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Health claims on food labels

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Overview

A health claim is any representation in labelling or advertising that states, suggests, or implies that a relationship exists between the consumption of a food and health.

All aspects of food labels and advertisements contribute to the overall impression made by a food product, including health claims. For this reason, health claims are also subject to the general principles for labelling and advertising.

Some health claims are also subject to other specific requirements. For example some of them require a premarket approval before their use. There are different types of health claims, all of which highlight the link between a food or a constituent of a food and health. The specific requirements for each type of health claim will be elaborated on in their respective sections below.

As there are many different types of health claims, it is important to determine the appropriate requirements related to the specific type of health claim being made. Steps have been developed with some questions and links to further information to help you find the appropriate requirements for the claim being made.

Note: nutrient content claims are another type of voluntary nutrition related claim. For more information on their specific requirements, refer to Nutrient content claims.

Steps for determining the type of health claim

1. Is the product a food or a natural health product (NHP)?

Use Foods or natural health products (NHP) to verify the status of the product. Depending on whether the product is a food or an NHP, it is subject to the Food and Drug Regulations or the Natural Health Products Regulations respectively.

If the product is a food, continue to step 2.

2. Does the claim refer to a Schedule A disease or meet the Food and Drugs Act definition of a drug?

Use Drugs versus foods to verify if the claim refers to a Schedule A disease or is a drug claim. If yes, see Drug representations and pre-market approval to learn about their specific requirements such as obtaining a pre-market approval in certain cases. Disease risk reduction claims or therapeutic claims must be based on sound scientific evidence that has established a relationship between certain elements of healthy diets and the reduction of risk of developing certain diseases.

Example of a disease risk reduction claim, "[Naming the food or food constituent] may reduce the risk of cardiovascular disease".

If this is not the type of claim being made, continue to step 3.

3. Does the claim refer to a relationship between an ingredient and a function of the body?

Function claims relate to the specific beneficial effects that the consumption of a food or a constituent of a food (nutrient or other component) has on the normal functions of the body. For example, "[Naming the food or food constituent] promotes regularity or laxation".

If yes, see Function claims to learn about their specific requirements.

If this is not the type of claim being made, continue to step 4.

4. Does the claim refer to a relationship between a nutrient and a function of the body?

Nutrient function claims describe the well-established roles of energy or known nutrients that are essential for the maintenance of good health or for normal growth and development. For example, "Milk is an excellent source of calcium which helps build strong bones and teeth".

If yes, see Nutrient function claims to learn about their specific requirements.

If this is not the type of claim being made, continue to step 5.

5. Does the claim refer to a relationship between probiotic microorganisms/prebiotic(s) and health benefits?

Probiotic claims are statements about the nature of the probiotic microorganism that is generally required in supporting the health effects or benefits of these microorganisms. For example, "Probiotic that contributes to healthy gut flora".

The use of the term prebiotic(s) is part of a statement that describes the specific and measurable health benefits conferred by the prebiotic substance. For example, "Prebiotic X increases calcium absorption".

If yes, see Probiotic claims or Use of the term "prebiotic(s)" to learn about their specific requirements.

If this is not the type of claim being made, continue to step 6.

6. Does the claim refer to healthy eating patterns?

General health claims are broad claims that promote health through healthy eating or that provide dietary guidance. For example, "The consumption of [Naming the food] which is low in fat is part of a healthy diet".

If yes, see General health claims to learn more about their specific requirements.

Foods or natural health products (NHP)

In order to understand how health claims are regulated in Canada, one must first examine the definitions for a food and natural health products.

The term "food" is defined in the Food and Drugs Act (FDA). Natural health products (NHP), which are a subset of drugs, are defined and regulated under the Natural Health Products Regulations (NHPR). These definitions are central to determining the correct classification of a product (that is to say, a food or NHP) and consequently whether the food or NHP regulatory framework applies.

This web page applies to health claims made on foods. The Canadian Food Inspection Agency (CFIA) is responsible for compliance and enforcement of requirements related to food, whereas Health Canada carries out this role for NHPs.

It is also Health Canada's responsibility to determine product classification. Health Canada takes the following 4 factors into consideration to classify a product:

For more information on the above criteria or on NHPs, please consult Health Canada's webpage Natural health product regulation in Canada.

Natural product number

NHPs that have been authorized for sale by Health Canada bear a natural product number (NPN) or homeopathic medicine number (DIN-HM) on the label. These numbers are indications that the product is classified as a NHP and falls under Health Canada's responsibility.

