KEY POINTS

  • The FDA issued warning letters to four companies that sell or promote "misbranded" products 
  • The agency cited company posts and blogs that claim the products' efficacy against COVID-19
  • FDA urged the companies to make changes so they don't "misleadingly" represent their products

The U.S. Food and Drug Administration (FDA) sent warning letters to four companies for promoting or selling products that the agency said has made misleading claims relating to COVID-19. This is a part of the agency's ongoing efforts to protect consumers.

Even early on in the coronavirus pandemic, the FDA has been urging consumers to be aware of products that claim to diagnose, treat or prevent COVID-19. In March, for instance, the FDA warned against unauthorized and fraudulent COVID-19 test kits, and it continues to urge people to be alert for such products as well as others that make misleading claims regarding COVID-19.

On Monday, the FDA said in its COVID-19 update that along with the Federal Trade Commission (FTC), it has sent warning letters to three companies that it said either sold or promoted "unapproved and misbranded products" with claims regarding COVID-19 and one company that promotes such products.

These companies are Heavenly Natural Products, Health & Wellness Center International One, L.L.C. dba Hotze Vitamins, Indigenous Products and iThrive.health.

In the agency's letters, it noted Facebook posts, tweets and even a YouTube video in which the FDA says the companies were "misleadingly" representing products to be effective for the prevention or treatment of COVID-19.

In the case of Heavenly Natural Products, the FDA noted several products including the "AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION," citing blog posts that suggested the products' anti-viral efficacy against coronavirus. One blog post that the FDA noted was also about the anti-viral benefits of colloidal silver, which is one of the types of product that the agency has been watching out for since earlier in the pandemic.

The FDA also noted Facebook posts and blog entries from Health & Wellness Center International One, L.L.C. dba Hotze Vitamins promoting products such as Dr. Hotze's Immune Pak for Adults and Dr. Hotze's Teen Immune Pak as safe or effective in boosting the immune system against COVID-19.

Another company that received the warning letter is Indigenous Products, which the FDA said promoted products such as the Ionic Plus to be effective against COVID-19.

In the case of iThrive.health, the FDA noted the company's promotion and sale of such products while representing them as effective in preventing or treating COVID-19. The FDA noted company blog posts about how to boost the immune system against COVID-19.

The agency's warning letters to these companies urged them to make the necessary changes so that they are not "misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA."

A warning that the products have not been evaluated by the FDA and are not intended to prevent or cure any disease is available in the Heavenly Natural Products' website, while a Dec. 12 update of Indigenous Products' Facebook page also provides a similar disclaimer.

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland
The headquarters of the U.S. Food and Drug Administration is seen in Silver Spring, Maryland. Reuters
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