September 19, 2021

Volume XI, Number 262

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September 17, 2021

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FDA Issues Warning Letters to Companies Selling CBD Products for Pain Relief

Last week the FDA issued warning letters to Honest Globe, Inc. (March 15, 2021) and Biolyte Laboratories, LLC (March 18, 2021) for selling products containing cannabidiol (CBD) in violation of the Federal Food, Drug and Cosmetic Act (the “Act”).

A principle issue addressed by FDA in the letters is the sale of the CBD containing products as unapproved drugs. The CBD products at issue claimed to provide pain relief as well as a variety of other beneficial effects (e.g., anti-inflammatory, anxiety and depression treatment).  Examples of claims include: “Elixicure pain relief with CBD”, “Deep-penetrating natural pain relief . . . non-addictive pain relief”, “relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more”, “demonstrates antiviral, antibacterial, and antifungal effects for virtually every surface and tissue in the body”, “for temporary relief of occasional . . . minor aches and pains . . . Stiffness of muscles, joints and tissues.”  Therefore, consistent with the definition of drug,  the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the body. Both letters also state that the products do not meet the requirements under section 505G of the Act which would allow them to be marketed without an approved new drug application. Specifically, among other shortcomings, the active ingredient, CBD, was not an active ingredient in any applicable final monograph or tentative final monograph (TFM). Further, even if CBD was considered an inactive ingredient, the products would still not qualify for the 505G exception because CBD does not conform with the general requirement that it be safe and suitable since it has known pharmacological activity with demonstrated risks.

The letters also address a number of other deficiencies and violations, including failure to comply with current good manufacturing practices.

As we have previously reported, FDA taken the position that CBD is not a lawful dietary ingredient or dietary supplement, but has focused its enforcement efforts on Warning Letters against companies making unsubstantiated health claims. These letters are consistent with that policy. We will continue to monitor and report on any development in CBD regulation and enforcement.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 82
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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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