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Volume X, Number 304

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FDA and FTC Warn Companies for Unauthorized Coronavirus Disease 2019 (COVID-19) Claims

On March 6, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly issued seven warning letters to companies making alleged unauthorized claims related to the prevention or treatment of the Coronavirus Disease 2019 (COVID-19). In addition to issuing the joint warning letters, the FDA issued a press release announcing the actions taken and pages on its website (www.fda.gov) dedicated to COVID-19 issues. The FDA also posted an album of pictures of the alleged fraudulent products being promoted for the treatment or prevention of COVID-19.

In the letters, the FDA reiterated that non-drug products promoted to mitigate, prevent, treat, diagnose, or cure diseases such as COVID-19 are unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (FD & C Act). The FDA and the FTC identified information on company websites and social media platforms that allegedly constituted claims for the treatment or prevention of COVID-19. Due to the public health emergency existing nationwide regarding COVID-19, the FDA and the FTC demanded more immediate action than is usually required regarding warning letters. Companies were requested to respond within 48 hours to describe the steps taken to correct the alleged violations; the agencies indicated that failure to do so could result in legal action, including injunction and seizure.

The letters further indicated that, pursuant to the FTC Act, all advertising must be substantiated by competent and reliable scientific evidence. As there are currently no authorized vaccines, pills, potions, lotions, lozenges, or other prescription or over-the-counter products available to treat or cure COVID-19, the FTC asserted that there is no competent and reliable scientific information to support any claims. So, even if it were legal to sell non-drug products to treat COVID-19 under the FD & C Act, which it is not, the claims would not be substantiated either.

The FDA and the FTC have historically demonstrated aggressive action against alleged unauthorized advertising pertaining to pandemic outbreaks. The agencies previously sent joint warning letters to companies promoting products for the unauthorized treatment or prevention of the Ebola virus, the Avian Flu, and SARS (Severe Acute Respiratory Syndrome). The actions by the two agencies should make it clear to companies that the FDA and the FTC will be closely scrutinizing marketing and advertising across all platforms to ensure that no unauthorized claims are made regarding the mitigation, prevention, treatment, diagnosis, or cure of
COVID-19.

©2020 Greenberg Traurig, LLP. All rights reserved. National Law Review, Volume X, Number 70
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About this Author

Justin Prochnow, Greenberg Traurig Law Firm, Denver, Healthcare and Litigation Law Attorney
Shareholder

Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration, the Federal Trade Commission and other regulatory agencies. This includes the review of product labels, labeling, advertising, websites and other marketing materials. Justin assists companies with responding to governmental and regulatory actions, including FDA...

303-572-6562
Nancy Taylor, Greenberg Traurig Law Firm, Washington DC, Health Care Law Attorney
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Nancy Taylor is Co-Chair of the Health Care & FDA Practice and has advised clients on health and FDA related matters for more than two decades. She has broad experience in areas relating to the Affordable Care Act provisions, CMS reimbursement and policy issues relating to providers and plans, and she has done a significant amount of FDA regulatory work. Prior to joining Greenberg Traurig, Nancy served 10 years as Health Policy Director for the Senate Committee on Labor and Human Resources and worked on a number of significant health and FDA laws, including NLEA,...

202-331-3133
Michael R. Goodman ASSOCIATE Intellectual Property & Technology Food, Beverage & Agribusiness
Associate

Michael R. Goodman is an attorney and registered patent agent who advises clients on FDA regulatory compliance and intellectual property needs in the food, medical device, pharmaceutical, biotechnology, dietary supplement, and consumer products industries. Michael assists companies of all sizes in navigating regulatory compliance and developing strategies to avoid delays in their operations. He also prepares, reviews, and negotiates supply and distribution, manufacturing, and advertising agreements, as well as assists with stock and asset purchase agreements.

303-572-6500
James R. Prochnow SHAREHOLDER Health Care & FDA Practice Federal Regulatory & Administrative Law Marketing, Advertising, Sweepstakes & Promotions Law Life Sciences & Medical Technology
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Jim Prochnow concentrates his practice on Food and Drug Administration (FDA), Federal Trade Commission (FTC), and Drug Enforcement Agency (DEA) actions, advice and related litigation, which includes import detentions, government inspections, investigations and defense of class actions. He also counsels clients about regulatory issues associated with cosmetics, dietary supplements, homeopathic drugs, Over-the-counter (OTC) drugs, the use of CBD oil in products, the protocols and contracts associated with clinical trials, and cGMP compliance.

303.572.6546
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