On October 27, the New York Department of Health (“DOH”) published eagerly anticipated proposed rules to regulate the processing, manufacture, sale and marketing of cannabinoid hemp products in the state (the “Rules”).
In accordance with A08977, which Governor Andrew Cuomo passed earlier this year, the DOH has been tasked with creating a program that licenses cannabinoid hemp processors and retailers and sets quality control standards for these products.
While New York is one of many states that in recent months has explicitly legalized the manufacture and sale of hemp products, the state is proposing one of the most comprehensive – if not the most comprehensive – regulatory frameworks published to date. In addition, many of the rules included in the DOH draft address regulatory issues that are of great concern to the industry, but that have not been discussed by other government regulators. Some of the most notable regulations are covered below.
The rules contain key terms and definitions that are seldom found in the regulations of the hemp state.
In particular, the rules regulate Cannabinoid hemp product and define the term Cannabinoid say:
Any phytocannabinoid found in hemp, including but not limited to tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicylicyl ), Cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethylether (CBGM), cannabielsoin (CBE), cannabicitran (CBT).
The use of these terms shows that the DOH is aware of the need to regulate cannabinoids other than CBD, which have become increasingly popular but do not yet need to be specifically regulated by most states.
The rules also explicitly define terms that have become standard in the industry but that few regulators have included in their rules: The whole spectrum, Broad spectrum, distillate, and Isolatewhich are defined as follows:
- The whole spectrum means “a cannabinoid hemp product that is: (1) made from a hemp extract; (2) contains cannabinoids, aromatics, essential vitamins and minerals, fatty acids, proteins, chlorophyll, flavonoids or terpenes; and (3) has not been reformulated or cannabinoid isolates or distillates have been added. “
- Broad spectrum means “a concentrate extracted from hemp that contains several cannabinoids but with all of the Δ9-tetrahydrocannabinol (THC) removed.”
- distillate means “a concentrate in which a segment of cannabinoids from an initial extraction is selectively concentrated by heating and cooling, removing all impurities.”
- Isolate means “a concentrate that is greater than 95 percent of a single cannabinoid compound made by a chemical extraction process.”
By defining these commonly used terms, the DOH helps manufacturers comply with labeling laws, but also provides consumers with the transparency they need to understand the contents of these products.
THC limits for different stages in the supply chain
Like most government regulations that authorize the manufacture, sale, and marketing of hemp products, the DOH requires that these end products contain no more than 0.3% total THC. What makes the rules stand out, however, is that they also deal with the legality of hemp extract (i.e. intermediate hemp not intended for end users) and the possession and intermediate sale of hemp extract by and between approved cannabinoid hemp processors is permitted, provided that it is :
- When the extract leaves the licensed premises, it will be accompanied by (a) a certificate of analysis showing that the extract contains less than 3% THC and (b) a copy of the cannabinoid hemp processor’s license; and
- The hemp extract is only transported within the state.
The legality of intermediate hemp is particularly relevant given the publication of a rule by the US Drug Enforcement Administration (DEA) in August that appears to be wrongly criminalizing the hemp material, which is part of the extraction process that is nearing THC levels always spike.
Specific concentration limits per serving and per product
The rules also set limits on cannabinoid concentration. In particular, the rules stipulate that the cannabinoid hemp product, if it is a food or drink, must not contain more than 25 milligrams of cannabinoids. and if it’s a dietary supplement, it can’t contain more than 3,000 milligrams per product.
The rules also state that the cannabinoid hemp products must contain no less than 90% or more than 110% of the concentration of total THC stated on the label. Note that the rules mention that the DOH may set a total THC limit in milligrams per serving and per pack depending on the shape, volume, number of servings, and ratio of CBD to THC.
Specific regulations for cannabinoid hemp products for inhalation
The rules state that all inhalable cannabinoid hemp products, except cigarettes, cigars and pre-rolls containing hemp flowers, must meet the following additional requirements:
- be a closed system with a pre-filled, disposable cartridge attached to a battery or a disposable product that cannot be recharged
- Electronic vaporizing devices must have internal or external temperature controls to prevent combustion and a heating element made of an inert material such as glass, ceramic, or stainless steel, rather than plastic or rubber.
- not sold to anyone under the age of 21;
- With the exception of hemp terpenes, excipients and ingredients must be of pharmaceutical grade, unless otherwise approved by the DOH, and must not include:
- synthetic terpenes;
- Polyethylene glycol (PEG);
- Vitamin E acetate;
- medium chain triglycerides (MCT oil);
- medical compounds;
- illegal or controlled substances;
- artificial food coloring;
- Benzoic acid;
- Diketones; and
- any other compound or ingredient as determined by the DOH;
- does not contain any flavors or flavorings, except for terpenes from hemp; and
- Starting June 1, 2021, add a DOH approved symbol in a clear and eye-catching way.
Labeling and packaging requirements
In addition to the requirements for including labeling requirements that have become standard in those states that allow the sale and marketing of these products, the rules also require that labels contain:
- the name of the state or country of origin of the hemp used in the cannabinoid hemp product; and
- means to report serious adverse events and / or side effects caused by the product.
Additionally, hemp cannabinoid products sold in New York must be contained in spirited packaging that minimizes exposure to oxygen and light to prevent the products and cannabinoids from degrading.
As this brief overview of the rules shows, the rules proposed by the DOH could serve as a template for other states and even inspire the federal legal framework for these products. Look forward to updates.