Health Canada has published a new monograph on prebiotics, providing a regulatory framework to streamline approvals and allow science-backed claims on natural products.
The Global Prebiotic Association (GPA) worked closely with Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) during the multiyear monograph development process.
Len Monheit, GPA executive director, shared a behind-the-scenes look and his thoughts on where prebiotics are headed next.
Prebiotic regulatory guidance rooted in science
The monograph covers prebiotic fibers with sufficient scientific evidence to demonstrate efficacy and health benefits, including inulin, fructooligosaccharides (FOS), xylooligosaccharides (XOS) and gum acacia. It also includes relevant doses and scientific references used to establish usage levels and claims.
The monograph also separates prebiotics from fibers, although some ingredients qualify as both, but are assessed independently.
That said, all ingredients listed in the monograph are prebiotic fibers, although the monograph explicitly states, “not all prebiotics contain fiber, and not all fibers are prebiotics.”
Before the current developments, Health Canada had published only one prebiotic-related monograph — for inulin — which has since been removed and incorporated into the broader monograph, Monheit explained.
“The science on prebiotics has moved well past inulin,” Monheit said.
The claims afforded by the monograph differ from health claims approved for individual ingredients, Monheit said. He cited Clasado Biosciences Bimuno galactooligosaccharides (GOS) as an example, which has health claims approved on the branded ingredient, but also qualifies for prebiotic claims outlined in the monograph.
This means companies can still submit ingredients for approval of health claims beyond the scope of the prebiotic monograph.
What implications does the monograph have for supplement manufacturers and brands?
Monheit highlighted that the monograph reclassifies prebiotics from Class III to Class I. The Natural and Non-prescription Health Products Directorate groups applications for natural health products (the Canadian term for dietary supplements) into three classes:
Class I: Must comply with conditions set forth in one individual monograph.
Class II: Can reference more than one monograph.
Class III: Not included within the scopes of Class I or II, may include non-traditional or homeopathic ingredients.
Because ingredients in Class I or Class II rely on Health Canada monographs, any product applications referencing these monographs will likely face shorter approval times. The prebiotic monograph does note a handful of exceptions for which Class II applications will not be accepted.
“Because time to market is money, companies will be using these monographs, which means awareness of the category in a very visible marketplace,” Monheit said.
He also said that Health Canada is highly regarded because of its stringent standards, and the monograph provides an exportable framework that other countries could use, further validating the category.
“People do look to Canada because of the claims you can make; people will see the validation of the prebiotic category,” Monheit said.
How does the regulatory landscape of prebiotics differ between Canada and the United States?
The primary differentiator between the regulatory landscapes of the United States and Canada is the Dietary Supplement Health and Education Act of 1994 (DSHEA), which created a separate framework from food or drugs under which supplements are regulated.
While DSHEA limits ingredient claims to structure-function claims (except for qualified health claims allowed in food), the Canadian regulatory system allows for approval of health claims related to the prevention or treatment of a disease.
The prebiotic monograph specifies claims such as:
“Helps stimulate the growth of healthy bacteria in the intestine/gut.”
And “a source of prebiotic(s) that help(s) support/maintain a healthy digestive system.”
Health Canada also has approved claims around constipation or irregularity relief for inulin and FOS at proper dosages.
Currently, no “prebiotic” definition exists in U.S. regulations. For this reason, the Global Prebiotic Association launched its NutraStrong Prebiotic Verified program in cooperation with SGS Nutrasource, a clinical research organization and regulatory service provider. Ingredients or raw products qualify for the certification by meeting the scientific and quality standards established by the program.
One of the hallmarks of the program is ensuring the prebiotic ingredient usage level matches the dosage providing a health benefit in clinical trials. This aims to prevent issues a la Poppi in which the product does not contain enough prebiotics to have a positive health impact.
Monheit said the verification is applicable globally (with some exceptions) but has proven most valuable so far in the United States because of the lack of a regulatory definition for “prebiotic.”
But he also shared a hot take on product labeling to improve transparency.
“In GPA’s perfect universe, there would be a requirement to separate fiber and prebiotic fiber because that would be more informative for consumers and the health care community,” Monheit said.
What’s next for the monograph and the prebiotic category?
Monheit predicts resistant starches and dextrins will be among the next prebiotic ingredients added to the monograph. He explained that Health Canada started with non-controversial ingredients to avoid delaying the initial establishment of the monograph.
“This is a starting point, not a finish line,” the GPA said in its statement on the monograph publication.
In terms of need states impacted by prebiotics, Monheit expects inflammation and metabolic health to become very strong areas, as prebiotics impact the production of short-chain fatty acids, which in turn strengthen the gut lining and reduce inflammation.
“I think that linkage is going to be very, very strong in consumers’ minds,” Monheit said.