FDA, FTC Issue Warning Letters for COVID-19 Claims

Washington, D.C.—The Food and Drug Administration (FDA) announced that the FDA and Federal Trade Commission (FTC) issued warning letters to three companies for selling fraudulent COVID-19 products. The letters went to Gaia’s Whole Healing Essentials LLC, Homeomart Indibuy, and Health Mastery Systems DBA Pure Plant Essentials.

  • Gaia’s Whole Healing Essentials LLC. was warned for selling unapproved and misbranded colloidal silver products with misleading claims that the products can build immunity for the treatment or prevention of COVID-19.
  • Homeomart Indibuy was warned for offering homeopathic drug products for sale in the U.S. that are unapproved and misbranded with misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19.
  • Health Mastery Systems DBA Pure Plant Essentials was warned for selling essential oils with misleading claims that the products are safe and/or effective for the treatment or prevention of COVID-19.

The companies were instructed to take immediate action to correct the violations cited in the warning letters.

The compaies were advised: “Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.”

As WholeFoods has previously reported, industry leaders have issued strong cautions against making claims.

On January 27, 2020, President and CEO of NPA Daniel Fabricant, Ph.D., urged FDA to take action, saying: “As you are aware, the Wuhan Coronavirus is a substantial emerging health issue, any such issue creates fear, and unfortunately unreputable actors look to capitalize on that fear, including those that will market anything to make money with little regard for the harm that their actions will cause. These scams put consumers at risk when they claim that their products will treat or prevent illnesses, like the newly identified Coronavirus. Individuals that choose these fraudulent products rather than seeking therapy or treatment from a reputable health care provider are putting their health at risk.”

In February, a coalition of industry trade associations reminded consumers and retailers that dietary supplements cannot claim to treat, prevent, or cure the coronavirus. The American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) note in a joint statement that they support the responsible sale and use of vitamins, minerals, herbs, and other dietary supplements that provide many positive benefits promoting better health and wellness. “However, we are concerned that some marketers of dietary supplements or other products may be promoting them with claims of prevention or treatment of Coronavirus.” Details of their advisory can be found here.

Related: FDA, FTC Issue Warning Letters to 7 Companies for Coronavirus Claims
Industry Warns Against Supplements Claiming to Treat Coronavirus
NPA Urges FDA: Take Action Against Coronavirus Claims