Probiotics are microorganisms that are beneficial to human health. Most probiotic claims are function claims. However, due to the special nature of probiotic microorganisms, Health Canada has prepared a guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), that sets out the conditions under which health claims about probiotics would be considered acceptable.
Probiotic claims that are therapeutic in nature or that are considered "drug" claims are required to undergo a pre-market assessment by the Food Directorate of Health Canada and a regulatory amendment to the Food and Drug Regulations to allow their use.
Probiotics are defined as "live microorganisms which when administered in adequate amounts confer a health benefit on the host" (FAO/WHO, 2001; see reference list in Annex 8-3 of this Guide). 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 or in advertising that suggest a food confers a health benefit are examples of health claims.
Two types of probiotic claims can be made on food: strain-specific claims and non-strain-specific claims.
- Strain-specific claims are claims about the health benefits or effects of specific strains of probiotics. At the present time, no strain-specific claims have been accepted by Health Canada. As these claims are reviewed and accepted, Health Canada will update a list of acceptable strain-specific claims that will be available on its web site.
- Non-strain-specific claims are statements about the nature of probiotics. A closed list of non-strain-specific probiotic claims that would be acceptable without the need for the manufacturer to conduct a detailed review of the scientific basis for the claim is provided in 8.7.2 of this Guide.
See 8.2.2 and 8.5.4 of this Guide for more information on the acceptability of new health claims, including new function claims.
Health Canada has prepared a guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), that sets out the conditions under which health claims about probiotics would be considered acceptable. The following is a summary of the guidance; the guidance document should be consulted for specific details.
- The use of "probiotic" and other similar terms and representations (including trade names that suggest a health benefit) should be accompanied by specific, validated statements about the benefits or effects of the probiotic. This will reduce the possibility of these statements being vague, uninformative or misleading.
- Validated health claims about the health benefits or effects of probiotics are statements that are supported by strain-specific evidence.
- When making any probiotic claim, the manufacturer or importer of the product should have documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product.
- The manufacturer or importer should follow all requirements applicable to the sale of food, including those related to the use and labelling of ingredients used in novel technology in the delivery of a viable microorganism for food application.
- The food should contain, at a minimum, the amount of the probiotic microorganism(s) required to result in the claimed effect or health benefit throughout the shelf life of the product. Documentation to support the functionality aspects of the product (i.e. stability and viability of the probiotic strain or mixed culture) should be maintained.
General information about evidence requirements applicable to health claims of all types, including function claims, also apply to probiotic claims (see 8.2.2 and 8.5.4 of this Guide).
Specific Labelling Guidelines
Specific labelling guidelines relevant to products containing probiotic microorganisms are listed below.
- Identification of Strain
A probiotic claim should be accompanied by the Latin name of the microorganism (i.e. genus and species), along with the identity of the strain of the microorganism, using acceptable nomenclature (see Table 8-4 of this Guide for nomenclature of selected bacterial species. For consistency, it is recommended that the strain be identified by using the number assigned by an internationally recognized culture repository (e.g. American Type Culture Collection; ATCC 2008; see reference list in Annex 8-3 of this Guide).
In the case of advertising, if the probiotic microorganism is identified or referred to in the advertisement, then the identity of the microorganism (genus, species and strain) should be declared using acceptable nomenclature. For example, the claim "contains two probiotics" would trigger the identification of both microorganisms in the advertisement.
- Quantitative Declaration
The amount of the probiotic microorganism(s) contained in the product at the end of its shelf life must be declared in colony forming units (cfu) per serving of stated size of the food. This statement should appear adjacent to the Nutrition Facts table or the list of ingredients, or in close proximity to the claim.
In mixed culture, if multiple probiotic genera are used, declaration of the quantity of each genus is generally expected. If multiple species or strains of the same genus are added to a food, the need for the separate declaration of individual species would be determined case by case.
- Ingredient List
Food containing probiotic microorganism(s) must be labelled with a list of ingredients in accordance with sections B.01.008-B.01.010, FDR (see 2.8 of this Guide). The probiotic microorganism(s) must be identified by its (their) common name(s) or by a class name set out in section B.01.010. The class name "bacterial culture" may be used to describe all bacterial species added to a food product. When the class name (e.g. bacterial culture) is used in the list of ingredients, the identity (i.e. the genus, species and strain) of the probiotic bacterial culture(s) should be declared in close proximity to the claim using acceptable nomenclature.
Probiotic microorganisms generally have been isolated from the gastrointestinal tract of healthy individuals. A limited number of non-strain-specific claims about the nature of probiotics (e.g. that they naturally form part of the gut flora) have been accepted for use on food. Any of the statements listed in Table 8-4 of this Guide may be made for one or more of the specific bacterial species included in the table when the guidance specified below is followed.
Conditions of Use for These Claims
- General Conditions
When making any of the claims listed in Table 8-4 of this Guide, the manufacturer or importer of the product should follow guidelines outlined in 8.7.1 of this Guide regarding documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product, as well as specific labelling requirements.
- Specific Conditions
- Eligible species
These claims can be used only when the product contains one or more of the specific species listed in Table 8-4 of this Guide
- Minimum levels in the product
A serving of stated size of a product should contain a minimum level of 1.0 x 109 cfu of one or more of the eligible microorganism(s) that is(are) the subject of the claim (Gill and Prasad 2008; Hawrelak 2006; Lenoir-Wijnkoop et al. 2007; Picard et al. 2005; Reid et al. 2003; see reference list in Annex 8-3 of this Guide).
- Eligible species
8.7.3 Summary Table of Acceptable Non-Strain Specific Claims for Probiotics and Eligible Species for the Claims
The non-strain-specific probiotic claims listed in Table 8-4 are considered to be acceptable when the guidance outlined in 8.7.1 and 8.7.2 of this Guide is followed.
Summary Table of Acceptable Non-Strain Specific Claims for Probiotics and Eligible Species for
|Eligible bacterial species1
Latin name (acceptable nomenclature2) and synonym where applicable
|Acceptable Non-Strain Specific Probiotic Claim for Food|
1References reviewed for the bacterial species included: EFSA 2007, Gilliland 2001, Reid 2001 (see Annex 8-3 of this Guide).
2References reviewed for acceptable nomenclature: ATCC 2008, Euzéby 2008, Skerman et al. 1989 (see Annex 8-3 of this Guide).
3In product labelling, Bifidobacterium longum subsp. infantis and Bifidobacterium longum subsp. longum would be considered acceptable nomenclature.
4The word "gut" may be replaced by the expression "digestive tract" in these claims.
In an advertisement or on a label of a food that is represented as containing a vitamin or mineral nutrient, it is prohibited to give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the vitamin or mineral nutrient to a person's diet. It is also prohibited to refer to or reproduce any testimonial [D.01.012, D.02.008].
In certain situations, information may be provided about nutrition, diet and disease, even if this information is identified with a corporation or business, (such as part of corporate announcements, corporate sponsorships, or corporate brand sponsorships). For example:
- Messages describing the role of diet in disease prevention which are not product-specific (e.g., public service
- Books and educational material describing the role of diet in disease prevention providing that the material is not deemed to be an advertisement
for a food product. (See Educational Material Versus Advertising Material, 8.12 of this Guide, for more
- Dietary guidelines/recommendations on food labels and in advertising which are endorsed by a non-governmental health agency provided there is no mention of disease prevention, treatment or cure. (See Third-Party Endorsements, Logos and Seals of Approval, 8.13 of this Guide, for more information.)
Example of a Permissible General Statement
The following general statement is only permissible if no linkage is made to a specific product. This is a statement that would meet the first two bullets above.
"A diet high in vitamin D may help reduce the risk of rickets."
Such claims should be used with caution to avoid positioning a food as a drug, or offending Section 3 of the Food and Drugs Act concerning Schedule A diseases. The same message placed on a food label, in a product-specific advertisement, or positioned adjacent to a food that is offered for sale would be deemed to offend subsections 3.(1) and 3.(2) of the Food and Drugs Act.
A product cannot be sold as a food if it is described on the label as "medicated". Since this term is used to describe products containing an added medicinal substance to treat or prevent a disease, the product falls within the definition of a drug under the Food and Drugs Act. It must be labelled and advertised as a drug as required by the Food and Drug Regulations.
Products represented as laxatives fall within the definition of a drug. The mention of "laxative" or "relief of constipation" on a label or advertisement characterizes the product as a drug.
