Health Canada’s decision to recognize yeast-derived resveratrol and beta-glucan in its natural health product monographs earlier this year has given manufacturers a clearer path to licensing products containing these ingredients.
Under the updated monographs, qualifying products can instead rely on information the agency has already evaluated.
NutraIngredients spoke with Nassim Naderi, regulatory affairs specialist at Lallemand Bio-Ingredients, about what has changed for manufacturers, how the revisions affect ingredient sourcing decisions and what companies need to know about the permitted health claims.
What changes for manufacturers?
Naderi explained that manufacturers can now work within established requirements rather than providing separate justification for a recognized ingredient source.
“Rather than having to provide extensive source-specific justification, companies can rely on Health Canada’s established monograph framework when their products meet the defined conditions,” she said.
Health Canada revised its Antioxidants monograph in June to include trans-resveratrol produced through biosynthesis using Saccharomyces cerevisiae. The monograph identifies whole yeast cells as the source part and allows qualifying products to use established antioxidant claims.
“The update places qualifying fermentation-derived resveratrol on a more comparable regulatory footing with established resveratrol sources already recognized under the Antioxidants monograph,” Naderi said.
According to Naderi, the update could give manufacturers greater flexability to evaluate resveratrol sources could now focus more on ingredient quality, sustainability, supply reliability and product positioning.
The financial implications are less straightforward.
“The biggest benefit is not necessarily a specific cost saving, because that will vary by company and product,” Naderi said. “The more immediate advantage is greater predictability.”
Companies may also avoid duplicating some scientific documentation when their products meet the monograph requirements, although formulations that fall outside those conditions could still need additional evidence, she added.
The evidence behind the beta-glucan claims
Health Canada’s July update to its Beta-Glucan monograph recognized S. cerevisiae as a source of yeast beta-glucan and included specific immune health claims.
These include “Source of yeast beta-glucans with immunomodulating properties” and a claim for helping reduce the severity of common cold symptoms in adults prone to recurrent colds.
According to Naderi, Health Canada cited three randomized, double-blind, placebo-controlled human studies evaluating yeast beta-1,3/1,6-glucan in adults with recurring infections. The research examined outcomes related to common colds and upper respiratory tract infections.
The common-cold claim is limited to products containing beta-glucan derived from the cell wall of S. cerevisiae, with at least 80% beta-1,3/1,6-glucan and a specified dose of 450 mg twice daily.
It also applies to adults prone to recurrent colds when the ingredient is taken preventively during winter months. The permitted claim concerns reducing symptom severity, not preventing colds or treating an existing infection.
Naderi cautioned that simply using yeast fermentation does not make an ingredient eligible for the monograph pathway.
“In practical terms, simply describing an ingredient as ‘fermentation-derived’ or ‘yeast-derived’ is not enough,” she said. “To benefit from the monograph pathway, the product must meet the specific source, composition and quality criteria established by Health Canada.”
Manufacturers must still obtain a Natural Product Number (NPN) and comply with applicable identity, purity, potency, safety and quality requirements, as well as labeling and manufacturing standards. Products that fall outside the monographs’ specified sources, compositions or conditions of use may require additional evidence during the licensing process, Naderi added.
