September 24, 2021

Volume XI, Number 267

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Senators Unveil Draft Bill with Pathway for CBD

Senators Chuck Schumer (D-NY), Cory Booker (D-NJ), and Ron Wyden (D-OR) unveiled a lengthy discussion draft titled the Cannabis Administration and Opportunity Act on July 14. The draft language is meant to spur and inform discussions as the senators work to create a final legislative proposal to be introduced as a formal Senate bill.

Section 505 of the discussion draft proposes creating a legal pathway for cannabidiol (CBD) in dietary supplements. Specifically, the draft proposes amending the definition of “dietary supplement” in 21 U.S.C. § 321(ff) to except CBD derived from hemp from the prohibition against using substances that have been approved as drugs. The draft also proposes a section that states dietary supplements would be adulterated if they contain more CBD than a limit to be set by the Secretary of the Department of Health and Human Services. Additional language would give FDA enforcement authority over noncompliant products containing CBD that are improperly labeled as dietary supplements and give FDA the authority to require safety-related labeling or packaging as needed for CBD-containing dietary supplements. The proposed language limits the possibility of CBD in dietary supplements to CBD derived from cannabis plants, limiting opportunities for synthetically-produced CBD.

Other provisions in the draft would decriminalize marijuana by removing “marihuana” and “tetrahydrocannabinols” from the list of Schedule I controlled substances at 21 U.S.C. § 812, expunge non-violent marijuana crimes, and allow compliant cannabis businesses access to financial services, among other items.

The sponsoring senators request comments from stakeholders. A comprehensive summary of the discussion draft is available here. If final language is developed and a bill is introduced, the bill would join S. 1698 and H.R. 841, other bills introduced in Congress this session that seek movement on CBD.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 197
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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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