On the other hand, the term "laxation" and the action of "promoting laxation" are not considered to be drug claims when used in connection with certain foods. The term "laxation" is accepted as referring to the normal softness and bulking of the stool resulting from such factors as increased undigested residue or bacterial mass, trapping of gases or water retention.
Claims for the promotion of "laxation" or "regularity" are acceptable for foods when a reasonable daily intake of the food contains a minimum of 7 grams of dietary fibre from coarse wheat bran. Such claims may be made for other foods provided that the claim is substantiated by evidence from clinical studies that a Reasonable Daily Intake of the foods has a laxation effect and no adverse effects. If a Reasonable Daily Intake is made up of several servings, the amount of the food required to produce the laxation effect and the number of servings it comprises should be declared as part of the claim. (See 6.8.1 of this Guide, Dietary Fibre, and 7.24, Fibre Claims, for further information on fibre sources and claims.)
The term "tonic" has been used in the past to describe a class of foods believed to have the power to restore a normal degree of vigour or to restore good health. Today, this term should not be used, as no food can be described as an effective tonic. However, exceptions may be made due to long term use, such as "tonic water".
As obesity is included in Schedule A of the Food and Drugs Act, foods may not be advertised as a treatment, preventative or cure for this condition. However, a distinction has been made between being obese and being overweight. For the purposes of Schedule A, anyone with a body mass index (BMI) of 30 or higher is considered to be suffering from obesity. The BMI is a measurement tool that relates body weight to health. More information on BMI is available on Health Canada's web site at: www.hc-sc.gc.ca/index-eng.php
The only foods allowed to be advertised for use in weight-reduction plans are described under Division 24, FDR:
- specially formulated meal replacements,
- prepackaged meals represented for weight reduction,
- foods sold by weight-reduction clinics, and
- foods represented for use in very low-energy diets.
The labels of meal replacements which do not make up the entire diet, as well as prepackaged meals for weight reduction, must include in the directions for use a seven-day menu plan which, if followed, would result in a daily energy intake of at least 1200 Calories (5040 kJ). Advertisements for these meals must state, as required by regulation, that adherence to the directions for use may reduce energy intake, which is a requirement for weight loss. Testimonials claiming rapid weight loss, which is considered hazardous to health, and testimonials for weight reduction by people who were obese, are unacceptable. (See 8.1 and 8.2, and Annex 8-1, Schedule A Diseases.)
[Information Letter No. 793, Health Canada, 1991]
Foods may be represented for use in achieving and maintaining a healthy body weight. However, they should meet the following five conditions.
- The principal display panel of the label of the food and any advertisements for the food should carry the statement, "As part of healthy eating, this food may assist in achieving and maintaining a healthy body weight because it is... (e.g., "lower in energy than...", "low in fat", "portion controlled", etc.).
- The label must display the Nutrition Facts table (see Chapter 5 of this Guide for the general requirements for declaring the Nutrition Facts table).
- Labels or advertisements may make reference to the statements from Health Canada's Eating Well with Canada's Food Guide , see Health Canada's web site General Principles for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising for the use of statements.
- The label, packaging or advertisements should not give the impression that the food is for use in a weight-reduction diet. Requirements regarding foods represented for use in a weight-reduction diet are set out in Division 24, FDA and summarized in 9.9 of this Guide.
- Brand and trade names traditionally considered as claims for weight reduction should be qualified with the statement "for weight maintenance" next to the brand or trade name on the principal display panel.
[Policy - Educational Material versus Advertising Material, Food Division, Consumer and Corporate Affairs Canada, March 1991.]
It can sometimes be difficult to distinguish between material which promotes or advertises a product and material intended only to educate or inform. However, it is important to do so in order to determine whether the Food and Drugs Act and the Food and Drug Regulations apply.
"Advertisement", as defined in Section 2 of the Food and Drugs Act " includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food". (For further definitions, see Chapter 1 of this Guide.) The recipient of the representation is "anyone" as no exclusions are mentioned.
Printed and broadcast material will be assessed on a case-by-case basis as to whether it promotes the sale of a food and is considered to be advertising, or whether it is uniquely for educational purposes.
In general, information or material produced or sponsored by the food industry may be considered "educational" rather than "advertising" when it meets the following five criteria.
- The material should be obviously designed for the purpose of informing consumers in a factual manner rather than promoting the sale of a product. That is, the material is a statement or presentation of fact without commercialization. It gives relevant facts and points of view, not just those that favour the sponsor.
