FDA warns against fake treatments for infertility

You may know someone who has been unable to get pregnant due to infertility issues. According to the Centers for Disease Control and Prevention, about 12 percent of women aged 15 to 44 in the United States have difficulty becoming pregnant or carrying a pregnancy to term.

"Fertility" products prey on vulnerability

Marketers are targeting this population by 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.

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 Food and Drug Administration (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. It is important to know that these products are not based on proven scientific information, and they have not been reviewed for safety and efficacy.

Be wary of unproven claims regarding infertility

Your first course of action is always to talk to your health care provider before buying or using any over-the-counter product, including those labeled as dietary supplements. 

One of the best ways to protect yourself from fake treatments is to ask whether a claim sounds too good to be true or if it contradicts what you've 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. These include statements such as:

• "You will get pregnant very fast and give birth to healthy children regardless of … how severe or chronic your infertility disorder."
• " … a perfect natural alternative to infertility drugs or invasive treatments."
• "best fertility supplements to boost your chance of pregnancy or improve your IVF success rate."
• "… treat infertility… effectiveness in preventing recurrent miscarriages during early stage pregnancy."

Also be wary of statements containing language such as the following:

• "One product does it all." 
• "Miracle cure" or "scientific breakthrough."
• Products claiming to be a "cure all."

FDA protects consumers from companies selling unapproved new drugs

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.

You can help 

If you know of a product being sold as a therapy for infertility or other reproductive health conditions and diseases, you can notify the FDA by going to our Reporting Unlawful Sales of Medical Products on the Internet page. If you think that a product might have caused a reaction or an illness, the FDA encourages consumers and health care professionals to report the adverse reaction to the agency through the Safety Reporting Portal.