Food > Labelling > Guide to Food Labelling and Advertising > Chapter 8 

Chapter 8 - Diet-Related Health Claims

Chapter 8: Sections 8.1-8.7 | Sections 8.7-8.14 | Annexes

8.1 Drugs Versus Foods: Definitions

The Food and Drugs Act, Section 2, defines food as follows:

"food" includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever."

The definition of a drug under the Food and Drugs Act, Section 2, is:

"drug" includes any substance or mixture of substances manufactured, sold or represented for use in:

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

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

8.2 Drug Claims

In order for a food product to be regulated as a food, it must not carry a drug claim on its label or in an advertisement. A drug claim will bring a food product within the definition of a drug and the food product would then be subject to all the drug provisions of the Food and Drugs Act and Regulations (see 8.4 of this Guide for an exception).

A claim that suggests that the food may have an effect on the body (as described in the definition of a drug in the Food and Drugs Act) is considered to be drug claim. Some examples of claims that would bring the food within the definition of a drug include:

• "lowers blood cholesterol"
• "lowers blood triglyceride levels"
• "regulates blood sugar levels"
• "is formulated to have the lowest potential for stomach upset and gas"
• "promotes health of the immune system"
• "is a rehabilitative supplement"
• "balances hormone levels"
• "soothes bladder infections"
• "improves memory"

8.2.1 Claims Relating to Treatment for Schedule A Diseases

In addition, 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 8-1 of this Guide, Schedule A Diseases).

For example, a claim stating that a product "prevents or cures cancer" may not be made, as cancer is a Schedule A disease. Subsection 3(1) of the Food and Drugs Act was enacted to prevent claims directed at the general public concerning serious health problems, which should be diagnosed and treated by a medical practitioner. Such claims are prohibited.

8.3 General Requirements for Diet-Related Health Claims and Biological Role Claims

Sections 8.4 and 8.5 below deal with the recently-permitted diet-related health claims (new) and biological role claims, respectively. Before moving into the specifics for these two types of claims, this section will deal with some of the generic requirements common to both types of claims.

8.3.1 Language Requirements

These claims must appear on the label in both English and French unless the mandatory information is permitted to be shown in only one of those languages, such as in the case of local foods permitted under B.01.012 [B.01.012(3) or (7), B.01.311(5), B.01.600].

8.3.2 Labelling Requirements

Where diet-related health claims or biological role claims appear on the label or in advertisements placed by or on the direction of the manufacturer of a food, the Nutrition Facts table is triggered on the label of foods otherwise exempted from showing the Nutrition Facts table under B.01.401(2) (a) and (b). The use of these claims may also trigger additional information in the Nutrition Facts table, as required. Refer to Sections 8.4.3 and 8.5.4 for the specifics.

8.3.3 Requirements for Claims for Non-Prepackaged Products or for Advertisements Placed by Someone Other Than the Manufacturer [B.01.312, B.01.602]

Where diet-related health claims or biological role claims appear on the label or in an advertisement for non-prepackaged products or in advertisements for prepackaged products not made or placed by or on the direction of the manufacturer, the required accompanying information - namely the required information outlined in Column 3 of the table following B.01.603 (see Table 8-1 below) in the case of diet-related health claims or the quantitative amount of the energy or nutrient value or the % DV of the vitamin or mineral nutrient value (per serving of stated size) that is the subject of the biological role claim - must also appear on the label or in the advertisement as outlined below.

Where these claims appear in an advertisement other than radio or television, and the required accompanying information does not already appear on the label, the accompanying information must appear adjacent to, without any intervening material, the most prominent claim in letters the same size and prominence.

Where these claims are made in a radio or in the audio portion of a television advertisement, and the required accompanying information does not already appear on the label, the accompanying information must immediately precede or follow the claim, and in the case of a television ad, the accompanying information must also be in the audio mode.

If the claim is made in the visual portion of a television ad, and the required accompanying information does not already appear on the label, the accompanying information may appear in the either audio or visual mode. In the case where the accompanying information appears in the visual mode, it must appear at the same time and for the same length of time as the claim; must be adjacent to (without intervening material) the most prominent (or only) claim; and must be in letters of at least the same size and prominence as the claim.

In the case where the claim is made in both the audio and visual portions of a television ad, the accompanying information must be in the audio mode.

