2 Canadian fertility supplements among those under fire from U.S. watchdog

UPDATE: After this story was published, Health Canada authorized Fertilify to make two additional claims in July 2022: Helps maintain/support fertility and contributes to normal fertility. About 30 claims were initially authorized in 2018.

An influential U.S. consumer watchdog is calling on American regulators to take enforcement action against 27 companies — including two Canadian ones — that sell over-the-counter fertility supplements after its investigation found that there's no scientific evidence the products help women get pregnant.

The Washington-based Center for Science in the Public Interest (CSPI) made the move after it asked the makers of 39 fertility supplements sold in the U.S. for research proving their products are effective. 

"Really nobody was able to provide anything that was convincing, if they provided a study at all," said CSPI executive director Dr. Peter Lurie, adding that his researchers "reviewed the medical literature to find evidence that particular ingredients work, but in the end we came up empty."

The supplements are commonly a mixture of vitamins, minerals, botanicals and herbal extracts that can sell for as much as $90 for a month's supply of capsules. The products are sold online, at pharmacies, by complementary health practitioners and even at fertility clinics run by doctors.

CSPI questioned the promotional language used by the Canadian makers of two products, Fertilify and Fertil Pro.

Toronto's Fertilify says on its website that its products are designed to "support fertility." The product page for its pre-pregnancy supplement until recently said it "supports fertility when trying to conceive naturally.'' The Montreal-based maker of Fertil Pro says its products "boost fertility." In both cases, CSPI said the evidence the companies provided didn't come close to backing those claims.

Lurie has demanded that the U.S. Food and Drug Administration and Federal Trade Commission investigate the claims, to protect consumers who are struggling to conceive.

"The clock is ticking for them," Lurie said in an interview with CBC News. "They've got a strong desire to do one of the fundamental parts of human activity, which is to bear children and to raise them. So they're absolutely desperate, and it's that desperation that these companies are exploiting."

The FDA has acted on similar complaints by the CSPI about natural supplements that promise to treat opioid addiction.

Variations of 'fertility' in supplement names

Both Fertilify and Fertil Pro are licensed by Health Canada as natural health products. There are dozens of other supplements that use variations of the word "fertility" in their names such as Fertiplex, Fertil Propolis, Forta Fertility, Medfertil, Fertilaid, Fertility Matrix and Fertility Optimizer, to name a few.

Under Canadian law, natural health products are not allowed to make explicit health claims such as "boosting fertility."

In response to CSPI's findings, Health Canada stated in an email to CBC News, "Based on the information provided, we are taking steps to verify compliance of these ads with the Food and Drugs Act and its regulations. We will take required compliance and enforcement actions if non-compliance is identified."

The email said Health Canada received one complaint about a natural health product making "fertility claims" in 2015, but nothing recently.

Both Canadian companies identified by CSPI declined interview requests by CBC News and instead issued statements.

Canadian companies respond

Yohann Abitbol, president of Yad-Tech Inc., the maker of Fertil Pro, wrote in an email that he would not address the findings by CSPI, but he added, "Over 80 per cent of fertility clinics sell or recommend our supplement across Canada for the past nine years with positive results."

Fertilify Inc. also responded by email, stating, "Fertilify has never claimed to increase fertility."

Dr. Clifford Librach, who works at one of Canada's largest fertility clinics in Toronto, said the mere suggestion of the word "fertility" in the names of dietary supplements is problematic.

"I think that's false advertising to some degree," Librach said. "It's very important that Health Canada looks at this," the obstetrician-gynecologist added.

Librach said the supplements give patients "false hope" that they will correct fertility issues, potentially delaying appropriate medical care prescribed by a doctor.

"So I fear that somebody might take these vitamins and think that's going to help them have a child when they may have some type of egg problem that we may be able to solve fairly easily with treatment," Librach said.

'Grasping at straws'

Carolynn Dubé, 38, began taking natural fertility supplements in 2017 while undergoing in vitro fertilization treatments.

"You're grasping at straws and you feel like, OK, if someone is telling me this will work, I'm going to do it because I need to make sure that I have covered every avenue to build this family that I want so desperately," the Moncton mother of three said, adding she didn't know whether the supplements played any role in helping her conceive.

Dubé said she and her husband didn't think twice about spending hundreds of dollars on the supplements, because compared to IVF treatments, which cost her $10,000 to $15,000, "it was a drop in the bucket."

The Public Health Agency of Canada estimates one in six couples experience infertility, a number which has doubled since the 1980s.

Dubé, who works for a fertility support group, said Health Canada has a responsibility to ensure the claims fertility supplements make are valid, to protect women who use them.

"These patients are incredibly vulnerable and will try anything," she added.

It's estimated three-quarters of Canadians take vitamins and supplements daily, spending approximately $1.4 billion annually.

Health Canada has faced criticism for its lax approach to licensing natural health supplements that include homeopathic remedies and traditional Chinese medicine, compared to prescription drugs.

The agency is currently in the process of tightening its regulatory requirements for licensing natural supplements.