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	Guide to Food Labelling and Advertising
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Canadian Food Inspection Agency
Guide to Food Labelling and Advertising

Section VII : Health-Related Claims
Sections 7.10 to 7.17.2

7.10 Dietary Standards

Advertisements should not use official or quasi-official dietary standards that list or suggest intakes of specific nutrients to recommend the consumption of specific foods. Such dietary standards deal with total dietary needs and are not designed for the promotion of one food or a class of foods. For example, it would be considered misleading to claim that 100 percent of the "recommended daily intake" of a nutrient could not be met unless a specific food was consumed.

7.11 Disease Prevention and Drug-Like Claims

7.11.1 Treatment for Schedule A Diseases

Subsection 3(1) of the Food and Drugs Act states that "No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A" (see Annex 1).

Subsection 3(1) of the Food and Drugs Act was enacted to prevent claims directed to the general public concerning serious health problems which should be diagnosed and treated by a medical practitioner.

7.11.2 Diet and Disease Information Which Does Not Offend Section 3 of the Food and Drugs Act

A statement such as "a diet low in saturated fat may help reduce the risk of heart disease" is only permissible if no linkage is made to a specific product. Such a message positioned on a food label or in a product-specific advertisement would be deemed to offend subsections 3(1) and 3(2).

The following general fact situations are not considered to offend subsections 3(1) and 3(2):

messages which are non-product specific, describing the role of diet in disease prevention with corporate announcements (e.g., public service announcements);
books and educational material (see Advertisement versus Educational Material, Section 7.2.4) which describe the role of diet in disease prevention with corporate sponsorship or corporate brand sponsorship providing that such is not deemed to be an advertisement for the food product;
dietary guidelines/recommendations on food labels and in advertising which are endorsed (see Third-Party Endorsements, Logos and Seals of Approval, Section 7.3) by a non-governmental health agency but which do not mention disease prevention, treatment or cure.

7.11.3 Treatment of Other Diseases

Although there is no specific prohibition against the advertising of a food(s) for the prevention or cure of diseases other than those shown under Schedule A, such claims bring the food within the definition of a drug under the Food and Drugs Act, section 2, which defines a drug as "any substance or mixture of substances manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal;

restoring, correcting or modifying organic functions in man or animal."

7.12 Obesity: Diet Plans

Since obesity is included in Schedule A of the Food and Drugs Act, foods may not be advertised as a treatment, preventative or cure. However, a distinction has been made between being obese and being overweight. For the purposes of Schedule A, anyone with a body mass index in excess of 37 is considered to be suffering from obesity.

The only foods allowed to be advertised for use in weight reduction plans are described under Division 24 of the Food and Drug Regulations (see Foods for Special Nutritional Purposes, Section 7.15), and are:

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 not making up the entire diet and pre-packaged meals for weight reduction must include in the directions for use a 7-day menu plan which, if followed, would result in a daily energy intake of at least 1200 Calories (5040 kJ).

The advertisement for a meal replacement or a prepackaged meal is required by regulation to state 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 Schedule A Diseases, Annex 1)

7.13 Medicated

A product should not be sold as a food if it is described as "medicated" since this is a term used to describe products containing an added medicinal substance to treat or prevent a disease. Such a claim would bring the food within the definition of a drug under the Food and Drugs Act and must be labelled and advertised as drugs as required by the Food and Drug Regulations.

7.14 Laxative/Laxation Claims

Products represented as laxatives are considered as falling within the definition of a drug. The mention of "laxative effect" or "relief of constipation" on a label or advertisement characterizes the product as a drug. The term "laxation" and the action of "promoting laxation", on the other hand, are not considered to be drug claims when used in connection with a food. 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 (see Claims for Physiological Effects of Fibre, Section 7.5.3).

7.15 Foods for Special Nutritional Purposes

7.15.1 Foods for Special Dietary Use [FDR, Division 24]

The compositional and labelling requirements for "foods for special dietary use" contained in the Regulations are detailed and explicit.

A "food for special dietary use" is defined in section B.24.001 of the Regulations as a food that has been specially processed or formulated to meet the particular requirements of a person:

in whom a physical or physiological condition exists as a result of a disease, disorder or injury; or
for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods.

In general, only foods listed in section B.24.003(1) of the Regulations may be represented in a manner likely to create the impression that it is a food for special dietary use. Foods described as "carbohydrate-reduced", "sugar-free", "calorie-reduced", "energy-reduced", "low in energy", "low-calorie", "low-sodium" and their synonyms, must meet the requirement for foods for special dietary use in Division 24. A formulated liquid diet, a meal replacement for weight reduction and a nutritional supplement as well as a gluten-free food, and a food represented for either a protein-restricted diet, low-amino acid diet or very low-energy diet are also considered to be foods for special dietary use in Division 24.

