Questions and Answers on Health Claims

Q#1. What kinds of claims can be made for a food product?

The following claims can be made for a food product:

• food claims;
• nutrition (nutrient content) claims;
• health claims

A food claim is a claim that expresses the composition, quality, quantity or origin of a food product. Chapter 4 of CFIA guidance

A nutrition (nutrient content) claim is a claim that characterizes the energy value of the food or the amount of a nutrient contained in a food. It provides a quick and easy way to identify foods with specific nutritional features of interest. An example of a nutrition claim is "low in sodium or sodium free" Chapter 7 of CFIA guidance

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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 a person's health. Codex Alimentarius Commission (PDF Version - 40 K)

Q#2. Are there different types of health claims that can be made for a food product?

There are several different types of health claims that can be made for a food product, and these are categorized based on how they are regulated and evaluated. The following categorization of health claims was adopted following the 2007 consultation on Health Canada's initiative in modernizing the management of health claims on foods in Canada:

• Disease risk reduction and therapeutic claims:
  • These claims are used to describe the link between the characteristics of a diet, a food or food constituent and the risk reduction of a disease or the therapeutic effect of a food or food constituent or diet, (including restoring, correcting, or modifying body functions).
  • Example: The claim "(naming the diet characteristics, food or food constituent) reduces the risk of heart disease" or "lowers blood cholesterol" can be used when the food carrying the claim meets conditions for use set out in the food regulations.
• Function claims:
  • These claims are used to describe the specific physiological effects of foods and food constituents associated with health or performance
  • Example: The claim "(naming the food or food constituent) promotes regularity or laxation" can be usedfor coarse wheat bran providing a minimum of 7 grams of dietary fibre in a reasonable daily intake of the food.
  • Nutrient function claims (formerly known as biological role claims), are a type of function claim that describe the well-established functions of nutrients or energy necessary for the maintenance of good health, normal growth and development
  • Example: The claim "Calcium aids in the formation and maintenance of bones and teeth" may be used for foodsproviding a minimum of 5% of the Recommended Daily Intake of the nutrient per serving of stated size and reference amount of the food.
• General health claims:
  • These claims are broad general 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.
  • Example: The claim "Include low fat product x as part of healthy eating" may be made on a food when the claim is truthful and not misleading (Section 5(1) of the Food and Drugs Act).

For additional information, refer to chapter 8 of the CFIA Guide to Food Labelling and Advertising

Q#3. How are health claims for food products regulated?

Health claims that appear on packaging or in advertisements for foods sold in Canada are regulated under the Food and Drugs Act and the Food and Drug Regulations. The Section 5(1) of the Food and Drugs Act requires that all health claims be truthful and not misleading or deceptive. However, the regulatory requirements permitting the use of claims vary significantly depending on the nature and type of the claim. Some claims may be made without pre-market approval provided they are truthful and not misleading or deceptive, whereas other claims, such as disease risk reduction or therapeutic claims are only allowed once a regulatory amendment specifying the conditions for their use has been completed.

Q#4. What is the process for approval for new health claims for food products?

At present, depending on the nature of the claim, there are different regulatory requirements. Some claims may be made without approval provided they are truthful and not misleading, whereas other claims are only allowed once a regulatory amendment specifying the conditions for their use has been made.

For example, to make a new disease risk reduction claim, a regulatory amendment to the Food and Drug Regulations is required. Once a claim of this type is permitted by the Regulations, any food that meets the stated criteria may carry the claim using the prescribed wording for the claim.

Function claims for nutrients, while also subject to regulations, have fewer requirements that must be met in order to make the claim. Health Canada's Food Directorate will review requests for new nutrient function claims.

Pre-market assessment of non-nutrient function claims is voluntary, however encouraged.

General health claims, like all claims, are subject to the Food and Drugs Act which prohibits false, misleading or deceptive product representation.

To facilitate the preparation of submissions for the approval of health claims for foods, such as disease risk reduction claims, Health Canada has published the Guidance Document for Preparing a Submission for Food Health Claims, 2009. The standards of evidence in this document are also used by Health Canada as the basis for reviewing function claims.

Q#5. What disease risk reduction claims are currently allowed in Canada?

Since 2003, Health Canada has allowed certain disease risk reduction claims to be used on food labels or in advertisements that reflect the following relationships:

• a healthy diet low in sodium and high in potassium and reduced risk of high blood pressure;
• a healthy diet with adequate calcium and vitamin D and reduced risk of osteoporosis;
• a healthy diet low in saturated and trans fat and reduced risk of heart disease;
• a healthy diet rich in vegetables and fruit and reduced risk of some types of cancers; and
• non-fermentable carbohydrates in gums and hard candies and the non-promotion of dental caries (cavities).

Q#6. Prior to the acceptance of the above-noted disease risk-reduction claims, what other kind of claims were permitted?

Prior to the acceptance of the above-noted claims, only function claims related to the well-established biological roles of known nutrients (eg. "calcium aids in the formation and maintenance of bones and teeth") were permitted by regulation in Canada.

Manufacturers are permitted to use general healthy eating claims, such as "healthy for you", however, in recent years there has been a proliferation of a number of company- led programs, logos and slogans, usually highlighting specific nutritional features of their products. Health Canada will undertake consumer research to identify issues related to consumer interpretation and use of these claims, and to assess the need for further policy.