Health Canada is in the process of working with manufacturers to safely transition food products previously marketed as NHPs to the food regulatory framework. This has been facilitated through the issuance of Temporary Marketing Authorization Letters (TMAL) by the Food Directorate. For a complete list of TMALs, see the List of foods that have received Temporary Marketing Authorization Letters.

For more information on authorized NHPs, please consult Health Canada's Licensed Natural Health Products Database and Natural Health Products Ingredients Database.

Drugs versus foods

Just like the term "food", the term "drug" is also defined in the Food and Drugs Act (FDA). One difference between foods and drugs is in how they are represented. If a product meets the definition of a food and is regulated as a food, the product is not permitted to carry a drug claim, unless exempted. See Acceptable disease risk reduction claims and therapeutic claims for acceptable examples.

Furthermore, section 3 of the FDA prohibits the sale of a food that is labelled or advertised to the general public as a treatment, preventative or cure for any of the diseases referred to in Schedule A.

Drug representations and pre-market approval

When a health claim brings a food under the definition of a "drug" through the use of a disease risk reduction claim or a therapeutic claim, a pre-market assessment of the claim, by the Food Directorate of Health Canada, may be required.

Schedule A disease claims

Section 3 of the Food and Drugs Act (FDA) prohibits the sale of a food that is labelled or advertised to the general public as a treatment, preventative or cure for any of the diseases referred to in Schedule A, unless exempted within the Food and Drug Regulations (FDR).

Health Canada has authorized the use of some disease risk reduction claims through specific regulatory exemptions in the 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.

When a health claim makes reference to a Schedule A disease, a pre-market assessment of the claim by Health Canada's Food Directorate is mandatory and an amendment to the FDR is required before the use of the claim is permitted.

For information on obtaining a pre-market approval, visit Health Canada's Guidance Document for Preparing a Submission for Food Health Claims.

Note: disease risk reduction claims are not permitted on the following:

Drug claims not listed in Schedule A

Drug claims about diseases or health conditions not listed in Schedule A are subject to the same level of standards of evidence as claims about Schedule A diseases or conditions; however, pre-market assessment of the claim is voluntary.

Health claims that have been voluntarily submitted and accepted by Health Canada's Food Directorate will be added to the list of accepted claims and may be used on all food products meeting the conditions of use for that claim. A summary of health claim assessments is published on their website for claims that have already been reviewed.

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

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

Claims that have not been reviewed must be able to disclose evidence supporting these claims upon request by the CFIA.

For information on submitting a pre-market assessment, visit Health Canada's Guidance Document for Preparing a Submission for Food Health Claims.

Drugs claims not permitted on food

Medicated claims

A food cannot be described as "medicated". Since this term is used to describe products containing an added medicinal substance to treat or prevent a disease, the representation causes the product to fall within the definition of a drug under the Food and Drugs Act. Such products must be labelled and advertised as a drug as required by the Food and Drug Regulations.

Laxative claims

Products represented as laxatives fall within the definition of a drug. The mention of "laxative" or "relief of constipation" on a label or advertisement characterizes the product as a drug.

Contrarily, the term "laxation" and the action of "promoting laxation" are not considered to be drug claims when used in connection with certain foods. See the Acceptable function claims table for more information.

Tonic foods

The term "tonic" has been used in the past to describe a class of foods believed to have the power to restore a normal degree of vigour or to restore good health. Today, this term should not be used, as no food can be described as an effective tonic. However, exceptions may be made due to long term use, such as "tonic water".

Acceptable disease risk reduction claims and therapeutic claims

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 (FDR), see the Table of disease risk reduction claimsConditions 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 for 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:

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 FDR 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 item 2 of the Table of Permitted Nutrient Content Statements and Claims for the subject Low in energy set out in column 1

(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 item 19 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Low in saturated fatty acids set out in column 1

(d) contains 0.5% or less alcohol

(e) meets the conditions set out in column 2 of item 31 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Free of sodium or salt set out in column 1, 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 item 32 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Low in sodium or salt set out in column 1, if the label of or advertisement for 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

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 sodium and potassium per serving of stated sized, in accordance with B.01.602 of the FDR if applicable.

However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) and (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 item 2 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Low in energy set out in column 1

(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.

However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) and (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 item 2 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Low in energy set out in column 1

(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

(i) column 2 of item 25 of the Table of Permitted Nutrient Content Statements and Claims for the subject Source of omega-3 polyunsaturated fatty acids set out in column 1

(ii) column 2 of item 26 of the Table of Permitted Nutrient Content Statements and Claims for the subject Source of omega-6 polyunsaturated fatty acids set out in column 1, 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 item 18 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Free of saturated fatty acids set out in column 1, if the label of or advertisement for the food carries statement or claim (1) set out in column 1 of this item, and

(h) meets the conditions set out in column 2 of item 19 of the Table of Permitted Nutrient Content Statements and Claims  for the subject Low in saturated fatty acids set out in column 1, if the label of or advertisement for the food carries statement or claim (2) set out in column 1 of this item

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.

