A health and science watchdog group petitioned federal regulators on Monday to take enforcement action against 27 manufacturers of dietary supplements marketed as helping women become pregnant, but for which the makers provided no scientific evidence of efficacy.
In letters to the Food and Drug Administration and the Federal Trade Commission, the nonprofit Center for Science in the Public Interest said its nearly yearlong investigation of 39 “fertility” supplements — pills and powders with names such as Fertile CM, Pregnitude, FertilHerb for Women, OvaBoost, and Pink Stork — found no evidence they increase a woman’s chance of conceiving. The products are sold online as well as at retailers including Walmart and CVS (CVS). CSPI called on the agencies to issue warning letters to the companies, prohibit the sale of the supplements, and have FDA inspectors seize the products.
Most of the manufacturers contacted by STAT after business hours did not immediately reply to a request for comment. A spokesperson for the Belgium company Sasmar said its Conceive Plus Women’s Fertility Support “contains compounds that have substantial documented evidence to aid the natural reproductive functions of the human body.” He called trying to conceive “an emotional time,” adding that the company “understands the willingness of some consumers to expect more from a product than it may offer.” He did not offer any studies showing that taking the supplement increases a woman’s likelihood of becoming pregnant, but said the pills’ effectiveness is supported by “user experience and testimonials.”
Dietary supplements can be legally sold without proof of safety or efficacy, under the 1994 Dietary Supplement Health and Education Act. But the law allows manufacturers to make only general health claims, such as that a supplement “boosts energy” or “improves well-being.” They are prohibited from claiming a product helps a specific medical condition unless they submit results from clinical trials showing such a benefit. None of the fertility-supplement makers have done so.
The 39 products that CSPI investigated, however, do make specific, fertility-related claims, such as that they are “formulated for women to get pregnant,” “boost your chances of conception,” and “improve your pregnancy chances.” When CSPI asked the manufacturers for evidence backing such claims, four cited customer reviews as scientific evidence, seven cited studies that either did not measure rates of pregnancy or found no increase, and most of the rest did not respond.
Others seemed confused about the evidence they cited. On its website, Fairhaven Health, which sells FertilAid and seven other fertility supplements, touts a clinical trial in which 12 of 16 previously infertile women conceived after taking PABA, a compound in folic acid. But the trial, published in 1942, in fact studied PABA taken by men, not women.
In another exchange, a representative of the manufacturer of Premama Fertility Support replied to CSPI’s request for supportive scientific studies by acknowledging, “I think you’ll be hard pressed to find any supplement company that can definitively say that their product increases the chances of becoming pregnant. If you do, I’d be very curious to see.”
Several FDA-approved drugs are backed by clinical trials that demonstrated their safety and efficacy, including clomiphene, clomiphene citrate, letrozole, gonadotropins, human chorionic gonadotropin, bromocriptine, and cabergoline, most of which act by stimulating ovulation or by suppressing hormones that impede conception.
In the letter to the FDA, CSPI president Dr. Peter Lurie and policy director Laura MacCleery argued that the claims made by supplement makers “could deter patients from seeking effective FDA-approved drugs.” FertilHerb for Women, for example, calls its “advanced fertility formula” a “perfect natural alternative to fertility drugs,” while Sasmar’s ads for Conceive Plus Women’s Fertility beckons patients who “are tired of fertility drugs and their lame promises.”
Long-time critics of the fertility industry welcomed CSPI’s investigation.
“Kudos to the Center for Science in the Public Interest for highlighting this predatory behavior and for demanding change,” said Pamela Mahoney Tsigdinos, an advocate for greater transparency from the fertility industry and co-author of a recent analysis of pricey but ineffective IVF procedures. “I’m embarrassed to say I purchased my share of ‘alternative therapies’ when I was at my wits end” while an IVF patient. “Companies selling supplements claiming to boost fertility are the natural extension of an industry that prioritizes opaqueness and obfuscation over transparency and scientific rigor.”