These are the first warning letters to be issues by FDA for unapproved products intended to prevent or treat COVID-19.
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters to seven companies for fraudulently selling COVID-19 products. These are the first warning letters to be issues by FDA for unapproved products intended to prevent or treat COVID-19.
“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release. Hahn urges consumers to seek the advice of health care professionals if they are concerned about COVID-19.
“There already is a high level of anxiety over the potential spread of coronavirus,” added FTC Chairman Joe Simons, in a press release. “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
The recipients of the warning letters are Vital Silver, Quinessence Aromatherapy Ltd., Xephyr LLC (doing business as N-Ergetics), GuruNanda LLC, Vivify Holistic Clinic, Herbal Amy LLC, and The Jim Bakker Show. Some products cited in the warning letters were teas, essential oils, tinctures, and colloidal silver. The companies were given 48 hours to respond to the letters, describing the specific steps taken to correct the violations.
FDA and FTC are actively monitoring social media, online marketplaces, and incoming complaints to ensure the companies do not continue to sell fraudulent products under a different name or another website. An FDA cross-agency task force was established specifically to closely monitor for fraudulent products related to COVID-19. The task force has also reached out to major retailers for help in monitoring online marketplaces and has already removed more than three dozen listings of fraudulent COVID-19 products.
On February 11, 2020, the industry attempted to get ahead of the issue, when an industry coalition that included The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) released a joint advisory. In the statement, the coalition of trade organizations advised marketers and retailers to refuse to stock or sell supplements that are presented as treating, curing, or preventing COVID-19, and refrain from promoting any dietary supplement for this purpose. They also advised consumers to avoid supplements that claim to treat, cure, or prevent COVID-19 and report them to FDA.