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Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 1
Guidance Document for the Food
Industry: Consumption Incident
Reporting
June 2014
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 2
Table of Contents
1.0 Introduction ............................................................................................................................. 3
1.1 Scope ............................................................................................................................ 3
2.0 Annual Consumption Incident Reports ................................................................................ 3
2.1 Consumption Incidents ................................................................................................... 4
2.2 Serious Consumption Incidents ........................................................................................ 5
2.3 Purpose of Consumption Incident Reporting by Implicated Temporary Market Authorization
Letter Holders ..................................................................................................................... 5
3.0 Good Case Management Practices ........................................................................................ 5
3.1 Assessing Consumer and Reporter Identifiability ............................................................... 6
3.2 Evaluation of Consumption Incident Reports ..................................................................... 6
3.3 Reports via the Internet ................................................................................................... 6
3.4 Other Reports ................................................................................................................ 7
Annex A: Consumption Incident Reporting Form .................................................................... 8
Annex B: Sample Annual Summary Report: Caffeinated Products Requiring
Consumption Incident Reporting .............................................................................................. 14
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 3
1.0 Introduction
Health Canada recently completed transitioning food products that previously gained market
access as natural health products (NHPs) to the food regulatory framework. As a first step, the
Department announced on October 6, 2011, its policy intent to transition eligible caffeinated
energy drinks to the food regulatory framework using Temporary Marketing Authorization
Letters (TMALs). TMALs are regulatory instruments that allow market access while regulations
are being amended and are temporary in nature. On April 17, 2012, a similar process was
launched for other product categories (i.e., beverages, beverage mixes and concentrates,
powders, bars and some types of confectionaries). The transition of most eligible products was
completed by December 2012.
As NHPs, these products were subject to the adverse reaction reporting requirements of the
Natural Health Products Regulations. This meant that product license holders were required to
report adverse events associated with their products to Health Canada’s Marketed Health
Products Directorate (MHPD), as well as to prepare and maintain annual summary reports. As
foods these products are no longer subject to NHP adverse reaction reporting requirements.
However, as a condition of their TMAL, TMAL holders are required to report all consumption
incidents associated with some categories of products (e.g., caffeinated energy drinks,
caffeinated products and/or those containing ingredients for which there may be uncertainty
regarding long-term safety for general use in food) annually to the Food Directorate. Generally,
consumption incident reporting is required under TMALs when some form of cautionary
labelling is required for a product. This information is intended to complement data that is
gathered as part of research conducted during the TMAL period and will be used to further
inform the development of a regulatory framework for these products.
Health Canada developed this guidance document and associated forms to assist TMAL holders
in fulfilling their annual consumption incident reporting requirements.
1.1 Scope
This guidance applies to all TMAL holders for caffeinated energy drinks, other caffeinated
products and /or products containing ingredients for which there may be uncertainty regarding
long term safety for general use in food. This guidance document provides TMAL holders with
information on how to comply with the consumption incident reporting condition of their
TMAL. Consumption incidents within the scope of this guidance document are to be reported to
Health Canada’s Food Directorate on an annual basis, by the date prescribed by the Department.
2.0 Annual Consumption Incident Reports
TMAL holders required to submit annual domestic consumption incident reports as a condition
of their TMAL should put into place internal written procedures for the receipt, evaluation, and
reporting of consumption incidents.
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 4
Implicated TMAL holders must submit annual domestic consumption incident reports to Health
Canada’s Food Directorate. The preferred reporting format for consumption incidents is via the
Consumption Incident Reporting Form for Mandatory Industry Reporting (Annex A). These
reporting requirements commence when a TMAL for a product has been issued, and reports will
be due by June 30 every year following the subsequent year of reporting (January 1 to December
31). Consumption incident reporting requirements will continue until the TMALs have expired.
Annual consumption incident reports may be submitted by mail or email to:
Submission Management and Information Unit
Food Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2202E
Ottawa, Ontario, Canada, K1A 0K9
Email: [email protected]
Should the company receive no reports of incidents within the reporting timeframe, a nil report
should also be indicated to Health Canada. Failure to complete and submit annual consumption
incident reports may result in Health Canada’s Food Directorate taking appropriate action, which
could include revoking the holder’s TMAL.
For further questions or clarification regarding consumption incident reporting, please contact
the Submission Management and Information Unit.
Should a TMAL holder have several consumption incidents to report, Health Canada would
appreciate a summary sheet that collates specific data as a means of facilitating its review
activities. A sample summary sheet is provided in Annex B.
2.1 Consumption Incidents
A consumption incident is characterized by a suspected or established relationship between the
consumption of a food product and the occurrence of an adverse health effect. For the purposes
of this document, an adverse health effect is defined as an undesired harmful effect. Health
professionals and consumers often times report consumption incidents when they suspect or have
confirmed such a link. The description of experiences in these reports should therefore be
considered consumption incidents. Reportable consumption incidents also include those
suspected of being the result of an interaction between a health product (e.g. pharmaceuticals,
natural health products, etc.) and a product required to report consumption incidents as per its
TMAL. These reporting requirements apply only to incidents that occur domestically and for
which the product consumed is available on the Canadian marketplace.
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 5
2.2 Serious Consumption Incidents
A serious consumption incident is a harmful and unintended response to a product and that
requires in-patient hospitalization or causes congenital malformation, results in persistent or
significant disability or incapacity, is life-threatening or results in death. Health Canada strongly
recommends that serious consumption incidents be reported to the Canadian Food Inspection
Agency (CFIA) on an expedited basis, as they should for any food, so that the CFIA can take
appropriate action.
The annual reporting requirements under the TMAL do not replace the responsibility to report
serious consumption incidents to the CFIA. However, all incidents, including serious ones, are
required to be included in the annual report that is submitted to Health Canada’s Food
Directorate.
2.3 Purpose of Consumption Incident Reporting by Implicated Temporary Market
Authorization Letter Holders
The success of Health Canada's annual consumption incident reporting system depends on the
quality, completeness and accuracy of the information submitted. Reporting of consumption
incidents and the monitoring thereof remain an important means of identifying previously
unrecognized, rare or serious consumption incidents. Analyzing such incidents may result in
changing product safety information, facilitating decisions on regulatory development,
contributing to international data regarding risks of products, and imparting food product safety
knowledge that benefits all Canadians. Regulatory compliance action may be taken by the CFIA
for serious incidents if necessary to protect the health of Canadians.
3.0 Good Case Management Practices
The following section provides some guidelines on practices to assist in developing good case
management practices.
Following receipt and review of a reported consumption incident, TMAL holders may have to
follow up with the incident reporter to seek additional information. The TMAL holder is
expected to exercise due diligence to collect key data elements to complete Health Canada’s
Consumption Incident Reporting form to the best of their ability. For the determination of
reportability, the minimum criteria are that there be an identifiable reporter, identifiable
consumer, suspect product and consumption incident.
It is important that at the time of the original report, sufficient details about the consumer and/or
reporter be collected and retained to enable follow-up in accordance with the collection, use and
disclosure provisions of the Personal Information Protection and Electronic Documents Act or
equivalent provincial privacy legislation.
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 6
3.1 Assessing Consumer and Reporter Identifiability
Consumer and reporter identifiability is important in order to avoid case duplication and
facilitate follow-up of appropriate cases. The term "identifiable" in this context refers to the
verification of the existence of a consumer and a reporter. All parties submitting case
information or approached for case information should be identifiable: not only the initial
reporter (the initial contact for the case), but also others supplying information. In addition, in the
event of second-hand reports, the TMAL holder should make every reasonable effort to verify
the existence of an identifiable consumer and reporter. In some instances, the patient will be the
one who is reporting the incident.
The TMAL holder should assign a unique identifier to each incident to facilitate follow up and to
avoid case duplication. One form should be used for each separate incident report. However, if
submitting information about more than one incident, Section A of the form only needs to be
filled out once.
3.2 Evaluation of Consumption Incident Reports
The purpose of careful medical review by qualified health professionals is to ensure correct
interpretation of medical information. Preferably, information about the case should be collected
from the health professionals who are directly involved in the consumer's care, where possible.
Regardless of the source of a consumption incident report, the TMAL holder should carefully
review the report for the quality and completeness of the medical information.
Every effort should be made to use terms consistently and in accordance with recommended
standards for diagnosis. The report should include the verbatim term as used by the reporter, or
an accurate translation. Any TMAL holder receiving reports should provide an unbiased and
unfiltered report of the information from the reporter. While the report recipient is encouraged to
actively query the reporter to elicit the most complete account possible, inferences and assigning
responsibility should be avoided in the report submission. However, clearly identified
evaluations by the TMAL holder are considered appropriate.
When a case is reported by a consumer, his/her description of the event should be retained,
although confirmatory or additional information from any relevant qualified health care
professionals should also be sought where possible.
3.3 Reports via the Internet
TMAL holders should regularly screen Web sites, email accounts or 1-800 numbers under their
management or responsibility for potential domestic consumption incident case reports. TMAL
holders are not expected to screen external websites for consumption incident information.
However, if a TMAL holder becomes aware of a consumption incident on a website that it does
not manage, the TMAL holder should review the case and report it.
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 7
TMAL holders should consider using their websites to facilitate consumption incident data
collection (e.g., by providing forms for reporting or by providing appropriate contact details for
direct communication).
For internet reports, the same minimum criteria (i.e., identifiable consumer, identifiable patient,
suspect product and consumption incident) should be applied as for cases provided via other
ways.
