Health Claims
Acceptable Disease Risk Reduction Claims and Therapeutic Claims

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Within the Food and Drug Regulations

Health Canada has authorized the use of some disease risk reduction claims through specific regulatory exemptions in the Food and Drug Regulations (FDR) (see the Table of Disease Risk Reduction Claims). This was made possible with section B.01.601 of the FDR, which exempts certain foods bearing specified disease risk reduction claims from the provisions of subsections 3(1) and 3(2) of the FDA.

In addition, B.01.601 of the FDR also maintains the food status of foods labelled with these disease risk reduction claims, by exempting them from the provisions of the FDA and FDR applicable to drugs.

The permitted disease risk reduction claims are based on sound scientific evidence that has established a relationship between certain elements of healthy diets and the reduction of the risk of developing certain diseases.

Note: Disease risk reduction claims are not permitted on foods represented for use in very low energy diets nor are they permitted on foods that are intended solely to be consumed by children under two years of age [B.01.601(1)(c)(i), FDR].

On Health Canada's Website

In the case of health claims not making reference to a Schedule A disease, Health Canada has reviewed submitted scientific evidence supporting some claims. A summary of health claim assessments is published on their website.

Each document contains the information concerning the scientific evidence evaluated, and also mentions:

  • Health claim statements that may be made
  • Conditions for the food to carry the claim
  • Conditions for the label and advertisement

The CFIA uses these documents and the information contained therein in order to verify the compliance of the claims used on products.

In order to have documentation reviewed, follow the Guidance Document for Preparing a Submission for Food Health Claims (Health Canada, 2009).

General Conditions

When a permitted disease risk reduction claim or a therapeutic claim is made for a food, compositional criteria for the food to qualify for the claim, and labelling and advertising requirements must be met.

For claims listed in the Food and Drug Regulations, see the Table of Disease Risk Reduction Claims, Conditions of Use for Disease Risk Reduction Claims and Therapeutic Claims and Advertisements for Disease Risk Reduction Claims and Therapeutic Claims. For compositional requirements for nutrient content claims that form part of the conditions for disease risk reduction claims, see Nutrient Content Claims.

For claims listed on Health Canada's website, see the health claim assessment of the claim made.

Disease Risk Reduction Claims Table

The table in this section lists the disease risk reduction claims permitted for foods in the FDR. In order for a disease risk reduction claim to be made:

  1. the prescribed wording must be used for the claim (see column 1 "Claim"), and
  2. the food must meet the compositional criteria for the claim (see column 2 "Conditions – Food"), and
  3. the label or the advertisement must state the specific information required for that claim (see column 3, "Conditions – Label or Advertisement").

For example, if a manufacturer claims that the food "won't cause cavities" (see column 1, item 5 in the Table of Disease Risk Reduction Claims below), the food must meet the conditions in column 2, item 5 and the amount of sugar alcohols must be declared, if present (see column 3). The Food and Drug Regulations prescribe how this must be done [B.01.601(1), FDR].

Table of Disease Risk Reduction Claims
Column 1
Claim
Column 2
Conditions - Food
Column 3
Conditions - Label or Advertisement

1. Disease Risk Reduction Claims with Respect to Sodium and Potassium

(1) "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 sodium-free."

(2) "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."

(3) "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 a good source of potassium and is sodium-free."

(4) "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 a good source of potassium and is low in sodium."

(5) "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 high in potassium and is sodium-free."

(6) "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 high in potassium and is low in sodium."

The food

(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of the subject "low in energy" set out in item (b) of the Summary Table of Energy and Calorie Claims.

(b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient (see Weighted Recommended Nutrient Intake Table),

(i) per reference amount and per serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal;

(c) meets the conditions set out in column 2 of the subject "low in saturated fatty acids" set out in item (b) of the Summary Table of Saturated Fatty Acid Claims;

(d) contains 0.5% or less alcohol;

(e) meets the conditions set out in column 2 of the subject "free of sodium or salt" set out in item a) of the Summary Table for Sodium (Salt) Claims, if the label of or advertisement for the food carries statement or claim (1), (3), or (5) set out in column 1 of this item;

(f) meets the conditions set out in column 2 of the subject "low in sodium or salt" set out in item b) of the Summary Table for Sodium (Salt) Claims, if the label of or advertisement of the food carries statement or claim (2), (4), or (6) set out in column 1 of this item; and

(g) contains 350 mg or more of potassium, if the label of or advertisement for the food carries statement or claims (3), (4), (5), or (6) set out in column 1 of this item,

(i) per reference amount and per serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal.