For example, "contains 25% less salt than...", "unsalted", "no added salt", are not considered to be for special dietary use. Similar claims for carbohydrate, sugar, Calories and carbohydrates may be permitted for foods which are not foods for special dietary use (see Nutrient Content Claims, Section VI).

The following foods for special dietary use may be represented for use in a weight reduction diet if they meet the requirements set out in Division 24 -- meal replacements for weight reduction, prepackaged meals for weight reduction, foods sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic, and foods represented for use in very low-energy diets.

7.15.2 Carbohydrate-Reduced Foods [FDR, B.24.004 and B.24.009]

A "carbohydrate-reduced" food is defined as a food:

that would, if it were not carbohydrate-reduced, derive at least 25 percent of the Calories in that food from its carbohydrate content; and
that, when ready-to-serve, contains not more than 50 percent of the carbohydrate content and provides no more Calories than would be present in the food if it were not carbohydrate-reduced.

A "carbohydrate-reduced" food must carry a declaration of the content of specific nutrients on the label, as well as the expression "carbohydrate-reduced" on the principal display panel in close proximity to, and in the same size type as, the common name. Both the label and advertisement for a "carbohydrate-reduced" food are required to carry a statement to the effect that the food is suitable or recommended for "carbohydrate-reduced diets" (B.24.009).

7.15.3 Sugar-Free Foods [FDR, B.24.005, B.24.010]

A "sugar-free" food is defined as a carbohydrate-reduced food that, when ready to serve:

contains not more than 0.25 percent available carbohydrate, as determined by an acceptable method; and
provides, except in the case of chewing gum, not more than one calorie per 100 g or per 100 ml of that food.

A "sugar-free" food must carry a declaration of the content of specific nutrients on the label, as well as the expression "sugar-free" or "sugarless" on the principal display panel in close proximity to, and in the same size type as, the common name. Both the label and advertisement for a "sugar-free" food are required to carry a statement to the effect that the food is suitable or recommended for "carbohydrate-reduced diets" (B.24.010).

7.15.4 Calorie-Reduced Foods [FDR, B.24.006, B.24.011]

A "calorie-reduced" food is defined as a food that, when ready to serve, provides not more than 50 percent of the Calories that would be normally provided in that food if it were not calorie-reduced.

A "calorie-reduced" food must carry a declaration of the content of specific nutrients on the label, as well as the expression "calorie-reduced" on the principal display panel in close proximity to, and in the same size type as, the common name. Both the label and advertisement for a "calorie-reduced" food are required to carry a statement to the effect that the food is suitable or recommended for "calorie-reduced diets" (B.24.011).

7.15.5 Low-Calorie Foods [FDR, B.24.007, B.24.012]

A "low-calorie" food is defined as a food that:

is a calorie-reduced food; and
when ready to serve, provides not more than 15 Calories per average serving and not more than 30 Calories in a reasonable daily intake of that food as set out in Schedule K (see Section VI, Annex 1).

A "low-calorie" food must carry a declaration of the content of specific nutrients on the label as well as the expression "low-calorie" on the principal display panel in close proximity to, and in the same size type as, the common name. Both the label and advertisement for a "low-calorie" food are required to carry a statement to the effect that the food is suitable or recommended for "calorie-reduced diets" (B.24.012).

7.15.6 Low-Sodium Foods [FDR, B.24.008, B.24.013]

A "low-sodium" food is defined as a food that, when ready to serve, contains:

not more than 50 percent of the sodium that would normally be present in that food if it were not sodium reduced;
not more than 40 mg of sodium per 100 g of food, except in the case of meat, fish and poultry products, and cheddar cheese;
not more than 80 mg of sodium per 100 g of food, in the case of meat, fish and poultry products;
not more than 50 mg of sodium per 100 g of food, in the case of cheddar cheese; and
except in the case of salt substitutes, no added salts of sodium.

A "low-sodium" food must carry a declaration of the content of specific nutrients on the label, as well as the expression "low-sodium" on the principal display panel in close proximity to, and in the same size type as, the common name. Both the label and advertisement for a "low-sodium" food are required to carry a statement to the effect that the food is suitable or recommended for "sodium-restricted diets" (B.24.013). (see Section 7.3 and Appendix II)

7.15.7 Gluten-Free Foods [FDR, B.24.018, B.24.019] (Amended 31/01/97)

A food is not permitted to be labelled, packaged, sold or advertised in a manner likely to create an impression that it is "gluten-free" unless it does not contain wheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof.

A food represented as "gluten-free" must declare the content of energy value, protein, fat and carbohydrate on the label (B.24.019). (see Section7.3 and Appendix II)

7.15.8 Formulated Liquid Diets[FDR, B.01.001, B.24.100 to B.24.103]

A "formulated liquid diet" is defined in section B.24.001 of the Regulations as a food that

is sold for consumption in liquid form; and
is sold or represented as a nutritionally complete diet for oral or tube feeding of a person in whom a physical or physiological condition exists as a result of a disease, disorder or injury.

