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