Supplemented Foods and Caffeinated Energy Drinks (CEDs) is a growing market within Canada. Primarily products in this category are ready-to-drink (RTD) beverages, Beverages mixes/concentrates or CED. However, temporary marketing authorization (TMA) applications for other product categories are still permitted, to allow for fortification with vitamin, mineral or bioactive ingredients in food products that do not currently permit fortification. Early data has been received from the Market Research Protocol (MRP) informing Health Canada that labeling variances from conventional foods will be required such that consumers can readily distinguish supplemented foods from conventional foods.

A Look at the Numbers:

• As of December 31, 2018:
  • 820 TMA submissions for CED  have been received by the Food Directorate
    • 553 have received TMALs (~67% success rate)
  • 1110 submissions for Supplemented Foods (non-CEDs) have been received by the Food Directorate
    • 469 have received TMALs (~42% success rate)
  • A total of 132 TMALshave been revoked by Health Canada from 2012 -2017 due to failure to respond to Annual Sales or CIRs
    • Health Canada aims to work with companies to receive the Annual Sales and CIRs by the due date, but will not hesitate to revoke a supplemented foods market authorization if the company will not respond or provide information to Health Canada
    • dicentra has not had a single TMAL revoked

Required Reporting

• Consumption Incident Reporting (CIR) –  remains a requirement for CEDs and certain Supplemented Foods that specifically have a requirement for the CIR outlined in their Letter of Agreement (LofA)
  • Reporting deadline remains September 1 each year
  • The form must be completed even if zero incidents (nil report filed)
  • If not filed, TMAL can be revoked
• Annual Sales Data Collection–  is required for all supplemented foods (CEDs and non-CEDs
  • Reporting deadline remains September 1 each year
  • If not filed, TMAL can be revoked
• Market Research Protocol (MRP)
  • Remains to be a condition in newly received TMALs as part of the Letter of Agreement signed by the client
  • The MRP requires companies to conduct research to help close the gaps in the data regarding fortification of foods not specifically noted by Regulation
  • The goal is to better understand how consumers consume CEDs and Supplemented Food in order to amend the regulations such that pre-market authorization (TMAL) will not be required for these products to be legally marketed and sold, like conventional foods
  • Health Canada has already received the results of the MRP from some TMAL holders, but data collection remains ongoing
  • Health Canada is also collecting data independently of the data provided by TMAL holders, as part of the PAUSE study (Prevalence and consumer Attitudes, Understanding and use of Supplemented foods to inform Education in Canada)
  • The target for the Canada Gazette II Amendment remains to be December 31, 2021
    • Health Canada will continue to issue TMALs that will be valid until December 31, 2021 (regardless of whether they are for a CED or Supplemented food. Previously CEDs received TMALs for 5 years and Supplemented Foods for 2 years
    • Health Canada will be holding consultations over the next couple of years on various aspects of the proposed amendments
    • If the information required to adequately amend the regulations is not ready by December 31, 2021, Health Canada may seek to extend this time period and all TMALs that expire on this date. This will be addressed at a later date if required

Key Takeaways from MRP Data Received to Date:

• MRP data that has been received by Health Canada to date has already identified gaps as follows:
  • Consumers cannot easily distinguish supplemented foods from convention foods
    • Health Canada is proposing to have a Front of Pack identifier on the label to clearly identify a Supplemented food
• Consumers find cautionary labeling difficult to locate on the label
• Health Canada is proposing to develop a Standard Box to highlight conditions of use (e.g. caution statements, directions of use on the label)
• No further guidance has been provided to date demonstrating how this Standard box will look and what the graphics requirements will be
• Consumers are unclear what caution statements are connected to which ingredient
  • Health Canada is proposing to develop a Standard Box to highlight ingredients that are considered Supplemental Ingredients (i.e. Ingredients noted in Appendix 2 of the TMAL) and their levels
  • No further guidance has been provided to date demonstrating how this Standard box will look and what the graphics requirements will be

If you need assistance navigating safety, quality and compliance matters related to the production, distribution, and sale of food and beverage products please fill out the form below or contact us directly.

1-866-647-3279 | info@dicentra.com

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.