Health Claims

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Table of Contents

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 a NHP, it is subject to the Food and Drug Regulations or Natural Health Products Regulations respectively.

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

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

Use Drugs vs. Foods to verify if the claim refers to a schedule A disease or is a drug claim. If yes, see Drug Representations and Premarket Approval to learn about their specific requirements such as obtaining a premarket approval in certain cases. Disease risk reduction claims (definition) or therapeutic claims (definition) 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 three.

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

Function claims (definition) 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 four.

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

Nutrient function claims (definition) 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 five.

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

Probiotic (definition) 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) (definition) 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 Prebiotics to learn about their specific requirements.

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

6. Does the claim refer to healthy eating patterns?

General health claims (definition) 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" (definition) is defined in the Food and Drugs Act (FDA). Natural health products (definition), 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 (i.e. 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 four factors into consideration to classify a product:

  • Product composition
  • Product representation
  • Product format
  • Perception of history and use

For more information on the above criteria or on NHPs, please consult Health Canada's webpage on Authorized food products.

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. For further information on NHPs that have been authorized for sale in Canada, see the Licensed Natural Health Products Database (LNHPD).

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 information on applying for licensing, see About Natural Health Product Regulations in Canada.

Drugs vs. Foods

Just like the term "food" (definition), the term "drug" (definition) is also defined in the Food and Drugs Act. 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, 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.

Below are examples of drug claims that are not permitted on foods.

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" (definition) 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".

Drug Representations and Pre-market Approval

When a health claim brings a food under the definition of a "drug" (definition) through the use of a disease risk reduction claim (definition) or a therapeutic claim (definition), a pre-market assessment of the claim, by the Food Directorate of Health Canada, is mandatory. Furthermore, when a health claim makes reference to a Schedule A disease, a premarket review 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.

Acceptable Disease Risk Reduction Claims and Therapeutic Claims

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].

Function Claims

Function claims (definition) relate to the effects that a food has on the normal functions of the body. They are based on the role that the food or the food constituent plays when consumed at levels consistent with normal dietary patterns.

Function claims also contain two subcategories of claims:

Both these categories have different labelling requirements. To obtain more information on the requirements related to each claim, select the appropriate link above.

Conditions of Use for Function Claims

As with all health claims, function claims are subject to the General Principles for Labelling and Advertising.

No Drug Representations for Function Claims

A function claim about the physiological effects of food or food constituents must not refer directly or indirectly to the treatment, mitigation or prevention of any disease, disorder or abnormal physical state, or of their symptoms. In addition, claims about restoring or correcting abnormal functions of the body or modifying body functions beyond the normal physiological effects of food are considered to be drug claims, not function claims (see Drugs vs. Foods).

Language Requirements for Function Claims

There are no specific language requirements set out in the Food and Drug Regulations for general function claims. However, it is recommended that when a function claim is made on the label of a food, it appear in both English and French unless a bilingual labelling exemption applies to the product [B.01.012(3) or (7), FDR].

Declaration of a Nutrition Facts Table for Function Claims

When a function claim appears on the label of a prepackaged food or in advertisements made or placed by or on the direction of the manufacturer of the food, the label of a food that is normally exempt from declaring a Nutrition Facts table (NFT) loses its exemption and is required to declare a NFT. See Reasons for losing the exemption [B.01.401.(3)(e)(ii), FDR].

Quantitative Statements for Function Claims

The Table of Acceptable Food or Food Constituent Function Claims outlines the conditions for each function claim. In many cases, these conditions include a quantitative declaration.

While there are no requirements for quantitative declarations set out in the Food and Drug Regulations for general function claims, it is strongly recommended that when a function claim is made about a food constituent on the label of a prepackaged product or in any advertisement for the food that is made or placed by or on the direction of the manufacturer or importer, a quantitative declaration of the amount of the food constituent (per serving of stated size) appear on the label.

When a function claim appears on the label or in an advertisement for a non-prepackaged product or in any advertisement for a prepackaged product not made or placed by or on the direction of the manufacturer or importer, the quantitative amount of the food constituent (per serving of stated size) that is the subject of the function claim should also appear on the label or in the advertisement.

