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Questions and Answers on Probiotics

General Questions & Answers on Probiotics

Q1. What are probiotics?

Probiotics are considered to be live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. It is recommended that the use of the term "probiotics" and similar terms or representations on food labels and in advertising of food products only be used when accompanied by specific, validated statements about the benefits or effects of the probiotic microorganism in the food.

Q2. What types of food contain probiotics in the Canadian marketplace?

At present, probiotics are primarily found in dairy products such as yogurts, cheeses, and milk-based beverages. Other types of food products containing probiotics are also available to Canadian consumers both on store shelves and via the internet.

Q3. How are probiotics regulated in Canada?

Probiotics in Foods

Under the food provisions of the Food and Drug Regulations, live bacterial cultures, including those represented as "probiotics", are food ingredients and can be added to food products.

While there are currently no specific regulations pertaining to probiotic bacteria in foods, the general provisions of the Food and Drugs Act and Regulations apply to foods containing microorganisms including those microorganisms represented as probiotics. These provisions govern the safety of foods and their ingredients, as well as the claims made on food labels and in advertising, including claims about probiotics.

Under Section 4 of the Food and Drugs Act, manufacturers and importers of foods are responsible for the safety of food products they produce and sell. The Act also requires all product representations (including claims) to be truthful and not misleading, deceptive, or likely to create an erroneous impression regarding the character, value, quantity, composition, merit, or safety of a product.

Also, the Food and Drug Regulations and the Dairy Products Regulations (which fall under the Canada Agricultural Products Act) recognize the use of bacterial cultures for example, in cheese making.

The Canadian Food Inspection Agency (CFIA) is responsible for enforcing all provisions of the Food and Drugs Act and Regulations with respect to food and associated policies and guidance, including the guidance on probiotics in foods, which are established by Health Canada.

Food products containing probiotic microorganisms are generally classified as food. Where a food product is represented as having a therapeutic use or purpose (e.g. carrying claims about disease risk reduction or treatment), the product is generally classified as a natural health product, depending on the nature of and risks associated with the microorganism and taking into consideration the product's represented therapeutic use, as well as the history of use and public perception of the product's intended use (see "Probiotics in Natural Health Products" below).

Probiotics in Natural Health Products

Probiotics can also be sold in pharmaceutical dosage forms (e.g. tablets, capsules) as natural health products (NHPs). The manufacture, packaging, labelling and importation for sale of NHPs is regulated under the Natural Health Products Regulations.

To be sold in Canada, all NHPs must have product licences and the Canadian sites which manufacture, package, label and/or import NHPs must have site licences.

Health Canada has developed a Probiotics Monograph, which can assist industry stakeholders in obtaining product licences for their probiotic NHPs in capsule and tablet form. The monograph includes detailed information on acceptable health claims, associated doses, source materials and required risk information.

Probiotic NHPs are not limited to the claims and doses indicated in the monograph. A product licence may be sought for a different claim at a different dose. However, additional evidence supporting the product's efficacy, safety and quality would be required.

An NHP containing probiotics could potentially be sold in food format (e.g. fermented food products). The decision as to whether such a product would be classified as a food or an NHP would be based on the criteria outlined in Health Canada's guidance document "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats".

Probiotics as NHPs are regulated by Health Canada's Natural Health Products Directorate (NHPD). The Health Products and Food Branch Inspectorate (HPFBI) is responsible for enforcing the regulations pertaining to NHPs.

Q4. What is Health Canada doing to ensure that probiotics in food are safe?

Common "probiotic" bacteria (primarily lactobacilli and bifidobacteria) added to foods have a history of safe use in food products. Live bacterial cultures added to foods are food ingredients under the food provisions of the Food and Drug Regulations. Bacterial cultures that are not novel food do not require premarket safety review by Health Canada. Under Section 4 of the Food and Drugs Act, manufacturers and importers of foods are responsible for the safety of food products they produce and sell.

However, if the culture(s) meets the definition of novel food, as, for instance, in cases where there is no history of safe use in foods or the strain is genetically modified, then it would require premarket notification as per Division 28 of Part B of the Food and Drug Regulations. These provisions require demonstration of the safety of the novel food.

Q5. How are health claims about probiotics in food regulated in Canada?

All health claims made for food , including claims about probiotics, are subject to Subsection 5(1) of the Food and Drugs Act (the Act), which requires that all claims and representationson food products be truthful and not misleading, deceptive or likely to create an erroneous impression about the product. Claims are more likely to meet this requirement when they are supported by acceptable scientific evidence. However, the regulatory requirements permitting the use of health claims vary and are dependent on the nature and the type of claim.

