Disease Risk Reduction Claims and Therapeutic Claims

Disease risk reduction claims highlight a specific relationship between a food, a food constituent, or the characteristics of a diet and a reduced risk of developing a diet-related disease or condition. For example, "[naming the food or food constituent] may reduce the risk of cardiovascular disease". Any food that meets the criteria may carry the claim using the prescribed wording for the claim.
Since 2003, Health Canada has allowed disease risk reduction claims that reflect five substantiated relationships:

• low sodium, high potassium and reduced risk of high blood pressure;
• calcium, vitamin D and reduced risk of osteoporosis;
• low saturated and trans fat and reduced risk of heart disease;
• 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).

Therapeutic claims highlight the therapeutic effect of a food, food constituent or diet, including restoring, correcting, or modifying body functions. For example, "[naming the food or food constituent] lowers blood cholesterol". The composition of a food that carries the claim must contribute to a healthy dietary pattern as outlined in the conditions for use.
Health Canada has authorized the use of therapeutic claims on the following food–health relationships:

• replacement of saturated fats with unsaturated fats and blood cholesterol lowering;
• psyllium fibre and blood cholesterol lowering;
• plant sterols (phytosterols) and blood cholesterol lowering;
• oat fibre and blood cholesterol lowering; and
• barley fibre and blood cholesterol lowering.

If a disease risk reduction or a therapeutic claim associates a food as a treatment, preventative or cure for any of the diseases referred to in Schedule A of the Food and Drugs Act, then a regulatory amendment is needed. Otherwise a regulatory amendment may not be required before the claim can be used.

Probiotic claims are claims about live microorganisms in foods which, when administered in adequate amounts, may confer a health benefit (e.g. "promotes regularity" and "improves nutrient absorption and aids in digestion"). Pre-market consultation is recommended for new probiotic claims as there are specific requirements for the safety, quality (stability) and labelling of such food products. The type of claim available will be determined by the scientific evidence.