Decision on glucosamine hydrochloride and glucosamine sulfate as supplemental ingredients in foods

Health Canada's Food and Nutrition Directorate has assessed glucosamine hydrochloride and glucosamine sulfate for use as supplemental ingredients in supplemented foods. These are two 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}

Glucosamine hydrochloride and glucosamine sulfate have no history of safe use as a food ingredient.

The Food and Nutrition Directorate assessed the use of glucosamine hydrochloride and glucosamine sulfate as supplemental ingredients in foods. 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 the use of glucosamine hydrochloride or glucosamine sulfate as supplemental ingredients 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 glucosamine hydrochloride and glucosamine sulfate, 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 Glucosamine hydrochloride and glucosamine sulfate" 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 glucosamine hydrochloride or glucosamine sulfate as supplemental ingredients in supplemented foods

General guidance

1. Characterise in detail the glucosamine hydrochloride or glucosamine sulfate that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested glucosamine hydrochloride or glucosamine sulfate as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular glucosamine hydrochloride or glucosamine sulfate apply to such use of the requested glucosamine hydrochloride or glucosamine sulfate.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the 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 glucosamine hydrochloride or glucosamine sulfate at doses that would provide adequate evidence of safety to support use as ingredients in foods suitable for consumption by the general population.

2. Reproductive and developmental toxicity testing of orally administered glucosamine hydrochloride or glucosamine sulfate at doses that would provide adequate evidence of safety to support use as ingredients 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 glucosamine would not pose a significant health concern if they were to be consumed by these sensitive population sub-groups.

3. Information on the safety of glucosamine hydrochloride or glucosamine sulfate with respect to its potential activity on various drug metabolizing enzyme systems and the potential for glucosamine hydrochloride or glucosamine sulfate/drug interaction.

Nutritional information:

1. Information on how glucosamine hydrochloride or glucosamine sulfate may affect digestion and absorption of other nutrients, especially minerals like calcium in the intestines, and/or whether they could pose nutritional safety concerns if foods containing these compounds are consumed frequently, in large amounts, over a long period of time.

This information is required to address the safety of glucosamine hydrochloride and glucosamine sulfate as ingredients added to 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}