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Chapter 8 - Health Claims

Chapter 8: Sections 8.1-8.7 | Sections 8.8-8.14 | Annexes

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8.1 Introduction

A health claim is any representation in labelling or advertising that states, suggests, or implies that a relationship exists between consumption of a food, or an ingredient in the food, and health. Health claims may be stated explicitly with words, or implied through symbols, graphics, logos or other means such as a name, trade mark or seal of approval. While the term "health claim" is not formally defined in food regulations in Canada, health claims have been classed into three main categories: disease risk reduction and therapeutic claims; function claims; and general health claims.

Most disease risk reduction and therapeutic claims are drug claims. A drug claim is a claim that suggests 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). Disease risk reduction claims and therapeutic claims are allowed on food only where specifically permitted by the Food and Drug Regulations (FDR; the Regulations). Disease risk reduction claims are generally statements that link a food or a constituent of a food to reducing the risk of developing a diet-related disease or condition (e.g. osteoporosis, cancer, hypertension) in the context of the total diet. The composition of a food that carries the claim must contribute to a dietary pattern associated with the claimed benefit. One example of such a claim is "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." Currently, there are several disease risk reduction claims permitted on food in Canada; these are discussed in 8.4 of this Guide. Therapeutic claims, on the other hand, are claims about treatment or mitigation of a health-related disease or condition, or about restoring, correcting or modifying body functions. At present, no therapeutic claims have been approved for food in Canada.

Broadly defined, function claims are claims about the specific beneficial effects that the consumption of a food or a constituent of a food (i.e. nutrient or other component) has on normal functions or biological activities of the body. Such claims relate to a positive contribution to health and to the maintenance of a physiological function or to physical or mental performance (see 8.5 of this Guide). Examples of function claims include "Consumption of green tea helps to protect blood lipids from oxidation" and "1/4 cup of Product X contains 7 grams of coarse wheat bran, which promotes regularity". Claims of this type must be clearly distinguishable from claims about disease risk reduction or therapeutic effects. Nutrient function claims, formerly known as biological role claims, are a subset of function claims that 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 (see 8.6 of this Guide). An example of a nutrient function claim is "Vitamin A aids in the development and maintenance of night vision".

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. In this Guide, 8.8 and 8.11-8.15 provide information on specific aspects of general health claims as they relate to vitamin and mineral nutrients (8.8), body weight (8.11), the use of educational material (8.12), third-party endorsements and logos (8.13), heart symbols (8.14), and guidance for healthy eating (8.15).

Compatibility with International Policy

Codex Alimentarius, an international standard-setting body to which Canada is a signatory, has guidelines that set out categories of health claims and conditions for their use (Guidelines for Use of Nutrition and Health Claims - PDF (33 kb) CAC/GL 23-1997, Rev. 1-2004 http:www.codexalimentarius.net/download/standards/351/CXG_023e_u.pdf.)

While there are some differences in the nomenclature and organization of the health claims categories, Canada allows for disease risk reduction claims, nutrient function claims, and function claims for other food substances, consistent with the categories in the Guidelines. Canada also allows the use of claims related to nutrition recommendations. More information on all of these types of claims are provided in this chapter of this Guide

8.2 General Principles for Health Claims

8.2.1 Avoiding Misleading Claims

All health claims are subject to subsection 5.(1) of the Food and Drugs Act (FDA; the Act), which states:

"No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

The following principles will promote the use of health claims that are less likely to be misleading or misunderstood:

  • The claim is meaningful. For example, claims that are too vague in nature may be misleading and may not provide clear and meaningful information to the consumer.
  • The health claim is based on science and supported by adequate scientific evidence.
  • It should be feasible to consume the effective amount of the food or the food constituent that is the subject of the claim in the context of a healthy, balanced diet.
  • When a claim is made about disease risk reduction, the food carrying the claim should contribute to a dietary pattern associated with the claimed benefit.
  • When a function claim is made about the benefit of a nutrient, the food carrying the claim should be at least a dietary "source" of the nutrient.
  • Some food constituents do not have established recommended nutrient intakes (RNI's) and therefore source levels of these substances have not been set. Where these are the subject of a health claim the amount of the food constituent in a serving of stated size of the food should be shown in conjunction with the claim. The amount of the food constituent required to achieve the claimed effect or benefit should also be shown.

