FDA Warns Companies Claiming to Treat Monkeypox

The FDA is warning several companies that are illegally selling products claiming to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment from a healthcare professional, the agency added.

There are no FDA-approved treatments for mpox. The products being flagged by the regulatory agency — which are often sold online — have not been reviewed by the FDA or proven to be safe and effective to treat mpox or other diseases or conditions, the FDA said in a notice.

Shabbir J. Imber Safdar

“We’ve seen criminals — both foreign and domestic — exploit new diseases as opportunities to defraud American patients; the emergence of monkeypox is no different. We hope the FDA can stop these harmful fake products from victimizing any more Americans,” Shabbir J. Imber Safdar, executive director of the Partnership for Safe Medicines, told Formulary Watch.

Companies that received warning letters from the agency on January 30 include: monkeypox-treatment.com, Dr. Green Mom, Noble Elements, Old Tiles Wallpaper, and Organic Heirloom Plants.

The supplements — including colloidal silver and vitamin D — are misbranded as drugs “because they are intended for use in the cure, mitigation, treatment, or prevention of disease,” the FDA said in a warning letter to Dr. Green Mom and the other companies.

Several of Dr. Green Mom’s claims for its vitamin products — Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver — would indicate they are drugs that would require clinical trials to determine if they are safe and effective, the FDA said in its warning letter to the company.

In addition, Monkeypox-treatments.com's claims such as “Monkeypox fever reducer” in its Advil, Aleve, and Amazon Children’s Ibuprofen product descriptions indicate that the products are intended to mitigate, prevent, treat, diagnose, or cure mpox in people, the FDA said in its warning letter to the company. “We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox,” The agency said.