1. When the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the Nutrition Facts table shall include the amount of potassium, in accordance with item 9 of Additional Nutrition Information Table [B.01.402(2), FDR].

2. When the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of sodium and potassium per serving of stated sized, in accordance with B.01.602 of the FDR if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2) (a)&(b) of the FDR [B.01.401(3)(e)(ii), FDR].

(See Reasons for losing the exemption)

[Item 1, Table following B.01.603, FDR]

2. Disease Risk Reduction Claims with Respect to Calcium and Vitamin D

(1) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium."

(2) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is high in calcium."

(3) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium."

(4) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium."

(5) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium and vitamin D."

(6) "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium and vitamin D."

The food

(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of the subject "low in energy" set out in item (b) of the Summary Table of Energy and Calorie Claims.

(b) contains no more phosphorus, excluding that provided by phytate, than calcium;

(c) contains 0.5% or less alcohol;

(d) contains, if the label of or advertisement for the food carries statement or claim (1) or (2) set out in column 1,

(i) 200 mg or more of calcium per reference amount and per serving of stated size, or

(ii) 300 mg or more of calcium per serving of stated size, if the food is a prepackaged meal;

(e) contains, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1,

(i) 275 mg or more of calcium per reference amount and per serving of stated size, or

(ii) 400 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; and

(f) contains 1.25 µg or more of vitamin D, if the label of or advertisement for the food carries statement or claim (5) or (6) set out in column 1,

(i) per reference amount and per serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal.

1. When the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the Nutrition Facts table shall include the amount of vitamin D and phosphorus, in accordance with item 14 of Additional Nutrition Information Table [B.01.402(2), FDR].

or

2. When the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of vitamin D, calcium, and phosphorus per serving of stated sized, in accordance with section B.01.602 of the FDR, if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2) (a) & (b) of the FDR [B.01.401(3)(e)(ii), FDR].

(See Reasons for losing the exemption)

[Item 2, Table following B.01.603, FDR]

3. Disease Risk Reduction Claims with Respect to Saturated and Trans Fats

(1) "A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is free of saturated and trans fats."

(2) "A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is low in saturated and trans fats."

The food

(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of the subject "low in energy" set out in item (b) of the Summary Table of Energy and Calorie Claims.

(b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient

(i) per reference amount and per serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal;

(c) contains 100 mg or less of cholesterol per 100 g of food;

(d) contains 0.5% or less alcohol;

(e) if it is a fat or an oil, meets the conditions set out in column 2

(i) of the subject "source of omega-3 polyunsaturated fatty acids" (item (a) of the Summary Table of Omega-3 and Omega-6 Fatty Acids) or

(ii) the subject "source of omega-6 polyunsaturated fatty acids" (item (b) of the Summary Table of Omega-3 and Omega-6 Fatty Acids), or

(iii) both (i) and (ii);

(f) contains

(i) 480 mg or less of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less, or

(ii) 960 mg or less of sodium per serving of stated size, if the food is a prepackaged meal;

(g) meets the conditions set out in column 2 of the subject "free of saturated fatty acids" (item (a) of the Summary Table of Saturated Fatty Acid Claims), if the label of or advertisement for the food carries statement or claim (1) set out in column 1 of this table; and

(h) meets the conditions set out in column 2 of the subject "low in saturated fatty acids" (item (b) of the Summary Table of Saturated Fatty Acid Claims), if the label of or advertisement for the food carries statement or claim (2) set out in column 1 of this table.

If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of saturated fatty acids and trans fatty acids per serving of stated size, in accordance with B.01.602 of the FDR, if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) & (b) of the FDR [B.01.401(3)(e)(ii), FDR].

(See Reasons for losing the exemption)

[Item 3, Table following B.01.603, FDR]

4. Disease Risk Reduction Claims with Respect to Cancer Risk Reduction Table Note 1

"A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer."

