FDA WARNING_LETTER - Molluscumaway LLC - August 22, 2023

The FDA issued a Warning Letter to Erica Groussman on August 18, 2023, following a July 2023 review of the websites https://molluscumaway.com/, https://www.facebook.com/MolluscumAway, and https://www.instagram.com/molluscumaway/. The FDA found that "MolluscumAway Hydrating Patches," "Little Skins Smoothing Skin Ointment," and "Little Skins Gentle Body Wash" are unapproved new drugs.

These products are considered drugs under section 201(g)(1) of the FD&C Act due to claims indicating their intended use for the diagnosis, cure, mitigation, treatment, or prevention of molluscum contagiosum, or to affect body structure/function. Examples of such claims include "MAKE THOSE MOLLUSCUM RUN AWAY," "ALL the molluscum is gone," and "cleared her skin in less than 3 weeks."

Molluscum contagiosum is not amenable to self-diagnosis and treatment, and no legally marketed OTC drugs exist for it. The FDA expressed public health concerns, especially since the products are marketed for children, potentially delaying proper medical diagnosis and treatment for a serious condition.

The products are not generally recognized as safe and effective (GRASE) for their intended uses, making them "new drugs" under section 201(p)