Warning letters were issued by the Food and Drug Administration (FDA) and the Federal Trade Commission to 5 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent infertility and other reproductive health disorders.

The companies issued the letters include LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc. According to the FDA, the claims made on these websites establish these products as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act); however, none of the products have undergone regulatory review for their intended uses.

“Dietary supplements that claim to cure, treat or prevent infertility and other reproductive health conditions can potentially harm consumers who use these products instead of seeking effective treatments, such as FDA-approved drugs or assisted reproductive technology,” said Judy McMeekin, PharmD, FDA’s Associate Commissioner for Regulatory Affairs.

The FDA advises caution when purchasing dietary supplements online, especially those with claims that appear to be too good to be true. Health care providers and consumers are urged to report adverse reactions associated with FDA-regulated products to the MedWatch reporting system.


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Reference

FDA, FTC warn five companies illegally selling dietary supplements claiming to treat infertility. [press release]. Silver Spring, MD: US Food and Drug Administration; May 26, 2021.