In certain situations the amount of the food or food constituent in a serving of food is less than that required to achieve the claimed physiological effect. In these cases, the amount of the food or food constituent required to produce the desired effect and the amount of the food or food constituent in a serving of stated size of the food must be declared as part of the function claim. For example, "1 tsp of (naming the product) provides 3g of fibre from coarse wheat bran. Consuming 7 grams of fibre from coarse wheat bran daily promotes regularity".

Science Research

Companies wanting to make function claims must have scientific evidence to validate the claim prior to its use on food labels or in advertisements. This evidence may be used by the CFIA, in collaboration with Health Canada, to evaluate product compliance with the Food and Drugs Act and Regulations. Consequently, manufacturers and importers are encouraged to contact the Food Directorate of Health Canada for advice regarding the acceptability of function claims on food products prior to their use. Claims reviewed and found to be acceptable will be added to the Table of Acceptable Food or Food Constituent Function Claims.

Health Canada considers the following factors in determining the acceptability of new function claims:

  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 (e.g. promotes normal transit time) is not considered to be supported when the evidence is based on therapeutic (treatment) effects in sick populations (e.g. treatment of diarrhea).
    • The amount of the food or food constituent required to achieve the claimed physiological effect must be based on the evidence supporting the claim.
    • The target population must be able to consume the amount of food or food constituent required to achieve the effect as part of a healthy, balanced diet. The amount of the food or food constituent required to achieve the claimed physiological effect could be consumed in a Reasonable Daily Intake (RDI) of the food. (Refer to Reasonable Daily Intake of Various Foods). Where no RDI has been established, the amount of the food or food constituent to achieve the claimed physiological effect is to be consumed in a single serving of stated size, unless the function claim is related to a food constituent that is available in a variety of foods. In this case, the amount of the food constituent in the food per serving of stated size and the amount of the food constituent required to achieve the claimed effect or benefit must be declared along with the claim.
  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 (e.g. promotes regularity) associated with good health or performance. Claims that state a specific effect provide more useful information for the consumer and are less likely to be misleading or misunderstood than a claim about a general or broad effect.

Function claims also must not give the impression that the food is "healthier" than, or "nutritionally superior" to, other similar foods not bearing the claims.

Claims that state a general or broad effect (e.g. supports immune function/system) are not considered acceptable. As a general rule, a vague, non-specific or broad claim is acceptable only for a well-established role of energy or a known nutrient in maintaining the functions of the body essential for the maintenance of good health or for normal growth and development (see Nutrient Function Claims). A non-specific or broad claim is also subject to interpretation and inference and in some cases could be considered a drug claim (see No Drug Representations for Function Claims).

Use these examples to help you determine if a claim is "Specific" or "Vague".

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 Notes

Table Note 3

Use of the phrase shown in parentheses is optional. For the claims for green tea, Consumption of 1 cup (250 ml) of may be replaced by Consumption of 1 cup of or Consumption of 250 ml of.

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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 one serving contains a minimum of 7 grams of dietary fibre from coarse wheat bran.

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

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

See Drugs vs. Foods for more information on laxative claims.

Green Tea
unfermented leaves and/or bud from Camellia sinensis

Consumption of [1 cup (250 ml) of Table Note 4] green tea helps to protect blood lipids from oxidation.

[Consumption of 1 cup (250 ml) of Table Note 4] green tea has an antioxidant effect in blood [or on blood lipids].

[Consumption of 1 cup (250 ml) of Table Note 4] green tea increases antioxidant capacity in the blood.

A green tea infusion brewed following manufacturer directions, which contains at least:

  • 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 (e.g. iced green tea) containing at least 0.8 grams freeze dried or spray dried tea infusion per reference amount and serving of stated size when prepared according to manufacturer directions.

Advertising and/or labelling may include a precautionary statement indicating that a maximum of 9 cups per day should not be exceeded due to the caffeine content.

Psyllium Table Note 5
  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 one serving contains a minimum of 3.5 grams of dietary fibre from psyllium seed.

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

Where the RDI of a food product comprises more than one serving and the product provides less than 3.5 grams of fibre from psyllium seed in one serving of stated size, claims (c) or (d) may be made.

See Dietary Fibre in Elements within the Nutrition Facts Table for more information about the acceptability and labelling of fibre sources.

Table Notes

Table note 4

Use of the phrase shown in parentheses is optional. For the claims for green tea, Consumption of 1 cup (250 ml) of may be replaced by Consumption of 1 cup of or Consumption of 250 ml of.

