Dr. Green Mom, LLC – FDA Warning Letter, Jan 31, 2023

The FDA issued a Warning Letter to Ms. Mayer regarding products sold on www.drgreenmom.com, including Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm. An October 2022 website review found claims establishing these products as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)], intended for disease cure, mitigation, treatment, or prevention.

Specifically, the FDA cited claims related to mpox (formerly monkeypox) and other conditions, making these products unapproved new drugs in violation of section 505(a) of the Act, 21 U.S.C. § 355(a). The products are also deemed misbranded under section 502 of the Act, 21 U.S.C. § 352, because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision. The FDA expressed particular concern about the marketing of Colloidal Silver for infants and children, noting the lack of safety, effectiveness, and quality evaluations for these vulnerable populations.

The letter requires a written response within fifteen working days detailing corrective actions taken to address the violations and prevent recurrence. Failure to comply may