Thrasio, LLC D/B/A ZymaDerm

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

Your “ZymaDerm for Molluscum” product is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

Your “ZymaDerm for Molluscum” product includes non-homeopathic ingredients that, although listed as “other ingredients,” are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted on your website in various places with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body.