The Food and Drug Administration (FDA) has issued a warning about the growing number of unapproved treatments being marketed for infertility. The agency is concerned that dietary supplements claiming to cure, treat, mitigate, or prevent infertility are being sold without proper scientific backing or regulatory approval.
According to the Centers for Disease Control and Prevention, about 12 percent of women aged 15 to 44 in the United States experience difficulty becoming pregnant or carrying a pregnancy to term. This population has become a target for marketers promoting products with unproven claims related to reproductive health.
Under federal law, any product that claims to prevent, treat, or cure medical conditions must be approved by the FDA before it can be marketed. The FDA emphasized that dietary supplements making such claims about infertility have not been approved and may delay patients from seeking effective treatments.
“These purported fertility aids seek to profit off of the vulnerability and frustration many may feel as they face difficulties in getting pregnant. Relying on ineffective, unproven products can be a waste of time and money and can possibly result in illness or serious injury,” stated the FDA.
Most of these unapproved drugs are available online and are often falsely labeled as dietary supplements. The FDA cautioned consumers that these products lack proven scientific evidence and have not undergone safety or efficacy review.
The agency advises individuals to consult with healthcare providers before using any over-the-counter product, including those marketed as dietary supplements. Consumers should also be skeptical of claims that seem exaggerated or conflict with information from reputable sources.
The FDA continues to take action against companies marketing unapproved new drugs for infertility and other reproductive health issues. This includes issuing warning letters requiring companies to change misleading claims or remove their products from the market if they do not comply with regulations. Further legal action may follow if necessary.
Consumers who encounter products claiming to treat infertility can report them through the FDA’s Reporting Unlawful Sales of Medical Products on the Internet page. Suspected adverse reactions should be reported via the Safety Reporting Portal.