While manufacturers are responsible for the validity of function claims about the physiological effects of probiotic microorganisms under Subsection 5(1) of the Act, consultation with the Food Directorate of Health Canada is encouraged before food manufacturers use such claims. On the other hand, claims about the diagnosis, treatment or mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans, or restoring, correcting, or modifying body functions in humans are representations about the therapeutic use of a product. Products with such representations or claims are generally classified as NHPs. Nevertheless, some claims of this type may be permitted on foods when the claimed effect derives from the product's nature and use as a food. To seek additional or new claims of this type that are not already permitted for use on food in the Food and Drug Regulations, manufacturers must make a submission to the Food Directorate of Health Canada for premarket review prior to marketing the product. If the claim is supported by acceptable scientific evidence, its use would be permitted on food only following amendments to the Food and Drug Regulations specifying the conditions for their use.

It is recommended that the use of terms such as "probiotic(s)"on foods only be used when accompanied by specific, validated statements about the benefits or effects of the probiotic microorganism in the food to comply with Subsection 5(1) of the Food and Drugs Act and to provide more information to consumers.

Q6. What is being done to prevent the use of false or misleading claims about probiotics in foods in Canada?

Health Canada has posted a guidance document "The Use of Probiotic Microorganisms in Food". This guidance document explains the conditions under which health claims about probiotics would be considered acceptable for food. This guidance will be used by the Canadian Food Inspection Agency (CFIA) to assess compliance of food products containing microorganisms represented as probiotics with the Food and Drugs Act and Regulations.

Authorized health claims that require regulatory amendment before they are permitted on foods are listed in the Food and Drug Regulations. Currently, only certain disease risk reduction claims are permitted on food. For function claims that do not require premarket assessment and regulatory amendment, the Food Directorate of Health Canada may, upon request, provide advice regarding their acceptability. As evidence is submitted, reviewed and found to support a probiotic health claim, a list of acceptable claims according to the specific strains of the probiotic microorganisms (strain-specific probiotic claims) will be published on Health Canada's website and linked to the CFIA Guide to Food Labelling and Advertising. A limited number of claims about the nature of probiotics that are not based on strain-specific evidence may also be made for food when guidance for their use is followed. These additional claims will also be incorporated in the CFIA Guide, along with guidance for their use.

The development of this guidance is part of a broader initiative undertaken by Health Canada towards a modernized framework for managing health claims for foods in Canada. Health Canada is conducting a review on how different types of health claims should be managed, including those that apply to probiotics.

Questions & Answers Specific to the Guidance Document

Q7. How will the guidance document be applied?

Following publication of the guidance document, industry will be advised of a window in which products have to come into compliance with applicable sections of the Food and Drugs Act and related regulations before enforcement actions begin.

Food manufacturers are encouraged to consult the Food Directorate of Health Canada regarding the acceptability of claims prior to their use. For a claim that is subject to Subsection 5(1) of the Food and Drugs Act, a company that has received advice from the Food Directorate of Health Canada supporting the acceptability of the claim will be considered by CFIA to be in compliance. As evidence is submitted, reviewed and found to support a probiotic claim, a list of acceptable strain-specific probiotic claims will be published on Health Canada's website along with guidance for their use. The list will also be linked to the CFIA Guide to Food Labelling and Advertising. In the absence of such advice or the use of a listed claim, a product may or may not be in compliance. Companies that are not in compliance will be subject to enforcement actions in proportion to the severity of the violation.

Q8. What is the expected impact of the guidance document on the food industry?

Food products that are represented as containing "probiotic" microorganisms may need to be re-labelled, including removal of the term "probiotic", if they are not accompanied by claims about the nature of probiotics considered acceptable by Health Canada, or by specific, validated statements about the benefits or effects of the microorganism. In addition, products making probiotic claims that do not currently declare the microbial strain used or the level of the microorganisms expected at the end of product shelf-life would also require re-labelling. As well, advertisements and websites may also need to be changed to come into compliance with applicable sections of the Food and Drugs Act and related Regulations.

In the longer term, the guidance is expected to promote a level playing field for the industry so that only food products with substantiated claims about probiotics would prevail in the marketplace.

Q9. What is the expected impact of the guidance document on consumers?

The guidance outlines how different types of claims for probiotics in foods would be regulated under the Food and Drugs Act and the standards of evidence expected to support the claims made on foods. The document also provides guidance with respect to the safety and stability of the probiotic microorganism, as well as the labelling of foods containing probiotics. The initiative to publish a list of acceptable claims for foods will facilitate the use of credible claims on food products.

Q10. Is the use of terms such as "probiotics" considered a health claim?

The term "probiotics" and similar terms or representations (e.g. "with beneficial probiotic cultures"; "contains bacteria that are essential to a healthy system"; and a Latin name of a microbial species modified to suggest a health benefit) in text or graphics on food labels and in advertising that suggest a food confers a health benefit are examples of health claims. Health claims are subject to Subsection 5(1) of the Food and Drugs Act and must not be false, misleading or deceptive.

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