The FDA and FTC issued joint warning letters to companies selling products purporting to prevent or treat COVID-19. The agencies claim that the companies are making unsubstantiated claims about their unapproved and misbranded products. The letters require the companies to respond within 48 hours outlining specific steps taken to address the agencies’ concerns. Companies receiving warning letters include:

  • Herbs of Kedem, for selling unapproved and misbranded herbal products for the prevention and treatment of COVID-19;
  • Alpha Arogya India Pvt, Ltd, for offering unapproved and misbranded ayurvedic products falsely claiming to prevent and treat symptoms of COVID-19; and
  • Gaia Arise Farms Apothecary, for making misleading claims that its products, including its “True Viral Defense” or “Viral Defense Tincture” product, are safe and/or effective for the treatment of COVID-19.

In addition, the FTC separately issued warning letters to several other companies for making unsubstantiated COVID-19-related efficacy claims. While the FTC’s prior letters have targeted companies selling supplements, colloidal silver, teas, and essential oils, this round of letters addressed a wider variety of COVID-19-related products, as well as purported treatments offered in clinics or at a consumer’s home.  The letters warn that if the companies do not cease to make claims that their products can treat or cure COVID-19, the FTC may seek court injunctions as well as orders requiring the companies to refund money to customers. Finally, the letters instruct the recipients to notify the Commission within 48 hours about the specific actions taken to address the agency’s concerns.

View the press release