8.4 Diet-Related Health Claims

The 2002 amendments to the Food and Drug Regulations allow diet-related health claims on foods for the first time in Canada. These claims are based on sound scientific evidence that has established a relationship between certain elements of healthy diets and reduction of risk of certain diseases.

Section 3, FDA,  makes it an offence to advertise or sell a food to the general public as a treatment, preventative or cure for any of the diseases referred to in Schedule A. Heart disease, hypertension and cancer, which are the subjects of three of the permitted claims, are listed in Schedule A.

To permit the use of diet-related health claims, foods bearing the permitted claims are exempted from the provisions of subsections 3(1) and 3(2), FDA. In addition, foods labelled in such a way are exempt from the provisions of the Act and Regulations applicable to drugs, except where the food would come within the definition of a "drug" for a reason other than the fact that its label or advertisement carries one of these claims. This means that although the Regulations allow for the use of the permitted diet-related health claims, other therapeutic statements or "drug" references would not be allowed on the same food. [B.01.601].

A diet-related health claim is a statement that describes the characteristics of a diet that may reduce the risk of developing a diet-related disease or condition, such as osteoporosis or stroke, and the properties of a food that make it a suitable part of the diet.

For example, the label of or an advertisement for a food which is low in sodium might carry the following diet-related health claim (providing specific composition and labelling conditions are met): "A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is low in sodium."

8.4.1 Permitted Diet-Related Health Claims

The Regulations now provide for claims which deal with the following relationships:

• a diet low in sodium and high in potassium, and the reduction of risk of hypertension;

• a diet adequate in calcium and vitamin D, and the reduction of risk of osteoporosis;

• a diet low in saturated fat and trans fat, and the reduction of risk of heart disease;

• a diet rich in vegetables and fruits, and the reduction of risk of some types of cancer; and

• minimal fermentable carbohydrates in gum, hard candy or breath-freshening products, and the reduction of risk of dental caries.

8.4.2 Prescribed Wording [B.01.601, B.01.603]

The Regulations prescribe the exact wording for the permitted diet-related health claims in the table following B.01.603 (see Table 8-1 of this Guide). The wording of the health claims cannot be modified, and no intervening information, graphic sign or symbol may come between parts of the claim. The whole claim must be stated, as prescribed in quotations. The claim cannot be separated or reordered and it must be displayed in equal prominence with no part highlighted. Words, numbers, signs or symbols may come before or after the health claim, provided that the nature of the claim is not changed.

8.4.3 Presenting Required Information

When a health claim is made for a food, the information in column 3 of Table 8-1, Summary Table of Diet-Related Health Claims, must be provided as required. For example, if a manufacturer claims that the food "won't cause cavities" (see column 1, item 5 in Summary Table 8-1), the amount of sugar alcohols must be declared, if present (see column 3). The Food and Drug Regulations prescribe how this must be done.

When a manufacturer makes one of the diet-related health claims set out in column 1 of the table above, whether in an advertisement or on a label for a prepackaged product, the nutrition information required by column 3 must appear in the Nutrition Facts table on the label [B.01.401(3)(e)(ii)].

When the health claim is contained in an advertisement made by someone other than the manufacturer (such as a marketing board), or when the claim applies to any non-prepackaged food (such as bulk foods), the nutrition information required by column 3 must still be displayed. In these cases, it must be adjacent to the most prominent claim in the advertisement (without intervening material), and it must appear in letters of the same size and prominence as the claim [B.01.602(1)]. The specific requirements are outlined above in 8.3.3 of this Guide.

Note that 8.3.3 of this Guide lists how these claims are to be made for products that are not prepackaged or in advertisements placed by someone other than the manufacturer.

8.4.4 Prohibitions [B.01.601(1)(c)]

Foods Intended Solely for Children Under Two Years of Age. Diet-related health claims are not permitted on foods that are intended solely to be consumed by children less than two years of age, such as infant cereal and pureed fruits and vegetables.

Foods Represented for Use in a Very Low Energy Diet. These claims are also not permitted on foods represented for use in very low energy diets.

8.4.5 Summary Table of Diet-Related Health Claims

Table 8-1, Summary Table of Diet-Related Health Claims, describes permitted diet-related health claims, including compositional criteria for the food to qualify for the claim and labelling and advertising requirements. (For the compositional requirements for nutrient content claims that form part of the conditions for health claims, see Chapter 7 of this Guide.)

