Probiotics supplier Lallemand has announced a big regulatory win: Canadian authorities have approved health claims on five of its probiotic formulas.
The Natural Health Products Directorate (NHPD), the regulatory agency for natural health products in Canada, has granted new condition specific health claims in the areas of digestive health, natural defenses and stress. According to Lallemand, based in Montreal, this culminates many years of work and research in partnership with leading universities and hospitals and it a recognition by NHPD of the quality scientific and clinical data supporting each benefit and condition of use.
The Canadian market is mature as far as probiotics are concerned, said Isabelle Champié, global marketing director for Lallemand. But the claims approval still will help push sales forward, she said.
“There is still room for further development as Canadian consumers, like many others in the world, become more and more aware of the benefits of probiotics,” Champié told NutraIngredients-USA.
“Having approved claims will bring confidence and trust on the effectiveness and quality of our products and our company and will also help consumer better select the products they need,” she said.
NHPD approved claims for the following Lallemand products:
- ProbioKid: “Helps to reinforce the body's natural defences in children.”(Claim NPN 80019993).
- Probio’Stick: “Helps to reduce stress-related gastrointestinal complications like nausea.” (ClaimNPN 80021343).
- Protecflor: “Helps to reduce the risk of traveler's diarrhea.”(ClaimNPN 80021342).
- Lacidofil : “Restoring and maintaining intestinal flora”;“Helps to reduce the risk of antibiotic associated diarrhea AAD (in children and adolescents from 2 to 18 years of age).” (ClaimNPN 80020017)
- Lalflor (sachets or capsules) (Saccharomyces cerevisiae Boulardii CNCM I-1079): “Helps to reduce the risk of antibiotic associated diarrhea.” (Claim NPN 80038395).
Model for EFSA?
Like many other probiotics suppliers, Lallemand submitted claims to EFSA for approval in the European market. And, like other companies, all of their claims were rejected. Champié said the experience with NHPD could serve as a model for how companies and regulators in other markets could fruitfully.
“One of the main positive takeaways from the Health Canada claim submissions experience was that there was dialogue with the authorities, to understand what they were looking for in presenting comprehensive dossiers,” Champié said.
“If we are to achieve progress in the EU this will require the same type of dialogue with EFSA and the NDA panel which conducts the dossiers reviews. Hopefully this can be a segue leading into the same possible results in Europe with EFSA – or at least lend itself as an example of what other regulatory agencies are doing worldwide,” she said.
In addition the health claims news, Lallemand recently announced an internal reorganization. The company has created a new division, called Lallemand Health Solutions, that consolidates previously separate probiotic manufacturing arms Institut Rosell and Harmonium International. According to the company, these entities collectively possess close to a century of probiotic expertise in the selection, development, production and marketing of probiotic strains and formulations that support human health and well-being.
The company said the new division will be capable of providing solutions from fermentation and lyophilization all the way to finished products.