Last week, New York’s Cannabis Control Board (“CCB”) held its first meeting since the enactment of the Marijuana Regulation and Taxation Act (the “MRTA”) and announced the transition of the State’s Cannabinoid Hemp Program (the “Program”) from the Department of Health (“DOH”) to the Office of Cannabis Management (“OCM”) – OCM is tasked with administering the cannabis rules and regulations CCB will eventually implement.
If you follow this blog, you may recall that in the spring of 2020, New York enacted A08977, which instructed DOH to develop the Program. Although DOH launched the Program in November 2020 and began accepting licensing and permit applications for cannabinoid hemp processors, distributors, and retailers, the state agency didn’t initiate the formal rulemaking process until June 2 of this year.
Since the publication of the DOH regulations (the “Rules”) in the New York State Register, licensees – as of September 30, 2021, licensees included 2,275 retailers, 384 distributors, 36 processors (hemp extract) and 34 manufacturers (finished products) – have had to comply with licensing, manufacturing, distribution, and sale requirements. Some of these requirements include:
Manufacturing cannabinoid hemp products pursuant to current good manufacturing practices (“cGMPs”). Cannabinoid hemp products regulated by DOH include food products (foods and beverages), dietary supplements, and inhalable products (i.e., vaping products only), which cannot be or contain:
– Tobacco or nicotine;
– An injectable product;
– An Inhaler product;
– Cannabinoid hemp products clearly labeled or advertised for the purposes of smoking or in the form of a cigarette, cigar, or pre-roll, or packaged or combined with other items designed to facilitate smoking such as rolling papers or pipes; a
– Synthetic cannabinoids, including Delta-8 THC obtained through the process of isomerization.
Ensuring cannabinoid hemp products meet specific concentration limits. For example, food products cannot contain more than 25 mg of cannabinoids; whereas dietary supplements must contain no more than 3,000 milligram of total cannabinoids per products, with no more than 75 milligrams per individual serving. The Rules also specify that the concentrations listed on the product label must be no less than 80% or more than 120% of concentration of total cannabinoids listed on label.
Satisfying additional safety requirements imposed on inhalable products, such as internal or external temperature controls to prevent combustion and prohibiting the use of flavoring agents.
Limiting the sale of cannabinoid hemp products, including out-of-state products, to those that meet manufacturing, packaging and labeling, and testing requirements mandated under the Rules.
Restricting the sale of inhalable cannabinoid hemp products to consumers 21 years of age or older.
Only selling intermediary hemp extract to licensed hemp processors or to Medical Marijuana Program registrants and ensure the intermediary hemp extract is transported, intrastate only, in a fully enclosed vehicle or container, and accompanied by a certificate of analysis certifying that the extract is less than 0.3% total THC along with a copy of the cannabinoid hemp processor’s license.
Starting on November 1, licensees will also be required to ensure that every cannabinoid hemp product manufactured, distributed, and sold in the State meets specific testing, labeling and packaging requirements:
Testing Requirements: Cannabinoid hemp products will have to be tested by a laboratory approved to test medical marijuana, that is ISO/IEC 17025 accredited to verify compliance with specific contaminants limits.
Labeling and Packaging Requirements: The labels of cannabinoid hemp products will have to include specific elements, such as the list of ingredients, number of servings, expiration date, a QR code, specific warnings, and the total milligram content of CBD, total THC, and marketed cannabinoids per serving and container.
It is unclear following CCB’s first meeting whether the newly formed cannabis regulatory body will adopt the Rules in their current form or whether the group will conduct its own, independent rulemaking process in the weeks or months to come. What we do know, however, is that for now, and pursuant to the MRTA, the Rules will “continue in full force and effect until duly modified or abrogated by CCB.” Therefore, until then, licensees and stakeholder wishing to enter New York’s cannabinoid hemp market should familiarize themselves with the Rules and the Program to ensure compliance with all regulations currently in effect.
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