The food

(a) is one of the following vegetables, fruit, or juice and may contain only sweetening agents, food additives as permitted by these Regulations, salt, herbs, spices, seasonings or water:

(i) a fresh, frozen, canned or dried vegetable,

(ii) a fresh, frozen, canned or dried fruit,

(iii) a vegetable or fruit juice, or

(iv) a combination of the foods set out in subparagraphs (i) to (iii);

(b) is not one of the following

(i) potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices,

(ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,

(iii) jams or jam-type spreads, marmalades, preserves and jellies,

(iv) olives, and

(v) powdered vegetables or fruit; and

(c) contains 0.5% or less alcohol.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) & (b) of the FDR [B.01.401(3)(e)(ii), FDR].

(See Reasons for losing the exemption)

[Item 4, Table following B.01.603, FDR]

5. Disease Risk Reduction Claims with Respect to Dental Caries Table Note 2

(1) "Won't cause cavities."

(2) "Does not promote tooth decay."

(3) "Does not promote dental caries."

(4) "Non-cariogenic."

The food is a chewing gum, hard candy or breath freshening product that

(a) contains 0.25% or less starch, dextrins, mono-, di- and oligosaccharides or other fermentable carbohydrates combined; or

(b) does not, if it contains more than 0.25% fermentable carbohydrates, lower plaque pH below 5.7 by bacterial fermentation during 30 minutes after consumption as measured by the indwelling plaque pH test, referred to in "Identification of Low Caries Risk Dietary Components" by T.N. Imfeld, Volume 11, Monographs in Oral Science, 1983.

If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the Nutrition Facts table shall include the amount of sugar alcohols, if present, in accordance with item 12 of the Additional Nutrition Information Table [B.01.402(2), FDR].

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) & (b) of the FDR [B.01.401(3)(e)(ii), FDR].

(See Reasons for losing the exemption)

[Item 5, Table following B.01.603, FDR]

Table Notes

Table Note 1

This claim can only be made on vegetables and fruits listed in Item (a). This claim could be made on a fresh fruit salad with fruit juice, a mixed vegetable juice, or mixed frozen vegetables (provided that they don't contain one of the vegetables not permitted to carry the claim, such as corn). This claim would not be allowed on foods that contain more than 0.5% alcohol, e.g. relish, ketchup, strawberry jam, wine, fruit juice based alcoholic beverage. Foods listed in Item (b) have been excluded as there are data to support the exclusion of white potatoes, and there is still a lack of data to support the role of the others in reducing the risk of cancers. It also cannot be made on combination foods that have ingredients other than those listed in Item (a), e.g. cherry pie, vegetable lasagna.

Under Item (b)(i) of Column 2 above, one of the items excluded from making the claim is mature legumes. This is to differentiate the mature seeds of legumes such as split peas, kidney beans, black eyed peas, from young pods of legumes, such as edible podded peas, and from immature seeds such as sweet peas, which are considered vegetables.

Return to table note 1  referrer

Table Note 2

The list of substances recognized as non-cariogenic includes aspartame, sorbitol, xylitol and mannitol.

Return to table note 2  referrer

Conditions of Use for Disease Risk Reduction Claims and Therapeutic Claims

There are general conditions for making disease risk reduction claims which are outlined below.

Legibility

There is currently no requirement in the Food and Drug Regulations that requires all words of a disease risk reduction claim to appear in the same size type and prominence on a label, unlike a similar requirement for nutrient content claims (see B.01.503(3), FDR).

Language Requirements for Disease Risk Reduction Claims and Therapeutic Claims

When these claims appear on a label, they must be present in both English and French unless a bilingual labelling exemption applies to the product [B.01.012(3) and (7) and B.01.600, FDR].

Declaration of a Nutrition Facts Table for Disease Risk Reduction Claims and Therapeutic Claims

When a 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 carry a Nutrition Facts table (NFT) [B.01.401, FDR]. Foods that are normally exempt from providing a NFT lose their exemption and are required to declare a NFT. See Reasons for losing the exemption. In addition, the nutrition information required by column 3 of the Table of Disease Risk Reduction Claims must appear in the NFT [B.01.401(3)(e)(ii), FDR].

