CSPI asks the FDA and FTC to take enforcement action

The pills and powders have unsubtle names like Pregnitude, OvaBoost, and Pink Stork. But an investigation by the Center for Science in the Public Interest of dietary supplements marketed as fertility aids for women found that there is no evidence that they help women become pregnant. Today, the nonprofit watchdog group is asking the Food and Drug Administration and the Federal Trade Commission to take enforcement action against the manufacturers, who CSPI charges are marketing the supplements as unapproved drugs.

CSPI’s marketplace scan identified 39 women’s fertility supplements—containing a total of 94 different ingredients—manufactured by 27 companies. The manufacturers claim that the products are intended for women who have had difficulty conceiving or who have underlying health conditions that put them at risk of infertility. “[R]ecognized as a viable non-prescription option for women who may be having difficulty conceiving,” claims Pregnitude.

Some of the manufacturers make claims that could deter patients from seeking effective FDA-approved drugs. FertilHerb for Women, for example, claims to be a “perfect natural alternative to fertility drugs or invasive treatments.” And Conceive Plus Women’s Fertility Support promises that “If you are tired of fertility drugs and their lame promises, we have news for you!” A testimonial for one product, FertileDetox, asserts that the user’s results were “better than when I took Clomid”—an FDA-approved medicine that stimulates ovulation.

Not a single manufacturer of any of the 39 products identified by CSPI provided any reasonable scientific substantiation that its products help women become pregnant. The products’ websites were no more helpful: four studies cited showed no increase in pregnancy rates, four others didn’t look at pregnancy rates, and one assessed its ingredient using a dose that was eight times the dose in the supplement. When CSPI pressed the 39 products’ manufacturers via email for scientific evidence, 11 did not reply and 16 cited no supportive studies. Four cited customer reviews as evidence and three cited studies that showed no increase in pregnancy rates.

One particularly egregious misrepresentation was made by Fairhaven Health of Bellingham, WA, which sells eight fertility supplements. Its website for FertilAid for Women claims that “One Clinical Trial Reported that 12 of 16 Previously Infertile Women Were Able to Get Pregnant after Supplementing with PABA over Several Months.” But CSPI found that the uncontrolled study—it didn’t compare FertilAid to an inactive-but-lookalike placebo—was 77 years old…and was conducted in men, not women. The manufacturer of another product acknowledged in an email to a CSPI investigator that it lacked evidence. “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,” wrote the manufacturer of Fertility Support for Her. “If you do, I’d be very curious to see.”

“Supplement manufacturers marketing fertility aids are making promises on which they can’t deliver,” said CSPI president Dr. Peter G. Lurie. “They are selling false hope. They are preying on a vulnerable population. And they are diverting women away from treatments that actually have FDA approval and scientific evidence of effectiveness.”

In a letter to Acting FDA Commissioner Admiral Brett Giroir and other FDA officials, CSPI says that the products’ claims that they can treat diseases turn the supplements into unapproved drugs, and that they meet several of the FDA’s principles for enforcement priority since they lack evidence of effectiveness, compete with approved drugs, and meet the FDA’s definition of “health fraud products.” CSPI asks the FDA to send warning letters to the manufacturers and allow inspectors to seize the products.

CSPI routinely identifies categories of dietary supplements for federal enforcement action. In December 2017, the group urged the FDA and the FTC to crack down on manufacturers of supplements marketed as opiate withdrawal aids, and in April of this year, it asked the FDA to take enforcement action against supplement companies claiming that their products help smokers quit cigarettes.