March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient health and violate federal law,” according to an FDA press 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,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
FTC Chairman Joe Simons said that “There already is a high level of anxiety over the potential spread of coronavirus. 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 March 9 enforcement letters were issued jointly by both agencies, citing products including teas, essential oils, tinctures and colloidal silver, and stating that companies selling products that fraudulently claim to prevent, treat or cure COVID-19 “may be subject to legal action, including but not limited to seizure or injunction.”
The companies that received Warning Letters are:
- Vital Silver
- Quinessence Aromatherapy Ltd.
- Xephyr LLC, doing business as N-Ergetics
- GuruNanda LLC
- Vivify Holistic Clinic
- Herbal Amy LLC
- The Jim Bakker Show
The FDA stated that it is concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 “may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.” The agency also reminded consumers to be cautious of Websites and stores selling COVID-19 products.
In January the FDA issued a Warning Letter to GOJO Industries Inc. regarding the company’s marketing of the PURELL® Healthcare Advanced Hand Sanitizer product line, which has been selling out at stores across the nation in recent weeks amid the COVID-19 outbreak. The Jan. 17 enforcement letter said that GOJO’s claims – on product Websites, www.gojo.com, www.purell.com and related social media accounts – which stated that PURELL products may be effective against viruses such as the Ebola virus, norovirus and influenza, render the products unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act.
“In the area of hand sanitizers, the FDA has generally been skeptical that these products offer an advantage over washing with ordinary soap and water,” explained Coalition for Healthcare Communication Executive Director Jon Bigelow. “The FDA requires – for both prescription and over-the-counter products – that promotion stay within approved labeling.”