Health claims on food labels
Function claims
Function claims (definition) relate to the effects that a food has on the normal functions of the body. They are based on the role that the food or the food constituent plays when consumed at levels consistent with normal dietary patterns.
Function claims also contain two subcategories of claims:
Both these categories have different labelling requirements. To obtain more information on the requirements related to each claim, select the appropriate link above.
Conditions of use for function claims
As with all health claims, function claims are subject to the General Principles for Labelling and Advertising.
No Drug Representations for Function Claims
A function claim about the physiological effects of food or food constituents must not refer directly or indirectly to the treatment, mitigation or prevention of any disease, disorder or abnormal physical state, or of their symptoms. In addition, claims about restoring or correcting abnormal functions of the body or modifying body functions beyond the normal physiological effects of food are considered to be drug claims, not function claims (see Drugs vs. Foods).
Language Requirements for Function Claims
There are no specific language requirements set out in the Food and Drug Regulations for general function claims. However, it is recommended that when a function claim is made on the label of a food, it appear in both English and French unless a bilingual labelling exemption applies to the product [B.01.012(3) or (7), FDR].
Declaration of a Nutrition Facts Table for Function Claims
When a function claim appears on the label of a prepackaged food or in advertisements made or placed by or on the direction of the manufacturer of the food, the label of a food that is normally exempt from declaring a Nutrition Facts table (NFt) loses its exemption and is required to declare a NFt. See Reasons for losing the exemption [B.01.401.(3)(e)(ii), FDR].
Quantitative Statements for Function Claims
The Table of Acceptable Food or Food Constituent Function Claims outlines the conditions for each function claim. In many cases, these conditions include a quantitative declaration.
While there are no requirements for quantitative declarations set out in the Food and Drug Regulations for general function claims, it is strongly recommended that when a function claim is made about a food constituent on the label of a prepackaged product or in any advertisement for the food that is made or placed by or on the direction of the manufacturer or importer, a quantitative declaration of the amount of the food constituent (per serving of stated size) appear on the label.
When a function claim appears on the label or in an advertisement for a non-prepackaged product or in any advertisement for a prepackaged product not made or placed by or on the direction of the manufacturer or importer, the quantitative amount of the food constituent (per serving of stated size) that is the subject of the function claim should also appear on the label or in the advertisement.
In certain situations the amount of the food or food constituent in a serving of food is less than that required to achieve the claimed physiological effect. In these cases, the amount of the food or food constituent required to produce the desired effect and the amount of the food or food constituent in a serving of stated size of the food must be declared as part of the function claim. For example, "1 tsp of (naming the product) provides 3g of fibre from coarse wheat bran. Consuming 7 grams of fibre from coarse wheat bran daily promotes regularity".
Science Research
Companies wanting to make function claims must have scientific evidence to validate the claim prior to its use on food labels or in advertisements. This evidence may be used by the CFIA, in collaboration with Health Canada, to evaluate product compliance with the Food and Drugs Act and Regulations. Consequently, manufacturers and importers are encouraged to contact the Food Directorate of Health Canada for advice regarding the acceptability of function claims on food products prior to their use. Claims reviewed and found to be acceptable will be added to the Table of Acceptable Food or Food Constituent Function Claims.
Health Canada considers the following factors in determining the acceptability of new function claims:
- Standards of Evidence
Manufacturers who make function claims on their food products must ensure that they meet acceptable standards of evidence in supporting their claims.
- The evidence must be applicable to the target group for the claim. For example, the physiological effect of a food or food constituent (e.g. promotes normal transit time) is not considered to be supported when the evidence is based on therapeutic (treatment) effects in sick populations (e.g. treatment of diarrhea).
- The amount of the food or food constituent required to achieve the claimed physiological effect must be based on the evidence supporting the claim.
- The target population must be able to consume the amount of food or food constituent required to achieve the effect as part of a healthy, balanced diet. The amount of the food or food constituent required to achieve the claimed physiological effect could be consumed in a Reasonable Daily Intake (RDI) of the food (refer to Reasonable Daily Intake of Various Foods). Where no RDI has been established, the amount of the food or food constituent to achieve the claimed physiological effect is to be consumed in a single serving of stated size, unless the function claim is related to a food constituent that is available in a variety of foods. In this case, the amount of the food constituent in the food per serving of stated size and the amount of the food constituent required to achieve the claimed effect or benefit must be declared along with the claim.
- Clearly Stated Specific Physiological Effect
Acceptable function claims are claims about a food or food constituent that clearly state a specific and scientifically supported physiological effect (e.g. promotes regularity) associated with good health or performance. Claims that state a specific effect provide more useful information for the consumer and are less likely to be misleading or misunderstood than a claim about a general or broad effect.
Function claims also must not give the impression that the food is "healthier" than, or "nutritionally superior" to, other similar foods not bearing the claims.