Q#7. Is Health Canada reviewing any additional disease risk reduction claims?

Health Canada is reviewing five additional disease risk reduction claims that have been approved for use in the United States and are being considered for use in Canada. It is Health Canada's intent to proceed with regulatory amendments that would allow for two of the five additional disease risk-reduction claims in food labelling and advertising. Health Canada's position is summarized in the document posted in December of 2006 which is entitled, "Position Paper on Five US Health Claims Considered for Use in Canada"

Q#8. What is "front of package" labelling?

Front of package (FOP) labelling is the term sometimes used for simplified nutritional or health-related claims, symbols and logos that are highlighted and positioned on the front of a food package.

Q#9. Why is Health Canada modernizing the system for managing health claims in Canada?

Given increased consumer awareness of the relationship between diet and health, there is an increasing demand for health-enhancing foods. Since health claims are regarded as a tool that can help consumers make informed food choices, manufacturers would like the ability to use claims in labelling and advertising to market the health benefits of their food products. Health Canada is reviewing its current framework for managing health claims for foods to ensure that the system supports a fair and competitive market environment that will allow for more consumer choice, while continuing to protect consumers from misleading and unsubstantiated claims.

The objective of the review is to increase government efficiency and flexibility in the approval of health claims, while retaining high standards of oversight to ensure their credibility. As part of this review, Health Canada developed and posted a discussion paper, Managing Health Claims for Foods in Canada: Towards a Modernized Framework in November 2007.

Regional workshops were also held with stakeholders across Canada on the discussion paper in late January and early February 2008.

The Health Canada's Report on Stakeholder Feedback on Modernizing Canada's Framework for Health Claims on Food and the Report of Regional Workshops on Modernizing Canada's Framework for Health Claims on Food summarize stakeholders' feedback on various issues related to health claims. Stakeholders included health professionals, consumers, health/disease organizations, academia, industry, and federal, provincial, territorial or municipal government representatives.

Health Canada's Action Plan in Response to Stakeholder Feedback from Consultations on  Modernizing Canada's Framework for Health Claims on Food  provides an account of the activity already undertaken by Health Canada with respect to modernizing Canada's framework on health claims as well as activity to be taken by Health Canada over the next few years. This Action Plan takes into account stakeholder feedback that was provided in response to the discussion paper, Managing Health Claims for Foods in Canada: Towards a Modernized Framework, which was posted in November of 2007.

Q#10 Who is responsible for ensuring health claims on foods are accurate?

Manufacturers are responsible for the accuracy of all information on the labels and advertisements for food and for compliance with all relevant food legislation and policies, including those pertaining to health claims. The Canadian Food Inspection Agency is responsible for ensuring that industry complies with these requirements.

Q#11. How does our system for managing health claims compare with the U.S.?

Both Canada and the U.S. require regulatory authorization for the use of disease risk reduction claims supported by "significant scientific agreement". However, in the U.S., risk reduction claims can be made with limited scientific evidence if the product carries a qualifying statement set out by the U.S. Food and Drug Administration (FDA). However, the approach to qualifying health claims is currently under review in the U.S.

Neither Canada nor the U.S. require regulatory amendments for the use of most function claims. Canada maintains a list of function claims which are deemed to be truthful and not misleading; however the U.S. does not maintain such a list.

With respect to general health claims, in the U.S., foods carrying "healthy" claims must meet specified conditions for the levels of fat, saturated fat, cholesterol, sodium and sometimes other nutrients such as vitamin A, vitamin C, calcium, iron, protein and fibre. In Canada, while some guidelines exist, no specific criteria have been included in the regulations for these types of claims.

Q#12 What is a functional food? What health claims are allowed for this type of food?

There is no standard definition for functional foods - the term is generally used to refer to a food with specific health-enhancing characteristics. For discussion purposes, Health Canada refers to functional food as a food that is similar in appearance to, or may be a conventional food, that is consumed as part of a usual diet and that is demonstrated to have physiological benefits or that reduces the risk of chronic disease beyond basic nutritional functions.

An example of a functional food would be a margarine containing added phytosterols that help in cholesterol lowering.

The type of food and related properties along with the evidence base for the claim would determine what, if any, disease risk reduction or function claim it could carry.

Q#13. What are "natural health products in food form"? How are they regulated in Canada?

Since the Natural Health Products (NHP) Regulations came into force in January 2004, Health Canada has received several hundred product license applications for products in a food format which carry health claims and have characteristics of both foods and natural health products (NHPs). Examples include energy drinks, protein supplements and nutritional supplements.

Depending on the claims and the types of ingredients present in a product, it is sometimes difficult to know under which regulatory scheme a given product may fall (i.e. the food regulations or the Natural Health Products Regulations).

To help determine whether a product of this type should be classified and regulated as a food or natural health product, a guidance document entitled, "Guidance Document Classification of Products at the Food -Natural Health Product Interface" has been developed by Health Canada. This guidance document outlines the criteria to be used in determining whether products that share characteristics of both foods and natural health products are classified as food or NHP. It should be noted that each product or class of products will be assessed on a case-by-case basis based on all relevant factors.