Decision on Rhodiola rosea root extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed Rhodiola rosea root 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 Food.^{Footnote 1}

Rhodiola rosea root extract has no history of safe use as a food ingredient. While traditional herbal uses have been documented to treat a variety of ailments (e.g., fatigue, infections, gastrointestinal disorders); these are for health and not nutritional purposes. Unlike a food ingredient, the traditional use of Rhodiola rosea root extract does not apply to the general population or for ad libitum consumption.

The Food and Nutrition Directorate assessed the use of R. rosea 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 a supplemental ingredient in supplemented foods.

Consequently, Health Canada is not acceding to use R. rosea root extract as a supplemental ingredient in supplemented 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 R. rosea 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 Rhodiola rosea 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 Rhodiola rosea root extract as a supplemental ingredient in supplemented foods

General guidance

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

3. Information characterising the potential hormone modulating activity of R. rosea root extract and its potential to alter serotonin levels and contribute to the condition known as "serotonin syndrome".
4. Information characterising the potential activity of R. rosea root extract on various drug metabolising enzyme systems and the potential for R. rosea root extract/drug interactions.

Nutritional information

1. Information on constituents in R. rosea 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 R. rosea 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 R. rosea 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}