The FDA targets supplements claiming to treat infertility more than a year after being asked by a consumer advocacy group to take enforcement action against manufacturers of fertility supplements. The U.S. Food & Drug Administration and Federal Trade Commission warned five companies in letters that their products are intended to treat diseases.
U.S. regulators this week announced them sending warning letters to five companies for making unlawful claims that their dietary supplements cure, treat, mitigate or prevent infertility and other reproductive health disorders. Such products intended to treat disease are considered drugs under the Federal Food, Drug & Cosmetic Act, even if they are labeled as dietary supplements, according to an FDA news release announcing the warning letters.
FDA said it has not evaluated whether the products subject to the warning letters are effective for their intended use. The agency added it has not evaluated the products’ proper dosage, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
“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, FDA’s associate commissioner for regulatory affairs, in a statement. “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.”
FDA and FTC, which polices deceptive or fraudulent advertising practices, sent the letters to LeRoche Benicoeur/ConceiveEasy, EU Natural Inc., Fertility Nutraceuticals LLC, SAL NATURE LLC/FertilHerb and NS Products, Inc.
EU Natural plans to respond to regulators “in a timely manner” to address their concerns, according to the company’s president, Vinay Amin. “Eu Natural is committed to consumer health and wellbeing and takes its obligations with respect to truthful and non-misleading communication seriously,” he said in an emailed statement.
None of the other four companies immediately responded substantively to requests for comment for this article.
The letters identified unlawful claims made through websites, social media and personal testimonials.
FDA requested the companies respond within 15 working days, explaining how they will address the issues or providing their rationale and evidence regarding why they believe the products are not in violation of the law. Failure to promptly correct the alleged violations of law, FDA said, may result in legal action, such as seizure of products and/or an injunction.
The Center for Science in the Public Interest (CSPI), a consumer advocacy group in Washington, D.C., commended federal regulators for issuing the warning letters.
“For too long, dietary supplement manufacturers have been selling false hope to women and couples who are trying to conceive a baby,” Dr. Peter Lurie, president of CSPI, said in a statement. “Besides making promises on which they can’t deliver, supplement marketers may be diverting women from medical treatments that may actually help, and squandering some of the finite time women have to conceive.”
“As the FDA and the FTC made plain yesterday, it is illegal for supplement makers to claim their pills or powders can cure, treat or prevent reproductive conditions that may impair fertility,” Lurie said. “Companies that continue to sell false hope to women should expect that law enforcement will eventually knock at their doors.”
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