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Latest Posted February 6, 2023

FDA Warns Companies Promoting Products to Treat Monkeypox, COVID-19, & Other Viruses

On January 30, 2023, the FDA issued a warning letter to four companies following review of the company websites, which found statements about company products to be drug claims because they were promoted to mitigate, prevent, treat, diagnose, or cure viruses such as monkeypox.

To see the warning letter for each product, click the link below.

  • Dr. Green Mom, LLC (Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm) promoted Colloidal Silver products with statements such as, “As an antiviral, silver can kill the virus that causes Covid-19 and may be an effective adjunctive treatment. There is also evidence that it may be effective against other viruses of interest including monkeypox, herpes, RSV, and viruses that cause upper respiratory tract infections (like influenza).”
  • Organic Heirloom Plants (Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature’s Ancer, Zeolite, and Chaga Mushroom) promoted Sarracenia Purpurea products with statements such as, “For decades, research has shown the effectiveness of Sarracenia Purpurea (Pitcher Plant) against past outbreaks of small pox [sic] in the 19th Century, found to halt viral replication in viral, derived from the Variola Virus also associated with Monkey Pox.” Other products were also promoted to treat cancer, COVID-19, and other illnesses.
  • Monkeypox-treatment.com (Garden of Life B12 Vitamin, Crystal Star Adrenal Support, Advil, Aleve, Tylenol 8HR, Amazon Children’s Ibuprofen, Amazon Hydrocortisone 1% Lotion, and A+D PREVENT) promoted products with statements such as “TREATMENT AND PREVENTION FROM MONKEYPOX. . .SHOP FROM OVER 500 PRODUCTS. . .VISIT STORE”
  • Noble Elements (Coated Silver products) promoted products with statements such as, “Colloidal Silver is effective against viruses, bacteria, and even fungi. Scientists are also examining the potential of AgNPs [silver nanoparticles] to tackle deadly viruses.” Coated Silver products were also promoted to kill viruses such as HSV-1 and HIV-1.

The FDA stated it considers these products to be “new drugs” because they are not recognized as safe and effective for their promoted uses. Products were also found to be misbranded because the labels did not provide adequate directions for their intended use.

The companies are required to respond to the agency within 15 days of receipt of the letter outlining any steps to address any violations.

See ConsumerLab’s Reviews of B Vitamin Supplements, Lion’s Mane and Chaga Supplements, Vitamin A Supplements, Vitamin D Supplements, and Zinc Supplements and Lozenges for more information and tests of related products.

Also see ConsumerLab’s answer to:

Is ingesting colloidal silver helpful for any condition and is it safe to use?

Do any supplements help with COVID-19? Do supplements like vitamin D, zinc, vitamin C, or herbals work?

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