Health Canada said its new monograph, published in February and relevant to probiotic supplements, 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”.
However, the monograph has come under fire for being lacking and uninformed. According to Professor Gregor Reid from the Canadian R&D Centre for Probiotics at the Lawson Health Research Institute and The University of Western Ontario, “the monograph is a fraction of the way towards what 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,” he told NutraIngredients-USA.com last month.
To read his full comments, click here.
Filling in the gaps
The International Probiotics Association (IPA), which was founded in part to establish probiotic standards, agreed with Professor Reed’s comments, but highlighted that the monograph must be considered a work in progress.
“I don’t think the industry was consulted regarding the monograph, we met with them after they decided what they want to put into their monograph and we are now filling the gaps by standardizing some of the info they require (such as antibiotic resistance),” said IPA director general Ioannis Misopoulos.
“I do want to point out that their monograph is a work in the making with many revisions to come in the future, and I am hoping we can help them to tailor it appropriately,” he told NutraIngredients-USA.com.
Listen to Misopoulos commenting on the monograph here.
The monograph essentially provides two approaches for probiotic PLAs to be approved for NHP market authorization.
If the strains are recognized and listed in the monograph, the PLAs can be submitted through the Natural Health Products Directorate's (NHPD) compendial application stream.
If the strains are not listed in the monograph, then PLAs are submitted outside of the compendial stream, and must be accompanied by adequate supporting evidence, as required by Canada’s Natural Health Products Regulations (NHPR).
To view the monograph, click here.
Guidance for probiotics in food
Health Canada has also recently released a separate guidance document for the use of probiotics in food.
The guidance document is designed to clarify the acceptable use of probiotic health claims on food labels and in advertising. It also provides guidance on the safety, quality (stability) and labelling aspects of food products containing probiotic microorganisms.
To access the document – entitled Guidance Document - The Use of Probiotic Microorganisms in Food – click here.