Dr. Green Mom, LLC

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, the claims on your website establishes that these products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Act, 21 U.S.C. § 355(a).

Passage 2

Your Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for their intended purposes. Accordingly, your Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].