Claims that state a general or broad effect (e.g. supports immune function/system) are not considered acceptable. As a general rule, a vague, non-specific or broad claim is acceptable only for a well-established role of energy or a known nutrient in maintaining the functions of the body essential for the maintenance of good health or for normal growth and development (see Nutrient Function Claims). A non-specific or broad claim is also subject to interpretation and inference and in some cases could be considered a drug claim (see No Drug Representations for Function Claims).
Use these examples to help you determine if a claim is "Specific" or "Vague".
| Vague (unacceptable) Health Claims |
Specific (acceptable) Health Claims |
|---|---|
| (Name the specific ingredient) supports and protects healthy cells and their functioning. | (Vitamin C) a dietary antioxidant that helps to reduce free radicals and lipid oxidation in body tissues (Table of Acceptable Nutrient Function Claims). |
| (Name the specific ingredient) improves digestive functions. | ...of fibre from coarse wheat bran, which promotes regularity (Table of Acceptable Food or Food Constituent Function Claims). |
| DHA helps in cognitive performance. | DHA, an omega-3 fatty acid, supports the normal physical development of the brain, eyes and nerves, primarily in children under two years of age. (Table of Acceptable Nutrient Function Claims). |
| "Antioxidant" | (Selenium) a dietary antioxidant involved in the formation of a protein that defends against oxidative stress (Table of Acceptable Nutrient Function Claims). |
| (Name the specific ingredient) is good for your eye health. | (Name the specific ingredient) aids certain retina cells in the development and maintenance of night vision |
| Source of naturally occurring polyphenols, an antioxidant, that helps in the maintenance of a healthy circulatory system | [Consumption of 1 cup (250 mL) of Table Note 3] green tea increases antioxidant capacity in the blood (Table of Acceptable Food or Food Constituent Function Claims). |
Table Notes
- Table Note 3
-
Use of the phrase shown in parentheses is optional. For the claims for green tea, "Consumption of 1 cup (250 mL) of" may be replaced by "Consumption of 1 cup of" or "Consumption of 250 mL of".
Acceptable function claims table
The function claims listed in the table below, when used with the specified conditions (see column 3, "Conditions for use"), are acceptable. The table will be updated as new claims for food or food constituents are reviewed and found to be acceptable by Health Canada.
| Column 1 Food or Food Constituent |
Column 2 Acceptable Claim |
Column 3 Conditions for use |
|---|---|---|
| Coarse Wheat Bran Table Note 4 |
|
A Reasonable Daily Intake (Part D; FDR; Schedule K) of the food or one serving contains a minimum of 7 grams of dietary fibre from coarse wheat bran. Where the RDI of a food product comprises one serving and the product provides a minimum of 7 grams of fibre from coarse wheat bran in one serving of stated size, claims (a) or (b) may be made. Where the RDI of a food product comprises more than one serving and the product provides less than 7 grams of fibre from coarse wheat bran in one serving of stated size, claims (c) or (d) may be made. See Drugs vs. Foods for more information on laxative claims. |
| Green Tea unfermented leaves and/or bud from Camellia sinensis |
Consumption of [1 cup (250 mL) of Table Note 4] green tea helps to protect blood lipids from oxidation. [Consumption of 1 cup (250 mL) of Table Note 4] green tea has an antioxidant effect in blood [or on blood lipids]. [Consumption of 1 cup (250 mL) of Table Note 4] green tea increases antioxidant capacity in the blood. |
A green tea infusion brewed following manufacturer directions, which contains at least:
or A reconstituted green tea product (e.g. iced green tea) containing at least 0.8 grams freeze dried or spray dried tea infusion per reference amount and serving of stated size when prepared according to manufacturer directions. Advertising and/or labelling may include a precautionary statement indicating that a maximum of 9 cups per day should not be exceeded due to the caffeine content. |
| Psyllium Table Note 5 |
|
A Reasonable Daily Intake (Part D; FDR; Schedule K) of the food or one serving contains a minimum of 3.5 grams of dietary fibre from psyllium seed. Where the RDI of a food product comprises one serving and the product provides a minimum of 3.5 grams of fibre from psyllium seed in one serving of stated size, claims (a) or (b) may be made. Where the RDI of a food product comprises more than one serving and the product provides less than 3.5 grams of fibre from psyllium seed in one serving of stated size, claims (c) or (d) may be made. See Dietary Fibre in Elements within the Nutrition Facts Table for more information about the acceptability and labelling of fibre sources. |
Table Notes
- Table note 4
-
Use of the phrase shown in parentheses is optional. For the claims for green tea, "Consumption of 1 cup (250 mL) of" may be replaced by "Consumption of 1 cup of" or "Consumption of 250 mL of".
- Table Note 5
-
Cummings JH. 2001. The effect of dietary fiber on fecal weight and composition. In: CRC Handbook of Dietary Fiber in Human Nutrition. 3rd ed. Spiller GA (ed.), pp 183-252. Boca raton (FL): CRC Press
Laxation Claims
The term "laxation" (definition) 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 Dietary Fibre of the Elements within the Nutrition Facts Table web page for further information on fibre sources.
For the use of the term Laxative, refer to Laxative Claims under the Drugs vs. Foods.
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