Wording of the Claim

The Regulations prescribe the exact wording for the permitted disease risk reduction claims in column 1 of the Table of Disease Risk Reduction Claims. The wording of the health claims cannot be modified, and no intervening information, graphic sign or symbol may come between parts of the claim. However, words, numbers, signs or symbols may come before or after the health claim, provided that they do not change the nature of the claim [B.01.603, FDR]. In the case of advertisements, all parts of the claim must be displayed in equal prominence with no parts highlighted [B.01.602(1)(a), FDR].

Split claims are not permitted, i.e. presenting the claim in two sections on different parts of the label. Because the risk reduction is associated with the total diet and not with the individual food, the diet part of the claim is the most important.

Naming the Food

The "Naming the food" segment of the claim must be completed appropriately. This can be done with the use, at a minimum, of the common name of the food. If the nutrient content claim portion of the health claim does not apply to all foods of that type, then a brand name may accompany the common name. If other information is required to distinguish the food from another similar food with the same common name and brand name, other information may be permitted as part of the description of the food. For example "A healthy diet low in saturated and trans fat may reduce the risk of heart disease. Johnny's 100% fat-free turkey breast is free of saturated and trans fat" would be acceptable to distinguish the food from Johnny's regular turkey breast with 4% fat.

If the nutrient content claim portion describes all foods of that type, then "Naming the food" must be stated in such a way as to indicate that the claim characterizes all foods of that type. A brand name may not be used to name the food. This is consistent with the requirements set out in section B.01.511, FDR. For example, "A healthy diet low in saturated and trans fat may reduce the risk of heart disease. Applesauce is free of saturated and trans fats."

It is not appropriate to only use a brand name or trade name to name the food. For example, to only use a brand name in the following claim would not be acceptable as the brand name does not name the food. "A healthy diet low in saturated and trans fat may reduce the risk of heart disease. Johnny's is free of saturated and trans fat."

Other than the "Naming the food" segment, only the last few words of the claim change, depending on the circumstances. For example, notice the difference between item 3 (1) and item 3 (2). In item 3(1) the food is "free" of saturated and trans fat, whereas in item 3(2), the food is "low" in saturated and trans fat.

Advertisements for Disease Risk Reduction Claims and Therapeutic Claims

Accompanying information is required when a disease risk reduction claim is present in an advertisement for a prepackaged product (other than a radio or television advertisement) made by someone other than the manufacturer (such as a marketing board). The accompanying information required is namely the nutrition information as per column 3 of the Table of Disease Risk Reduction Claims. It must be adjacent to the most prominent claim in the advertisement (without any intervening material), and it must appear in letters of the same size and prominence as the claim [B.01.602(1)(a), FDR].

Similarly, when a disease risk reduction claim appears on the label or in an advertisement for a non-prepackaged food (such as bulk food), the nutrition information required by column 3 of the Table of Disease Risk Reduction Claims) must appear on the label or the advertisement. The same requirements for placement of information would apply [B.01.602(1)(a), FDR].

Radio Advertisements

When these claims are made in a radio advertisement the accompanying information, being the nutrition information required by column 3 of the Table of Disease Risk Reduction Claims, must be communicated immediately preceding or following the claim [B.01.602(1)(b), FDR].

Television Advertisements

In the case of a television advertisement, the accompanying information, namely the nutrition information required by column 3 of the Table of Disease Risk Reduction Claims, must be declared based on the manner in which the disease risk reduction claim is delivered, i.e., audio mode, visual mode, or both the audio and visual modes.

  • When the claim is delivered in the audio portion of the advertisement only, the accompanying information must be communicated immediately preceding or following the claim in audio mode, or in both the audio and visual modes [B.01.602(1)(c), FDR].
  • When the claim is delivered in the visual portion of the advertisement only, the accompanying information must be communicated immediately preceding or following the claim in the audio mode or in the visual mode [B.01.602(1)(c), FDR].
  • In the case where the claim is made in both the audio and visual portions of a television advertisement the accompanying information must be in the audio mode or in both the audio and visual modes.
  • 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 [B.01.602(2), FDR].
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