FDA Issues Warning to Companies Selling Products Claiming to Treat Mpox

The letters cite violations related to drug misbranding failing to bear adequate directions for their intended use(s).

Warning letters were issued to 5 companies illegally selling products claiming to cure, treat, mitigate, or prevent human monkeypox (mpox) infection, the Food and Drug Administration (FDA) reported in a recent statement to consumers.

Companies that were flagged for selling these products included:

  • Dr. Green Mom, LLC; Product Name – Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm
  • Monkeypox-treatment.com; Product Name – Advil, Aleve, Tylenol 8HR, Amazon Children’s Ibuprofen, Amazon Hydrocortisone 1% Lotion, and A+D PREVENT, as well as Garden of Life B12 Vitamin, and Crystal Star Adrenal Support
  • Noble Elements LLC; Product Name – Coated Silver product 
  • Old Tiles Wallpaper, LLC DBA Old Tiles Decor; Product Name – “Wind River Skin Comfort Blend,” “Wind River Cayenne Tincture,” and “Wind River Elderberry Tincture”
  • Organic Heirloom Plants; Product Name – Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature’s Ancer, Zeolite, and Chaga Mushroom

According to the Agency, these products have not been reviewed or been proven to be safe or effective to treat mpox or other diseases or conditions.

The FDA has licensed 2 vaccines for the prevention of mpox infection: ACAM2000 (smallpox [vaccinia] vaccine, live) and Jynneos (smallpox and monkeypox vaccine, live, nonreplicating). In August 2022, the Agency authorized the intradermal use of Jynneos to increase supply during the outbreak.

There are currently no FDA-approved treatments for human mpox. Tecovirimat (Tpoxx) and brincidofovir (Tembexa), antivirals indicated for smallpox, have been used to treat mpox under the FDA’s Expanded Access program.


  1. Illegally sold monkeypox (Mpox) products. News release. US Food and Drug Administration. Accessed February 1, 2023. https://www.fda.gov/consumers/health-fraud-scams/illegally-sold-monkeypox-mpox-products.
  2. FDA Mpox Response. Accessed February 1, 2023. https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/fda-mpox-response#therapeutics.
  3. O’Laughlin Kevin, Tobolowsky FA, et al. Clinical use of tecovirimat (Tpoxx) for treatment of monkeypox under an Investigational New Drug Protocol – United States, May-August 2022. Published online September 16, 2022. MMWR. doi:10.15585/mmwr.mm7137e1