A formulated liquid diet is required to be a complete substitute for the total diet in meeting the nutritional requirements of a person (B.24.102). It is not permitted to be advertised to the general public (B.24.100) and is not to be confused with infant formula (see Infant Foods and Infant Formulas, Section 7.16).

The compositional requirements for a formulated liquid diet are set out in section B.24.102 of the Regulations. The labelling requirements are set out in section B.24.103.

7.15.9 Meal Replacements [FDR, B.24.200, B.24.202, B.24.204]

A "meal replacement" is defined in section B.01.001 of the Regulations as a formulated food that, by itself, can replace one or more daily meals.

The compositional requirements for a meal replacement are set out in section B.24.200 of the Regulations. They include a minimum food energy value of 225 Calories per serving, a specified amount and quality of protein, a maximum amount of fat (35 percent of energy), and a specified amount of various vitamins and mineral nutrients. Where a meal replacement is represented as a replacement for all daily meals, the maximum amount of fat is 30 percent of energy and the maximum of saturated fat is 10 percent of energy.

The labelling requirements for a meal replacement are set out in sections B.24.202 and B.24.204 of the Regulations. Labelling requirements differ according to whether a meal replacement is sold or advertised as a replacement for all daily meals, for some daily meals or for use in a weight reduction diet. Some labelling requirements include:

specific nutrient content declarations per serving as sold and per stated quantity when ready-to-serve;
directions for use that would result in the daily energy intake of at least 1200 Cal (5040 kJ) where sold or advertised for use in a weight reduction diet (B.24.204(b)). If the meal is a replacement for all daily meals, directions for use that would result in the daily energy intake of 900 Cal (3780 kJ) must be provided;
the statement "useful in weight reduction only as part of an energy-reduced diet / utile pour perdre du poids seulement dans le cadre d'un régime à teneur réduite en énergie" prominently displayed on the principal display panel, when sold or advertised for use in a weight reduction diet (B.24.202(e)). (This statement must also be included in all advertisements for the product);
where the meal replacement is not represented as a replacement for all daily meals, a sample seven-day menu in the directions for use, showing the meal replacement being used, when it is packaged, sold or advertised for use in a weight reduction diet.

The requirements for the menu plan are set out in section B.24.204 of the Regulations. The daily menu must include at least one serving from each of the four food groups in Canada's Food Guide to Healthy Eating. In addition to the menu providing a minimum daily food energy intake of 1200 Calories, the content of other nutrients (e.g., fat, saturated fat, vitamins and mineral nutrients) is also regulated. The menu must not include any reference to vitamin or mineral supplements.

No direct or indirect reference is permitted on labels or in advertisements to any vitamin or mineral nutrient supplement. The label or advertisement must not create the impression that consumption of any vitamin or mineral nutrient supplement must or should be part of a weight reduction diet.

7.15.10 Nutritional Supplements [FDR, B.24.201, B.24.202]

A "nutritional supplement" is defined in section B.01.001 of the Regulations as a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients.

The compositional requirements for a nutritional supplement are set out in section B.24.201 of the Regulations. Requirements differ depending on the Calories per serving provided by the nutritional supplement. For example, when a nutritional supplement contains less than 225 Calories per serving, requirements include a minimum food energy content of 150 Calories per serving, a specified amount and quality of protein and a specified amount of various vitamins and mineral nutrients. When a nutritional supplement provides 225 or more Calories, requirements include a specified amount and quality of protein, a maximum amount of fat, and a specified amount of various vitamins and mineral nutrients.

The labelling requirements for a nutritional supplement are set out in section B.24.202 of the Regulations. Some labelling requirements include the declaration of the content of specific nutrients per serving as sold and per stated quantity when ready-to-serve.

7.15.11 Prepackaged Meal Definition

A "prepackaged meal" is defined in section B.01.001 of the Regulations as a prepackaged selection of foods for one individual that require no preparation other than heating and that contains at least one serving, as described in Canada's Food Guide to Healthy Eating, of

meat, fish, poultry, legumes, nuts, seeds, eggs, milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet; and
vegetables, fruit or grain products.

There are no specific labelling requirements for a prepackaged meal when it is not packaged, sold or advertised for use in a weight reduction diet. For prepackaged meals represented for use in weight maintenance, see Foods Represented for Use in Weight Maintenance, Section 7.4.

