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People facing infertility have a lot to think about in exploring the options available to them. But one thing that shouldn’t be on that list are unapproved products that make questionable claims to “treat” infertility. That’s the warning the FTC and the FDA have sent to companies that have pitched products to consumers searching for answers to what can be a complex medical condition.

The agencies sent joint warning letters to five companies making fertility representations. Here are just a few of the claims cited in the letters:

• LeRoche Benicoeur.  In advertising a product called ConceiveEasy, the California company has claimed that it “does not treat only one cause of infertility, but tackles them all simultaneously: it regulates menstrual and ovulatory disorders; it helps eliminate luteal phase defects . . . .”
• EU Natural Inc.  According to the Nevada company, a substance in its Conception Female Fertility Prenatal product “can absolutely combat infertility issues.” The company has further claimed that in one study of 25 women with Polycystic Ovary Syndrome, “10 of the 25 women actually got pregnant” while taking the ingredient.
• Fertility Nutraceuticals LLC.  The New York business has advertised multiple products on its website for the treatment of infertility, including Conflam-Forte, Fertinatal DHEA, and Ovoenergen CoenzymeQ10. For example, the company has claimed that “Fertinatal Fertility DHEA has been shown in multiple studies to . . . reduce miscarriage risk.”
• NS Products, Inc.  In marketing a product called NaturaCure, the Washington company has claimed, “You will get pregnant very fast and give birth to healthy children regardless of . . . how severe or chronic your infertility disorder.” NS Products further stated, “Depending on individual customers and the types of infertility treated, success rates ranged from about 50% up to 98%.”
• Sal Nature LLC.  The Wyoming company sells a product called FertilHerb. On its website, the company has represented that “many studies” have found an ingredient in FertilHerb “to be a simple and safe treatment capable of restoring . . . fertility in most patients with PCOS.”

The letters remind the companies of their obligation under the FTC Act to have competent and reliable scientific evidence – which, depending on the circumstances, may mean well-controlled human clinical testing – to support advertising claims that a product can prevent, treat, or cure a disease. That includes both express misrepresentations as well as exaggerations, whether conveyed directly or indirectly through the use of a product name, website, metatags, or other means. The letters further state that recipients may be subject to civil penalties of as much as $43,792 per violation under Section 5(m)(1)(B) of the FTC Act, and may have to pay refunds to consumers or provide other relief under Section 19(b). The five companies have 15 working days to get back to the FTC with the steps they’ve taken to address the concerns about their possibly deceptive claims.

In addition, the letters let the advertisers know that their products are considered “new drugs” under the FDA’s Food, Drug, & Cosmetic Act and thus can’t be legally introduced without prior FDA approval. According to the FDA, “Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.” The recipients also have 15 working days to notify the FDA of the specific steps they have taken to address any violations.

From the FTC’s perspective, the message should be clear to those five companies and others making fertility-related claims for their products. Infertility is a serious medical concern that can be caused by many different multi-factorial conditions. Don’t make advertising claims unless you can back them up with the highest level of methodologically sound science.