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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

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Laxation Claims

The term "laxation" (definition) is accepted as referring to the normal softness and bulking of the stool resulting from such factors as increased undigested residue or bacterial mass, trapping of gases or water retention.

Claims for the promotion of "laxation" or "regularity" are acceptable for foods when a Reasonable Daily Intake of the food contains a minimum of 7 grams of dietary fibre from coarse wheat bran. Such claims may be made for other foods provided that the claim is substantiated by evidence from clinical studies that a Reasonable Daily Intake of the foods has a laxation effect and no adverse effects. If a Reasonable Daily Intake is made up of several servings, the amount of the food required to produce the laxation effect and the number of servings it comprises should be declared as part of the claim. See Dietary Fibre of the Elements within the Nutrition Facts Table web page for further information on fibre sources.

For the use of the term Laxative, refer to Laxative Claims under the Drugs vs. Foods.

Nutrient Function Claims

Nutrient function claims (definition), a subset of function claims, describe the well-established roles of energy or nutrients that are essential for the maintenance of good health or for normal growth and development.

Nutrients include carbohydrate, protein, fat, fatty acids, sugars and the vitamins and minerals listed in Division D, Food and Drug Regulations. Additionally, substances recognized as nutrients by the Institute of Medicine of the National Academies of Science, Washington, D.C. are considered nutrients. Other food components, such as lycopene, lutein, anthocyanins and other compounds found in foods are not considered nutrients for labelling purposes.

Conditions of Use for Nutrient Function Claims

Provisions for nutrient function claims are made in B.01.311, D.01.006 and D.02.004 of the FDR.

No Drug Representations for Nutrient Function Claims

Nutrient function claims may not refer to the treatment, prevention or cure of a Schedule A disease; or claim to treat, mitigate, or prevent a disease, disorder or physical state; or claim to correct, restore or modify an organic function [3(1) and 3(2), FDA]. Such claims are considered to be drug claims (see Drugs vs. Foods).

Language Requirements for Nutrient Function Claims

Nutrient function claims must be present in both English and French unless a bilingual labelling exemption applies to the product [B.01.311(5) and B.01.012(3) or (7), FDR].

Declaration of the Amount of the Nutrient

Whenever a nutrient function claim is made, the consumer must be informed as to the amount of energy or nutrient present in a serving of the food. This may be achieved through a declaration in the Nutrition Facts table (NFT) or in a quantitative statement outside the NFT; the manner in which the information is provided depends upon a number of factors described below [B.01.311(4), B.01.401(3)(e), D.01.004(1)(c) and D.02.002(1)(c), FDR].

1. Nutrition Facts Table

When a nutrient function claim appears on the label of a prepackaged food or in advertisements placed by or on the direction of the manufacturer of the food, the label of the food must declare a Nutrition Facts table (NFT) [B.01.401, FDR]. Foods that are normally exempt from declaring a NFT lose their exemption and are required to declare a NFT containing the energy value or nutrient value that is the subject of the claim. See Reasons for losing the exemption [B.01.401(3)(e)(ii), FDR].

2. Quantitative Statement for Nutrient Function Claims

Information for Prepackaged Products and Advertisements Placed by the Manufacturer

The Regulations also permit nutrient function claims to be made for nutrients other than those permitted in the NFT, e.g. essential fatty acids such as DHA. In these cases, a quantitative declaration of the amount of the nutrient(s), in grams per serving of stated size, must appear on the label of the food [B.01.311(4), FDR].

Information for Non-Prepackaged Products or Advertisements Placed by Someone Other than the Manufacturer

When a nutrient function claim appears on the label or in an advertisement for a non-prepackaged product or in an advertisement for a prepackaged product not made or placed by or on the direction of the manufacturer or importer, the quantitative amount of energy or nutrient present, shall be declared per serving of stated size and shall appear on the label or in the advertisement, where the claim is made.

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.01.300, B.01.311(3), B.01.312, D.01.004(1)(c), D.02.002(1)(c), FDR]

See Advertisements for Nutrient Function Claims below for more information regarding quantitative statements in television and radio advertisements.

See Nutrient Content Claims for more information on quantitative statements.

