An Important Update as of April 13, 2016:
You may have received a notice from the Food Directorate of Health Canada advising you of 3 options for collecting research data as a condition of your TMAL.
If you choose Option (ii) or (iii), you will be required to submit your research plan to the Submission Management Information Unit (SMIU-UDGI@hc-sc.gc.ca) by November 30, 2016 for all Caffeinated Energy Products. No date has been provided yet for other Supplemented Food products, but will be provided once it is released.
Health Canada is encouraging people use Option (iii) and will provide you with contacts of companies with similar products to provide more robust data. If you would like to exercise this option you must contact Submission Management Information Unit by June 30, 2016 and they will provide you with contacts for these companies to open a dialogue between parties with similar product(s) or product lines.
Dear Dicentra Customer,
We are emailing you because our records indicate that you have at least one valid Temporary Market Authorization Letter (TMAL) for a food product in Canada.
As per the Letter of Agreement that you signed with the Food Directorate, an expiry date was set on your TMA for the time you would be permitted to legally market your product. In addition to access to marketing your product legally for the length of your TMAL (2 years for Supplemented Foods and 5 years for Caffeinated Energy Drinks (CEDs)), you have agreed to collect data on your product. Up until now, the only information that the Food Directorate has requested has been Annual Sales Data (where do you sell the product, and how much do you sell, etc.), and if required Consumption Incident Reporting (for highly caffeinated products, or those with uncertainty surrounding safety).
The Food Directorate has begun advising companies with TMALs for CEDs of an additional requirement, previously indicated in your Letter of Agreement, that you must develop a Market Research Protocol (MRP) and collect data using this Protocol over a 3 year period. The MRP is a requirement to continue to sell your product compliantly and must be specific to the consumption patterns and demographics of your particular product. It will provide data to the Food Directorate to determine if these products are safe to be consumed as conventional foods, and if any revisions to labeling are necessary.
While Supplemented Foods also require a MRP, the Food Directorate has not sent out a call for a Protocol for these products yet. As our contacts at the Food Directorate have advised, these products will be targeted in the second phase of the call for data from the Food Directorate. Please remember that the MRP must be developed and agreed upon with the Food Directorate in order to maintain your market access.
How do companies collect this data? Some companies are turning to associations for guidance. Others are teaming up with like-product companies – collaborating together to collect data. Others are going at it alone. Dicentra has been working with many of these companies, as we have obtained hundreds of TMAs on behalf of our clients throughout the years. With this in mind, the Food Directorate has been very kind and sincere in collaborating with Dicentra and providing guidance on how MPRs should be designed and on what data should be reported.
We are reaching out to you at this point to see how many of our clients would be interested in collaborating with us on developing an appropriate MPR. If we obtain enough interest we will then proceed with preparing an action plan and possible shared costs and forward you the information to confirm your involvement. At this point we would just need an answer to the following question:
Would you be interested in potentially collaborating with Dicentra in a joint effort with other Dicentra clients to develop a TMA Market Research Protocol for your CED or Supplemented Food?
dicentra is regarded in the food industry as an expert consulting group on food safety and quality matters. We can be reached at 1-866-647-3279 or firstname.lastname@example.org.
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