Decision on ashwagandha root extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed ashwagandha root extract 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 1}

The assessment considered publicly available information and found the data insufficient to establish acceptable conditions for use as a supplemental ingredient in supplemented foods. Consequently, Health Canada is not acceding to the use of ashwagandha root extract as a supplemental ingredient, and there is no history of use as an ingredient added to food.

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 ashwagandha root 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 Ashwagandha Root Extract" in the subject line of your e-mail.

Appendix – Information to support a request for Health Canada to reconsider the decision on the use of ashwagandha root extract as a supplemental ingredient

General guidance

1. Characterise in detail the ashwagandha root extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information provided apply to use of the requested, well-characterised, ashwagandha root extract as a supplemental ingredient in supplemented foods. For example, ensure that the composition of the test material and the results of the toxicity testing of a particular ashwagandha extract apply to the use of the requested ashwagandha extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the ashwagandha root extract test material, as well as a full description of the study design, including methods used, the type and number of animals treated, the doses administered, and the endpoints measured. Studies should also provide detailed documentation of the test results.

Toxicological information

1. Repeated-dose toxicity test of orally-administered ashwagandha root extract, at doses that would provide adequate evidence of safety to support its use as a supplemental ingredient in food.
2. Genotoxicity testing of ashwagandha root. In general, a basic test battery would be comprised of 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 ashwagandha root extract, at doses that would provide adequate evidence of safety to support its use as a supplemental ingredient 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.

Nutritional information

1. Information that would provide adequate evidence that ashwagandha root extract would not affect digestion or absorption of other nutrients, especially in the intestines, and/or information that ashwagandha root extract would not pose nutritional safety concerns if foods supplemented with ashwagandha root 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 ashwagandha root 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 2}