Decision on pomegranate rind extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed pomegranate rind extract^{Footnote 1} for use as a supplemental ingredient. 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 2}

The assessment considered publicly available information, and found the data insufficient to establish acceptable conditions for its use as a supplemental ingredient in supplemented foods.

Consequently, Health Canada is not acceding to the use of pomegranate rind extract as a supplemental ingredient in supplemented foods. Although some constituents of pomegranate rind extract may be incidentally present in pomegranate fruit arils (seeds) or pomegranate juice when consumed as foods, a significant fraction of pomegranate rind extract remains uncharacterized. The composition of pomegranate juice (fully, or in part) cannot be considered equivalent to pomegranate rind extract.

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 pomegranate rind 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 Pomegranate Rind 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 pomegranate rind extract as a supplemental ingredient

General guidance

1. Characterise in detail the pomegranate rind extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to the use of the requested pomegranate rind extract as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular pomegranate rind extract apply to such use of the requested pomegranate rind extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the pomegranate rind 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 tests of orally administered pomegranate rind 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. Genotoxicity testing of pomegranate rind extract. In general, a basic test battery would comprise two or more in vitro tests, or in vitro tests plus an in vivo test to evaluate genotoxic potential. In vivo studies should be conducted via the oral route of exposure.

3. Reproductive and developmental toxicity testing of orally administered pomegranate rind 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 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 pomegranate rind 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 pomegranate rind extract with respect to its potential activity on various drug-metabolizing enzyme systems, and the potential for pomegranate rind extract/drug interaction (e.g., with warfarin).

Nutritional information

1. Information on constituents in pomegranate rind extract that could affect digestion or absorption of nutrients, especially in the intestines, and/or information on whether it could pose nutritional safety concerns if foods containing pomegranate rind extract were to be consumed frequently, in large amounts, over a long period of time.

This information is required to address the safety of pomegranate rind extract for use as a supplemental ingredient in supplemented foods, 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}