Health claims on food labels
Nutrient function claims
Nutrient function claims (definition), a subset of function claims, describe the well-established roles of energy or nutrients that are essential for the maintenance of good health or for normal growth and development.
Nutrients include carbohydrate, protein, fat, fatty acids, sugars and the vitamins and minerals listed in Division D, Food and Drug Regulations. Additionally, substances recognized as nutrients by the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine, Washington, D.C. are considered nutrients. Other food components, such as lycopene, lutein, anthocyanins and other compounds found in foods are not considered nutrients for labelling purposes.
Conditions of use for nutrient function claims
Provisions for nutrient function claims are made in B.01.311, D.01.006 and D.02.004 of the FDR.
No Drug Representations for Nutrient Function Claims
Nutrient function claims may not refer to the treatment, prevention or cure of a Schedule A disease; or claim to treat, mitigate, or prevent a disease, disorder or physical state; or claim to correct, restore or modify an organic function [3(1) and 3(2), FDA]. Such claims are considered to be drug claims (see Drugs vs. Foods).
Language Requirements for Nutrient Function Claims
Nutrient function claims must be present in both English and French unless a bilingual labelling exemption applies to the product [B.01.311(5) and B.01.012(3) or (7), FDR].
Declaration of the Amount of the Nutrient
Whenever a nutrient function claim is made, the consumer must be informed as to the amount of energy or nutrient present in a serving of the food. This may be achieved through a declaration in the Nutrition Facts table (NFt) or in a quantitative statement outside the NFt; the manner in which the information is provided depends upon a number of factors described below [B.01.311(4), B.01.401(3)(e), D.01.004(1)(c) and D.02.002(1)(c), FDR].
1. Nutrition Facts Table
When a nutrient function claim appears on the label of a prepackaged food or in advertisements placed by or on the direction of the manufacturer of the food, the label of the food must declare a Nutrition Facts table (NFt) [B.01.401, FDR]. Foods that are normally exempt from declaring a NFt lose their exemption and are required to declare a NFt containing the energy value or nutrient value that is the subject of the claim. See Reasons for losing the exemption [B.01.401(3)(e)(ii), FDR].
2. Quantitative Statement for Nutrient Function Claims
Information for Prepackaged Products and Advertisements Placed by the Manufacturer
The Regulations also permit nutrient function claims to be made for nutrients other than those permitted in the NFt, e.g. essential fatty acids such as DHA. In these cases, a quantitative declaration of the amount of the nutrient(s), in grams per serving of stated size, must appear on the label of the food [B.01.311(4), FDR].
Information for Non-Prepackaged Products or Advertisements Placed by Someone Other than the Manufacturer
When a nutrient function claim appears on the label or in an advertisement for a non-prepackaged product or in an advertisement for a prepackaged product not made or placed by or on the direction of the manufacturer or importer, the quantitative amount of energy or nutrient present, shall be declared per serving of stated size and shall appear on the label or in the advertisement, where the claim is made.
Fresh vegetables and fruits without any added ingredients are always exempted from the requirement to carry an NFt. The use of a nutrient function claim, on the label or in an advertisement, does not trigger the NFt or any accompanying nutrition information [B.01.312(1.1), FDR].
The quantitative value shall be expressed in calories in the case of energy; in percent Daily Value for vitamins and minerals nutrients; in milligrams for potassium, sodium, and cholesterol; and in grams for any other case. [B.01.311(3), B.01.312, D.01.004(1)(c), D.02.002(1)(c), FDR].
See Advertisements for Nutrient Function Claims below for more information regarding quantitative statements in television and radio advertisements.
See Nutrient Content Claims for more information on quantitative statements.
Food vs. Nutrient
Nutrient function claims are not made for a food per se; they may only be made respecting the energy value or nutrients in a food. For example, the nutrient function claim "Milk helps build strong bones and teeth" is unacceptable, because a nutrient function claim refers to the nutritional function of energy or a nutrient (e.g., calcium) in a food, not a particular food (e.g., milk). An acceptable claim is "Milk is an excellent source of calcium which helps build strong bones and teeth".
Additional requirements must be met for the following nutrients function claims.
Protein [B.01.305(1), FDR]
When nutrient function claims are made for protein, the food must meet the requirements for the "source of protein" claim, which includes having a minimum Protein Rating (PR) of 20 (See Item b of Summary Table of Protein Claims).
Vitamin and Mineral Nutrients [D.01.004, D.02.002, FDR]
When nutrient function claims are made for vitamin and mineral nutrients, the vitamin or mineral nutrient must be listed in column 1 of Part 2 of the Table of Daily Values. The food must contain a minimum of 5% of the Daily Value for the vitamin or mineral stated in the claim (i.e. being at least a dietary source of the nutrient), as per the Table of Daily Values. The quantity of the vitamin or mineral nutrient that is the subject of the claim must appear in the Nutrition Facts table in absolute amount and percent Daily Value (% DV), if not already required.
