September 19, 2021

Volume XI, Number 262

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September 17, 2021

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FDA & FTC Issue Warning Letters to 10 Companies

  • On September 9, 2021, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued warning letters to 10 companies for illegally selling dietary supplements claiming to treat diabetes.

  • The claims were found on the 10 companies’ websites, social media pages, and Amazon storefronts, and included a variety of statements regarding the products’ claimed abilities to control blood sugar and help diabetics. Therefore, because the advertising materials indicate that the products are intended for use in the cure, mitigation, treatment, or prevention of disease, they are considered drugs under the Federal Food, Drug, and Cosmetic Act (FDCA), even if advertised as dietary supplements. And, because the products have not been approved by FDA as drugs, under the FDCA, they are considered adulterated once introduced into interstate commerce.  Further, by the authority of the FTC Act, the letters also demand that companies cease and desist making claims that are not substantiated by competent and reliable scientific evidence.

  • We note that that by agreement the FDA has primary jurisdiction over labeling of dietary supplements while the FTC has primary jurisdiction over the advertising of dietary supplements. However, the term “labeling” is broadly interpreted and can include websites and other materials that are also considered advertising. Thus, as is the case here, both agencies may share jurisdiction and decide to act to remedy unlawful behavior.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 257
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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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