The Official Omega 5 Oil Site: Managing Health Claims for Foods in Canada: Towards a Modernized Framework that will also cover Omega 5 oil dietary products

Health Canada is conducting a review of the current framework for the management of health claims for foods. The goal is to develop a modernized framework that will increase government efficiency and flexibility in the approval of health claims, while retaining high standards of oversight to ensure their credibility. Stakeholder consultations are planned to gain a wide range of perspectives on the identified issues and proposed actions

Q&As On Health Claims

Q#1. What is a health claim?

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.

Q#2. Are there different types of health claims?

There are three main types of health claims: disease risk reduction, function and general. Disease risk reduction claims refer to the reduction of the risk of disease (i.e. "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."). Function claims refer to the maintenance or support of specific body functions, such as "Vitamin A aids in the maintenance of night vision." General health claims do not refer to a specific health effect, disease or health condition. They include broad "healthy for you" or "healthy choice" claims that promote choosing a food for overall health, promote healthy eating, or provide dietary guidance.

Q#3. What is "front of package" labelling?

Front of package (FOP) labelling is the term sometimes used for nutritional or health-related claims which are highlighted and positioned on the front of a food package. While the longer statements for disease risk reduction claims, function claims or general healthy eating messages can also be found on the front of a food package, manufacturers sometimes use symbols or logos on the front of a package to imply these messages in a simplified manner.

Q#4. What health claims are currently allowed in Canada?

Since 2003, Health Canada has allowed 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 reduction in dental caries (cavities).
Prior to the publication of these claims, only function claims related to the well-established biological roles of known nutrients (i.e. "calcium aids in the formation and maintenance of bones and teeth") were permitted by regulation in Canada.

Manufacturers may use general healthy eating claims, e.g. "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.

Q#5. What is the process for a new health claim to be made on foods?

At present, depending on the nature of the claim, there are different regulatory requirements. Some claims may be made without pre-market approval provided that 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. Any foods carrying such claims must meet an established set of criteria and must use 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.

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

Q#6. Why does Health Canada want to modernize the current 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 framework for managing health claims on foods in Canada 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.

In addition, Health Canada recognizes that the proliferation of implied health claims expressed in commercial logos and symbols is creating confusion in the marketplace and is exploring ways to address this problem through its revised health claims framework.

Q#7. Who is Health Canada consulting with? How is the consultation being carried out?

Health Canada is consulting with all interested stakeholders, including health professionals, consumers, health/disease organizations, academia, industry, and federal, provincial, territorial or municipal government representatives.

Stakeholders are invited to provide feedback on the discussion document until the end of February 2008. Regional face-to-face consultations are planned for early 2008. Following analysis of comments received, Health Canada will determine what steps are required for implementation, including any possible regulatory amendments to the Food and Drug Regulations.

Q#8. 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#9. How does our system for managing health claims compare with the U.S.?

As in Canada, the U.S. requires regulatory authorization for the use of disease risk-reduction claims supported by "significant scientific agreement". Unique to the U.S., however, is the fact that such 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).

For the use of most function claims, like Canada, the U.S. does not require regulatory amendments. However, the U.S. does not maintain a list of function claims which are deemed to be truthful and not misleading - this is unique to Canada.

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#10. 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 which is similar in appearance to, or may be a conventional food
a food that is consumed as part of a usual diet
a food that has demonstrated to have physiological benefits
a food that reduces the risk of chronic disease beyond basic nutritional functions.
The type of food and related properties would determine what, if any, disease risk reduction or function claim it could carry.

Q#11. The discussion paper references "natural health products in food form". What are these?

How are they regulated in Canada?

Since the Natural Health Products (NHP) regulations came into force in January 2004, Health Canada has received a number of NHP product licence applications for products in food formats and food mediums that carry health claims.

The Food and Natural Health Products Directorates within Health Canada are currently collaborating to determine how best to regulate these NHPs in food formats. In the mean time, these Directorates will continue to work together to evaluate submissions to ensure that all food-like NHPs are safe to be consumed as foods and that all health claims are truthful and not misleading.