TORONTO -- UPDATE: Fertilify's formula Pre-Pregnancy Supplement for Women has now been authorized for use by Health Canada.
-------
Two Canadian fertility supplements are among dozens “selling false hope” to women trying to conceive, according to a U.S. consumer watchdog.
The Washington, D.C.-based Center for Science in the Public Interest has urged the U.S. Federal Drug Administration and the Federal Trade Commission to take enforcement action against the manufacturers of 39 women’s fertility supplements after it found “there is no evidence that they help women become pregnant.”
Two of these dietary supplements made in Canada, Fertilify from Toronto and Fertil Pro, made by YadTech in Montreal, were identified in the CSPI investigation.
“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,” according to the CSPI press release.
“Some of the manufacturers make claims that could deter patients from seeking effective FDA-approved drugs.”
When CSPI asked the 27 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.
Toronto-based Fertilify claims on its label it “supports fertility when trying to conceive naturally” and there are a number of testimonials on its website.
In an email reply to the CSPI, Fertilify said it “leverages third party scientific studies on our individual ingredients.” The company provided CSPI with a link to a study about the effect of one of the supplement ingredients on mice.
“What Fertilify does is help support reproductive health, which can help increase your chances of conception,” the manufacturer wrote in an email.
“The mice model is used with a specific type of lab mouse that is designed to help scientists find solutions for human use. It’s extremely rare for supplements (non-drugs) to even get so far as to have an animal based study.
“Our position is that we are the only supplement that leverages this advanced form of study.”
Fertil Pro Women, made in Montreal, costs $52.99 for 90 tablets. It claims to “optimize fertility in fertile and hypofertile women through a special blend of vitamins to boost fertility levels.”
Hypofertility is defined by the National Center for Biotechnology Information as the absence of conception after one year of trying.
Claims made on its website include “women can significantly increase their chances of getting pregnant with Fertil Pro for women and Vitamin D3.”
In response to queries from the CSPI for studies to prove that Fertil Pro increases chances of conceiving, Yadtech referred the watchdog to its website and studies there.
“Our vitamins are developed by gynecologists and urologist,” the company said.
“Our formulas are all based on scientific evidence. Yadtech has been around since 2010 and our fertility products are recommended by 90 per cent of fertility clinics across Canada.”
Health Canada has not approved a fertility claim for any Yadtech product as of Sept. 1, 2019, CSPI said.
“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 the FDA, the CSPI said because the products claim they can treat diseases it turns the supplements into unapproved drugs.
“The manufacturers claim the products are intended for women who have had difficulty conceiving or who have underlying health conditions that put them at risk of infertility,” the CSPI said.
“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.’”
The CSPI urged the FDA to send warning letters to the manufacturers and allow inspectors to seize the products.
The Public Health Agency of Canada estimates one in six couples experience infertility, a number which has doubled since the 1980s.
For the Lacroix family it meant four rounds of in-vitro fertilization and every way they could think of to boost their chances.
“As a woman you feel like a failure, this is in my DNA to procreate. How come I cannot do that, ” Olga Lacroix told CTV News.
But after five years of disappointment and $70,000 dollars the family recently welcomed a “little miracle,” seven-week-old Mateo.
His parents credit his birth to IVF, but they were also convinced to take natural health supplements including Fertilify and Fertil Pro.
“To exploit such a group of people with products that have no effectiveness whatsoever is just wholly inappropriate,” Dr. Lurie added.
Doctors who have dedicated their life to fertility have said the product names are misleading patients.
“Maybe in the future we should be looking at doing proper trials on these things like we do with pharmaceuticals, to allow them to make these kinds of claims,” Dr. Clifford Librach, Create Fertility Centre Founder, told CTV News.
The Lacroix family agrees, “there should be some responsibility to consumers.”
Health Canada told CTV News it received one complaint about advertising three years ago and asked Fertil Pro to change its content.
