Guidance on the implementation of the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 with respect to foods for a special dietary purpose  

Disclaimer: This document does not constitute part of the Food and Drugs Act or associated regulations. In the event of any inconsistency or conflict between this document and the Act or regulations, the Act or regulations take precedence. This document is administrative and intended to facilitate compliance with the Acts, regulations, and applicable policy by regulated parties.

Table of Contents

• 1.0 Purpose
• 2.0 Background and Scope
• 3.0 Instructions on How to Add an FSDP to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale
• 4.0 Implementation of the Interim Order
• 5.0 Contact Information
• Appendix: Designated Food for a Special Dietary Purpose Notification Form

1.0 Purpose

This document provides guidance to manufacturers and importers of foods for a special dietary purpose (FSDP) wishing to invoke section 24 of the Interim No. 2 Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order).

This document provides instructions for manufacturers on how to add FSDP to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale (the List). It also provides guidance to importers on the requirements for submitting a Notification to the Minister, in order to import a designated FSDP, as per sections 25 and 26 of the Interim Order.

2.0 Background and Scope

A. Background

On March 17, 2021, the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. The Interim Order repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This previous interim order was made by the Minister on March 30, 2020, and approved by the Governor in Council (GIC) on April 8, 2020. It extends measures for drugs, medical devices and foods for a special dietary purpose introduced in the interim order that continue to be necessary to help prevent or alleviate the effects of shortages caused or exacerbated, directly or indirectly, by COVID-19.

The Interim Order is effective for a period of one year, or until such a time that the Interim Order is repealed or regulations having the same effect come into force.The Interim Order allows the Minister to permit the importation and sale of drugs, medical devices, and foods for a special dietary purpose that do not fully comply with Canadian requirements but are approved by a foreign regulatory authority, or are allowed to be sold in foreign jurisdictions that have high quality and manufacturing standards similar to Canada.

The Interim Order, among other things, is a mechanism to enable Canadians continued access to specialized food products, despite potential reductions in product manufacturing or transportation, or surges in demand, related to COVID-19. The Interim Order allows the importation of Designated Foods for a Special Dietary Purpose from other countries into Canada, in the event that the comparable Canadian product is unavailable.

FSDP imported for the purposes of these sections of the Interim Order must first be added to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale. Canadian manufacturers of FSDP are responsible for contacting Health Canada if they are expecting shortages as a result of COVID-19. Once a designated FSDP has been added to the List, importers of designated FSDP are required to notify the Minister at least five calendar days before the day on which the food is imported.

B. Scope

This document is intended to provide guidance for industry on the process through which an eligible FSDP can become a designated food for a special dietary purpose (designated FSDP) as defined in the Interim Order and set out in the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale.

Guidance on the Interim Order with respect to drugs or medical devices is provided in a separate document.

3.0 Instructions on How to Add an FSDP to the List

A. What is a Designated FSDP?

To ensure that Canadians continue to have access to FSDP, despite shortages directly or indirectly related to COVID-19, the Interim Order provides a mechanism to temporarily permit the sale in Canada of an FSDP which is not fully compliant with the Canadian regulations. These products must be approved or allowed to be sold in foreign jurisdictions that have high quality and manufacturing standards similar to Canada.

Sections A.01.014 and A.01.16 of the Food and Drug Regulations, the provisions of Parts B of those Regulations -- other than sections B.24.100 and B.24.300 -- and the provisions of Part D of those Regulations do not apply to designated FSDP, when they are included on the List.

A designated FSDP is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act (FDA) in respect of the use or presence of any of the following substances or materials if the applicable condition in subsection (1)(a) or (b) of the Interim Order is met:

1. a food additive;
2. any nutritive material that is used as an ingredient of the food;
3. vitamins, mineral nutrients and amino acids;
4. agricultural chemicals;
5. food packaging materials and components of those materials;
6. drugs recommended for administration to animals that may be consumed as food; and
7. any substance specified in the List in respect of the food.

An FSDP becomes a designated FSDP when it is added to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale. The List is available on the Government of Canada website and will be updated regularly.

B. Which Foods are Eligible to Become a Designated FSDP?

Foods that may be eligible to become a designated food for a special dietary purpose include:

• Food for special dietary use, as defined in FDR B.24.001
• Human milk substitutes (infant formula), as defined in FDR B.25.001; and
• Human milk fortifiers, which are foods labelled and advertised as intended to be added to human milk to increase its nutritional value, and are used by infants for whom it is medically required.

C. How is an FSDP Added to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale?

In the event that a Canadian manufacturer of FSDP anticipates a shortage of products for reasons related to COVID-19, they must contact Health Canada in order to add the category of FSDP to the List, so that they become designated FSDP. This will permit the importation and sale of similar products with comparable quality and manufacturing standards, but do not fully comply with Canadian regulatory requirements.

Manufacturers wishing to add FSDP to the List may contact the Bureau of Nutritional Sciences, Food Directorate via phone at (613 948-8476) or via email by contacting hc.bns-bsn.sc@canada.ca.

Once added to the List, a designated FSDP is permitted for import and sale in Canada for a duration of up to one year, and not beyond March 17, 2022, or until such a time that the Interim Order is repealed or regulations having the same effect come into force.

