Lallemand Health Solutions has obtained new Canadian health claims for its longevity, prenatal health, infant microbiome development, and gut-brain-skin axis formulas. Manufacturers using the supplier’s Cerenity, Prenatis, and Cerebiome probiotics can add these authorized claims to their products.
Nutrition Insight meets with Solange Henoud, Lallemand Health Solutions’ VP of Regulatory and Compliance, to discuss the importance of authorized health claims, which she says transform probiotics from a “nice-to-have wellness ingredient into a validated health solution.”
“Authorized health claims fundamentally shift the value proposition for clients because they replace marketing-driven storytelling with regulator-validated credibility,” says Henoud. “Especially since structure or function claims and trend-based positioning can be misused, as they rely on companies’ self-judgments.”
“However, authorized claims give clients permission to communicate precise, science-backed benefits that have been evaluated by independent third parties, such as competent regulators.”
Henoud highlights that while an approval itself is proof of compliance in a specific country, it can also support companies in other locations by constituting a robust basis for substantiation. “An approved claim reduces legal risk, strengthens differentiation, and increases consumer trust.”
She adds that these “major milestones” demonstrate that the products meet the highest current standards for safety, quality, and efficacy. “They confirm that our strains and formulations are backed by robust, targeted, and specific clinical evidence rather than generic data, strengthening our credibility with regulators and partners across the globe.”
“Regulatory springboard”
Henoud explains that Health Canada claim approvals act as a regulatory springboard, elevating credibility, reducing uncertainty, and helping transform strong science into globally scalable health claims.
“The Natural Health Products framework for probiotics in Canada is recognized as one of the most balanced, rigorous, and science-driven regulations. It is often provided as a gold reference, as it keeps up with scientific advancements and fosters innovation at the same time.”
Solange Henoud, Lallemand Health Solutions’ VP of Regulatory and Compliance.“Health Canada requires strain-specific identification, robust clinical evidence, and a clear demonstration of safety, quality, and efficacy for the approval of any probiotic or any statement about it that is specific,” she details. “As a result, securing authorized claims in Canada provides a powerful regulatory benchmark that can strengthen and sometimes accelerate submissions globally.”
Specifically, she says that these approvals signal that a probiotic formulation has passed an in-depth evaluation process and one of the industry’s highest scientific thresholds, making the dossier highly credible when approaching other regulators.
Moreover, they can support a faster regulatory review, says Henoud. “A Canadian-approved dossier sometimes reduces the need for additional justification, as strain characterization, safety data, and clinical substantiation have already been reviewed by a competent authority.”
“Clients and brand owners can leverage Health Canada-approved claims to differentiate their products and enter multiple markets with a unified, science-based positioning and be able to rely on the approval to substantiate their strategy.”
Lastly, she notes that approvals enable long-term global expansion, as Canadian decisions showcase a company’s ability to generate high-quality, innovative clinical evidence. She says this reinforces global regulatory trust and paves the way for future submissions in categories such as women’s health, early-life nutrition, mental wellness, and nutricosmetics.
For the company’s clients, she adds that these claims offer greater commercial confidence, a stronger competitive edge, faster market adoption, global scalability, and long-term brand protection.
Healthy aging benefits
With Health Canada approvals, companies using Cerenity, Lallemand Health Solutions’ healthy aging formula, can now claim that it “helps support muscle health in aging adults” and “helps reduce, improve, or moderate feelings and symptoms of mild to moderate stress.”
The healthy aging formula Cerenity achieved claims for muscle health support and reducing stress in aging adults.Henoud points out that the product’s claims align with a move toward science-based probiotics for healthy aging, as it is grounded in substantiated human data and responsible messaging.
“Regulatory evolution around probiotics and healthy aging is balancing innovation with robust evidence. It supports products with credible science behind them while protecting consumers from overstatement.”
“Health authorities, including Health Canada, are increasingly recognizing that the gut microbiome plays a role in physiological functions that change with age,” she adds. “This has opened the door to evaluation of probiotic interventions that support aspects of healthy aging such as digestive health, immune resilience, and metabolic balance.”
At the same time, she explains that regulators continue to see “healthy aging” as a paradigm that targets multiple age groups, rather than as an indication for a specific group. “They apply rigorous standards for substantiation of claims, depending on the targeted aspect of healthy aging.”
