Women’s health advocates are calling for more clinical research and transparency for nutraceutical products marketed toward women.

At a panel discussion during SupplySide East in April, experts discussed what’s needed to generate more momentum for the women’s health and wellness market, such as overcoming clinical research gaps and how research is marketed.

For women’s health products and more broadly, the Federal Trade Commission (FTC) is looking for claims substantiation as well, noted Lauren Aronson, advertising and consumer protection partner at Amin Wasserman Gurnani.

In 2022 the agency issued its “Health Products Compliance Guidance,” which updated and replaced the 1998 “Dietary Supplements: An Advertising Guide for Industry.”

Whereas FDA focuses on the type of claims made (disease vs. structure/function), FTC is concerned about whether claims are backed by competent and reliable scientific evidence (CARSE), a phrase that was a key focus of the 2022 update.

FTC generally expects claims, especially those based on proprietary ingredients, to be backed by adequately-sized, randomized, controlled human clinical studies, which will generally be accepted in a broader context by experts, Aronson said.

With that in mind, FTC also expects clinical studies that form the basis of a health claim to include populations that match the target consumer audience. This is especially important for products or claims intended for women, women with menopause, or pregnant women. A mismatch between how a product was used in a study, and how consumers are instructed to use the product, is also a glaring issue, Aronson noted.

Rachel Kreider, vice president of product innovation and science at GNC Holdings, said the company takes CARSE standards seriously, whether it concerns claims made by an ingredient supplier or a third-party finished product brand. GNC performs both domestic and overseas evaluations of brands, she added. 

“There’s a lot to wade through, and we really tear studies apart and ask for the raw data so we can fully ensure that we stand behind an ingredient,” Kreider said. “We also do a very thorough scrub of research that is in the public domain to see how well that evidence holds up against anything contradictory by CARSE standards, and if a panel of experts would agree that a claim is substantiated.”

Overcoming Research Gaps

Having an internal research team enables brands to have more control over finished product development from the preclinical stage onward, said Salma Fathalla, senior director of quality and regulatory at Bonafide Health.

Each of the company’s products — positioned for relief from menopausal hot flashes, mood swings, vaginal odor/dryness, libido issues, and hair/skin health complaints — are tested in a double-blind, placebo-controlled clinical study that includes a population the same age, gender, and health status as the target consumer.

While consumers today might already expect that of brands marketing specifically toward women, Bonafide is one of a few standouts that can make such a claim for all of its women’s health products.

Women make up 23% of spending on sports nutrition supplements, but only 6% of clinical studies are exclusively focused on female athletes, and fewer than 3% of sports nutrition products on the market actually target a female audience, noted Linda Alvarez, MD, co-founder and CEO of Levelle Nutrition. “Of those products, many are focused on weight loss or looking sexy, but believe it or not, we actually have other needs,” she said.

Alvarez noted that the menstrual cycle has long been overlooked by nutrition researchers, who would rather exclude menstruation from studies as a confounding factor in order to “stack” results. “Products focused on endurance sports are made based on men’s physiology and don’t address, depending on where you are in a menstrual cycle, issues like headaches, nausea, vomiting, diarrhea, or muscle cramps,” she said. “It’s important when looking at an ingredient to not just see how many women were recruited into a study, but how many were also included in the final results.”

These research challenges can be overcome, Alvarez noted. “It’s important to understand the mechanism of action of the ingredient in order to determine how the menstrual cycle will affect it across different phases.” Meanwhile, actually tracking menstrual cycles in a study can help to account for its influence on endurance, or on the metabolism of certain macronutrients.

“Clinical studies are a gamble, and while it’s easier to stack the deck to get a favorable outcome, longer-term studies allow for enough menstrual cycles to pass in order to not have to rule them out as confounding factors,” concurred Kreider.

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“We really tear studies apart and ask for the raw data so we can fully ensure that we stand behind an ingredient. We also do a very thorough scrub of research that is in the public domain to see how well that evidence holds up against anything contradictory by CARSE standards, and if a panel of experts would agree that a claim is substantiated.”
— Rachel Kreider, GNC Holdings

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Industry Stewardship

Brands stand to gain a great deal if they can establish themselves as stewards for women’s health at a time when trust is hard to come by, especially from vulnerable populations like pregnant or breastfeeding women.

“When we first started our company, we interviewed 100 female athletes, and every single one of them thought it was her body that was the problem, and not the products on the market available to them,” said Alvarez. “Women are very hesitant when they hear product claims, so much so that we decided to go the route of food instead of supplements due to the distrust of proprietary blends. They don’t know what’s in that product, and if they’re going through pregnancy, breastfeeding, or menopause, they don’t know how that product will act on them.”

With that said, it’s worthwhile to source ingredients from suppliers that are funding clinical studies over those who “borrow” science to create generic versions of ingredients, in order to incentivize continued clinical research, Alvarez said.

“I feel strongly that we would have support from our suppliers if something came up [related to marketing claims] but we do take our responsibility very seriously … if everyone constantly opts for cheaper alternatives, the studies will never happen,” she said.

Further, emerging certifications specific to women’s health can help to improve trust and transparency.

The Clean Label Project, for instance, recently introduced the First 1,000 Day Promise certification, which utilizes elements of European baby food regulations to set maximum contaminant thresholds for foods, supplements, and other consumer products targeting pregnant women, infants, lactating mothers, and children.

“That’s something to consider,” said Alvarez. “Smaller particles can get through the placental barrier. A pregnant woman’s kidneys experience a 30% increase in blood flow, and in the liver, there’s increased hepatic congestion in the second and third trimester.”  

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About the Author: Mike Montemarano has been the associate editor of Nutraceuticals World since 2020. He can be reached at mmontemarano@rodmanmedia.com.