FDA WARNING_LETTER - leroche benicoeur - May 26, 2021

The FDA issued a Warning Letter to Mary Whittaker regarding the product "ConceiveEasy," sold on www.conceiveeasy.com. The FDA reviewed the website in March 2021 and determined that "ConceiveEasy" is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because its website and social media claims indicate it is intended for the cure, mitigation, treatment, or prevention of diseases, including luteal phase defect, PCOS, ovarian inflammation, ovarian cysts, recurrent miscarriages, endometriosis, uterine cysts, and irregular menstrual periods. Specific claims cited include "Sabina is used to help treat infertility for its effectiveness in preventing recurrent miscarriages," "Apis mellifica is most widely used ... in the treatment of ovarian inflammation and ovarian cysts," and "Vitex ... can help to reduce the size of uterine cysts." Testimonials also support these intended uses.

As a "new drug," "ConceiveEasy" lacks FDA approval based on scientific data demonstrating safety and effectiveness, violating sections 301(d) and 505(a) of the Act. Furthermore, it is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as the conditions it addresses require supervision by a licensed practitioner. The introduction of this misbranded drug into interstate commerce violates section 301