Consumption Incident Reporting For Supplemented Foods

Last updated: 2020-09-30

To market supplemented foods in Canada, including caffeinated energy drinks, manufacturers or distributors must obtain a Temporary Marketing Authorization Letter (TMAL) from Health Canada, as provided by Sections B.01.054 and B.01.055 of the Food and Drug Regulations. The purpose of a Temporary Marketing Authorization (TMA) is to allow the sale of certain foods not compliant with the Regulations, and generate in-market information to support an amendment to the Regulations, to permit their legal sale.

The in-market information collected from TMAL holders includes sales data, research data on Canadians' consumption patterns of these foods, and consumers' understanding and use of label information on the product.

For certain supplemented foods that carry cautionary label statements, there is an additional requirement to provide consumption incident reports. All caffeinated energy drinks have cautionary labelling and therefore, require consumption incident reporting whereas other supplemented foods have this requirement only for products that carry cautionary label statements.

All consumption incident reports received by TMAL holders must be reported to Health Canada on an annual basis for the duration of the TMA. If a manufacturer or distributor fails to provide this information, Health Canada will revoke the TMA for the product(s) in question.

A consumption incident is a harmful and unintended response to the food. Consumption incidents can be of a serious or non-serious nature.

A serious consumption incident is something that:

Consumers can report consumption incidents to the manufacturers or distributors of any food product, as well as to the Canadian Food Inspection Agency using their Report a food safety or labelling concern webpage. TMA holders should report serious consumption incidents to the Canadian Food Inspection Agency on an expedited basis, within two weeks of the reaction.

In line with the government's commitment to greater transparency and openness, Health Canada is making more data and information available to Canadians. As a result, a summary of consumption incident reports received for supplemented foods as part of the TMA requirements is being made available.

Tables below summarize consumption incident reports received by Health Canada's Food Directorate for supplemented foods, reported by TMAL holders. The quality and completeness of the information contained in the reports submitted by TMAL holders reflects information received by them and does not permit establishment of a cause and effect relationship between the food and the reported consumption incident. This information will be used, along with TMAL holder research results, sales data, scientific literature, and other information available to Health Canada to inform regulatory amendments for supplemented foods.

Summary of Consumption Incidents

Tables with summaries of consumption incidents reported on a yearly basis for supplemented foods are shown below. Multiple consumption incident reports can be associated with the same product. In addition, multiple symptoms can be reported for the same consumption incident.

Beverages, beverage mixes and concentrates (excluding caffeinated energy drinks)

The number of active TMAs in the summary tables below do not represent the total number of products that were active in this category. The summary tables below are only applicable to products that are required to carry cautionary labelling statements and require consumption incident reporting. A complete list of products in this category that have been issued TMALs is available on Health Canada's website.

2018

During the 2018 calendar year, consumption incident reporting was required for 104 products with active TMAs from 25 companies. In total, 22 companies provided consumption incident reports for their products. The TMAs for products from 3 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2018
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
4 0 4 - Symptoms reported included vomiting, gastrointestinal discomfort, and allergic reaction Use of medication reported for one consumption incident. Unknown: 4 Female: 3
Unknown: 1

2017

During the 2017 calendar year, consumption incident reporting was required for 97 products with active TMAs from 26 companies. In total, 24 companies provided consumption incident reports for their products. The TMAs for products from 2 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2017
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
8 1 - Blood in stool (subsequently diagnosed with bladder infection) 7 - Symptoms reported include feeling ill, headache, allergic reaction, and stomach discomfort Use of medication reported for one consumption incident. 0 - 9 years: 4
20 - 29 years: 1
30 - 39 years: 1
80 - 90 years: 1
Unknown: 1
Female: 5
Male: 3

2016

During the 2016 calendar year, consumption incident reporting was required for 88 products with active TMAs from 24 companies. All 24 companies provided consumption incident reports for their products. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2016
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
3 0 3 - Symptoms included vomiting, gastrointestinal discomfort, diarrhea, fever, and hyperactivity Unknown 0 - 9 years: 3 Female: 1
Male: 2

2015

During the 2015 calendar year, consumption incident reporting was required for 30 products with active TMAs from 15 companies. In total, 12 companies provided consumption incident reports for their products. The TMAs for products from 3 companies were revoked due to a failure to provide the required reports. As per the reports, all companies reported zero consumption incidents for their products.