Food vs. Nutrient

Nutrient function claims are not made for a food per se; they may only be made respecting the energy value or nutrients in a food. For example, the nutrient function claim "Milk helps build strong bones and teeth" is unacceptable, because a nutrient function claim refers to the nutritional function of energy or a nutrient (e.g., calcium) in a food, not a particular food (e.g., milk). An acceptable claim is "Milk is an excellent source of calcium which helps build strong bones and teeth".

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 (See Item b of Summary Table of Protein Claims).

Vitamin and Mineral Nutrients [D.01.004, D.02.002, FDR]

When nutrient function claims are made for vitamin and mineral nutrients, the vitamin or mineral nutrient must have an established Recommended Daily Intake (RDI). The food must contain a minimum of 5% of the RDI for the vitamin or mineral stated in the claim (i.e. being at least a dietary source of the nutrient). Recommended Daily Intakes for vitamins and mineral nutrients are found under Recommended Daily Intake (RDI). The percent Daily Value (% DV) of the vitamin or mineral nutrient that is the subject of the claim must appear in the Nutrition Facts table, if not already required.

Acceptable Nutrient Function Claims Table

Note that when a nutrient function claim is made for a nutrient, the food is not required to be a source of that nutrient unless it has an established "source" claim criteria, as listed above for protein and vitamin and mineral nutrients.

Nutrient function claims can also be made about a nutrient that is not a core nutrient (listed in B.01.401, FDR) nor an "additional" nutrient (listed in B.01.402, FDR), e.g., essential fatty acids such as linoleic acid and DHA (docosapentaenoic acid).

General Nutrient Function Claims

The following statements are two general nutrient function claims that are permissible for all nutrients. [B.01.311, B.01.312, D.01.006 and D.02.004, FDR]:

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

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

Specific Nutrient Function Claims

In addition to the two general nutrient function claims listed above, the Table of Acceptable Nutrient Function Claims below lists specific nutrient function claims associated with nutrients. The claims in the table refer to the scientifically recognized specific role each nutrient has in maintaining good health or in supporting normal growth and development. Other nutrient function claims may also be acceptable and will be evaluated on a case by case basis. The table will be updated as new nutrient function claims are reviewed and found to be acceptable by Health Canada. See Acceptability of New Nutrient Function Claims for more information on approval of a new nutrient function claim.

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 two general nutrient function claims are permissible for all nutrients [B.01.311, B.01.312, D.01.006, D.02.004, FDR]:

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

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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.

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Table Note 8

In order to make these two claims for folate, the food must contain at least 40 micrograms of folate (20% Daily Value) per reference amount and per serving of stated size. This is a higher minimum amount than usual for a nutrient function claim for a vitamin because the function referred to in these two claims is associated with an intake that is higher than the Daily Value. These claims should not be used on foods intended solely for children under 2 years of age.

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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, i.e., audio mode, visual mode, or both audio and visual modes.

  • When the claim is delivered in the audio portion of the advertisement only then the quantitative statement must be communicated immediately preceding or following the claim in the audio mode or in both the audio and visual modes [B.01.312(4)(a), FDR].
  • When the claim is delivered in the visual portion of the advertisement only the quantitative statement must be communicated immediately preceding or following the claim in the audio mode or in the visual mode [B.01.312(4)(b), FDR].
  • In the case where the claim is made in both the audio and visual portions of a television advertisement the quantitative statement must be in the audio mode or in both the audio and visual modes.
  • In the case where the quantitative statement appears in the visual mode, it must appear at the same time and for the same length of time as the claim; must be adjacent to (without intervening material) the most prominent (or only) claim; and must be in letters of at least the same size and prominence as the claim [B.01.312(5), FDR].

Acceptability of New Nutrient Function Claims

This section applies to nutrients that meet the following criteria:

  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:

  1. the name of the authoritative body;
  2. the exact wording of the statement;
  3. a copy of the source document in which the statement is published;
  4. a description of the review process undertaken by the authoritative body to develop the statement; and
  5. an indication that there is no conflicting authoritative statement.

See Science Research for information on how function claims are assessed for nutrients for which no Recommended Dietary Allowance (RDA), Adequate Intake (AI), or Acceptable Macronutrient Distribution Ranges (AMDR) have been established by the Institute of Medicine of the US National Academies (e.g. DHA).

Probiotic Claims

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

  • the term "probiotics" and similar terms or representations;
  • "with beneficial probiotic cultures";
  • "contains bacteria that are essential to a healthy system"; and
  • Latin name of a microbial species modified to suggest a health benefit.

