Regulatory Affairs: Understanding Probiotics

Function claims are also administratively defined by Health Canada as “health claims that describe the physiological effects of foods or food constituents on normal functions or biological activities of the body associated with health or performance.” Therapeutic claims for foods are not permitted. The guidance document from Health Canada does mention dietary health claims that are specifically regulated in the FDR and for which accommodation has taken place to work around otherwise prohibited therapeutic contexts, for example the dietary role of calcium in reducing risk of osteoporosis. It should be clear that these claims do not speak of food or an ingredient as being therapeutic, but rather a nutrient and the diet in the role of the disease. In order to establish the legitimacy of any similar type claims, the current FDR must be amended.

This would be a good time then to get immersed in another revamped Health Canada guidance document, The Guidance Document for Preparing a Submission for Food Health Claims. While notifications for function and general health claims are not obliged in the FDR, they must be factual and not misleading. That can be a very thin line, and Health Canada can be asked to review such a health claim. The Canadian Food Inspection Agency is to include a list of examples for strain specific claims in its Guide to Food Labelling and Advertising.

A label that claims to contain probiotics is expected to be supported with a legitimate health claim, include the number of colony forming units per serving of stated size and identify the genus, species and strain of the probiotic culture(s). Sounds fair to me.

Gary Gnirss is a partner and president of Legal Suites Inc., a Mansfield, Ont.-based firm specializing in regulatory software and services. E-mail: president@legalsuites.com