Nonprofit Calls on FDA to Take Enforcement Action on 39 Fertility Supplements

Regulatory NewsRegulatory News
| 18 November 2019 | By Zachary Brennan 

The Center for Science in the Public Interest (CSPI), a Washington, DC-based nonprofit, sent letters to the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Monday, calling on the agencies to take enforcement action against 39 supplements purporting to aid fertility but without evidence to support their claims.

CSPI said none of the manufacturers of the products could provide “scientific substantiation of their products’ claims regarding female fertility,” and some of the products targeted their marketing to women with difficulties conceiving or who may have underlying health conditions that put them at risk of infertility, such as polycystic ovary syndrome, obesity or diabetes.

“Some manufacturers make claims that could deter patients from seeking effective, FDA approved drugs because they indicate that the supplements are effective alternatives to conventional care. Some such claims even deride FDA-approved fertility treatments as invasive, expensive, or ineffective, further discouraging women from using these options,” CSPI said.

Of the websites for the 39 supplements, the nonprofit found that 30 websites cited no studies at all, four cited studies that showed no increase in rates of pregnancy, four cited studies that did not look at pregnancy rates and one “cited a study that only assessed the ingredient using a dose that was eight times the dose contained in the supplement.”

The letters, written by CSPI president Peter Lurie, who’s a former associate commissioner at FDA, and policy director Laura MacCleery, explain how one manufacturer acknowledged a lack of evidence for its supplement and seemed skeptical of other similar supplements: “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.”

The letters note how the matter is an urgent one, as some women may be under time pressure to conceive, and relying on ineffective supplements may not help.

Letter to FDA (identical letter sent to FTC)


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