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.

  • Strain-specific claims are claims about the health benefits or effects of specific strains of probiotics. At the present time, no strain-specific claims have been accepted by Health Canada. As these claims are reviewed and accepted, Health Canada will create a list of acceptable strain-specific claims that will be available on their website.
  • Non-strain-specific claims are statements about the nature of probiotics. A closed list of non-strain-specific probiotic claims that are acceptable without the need for the manufacturer to conduct a detailed review of the scientific basis for the claim is provided in the Table of Acceptable Non-Strain Specific Claims for Probiotics.

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.

  • The use of "probiotic" and other similar terms and representations (including trade names that suggest a health benefit) should be accompanied by specific, validated statements about the benefits or effects of the probiotic. This will reduce the possibility of these statements being vague, uninformative or misleading.
  • Validated health claims about the health benefits or effects of probiotics are statements that are supported by strain-specific evidence.
  • When making any probiotic claim, the manufacturer or importer of the product should have documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product.
  • The manufacturer or importer must follow all requirements applicable to the sale of food, including those related to the use and labelling of ingredients used in novel technology in the delivery of a viable microorganism for food application.
  • The food should contain, at a minimum, the amount of the probiotic microorganism(s) required to result in the claimed effect or health benefit throughout the shelf life of the product. Documentation to support the functionality aspects of the product (i.e. stability and viability of the probiotic strain or mixed culture) should be maintained.

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 (i.e. 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 (e.g. 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-B.01.010, 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 section B.01.010 of the FDR. The class name "bacterial culture" may be used to describe all bacterial species added to a food product. When the class name (e.g. bacterial culture) is used in the list of ingredients, the identity (i.e. 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 (e.g. 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 one 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 one 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 of 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 of 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.

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. In order to properly make a reference to Canada's Food Guide see Canada's Food Guide References below.

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 vs. 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 Trade Marks.

Canada's Food Guide References

In order to refer to or quote Eating Well with Canada's Food Guide and Eating Well with Canada's Food Guide: A Resource for Educators and Communicators, the official title must be used and complete quotations must be used. The General Principles for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising can be found on the Health Canada website.

Information detailing the policies around Eating Well with Canada's Food Guide and Eating Well with Canada's Food Guide: A Resource for Educators and Communicators can be found on the Health Canada website.

Canada's Food Guide Serving Claims

When making a Canada's Food Guide serving claim, for example "[Naming the food] contains one serving of vegetables", the product would have to contain an amount of vegetables equivalent to a Food Guide Serving in an appropriate serving size. Health Canada has established that all fruits and vegetables that are fresh, frozen, canned or dried can be included to determine the amount of fruits and vegetables in a product. However, fruits and vegetable in powdered form cannot be included in determining the amount of fruit and vegetable of a product.

Visit Health Canada's website to view a copy of Eating Well with Canada's Food Guide.

Use of the Terms "Nutritious" and "Healthy"

The word "nutritious" can be used on a food that contains at least a "source" of one nutrient permitted in the Nutrition Facts table. For more information on "source claims" please refer to How to Use the Claims Tables and Summary Table of Vitamin and Mineral Claims. See Nutrient Function Claims (definition) for the definition of a nutrient.

The word "healthy" refers to the healthy eating patterns recommended by Eating Well with 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 NFT 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 vs. 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, 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 five 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... (e.g., "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 the statements from Health Canada's Eating Well with Canada's Food Guide, see Health Canada's webpage on General Principles for the Use of Content from Canada's Food Guide Resources in Labelling and Advertising for the use of statements.
  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, FDA 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", etc.), 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 two 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 year 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.

Children Under Two Years of Age

There is no prohibition in the Food and Drug Regulations against the use of health claims on foods for children under two 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 (definition) are not permitted on foods that are intended solely to be consumed by children less than two years of age, such as infant cereal and pureed fruits and vegetables [B.01.601(1)(c)(i), FDR]. Likewise, the new 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 Two Years of Age

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

  • a factor in normal early fetal development, and
  • a factor in the normal early development of the fetal brain and spinal cord.

