Decision on Schisandra chinensis fruit extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed Schisandra chinensis fruit extract 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 Foods.^{Footnote 1}

Schisandra chinensis fruit extract has a history of safe use as a food ingredient up to and including 200 mg per day of dried berry quantity crude equivalent^{Footnote 2} (QCE). On this basis, the Food and Nutrition Directorate assessed the use of S. chinensis fruit extract as a supplemental ingredient in supplemented foods that results in an intake from the food of greater than 200 mg per day of dried berry QCE. 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 the use of S. chinensis fruit extract as a supplemental ingredient in supplemented foods that would result in an intake of dried berry QCE from the food of greater than 200 mg per day.

The decision does not apply to the use of S. chinensis fruit extract as a food ingredient that results in an intake of dried berry QCE from the food that is 200 mg or less per day. In this case, the food seller continues to be responsible for ensuring that the sale of a food containing S. chinensis fruit extract 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 S. chinensis fruit extract, 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 Schisandra chinensis Fruit Extract" 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 S. chinensis fruit extract as a supplemental ingredient in supplemented foods

General guidance

1. Characterise in detail the S. chinensis fruit extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested S. chinensis fruit extract as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular S. chinensis fruit extract apply to such use of the requested S. chinensis fruit extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the S. chinensis fruit extract 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. Repeated-dose toxicity testing of orally administered S. chinensis fruit extract 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.
2. Mutagenicity and genotoxicity testing for S. chinensis fruit extract.

3. Reproductive and developmental toxicity testing of orally administered S. chinensis fruit extract 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 standardised S. chinensis fruit extract would not pose a significant health concern if they were to be consumed by these sensitive population sub-groups.

4. Information on the safety of S. chinensis fruit extract with respect to its potential activity on various drug metabolizing enzyme systems (e.g., cytochrome P450) and the potential for S. chinensis fruit extract/drug interaction, including but not limited to individuals taking talinolol, warfarin, and other blood-thinning medications.

Nutritional information

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

This information is required to address the safety of S. chinensis fruit extract, 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 3}