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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



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



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.



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.

mailto:[email protected]



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.

http://laws-lois.justice.gc.ca/eng/acts/P-8.6/page-1.html



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.



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.



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



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)


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)



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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?



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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?



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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



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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