Health Canada’s probiotics monograph ‘insufficient’: Expert

Since the Canadian Natural Health Products Regulation came into effect in 2004, Health Canada has issued a number of monographs on natural health products. These are described as "scientific documents that provide authoritative information about the safe and effective use of a substance or ingredient"​.

The new monograph, published initially in February, is intended to “serve as a guide to industry for the preparation of Product Licence Applications (PLAs) for natural health product (NHP) market authorization of probiotics”​, said Health Canada.

However, in reaction to the monograph, Professor Gregor Reid from the Canadian R&D Centre for Probiotics at the Lawson Health Research Institute, and The University of Western Ontario was highly critical of Health Canada’s document.

Prof Reid told NutraIngredients-USA.com: “The monograph is a fraction of the way towards what is needed. ​

“It basically says you need to genotype the strain (which is good) and you can call it probiotic, and this is insufficient! You also need to state total viable count - but they don't require this at end of shelf life (which is needed). ​

“Health Canada has no expertise on its Expert Advisory Committee to assist with preparation of this Monograph, and I assume no consultation was made with anyone who actually knows anything about probiotics.”​

“They don't understand that unless you show that a product confers a health benefit on the host (which by itself requires a properly designed human study) then it should not be called probiotic. NHPD need only ask companies to show such documentation, refer to the FAO/WHO document and if they can't satisfy this, then they need to call their product something else,” ​said Prof Reid.

“Sadly, we have probiotic chocolate, bread, orange juice, certain dairy products and even an ice cream that has a flyer which mentions probiotics can prevent colon cancer (how much ice cream should I take every day to do this?). I am not questioning the quality of these products or that they might be beneficial, I just want to see some data on what they have been shown to do. Otherwise, we are fooling the consumer and/or not giving them sufficient information.”​

“This baby step Monograph is not sufficient for other countries to utilize, unless it's as a starting point for a proper monograph,”​ added Professor Reid.

To read Health Canada’s monograph, please click here​.