Code and recognized as such by the office.

(m)Craft means a cannabinoid hemp product manufactured from hemp grown by a licensed hemp grower who grows less than 1,000 pounds of dried hemp flower annually and the hemp is hand trimmed, hang dried if a flower product hand packaged.

(n)Distillate means hemp extract where a segment of one or more cannabinoids from an initial extraction are selectively concentrated through heating and cooling, with all impurities removed.

(o)Distribute means to offer or sell cannabinoid hemp products to a cannabinoid hemp retailer, for retail sale to consumers within New York State.

(p)Exit package means exit package as defined in Part 128 of this Title.

(q)Extract or Extraction means the process of concentrating or isolating one or more cannabinoids from hemp or cannabinoid hemp.

(r)Flower product means any form of cannabinoid hemp product consisting of the flower, buds, leaves, or stems of the hemp plant, including trimmings thereof, intended for retail sale to consumers with minimal processing. Provided, however that flower product shall not include:

(1) any food, food ingredient, food additive, or items that are generally recognized as safe, pursuant to state or federal law; or

(2) any other product, including microgreens, sprouts or certain hemp leaf products, as determined by the office.

(s)Full spectrum means hemp extract or cannabinoid hemp product containing multiple hemp-derived cannabinoids, terpenes, and other naturally occurring compounds, processed without intentional complete removal of any compound and without the addition of isolated cannabinoids, with a final [DELTA] 9-Tetrahydrocannabinol concentration of not greater than 0.3%.

(t)Health claim means health claim as defined in Part 128 of this Title.

(u)Hemp means the plant Cannabis sativa L. and any part of such plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a [DELTA] 9-Tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis.

(v)Hemp extract means all derivatives, extracts, cannabinoids, isomers, acids, salts of isomers derived from hemp and used for human consumption, with a [DELTA] 9-Tetrahydrocannabinol concentration of not more than an amount determined by the office pursuant to this Part. Hemp extract shall not include:

(1) any food, food ingredient or food additive that is generally recognized as safe pursuant to federal law; or

(2) any extract derived from hemp that is not used for human consumption.

(w)Isolate means hemp extract or cannabinoid hemp product comprised of 95 percent or more of a single cannabinoid compound.

(x)Lot or batch means any cannabinoid hemp product produced during a period of time under similar conditions and identified by a specific code that allows traceability.

(y)Manufacture means to prepare, treat, modify, compound, process, package or otherwise manipulate hemp or hemp extract into a cannabinoid hemp product. Manufacturing shall not include:

(1) growing, cultivating, cloning, harvesting, drying, curing, grinding or trimming when authorized pursuant to Article 29-A of the Agriculture and Markets Law; or

(2) extraction as defined in section 114.1 of this Part.

(z)New York Hemp Product means a cannabinoid hemp product that is derived from hemp exclusively grown, extracted and manufactured in New York, in compliance with section 114.13 of this Part.

(aa)Orally consumed product means any cannabinoid hemp product intended for use or consumption through ingestion, including sublingual or oral absorption.

(ab)Package means a sealed, hard or soft-bodied, receptacle in which the cannabinoid hemp product shall be placed before retail sale. Retail package does not mean:

(1) inner wrapping or lining;

(2) an exit package; or

(3) a non-consumer package used to transfer cannabinoid hemp from one licensee to another.

(ac)Person means person as defined in article 1 of the Cannabis Law.

(ad)Resealable means a package that preserves the integrity of cannabinoid hemp products contained within, for multiple servings.

(ae)Serious adverse event means a medical occurrence associated with the use of a cannabinoid hemp product in a human that results in one or more of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

(af)Tincture means a non-potable edible cannabinoid hemp product that is a cannabinoid hemp extract solution, intended for human consumption or ingestion, dissolved in alcohol, glycerin, or plant-based oil.

(ag)Total [DELTA] 9-Tetrahydrocannabinol concentration means [DELTA] 9-Tetrahydrocannabinol + (0.877 x tetrahydrocannabinolic acid.)

(ah)Total THC means as defined in article 1 of the Cannabis Law.

(ai)Used for human consumption means intended by the manufacturer or distributor to be:

(1) used for human consumption for its cannabinoid content; or

(2) used in, on or by the human body for its cannabinoid content.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 114.1

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