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December 2018

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EXTRA

A topline report from the Council for Responsible Nutrition (CRN), 
the leading trade association for the dietary supplement and functional food industry

FDA Reiterates CBD-containing Food and Supplements Still Illegal

Yesterday afternoon, the President signed into law the 2018 Farm Bill, which includes provisions removing hemp from the definition of marijuana in the federal Controlled Substances Act. Removing hemp and its non-THC constituents from the controlled substances schedules clears a significant hurdle on the path to legal marketing of cannabidiol (CBD). However other legal barriers still exist.

Contemporaneously with yesterday’s bill signing, FDA Commissioner Scott Gottlieb, M.D., issued a statement reiterating FDA’s views towards using CBD in food and dietary supplements. In the statement, Dr. Gottlieb reiterates FDA's position that  "Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act."

Dr. Gottlieb further notes, ” Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act,  it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

See FDA's full statement, issued contemporaneously with the signing of the Farm Bill,  here. 

Contact CRN with Questions:

If you have questions about the marketing of CBD-containing products, please feel free to contact Dr. Duffy MacKay ( DMackay@crnusa.org ), Megan Olsen, Esq. ( MOlsen@crnusa.org ) or Steve Mister ( SMister@crnusa.org ) at CRN.