Information on the use of L-theanine in supplemented foods

On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR) in the Canada Gazette, Part II, creating a regulatory framework for the sale of supplemented foods in Canada (hereinafter referred to as the "supplemented foods regulations").

Since then, Health Canada has received several requests for clarification regarding the ingredient L-theanine. This ingredient was permitted during the Temporary Marketing Authorization (TMA) period on a case-by-case basis, but does not appear in the Threshold levels for cautionary statements and other conditions of use for products eligible for a transition period under the supplemented foods regulatory framework, or as a supplemental ingredient in the List of Permitted Supplemental Ingredients.

The purpose of this communication is to provide additional information on the use of L-theanine in supplemented foods.

General information regarding the transition period for products that have received TMA Letters or Notice Letters

Prior to the coming into force of the supplemented foods regulations, manufacturers and distributors of supplemented foods gained market access via TMAs, which were issued by Health Canada on a product-by-product basis. In addition, for TMA requests received but not completed prior to the coming into force of the supplemented foods regulations, Health Canada authorized products by issuing Notice Letters. Manufacturers and distributors of products with valid authorizations (TMA Letters and Notice Letters) are eligible for a transition period to come into full compliance with the supplemented foods regulations.

TMA Letters (TMAL) established, in the Letter of Agreement and Appendix 2, specific conditions of use for the product and various ingredients. Notice Letters authorized the use of any ingredients in the product formulation that are used in accordance with the incorporated by reference document, Threshold levels for cautionary statements and other conditions of use. Products with TMALs or Notice Letters remain eligible for the transition period as long as the product formulation (including container size) is consistent with what appears in the authorization (i.e., Appendix 2 of the TMAL or Notice Letter, as applicable). The transition period ends on December 31, 2025, after which all products must fully comply with the supplemented foods regulations.

The Canadian Food Inspection Agency (CFIA) is responsible for enforcing the supplemented foods regulations, including the transitional provisions. Between July 21, 2022 and December 31, 2025, the CFIA will take an educational approach towards compliance for products that remain eligible for the transition period. More information on CFIA's and Health Canada's multi-year implementation plan for these supplemented foods amendments is available at the Implementation plan for amendments to the Food and Drug Regulations (Supplemented Foods) webpage.

Any new supplemented food coming onto the market that does not already have a valid authorization is required to immediately comply with the supplemented foods regulations.

Information on the use of L-theanine in foods

L-theanine has been determined to have a history of safe food use; therefore, it is generally permitted in foods, including supplemented foods that are not eligible for the transition period, under conditions that are consistent with its history of safe food use (for example, its presence as a constituent in Camellia sinensis tea preparations, which may impart flavour). One cup (i.e., serving) of green tea may provide approximately 23 mg of L-theanine^{Footnote 1}, and a typical background dietary exposure is one cup of green tea per day (Health Canada, 2019).

Based on this history of safe food use, L-theanine is considered a non-novel food ingredient when used at a level not exceeding 23 mg per day (see Health Canada's list of non-novel determinations for food and food ingredients). Usage of L-theanine exceeding 23 mg per day would require a pre- market assessment as either a novel food or as a supplemental ingredient if intended for conventional or supplemented food use, respectively. A product providing more than 200 mg per day of L-theanine may result in a potentially therapeutic level, as per the Natural Health Products Monograph.

L-theanine is not currently a permitted supplemental ingredient (i.e., it does not appear on the List of Permitted Supplemental Ingredients), and thus there is no alternative acceptable use for this ingredient in food other than in a manner consistent with a history of safe food use (i.e., at levels consistent with its presence in Camellia sinensis tea preparations).

As mentioned above, authorization for the use of any ingredient, including L-theanine, under conditions that are not consistent with a history of safe food use can be sought through either the novel food route (Division 28, Part B of the FDR) if intended for general use in the food supply, or as a supplemental ingredient, if the ingredient is intended to be represented as such. Food ingredients requiring conditions of use for safe consumption (e.g., maximum amounts, cautionary statements) are more appropriately represented as supplemental ingredients because the supplemented foods regulations have additional labelling provisions designed to mitigate potential health risks associated with overconsumption or consumption by vulnerable subpopulations.

For those wishing to use any ingredient, including L-theanine, as a supplemental ingredient (e.g., to include it in the Supplemented Food Facts table), a pre-market request must be submitted to Health Canada's Food and Nutrition Directorate. It is recommended that petitioners request a pre-submission consultation by emailing the Food and Nutrition Directorate's Submission Management and Information Unit at smiu-ugdi@hc-sc.gc.ca so that a complete submission can be filed at the outset.

Please note that Health Canada updates the list of non-novel determinations for food and food ingredients as new determinations are made. If you reference this list, it is your responsibility to consult the list for updates.

It is the responsibility of the food manufacturer or distributor to ensure that a food, including a supplemented food, offered for sale in Canada complies with all applicable legislation and regulations including the Food and Drugs Act and the Safe Food for Canadians Act, and their regulations. The food seller is responsible for ensuring that sale of a food or food ingredient does not pose a hazard to the health of consumers, as this would contravene the provisions of the Food and Drugs Act.

Appendix 1 – References

Balentine et. al., 1997. The Chemistry of Tea Flavonoids. Critical Reviews in Food Science and Nutrition, 37(8):693-704. https://doi.org/10.1080/10408399709527797

Chow, H-H.S., Hakim, I.A. 2011. Pharmacokinetic and chemoprevention studies on tea in humans. Pharmacological Research, 64: 105-112. https://doi.org/10.1016%2Fj.phrs.2011.05.007

Health Canada. 2019. Food consumption Table derived from Statistics Canada's 2015 Canadian Community Health Survey, Nutrition, Share File. Ottawa. Available from: https://www.canada.ca/en/health-canada/services/food-nutrition/food-nutrition-surveillance/health-nutrition-surveys/canadian-community-health-survey-cchs/2015-canadian-community-health-survey-nutrition-food-nutrition-surveillance.html

Yang, C.S. and Pan, E. 2012. The effects of green tea polyphenols on drug metabolism. Expert Opinion on Drug Metabolism and Toxicology, 8(6): 677-689 https://doi.org/10.1517/17425255.2012.681375