Consumption Incident Reporting Guidance Releases for Food Products That Require a Temporary Market Authorization (TMA)

August 11, 2014 By

In June 2014, the CFIA released a Final Guidance Document indicating the requirements of Consumption Incident Reporting for food commodities that require mandatory reporting as part of their TMA License (TMAL).

As part of the conditions of certain TMA licenses (e.g. caffeinated energy drinks, caffeinated products and/or those containing ingredients for which there may be uncertainty regarding long term ad libitum consumption) certain food commodities require mandatory Consumption Incident Reporting. If mandatory reporting is required of a license holder it will be indicated on the cover page of the license holder’s TMAL.

The CFIA defines a consumption incident as “a suspected or established relationship between the consumption of a food product and the occurrence of an adverse health effect”, where an adverse health effect is defined as an undesired harmful effect. It is of note that consumption incidents that are considered reportable apply only to products that are consumed and available in the Canadian marketplace and where the incident occurred domestically. Bearing in mind that in order to meet these requirements TMAL holders should regularly screen websites, email accounts and 1-800 numbers under their control when preparing their reports. However, websites external to the company are not required to be monitored for consumption incidents.

Consumption incident reports must be submitted annually by TMAL holders to the Food Directorate as per the date indicated by the Food Directorate. As per the guidance document, the reporting requirements begin when a TMAL is issued and are due on June 30 every year with incidents reported for the previous calendar year (i.e. January 1 to December 31). While a company can develop their own form, the Food Directorate has provided a Reporting Form in Appendix A of this guidance document and recommends using this template.

Completed annual consumption incident reports can be submitted by mail to the Submissions Management and Information Unit or email to: . It is important to note that even if no consumption incidents occur for a particular TMA food commodity, it is still mandatory to submit a nil report to the Food Directorate. If a product has multiple consumption incidents, a consumption incident report should still be prepared for each incident and a summary sheet included with the annual report to collate the data to facilitate the Food Directorate’s review.

In addition to annual consumption incident reports, serious consumption incidents (defined as “a harmful or unintended response to a product that requires in-patient hospitalization or causes congenital malformation, results in persistent or significant disability or incapacity or is life threatening or results in death) are subject to expedited reporting.

TMAL holders should also have written procedures put into place for the receipt, evaluation and reporting of consumption incidents. Moreover, evaluation of consumption incidents should be completed and reviewed by qualified health professionals. dicentra can assist your company be writing, and/or reviewing Standard Operating Procedures for consumption incident reporting and collection, review and preparation of both expedited and annual reports. Contact us at or at 1-866-647-3279.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces.