An investigation into 39 dietary supplements marketed as fertility aids for women found no evidence that the products help women become pregnant, according to a watchdog group.
The Center for Science in the Public Interest (CSPI) alleged the supplements are being marketed as unapproved new drugs, and the nonprofit group requested U.S. regulators take enforcement action against the manufacturers of the products.
The manufacturers assert the products are for women facing “difficulty conceiving or who have underlying health conditions that put them at risk of infertility,” according to CSPI in a Nov. 15 news release. But the watchdog group reported none of the manufacturers were able to produce reasonable scientific evidence to show its products help women become pregnant.
Pressed for such evidence through email, 16 cited no supportive studies while 11 didn’t reply to requests, according to CSPI.
“Supplement manufacturers marketing fertility aids are making promises on which they can’t deliver,” Peter G. Lurie, M.D., president of CSPI, said in a statement. “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.”
FDA is reviewing a letter it received from CSPI.
“We appreciate CSPI’s commitment to promoting the integrity of the dietary supplement marketplace,” an FDA spokesperson, Lindsay Haake, said in an email. “The agency takes these concerns seriously and intends to follow up on the information provided in this letter. The FDA is committed to doing everything within its resources and authorities to identify and remove unsafe and otherwise illegal products from the market.”
Based on its available resources and public health priorities, FDA will take appropriate action if it determines a product labeled as a dietary supplement violates the law, she said. Such action could include a warning letter or an enforcement action, such as a seizure of products.
FDA recommends consumers consult with their doctor, pharmacist or other health care professional before deciding to use or buy a dietary supplement. Some supplements, FDA and others warn, might interact adversely with prescription medicines.
“[I]f claims sound too good to be true,” Haake said, “they probably are.”
CSPI also urged FTC in a letter to take legal actions against the manufacturers of the fertility supplements on the basis that the products are misbranded under the FTC Act. An FTC spokesman, Mitchell Katz, said the agency does not comment on letters received from external parties.
According to CSPI, some manufacturers make claims that could dissuade patients from seeking effective FDA-approved drugs. For example, it noted Conceive Plus Women’s Fertility Support promises that “If you are tired of fertility drugs and their lame promises, we have news for you!”
In response to a request for comment, Conceive Plus said the above statement appears on a Amazon.com product description page and “in its context refers to other competitor supplements.” The company said it neither provided nor authorized the statement, and Conceive Plus said it had no record that CSPI made an official request for information to the manufacturer.
“Trying to conceive can be an emotional time and we understand the willingness of some consumers to expect more from a product than it may offer,” Conceive Plus added in an email for this article. “Our marketing and customer satisfaction teams focus on communicating the correct use of our products as per labelling indication and directions for use as a dietary supplement.”
CSPI said one brand acknowledged the challenges in substantiating claims that products help women become pregnant.
“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,” the manufacturer of Fertility Support for Her allegedly wrote to CSPI. “If you do, I’d be very curious to see.”
Premama—the Providence, Rhode Island-based manufacturer of Fertility Support for Her—did not immediately respond to an emailed request for comment for this article.
CSPI alleged one company—Fairhaven Health—in Bellingham, Washington made “one particularly egregious misrepresentation” by claiming 12 of 16 women in a clinical trial previously suffering from infertility were able to get pregnant through supplementation of PABA, a complex B vitamin. But the 77-year-old study was conducted in men, not women, the watchdog group reported.
Suzanne Munson, vice president of product development and compliance with Fairhaven Health, said the study referenced by CSPI "appeared in error and has been removed."
"Since 2003, Fairhaven Health has been distributing dietary supplements aimed at supporting female and male reproductive health in a manner consistent with relevant FDA (under the Dietary Supplement Health and Education Act) and FTC regulations," she added in an email. "We are surprised and disappointed that the CSPI chose to take aim at this category of supplements and many reputable supplement manufacturers as we believe that women (and their partners) have a legal right to take dietary supplements that they believe to be supportive of their reproductive health."