CBD Regulation: Recent FDA Enforcement Casts A Wider Net Over CBD Products

• Published date: 06 May 2021
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp, Food and Drugs Law
• Law Firm: Perkins Coie LLP
• Author: Mr LaDale K. George and Helen Goldstein

On March 22, 2021, the U.S. Food and Drug Administration (FDA) released two warning letters to U.S. companies selling products containing cannabidiol (CBD). These warning letters highlight the FDA's continuing vigilance on marketing of products containing CBD. Without having undergone rigorous testing and FDA review and approval, it remains a violation of the Federal Food Drug and Cosmetics Act (FD&C Act) to sell products containing CBD that make specific health claims related to the treatment or prevention of disease or other conditions or the function or structure of the body. This includes claims on a product's label and applies to any marketing material in any form.

In these letters, the FDA highlights that "a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient." In other words, a drug manufacturer cannot add CBD to a non-prescription over-the-counter (OTC) pain cream, even if CBD is listed as in "inactive ingredient."

The FDA made clear that the products targeted in the warning letters portrayed CBD as "active" even if the ingredient labeling categorized it otherwise (e.g. "Pain Relief Cream with Rejuvenating CBD"). The labeling of a drug may be considered misleading, and thus a violation of the FD&C Act, if it features "inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation." (21 CFR 201.10(c)(4)).

The FDA has generally been less interested in so called "wellness language" such as "rejuvenating", and, for this reason, industry participants often...