Consumption incident Reports Summary-2015
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable

2014

During the 2014 calendar year, consumption incident reporting was required for 47 products with active TMAs from 18 companies. In total, 16 companies provided consumption incident reports for their products. The TMAs for products from 2 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2014
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
1 0 1 - Headache Unknown Unknown: 1 Male: 1

2012 and 2013

During the 2012 and 2013 calendar year, consumption incident reporting was required for 38 products with active TMAs from 15 companies. All 15 companies provided consumption incident reports for their products. As per the reports, all companies reported zero consumption incidents for their products.

Consumption incident Reports Summary-2012 and 2013Footnote *
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable
*

The issuance of TMAs for products began part way through the 2012 calendar year; therefore, information for the 2012 and 2013 calendar years was requested together.

Return to footnote * referrer

Caffeinated Energy Drinks

All caffeinated energy drinks are required to carry cautionary labelling statements and therefore all products in this category require consumption incident reporting. Summary tables below represent the total number of caffeinated energy drinks active in each year. A complete list of products in this category that have been issued TMALs is available on Health Canada's website.

2018

During the 2018 calendar year, consumption incident reporting was required for 259 products with active TMAs from 37 companies. All 37 companies provided consumption incident reports for their products. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2018
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
24 1 - Seizure 23 - Commonly reported symptoms included chest pain, headache, stomach discomfort, nausea, and vomiting. Use of alcohol reported for one consumption incident 10 - 19 years: 1
20 - 29 years: 2
40 - 49 years: 2
50 - 59 years: 1
Unknown: 18
Female: 3
Male: 13
Unknown: 8

2017

During the 2017 calendar year, consumption incident reporting was required for 287 products with active TMAs from 37 companies. In total, 32 companies provided consumption incident reports for their products. The TMAs for products from 5 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2017
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
20 3 - Death, anaphylaxis reaction, chest pain (subsequently diagnosed with pericarditis after numerous ER visits) 17 - Commonly reported symptoms included vomiting, stomach discomfort, diarrhea, headache, and, increased heart rate Use of other products such as medication, benzodiazepines and possible use of narcotics reported for some consumption incidents. 10 - 19 years: 3
20 - 29 years: 6
30 - 39 years: 1
40 - 49 years: 2
50 - 59 years: 3
Unknown: 5
Female: 3
Male: 16
Unknown: 1

2016

During the 2016 calendar year, consumption incident reporting was required for 319 products with active TMAs from 43 companies. In total, 34 companies provided consumption incident reports for their products. The TMAs for products from 4 companies were revoked due to a failure to provide the required reports. The TMAs for products from 3 companies were revoked for failing to meet their research requirements. The TMAs for products from 2 companies expired during the year. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2016
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
19 1 - Death 18 - Commonly reported symptoms included stomach discomfort, nausea, vomiting and diarrhea Use of other products such as alcohol and prescription drugs reported for some consumption incidents. 10 - 19 years: 2
20 - 29 years: 3
30 - 39 years: 4
40 - 49 years: 2
50 - 59 years: 1
Unknown: 7
Female: 1
Male: 12
Unknown: 6

2015

During the 2015 calendar year, consumption incident reporting was required for 335 products with active TMAs from 44 companies. In total, 40 companies provided consumption incident reports for their products. The TMAs for products from 4 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2015
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
17 0 17 - Commonly reported symptoms included vomiting, stomach discomfort, headache, dizziness, heart burn, and nausea Use of two different caffeinated energy drinks reported for one consumption incident. 10 - 19 years: 1
20 - 29 years: 9
Unknown: 7
Female: 3
Male: 14

