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New Bipartisan Senate Bill Seeks Movement on CBD

U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR) introduced S. 1698 on May 19, a bill to allow the use of cannabidiol (CBD) and other hemp derivatives in foods and dietary supplements. As our readers know, FDA has stated it does not consider CBD to be a legal food additive or dietary ingredient because it has previously been the subject of clinical investigations for use in drugs and is currently the active ingredient in the approved drug Epidiolex, marketed by GW Pharmaceuticals for treatment of seizures related to epilepsy.

If passed, the Hemp Access and Consumer Safety Act (bill text available here) would specifically amend the definition of a dietary supplement in 21 U.S.C. § 321(ff)(3)(B) to except “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from the requirement that dietary ingredients may not include articles that have been approved as new drugs. It would also except the same substances from the requirement in 21 U.S.C. § 331(ll) that foods may not contain articles that have been approved as drugs or the subject of substantial clinical investigations. It would further permit FDA to establish requirements for labeling and packaging of dietary supplements and foods containing hemp and hemp derivatives and take enforcement actions regarding products that are labeled as dietary supplements but that do not meet the definition of dietary supplements in § 321(ff)(3)(B).

The bill would allow firms to move forward with submissions to FDA seeking an appropriate clearance for CBD as a dietary ingredient or food additive through existing pathways, such as through a New Dietary Ingredient Notification, Food Additive Petition, GRAS Notice (a submission demonstrating that a food additive is “generally recognized as safe” for its intended use). It would also allow FDA to begin inspecting manufacturing facilities where hemp derivatives and related products are made.

S. 1698 has bipartisan support in Congress and industry backing. It joins a CBD-focused House bill, H.R. 841, that was introduced in February and seeks to allow CBD for use in dietary supplements only. We will continue to track CBD-related legislation and report on the progress of these bills.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 141
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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...

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