Applying these principles and conditions increases the likelihood of developing a claim that is truthful and not misleading under subsection 5.(1) of the Act.

Disease risk reduction claims and nutrient function claims are also governed by specific provisions under Part B and Part D of the Food and Drug Regulations. These requirements will be discussed in further detail later in this chapter in the sections dealing with these classes of claims.

Wording of Claims

Care must be given to ensure that the meanings of claims are clear and that consumers are not misled. The context in which a word or phrase is used may have a profound effect upon the message conveyed. For example, the words "soothe" and "relax" may be used to express the comforting qualities of a food (e.g. "a soothing hot drink for those cold days" and "relax with a cup of Earl Grey tea"). However, the same words used in a different context could suggest a health effect or benefit (e.g. "a soothing tea for a good night's sleep" or "helps to relax stiff muscles"). These latter claims would be considered health claims and would be subject to the requirements for health claims set out in this chapter.

Trade Marks, Brand Names, Logos, Slogans

Trade marks, brand names, logos and slogans are subject to subsection 5.(1) of the Food and Drugs Act, and must not be false, misleading or deceptive. Any trade mark, brand name, logo or slogan that suggests or implies a health benefit by any means, including through nuance, double meanings, or implied meanings, are generally considered a health claim.

8.2.2 Industry's Responsibility for Health Claims That Are Truthful and Not Misleading

  • It is the responsibility of all food manufacturers and importers to ensure that their products comply with Canadian legislation.
  • New disease risk reduction claims and therapeutic claims require an amendment to the Food and Drug Regulations to permit their use on food. Pre-market assessment of new claims of this type by the Food Directorate of Health Canada is mandatory.
  • Health claims are subject to subsection 5.(1) of the Food and Drugs Act and should be scientifically validated. For health claims that have not been approved by Health Canada (e.g., claims not listed in this Guide), companies should have acceptable scientific evidence to validate the claim prior to its use.
  • The CFIA may request a company to provide scientific evidence in support of a health claim. This information will be used by the CFIA to verify compliance with the Food and Drugs Act and Regulations.

The regulation of health claims varies depending upon the type of health claim being made. In some cases a pre-market assessment of the health claim and the scientific evidence in support of the claim by the Food Directorate of Health Canada is mandatory, while in other cases it is voluntary but encouraged.

Disease risk reduction claims and therapeutic claims require an amendment to the Food and Drug Regulations to permit their use on food. Consequently, pre-market assessment of new claims of this type by the Food Directorate is mandatory. In the case of function claims, companies are encouraged to consult with the Food Directorate for guidance on the requirements to comply with subsection 5.(1) of the Food and Drugs Act that would pertain to specific claims that companies plan to use on their food products.

It is the responsibility of the industry to ensure that the composition, labelling and advertising of their products comply with Canadian legislation. As stated earlier, all health claims are subject to subsection 5.(1) of the Food and Drugs Act, which prohibits the labelling or advertising of a food in a manner that is false, misleading or deceptive. In order for a health claim to be considered not misleading there must be scientific evidence that substantiates the claimed health effect. Consequently, in order to make a health claim, other than a claim set out in the Food and Drug Regulations or a claim set out in this Guide, it is expected that companies should have scientific evidence that validates the health claim prior to its use. This evidence may be requested by the CFIA while carrying out its inspection and compliance activities to evaluate compliance with the Act and Regulations. In these cases, the evaluation of the scientific data will be carried out in collaboration with Health Canada. See 8.5.4 and 8.6.5 of this Guide regarding the acceptability of new function claims and new nutrient function claims, respectively.

