Dietary Supplement Makers Warned By FDA For Illegally Claiming Products Are Fertility Treatments

Federal regulators issued letters on Wednesday to five companies for advertising products to treat or cure infertility, warning that the products have not been established as safe for consumers, and are not approved treatments.

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters on May 26, identifying companies which are illegally selling dietary supplements with claims they treat, cure or prevent infertility and other reproductive health disorders.

The warning letters were issued to LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc. The agencies warn the products can potentially harm consumers who use them instead of seeking medical treatment from doctors or using FDA-approved drugs or assisted reproductive technology that is proven safe and effective.

Products, even dietary supplements, which are intended to treat or cure disease are considered drugs and are subject to an approval process and drug safety and effectiveness requirements mandated by the FDA. These products have not gone through the drug approval process and have not been evaluated by the agency for safety.

For example, LeRoche Benicoeur marketed a product called Conceive Easy. Their website claimed the product treated women with polycystic ovary syndrome and boosted the effectiveness of in vitro fertilization (IVF) and the fertility drug Clomid. Claims made on their website include, “Treats infertility,” “prevents recurrent miscarriages,” “proven to treat mild endometriosis,” and “helps eliminate luteal phase defects.”

There has been no evaluation by the FDA regarding any of these claims. The products have not been evaluated for effectiveness, proper dosage, how the product may interact with other drugs, supplements, and substances, or any potentially dangerous side effects.

“Women and families who face fertility issues deserve the best that science has to offer,” said Daniel Kaufman, Acting Director of the FTC’s Bureau of Consumer Protection. “The FTC is proud to work with the FDA to ensure that when companies make claims about fertility treatments and cures, those claims are backed by solid scientific evidence.”

The five companies who received the warning letters are in violation of the Federal Food, Drug and Cosmetic Act, federal officials say. The companies are required to respond to the warning and address the concerns and steps being taken to address the violations.

The FDA and FTC recommend consumers talk to their doctor, pharmacist or healthcare provider before deciding to purchase or use any dietary supplement or drug, especially if it has not been approved by the FDA.

“Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant in warnings about products and companies that place consumers at risk,” said Judy McMeekin, FDA’s Associate Commissioner for Regulatory Affairs.

If consumers think a product may have caused a side effect or reaction, they should stop taking the product immediately and contact their doctor. The agency encourages doctors and consumers to report any side effects to the FDA’s MedWatch Adverse Event Reporting Program.