However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) and (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, fruits or juices and may contain only food additives that are referred to in section 2 of a marketing authorization, sweetening agents, 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

[item 4, table following B.01.603, FDR]

4.1 Disease risk reduction claims with respect to heart disease risk reduction

"A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of heart disease."

The food

(a) is one of the following vegetables or fruits and may contain only food additives that are referred to in section 2 of a marketing authorization, salt, herbs, spices, seasonings and water:

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

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

(iii) a vegetable juice or vegetable drink, or

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

(b) is not one of or does not contain any of the following:

(i) potatoes, yams, cassava, plantain, 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

(v) a fruit juice or fruit drink

(vi) powdered vegetables or fruit, or

(vii) the seed of a fruit known as a drupe, including almonds, cashews and coconuts

(c) contains 0.5% or less alcohol, and

(d) contains less than 15% of the daily value 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

[item 4.1, 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) and (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) of column 2. 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, for example, relish, ketchup, strawberry jam, wine, fruit juice based alcoholic beverage. Foods listed in item (b) of column 2 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), for example, 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 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).

When a health-related representation, such as a disease risk reduction claim or a therapeutic claim, appears on the principal display panel of a prepackaged product that also carries a nutrition symbol, certain restrictions for type size and prominence apply to the words and characters of the claim [B.01.357, FDR].

For more information refer to Nutrient and health-related claims and the front-of-package (FOP) nutrition symbol of the Front-of-package nutrition symbol labelling guide for industry.

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), 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 an NFt lose their exemption and are required to declare an 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].

Fresh vegetables and fruits without any added ingredients are always exempted from the requirement to carry an NFt. The use of a disease risk reduction claim, on the label or in an advertisement, does not trigger the NFt or any accompanying nutrition information [B.01.401(2)(c)(i), 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(1), 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].

For foods that meet the conditions set out in column 2 of the Table of disease risk reduction claims for more than 1 item of that table, common elements of the statements or claims set out in column 1 do not need to be repeated on the label of or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate [B.01.603(2), FDR].

Split claims are not permitted, that is to say, presenting the claim in 2 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 the Table of disease risk reduction claims. 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, that is to say, audio mode, visual mode, or both the audio and visual modes.

Function claims

Function claims 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 2 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 versus 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 an NFt. See Reasons for losing the exemption [B.01.401.(3)(e)(ii), FDR].

Front-of-package (FOP) nutrition symbol and function claims

When a health-related representation, such as a function claim, appears on the principal display panel of a prepackaged product that also carries a nutrition symbol, certain restrictions for type size and prominence apply to the words and characters of the claim [B.01.357, FDR]. For more information, refer to Nutrient and health-related claims and the front-of-package (FOP) nutrition symbol of the Front-of-package nutrition symbol labelling guide for industry.

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:

  1. 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 (for example, promotes normal transit time) is not considered to be supported when the evidence is based on therapeutic (treatment) effects in sick populations (for example, 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.
  2. 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 (for example, 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 (for example, 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".

Determining 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 note

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".

Return to table note 3  referrer

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.

Table of acceptable food or food constituent function claims
Column 1
Food or food constituent
Column 2
Acceptable claim
Column 3
Conditions for use
Coarse wheat bran table note 4
  1. (Naming the serving) of (naming the product) contains 7 grams (or naming the amount if more than 7 grams) of fibre from coarse wheat bran, which promotes laxation.
  2. (Naming the serving) of (naming the product) contains 7 grams (or naming the amount if more than 7 grams) of fibre from coarse wheat bran, which promotes regularity.
  3. (Naming the serving) of (naming the product) provides (naming the amount) of fibre from coarse wheat bran. Consuming 7 grams of fibre from coarse wheat bran (daily table note 4) promotes laxation.
  4. (Naming the serving) of (naming the product) provides (naming the amount) of fibre from coarse wheat bran. Consuming 7 grams of fibre from coarse wheat bran (daily table note 4) promotes regularity.

A reasonable daily intake (Part D, FDR; Schedule K) of the food or 1 serving contains a minimum of 7 grams of dietary fibre from coarse wheat bran.

Where the RDI of a food product comprises 1 serving and the product provides a minimum of 7 grams of fibre from coarse wheat bran in 1 serving of stated size, claims (a) or (b) may be made.