7.15.11.1 Prepackaged Meals for Use in a Weight-Reduction Diet [FDR, B.24.203, B.24.204, B.24.205]

The labelling requirements for a prepackaged meal that is packaged, sold or advertised for use in a weight-reduction diet are set out in sections B.24.203 and B.24.204 of the Regulations. Some of these labelling requirements include:

specific nutrient content declarations per serving as sold and per stated quantity when ready-to-serve (B.24.203 (a));
the statement "useful in weight reduction only as part of an energy-reduced diet / utile pour perdre du poids seulement dans le cadre d'un régime à teneur réduite en énergie" prominently displayed on the principal display panel (B.24.203(b)). (This statement must also be included in all advertisements for the product.); and
a sample seven-day menu in the directions for use, showing the prepackaged meal being used (B.24.204).

The requirements for the menu plan are set out in section B.24.204 of the Regulations. The daily menu must include at least one serving from each of the four food groups in Canada's Food Guide to Healthy Eating. In addition to the menu providing a minimum daily food energy intake of 1200 Calories, the content of other nutrients (e.g., fat, saturated fat, vitamins and mineral nutrients) are also regulated. The menu must not include any reference to vitamin or mineral supplements.

7.15.12 Foods Sold by Weight-Reduction Clinics [FDR, B.24.203, B.24.204, B.24.205]

Weight-loss clinics are permitted to represent and sell foods to their clients as part of a weight-reduction diet supervised by the clinic.

The labelling requirements for foods sold by weight-reduction clinics are set out in sections B.24.203, B.24.204 and B.24.205 of the Regulations. Some of these labelling requirements include:

specific nutrient content declarations per serving as sold and per stated quantity when ready-to-serve (B.24.203 (a));
the statement "useful in weight reduction only as part of an energy-reduced diet / utile pour perdre du poids seulement dans le cadre d'un régime à teneur réduite en énergie" prominently displayed on the principal display panel (B.24.203(b)). (This statement must also be included in all advertisements for the product.);
a sample seven-day menu in the directions for use, showing the food sold by the weight-reduction clinic being used (B.24.204).

The requirements for the menu plan are set out in section B.24.204 of the Regulations. The daily menu must include at least one serving from each of the four food groups in Canada's Food Guide to Healthy Eating. In addition to the menu providing a minimum daily food energy intake of 1200 Calories, the content of other nutrients (e.g., fat, saturated fat, vitamins and mineral nutrients) are also regulated. The menu must not include any reference to vitamin or mineral supplements.

7.15.13 Foods Represented for Use in Very Low-Energy Diets [FDR, B.24.300 to B.24.306]

The sale and advertising of foods represented for use in very low-energy diets is restricted. They are not permitted to be advertised to the general public (B.24.300). Only a pharmacist is permitted to sell these foods to the general public and only with a written order from a physician (B.24.301, B.24.302). Health Canada must be notified of the intention to sell the food or advertise the food for sale, including when the food has undergone a major change (B.24.306). The Regulations also set out the requirements for the pre-market notification, including labels.

The compositional requirements for foods represented for use in very low-energy diets are set out in section B.24.303 of the Regulations.

The labelling requirements for foods represented for use in very low-energy diets are set out in section B.24.304 of the Regulations.

7.16 Infant Foods and Infant Formulas [FDR, Division 25]

No person shall sell or advertise for sale an infant formula that, as normally consumed, does not comply with the compositional requirements set out in the Food and Drug Regulations for infant formula.

No person shall sell or advertise for sale an infant formula that, when prepared according to directions, requires the addition of a nutritive substance other than water, a source of carbohydrates or both.

Other than identifying the quantity of iron on the label, no person shall make any claim with respect to the iron content of an infant formula unless it contains at least 1 mg of iron per 100 available Calories.

Very explicit labelling requirements exist in Division 25 of the Food and Drug Regulations for infant formula.

All infant formula which has undergone any changes is subject to pre-market notification. Labels must be submitted to Health Canada for review as part of the pre-market notification.

The use of food additives in infant formula is strictly controlled under the Food and Drug Regulations.

Infant foods are subject to maximum sodium levels. It is an offence to sell or advertise for sale an infant food that contains more sodium than that provided for in the Regulations.

7.17 Beverages for Athletes, Isotonic

7.17.1 Beverages for Athletes

Beverages represented for use by athletes are subject to the requirements for foods in general and there are no special provisions for the addition to them of any vitamins, mineral nutrients (including electrolytes), or amino acids.

Claims made for such beverages should be restricted to those referring to the replacement of fluid (water) losses and, in the case of beverages containing a source of carbohydrates, to the provision of carbohydrate as a source of food energy (see Energy, Section 6.2.1). Claims regarding any specific functions of carbohydrate in these products will be examined on a case-by-case basis.

7.17.2 Isotonic

The term "isotonic", in reference to a beverage, denotes a solution having the same concentration of electrolytes and non-electrolytes as another solution with which it is being compared. For example, a beverage could be isotonic with perspiration, serum, etc. There is no objection to the use of this term when the claim is accurate and the comparison appropriate.

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Important Notices

Section VII : Health-Related Claims Sections 7.10 to 7.17.2