CANADA – FOOD CLAIM SUBSTANTIATION
Foods are required to have compliant labels, and any claims about the product must be truthful and not misleading. There are 4 types of claims that are applicable to foods: Function claims, general health claims, disease risk reduction and therapeutic claims.
Function and general health claims are broad claims that promote health through healthy eating or provide dietary guidance. These types of claims can be used when they are in line with the dietary recommendations outlined in Canada’s Food Guide, and no pre-market approval is required.
On the other hand, disease risk reduction and therapeutic claims are health claims that place the food under the definition of a drug and require mandatory pre-market submissions that must be approved by the Food Directorate of Health Canada. These pre-market submissions must include evidence of causality, generalizability and quality assurance.
For proposed health claims that do not bring the food under the definition of a drug, pre-market approval by Health Canada is not required. However, any claims made on product packaging must be truthful and not misleading, and manufacturers must keep evidence on-hand substantiating the claim in case requested. Manufactures may choose to prepare a voluntary submission to Health Canada in these cases to ensure the evidence they have on-hand provides acceptable support.
NHP Consulting will guide you through determining the type of claims made on your food products and their compliance, and can prepare the necessary evidence required for pre-market submissions.
USA – FOOD CLAIM SUBSTANTIATION
There are three types of claims available to be made for foods and dietary supplements: health claims, nutrient content claims, and structure/function claims.
Health claims describe a relationship between a food substance and a reduced risk of health-related condition and/or disease. There is always the option to submit petitions for qualified health claims, but the process is quite rigorous and expensive. That said, FDA has a list of health claims that are pre-approved and can be utilized on applicable foods.
Unlike health claims, nutrient content claims and structure/function claims are not subject to premarket review and approval by FDA. Structure/function claims for conventional foods focus on the effects derived from nutritive value, whereas for dietary supplements, these types of claims may focus on non-nutritive as well as nutritive effects.
When compared to Dietary Supplements, conventional food manufacturers are not required to notify FDA about their structure/function claims and disclaimers are not mandatory on conventional food packaging.