Where the RDI of a food product comprises more than 1 serving and the product provides less than 7 grams of fibre from coarse wheat bran in 1 serving of stated size, claims (c) or (d) may be made.

See Drugs versus 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:

  • 2.0 grams or more tea leaves per 250 mL, or
  • 1 tea bag (containing 2 grams tea leaves) per 250 mL

or

A reconstituted green tea product (for example, 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
  1. (Naming the serving) of (naming the product) contains 3.5 grams (or naming the amount if more than 3.5 grams) of fibre from psyllium seed, which promotes laxation.
  2. (Naming the serving) of (naming the product) contains 3.5 grams (or naming the amount if more than 3.5 grams) of fibre from psyllium seed, which promotes regularity.
  3. (Naming the serving) of (naming the product) provides (naming the amount) of fibre from psyllium seed. Consuming 3.5 grams of fibre from psyllium seed (daily table note 4) promotes laxation.
  4. (Naming the serving) of (naming the product) provides (naming the amount) of fibre from psyllium seed. Consuming 3.5 grams of fibre from psyllium seed (daily table note 4) promotes regularity.

A reasonable daily intake (Part D, FDR; Schedule K) of the food or 1 serving contains a minimum of 3.5 grams of dietary fibre from psyllium seed.

Where the RDI of a food product comprises 1 serving and the product provides a minimum of 3.5 grams of fibre from psyllium seed in 1 serving of stated size, claims (a) or (b) may be made.

Where the RDI of a food product comprises more than 1 serving and the product provides less than 3.5 grams of fibre from psyllium seed in 1 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".

Return to table note 4  referrer

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

Return to table note 5  referrer

Laxation claims

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.

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 Drugs versus foods.

Nutrient function claims

Nutrient function claims, 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 versus 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), 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 an NFt lose their exemption and are required to declare an 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, for example, 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 versus 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 (for example, calcium) in a food, not a particular food (for example, milk). An acceptable claim is "Milk is an excellent source of calcium which helps build strong bones and teeth".

Specific requirements

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. Refer to item 8 of table B. Protein Related Statements and Claims of the Table of Permitted Nutrient Content Statements and 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 (meaning 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), for example, essential fatty acids such as linoleic acid and DHA (docosapentaenoic acid).

General nutrient function claims

The following statements are 2 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 2 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.

Table of acceptable nutrient function claims
Nutrient Acceptable nutrient function claims table note 6
Protein
  • helps build and repair body tissues
  • helps build antibodies
  • helps build strong muscles
Fat
  • supplies energy
  • aids in the absorption of fat-soluble vitamins
DHA
  • DHA, an omega-3 fatty acid, supports the normal physical development of the brain, eyes and nerves primarily in children under two year of age table note 7
ARA
  • ARA, an omega-6 fatty acid, supports the normal physical development of the brain, eyes and nerves primarily in children under two year of age table note 7
Carbohydrate
  • supplies energy
  • assists in the utilization of fats
Vitamin A
  • aids normal bone and tooth development
  • aids in the development and maintenance of night vision
  • aids in maintaining the health of the skin and membranes
  • contributes to the normal function of the immune system
  • contributes to the maintenance of normal vision
  • helps build strong bones and teeth
  • supports night vision
  • supports healthy skin
Vitamin D
  • factor in the formation and maintenance of bones and teeth
  • enhances calcium and phosphorus absorption and utilization
  • helps build strong bones and teeth
  • builds and maintains strong bones and teeth
  • improves calcium absorption
  • improves calcium and phosphorus absorption
Vitamin E
  • a dietary antioxidant
  • a dietary antioxidant that protects the fat in body tissues from oxidation
Vitamin C
  • a factor in the development and maintenance of bones, cartilage, teeth and gums
  • a dietary antioxidant
  • a dietary antioxidant that significantly decreases the adverse effects of free radicals on normal physiological functions
  • a dietary antioxidant that helps to reduce free radicals and lipid oxidation in body tissues
  • factor in energy metabolism
  • helps build teeth, bones, cartilage and gums
  • protects against free radicals
  • protects against the damage of free radicals
  • protects against the oxidative effects of free radicals
Thiamine (Vitamin B1)
  • releases energy from carbohydrate
  • aids normal growth
Riboflavin (Vitamin B2)
  • factor in energy metabolism and tissue formation
Niacin
  • aids in normal growth and development
  • factor in energy metabolism and tissue formation
Vitamin B6
  • factor in energy metabolism and tissue formation
Folacin or folate
  • aids in red blood cell formation
  • a factor in normal early fetal development table note 8
  • a factor in the normal early development of the fetal brain and spinal cord. table note 8
  • contributes to normal amino acid synthesis
Vitamin B12
  • aids in red blood cell formation
  • factor in energy metabolism
Biotin
  • factor in energy metabolism
Vitamin K
  • contributes to the maintenance of bones
Pantothenic Acid
  • factor in energy metabolism and tissue formation
Calcium
  • aids in the formation and maintenance of bones and teeth
Phosphorus
  • factor in energy metabolism
  • factor in the formation and maintenance of bones and teeth
Magnesium
  • contributes to normal muscle function
  • factor in energy metabolism, tissue formation and bone development
Iron
  • factor in red blood cell formation
  • helps build red blood cells
Zinc
  • contributes to the maintenance of normal skin
  • contributes to the normal function of the immune system
  • factor in energy metabolism and tissue formation
Iodine
  • factor in the normal function of the thyroid gland
Selenium
  • a dietary antioxidant involved in the formation of a protein that defends against oxidative stress
  • dietary antioxidant
  • helps protect against oxidative stress
Chromium
  • contributes to normal glucose metabolism
Copper
  • contributes to the maintenance of normal connective tissue
Manganese
  • contributes to the formation and maintenance of bones
  • factor in energy metabolism

