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 FDA Alerts
July 3, 2021

Advice from FDA: Be Wary of Unproven Claims to Treat Infertility

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Infertility, not being able to have children, affects about 12% of women (aged 15 to 44) in the United States, according to the Centers for Disease Control and Prevention (CDC). Some companies claim their dietary supplements can help resolve infertility issues in these women. Many of these products are sold online. Dietary supplements are considered food, not drugs, and must be approved by the US Food and Drug Administration (FDA). But beware! FDA has NOT approved any dietary supplement for this purpose. Therefore, these products should not be marketed as treatments for infertility.

Marketing advertisements for these products include unsupported claims about the effectiveness of their products in resolving infertility as well as false testimonials. This may prevent infertile women from seeking advice from their healthcare providers. If a claim about product effectiveness sounds too good to be true, it probably is. Here are some examples of false claims:

• “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.”
• “...treat infertility...effectiveness in preventing recurrent miscarriages during early stage pregnancy.”

Also, it is important to be wary of advertisements that include phrases such as, “one product does it all,” “miracle cure,” or “cure all.”

Here’s what you can do: Talk to your healthcare provider if you are having fertility issues. Ask your doctor or pharmacist about the safety of over-the-counter products, including dietary supplements. Use extra caution before purchasing medicines and supplements online. Contact the FDA (www.ismp.org/ext/729) if you know of a supplement being sold to treat infertility. Your reports will help get these products off the market and keep other women safe.

Advice from FDA is a feature brought to you by the US Food and Drug Administration (FDA). You can find this information and more on FDA’s Consumer Health Information website at: www.ismp.org/ext/1134. This website features the latest updates on medicines and products regulated by FDA. Sign up for a free email subscription at: www.ismp.org/ext/262.

Published July 3, 2021

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Advice from FDA: Be Wary of Unproven Claims to Treat Infertility