Decision on astragalus root extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed astragalus 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}

Astragalus root extract does not have a history of safe food use. While Traditional Chinese Medicine uses include herbal soups and decoctions, these are for health and not nutritional purposes, and are not consumed by the general population nor ad libitum.

The Food and Nutrition Directorate assessed use of astragalus root extract as a supplemental ingredient in supplemented foods. 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 use of astragalus root extract as a supplemental ingredient in foods.

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 astragalus 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 Astragalus 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 astragalus root extract as a supplemental ingredient

General guidance

1. Characterise in detail the astragalus root extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested astragalus root extract as a supplemental ingredient in foods. For example, explain why the results of toxicity testing of a particular astragalus root extract apply to such use of the requested astragalus root extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the astragalus 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 testing of orally administered astragalus root 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. Reproductive and developmental toxicity testing of orally administered astragalus root 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 astragalus root extract would not pose a significant health concern if they were to be consumed by these sensitive population sub-groups.

3. Mutagenicity and genotoxicity testing of astragalus root extract, including a full battery of endpoints from both in vitro and in vivo studies. In vivo studies should be conducted via the oral route of exposure.
4. Information on the safety of astragalus root extract with respect to its potential activity on various drug-metabolising enzyme systems (e.g., cytochrome P450) and the potential for astragalus root extract/drug interactions, including but not limited to individuals taking immunosuppressive drugs.

Nutritional information

1. Information on constituents in astragalus root 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 astragalus 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 astragalus root 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 2}