Table notes

Table note 6

The following 2 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."

Return to table note 6  referrer

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.

Return to table note 7  referrer

Table note 8

In order to make these 2 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 2 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.

Return to table note 8  referrer

Advertisements for nutrient function claims

The information below applies to non-prepackaged products or advertisements placed by someone other than the manufacturer or importer.

Radio advertisements

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].

Television advertisements

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, that is, audio mode, visual mode, or both audio and visual modes.

Acceptability of new nutrient function claims

This section applies to nutrients that meet the following criteria:

  1. 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
    and
  2. 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:

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 (for example, DHA).

Probiotic claims

Probiotics are microorganisms that are beneficial to human health. A probiotic health claim can consist of one of the following examples:

A probiotic health claim can be presented in either text or graphic, on food labels or in advertisements to suggest that a food confers a health benefit.

Due to the special nature of probiotic microorganisms, Health Canada has prepared a guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), that sets out the conditions under which health claims about probiotics are considered acceptable.

Type of probiotic claims

Disease risk reduction or therapeutic probiotic claims

Probiotic claims that are therapeutic in nature or that are considered "drug" claims are required to undergo a pre-market assessment by the Food Directorate of Health Canada and a regulatory amendment to the Food and Drug Regulations to allow their use. Refer to Acceptable disease risk reduction claims and therapeutic claims for more information.

Probiotic function claims

Most probiotic claims are function claims. Two types can be made on food: strain-specific claims and non-strain-specific claims.

See Science research under Function claims for more information on the acceptability of new health claims, including new function claims.

Conditions of use for probiotic claims

Health Canada's guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), sets out the conditions under which health claims about probiotics are considered acceptable. The following is a summary of the guidance; the guidance document should be consulted for specific details.

General information about evidence requirements applicable to health claims of all types, including function claims, also apply to probiotic claims (See Science research under Function claims).

Identification of strain

A probiotic claim should be accompanied by the Latin name of the microorganism (that is to say, genus and species), along with the identity of the strain of the microorganism, using acceptable nomenclature (see the Table of acceptable non-strain specific claims for probiotics for nomenclature of selected bacterial species). For consistency, it is recommended that the strain be identified by using the number assigned by an internationally recognized culture repository (for example, American Type Culture Collection; ATCC 2008; see the Reference list for probiotic claims).

Language requirements for probiotic claims

While there are no specific language requirements set out in the Food and Drug Regulations for probiotic claims, it is recommended that when a 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].

Quantitative statements for probiotic claims

The amount of the probiotic microorganism(s) contained in the product at the end of its shelf life must be declared in colony forming units (cfu) per serving of stated size of the food. This statement should appear adjacent to the Nutrition Facts table or the list of ingredients, or in close proximity to the claim.

In mixed culture, if multiple probiotic genera are used, declaration of the quantity of each genus is generally expected. If multiple species or strains of the same genus are added to a food, the need for the separate declaration of individual species would be determined case by case.

Ingredient list

Foods containing probiotic microorganism(s) must be labelled with a list of ingredients in accordance with sections B.01.008 to B.01.010 of the FDR (see List of ingredients). The probiotic microorganism(s) must be identified by its (their) common name(s) or by a class name set out in Table 2 of the Common Names for Ingredients and Components document. The class name "bacterial culture" may be used to describe all bacterial species added to a food product. When the class name (for example, bacterial culture) is used in the list of ingredients, the identity (meaning the genus, species and strain) of the probiotic bacterial culture(s) should be declared in close proximity to the claim using acceptable nomenclature.