Companies should also consult the Guidance Document for Preparing a Submission for Food Health Claims (Health Canada, 2009)

http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/health-claims
_guidance-orientation_allegations-sante-eng.php

This document provides guidance for identifying the available scientific evidence and determining the validity of claims. It also provides guidance on how to prepare a submission for review by the Food Directorate of Health Canada for all new claims, other than for nutrient function claims (formerly known as biological role claims). For guidance on submissions for new nutrient function claims, see 8.6.5 of this Guide.

Questions about the substantiation of health claims may be directed to the following mailing address or email address:

Nutrition Labelling and Claims Section, Nutrition Evaluation Division
Food Directorate, Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator: 2202E
Ottawa, Ontario K1A 0K9

E-mail: healthclaims-allegationssante@hc-sc.gc.ca

As new claims are reviewed and accepted, they will be included in future updates of this Guide.

8.3 Food, Drugs, Natural Health Products and Claims

Definitions

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

The terms "food" and "drug" are both defined in the Food and Drugs Act. Natural health products (NHP), which are a subset of drugs, are defined and regulated under the Natural Health Products Regulations (NHPR). These definitions are central to determining the correct classification of a product (i.e. food, drug or NHP) and whether a specific claim is appropriate for a product.

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. (Section 2, FDA)

Drug includes any substance or mixture of substances manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
  2. restoring, correcting or modifying organic functions in human beings or animals. (Section 2, FDA)

Natural health product (NHP) means a substance set out in Schedule 1 [NHPR; see Annex 8-1] 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; see Annex 8-1], any combination 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. (Section 1, NHPR)

Drug Claims

A claim that suggests that a food has an effect on the body that is beyond that which is normally attributed to a food is considered to be a claim reserved for a drug. This includes claims that a food may be used in the diagnosis, treatment, or prevention of a disease, disorder, abnormal physical state or its symptoms, or that a food may be used to restore, correct or modify an organic function. It is inappropriate for a food to carry a drug claim unless the claim is specifically permitted by the Food and Drug Regulations. However, it should also be noted that function claims about the specific effects that the consumption of a food or food constituent has on the normal functions or biological activities of the body are not considered drug claims. (See 8.5 and 8.6 of this Guide for information on function claims and nutrient function claims, respectively.)

Some examples of non-permitted drug claims on foods include:

  • "lowers blood cholesterol"
  • "maintains healthy blood cholesterol levels"
  • "lowers blood triglyceride levels"
  • "regulates blood sugar levels"
  • "is formulated to have the lowest potential for stomach upset and gas"
  • "is a rehabilitative supplement"
  • "balances hormone levels"
  • "soothes bladder infections"
  • "improves memory"

Due to the broad definition for a NHP there is an overlap between the two regulatory frameworks. Examples of products found in the overlap may include beverages and bars that carry health claims and certain substances listed in Schedule 1 of the NHPR (eg. vitamins, minerals and herbs). To clarify the criteria used to determine if a product is subject to the Food and Drug Regulations or Natural Health Product Regulations, Health Canada published principles and considerations in a guidance document entitled Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/
food-nhp-aliments-psn-guide-eng.php) for determination of its status as either a food or an NHP. Products that are determined to be foods are expected to comply with all applicable food regulations and policies. It is the responsibility of manufacturers or importers to ensure that their products meet all Canadian food legislation.

In addition, subsection 3.(1) of the Food and Drugs Act states that:

"No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A." (See Annex 8-2 of this Guide for a list of Schedule A diseases.)

Subsection 3.(1) of the Food and Drugs Act was enacted to prevent claims directed at the general public concerning serious health problems, which should be diagnosed and treated by a medical practitioner. Cancer is an example of a Schedule A disease. Claims about such health conditions are prohibited on food products advertised to the general public unless the claim is specifically permitted by the Food and Drug Regulations.

Drug Claims That Are Permitted on Food

Certain disease risk reduction claims (see 8.4 of this Guide) are permitted on food. This has been made possible through specific regulatory exemptions in the Food and Drug Regulations that permit a closed list of drug-like claims on food. There are currently no therapeutic claims permitted on foods.

