On October 27, 2020, the New York State Department of Health issued proposed regulations regarding cannabinoid hemp products. These proposed regulations (available here) are open for public commentary until January 11, 2021. They would change how products containing hemp-derived cannabinoids, including cannabidiol (CBD), are manufactured and sold in New York State. While the industry continues to await federal guidance from the FDA, these proposed regulations offer a glimpse into what actions the federal government might take with regard to CBD.
Below is a review of some of the proposed regulations’ most salient features.
What do the proposed regulations cover?
The proposed regulations would create new requirements for “cannabinoid hemp products,” defined as “hemp or any product manufactured or derived from hemp, including hemp derived terpenes, in its final form, that are used for human consumption.” Cosmetics are expressly excluded from this definition.
The proposed regulations also cover more cannabinoids present in hemp than just the well-known CBD and Δ9-Tetrahydrocannabinol (THC) (the substance most commonly associated with a marijuana “high”). The regulations discuss cannabinoids more generally as “any phytocannabinoid found in hemp,” including, but not limited to, cannabinol (CBN) and cannabigerol (CBG). This definition would exclude synthetic cannabinoids. In addition, the proposed regulations would impose regulatory definitions on the words “isolate,” “full spectrum,” “broad spectrum,” and “distillate.”
In addition to the products themselves, the proposed regulations would create new requirements for extracting, manufacturing, and selling cannabinoid hemp products. Specifically, the State Department of Health proposed to create a new licensing regime for applicants to submit evidence of Good Manufacturing Practices and pay a license fee of $4,500 (for extracting) or $2,000 (for manufacturing). Retailers selling cannabinoid hemp products must also apply for and obtain a license, which would be $300 per retail location. Under the regulations, processors of cannabinoid hemp would test products to show that they meet limits for cannabinoids, heavy metals, residual solvents and pesticides, and other impurities.
How would the proposed regulations affect CBD product marketing?
The proposed regulations would create changes to the advertising and labeling of cannabinoid hemp products.
With regard to advertising, the proposed regulations would require that consumable hemp producers, processors, or retailers cannot:
- Make any false or misleading claims or statements regarding the products;
- Utilize claims that cannabinoid hemp or a cannabinoid hemp product can, or is intended to, diagnose, cure, mitigate, treat, or prevent disease;
- Use images of children or minors consuming the product or use words, a design, or brand that resembles a product that is commonly associated with children or minors, or otherwise be attractive to individuals under 18 years old; or
- Lead a reasonable person to believe that a cannabinoid hemp product is actually marijuana or medical marijuana.
The proposed regulations would also create new labeling requirements for cannabinoid hemp products, including, but not limited to:
- A cap at 25 milligrams of cannabinoids per product for food and beverages and 3,000 milligrams for dietary supplements;
- Clear statements of THC and cannabinoid content;
- Scannable codes for certificates of analysis;
- State(s) of origin for the hemp used in the product or country of origin if sourced from outside the country; and
- Required warnings, using the following language or variants thereof: (a) “Keep out of reach of children,” (b) “Use of this product may cause users to fail a drug test;” (c) “This product has not been tested for safety or efficacy by the Food and Drug Administration;” and (d) “Consult your healthcare provider before use if you are nursing or are pregnant.”
Further, cannabinoid hemp products would need to be shelf-stable and pre-packaged. This means that cannabinoids could not be added to food or beverage products at the point of sale.
Given the breadth of the proposed changes, interested parties should submit comments promptly to state officials before the comment period closes in January 2021. These proposed regulations offer some clarity regarding CBD product labeling, but also create new obligations for manufacturers, processors, and retailers. Those manufacturing or selling hemp-derived products in New York State, including those located out-of-state, will want to track these developments closely as the proposed regulations move through the rulemaking process.