Member Article

In a recent article, we discussed government efforts to combat fraud in connection with the COVID-19 pandemic. We have seen a number of government enforcement actions, including the marketing of coronavirus treatments;selling toothpaste, dietary supplements, creams and other products as treatments to prevent and cure the coronavirus; andprice-gouging on health and safety products.

On March 31, 2020, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued a warning letter to a Neuro XPF, which markets and sells hemp-derived cannabidiol (CBD) products for athletes. The letter states that the company made statements on its website and social media accounts that suggest that these products “are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

The company was directed to review its websites, product labels, and other promotional materials to ensure that they do not misleadingly represent the products as safe and effective for a COVID-19-related use not approved by the FDA. The company also was required to send an email to the FDA COVID-19 Task Force within 48 hours describing the specific steps taken to correct the violations. Failure to “immediately correct the violations” could result in legal action, including seizure and injunction. The FDA further noted that it was adding the company to its list of Fraudulent Coronavirus Disease 2019 (COVID-19) Products.

This warning letter is notable due to the speed in which it was issued by the FDA and FTC, and the 48-hour window provided to the company to come into compliance. This demonstrates the government’s commitment to reducing fraud during this pandemic.

It is critical for companies marketing and selling cannabis products, pharmaceuticals, medical devices, and other regulated products to ensure that promotional claims are truthful, accurate, not misleading, and otherwise consistent with FDA regulations. Extra care should be taken when promotional claims relate, directly or indirectly, to the COVID-19 pandemic.

Please contact the author or your Dinsmore attorney for additional information.