Health Canada states that it intends to follow the 2017 definition of prebiotics from the International Scientific Association for Probiotics and Prebiotics (ISAPP), which was adopted by the International Probiotics Association (IPA) in 2025.
ISAPP defines prebiotics as “a substrate that is selectively utilized by host microorganisms conferring a health benefit” (Gibson, et al. Nat Rev Gastroenterol Hepatol)
The monograph includes a defined list of accepted ingredients and sources, including Inulin, Acacia gum, Fructooligosaccharides (FOS), Transgalactooligosaccharides (GOS), Xylooligosaccharides (XOS), and the human milk oligosaccharides (HMOs) 2′-Fucosyllactose (2′-FL) and Lacto-N-neotetraose (LNnT).
It also distinguishes clearly between prebiotic claims and fiber claims, noting that not all prebiotics are fibers and not all fibers are prebiotics.
“This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients,” states the monograph.
The need for alignment
George Paraskevakos, executive director of IPA, which expanded its scope in 2023 to include prebiotics, welcomed the publication. “As was the case with the Probiotic Monograph, IPA has been actively engaged with Health Canada NNHPD, contributing scientific and regulatory perspectives to support the development of this monograph,” he said.
“We are pleased to have advocated from the start as the need for alignment in how prebiotics are defined, assessed, and positioned for both industry and consumers is greater than ever as confusion still exists.
“Much discussion and substantive input was provided by IPA member companies to Health Canada NNHPD in support of the newly released Prebiotic Monograph. This underscores the value of IPA’s active engagement and collaboration with regulators,” added Paraskevakos.
The monograph was also hailed by the Global Prebiotics Association (GPA). In a blog post on its website, Len Monheit, GPA’s executive director, called the document “a major milestone”.
“The current monograph does not include all well-substantiated prebiotic ingredients. GPA intends to continue engaging with Health Canada to ensure that emerging science and novel prebiotics are appropriately considered, with a viable pathway to market as the scientific evidence supports their inclusion,” he said. “GPA also recognizes that a symbiotic monograph would be beneficial and is exploring its implications.”
“We are proud of the cooperative process and the consistent representation of the category’s perspective. Throughout, GPA was able to support Health Canada by ensuring that evidence-based industry viewpoints were included.”
A credible and transparent process
“This was a collaborative effort to which NNHPD is grateful to both the IPA and GPA,” Michael Steller, Unit Head in the Health Products and Food Branch at NNHPD, told NutraIngredients. “I will however make clear that expectations, boundaries, and decision‑making authority always rested entirely with NNHPD, ensuring regulatory independence was well maintained.
“Still, this collaborative initiative reduced research burden on the internal development team throughout 2024 and 2025, improved the breadth of evidence considered, and (I hope) enhanced the credibility and transparency of the process.”
Steller will present more on the monograph at the upcoming Probiota Americas during a session dedicated to prebiotics. The session will also feature Dr. Doug Bolster, VP of scientific and medical affairs for Olipop, and Professor Bradley Saville from the University of Toronto. Probiota Americas will take place June 8-10 at the Westin Bayshore, Vancouver.
IPA has produced the following infographic for industry (reproduced with permission):