Acceptable non-strain specific claims

A limited number of non-strain-specific claims about the nature of probiotics (for example, that they naturally form part of the gut flora) have been accepted for use on food. Any of the statements listed in the Table of acceptable non-strain specific claims for probiotics may be made for one or more of the specific bacterial species included in the table when the conditions specified below are followed.

General conditions

When making any of the claims listed in the Table of acceptable non-strain specific claims for probiotics below, the manufacturer or importer of the product must follow guidelines outlined under Conditions of use for probiotic claims, regarding documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product, as well as specific conditions.

Specific conditions

  1. Eligible species

    These claims can be used only when the product contains 1 or more of the specific species listed in the Table of acceptable non-strain specific claims for probiotics below.

  2. Minimum levels in the product

    A serving of stated size of a product should contain a minimum level of 1.0 x 109 cfu of 1 or more of the eligible microorganism(s) that is (are) the subject of the claim Footnote 10

Table of acceptable non-strain specific claims for probiotics
Eligible bacterial species table note 11
Latin name (acceptable nomenclature table note 12) and synonym where applicable
Acceptable non-strain specific probiotic claim for food
  • Bifidobacterium adolescentis
  • Bifidobacterium animalis subsp. animalis
  • Bifidobacterium animalis subsp. lactis
     -synonym: B. lactis
  • Bifidobacterium bifidum
  • Bifidobacterium breve
  • Bifidobacterium longum subsp. infantis comb. nov. table note 13
  • Bifidobacterium longum subsp. longum subsp. nov. table note 13
  • Lactobacillus acidophilus
  • Lactobacillus casei
  • Lactobacillus fermentum
  • Lactobacillus gasseri
  • Lactobacillus johnsonii
  • Lactobacillus paracasei
  • Lactobacillus plantarum
  • Lactobacillus rhamnosus
  • Lactobacillus salivarius

Probiotic that naturally forms part of the gut flora. table note 14

Provides live microorganisms that naturally form part of the gut flora. table note 14

Probiotic that contributes to healthy gut flora. table note 14

Provides live microorganisms that contribute to healthy gut flora. table note 14

Table notes

Table note 11

References reviewed for the bacterial species included: EFSA 2007, Gilliland 2001, Reid 2001 (see Reference list for probiotic claims).

Return to table note 11  referrer

Table note 12

References reviewed for acceptable nomenclature: ATCC 2008, Euzéby 2008, Skerman et al. 1989 (see Reference list for probiotic claims).

Return to table note 12  referrer

Table note 13

In product labelling, Bifidobacterium longum subsp. infantis and Bifidobacterium longum subsp. longum would be considered acceptable nomenclature.

Return to table note 13  referrer

Table note 14

The word "gut" may be replaced by the expression "digestive tract" in these claims.

Return to table note 14  referrer

Advertisements for probiotic claims

In the case of advertising, if the probiotic microorganism is identified or referred to in the advertisement, then the identity of the microorganism (genus, species and strain) should be declared using acceptable nomenclature. For example, the claim "contains two probiotics" triggers the identification of both microorganisms in the advertisement. See Identification of strain for more information.

Use of the term "prebiotic(s)"

The term "prebiotic(s)" and similar representations (for example, "stimulates the growth of friendly intestinal microflora", "promotes healthy/beneficial bacteria in the large intestine") on food labels and in advertising that suggest a food confers a health benefit are considered to be implied health claims.

These implied health claims are only acceptable when accompanied by a statement of the specific and measurable health benefit conferred by the prebiotic substance, as demonstrated in humans, for example "Prebiotic X increases calcium absorption". Whether the use of the term "prebiotic(s)" is assessed as a function claim, disease risk reduction claim or therapeutic claim depends on the specific and measurable health effect supported by scientific evidence and the overall impression created by the labelling and advertising of the food. For information on the scientific criteria to substantiate claims about "prebiotic(s)", please contact: health.claims-allegations.sante@hc-sc.gc.ca.

Because prebiotics are non-digestible carbohydrates, they can be considered as fibre. However, use of the term "prebiotic(s)" must not be made in conjunction with a fibre claim in such a way as to imply that all fibres are "prebiotic(s)", as this is not the case.

General health claims

General health claims are broad claims that promote health through healthy eating or that provide dietary guidance. These claims do not refer to a specific or general health effect, disease or health condition.

