FDA WARNING_LETTER - Monkeypox-treatment.com - January 31, 2023

On October 31, 2022, the FDA reviewed www.monkeypox-treatment.com, operated by Eric Sminia, and found violations. As an Amazon Associate, the website promotes products like Advil, Aleve, Tylenol, Amazon Children’s Ibuprofen, Amazon Hydrocortisone 1% Lotion, A+D PREVENT, Garden of Life B12 Vitamin, and Crystal Star Adrenal Support with claims implying they can mitigate, prevent, treat, diagnose, or cure mpox.

These claims cause the products to be unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Examples of claims include "MONKEYPOX TREATMENT," "TREATMENT AND PREVENTION FROM MONKEYPOX," and product descriptions like "MONKEYPOX FEVER REDUCER," "MONKEYPOX MUSCLE ACHES & PAIN RELIEF," "MONKEYPOX RASH CREAM," and "MONKEYPOX FATIGUE SUPPLEMENTS."

The FDA states these products are not generally recognized as safe and effective (GRASE) for mpox uses, making them "new drugs" under section 2