Probiotic gut (claims) check

This article originally appeared in Food in Canada and is republished with the permission of the publisher.

The use of probiotics in foods in Canada has become commonplace but current policy toward probiotic claims is limited. For food producers willing to engage, Health Canada's Food Directorate can provide helpful premarket guidance.

Safety considerations notwithstanding, an otherwise compliant food producer could run afoul of the Food and Drugs Act (FDA) or Health Canada's policies on the labelling or advertising of probiotics in food, by making or implying unsubstantiated health claims regarding the probiotic itself. Health Canada has adopted the FAO/WHO definition of probiotics as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." Thus, there is an implied health claim associated simply with the use of the term "probiotic" itself due to the "health benefit" aspect highlighted in this definition. Such claims trigger the obligations that a food must not be false, misleading or deceptive. Therefore, the mere mention of a probiotic in food seemingly requires a food producer to have scientific data in support of such claims, or risk being in violation of the FDA.

In 2009, due to the multitude of products in the Canadian marketplace making probiotic claims, Health Canada authored guidance to assist producers in making compliant health claims for their probiotic products.[1] The CFIA has also published guidelines on probiotic claims.[2] This guidance establishes low-risk, function claims for a variety of bacterial strains generally regarded as both safe and efficacious. Specifically, the Table of Acceptable Non-Strain Specific Claims for Probiotics, therein, provides a list of pre-cleared probiotic claims for products providing a minimum total quantity of one billion colony forming units (cfu) per serving, of one or more of the specified bacterial species. In such instances, strain specific efficacy data is not required to support the specified probiotic claims.

While this provides a simplified path to market for producers using Health Canada approved probiotic species, it is possible to build upon this guidance without starting anew. As written, producers using otherwise safe species that do not appear in Health Canada's table, or using approved species in amounts less than one billion cfu per serving, must ensure they have sufficient evidence in support of the health benefit of their probiotic, or remain silent regarding the probiotic benefits of their product.

It has been our experience that engaging with Health Canada on the use of probiotic claims can be a beneficial strategy. Food producers using probiotic species not listed in the Table of Acceptable Non-Strain Specific Claims for Probiotics may leverage that table and make non-strain specific claims, by preparing a scientifically supported rationale that evidences the safety and limited efficacy of their strain. For example, if a food contains a species not included in Health Canada's table, but has been otherwise established as safe (perhaps through demonstrated presence in the food system), and provides some form of health benefit, even as simple as colonization of the gut, a producer may be able to avail themselves of a non-strain specific claim. This approach may be highly desirable since such rationale need not to be clinical, provided that a sufficient body of published data exists.

Similarly, with respect to dose, a food producer may be able to support the health benefits of a quantity less than the specified 1 billion cfu per serving if a reasonable argument may be made that a consumer would consume multiple servings over the course of the day, such that the total daily consumption provides at least one billion cfu. In these situations, engaging the regulator may be worthwhile, as the threshold to demonstrate a non-strain specific benefit may be lower than amassing clinical data supporting a strain-specific claim. Based on a thorough review of published data, coupled with a degree of creativity, proactive food producers may benefit from Health Canada's seemingly inapplicable guidance.