Henoud notes that meeting these standards requires a risk-based approach, with high expectations for well-designed human clinical studies that demonstrate clear, measurable effects on validated health outcomes rather than general or implied benefits.
Bridging nutrition and cosmetics
Lallemand Health Solutions’ Cerebiome achieved the health claim “helps support skin health or healthy skin” in Canada. According to Henoud, the nutricosmetics category is unique in its regulatory landscape because it sits at the intersection of nutrition, dermatology, mental wellness, and cosmetic science.
She explains that products in this category need to bridge two regulatory worlds at once: nutrition and natural health product regulations that require strain-specific, clinical evidence and cosmetic-type outcomes, which must be shown to result from biological, not topical, mechanisms.
Substantiating benefits through systemic mechanisms requires a higher level of scientific validation, says Henoud. “Regulators expect clear evidence that an oral ingredient can produce measurable, clinically meaningful changes on the skin, not just perceived cosmetic improvements.”
Nutricosmetics like Cerebiome need to bridge nutrition regulations with clinical evidence and cosmetic-type outcomes through biological mechanisms.She says that the authorized claims highlight that Cerebiome can support visible skin parameters through the gut-brain-skin axis.
“Our evidence has shown objective improvements in skin hydration, firmness, elasticity, and fine lines, supported by validated dermatological instruments and expert scoring,” details Henoud.
“The proof-of-concept study fulfilled these expectations by documenting consistent improvement in multiple skin quality measures, while also confirming decreases in perceived stress — a factor that strongly influences skin health.”
Benefiting pregnant women and newborns
Lallemand Health Solutions’ third probiotic, Prenatis, is gaining Health Canada-authorized claims to support maternal health during pregnancy and the development of a healthy infant microbiome. Claims now include “helps support vaginal health,” “helps support healthy vaginal flora,” and “in conjunction with breastfeeding, helps support a healthy gut flora in newborns.”
According to Henoud, obtaining claims for pregnant women and newborns indicates that a formula is effective and demonstrates a high level of maternal and infant safety, supported by physiological, immunological, and microbiome-level monitoring.
“Regulatory requirements are risk-based,” she details. “The more sensitive the targeted populations are, the higher and stronger the evidence must be to present.”
“Working with pregnant women and infants represents one of the most demanding areas of probiotic research, both scientifically and regulatorily. Pregnancy is characterized by profound physiological, hormonal, immune, and microbiome changes that increase women’s susceptibility to infections and can heighten their severity.”
She explains that this heightened vulnerability — combined with the developmental immaturity of newborns’ immune and gastrointestinal systems — places the mother–infant pair in a uniquely sensitive risk category requiring exceptionally rigorous safety oversight. Similarly, regulators are particularly cautious and reserved in approving claims on infant health.
Building on clinical data
Henoud details that Prenatis builds on two probiotic strains, Lactobacillus rhamnosus Rosell-11 and Bifidobacterium bifidum HA-132, and robust human evidence in the targeted population.
Obtaining claims for pregnant women and newborns indicates that a formula is effective and demonstrates a high level of safety, says Henoud.“One of the major challenges was conducting a large, randomized, double-blind, placebo-controlled clinical trial directly in pregnant women and their infants.”
The study of 180 healthy women in their third trimester monitored an extensive panel of maternal and neonatal outcomes, such as blood inflammatory markers and immunoglobulins, as well as vaginal, gut, and breast milk microbiota samples. The researchers also looked at vertical transmission pathways, infant growth, anthropometrics, gastrointestinal function, crying and sleep patterns, and detailed infection tracking.
According to Henoud, such breadth of monitoring is rarely achieved in probiotic trials and was crucial to supporting the product’s safety and efficacy.
“The study documented fewer maternal infections, a trend toward reduced bacterial vaginosis, and significantly shorter sick days in newborns. In addition, Prenatis positively shaped early microbiome establishment, increasing beneficial Bifidobacteria and promoting healthier mother-to-infant microbial transfer — even in more vulnerable subgroups such as C-section-born or exclusively breastfed infants.”
She adds that it revealed the induction of more interconnected and resilient microbiota networks, “contributing new scientific insight into early immune development.”
