Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website and social media websites establish that your Smart Women’s Choice product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2Based on our review of your websites, “Smart Women’s Choice” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Passage 3Your “Smart Women’s Choice” is not generally recognized as safe and effective for its above referenced uses and, therefore it is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).