Decision on resveratrol as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed Resveratrol for use as a supplemental ingredient in supplemented foods. This is one of the ingredients the Food and Nutrition Directorate identified for further assessment as set out in Health Canada's Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food.^{Footnote 1}

Resveratrol has a history of safe use as a food ingredient at an intake of less than or equal to 4 mg per day, based on its natural presence in the diet. An intake of greater than 4 mg per day would be inconsistent with a history of safe use as a food ingredient.

On this basis, the Food and Nutrition Directorate assessed use of resveratrol as a supplemental ingredient in supplemented foods that results in an intake greater than 4 mg per day. The assessment considered publicly available information, and found the data insufficient to establish acceptable conditions for this use.

Consequently, Health Canada is not acceding to use of resveratrol as a supplemental ingredient in supplemented foods that would result in an intake greater than 4 mg per day. The decision does not apply to use of resveratrol as a food ingredient that results in an intake from the food that is 4 mg or less per day. In this case, the food seller continues to be responsible for ensuring that the sale of a food containing resveratrol does not contravene section 4 of the Food and Drugs Act.

Health Canada is prepared to accept a request to reconsider this decision under the regulations for supplemented foods. The Appendix of this letter identifies the information required to support reconsideration.

For more information on Health Canada's decision on resveratrol, please contact the Food and Nutrition Directorate's Submission Management and Information Unit (SMIU) (E-mail: smiu-ugdi@hc-sc.gc.ca). Please use the words "Decision on Resveratrol" in the subject line of your e-mail.

Appendix 1 – Information to support a request for Health Canada to reconsider the decision on the use of resveratrol as a supplemental ingredient in supplemented foods

General guidance

1. Characterise in detail the resveratrol that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested resveratrol as a supplemental ingredient in supplemented foods.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the resveratrol test material and a full description of the study design, including methods used, the type and number of animals treated, the doses administered and the end-points measured. Studies should also provide detailed documentation of the test results.

Toxicological information

1. Reproductive and developmental toxicity testing of orally administered resveratrol at doses that would provide adequate evidence of safety to support its use as an ingredient in foods suitable for consumption by the general population, including foods that could be consumed by children and by individuals who are pregnant or who are trying to become pregnant.

   In the absence of results from such toxicity testing, Health Canada will also consider a scientifically sound rationale why foods containing resveratrol would not pose a significant health concern if they were to be consumed by these sensitive population sub-groups.

2. Information on the safety of resveratrol for individuals with diabetes.
3. Information on the safety of resveratrol with respect to its potential activity on various drug-metabolising enzyme systems (e.g., cytochrome P450) and the potential for resveratrol/drug interactions.

Nutritional information

1. Information on how resveratrol may affect digestion or absorption of other nutrients, especially in the intestines, and/or whether it could pose nutritional safety concerns if foods containing resveratrol were to be consumed frequently over a long period of time in different food matrices.

This information is required to address the safety of resveratrol, not to demonstrate efficacy or to support specific health claims. For substantiation of food health claims, please see Health Canada's guidance Substantiation of Health Claims (Scientific Evidence).^{Footnote 2}