FDA WARNING_LETTER - Smart Women's Choice - May 25, 2021

The FDA issued a Warning Letter to Dr. Farron after reviewing product labeling and websites (smartwomenschoice.com, Facebook, Instagram) from February to April 2021 for the product “Smart Women’s Choice.” The FDA determined that claims made on these platforms establish the product as an unapproved new drug. The product is intended for use in disease prevention or to affect body function, specifically as a contraceptive, with claims such as "natural birth control that cannot fail" and that it "immobilizes the sperm." These claims classify it as a "drug" under section 201(g)(1) of the FD&C Act. Moreover, it is deemed a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its intended uses. Introducing or delivering unapproved new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the FD&C Act, and no FDA-approved applications exist for “Smart Women’s Choice.” The FDA requires a written response within fifteen working days detailing specific corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to adequately address these violations may result in legal action, including seizure and/or injunction.