To enable additional or new drug-like claims for a food product, an amendment to the Food and Drug Regulations is required. Manufacturers or importers wanting to make such health claims on food must make a pre-market submission using the Guidance Document for Preparing a Submission for Food Health Claims (Health Canada, 2009 http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/
health-claims_guidance-orientation_allegations-sante-eng.php) to the Food Directorate of Health Canada requesting a regulatory change to allow the claim (see 8.2.2 of this Guide for contact information).

8.4 Disease Risk Reduction Claims (formerly called Diet-Related Health Claims)

Objectives of Disease Risk Reduction Claims

The provisions for disease risk reduction claims are designed to help consumers make informed choices, thereby reducing their risk of developing chronic diseases. The standards also aim to ensure that these claims:

  • are consistent and not deceptive;
  • are based on recognized health and scientific criteria; and
  • describe the characteristics of a diet associated with reduced risk of developing the chronic disease identified in the health claim.

The 2002 amendments to the Food and Drug Regulations allow disease risk reduction claims on foods for the first time in Canada. These claims are 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.

Section 3, FDA, makes it an offence to advertise or sell a food to the general public as a treatment, preventative or cure for any of the diseases referred to in Schedule A. Hypertension and cancer, which are the subjects of two of the permitted claims, in the table following section B.01.603, are listed in Schedule A.

However, section B.01.601 of the FDR exempts certain foods bearing specified disease risk reduction claims from the provisions of subsections 3.(1) and 3.(2) of the FDA. In addition, food labelled in such a way is exempt from the provisions of the FDA and FDR applicable to drugs, except where the food would come within the definition of a drug for a reason other than the fact that its label or advertisement carries one of these claims. This means that although the Regulations allow for the use of the permitted disease risk reduction claims, other therapeutic statements or drug references would not be allowed on the same food, unless otherwise permitted.

A disease risk reduction claim is generally a statement that links a food or a constituent of a food to reducing the risk of developing a diet-related disease or condition, (e.g. osteoporosis, cancer, hypertension) in the context of the total diet. The composition of a food that carries the claim must contribute to a dietary pattern associated with the claimed benefits.

For example, the label of or an advertisement for a food which is low in sodium might carry the following claim (providing specific composition and labelling conditions are met): "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."

8.4.1 Permitted Disease Risk Reduction Claims

The Regulations now provide for claims which deal with the following relationships:

  • a diet low in sodium and high in potassium, and the reduction of risk of hypertension;
  • a diet adequate in calcium and vitamin D, and the reduction of risk of osteoporosis;
  • a diet low in saturated fat and trans fat, and the reduction of risk of heart disease;
  • a diet rich in vegetables and fruits, and the reduction of risk of some types of cancer; and
  • maximal fermentable carbohydrates in gum, hard candy or breath-freshening products, and the reduced risk of dental caries.

8.4.2 Prescribed Wording [B.01.601, B.01.603]

The Regulations prescribe the exact wording for the permitted disease risk reduction claims in the table following B.01.603 (see Table 8-1 of this Guide). 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. And in the case of advertisements, all parts of the claim must be displayed in equal prominence with no parts highlighted.

Language Requirements

When disease risk reduction claims appear on a label, they must be present in both English and French unless unless the food is a "local food", a "test market food", or a "specialty food" within the meaning of the Food and Drug Regulations and the mandatory information is permitted to be shown in only one of those languages [Subsections B.01.012(3) and (7) and section B.01.600].

8.4.3 Presenting Required Information

When a disease risk reduction claim is made for a food, the information in column 3 of Table 8-1, Summary Table of Disease Risk Reduction Claims, must be provided as required. For example, if a manufacturer claims that the food "won't cause cavities" (see column 1, item 5 in Table 8-1 of this Guide), the amount of sugar alcohols must be declared, if present (see column 3). The Food and Drug Regulations prescribe how this must be done.

Declaration of a Nutrition Facts table on Labels for Prepackaged Products or Advertisements Placed by Manufacturer

When a disease risk reduction claim appears on the label of a prepackaged food or in advertisements placed by or on the direction of the manufacturer or importer of the food, the label of the food must declare a Nutrition Facts table (NFT) [B.01.401]. Foods that are normally exempt from declaring a NFT under B.01.401(2) (a) and (b) of the FDR, such as fresh fruit and vegetables, lose their exemption and are required to declare a NFT. In addition, the nutrition information required by column 3 of Table 8-1 in this Guide must appear in the NFT on the label [B.01.401(3)(e)(ii)].

Requirements for Claims in Advertisements for Prepackaged Products Placed by Someone Other Than the Manufacturer or Importer or for claims on the Label of or in Advertisements for Non-Prepackaged Products

When a disease risk reduction claim is declared in an advertisement for a prepackaged product (other than a radio or television advertisement) made by someone other than the manufacturer or importer (such as a marketing board), the accompanying information - namely the nutrition information required by column 3 of the table following B.01.603 (see table 8-1 below) - must appear in the advertisement 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)].

Similarly, when a disease risk reduction claim appears on the label of or in an advertisement for a non-prepackaged food (such as bulk food) the nutrition information required by column 3 must appear on the label or the advertisement, respectively. The same requirements for placement of information would apply.

Radio Advertisements

When these claims are made in a radio advertisement the accompanying information must be communicated immediately preceding or following the claim [B.01.602(1)(b)].

Television Advertisements

In the case of a television advertisement, the manner in which the accompanying information is communicated depends upon 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.
  • 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)]
  • 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)]

8.4.4 Prohibitions on the use of Disease Risk Reduction Claims [B.01.601(1)(c)]

Foods Intended Solely for Children Under Two Years of Age.

Disease Risk Reduction claims 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)

Foods Represented for Use in a Very Low Energy Diet.

Disease Risk Reduction claims are also not permitted on foods represented for use in very low energy diets.[B.01.601(1)(c)(i)

8.4.5 Summary Table of Disease Risk Reduction Claims

Table 8-1 describes permitted disease risk reduction claims, including compositional criteria for the food to qualify for the claim and labelling and advertising requirements. (For the compositional requirements for nutrient content claims that form part of the conditions for disease risk reduction claims, see Chapter 7 of this Guide.)

Summary Table of Disease Risk Reduction Claims
Table 8-1

(May 2009)

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 Table 7-3 of this Guide.

(b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient (see Table 6-6),
(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 Table 7-6 in this Guide

(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 Table 7-10 of this Guide, 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 Table 7-10, 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 Table 6-2 [B.01.402(2)].

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 if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2) (a)&(b). [B.01.401(3)(e)(ii)]
(See 5.3 of this Guide)

[Item 1, Table following B.01.603]

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 Table 7-3 of this Guide;

(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 Table 6-2 [B.01.402(2)].

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 if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2) (a) & (b). [B.01.401(3)(e)(ii)]
(See 5.3 of this Guide)

[Item 2, Table following B.01.603]

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 Table 7-3 of this Guide;

(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 Table 7-8) or
(ii) the subject "source of omega-6 polyunsaturated fatty acids" (item (b) of Table 7-8), 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 Table 7-6), 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 Table 7-6) , 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, if applicable.

Nutrition Facts table required on products otherwise exempted by B.01.401(2)(a) & (b). [B.01.401(3)(e)(ii)]
(See 5.3 of this Guide)

[Item 3, Table following B.01.603]

4. Disease Risk Reduction Claims with Respect to Cancer Risk Reduction1

"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). [B.01.401(3)(e)(ii)]

(See 5.3 of this Guide)

[Item 4, Table following B.01.603]

5. Disease Risk Reduction Claims with Respect to Dental Caries

(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 Table 6-2 of this Guide. (B.01.402(2))

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

(See 5.3 of this Guide)

[Item 5, Table following B.01.603]

1This 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 listed in Item (b) and on foods that contain more than 0.5% alcohol, e.g. relish, ketchup, strawberry jam, wine, fruit juice based alcoholic beverage. It also can not 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.

8.5 Function Claims

Food provides energy and the building blocks needed for growth, development, and the maintenance of life and health. Function claims relate to the specific beneficial effects that the consumption of a food or a constituent of a food (nutrient or other component) has on the normal functions or biological activities of the body. Such claims relate to a positive contribution to health and the maintenance of a physiological function or to physical or mental performance.

Function claims are based on the role that the food or the food constituent plays when consumed at levels consistent with normal dietary patterns. See additional information in this Guide regarding quantitative declarations (8.5.2) and standards of evidence (8.5.4(1)).

Nutrient Function Claims

Claims made about known nutrients and their well-established functions that are essential for the maintenance of good health or for normal growth and development are known as nutrient function claims. Nutrient function claims, formerly known as biological role claims, have been allowed on foods for a number of years in Canada. Examples of such claims include "Protein helps build and repair body tissues" and "Vitamin D is a factor in the formation and maintenance of bones and teeth."

Nutrient function claims are considered a subset of function claims. They are discussed separately in this Guide (8.6) because there is a separate set of conditions for making such claims.

8.5.1 Conditions for Function Claims

As with all health claims, function claims are subject to subsection 5.(1) of the Food and Drugs Act that prohibits false, misleading or deceptive product representations (see 8.2.1 of this Guide).

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. 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 8.3 of this Guide). Such claims would require a pre-market review by Health Canada and (if the claim is supported by sufficient scientific evidence) an amendment to the Food and Drug Regulations to permit their use on food.

8.5.2 Labelling Information for Function Claims

Language Requirements

While there are no specific language requirements set out in the Food and Drug Regulations for general function claims, it is recommended that when a function claim is made on the label of a food, it appear in both English and French unless the food is a "local food", a "test market food", or a "specialty food" within the meaning of the Food and Drug Regulations and the mandatory information is permitted to be shown in only one of those languages [B.01.012(3) or (7)]

Declaration of a Nutrition Facts table

When a function claim appears on the label of a prepackaged food or in advertisements placed by or on the direction of the manufacturer or importer of the food, the label of the food must declare a Nutrition Facts table (NFT) [B.01.401]. Foods that are normally exempt from declaring a NFT under paragraphs B.01.401(2) (a) and (b) of the FDR, such as fresh fruit and vegetables, lose their exemption and are required to declare a NFT [B.01.401.(3)(e)(ii)].

Quantitative Declarations

Table 8-2, Summary Table of Acceptable Function Claims as Applied to Food or Food Constituents, outlines the labelling 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 should be declared as part of the function claim. (See Standards of Evidence, 8.5.4(1) of this Guide.)

8.5.3 Summary Table of Acceptable Function Claims as Applied to Food or Food Constituents

The function claims listed in Table 8-2 when used with the specified conditions would be acceptable. The table will be updated as new claims for food or food constituents are reviewed and found to be acceptable by Health Canada. See 8.5.4 of this Guide on acceptability of new function claims.

Summary Table of Acceptable Function Claims as Applied to Food or Food Constituents
Table 8-2

(May 2009)

Food or Food Constituent Acceptable Claim Conditionsfor use

Coarse Wheat Bran1

  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*) 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*) promotes regularity.

A Reasonable Daily Intake (RDI) (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 8.10.2 of this Guide for more information on laxative and laxation claims.

Green Tea
unfermented leaves and/or bud from Camellia sinensis

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

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

[Consumption of 1 cup (250 ml) of*] 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.

Psyllium1
  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*) 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*) promotes regularity.

A Reasonable Daily Intake (RDI) (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 6.8.1 of this Guide for more information about the acceptability and labelling of fibre sources.

*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.

1Cummings 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.

8.5.4 Acceptability of New Function Claims

This section does not apply to new nutrient function claims (formerly known as biological role claims) for nutrients for which a Recommended Dietary Allowance (RDA), Adequate Intake (AI), or Acceptable Macronutrient Distribution Ranges (AMDR) have been established. See 8.6.5 of this Guide for relevant information on that type of function claim.

As discussed in 8.2.2, it is expected that companies, wanting to make function claims, 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 (see 8.2.2 of this Guide for contact and resource information). Claims reviewed and found to be acceptable will be added to Table 8-2 of this Guide.

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 should ensure that they meet acceptable standards of evidence in supporting their claims. The evidence should 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 should be based on the evidence supporting the claim. In addition, it should be feasible for the target population to consume the amount of food or food constituent required to achieve the effect as part of a healthy, balanced diet. Consequently, it is expected that 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 Schedule K in Part D of the Food and Drug Regulations for information on RDI.) Where no RDI has been established, the amount of the food or food constituent to achieve the claimed physiological effect should 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 should 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 should 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) would not be considered acceptable function claims. As a general rule, a 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 (i.e. a nutrient function claim; see 8.6 of this Guide). A non-specific or broad claim is also subject to interpretation and inference and in some cases could be considered a drug claim (see 8.5.1 of this Guide).

8.6 Nutrient Function Claims (Biological Role Claims)

Nutrient function claims, formerly known as biological role claims, describe the well-established roles of energy or known nutrients that are essential for the maintenance of good health or for normal growth and development. Provisions for nutrient function claims are made in B.01.311, D.01.006 and D.02.004 of the FDR.

"Nutrient" is not defined in the Food and Drug Regulations for the purposes of food labelling and advertising. A substance is considered a nutrient if it is recognized as such by the Institute of Medicine of the National Academies, Washington, DC (www.iom.edu).

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

  • "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."

Note: 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.

Acceptable and Unacceptable Nutrient Function Claim Examples

The claims for the action or biological role of nutrients should not imply that consumption of the food, by itself, will have the effect attributed to the nutrient.

The following statement is an acceptable claim.

  • "Milk is an excellent source of calcium which helps build strong bones and teeth."

The following statement is an unacceptable claim.

  • "Milk helps build strong bones and teeth."

In addition to the two general nutrient function claims listed above, Table 8-3, Summary Table of Nutrient Function Claims lists specific nutrient function claims associated with nutrients The claims in the summary table refer to the scientifically recognized specific role each nutrient has in maintaining good health or in supporting normal growth and development. The following sections (8.6.1-8.6.4) describe the conditions that apply to specific nutrient function claims and the labelling and advertising requirements for all nutrient function claims.

8.6.1 Conditions for Nutrient Function Claims

The conditions for function claims as described in 8.5.1 of this Guide also apply to nutrient function claims.

Nutrient Function Claims for Protein [B.01.305(1)]

When nutrient function claims are made for protein, the food must meet the requirements for "source of protein", which includes having a minimum Protein Rating (PR) of 20 (See Item b of Table 7-4 of this Guide).

Nutrient Function Claims for Vitamin and Mineral Nutrients [D.01.004, D.02.002]

When nutrient function claims are made for vitamin and mineral nutrients, the vitamin or mineral nutrient must have an established Recommended Daily Intake and the food must contain a minimum of 5% of the RDI for that vitamin or mineral (i.e. at least a dietary source of the nutrient). Recommended Daily Intakes for vitamins and mineral nutrients are found in Table 1 to Divisions 1 and 2 of Part D of the Food and Drugs Regulations, respectively.

8.6.2 Labelling Requirements for Nutrient Function Claims for Prepackaged Products and for Advertisements Placed by the Manufacturer or Importer

Language Requirements

When they appear on a label, nutrient function claims must be present in both English and French unless the food is exempt from bilingual labelling, such as in the case of local foods permitted under section B.01.012 [B.01.012(3) or (7), B.01.311(5)].

Declaration of a 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 or importer of the food, the label of the food must declare a Nutrition Facts table (NFT) [B.01.401]. Foods that are normally exempt from declaring a NFT under B.01.401(2)(a) and (b) of the FDR, such as fresh fruit and vegetables, lose their exemption and are required to declare a NFT [B.01.401(3)(e)(ii)].

Quantitative Declarations

As a general rule, whenever a nutrient function claim is made the consumer must be informed as to the amount of the 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. [B.01.311(4), B.01.401(3)(e), D.01.004(1)(c), D.02.002(1)(c)].

When a nutrient function claim is made on a label of a prepackaged product or in any advertisement for the product that is made or placed on the direction of the manufacturer or importer, the label of the food must declare a NFT (see above).

When a nutrient function claim is made for the energy value of a food or one of the nutrients listed in column 1 of the tables to B.01.401 and B.01.402 (which list the nutrients permitted in the NFT), the energy value or nutrient value must be declared in the NFT table on the label of the food.

However, the Regulations also permit nutrient function claims to be made for nutrients other than those listed in the tables to B.01.401 and B.01.402, e.g. essential fatty acids such as DHA. In these cases, a quantitative declaration of amount of the nutrient(s), in grams per serving of stated size, must appear on the label of the food. [B.01311(4)].

See section 7.4 of this Guide for further information on quantitative statements.

8.6.3 Requirements for Nutrient Function Claims for Non-Prepackaged Products or for Advertisements Placed by Someone Other Than the Manufacturer or Importer

When a nutrient function claim appears on the label of 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 the subject of the claim (i.e., energy or nutrient), 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)]

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)].

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)].
  • When the claim is delivered in the visual portion of the advertisement only the quantitative information must be communicated immediately preceding or following the claim in the audio mode or in the visual mode.
  • 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.

8.6.4 Summary Table of Acceptable Nutrient Function Claims

The nutrient function claims listed in Table 8-3 are considered to be acceptable. Other nutrient function claims may also be acceptable and will be evaluated case by case. The table will be updated as new nutrient function claims are reviewed and found to be acceptable by Health Canada. See 8.6.5 of this Guide on acceptability of new nutrient function claims.

Summary Table of Acceptable Nutrient Function Claims
Table 8-3

(updated May 2009)

Nutrient Acceptable Nutrient Function Claims1

PROTEIN

  • helps build and repair body tissues
  • helps build antibodies

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 age2

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 age2

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

VITAMIN D

  • factor in the formation and maintenance of bones and teeth
  • enhances calcium and phosphorus absorption and utilization

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

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

FOLATE

  • aids in red blood cell formation
  • a factor in normal early fetal development3
  • a factor in the normal early development of the fetal brain and spinal cord3

VITAMIN B12

  • aids in red blood cell formation

PANTOTHENIC ACID

  • factor in energy metabolism and tissue formation

CALCIUM

  • aids in the formation and maintenance of bones and teeth

PHOSPHORUS

  • factor in the formation and maintenance of bones and teeth

MAGNESIUM

  • factor in energy metabolism, tissue formation and bone development

IRON

  • factor in red blood cell formation

ZINC

  • 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

1The following two general nutrient function claims are permissible for all nutrients [B.01.311, B.01.312, D.01.006, D.02.004]:

  • "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."

2Note that this claim is a change from the claim previously allowed for DHA. 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.

3In 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.

8.6.5 Acceptability of New Nutrient Function Claims

This section applies to nutrients that meet the following criteria:

  1. the nutrient is one for which a 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,
    AND
  2. the function reflects consensus among the broad scientific community and has been published by an authoritative scientific body as its current position with regard to the function(s) within the past 15 years.

Authoritative scientific bodies include the Institute of Medicine (Dietary Reference Intake report series) and the European Food Safety Authority.

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 8.2.2 of this Guide for contact information for the Food Directorate.

See 8.5.4 of this Guide for information on how function claims are assessed for nutrients for which no Recommended Dietary Allowance (RDA), Adequate Intake (AI), or Acceptable Macronutrient Distribution Ranges (AMDR) have been established by the Institute of Medicine of the US National Academies (e.g. DHA).

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