April 5, 2020

April 03, 2020

Subscribe to Latest Legal News and Analysis

April 02, 2020

Subscribe to Latest Legal News and Analysis

Trade Associations Send Letter to All Members of Congress Urging Action on CBD in Dietary Supplements

  • On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make cannabidiol (CBD) derived from hemp a legal dietary ingredient for use in dietary supplements.

  • The letter requests that Congress carve out a statutory pathway for the lawful introduction of CBD-containing supplements into the marketplace. Specifically, the proposed law would create a limited waiver of § 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FDCA), which FDA has previously used to support its position that CBD may not be used in dietary supplements because it is an active ingredient in an FDA-approved drug and has been the subject of substantial clinical investigations. CBD derived from hemp would be exempt from this section, provided that the products meet established safety and quality criteria and comply with all other provisions of the FDCA. The letter also calls for increased funding on top of the $2 billion provided to FDA to address the issue of hemp-derived CBD in the FY 2020 Agriculture and Related Agencies Appropriations bills.

  • In the wake of rapidly increasing sales of hemp-derived CBD products, Congress has repeatedly pressured FDA to act quickly in establishing a regulatory framework for CBD. Thus far, FDA has stated that it is exploring additional regulatory pathways for CBD products, but that this process is likely to take 3 to 5 years. FDA maintains that dietary supplements containing hemp-derived CBD are illegal under the FDCA. Meanwhile, the Federal Trade Commission has stepped up enforcement against CBD products that are promoted via health-related claims.

© 2020 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...