3.4 Other Reports
If a TMAL holder becomes aware of a case report from non-medical sources (e.g., the lay press
or other media), it should also be reported. To be reportable, the same minimum criteria (i.e.,
identifiable reporter, identifiable consumer, suspect product and consumption incident) would
apply as for other reports.
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 8
Annex A: Consumption Incident Reporting Form
Consumption Incident Reporting Form for Mandatory Industry Reporting
PROTECTED B** (when completed)
This information is being collected for the purpose of informing Health Canada's regulatory
development in relation to caffeinated energy drinks, other caffeinated products, and/or products
containing ingredients for which there may be uncertainty regarding long-term safety for general
use in food.
Personal information that you provide is protected under the provisions of the Privacy Act.
Please fill out one form for each separate consumption incident. If submitting information about
more than one incident, Section A only needs to be filled out once.
It is expected that this form is filled out to the best of your ability, based on the information
at your disposal.
When completed, please send mail or email to:
Submission Management and Information Unit
Food Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2202E
Ottawa, Ontario, Canada, K1A 0K9
E-mail: [email protected]
A. Company Information
1. Company name
2. Company Address
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch 9
3. Name of contact person
4. Telephone Number of contact person:
Email Address of contact person:
5. Internal case number, if any:
6. Date Report sent to Food Directorate: (YYYY-MM-DD)
B. REPORTER INFORMATION
7. Reporter Qualification
Physician □ Lawyer □
Pharmacist □ Consumer □
Other health professional □ Other (specify):
(specialization): ___________________ __________________
8. Date of incident (YYYY-MM-DD)
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch
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C. CONSUMER INFORMATION
9. Unique Identifier (Please provide a reference number to facilitate any follow up
and to avoid case duplication)
10. Age of consumer at time of incident
11. Gender
Male □
Female □
Please indicate if pregnant □ or breastfeeding □
12. Height
In feet: and inches:
or cm: .
13. Weight
in lbs:______________
or kg:_________________
14. Other relevant medical conditions, history, including Pre-existing Medical
Conditions (e.g. allergies, pregnancy, smoker, caffeine sensitivity, liver/kidney/heart
dysfunction)
D. DESCRIPTION OF PRODUCT
15. Product (specify full name, volume, flavour, etc)
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch
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16. TMAL Number:
17. Product Use
Amount consumed on day of incident or around the time of the incident:
Date(s) of use:
Time to onset reaction:
E. DESCRIPTION OF THE CONSUMPTION INCIDENT
18. Describe during what activity and under what circumstances the product was
consumed: (e.g. during physical exertion, with alcohol, etc.)
19. Describe the incident
20. How long did the incident last?
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch
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21. Please check off criteria that apply to the incident:
□ Caused/Prolonged hospitalization
□ Disabling/Incapacitating □ Life-threatening
□ Allergic reaction □ Death _________ (YYYY-MM-DD)
□ Other medical condition or illness (e.g. Emergency visit or other medical attention,
specify):
22. Outcome
Recovered □ Not Recovered □ Recovering □
Fatal □ Recovered with pathological condition□
Unknown □
23. Date/period of time to recover from incident:
Date reported in YYYY-MM-DD or period of Time: in month(s), week(s) or day(s)
24. Did the reaction subside after discontinuation or reduction of use of the
product?
25. Did the reaction reappear after reintroduction of the product, if applicable?
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch
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26. List any concomitant medications, or other products (e.g. alcohol, cigarettes,
drugs, supplements, medications or natural health products) used before or during
the time of the incident, their dosage and length of use:
27. Relevant Tests/Laboratory Data (including dates) if available
F. For Incidents involving caffeinated products only
28. Were any other products or food containing caffeine consumed on that day or
around the time of the incident? Examples of products/foods containing caffeine are
caffeinated energy drinks, coffee, tea, colas, other caffeinated beverages, energy
gum, energy shots, caffeine pills.
Product How many
containers/cups?
What size
container/cup?
29. Previous use of Energy Drinks – List type, frequency of use and quantity
consumed and if patient had any reaction
Guidance Document for the Food Industry: Consumption Incident Reporting
Food Directorate, Health Products and Food Branch
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Annex B: Sample Annual Summary Report: Products Requiring Consumption Incident
Reporting
Company Name:
Number of Consumption Incidents within reporting period
Number of serious Consumption Incidents within reporting
period
Products involved
Number of incidents involving children
Number of incidents involving teens
Number of incidents involving males
Number of incidents with relevant pre-existing medical
conditions
Number of incidents where amount of product consumed was
beyond recommendation on label
Number of incidents taking place during physical exertion
Number of incidents involving alcohol or other drugs
Number of fatal incidents
Number of incidents requiring medical attention
Number of incidents with any other products involved
Number of incidents involving any other products or food
containing caffeine consumed around the time of the incident