FDA Issues Coronavirus-Related Warning Letters

The Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) have issued warning letters to 7 companies for marketing fraudulent novel coronavirus (COVID-19) products.

The warning letters are the first to be issued by the FDA over unapproved products which present themselves as treatment or prevention therapies for COVID-19.

There are currently no vaccines or any other prescription or over-the-counter treatments available to treat COVID-19.

The FDA indicated concern that the claims being made about these products may cause life threatening harm if consumers delay scientifically valid medical care.

Warning letters were issued to Vital Silver, Quinessence Aromatherapy Ltd, N-Ergetics, GuruNanda, Vivify Holistic Clinic, Herbal Amy, and The Jim Bakker Show.

The companies are required to email an FDA COVID-19 Task Force within 48 hours describing specific steps being taken to correct the violations.

The products cited in the warning letters are essential oils, tinctures, teas, and colloidal silver.

The Jim Bakker Show, for example, moderate their claims about the specific coronavirus but clearly intended to market an unapproved product for COVID-19 prevention.

“Well let’s say it hasn’t been tested on this strain of the coronavirus, but it’s been tested on other strains of the coronavirus, and has been able to eliminate it within 12 hours, totally eliminate it, kills it, deactivates it” the hosts of the show are recorded saying.

Vital Silver made similar false claims.

“…it’s actually widely acknowledged in both science and the medical industry that ionic silver kills coronaviruses. And it’s now known that the Chinese are employing ionic silver in their fight against the spread of the coronavirus,” the company claimed in a Facebook post.

Vivify Holistic Clinic made the claim that their “very strong boneset tea” used 6 times a day has been successful “with other corona virus infections, including SARS.”

“There already is a high level of anxiety over the potential spread of coronavirus,” said FTC Chairman Joe Simons in the FDA's news 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.”

While there are not any approved treatment options for COVID-19, there are treatments in clinicla development. The investigational antiviral compound remdesivir is being evaluated against COVID-19, for example.

In addition, the US Department of Health and Human Services has partnered with Regeneron in hopes of creating a coronavirus antibody treatment.

While empirically verifiable treatments are in development, clinicians can encourage patients to get information from reliable sources while practicing known prevention techniques.