Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA enforcement and let companies know what to expect if they do become the target of enforcement action. To do just that, MoFo’s product regulatory team has tracked and analyzed these enforcement efforts against COVID-19 products to bring you this year‑end guide.
Triggering FDA Enforcement
The COVID-19 pandemic has not significantly changed the scope of FDA’s regulatory authority. The agency regulates drugs and medical devices: instruments or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease or condition. Any product that makes these drug or device claims is subject to FDA’s regulatory authority.
Indeed, product manufacturers most commonly trigger FDA scrutiny by making an unauthorized COVID-19 claim in product advertising or labeling. For example, FDA has taken enforcement action against products claiming to:
- Provide any type of COVID-19 testing;
- “Treat” or “fight” COVID-19 or “inhibit” the virus;
- “Prevent” or “reduce the risk” of contracting COVID-19; or
- Treat or reverse bodily symptoms caused by COVID-19.
Even suggesting these claims, such as using a “#coronavirus” hashtag on social media for a disinfectant spray, can trigger enforcement.
Common Enforcement Actions
FDA generally uses one of two regulatory devices to remove dangerous or unauthorized COVID-19 products from the market.
In most circumstances, FDA takes enforcement action by issuing a warning letter to the manufacturer detailing violations of the Food, Drug, and Cosmetics Act. To date, FDA has issued over 140 warning letters to manufacturers of products like test kits, homeopathic drug products, disinfectant sprays, and various devices that claim to test for or treat COVID-19. FDA publishes these letters and maintains them in a list of “fraudulent” COVID-19 products. The Federal Trade Commission may also sign onto these letters because claiming that a product can prevent, treat, or cure disease without competent and reliable scientific evidence also violates the FTC Act.
Warning letters may require that a manufacturer remove impermissible product claims or take an unapproved product off the market altogether. FDA also demands expedited corrective action for COVID-19 products. Whereas general warning letter recipients typically have 15 business days to respond, COVID-19 product manufacturers have only 48 hours to describe the corrective steps they have taken to correct violations.
Failure to comply with a warning letter can lead to swift judicial intervention. In April, FDA and FTC issued a warning letter to a seller of “Miracle Mineral Solution,” a dangerous chlorine dioxide product touted as a COVID-19 cure. The seller refused to remove the product from the market. Within 10 days of the warning letter, a federal court issued a temporary restraining order against the seller, and later a permanent injunction against selling or distributing the misbranded products. The individual defendants have been charged with conspiracy to defraud the United States, conspiracy to violate the FDCA, and criminal contempt.
When a defective or potentially harmful product has already been sold to consumers and patients, FDA may ask a manufacturer to recall the product. A great example of this is FDA’s activity on hand sanitizers. Since shortages began early in 2020, hand sanitizer products have flooded the market to keep up with soaring demand. Some of these products include dangerous, prohibited ingredients like methanol and 1‑propanol instead of or in addition to the generally permitted ethanol or isopropyl alcohol. FDA has been working extensively to test the many sanitizers on the market and remove those that pose harm to consumers.
FDA has identified over 220 products on a do-not-use list of hand sanitizers, but has faced difficulty getting manufacturers to comply with its efforts to recall these products. While it has authority to issue mandatory recalls for dangerous biologics and medical devices, FDA does not have authority to forcibly recall over-the-counter drugs like hand sanitizer. Newly proposed legislation would vest FDA with that power so it would not need to rely on manufacturer cooperation to get dangerous drugs off store shelves.
FDA is currently able to prevent some these products, many of which are imported from Mexico, from entering the country by issuing an import alert for certain brands of sanitizers. Products on this list imported from abroad cannot pass through customs into the U.S., a restriction that serves as a reminder of FDA’s leverage over manufacturers that import goods from abroad.
We have reported on FDA’s unique abbreviated approval pathways for various COVID-19 products designed to encourage production and decrease time-to-market. In contrast to the innovative solutions the agency has deployed in product review and approval, the agency has continued to use its tried‑and‑true methods on the enforcement side. Warning letters and product recalls remain the primary weapons in FDA’s arsenal for unapproved treatment claims for COVID-19, but FDA is enforcing its policies more aggressively in relation to COVID‑19. Companies must take swifter compliance measures, and FDA will turn to more drastic actions like judicial intervention and import detention if those measures are inadequate.