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Health Canada’s probiotics monograph ‘insufficient’: Expert

By Stephen Daniells , 22-May-2009

A recently published monograph by Health Canada is ‘insufficient’ and could lead to a ‘fooling of the consumer’ according to a leading probiotics researcher.

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 .

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