- (a) Broad spectrum means hemp extract or cannabinoid hemp product containing multiple cannabinoids, but where Δ9-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 percent THC.
- (b) Cannabidiol or CBD means the naturally occurring hemp-derived phytocannabinoid cannabidiol, but does not include synthetic cannabidiol.
- (c) Cannabinoids means any hemp-derived phytocannabinoid, including but not limited to, Tetrahydrocannabinol (THC), 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 section 3306(g) 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.
- (d) 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.
- (e) 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.
- (f) 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.
- (g) 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.
- (h) 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.
- (i) 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.
- (j) 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.
- (k) Distribute means to offer or sell cannabinoid hemp products to a cannabinoid hemp retailer, for retail sale to consumers within New York State.
- (l) Extract or Extraction means the process of concentrating or isolating one or more cannabinoids from hemp or cannabinoid hemp.
(m) 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.
- (n) 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 Δ9-Tetrahydrocannabinol concentration of not greater than 0.3 percent.
- (o) 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 Δ9-Tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
(p) Hemp extract means all derivatives, extracts, cannabinoids, isomers, acids, salts of isomers derived from hemp and used for human consumption, with a Δ9-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.
- (q) Isolate means hemp extract or cannabinoid hemp product comprised of 95 percent or more of a single cannabinoid compound.
- (r) 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.
(s) 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 subdivision (l) of this section.
- (t) 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.
- (u) Person means an individual, partnership, corporation, limited liability company, association, or any business entity or institution of higher education, by whatever name designated and whether or not incorporated.
- (v) 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.
- (w) Total Δ9-Tetrahydrocannabinol concentration means [Δ9-Tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]).
(x) 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.
For purposes of this Part, the following terms shall have the following meanings: