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CBD Update: FDA Takes More Aggressive Enforcement Action in Warning Letters to Companies

On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, and water), vape pens, oral sprays, creams, and pet treats. In all cases, FDA alleges that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully. FDA repeats its long-standing position that CBD is not eligible to be used as an ingredient in conventional foods and dietary supplements, although the letters invite companies to submit evidence to rebut this conclusion.

FDA also published a revised Consumer Update detailing its continued safety concerns about CBD products more broadly. Notably, for the first time FDA has directly stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.” In a statement, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D noted, “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”

These latest warning letters suggest that FDA may be taking more aggressive enforcement action and increasing its scrutiny of CBD-containing products. The statement about the absence of a basis for GRAS status for CBD in food is significant because even if the ineligibility issue can be overcome, FDA’s view is that CBD would need to be the subject of an approved food additive regulation before it could be used in human or animal food.

The Agency continues to defer fulfilling its commitment to report on its progress in evaluating potential regulatory pathways for CBD products. In its press release discussing the warning letters, FDA states that it now “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.” Given FDA’s ongoing safety concerns and the present conclusion about the lack of GRAS status in food, it is clear that establishing a regulatory pathway for CBD in food and dietary supplements will need to address numerous significant challenges.

© 2020 Keller and Heckman LLP

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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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