September 29, 2020

Volume X, Number 273

September 29, 2020

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September 28, 2020

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FDA Issues Warning Letter for Fraudulent COVID-19 Treatment Product

  • FDA has issued warning letters to companies selling allegedly fraudulent products with claims to prevent, cure, treat, or diagnose COVID-19. Companies that sell products with unapproved claims regarding COVID-19 may be subject to enforcement actions that may include seizure or injunction.

  • On April 8, FDA announced that it had issued a joint warning letter with the Federal Trade Commission (FTC) to the Genesis 2 Church of Health and Healing for selling “Miracle Mineral Solution,” a chlorine dioxide product marketed for the prevention and treatment of COVID-19.

  • FDA previously warned consumers not to purchase or drink chlorine dioxide products sold online as medical treatments.  Chlorine dioxide products have not been shown to be safe and effective for any use.  Rather, FDA has received reports of people experiencing serious adverse effects after consuming chlorine dioxide, which FDA describes as “a powerful bleaching agent.”

  • FDA and FTC have asked that Genesis 2 Church of Health and Healing respond within 48 hours to describe steps that have been taken to correct violations.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 101

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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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