4.0 Implementation of the Interim Order

Any importer who uses the exemptions in this Interim Order to import a designated FSDP must notify the Minister at least five calendar days before importation, following the requirements in the Interim Order. These designated FSDP will still be subject to some of the requirements set out in the Food and Drugs Act and its Regulations, as well as the Safe Food for Canadians Act and its Regulations.

A. Information Required in the Designated FSDP Notification Form once the FSDP Has Been Added to the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale

The importer must submit all information in section 25(2) to the Minister at least five calendar days before the day on which the designated FSDP is imported. This information includes:

1. the importer's name and contact information;
2. information that demonstrates that the sale of the food is authorized by a foreign regulatory authority if such an authorization is required within its jurisdiction;
3. the name and contact information of the manufacturer of the food as it appears on the food's label;
4. the name and address of each establishment in which the food is manufactured;
5. in respect of the food that is intended to be imported,
   1. a copy of the food's labels,
   2. the special dietary purpose for which the food is represented,
   3. a list of the food's ingredients,
   4. the warnings, if applicable,
   5. directions for the preparation, use and storage of the food,
   6. the expiration date, and
   7. the lot number of the food, if applicable;
6. the intended port of entry into Canada;
7. the estimated date of arrival of the shipment of the food;
8. the customs identification number for the shipment; and
9. the total quantity of the food that is intended to be imported (i.e. number of units/packages).

The Designated FSDP Notification Form provided in the appendix should be used to help ensure that all of the required information has been provided. For a copy of a fillable form, please contact hc.smiu-ugdi.sc@canada.ca.

Completed information must be submitted to Health Canada, via email, at hc.smiu-ugdi.sc@canada.ca. It is recommended that a copy of the completed notification form be retained in your records.

Upon receipt of this information, Health Canada will send an acknowledgement of receipt via email to the applicant.

B. Information Required with the Designated FSDP

As per Section 26 of the Interim Order, an importer of a designated FSDP that sells it must ensure that the following information is available, in both English and French, in a manner that permits the safe preparation and use of the food:

• The special dietary purpose for which the food is represented;
• The warnings, if applicable;
• The directions for the preparation, use and storage of the food;
• The expiration date;
• The lot number of the food; and
• The list of food ingredients, including priority allergens.

5.0 Contact Information and References

Contact information

Bureau of Nutritional Sciences
Food Directorate
E-mail: hc.bns-bsn.sc@canada.ca
Telephone: 613-948-8476 613-948-8476

Submission Management and Information Unit
Food Directorate
Email: hc.smiu-ugdi.sc@canada.ca
Telephone: 613-960-0552 613-960-0552

References:

• Interim Order No.2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19
• Division 24 of the Food and Drug Regulations
• Division 25 of the Food and Drug Regulations

Appendix: Designated Food for a Special Dietary Purpose Notification Form

This completed form must be submitted to the Minister at least five calendar days before the day on which the designated food for a special dietary purpose is to be imported. Please submit to Health Canada, via email, at hc.smiu-ugdi.sc@canada.ca.

For a copy of a fillable form, please contact hc.smiu-ugdi.sc@canada.ca.

Contact information

Manufacturer Information

• Manufacturer Name (as it appears on the product label)
• Primary Contact Person
• Phone Number
• E-mail
• Mailing Address

Importer Information

• Importer Name
• Primary Contact Person
• Phone Number
• E-mail
• Mailing Address

General product information

• Brand and product name
• Product category
• Infant formula (Yes or No)
• Food for special dietary use (Yes or No)
• Human milk fortifier (Yes or No)
• Brief product description and the special dietary purpose for which the food is represented
• List of the food's ingredients
• Product warnings, if applicable
• Directions for the preparation of the product
• Directions for the use of the product
• Directions for the storage of the product

Please ensure that a copy of the product label(s) is included with this completed form.

Information on the product intended to be imported

• Expiration date for the product intended to be imported
• Lot number for the product intended to be imported (if available)
• Intended port(s) of entry into Canada for the product
• Estimated date of arrival in Canada of the shipment of the product
• Customs identification number for the shipment of the product
• Total quantity of the product that is intended to be imported (reported in total number of individual units)

Manufacturing and authorization information

• Country or countries of manufacture for the designated FSDP (if applicable)
• Name(s) and address(es) of each establishment in which the designated FSDP is manufactured
• Has the product been authorized for sale by a foreign regulatory authority? [Yes, No or Not applicable (authorization not required to sell within its jurisdiction)]
• List the foreign regulatory authority or authorities that have authorized the designated FSDP for sale, if applicable

If the product has been authorized for sale by a foreign regulatory authority, please ensure information demonstrating this authorization is included with this completed form

Attestation

1. I attest that the information provided in this form is complete, accurate and representative of the product intended to be imported;
2. I attest that the product is a designated FSDP as per the List of Foods for a Special Dietary Purpose for Exceptional Importation and Sale; and
3. I attest that the following information will be made available for the designated FSDP, in both English and French, in a manner that permits the safe preparation and use of the food:
   • the special dietary purpose for which the food is represented;
   • the warnings, if applicable;
   • the directions for the preparation, use and storage of the product;
   • the expiration date;
   • the lot number of the food, if applicable; and
   • the list of ingredients, including priority allergens.

Name:
Signature:
Date: