Decision on maca root extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed maca (Lepidium meyenii Walp.) 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}

Maca root powder has a history of safe use as a food ingredient^{Footnote 3}. However, the concentration of the components in maca root extracts cannot be assumed to be at the same levels that would be ingested when consumed as powdered maca root. Depending on the method of preparation, certain constituents may be concentrated and therefore extracts cannot be considered completely equivalent to powdered maca root.

The Food and Nutrition Directorate assessed the use of maca 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 the use of maca root extracts 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 maca 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 Maca 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 maca root extract as a supplemental ingredient in supplemented foods

General guidance

1. Characterise in detail the maca root extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to the use of the requested maca root extract as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular maca root extract apply to the use of the requested maca root extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the maca 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 tests of orally administered maca 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. Genotoxicity testing of maca root 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 maca 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 maca root 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 maca root extract for individuals with high blood pressure.
5. Information on the safety of maca root extract with respect to its potential activity on various drug-metabolising enzyme systems (e.g., cytochrome P450) and the potential for maca root extract/drug interaction, including but not limited to individuals taking selective serotonin reuptake inhibitor (SSRI) medications.

Nutritional information

1. Information on constituents in maca root extract that may affect digestion or absorption of nutrients, especially in the intestines, and/or could pose nutritional safety concerns if foods containing maca root extract were to be consumed frequently, over a long period of time.

This information is required to address the safety of maca 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 4}