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FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19

We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud (see here and here). These agencies and their respective law enforcement efforts have yet to slow down and appear to have accelerated as greater coordination begins to take root. As of May 29, 2020, the U.S. Food and Drug Administration (FDA) has issued 64 warning letters to companies making claims about a product alleged to be a COVID cure, treatment, or preventative product, while the U.S. Federal Trade Commission (FTC) had issued many, many more than that. In some cases, these warning letters are joint letters that come from both government agencies, which is never a good sign. The FTC in particular is making announcements on a regular basis about large batches of warning letters being issued, such as this one from May 21 highlighting that 50 more marketers of fraudulent COVID-19 products had received such a missive from the FTC. 

The warning letters are being sent not only to domestic companies but also to international companies making unsubstantiated claims about treating or preventing COVID-19. In addition, FDA reported in an enforcement update it provided on May 7, 2020 that it had “intercepted and investigated a case of mislabeled COVID-19 ‘treatment kits’ offered for import” that ultimately led to an international law enforcement effort and “the [U.S.] Department of Justice to bring a criminal complaint against a British man who sought to profit from this pandemic and jeopardize public health.” Upon failing to be responsive or taking the corrective action set forth in a warning letter, some companies have been quickly taken to federal court to receive court-issued injunctions. We expect to see more court actions such as these as the unprecedented public health crisis continues.

It is notable that many of the FDA’s and the FTC’s warning letters have been issued to companies involved in selling products, such as essential oils, cannabidiol (CBD) products, hand sanitizers, and homeopathic drugs, which can easily be bought from the comfort of home and immediately shipped to the end user. This easy consumer access has incentivized both agencies to react quickly to prevent or halt fraudulent advertising and purchases on social media platforms and various websites. These agencies are aware of the urgency of their enforcement efforts, since many consumers are laser-focused on COVID-19 and looking for ways to treat or prevent it while isolated under stay-at-home orders. And although none of the FDA warning letters to date have involved diagnostic or antibody tests or medical device products, the agency’s May 7 enforcement update mentioned previously did note that “as part of the FDA’s Operation Quack Hack, in just a few short weeks, the agency has discovered hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims. … FDA has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, who in most instances, have voluntarily removed the identified postings.” However, it seems inevitable that distributors of such illegitimate PPE and test kit products will end up on the receiving end of warning letters or even prosecutions at some point if the current trends continue.

Interestingly, the four joint FDA/FTC letters issued on May 26, 2020, specifically call out that the companies in question each participated in the Amazon Associates program and that “as an Amazon associate, [the company] earn[s] commissions by promoting the sale of [their respective products] with claims on [the company’s] website representing or implying that the products can mitigate, prevent, treat, diagnose, or cure COVID-19.” To our knowledge, these letters represent the first time FDA has mentioned this kind of marketing arrangement in one of its warning or untitled letters.

Similarly, as many consumers are constantly near their phones awaiting fresh news about COVID-19, the FTC has also issued robocall warning letters in an effort to prevent companies from “assisting and facilitating” illegal telemarketing calls related to COVID-19-related services or products. There has also been at least one warning letter sent to the marketer of an alleged COVID-19 vaccine product that both FDA and FTC signed onto on May 21, 2020, and tellingly, this letter only cited claims made for the alleged product on Facebook and LinkedIn and should remind everyone that traditional advertising is not the only thing that will come to the government’s attention.  

This type of oversight and enforcement is likely to continue for years, especially if the number of consumer complaints about fraudulent COVID-19-related products do not substantially decrease. The FDA and FTC both encourage consumers to continue reporting this type of misbehavior by companies to protect and promote the nation’s public health. There has been an overwhelming amount of information and news circulating during this pandemic, as Americans search for answers amidst the uncertainty the virus has created.  For now, at least one thing is certain: the government is not slowing down enforcement efforts related to COVID-19 fraud.

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Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.