Conditions of use for general health claims

General health claims are permitted on foods when the message being transmitted is in line with the dietary recommendations outlined in Canada's food guide.

No drug representations for general health claims

General health 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 versus foods).

Educational material

General health claims are founded on broad food principles; therefore they can often be mistaken or associated with educational material. For more information on educational material, refer to Educational material versus advertising material.

Third-party endorsements, logos and heart symbols

General health claims are often used in conjunction with trademarks or logos, for example, heart symbols. For information on third-party endorsements, logos and heart symbols, refer to Pictures, vignettes, logos and trademarks.

Use of the terms "nutritious" and "healthy"

The word "nutritious" can be used on a food that contains at least a "source" of 1 nutrient permitted in the Nutrition Facts table. For more information on "source claims", please refer to How to use the Table of Permitted Nutrient Content Statements and Claims  and Summary table of vitamin and mineral claims. See Nutrient function claims for the definition of a nutrient.

The word "healthy" refers to the healthy eating patterns recommended by Canada's food guide. The use of the word "healthy" on a food that does not meet the recommendations of Canada's food guide could be misleading.

It is important to note that the use of the word "nutritious" or "healthy" on foods that are normally exempt from declaring a Nutrition Facts table cause a loss of exemption (see Reasons for losing the exemption) [B.01.401(3)(e)(ii), FDR].

The use of these terms in reference to bulk foods does not trigger any additional information to be declared.

Weight loss claims versus weight maintenance claims

As obesity is included in Schedule A of the Food and Drugs Act, foods may not be advertised as a treatment, preventative or cure for this condition.

The only foods allowed to be advertised for use in weight reduction diets are meal replacements, prepackaged meals, foods sold by a weight reduction clinic and foods represented for use in very low energy diets as described under Division 24 of the FDR [B.24.003, FDR]. See Foods for special dietary use for information on these foods.

There is a distinction between weight loss or reduction claims and weight maintenance claims. Some foods may be represented for use in achieving and maintaining a healthy body weight. Industry can avoid creating a misleading or erroneous impression when making claims about weight maintenance by adhering to the following 5 conditions;

  1. The principal display panel of the label of the food and any advertisements for the food carries the statement, "As part of healthy eating, this food may assist in maintaining a healthy body weight because it is... (for example, "lower in energy than...", "low in fat", "portion controlled", etc.).
  2. The label displays the Nutrition Facts table (see Nutrition labelling for the general requirements for declaring the Nutrition Facts table).
  3. Labels or advertisements may make reference to statements from Canada's food guide. For more information on the conditions of use of content from the food guide, refer to the Government of Canada's website on Terms and conditions.
  4. The label, packaging or advertisements do not give the impression that the food is for use in a weight-reduction diet. Requirements regarding foods represented for use in a weight-reduction diet are set out in Division 24 of the FDR and summarized in Foods for special dietary use.
  5. Brand and trade names traditionally considered as claims for weight reduction are qualified with the statement "for weight maintenance" next to the brand or trade name on the principal display panel.

Implied health claims

Implied health claims can consist of logos, symbols or words (for example, "prebiotic", "probiotic", "antioxidant"), presented either alone or in combination. The logos, symbols or words used to make the implied health claim will contribute to the overall impression created about the product. This could result in a message that is not consistent with an acceptable health claim and therefore could be misleading.

An implied health claim could be, for example, the picture of a brain on a carton of eggs accompanied by the word "smart" because the combination of these 2 elements suggests that the consumption of these eggs could lead to improved intelligence or brain health. This could potentially be misleading and would not be permitted. However, if the accepted nutrient function claim from the Acceptable nutrient function claims table is included, "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", with the picture of the brain and the word "smart", the overall message and impression is clear and would be acceptable.

Implied health claims are evaluated on a case-by-case basis.

Health claims for children under 4 years of age

There is no prohibition in the Food and Drug Regulations against the use of health claims on foods for children under 4 years of age with the exception of disease risk reduction claims and therapeutic claims.

Disease risk reduction claims and therapeutic claims

Disease risk reduction claims are not permitted on foods that are intended solely to be consumed by children less than 4 years of age, such as infant cereal and pureed fruits and vegetables [B.01.601(1)(c)(i), FDR]. Likewise, the claims set out in Health Canada's Health Claim Assessments that are not in the FDR are only for use on food for adults.

Nutrient function claims for children under 2 years of age

The following nutrient function claims for folate should not be used on foods intended solely for children under 2 years of age:

Refer to the Acceptable nutrient function claims table for more information.

