Health Canada publishes probiotics monograph

By Stephen Daniells

- Last updated on GMT

Related tags: Probiotic

Health Canada publishes probiotics monograph
Health Canada has released a monograph for probiotics to guide industry for preparing Product Licence Applications (PLAs) and market authorization of labels for natural health products.

The monograph is limited to three strains of bacteria: Lactobacillus johnsonii, Lactobacillus rhamnosus GG​, and Saccharomyces boulardii​.

According to the Canadian agency’s monograph, products containing L. rhamnosus​ GG may make the following statements: “Helps to manage acute infectious diarrhoea”; “Helps to manage antibiotic-associated diarrhoea”; “Helps to reduce the risk of antibiotic-associated diarrhoea”​.

For S. boulardii​, the following label statement is allowed: “Helps to reduce the risk of antibiotic-associated diarrhoea”​, while for L. johnsonii​ La1, Lj1 or NCC 533 it is, “An adjunct to physician-supervised antibiotic therapy in patients with Helicobacter pylori infections”​.

Supplemental statements for products containing the specified strains include:

  • Probiotic that forms part of a natural healthy gut flora
  • Provides live microorganisms that form part of a natural healthy gut flora
  • Probiotic that contributes to a natural healthy gut flora
  • Provides live microorganisms that contribute to a natural healthy gut flora
  • Probiotic to benefit health and/or to confer a health benefit
  • Provides live microorganisms to benefit health and/or to confer a health benefit

However, according to an industry insider, the list is not limited to these strains, and stakeholders also have the option to present other species/strains and their claims, with the caveat of properly conducted clinical in-vivo​ research.

Dosage forms

According to the document, the monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

The accepted dosage forms for children between 1 and 5 years of age are listed as solution/ drops, or emulsion/ suspension, while for everyone over the age of five, the dosage forms include: chewables like gummies and tablets, capsules, strips, lozenges, powders or liquids.

Please click here to read the monograph.

Live micro-organisms

Health Canada has also published an abbreviated labelling standard (AbLS)​ for its Natural Health Products Ingredients Database for Live Microorganisms.

“This AbLS cannot be used to support probiotic or prebiotic claims. The use of the words ‘probiotic’ or ‘prebiotic’ on product labels, in brand names, or in marketing material is not supported by this AbLS,”​ states Health Canada.

The AbLS “includes generalized claims and is not intended to be a comprehensive review of the medicinal ingredient. Wording of the claim on the PLA and label must therefore be identical to this labelling standard.”

This allows for manufacturers to use the range of strains identified in the AbLS as live micro-organisms with the only statement associated to these live micro-organisms being “Provides live microorganisms that temporarily modify gut flora”​.

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1 comment


Posted by harry,

This is the only way to stop objections to a product. A World standard product monograph for all health foods is step to stop many objections from blocking a highly valued food.

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