October 21, 2020

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October 19, 2020

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FDA Sends Warning Letters to Companies Illegally Selling Hangover Supplements

In a July 29, 2020 news release, the U.S. Food and Drug Administration (FDA) announced that it had issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, which is in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).

In the letters to the seven companies, FDA noted that the claims on the products’ websites establish that the products are drugs under the FD&C Act because they are “intended for use in the cure, mitigation, treatment, or prevention of disease.”  By way of background, under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs.  FDA stated that a statement claims to mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, such as a hangover, which FDA described as “a sign or symptom of alcohol intoxication, a disease.”

In the warning letters, FDA noted that claims like “Ultimate Hangover Relief,” Protect your liver and brain,” “the most effective hangover preventing supplement currently available,” and “Helps prevent hangover symptoms” claim to mitigate, treat, cure, or prevent disease.  FDA warned that hangover products are not generally recognized as safe and effective for the proposed uses.  Therefore, the Agency concluded that these products constitute new drugs and that new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 212

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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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