2014

During the 2014 calendar year, consumption incident reporting was required for 303 products with active TMAs from 48 companies. In total, 44 companies provided consumption incident reports for their products. The TMAs for products from 4 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2014
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
17 0 17 - Commonly reported symptoms included stomach discomfort, nausea, vomiting, cramps and allergic reaction Use of sleeping pills, vitamin and mineral supplement, and birth control pills reported for some consumption incidents. 10 - 19 years: 1
20 - 29 years: 6
30 - 39 years: 2
Unknown: 8
Female: 9
Male: 8
Unknown: 1

2012 and 2013

During the 2012 and 2013 calendar years, consumption incident reporting was required for 273 products with active TMAs from 46 companies. In total, 40 companies provided consumption incident reports for their products. The TMAs for products from 6 companies were revoked due to a failure to provide the required reports. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2012 and 2013Footnote *
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
22 4 - Death (2), seizure, skin discoloration 18 - Commonly reported symptoms included vomiting, gastrointestinal distress, nausea, stomach discomfort, headache, diarrhea and tremors. Use of other products such as alcohol, natural health products and recreational drugs reported for some consumption incidents. 20 - 29 years: 6
30 - 39 years: 3
Unknown: 13
Female: 1
Male: 16
Unknown: 5
*

The issuance of TMAs for products began part way through the 2012 calendar year; therefore, information for the 2012 and 2013 calendar years was requested together.

Return to footnote * referrer

Conventional Foods

The number of active TMAs in the summary tables below do not represent the total number of products that were active in this category. The summary tables below are only applicable to products that carry cautionary labelling statements and require consumption incident reporting. A complete list of products in this category that have been issued TMALs is available on Health Canada's website.

2018

During the 2018 calendar year, consumption incident reporting was required for 10 products with active TMAs from 3 companies. All 3 companies provided consumption incident reports for their products. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2018
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
1 0 1 - Reported symptom included bloating Unknown Unknown: 1 Female: 1

2017

During the 2017 calendar year, consumption incident reporting was required for 9 products with active TMAs from 2 companies. Both companies provided consumption incident reports for their products. As per the reports, both companies reported zero consumption incidents for their products.

Consumption incident Reports Summary-2017
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable

2016

During the 2016 calendar year, consumption incident reporting was required for 9 products with active TMAs from 2 companies. Both companies provided consumption incident reports for their products. The reports with consumption incidents are summarized below.

Consumption incident Reports Summary-2016
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
4 0 4 - Reported symptoms included allergic reaction, increased heart rate, and vision problem Use of meal replacements reported for one consumption incident. Unknown: 4 Female: 4

2015

During the 2015 calendar year, consumption incident reporting was required for 4 products with active TMAs from 1 company. The company provided consumption incident reports for their products. As per the reports, the company reported zero consumption incidents for its products.

Consumption incident Reports Summary-2015
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable

2014

During the 2014 calendar year, consumption incident reporting was required for 7 products with active TMAs from 3 companies. All 3 companies provided consumption incident reports for their products. As per the reports, all companies reported zero consumption incidents for their products.

Consumption incident Reports Summary-2014
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable

2013

During the 2013 calendar year, consumption incident reporting was required for 3 products with active TMAs from 2 companies. Both companies provided consumption incident reports for their products. As per the reports, both companies reported zero consumption incidents for their products.

Consumption incident Reports Summary-2012 and 2013Footnote *
Number of consumption incidents Serious reports Non-serious reports Co-consumption Ages reported Gender reported
None reported Not applicable Not applicable Not applicable Not applicable Not applicable
*

The issuance of TMAs for products began part way through the 2012 calendar year; therefore, information for the 2012 and 2013 calendar years was requested together.

Return to footnote * referrer

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