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]

  • Acute alcoholism
  • Acute anxiety state
  • Acute infectious respiratory syndromes
  • Acute, inflammatory and debilitating arthritis
  • Acute psychotic conditions
  • Addiction (except nicotine addiction)
  • Appendicitis
  • Arteriosclerosis
  • Asthma
  • Cancer
  • Congestive heart failure
  • Convulsions
  • Dementia
  • Depression
  • Diabetes
  • Gangrene
  • Glaucoma
  • Haematologic bleeding disorders
  • Hepatitis
  • Hypertension
  • Nausea and vomiting of pregnancy
  • Obesity
  • Rheumatic fever
  • Septicemia
  • Sexually transmitted diseases
  • Strangulated hernia
  • Thrombotic and Embolic disorders
  • Thyroid disease
  • Ulcer of the gastro-intestinal tract

Reference List for Probiotic Claims

  • ATCC. 2008. American Type Culture Collection [online]. Manassas (VA): The Global Bioresource Center. Available from: www.atcc.org/ [Accessed 28 May 2008].
  • European Food Safety Authority (EFSA). Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal 2007;587:1-16; Appendix A: Scientific report on the assessment of gram-positive non-sporulating bacteria. Available from: http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/
    sc_appendixa_qps_en.pdf?ssbinary=true [Accessed 28 May 2008].
  • Euzéby JP. 2008. List of bacterial names with standing in nomenclature: a folder available on the Internet. Int J Syst Bacteriol 1997;47(2):590-592. Last full update: May 2, 2008. Available from: www.bacterio.cict.fr/ [Accessed 15 May 2008].
  • FAO/WHO. 2001. Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Córdoba, Argentina, October 1-4, 2001. Available from: www.who.int/foodsafety/publications/fs_management/probiotics/en/index.html [Accessed 3 April 2008]
  • FAO/WHO. 2002. Guidelines for the Evaluation of Probiotics in Food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, April 30 - May 1, 2002. Available from: www.who.int/foodsafety/publications/fs_management/probiotics2/en/index.html [Accessed 3 April 2008]
  • FAO/WHO. 2006. Probiotics in Food: Health and Nutritional Properties and Guidelines for Evaluation. FAO Food and Nutrition Paper 85. Food and Agriculture Organization of the United Nations and World Health Organization, Rome. Available at: ftp://ftp.fao.org/docrep/fao/009/a0512e/a0512e00.pdf [Accessed 3 April 2008]. (This document integrates the 2001 and 2002 FAO/WHO reports listed above).
  • Gill H, Prasad J. Probiotics, immunomodulation, and health benefits. Adv Exp Med Biol 2008;606:423-454.
  • Gilliland SE. 2001. Technological and Commercial Applications of Lactic Acid Bacteria; Health and Nutritional Benefits in Dairy Products [online]. Background paper for the Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). Available from: ftp://ftp.fao.org/es/esn/food/Gilli.pdf [Accessed 28 May 2008].
  • Hawrelak JA. 2006. Probiotics. In: Textbook of Natural Medicine, 3rd ed., Vol. 1. Pizzorno JE Jr, Murray MT (eds.), pp. 1195-1215. St. Louis (MO): Elsevier Ltd.
  • Health Canada. 2009. The Use of Probiotic Microorganisms in Food. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/probiotics_guidance-orientation_probiotiques-eng.pdf
  • Lenoir-Wijnkoop I, Sanders ME, Cabana MD, et al. Probiotic and prebiotic influence beyond the intestinal tract. Nutr Rev 2007;65(11):469-489.
  • Picard C, Fioramonti J, François A, et al. Review article: bifidobacteria as probiotic agents - physiological effects and clinical benefits. Aliment Pharmacol Ther 2005;22(6):495-512.
  • Reid G. 2001. Regulatory and clinical aspects of dairy probiotics [online]. Background paper for the Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). Available from: ftp://ftp.fao.org/es/esn/food/Reid.pdf [Accessed 28 May 2008].
  • Reid G, Jass J, Sebulsky MT, McCormick JK. Potential uses of probiotics in clinical practice. Clin Microbiol Rev 2003;16(4):658-672.
  • Skerman VBD, McGowan V, Sneath PHA (eds). 1989. Approved Lists of Bacterial Names, Amended Edition [online]. Washington (DC): American Society of Microbiology Press. Available from: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=bacname [Accessed 28 May 2008].

Information Letters/ Policy Updates

Labelling and Composition of Food Containing Probiotic Microorganisms

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 i.e. "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 of 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 (e.g. 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 (e.g. 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.

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".

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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