On October 28, 2020, the New York State Department of Health announced the release of the state’s cannabidiol (CBD) proposed regulations to regulate CBD hemp products in New York.  Once finalized and in effect, these new regulations would reverse New York State’s early 2019 ban on the sale of hemp-derived CBD-infused products.

By way of background, the U.S. Food and Drug Administration (FDA)’s current position is that CBD does not qualify for use in food or dietary supplements. FDA is investigating whether it can develop a regulatory framework that would permit the use of CBD under the Food Drug and Cosmetic Act, but the Agency has identified numerous safety questions that need to be addressed (discussed previously on this blog here) and little progress has been made to resolve them.  New York indicated that these proposed regulations would fill the regulatory void left by FDA’s refusal to set national standards.

The proposed rules reflect legislation enacted in December 2019 that called for the establishment of a Cannabinoid Hemp Program, setting out licensing requirements and quality control standards for both CBD hemp processors and retailers, as well as packaging and labeling requirements that all CBD products must meet.

The proposed rules

• Require all hemp CBD products to be manufactured using good manufacturing practices based on the end product’s intended use.

• State that individual food or beverage products cannot contain more than 25 milligrams of total CBD per product and supplements would be limited to 3,000 milligrams per product. In addition, products cannot exceed 0.3% total Δ9- Tetrahydrocannabinol (THC) concentration.

• Clarify that foods and drinks infused with CBD and other hemp derivatives must be packaged by the manufacturer and cannot be added at the retail level or in restaurants.

• Prohibit the addition of CBD to alcohol products.

• State that product labels must contain the total amount of CBD in the product, the number of cannabinoids per serving, a nutritional or supplement fact panel, and information on whether it contains THC.

• Require products to include warnings that state the product has not been evaluated by FDA, is not intended for children, and that it may cause drug test failures.

• Require labels to caution pregnant or nursing women to consult a healthcare provider before use.

• Require hemp producers to conduct lab tests for the CBD profile and for heavy metals, microbial impurities, mycotoxins, pesticides, and residual solvents.

• Require companies to make the testing information retrievable by consumers through a QR code or corresponding link on the product label.

• Bar claims that suggest CBD will diagnose, cure, mitigate, treat, or prevent disease.

New York Department of Health will take comments on the proposed regulations through January 11, 2021.  We will continue to monitor any developments.