FDA, FTC warn companies about selling fraudulent COVID-19 products

The FDA and Federal Trade Commission have issued warning letters to seven companies for selling products that fraudulently claim to prevent or treat the novel coronavirus, which has been officially named COVID-19. The products are unapproved drugs that pose significant risks to patient health and violate federal laws, according to an agency press release.

The release states that warning letters were jointly issued to Vital Silver, Quinessence Aromatherapy, Xephyr (doing business as N-Ergetics), GuruNanda, Vivify Holistic Clinic, Herbal Army and The Jim Bakker Show. Products cited in the warning letters include teas, essential oils, tinctures and colloidal silver. The agencies requested that companies respond in 48 hours describing the specific steps they have taken to correct the violations. Companies that sell products fraudulently claiming to prevent, treat or cure COVID-19 may be subject to legal action, including but not limited to seizure or injunction.

There are currently no vaccines or drugs approved to treat or prevent COVID-19. Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness, according to the release.

“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,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”

The FDA and FTC will continue to monitor social media, online marketplaces and incoming complaints to help ensure that the companies do not continue to sell fraudulent products under a different company name or on another website, the agency stated in the release.

Further, the FDA has established a cross-agency task force dedicated to closely monitor for fraudulent products related to COVID-19. The task force has contacted major retailers to request help in monitoring their online marketplaces for fraudulent products claiming to combat COVID-19 and other pathogens and has already worked to remove more than 3 dozen listings of fraudulent COVID-19 products, the FDA stated in the release.

“There already is a high level of anxiety over the potential spread of coronavirus,” FTC Chairman Joe Simons said in the 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 agency also reminds consumers to be cautious of websites and stores selling products claiming to prevent, mitigate, treat, diagnose or cure COVID-19. These fraudulent products may come in many varieties, including dietary supplements and other foods, as well as products purporting to be drugs, medical devices or vaccines. Using these products, the FDA warns, may lead to delays in getting proper diagnosis and treatment.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.