Decision on panax ginseng root extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed standardised Panax ginseng root extract^{Footnote 1} 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 2}

P. ginseng root extract has a history of safe use as a food. However, use as an ingredient that results in an intake of total ginsenosides greater than 8 mg per day would be consistent with use as a medicinal ingredient in natural health products.

On this basis, the Food and Nutrition Directorate assessed use of standardised P. ginseng root extract as a supplemental ingredient in supplemented foods that results in an intake of total ginsenosides from the food greater than 8 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 standardised P. ginseng root extract as a supplemental ingredient in supplemented foods that would result in an intake of total ginsenosides from the food greater than 8 mg per day.

The decision does not apply to use of P. ginseng root extract as a food ingredient that results in an intake of total ginsenosides from the food that is 8 mg or less per day. In this case, the food seller continues to be responsible for ensuring that the sale of a food containing P. ginseng root 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 standardised P. ginseng 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 Panax ginseng Root 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 standardised P. ginseng root extract as a supplemental ingredient in supplemented foods

General guidance

1. Characterise in detail the P. ginseng root extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested P. ginseng root extract as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular ginseng root extract apply to such use of the requested P. ginseng root extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the ginseng root 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. Reproductive and developmental toxicity testing of orally administered standardised P. ginseng 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 standardised P. ginseng root extract 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 standardised P. ginseng root extract for individuals with diabetes.
3. Information on the safety of standardised P. ginseng root extract with respect to its potential activity on various drug-metabolising enzyme systems (e.g., cytochrome P450) and the potential for P. ginseng root extract/drug interaction, including but not limited to individuals taking digoxin, warfarin and other blood-thinning medications, and phenelzine and other monoamine-oxidase inhibitor (MAOI) antidepressant medications.

Nutritional information

1. Information on constituents (including, but not limited, to saponins) in standardised P. ginseng root extract that could affect digestion or absorption of nutrients, especially in the intestines, and/or could pose nutritional safety concerns if foods containing standardised P. ginseng root extract were to be consumed frequently, in large amounts, over a long period of time.

This information is required to address the safety of standardised P. ginseng 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 3}