The U.S. Food and Drug Administration (FDA) has warned that marketers are pitching dietary supplements that make unproven claims to cure, treat, mitigate or prevent infertility and other reproductive health conditions. Some women may have had difficulties conceiving or have underlying health conditions that put them at risk of infertility.

According to the Centers for Disease Control and Prevention (CDC), about 12 percent of women aged 15 to 44 in the United States have difficulty becoming pregnant or carrying a pregnancy to term.

Under the Federal Food, Drug, and Cosmetic Act, claims to prevent, treat or cure such conditions establish that a product is a new drug and must be approved by the FDA before it can be safely marketed. In fact, dietary supplements making claims about infertility are not FDA approved and could deter patients from seeking effective, FDA-approved drug products.

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.

Most of these unapproved drugs are sold online and many are falsely labeled as dietary supplements. These products are not based on proven scientific information, and they have not been reviewed for safety and efficacy.

FDA stated one of the best ways to protect oneself from fake treatments is to ask whether a claim sounds too good to be true or if it contradicts what they have heard from reputable sources about treating infertility. Companies selling unproven infertility or pregnancy-related therapies often include a range of unsupported and expansive claims about the supposed effectiveness of their products. Some of these claims may be framed as consumer testimonials.

The FDA takes action against companies marketing unapproved new drugs that claim to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. The agency issues warning letters to advise companies to change or remove claims that misbrand products and result in their being unapproved new drugs. If the companies refuse to comply with FDA regulations, the agency may take further legal action to remove the products from the market.

For more information, visit www.fda.gov.