May 26, 2021
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. The dietary supplements discussed in these letters are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.
According to the Centers for Disease Control and Prevention, approximately six million American women of childbearing age face difficulties becoming or staying pregnant. Consumers who rely on unapproved products claiming to cure, treat, mitigate, or prevent infertility and other reproductive health conditions instead of seeking safe and effective therapies could potentially suffer harm and may not receive appropriate treatment.
Warning letters were sent to the following companies:
- LeRoche Benicoeur/ConceiveEasy
- EU Natural Inc.
- Fertility Nutraceuticals LLC
- SAL NATURE LLC/FertilHerb
- NS Products, Inc.
Under the Federal Food, Drug, and Cosmetic Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today 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 FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
For additional information: