FDA Warns 5 Companies Over Infertility Treatments

FDA and the Federal Trade Commission have sent Warning Letters to five companies for illegally selling unapproved new drugs as dietary supplements claiming to cure, treat, mitigate, or prevent infertility and other reproductive health disorders. An FDA media release says the warnings went to LeRoche Benicoeur/Conceive Easy, EU Natural Inc., Fertility Nutraceuticals LLC, Sal Nature LLC/FertilHerb, and NS Products, Inc.

The agency says it has not evaluated whether the unapproved products listed in the letters are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The companies were told to respond within 15 days with information on how they will address the issues or with their reasoning and supporting information as to why the products do not violate the law.