Regulatory Affairs: Understanding Probiotics

In April 2009 Health Canada unveiled its guidance document The Use of Probiotic Microorganisms in Food. This new guidance on probiotics has been several years in the making. It’s a bit of a catch up for Health Canada, as probiotic cultures and claims have been around equally as long. The concept of probiotic and health is, however, taking root among consumers, so guidance on the matter is thus still very relevant.

The Food and Agriculture Organization (FAO) and the World Health Organization (WHO) define probiotics as “Live microorganisms which when administered in adequate amounts confer a health benefit on the host.” This also forms the working understanding in Canada. The three crucial criteria involved are live microorganisms, adequate amounts and health. The first might seem obvious, but we are speaking of bacteria that could exist in an active or suspended “live” state. Perhaps it’s easier to appreciate them then as “not dead.”

Generally speaking the types of microbes considered probiotic include lactic acid bacteria and those of the genus Bifidobacterium. Health Canada also identifies probiotics associated with acceptable non-strain specific claims. Ultimately the manufacturer is responsible that the food, including the probiotic culture, is safe. Where a probiotic culture does not have a history of safe use in foods, or is a strain that has been applied in a novel manner (such as microencapsulation) it could be subject to notification requirements as a novel food.

The question concerning adequate amounts can also be a tough one. According to Health Canada the minimum amount needed, where non-strain specific claims are made, is one billion cfu (colony forming units) per serving of stated size. The amount for specific strains could be higher or lower depending on, for example, their proven health efficacy, the food matrix involved or the subpopulation that is targeted. The amount is expected to be stable through the shelf life of the food.

Some answers to the last question related to health are still being written. While Health Canada has generally recognized a few acceptable non-strain specific probiotic claims for food (such as “probiotic that contributes to healthy gut flora”), there is the potential for even more. Health Canada’s guidance document speaks of claims in three basic forms: health, function and therapeutic claims. It may be a bit surprising that there is no definition in the Food and Drugs Act or Regulations (FDA and FDR) for health claim, but the term nutrient is not defined either. Probiotic cultures are not nutrients as is classically appreciated, and thus are not subject to the general prohibitions on nutrient representations, except those afforded by the FDR (such as action and effect claims, or biological role claims). A health claim is generically appreciated as “any representation in labelling or advertising that states, suggests, or implies that a relationship exists between consumption of a food or food constituent (including an ingredient in the food) and a person’s health.” The term probiotic alone is seen by Health Canada as an implied health claim of sorts.