- While the sponsor may be identified, the content should be generic in nature and should not mention product brand names, other than in the sponsorship statement which should not be given undue prominence.
- If the material focuses on a class of foods (such as poultry), or a food group (such as vegetables and fruit), the class/group of foods should be presented in the context of the recommended pattern of eating in Canada's Food Guide (see section 8.15 of this Guide).
- Educational material as described above will usually cease to be considered educational when linked to a product, (e.g., by being displayed with a specific product or shown in close proximity to it at point-of-sale). However, depending upon the circumstances, it may be acceptable for educational material to be displayed away from a food which is the generic subject of the educational material (e.g., in another area of a store or restaurant). (Note: Advertising material may be displayed with or in close proximity to a food at point-of-sale provided it is not misleading, does not refer to the prevention of disease, and meets the requirements of the Food and Drugs Act and Regulations.)
- When educational material is produced solely by an organization which does not sell food (e.g., a health-related organization, producer group, marketing board, etc.), the retailer, restaurateur, etc. who has placed or displayed the material in close proximity to the food referenced in the material may be deemed responsible for its use as advertising.
Example of an Educational Brochure
A carrot grower wants to publish a brochure to inform consumers about the role of the diet in disease prevention. The brochure may focus on a food group or class of foods (vegetables and fruits), but must be presented in the context of Canada's Food Guide.
The grower may identify its corporate brand (Brand X) of carrots on the cover of the brochure without giving it undue prominence. However, the manufacturer may not mention Brand X carrots, or its other products or brands, within the brochure.
The brochure may not be displayed at point-of-sale in close proximity to either Brand X carrots or to any other brand of carrots.
This policy applies to printed and broadcast materials produced, sponsored or distributed by persons advertising or selling food, including manufacturers, retailers, restaurateurs, producer organizations and advertisers, with or without, the collaboration of health associations. If educational material is produced solely by an organization which does not sell foods, the retailer, restaurateur, etc., who has displayed the material may be deemed responsible for its use as advertising.
[Policy on the Use of Third-Party Endorsements, Logos, and Seals of Approval, Food Division, Consumer and Corporate Affairs Canada, March 1991.]
"Third-party endorsement" means the approval or sanction of a food by any health professional or health organization, or any individual or group. The use of a name, logo, symbol, seal of approval or other proprietary mark of a third-party organization, whether on a food label or in an advertisement, may lead consumers to believe that the food is endorsed by this third party.
Third-party endorsements may be considered misleading or deceptive when a food bearing an endorsement is perceived as being superior in terms of health, safety and/or nutrition to foods not bearing the endorsement. They may also be considered misleading if they are used in such a way as to suggest that consuming the food may, in and of itself, confer health benefits or prevent, treat or cure a disease.
Minimizing the potential for misrepresentation
Third-party endorsements or logos should be used with caution. The reason for their presence on the food label or advertisement should be made clear. Consumers must not be misled or confused about the merits of a food, and they should be able to judge the merit of the endorsing organization. The following principles should be followed:
- Does not give the impression that a single food or brand of food is "healthier" than, or nutritionally superior to, other foods not bearing the third party's name, statement, logo, symbol, seal of approval or other proprietary mark. Health is imparted by the total diet rather than by individual foods.
- Does not give the impression that the food is a treatment, preventative or cure for disease. A third-party's name, statement, logo, etc. must not suggest that a food may prevent a Schedule A disease. Such a suggestion is false and specifically prohibited by the Food and Drugs Act.
As such, at least one of the following should appear on the label:
- A statement that clearly explains the reason for the appearance of the third party's name, statement, logo, etc. (For example, is this a joint education program of Company X and Organization Y? Has Company X provided financial support, or is it a sponsor of a campaign such as a Nutrition Week Campaign of Organization Y? Is the symbol present because a certain amount of the proceeds from the sale of the product will go towards an organizational charity?)
- The name of the third party (with or without its logo, symbol, or other proprietary mark) clearly shown, in conjunction with its nutrition recommendations or dietary guidelines or those it endorses. The nutrition recommendations of this third-party must be consistent with the recommended pattern of eating presented in Eating Well with Canada's Food Guide.
