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FDA & FTC Issue Warning Letters to 10 Companies
Tuesday, September 14, 2021
  • 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.

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