Acceptable nutrient function claims table
Note that when a nutrient function claim is made for a nutrient, the food is not required to be a source of that nutrient unless it has an established "source" claim criteria, as listed above for protein and vitamin and mineral nutrients.
Nutrient function claims can also be made about a nutrient that is not a core nutrient (listed in B.01.401, FDR) nor an "additional" nutrient (listed in B.01.402, FDR), e.g., essential fatty acids such as linoleic acid and DHA (docosapentaenoic acid).
General Nutrient Function Claims
The following statements are two general nutrient function claims that are permissible for all nutrients. [B.01.311, B.01.312, D.01.006 and D.02.004, FDR]:
"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."
Specific Nutrient Function Claims
In addition to the two general nutrient function claims listed above, the Table of Acceptable Nutrient Function Claims below lists specific nutrient function claims associated with nutrients. The claims in the table refer to the scientifically recognized specific role each nutrient has in maintaining good health or in supporting normal growth and development. Other nutrient function claims may also be acceptable and will be evaluated on a case by case basis. The table will be updated as new nutrient function claims are reviewed and found to be acceptable by Health Canada. See Acceptability of New Nutrient Function Claims for more information on approval of a new nutrient function claim.
|Nutrient||Acceptable Nutrient Function Claims Table Note 6|
|Thiamine (Vitamin B1)||
|Riboflavin (Vitamin B2)||
|Folacin or folate|
- Table Note 6
The following two general nutrient function claims are permissible for all nutrients [B.01.311, B.01.312, D.01.006, D.02.004, FDR]:
- "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."
- Table Note 7
Note that this claim is based on available scientific evidence indicating that the development of the brain, eyes, and nerves in the human infant takes places very early starting in late pregnancy and up to 2 years of age. The Institute of Medicine in their 2005 report* stated that "The developing brain accumulates large amounts of DHA during the pre- and postnatal development and this accumulation continues throughout the first 2 years after birth". *Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, (DC): National Academies Press; 2005. P. 444-5.
- Table Note 8
In order to make these two claims for folate, the food must contain at least 80 ug DFE (= 20% Daily Value of 400 ug DFE) per reference amount and per serving of stated size. This is a higher minimum amount than usual for a nutrient function claim for a vitamin because the function referred to in these two claims is associated with an intake that is higher than the Daily Value. These claims should not be used on foods intended solely for children under 2 years of age.
Advertisements for nutrient function claims
The information below applies to non-prepackaged products or advertisements placed by someone other than the manufacturer or importer.
When these claims are made in a radio advertisement, the quantitative statement shall be communicated immediately preceding or following the claim [B.01.312(3), FDR].
In the case of a television advertisement, the manner in which the quantitative statement is communicated depends upon the manner in which the nutrient function claim is delivered, i.e., audio mode, visual mode, or both audio and visual modes.
- When the claim is delivered in the audio portion of the advertisement only then the quantitative statement must be communicated immediately preceding or following the claim in the audio mode or in both the audio and visual modes [B.01.312(4)(a), FDR].
- When the claim is delivered in the visual portion of the advertisement only the quantitative statement must be communicated immediately preceding or following the claim in the audio mode or in the visual mode [B.01.312(4)(b), FDR].
- In the case where the claim is made in both the audio and visual portions of a television advertisement the quantitative statement must be in the audio mode or in both the audio and visual modes.
- In the case where the quantitative statement 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 [B.01.312(5), FDR].
Acceptability of new nutrient function claims
This section applies to nutrients that meet the following criteria:
- the nutrient has an established Recommended Dietary Allowance (RDA), Adequate Intake (AI), or Acceptable Macronutrient Distribution Range (AMDR)
by the Institute of Medicine of the US National Academies
- the function reflects consensus among the broad scientific community and has been published by an authoritative scientific body Footnote 9 as its current position with regard to the function(s) within the past 15 years.
To seek advice on the acceptability of a new function claim for a nutrient that meets the above criteria, manufacturers are encouraged to contact the Food Directorate of Health Canada with the following information:
- the name of the authoritative body;
- the exact wording of the statement;
- a copy of the source document in which the statement is published;
- a description of the review process undertaken by the authoritative body to develop the statement; and
- an indication that there is no conflicting authoritative statement.
See Science Research for information on how function claims are assessed for nutrients for which no Recommended Dietary Allowance (RDA), Adequate Intake (AI), or Acceptable Macronutrient Distribution Ranges (AMDR) have been established by the Institute of Medicine of the US National Academies (e.g. DHA).
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