Wise Women’s Choice – FDA Warning Letter, Jul 25, 2023

The FDA issued a Warning Letter to Lauren Love concerning the product “Wise Women’s Choice,” sold through its website and social media, following a review of its labeling in May 2023. The FDA determined that the 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). It is classified as a drug under section 201(g)(1) (21 U.S.C. 321(g)(1)) due to claims on its labeling indicating an intent to affect the human body's structure or function. Furthermore, the product is deemed a “new drug” under section 201(p) (21 U.S.C. 321(p)) because it is not generally recognized as safe and effective (GRASE) for its intended uses. Since no FDA-approved application exists for “Wise Women’s Choice,” its introduction or delivery into interstate commerce constitutes a prohibited act, violating sections 301(d) and 505(a) of the FD&C Act (21 U.S.C. 331(d) and 355(a)). The letter requires a written response within fifteen working days detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure to adequately address these violations may result in legal action, including seizure and injunction. The FDA also noted a previous warning letter issued to Dr. Francoise Farron for a similar product, “Smart Women’s Choice,” and the company's stated association with Dr. Farron.