Health Canada recognizes that the foods we eat can affect our health in different ways. Some food labels contain statements about the beneficial effects of certain foods on a person's health, such as "a healthy diet low in saturated and trans fat may reduce the risk of heart disease". This type of statement is an example of 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 a person's health.
What do we do?
The Food Directorate of Health Canada is responsible for the development of policies, regulations and standards that relate to the use of health claims on foods. Health claims on foods may help people make informed decisions about food choices provided they are truthful and not misleading. The Food Directorate assesses whether health claims are truthful and not misleading by reviewing mandatory and voluntary pre-market submissions. Decisions about health claims which are based on Health Canada reviews are available on this website. Depending on the novelty of the substance that is the subject of the health claim, the food product may also be subject to safety assessment if it is considered a novel food.
What are the different types of food health claims?
Disease risk reduction claims: A disease risk reduction claim is a statement that links a food or constituent of a food to reducing the risk of developing a diet-related disease or condition (e.g. “A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer”). Therapeutic claims are a type of disease risk reduction claims about the treatment, or mitigation of a disease or health-related condition, or about restoring, correcting or modifying body functions (e.g. “Oat fibre helps lower cholesterol”).
Function claims: A function claim is a statement about the specific beneficial effects that the consumption of a food or food constituent has on normal functions or biological activities of the body (e.g. “Consuming 7 grams of fibre from coarse wheat bran promotes regularity”). Nutrient function claims are a subset of function claims that describe the well-established roles of energy or nutrients that are essential for the maintenance of good health or for normal growth and development (e.g. “Vitamin A aids in the development and maintenance of night vision”).
What are the regulatory requirements for health claims?
A health claim is optional for a food. However, when it is made, it must be truthful and not misleading according to Subsection 5(1) of the Food and Drugs Act (FDA). This means that manufacturers and importers must have scientific evidence to substantiate a food health claim prior to its use.
Health claims are also subject to Section 3 of the Food and Drugs Act that prohibits the labelling and advertising of any food to the general public, as a treatment, preventative or cure for any diseases and health conditions listed in Schedule A of the Food and Drugs Act. Therefore, claims about diseases and health conditions listed in Schedule A of the Food and Drugs Act (e.g. cancer, diabetes) cannot be directed to the general public unless authorized in regulations. These claims are subject to pre-market assessment which would involve preparing and submitting an application to Health Canada’s Food Directorate in accordance with the Guidance Documents for Preparing Health Claim Submissions.
Function claims and claims about diseases or health conditions not listed in Schedule A are subject to the same level of standards of evidence as claims about Schedule A diseases or conditions, but pre-market review is voluntary. An application in accordance with the Guidance Documents for Preparing Health Claim Submissions may be voluntarily submitted to request a health claim assessment by Health Canada’s Food Directorate. Health claims that have been reviewed and accepted will be added to the list of accepted claims and may be used on all food products meeting the conditions of use stated in the applicable summary of assessment. Where function claims and claims about diseases or health conditions not listed in Schedule A have not been reviewed by Health Canada’s Food Directorate, manufacturers and importers must be able to disclose the evidence supporting these claims upon request by the Canadian Food Inspection Agency.
In some cases, certain health claims or product representations may be subject to additional regulatory requirements. For example, the label, packaging or advertisement of a food must not give the impression that the food is for use in a weight reduction diet, unless the food is one of the foods listed in Subsection B.24.003(3) of the Food and Drug Regulations (FDR) and meets the requirements set out in Division 24 for those foods, including the requirement for the statement “Useful in weight reduction only as part of an energy-reduced diet”.
What information is available?
Resources for Health Claims:
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