Consumers have a right to expect that products that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders have been reviewed by the Food and Drug Administration and approved for such marketing. Accordingly, when unscrupulous companies mislead consumers by marketing and selling such products without having been approved the FDA, consumers have a right to hold that company accountable.
The U.S. Food and Drug Administration and the Federal Trade Commission recently issued warnings to five companies for “illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The agencies issued warning letters to:
- LeRoche Benicoeur / ConceiveEasy for its product “ConceiveEasy”;
- EU Natural Inc. for its products “CONCEPTION Female Fertility Prenatal” and “CONCEPTION MEN Male Fertility”;
- Fertility Nutraceuticals LLC for its products “CONFLAM- ForteTM,” “FERTINATAL® DHEA”, and “OVOENERGENTM CoenzymeQ10”;
- SAL NATURE LLC / FertilHerb for its product “FertilHerb for Women”; and
- NS Products, Inc. for its product “NaturaCure”.
Under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs. Such drugs may not be legally marketed or sold without prior approval from FDA, which approves new drugs based on scientific data and information demonstrating that the drugs are safe and effective. The FDA and FTC’s letters assert that the five companies may be making false or unsubstantiated claims about products that are unapproved and misbranded.
“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, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. (The FDA has not evaluated whether the unapproved products described in the warning 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.)
When consumers purchase a product reasonably believing that the product is safe and effective to use for advertised purposes due to deceptive and misleading product claims, the company selling that product has been unjustly enriched at consumers’ expense.
The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully recovered tens of millions of dollars on behalf of consumers aggrieved by such deceptive product claims. If you or someone you know has purchased ConceiveEasy, CONCEPTION Female Fertility Prenatal, CONCEPTION MEN Male Fertility, NFLAM- ForteTM, FERTINATAL® DHEA, OVOENERGENTM CoenzymeQ10, FertilHerb for Women, or NaturaCure based on claims made on their websites or elsewhere, please contact us to discuss your legal options.