CBD

Cannabidiol or CBD, is a common ingredient seen in a lot of products, especially dietary supplements. But what is the regulatory status of CBD?

This is a question that our office routinely receives but is heard more frequently following the passage of the Agriculture Improvement Act of 2018. Many wondered if CBD was a legal ingredient following an announcement by FDA Commissioner, Scott Gottlieb, M.D. (link here).

First, what did the AIA say about CBD? The new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

What the new law didn’t change was the Food Drug and Cosmetic Act. In particular, the definition of a dietary ingredient (21 U.S.C. 201(ff)) or provide CBD any status as a food additive. That means CBD has the same regulatory status now as it did before the AIA.

Under FDA regulations CBD is a questionable dietary ingredient. This is because no party has come forward with a successful New Dietary Ingredient application showing CBD was a dietary ingredient before it was studied as a drug (see, the approval of Epidiolex).

As a food ingredient no party has come forward to file a food additive petition or Generally Recognized As Safe (GRAS). Our office recently filed the first successful notice on hemp (see here) but the notified substance in those submissions wasn’t CBD directly.

Marketing, manufacturing and selling a CBD product is a complex area of regulation that often focucses on labeling.

Contact our offices with any questions about CBD.