- A clear indication that the name, statement, logo, etc. of the third party does not constitute an endorsement of the food.
When a health-related name, statement, logo, symbol, seal of approval or other proprietary mark appears on the label of a prepackaged food or in advertisements placed by or on the direction of the manufacturer or importer of the food, the label of the food must declare a Nutrition Facts table (NFT) [B.01.401]. Foods that are normally exempt from declaring a NFT under B.01.401(2) (a) and (b) of the FDR, such as fresh fruit and vegetables, lose their exemption and are required to declare a NFT [B.01.401(3)(e)(iii)].
This policy applies to third-party endorsements by organizations providing health and nutrition information for a single food or single brand of food. It applies whether the endorsement appears on food labels or in food advertisements, and whether the food is displayed in retail outlets, restaurants or food service establishments.
The policy does not apply to third-party endorsements by organizations providing health and nutrition information for groups or classes of foods (e.g. the Dairy Association providing nutrition information for dairy products). It also does not apply to the gluten-free symbol of the Canadian Celiac Association. This symbol is recognized by consumers with celiac disease and is unlikely to be perceived by the general public as an endorsement by a health organization. Additional exceptions will be considered case by case.
The use of heart symbols and heart healthy claims to describe a food or food choice (whether on labels, menus or in advertising) are generally not acceptable. They may give an erroneous impression that consuming a single food or menu selection will provide heart health or prevent heart disease.
Health authorities do agree that a single pattern of healthy eating should be recommended to the public. However, although a healthy diet may help reduce the risk of cardiovascular disease, it is only one factor in the multiple etiology of the disease.
Heart symbols may be acceptable on a food label or advertisement when they appear in the logo or name of a health organization, or are used in conjunction with that organization's health information program, provided that:
- no impression is given that the food may help prevent, treat or cure heart disease, and
- the appearance of the health organization's name or logo itself satisfies the conditions on the use of Third-Party Endorsements, Logos and Seals of Approval (see 8.13 of this Guide).
Terms employing the word "heart" may be acceptable as part of the name of an information program of a health organization provided the program is identified as such (e.g., "The Heart Smart program is a public education program of the Heart and Stroke Foundation of Canada.").
Heart symbols may be acceptable when used in a traditionally recognized manner to indicate affection or endearment. For example, there is no objection to heart-shaped cinnamon candies, or heart-shaped boxes of chocolates, or heart illustrations on food products sold for Valentine's Day.
Nutrition information programs incorporating heart health in restaurants may not identify menu items with hearts. Menu items can be identified using a check mark () to draw attention to good or healthy choices if the information provided satisfies the requirements outlined in this section and the reason for the program is made clear. For example, the menu might state: "The Heart Smart program is a public education program of the Heart and Stroke Foundation of Canada".
Objection will not be taken to the use of heart symbols in conjunction with the disease risk reduction claim "A healthy diet low in saturated and trans fats may help reduce the risk of heart disease. (Naming the food) is low in saturated and trans fats." The use of these symbols should not give the impression that the food itself may have a positive effect on health, or that there is a role beyond the disease risk reduction claim.
See Annex 8-4 for the Policy Respecting the Use of Heart Symbols and Heart Health Claims on Food Labels and in Food Advertisements.
8.15 Eating Well with Canada's Food Guide and Eating Well with Canada's Food Guide: A Resource for Educators and Communicators
See Annex 8-5 of this Guide: Eating Well with Canada's Food Guide.
Information detailing the policies around Eating Well with
Canada's Food Guide and Eating Well with Canada's Food Guide: A Resource for Educators and Communicators can be found on the
following Health Canada web site:
In order to refer to or quote Eating Well with Canada's Food Guide and Eating Well with Canada's Food Guide: A Resource for Educators
and Communicators, the official title should be used and complete quotations should be used. The General Principles
for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising can be found on the following Health Canada web
Information on Health Canada's web site has been posted with the intent that it be readily available for personal and public non-commercial use and may be reproduced, in part or in whole and by any means, without charge or further permission from Health Canada.
Health Canada asks only that:
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Guidelines for Non-Commercial Reproduction of Canada's Food Guide are available on Health Canada's web site:
SeeAnnex 8-6 of this Guide for a reference list of historical policy documents that are the basis of the information provided in this chapter. See Annex 8-3 of this Guide for a list of references related to probiotic claims.
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