Decision on alpha lipoic acid (ALA) as a supplemental ingredient in foods

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

The assessment considered publicly available information and found the data insufficient to establish acceptable conditions for use as a supplemental ingredient in foods.

Consequently, Health Canada is not acceding to use of ALA as a supplemental ingredient. While ALA is synthesized in the body and it occurs naturally in foods, both in relatively small amounts, there is no history of use of its addition to 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 ALA, 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 Alpha Lipoic Acid" 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 ALA as a supplemental ingredient

General guidance

1. Characterise in detail the ALA that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested ALA as a supplemental ingredient in foods.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the ALA 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. Information regarding the etiology of Insulin Autoimmune Syndrome (IAS) (e.g., prevalence in the Canadian population, possible link to pre-existing immune conditions, etc.), and specifically the relationship to supplemental ALA consumption (e.g., mechanism of action, doses triggering IAS, etc.).
2. Reproductive and developmental toxicity testing of orally administered ALA at doses that would provide adequate evidence of safety to support its use as a supplemental ingredient suitable for consumption by the general population, including foods that could be consumed by children and individuals who are pregnant or who are trying to become pregnant.

Nutritional information

1. Information that would provide adequate evidence that ALA would not affect digestion or absorption of other nutrients, especially in the intestines, and/or information that ALA would not pose nutritional safety concerns if foods supplemented with ALA were to be consumed frequently over a long period of time in different food matrices.

This information is required to address the safety of ALA for use as a supplemental ingredient in 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}