FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working with online marketplaces, domain name registrars, payment processors, and social media websites to remove unproven claims from their platforms.
To date, FDA has issued over 65 warning letters. In certain instances, FDA has followed those warning letters by asking DOJ to initiate formal legal proceedings against a product manufacturer. For some categories of products, FDA has used press announcements to effectively provide a generalized warning to all manufacturers in the space. In this article, we tabulate all of the enforcement efforts that FDA has been using to try to keep fraudulent COVID‑19 products off the market.
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Follow Morrison & Foerster’s Life Sciences and Products Liability blogs to stay informed as we continue to report on FDA’s evolving role in the medical product industry. Our COVID-19 Resource Center also provides multidisciplinary guidance to help you face these developing issues.