Canada: New Guidance For Temporary Marketing Authorization For Caffeinated Energy Drinks

On March 29, 2012, Health Canada released its long awaited category-specific guidance document on Temporary Marketing Authorization (TMA) for Caffeinated Energy Drinks (Energy Drinks). The guidance document outlines the TMA process that will be used to transition energy drinks from a natural health product (NHP) to a food which would be regulated accordingly. The guidance document provides details regarding the eligibility criteria for participation in the current TMA process for energy drinks, compositional criteria, permitted labelling, advertising and claims, as well as research and reporting requirements.

Although the guidance document is restricted to the specific requirements for energy drinks, it is relevant for all companies with food-like NHPs, given that energy drinks will probably be just the first product category to transition to foods from NHPs;. Health Canada has been holding off on licensing many food-like NHPs such as vitamin waters, gums and bars in order to develop a strategy to transition these types of products over to foods. Likely within the next few weeks, other food-like NHPs will be re-classified as foods based on Health Canada's assessment of their related consumption patterns, history of use and marketing. This long-awaited regulatory shift has already begun with certain NHP licence holders and applicants receiving notices that their products have been re-classified as foods. This will continue as Health Canada continues the process of classification of products at the food-NHP interface.

1. Temporary Marketing Authorization Letter (TMAL) Process

The transition of food-like NHPs to foods will begin with the issuance of Temporary Marketing Authorization Letters (TMALs), a mechanism built into the Food and Drugs Regulations (FDR) that allows Health Canada to issue a temporary authorization for the sale of a food that is determined to be safe but not compliant with the FDR's requirement for information in support of a regulatory amendment. With respect to the transition process, the timelines and requirements vary depending on the market access of the product and the status of its Product Licence Application (PLA).

2. TMAL Eligibility Criteria

In order to be issued a TMAL as an energy drink, products must contain caffeine, must be water-based and in beverage form. Currently, products such as powders, syrups and shots, or products that are dairy- or juice-based, will not form part of the transition. Products must meet the following specific criteria outlined in the guidance document with respect to the quantity of certain ingredients that may be added to the energy drink:

  • Caffeine - must contain a minimum of 200 ppm (mg/L) caffeine to be classified as an energy drink. Cannot contain more than 400 ppm (mg/L) caffeine, with a maximum amount of 180 mg per single serve container and per serving of 500 mL for multi-serve containers;
  • Taurine - cannot contain more than 3000 mg/day;
  • Vitamins & mineral nutrients - if added, must provide 5 per cent of the -daily value and cannot exceed maximum levels outlined in guidance document;
  • NHP ingredients - quantities based on NHPD monographs or other authoritative sources. It is possible that certain NHP ingredients may be considered novel food ingredients and will require pre-market assessment prior to being authorized for use in food products. A novel food notification involves demonstrating that a substance has a history of safe use as a food at levels that are similar to those expected or intended as a result of consumption of the food product. The review of the novel food submission would occur concurrent with the life of the TMAL.
  • Prohibited ingredients - alcohol, folic acid and Vitamin A (retinol). See guidance document Appendix for additional prohibited ingredients; and
  • Food additives, flavours & colours - must comply with FDR and guidance document. See guidance document Appendix for prohibited ingredients.

Please note: This list is not exhaustive: the guidance document and FDR should be consulted for details and other requirements.

3. TMA Labelling and Advertising

In order to be issued a TMAL, products must meet (or commit to meeting by December 2013) the specific labelling requirements outlined in the guidance document and the FDR including:

  • Nutrition facts table – must appear on label and be compliant with FDR;
  • Reference amount – set at 500 mL for energy drinks;
  • Serving size – all containers up to 750 mL will be considered single-serving containers; all non-resalable containers will be considered single-serving containers; only re-sealable containers above 750 mL will be considered multi-serving containers for which the serving size will be the reference amount (500 mL);
  • Daily consumption limits – recommended maximum number of containers/servings-per-day must not result in total daily vitamins, minerals, amino acids, NHP ingredients or other ingredients that are in excess of maximum limits as set out in the guidance document, monographs or authoritative references (as applicable);
  • Caffeine, taurine and NHP ingredient content label declaration - must appear on a per container basis for single-serving containers; must appear on a per serving basis (500 mL) for re-sealable, multi-serving containers. Should immediately follow nutrition facts table or be adjacent to ingredient listing;
  • Other ingredient content declarations – quantitative declarations of ingredients other than caffeine must comply with FDR and guidance document as applicable (e.g., artificial sweeteners). Should immediately follow nutrition facts table or be adjacent to ingredient listing;
  • "High caffeine content" – statement or equivalent must appear on the product label;
  • Caution statements – should appear grouped together, in bold or preferably under a bolded heading, e.g,, "Caution/Attention: Do not consume more than (X) container(s)/servings daily" or "Usage: (X) container(s)/serving(s) maximum daily"; "Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine"; "Do not mix with alcohol";
  • Toll free number – should be provided on the product label adjacent to the company name/principal place of business to facilitate reporting of consumption incidents.
  • Claims – claims must be in accordance with FDR and guidance document (see section 3.5) as applicable. An exemption from the reference amount requirement may be obtained to enable some products to make "calorie-free" and "sugar-free" claims. Issues arising from these exemptions will be reviewed during the life of the TMAL; and
  • Advertising – must be compliant with the Food and Drugs Act and the Consumer Packaging and Labelling Act and their related regulations. For certain media (e.g., television) advertising preclearance may be required by industry-imposed self-regulation mechanisms.

Please note: This list is not exhaustive: the guidance document and FDR should be consulted for details and other requirements.

4. TMA Research and Other Requirements

The purpose of the TMA process is to permit the sale of energy drinks so that Health Canada and the beverage industry have time to gather necessary information such as consumption data and incident reports that will aid government in designing an appropriate food regulatory framework for these products. As such, in order to be issued a TMAL, manufacturers have to agree to:

  • Either directly or through trade associations, and in partnership with Health Canada, undertake a series of consumer research projects in order to generate data on the consumption of energy drinks and to report on health-related incidents. While Health Canada will have a hand in designing the framework of these studies, it is shifting the burden and cost of gathering this information to industry; and.
  • Withdraw the product from sale if Health Canada determines it is in the public interest to do so.

5. Conclusion

The decision to transition energy drinks to foods brings Canada in line with other major trading partners such as the U.S. and the E.U., and will provide a framework for the transition of other food-like NHPs to the food regulatory framework. The Food Directorate has worked closely with industry to establish the above criteria and the time frame for industry to transition to the new food labelling, while balancing consumer interest in providing new information on food labels with the impact to the industry in making the above changes. The second step in the transition of energy drinks to foods will begin once analysis of consumer-generated data is completed by Health Canada. It is hoped that regulatory amendments will soon follow.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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