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

Additional information

Schedule 1 (subsection 1(1)) - included natural health product substances

  1. A plant or an animal material, an alga, a bacterium, a fungus or a non-human animal material
  2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
  3. Any of the following vitamins:
    1. biotin
    2. folate
    3. niacin
    4. pantothenic acid
    5. riboflavin
    6. thiamine
    7. vitamin A
    8. vitamin B6
    9. vitamin B12
    10. vitamin C
    11. vitamin D
    12. vitamin E
  4. An amino acid
  5. An essential fatty acid
  6. A synthetic duplicate of a substance described in any of the items 2 to 5
  7. A mineral
  8. A probiotic

Schedule 2 (subsection 1(1)) - excluded natural health product substances

  1. A substance set out in Schedule C to the Act
  2. A substance set out in Schedule D to the Act, except for the following:
    1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
    2. any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
  3. A substance regulated under the Tobacco Act
  4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
  5. A substance that is administered by puncturing the dermis
  6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic

Schedule A diseases from the Food and Drugs Act [Section 3]

Reference list for probiotic claims

Decisions

"Enzyme rich"

The claims "enzyme rich", "rich in enzymes", "excellent source of enzymes", "high source of enzymes", or other similar statements are not acceptable claims for foods. Such claims imply that enzymes, as a class, are beneficial when ingested. This is not the case. In addition, there are no established parameters to determine whether a food is "rich" in enzymes.

However, statements or claims that indicate the presence of enzymes are acceptable, that is to say, "contains (naming the enzyme or enzymes)".

Oxygen radical absorbing capacity (ORAC) statements and claims

Statements or claims about oxygen radical absorbing capacity (ORAC) are not acceptable on foods because the relationship between ORAC scores and health effect in humans has not been established. ORAC scores are a measure of the rate of reaction and antioxidant capacity of a substance, determined in an in vitro test.

However, a claim about an antioxidant effect may be made on foods when a specific antioxidant function is a well-substantiated physiological effect in healthy subjects, as determined in controlled human studies. See the Acceptable function claims table and the Acceptable nutrient function claims table for acceptable antioxidant claims as applied to foods or food constituents.

Definitions

Disease risk reduction claims

Statements that link a food to a reduced risk of developing a diet-related disease or condition in the context of the total diet. For example, "[Naming the food or food constituent] may reduce the risk of cardiovascular disease".

Drug

Includes any substance or mixture of substances manufactured, sold or represented for the use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, or
  2. restoring, correcting or modifying organic functions in human beings or animals, or
  3. disinfection in premises in which food is manufactured, prepared or kept [2, FDA]

Drug claims

Claims that suggest that the product has the properties of a drug (for example, the treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms) or that the product has an effect on the body that is beyond that which is normally associated with a food (for example, restoring, correcting or modifying organic functions in the body).

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 [2, FDA].

Function claims

Claims that refer to the specific beneficial effects that the consumption of a food or food constituent has on normal functions or biological activities of the body. Such claims relate to a positive contribution to health or performance. For example, "[Naming the food or food constituent] promotes regularity or laxation".

General health claims

Broad claims that promote health through healthy eating or that provide dietary guidance. These claims do not refer to a specific or general health effect, disease, or health condition.

Health claim

Any representation in labelling or advertising that states, suggests, or implies that a relationship exists between the consumption of a food and health.

Health-related representation

For the purposes of front-of-package (FOP) nutrition symbol labelling, a "health-related representation" means [B.01.357(3), FDR]:

Laxation

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.

Natural health product (NHP)

A substance set out in Schedule 1 [NHPR] or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
  2. restoring or correcting organic functions in humans, or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health

However, a natural health product does not include a substance set out in Schedule 2 [NHPR], any of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or traditional medicine that is or includes a substance set out in Schedule 2 [1, NHPR].

Nutrient function claims

Claims that relate to statements or other claims to the effect that a food's energy (Caloric) value or a nutrient contained in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development. For example, "Energy [or naming the nutrient] is a factor in the maintenance of good health".

Nutrition symbol

"Nutrition symbol" means a symbol that is carried on the principal display panel of a prepackaged product under subsection B.01.350(1) [B.01.001(1), FDR].

Prebiotic(s)

Non-viable food component that confers a health benefit on the host associated with modulation of the microbiota.

Probiotics

"Live microorganisms which when administered in adequate amounts confer a health benefit on the host" (FAO/WHO, 2001; see Reference list for probiotic claims).

Therapeutic claims

Claims that refer to the treatment or mitigation of a disease or health-related condition, or about restoring, correcting or modifying body functions. For example, "[Naming the food or food constituent] lowers blood cholesterol".

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