Public Notice: Classification of sports electrolyte products as foods
Health Canada is announcing the transition of sports electrolyte products from the Natural Health Product (NHP) framework to the food regulatory framework (formerly called Sports Electrolyte Supplement under the NHP framework).
This classification ensures that products in food formats, that are represented and marketed similar to other food products, are regulated as foods to ensure consistency and transparency for Canadians.
What are sports electrolyte products
Sports electrolyte products are typically in food formats, which include:
- Ready-to-drink beverages
- Concentrates, powders or effervescent tablets intended to be mixed with water
Sports electrolyte products are typically marketed with claims related to sport and exercise performance, using terms such as "hydration", "rehydration", and "electrolyte replacement".
These products are distinct from Oral Rehydration Solution (ORS) products, which are specifically designed for treating dehydration caused by diarrhea or vomiting (see the ORS monograph). ORS products are not part of this transition and will remain as NHPs.
Why are these products being transitioned to foods
The transition reflects the way these products are marketed and used similar to existing products already sold as foods. As such, based on the principles outlined in the Guidance Document: Classification of products at the food-natural health product interface: products in food formats, sports electrolyte products meet the definition of a food and are being classified as such. The classification of sports electrolyte products under the food regulatory framework will:
- Improve consistency in how similar products are regulated
- Improve consumer perception and understanding by reducing potential confusion caused by differing labelling requirements under two frameworks
- Decrease regulatory burden for industry and government while providing clear and predictable information for consumers to make informed food choices
What this means for industry
Manufacturers and licence holders of sports electrolyte products will transition from the NHP framework to the food regulatory framework. New products coming on to the market will need to comply with the Food and Drug Regulations (FDR).
This means:
Licence holders of existing Natural Product Numbers (NPNs) for sports electrolyte products will be encouraged to transition by December 31, 2027 in order to be considered compliant with the food regulatory framework. This will give licence holders time to ensure their products comply with the requirements in the FDR. This transition period is consistent with the Health Canada and Canadian Food Inspection Agency's joint food labelling coordination policy. If more time is needed, licence holders can submit their transition plan to the Natural and Non-Prescription Health Products Directorate (NNHPD) (rmd.communication-dgr@hc-sc.gc.ca)
- Current licence holders of ORS products that also carry sports electrolyte claims will be required to:
- remove the sports electrolyte claims and associated conditions of use to ensure their product's representation is consistent with only an ORS, and remain an NHP; or
- remove the ORS claims and associated conditions of use and transition to the food regulatory framework
Health Canada will work directly with affected licence holders to support a smooth transition.
As foods, sports electrolyte products with added ingredients such as mineral nutrients are considered supplemented foods and would need to comply with the regulations for supplemented foods. For information on supplemented foods, refer to Health Canada's webpage.
Products that comply with the applicable regulatory requirements of the FDR can be offered for sale directly without a pre-market submission. This also includes labelling requirements such as the front-of-package nutrition symbol, when applicable. For questions related to requirements applicable to new products or the requirements of the FDR as a transition product, industry stakeholders are encouraged to contact Health Canada's Food and Nutrition Directorate (supplementedfoods-alimentssupplementes@hc-sc.gc.ca).
All health claims, implied and expressed, on food including sports electrolyte products, are voluntary and must comply with the Food and Drugs Act and the FDR. Questions about health claims on sports electrolyte products can be sent to healthclaims-allegationssante@hc-sc.gc.ca.