Summary Table of Diet-Related Health Claims
Table 8-1

8.5 Biological Role Claims

Biological role claims are claims that refer to the generally recognized nutritional function of energy or nutrients as an aid in maintaining the functions of the body for the maintenance of good health, or for normal growth and development. Provisions for biological role claims are made in B.01.311, D.01.006 and D.02.004.

"Nutrients" are not defined in the Food and Drug Regulations. A substance is considered a nutrient if it is recognized as such by the Institute of Medicine of the National Academies, Washington, DC (www.iom.edu).

The following biological role claims are permissible for all nutrients [B.01.311, B.01.312, D.01.006, D.02.004].

"Energy (or Name of the nutrient) is a factor in the maintenance of good health."

"Energy (or Name of the nutrient) is a factor in normal growth and development."

In addition to the two general claims listed above, Table 8-2, Summary Table of Biological Role Claims lists specific biological role claims associated with nutrients (also see 8.4.2 of this Guide). The claims in the summary table refer to the scientifically recognized specific role each nutrient has in maintaining good health and normal growth and development.

Note: Biological role claims are not made for a food per se; they may only be made respecting the energy value or nutrients in a food. Claims may not be made for other components of food, such as lycopene, lutein, anthocyanins, etc. A quantitative statement would be permitted for these other components (e.g., "14 mg of lycopene per 50 g serving.").

8.5.1 Conditions for Biological Role Claims

A biological role claim may not refer directly or indirectly to the treatment, mitigation or prevention of any disease, disorder or abnormal physical state, or symptoms of same, nor may it refer directly or indirectly to correcting, restoring or modifying organic functions. In addition, the claim may not refer directly or indirectly to the treatment, prevention or cure of diseases listed in Schedule A of the Food and Drugs Act, subsection 3(1).

Examples of claims that are unacceptable on foods include the following statements.

• "This food will reduce the risk of cancer."

• "(Naming the nutrient) is a laxative."

• "Calcium fights bone disease such as osteoporosis."

8.5.2 Biological Role Claims for Protein [B.01.305(1)]

When biological role claims are made for protein, the food must meet the requirements for "source of protein", which includes having a minimum Protein Rating (PR) of 20 (See Item b) of Table 7-4 of this Guide).

8.5.3 Biological Role Claims for Vitamin and Mineral Nutrients   [D.01.004, D.02.002]

When biological role claims are made for vitamin and mineral nutrients, the vitamin or mineral nutrient must have an established Recommended Daily Intake (RDI) and the food must contain a minimum of 5% of the RDI for that vitamin or mineral. Where not already required, the percentage of the Daily Value (% DV) of the vitamin or mineral nutrient that is the subject of the claim must also appear in the Nutrition Facts table.

8.5.4 Biological Role Claims for Nutrients Not Listed in the Tables to B.01.401 and B.01.402

Biological role claims may be made for the energy value of a food or the nutrients listed in column 1 of the tables to B.01.401 and B.01.402, and the energy value or nutrient value must be declared as appropriate in the Nutrition Facts table on the label of the food, or as otherwise required (see 8.3.3 of this Guide for further information). The Regulations also permit biological role claims to be made about other nutrients that are not listed in the tables to B.01.401 and B.01.402, e.g. essential fatty acids such as linolenic acid and DHA, however, a quantitative statement of the nutrient(s) in grams per serving must appear on the label or in the advertisement for the food, as applicable. See 7.4 of this Guide for further information on quantitative statements.

8.5.5 Labelling and Advertising Requirements

A biological role claim may appear in advertisements placed by someone other than the manufacturer (such as a marketing board), or the claim may be made for a non-prepackaged product. In these cases, as in the case of health claims, the claim must be accompanied by a quantitative declaration of the energy value or the nutrient(s) concerned. (See further details in 8.3.2 and 8.3.3 of this Guide)

8.5.6

Summary Table of Biological Role Claims
Table 8-2

The examples of biological role claims listed in the table below have been considered to be acceptable by Health Canada and the CFIA. Other biological role claims for nutrients may also be acceptable and will be evaluated on a case-by-case basis.

8.6 Testimonials and Guarantees Regarding Vitamin and Mineral Nutrients

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, reproduce any testimonial [D.01.012, D.02.008].

8.7 Other Information About Diet and Disease

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 announcements).
  
• 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, 8.10 of this Guide, for more information.)
  
• 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, 8.11 of this Guide, for more information.)

Chapter 8: Sections 8.1-8.7 | Sections 8.7-8.14 | Annexes