July 7, 2020

Volume X, Number 189

July 07, 2020

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July 06, 2020

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FDA and FTC Issue Warning Letters to Companies Marketing and Selling Products Deemed Fraudulent for the Treatment or Prevention of COVID-19

  • On May 26, 2020, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint warning letters to four companies for the marketing and sale of products deemed fraudulent for the treatment or prevention of COVID-19 (Coronavirus Disease 2019).

  • FDA warned CBD Gaze (CBD products), Alternavita (grapefruit seed extract, colostrum, and cod liver oil products), Musthavemom.com (colloidal silver, vitamins, minerals, herb oils, and a homeopathic drug product), and Careful Cents, LLC (essential oil products), regarding the companies’ promotion, including through referrals as Amazon Associates, of their respective products with claims that they mitigate, prevent, treat, diagnose, or cure COVID-19.

  • FDA demanded that the four companies immediately cease to promote and participate in the sale of the products at issue, and requested confirmation in writing, within 48 hours, of the specific steps being taken by the companies to correct the violations. In addition, FDA indicated that the companies will be added to a list published on FDA’s website of companies that have received FDA warning letters for fraudulent products related to COVID-19.

  • There are currently no FDA-approved products for the prevention or treatment of COVID-19, and FDA indicates it is taking urgent measures to protect consumers from products that—without approval or authorization by FDA—claim to mitigate, prevent, treat, diagnose, or cure COVID-19. In addition, it is unlawful to market or advertise that a product can prevent, treat, or cure human disease, unless adequately substantiated by competent and reliable scientific evidence (including, when appropriate, well-controlled human clinical studies) supporting the validity of the claims at the time they are made (and there is no such evidence that applies to the products at issue here). Companies that sell products with unapproved claims regarding COVID-19 may be subject to enforcement actions such as seizure, injunction, and restitution.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 150

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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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