Interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages

March 10, 2022

Modified February 22, 2024

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Policy statement

Health Canada recognizes that the temporary closure of a large manufacturing plant in the United States continues to affect the supply of infant formulas, human milk fortifiers (HMF), and dietary products for the treatment of inborn errors of metabolism (herein referred to as metabolic products) for vulnerable populations in Canada, including infants and children.

Health Canada recommends that the Canadian Food Inspection Agency (CFIA) temporarily exercise enforcement discretion with respect to certain labelling and composition requirements on the importation and sale of products listed in Appendix A to prevent and mitigate shortages.

Purpose

This document sets out Health Canada's recommendation to the CFIA with respect to the temporary importation and sale of infant formula, HMF, and metabolic products that may not fully meet Canadian regulatory requirements with respect to labelling and/or composition, but are manufactured to comparable standards, and that provide information that ensures the safe preparation and use of the foods. The purpose of the enforcement discretion recommendation is to help prevent and mitigate shortages of these products in Canada in relation to the temporary closure of a large manufacturing plant in the United States, while ensuring a safe supply of these products to the vulnerable Canadians that rely on them.

Scope

The following policy applies only to the infant formulas, HMF, and metabolic products listed in Appendix A. Health Canada has conducted a safety assessment of each product prior to their inclusion in this list in order to support the CFIA in its food safety mandate and exercising its enforcement discretion.

It is recommended that the CFIA apply its enforcement discretion to foods listed in Appendix A, in respect of the provisions of Parts B and D of the Food and Drug Regulations (FDR). It is also recommended that the CFIA apply its enforcement discretion in respect of sections A.01.014, A.01.016, A.01.041 and A.01.044, to the extent necessary to give effect to the enforcement discretion.

Bilingual labelling provisions continue to apply with enforcement discretion recommended where there are reasonable alternative means of providing the required information in both official languages.

It is further recommended that the CFIA also apply its enforcement discretion, in respect of paragraphs 4(1)(a) and (d) of the Food and Drugs Act to foods listed in Appendix A, in relation to the use or presence of any of the following substances:

  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; and
  6. drugs recommended for administration to animals that may be consumed as food.

Roles and responsibilities

Health Canada: federal authority responsible for establishing standards and regulations regarding, among other things, the labelling and compositional requirements of infant formula, HMF, and dietary products for inborn errors of metabolism sold in Canada, under the Food and Drugs Act

Canadian Food Inspection Agency: federal authority responsible for the compliance and enforcement of regulatory food requirements including those relating to the import, production and sale of infant formulas, HMF, and metabolic products under the Food and Drugs Act and the Safe Food for Canadians Act.

Manufacturers and Importers: responsible for ensuring that their food products comply with applicable food policies, standards, and legislation.

Background

Protecting the health of Canadians is Health Canada's priority. Infant formulas and HMFs are regulated under Division 25 of the FDR, while metabolic products are regulated under Division 24 of the FDR. These provisions establish the regulatory requirements for the sale of these products in Canada, while Part A of the FDR establishes requirements applicable to the importation of these products. Part B of the FDR sets out additional applicable requirements, including with respect to labelling.

On February 17th, 2022, the CFIA issued a food recall warning in relation to certain powdered infant formula products produced in Abbott's Sturgis, Michigan manufacturing facility. Following this recall, the Sturgis facility was closed temporarily. This facility is a key supplier of infant formula, HMF, and metabolic products for the American and Canadian markets, as well as many countries.

Interim policy

Health Canada has determined that a shortage of infant formulas, HMF, and metabolic products in Canada related to the closure of the Abbott facility may be detrimental to the health of vulnerable Canadians. Therefore, Health Canada recommends that the CFIA apply its enforcement discretion to the importation and sale of certain infant formula, HMF, and metabolic products. This discretionary enforcement is limited to only those products that are included in the list in Appendix A. These products have been 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. However, they may not fully meet Canadian labelling and/or composition requirements set out in Part B, in particular, Division 24 and 25, and Part D of the FDR.

In the event that food safety issues arise with the products covered by this notice, licenced importers of these products must notify Health Canada and the CFIA immediately. In such case, appropriate action will be taken.

Health Canada is recommending that the CFIA exercise this enforcement discretion until December 31, 2024. Products imported before this date may continue to be sold until the end of their shelf-life while supplies last. If an extension to this policy is required, Health Canada will consider other options to mitigate the risk of shortages.

Appendix A

This list will be updated regularly.

Last updated: February 22, 2024

Products listed below include both hypoallergenic and regular infant formulas that are imported to alleviate the shortage. Hypoallergenic products will be available in pharmacies.

Table 1: Products imported for consumers
Product name Product type Manufacturer Country of origin Date added to list Labelling
Nestlé® Good Start® Plus Infant Formula Regular Infant Formula Nestlé Canada Inc. United States 10-Mar-2022 Bilingual label on product
Nestlé® Good Start® Soothe Infant Formula Regular Infant Formula Nestlé Canada Inc. United States 10-Mar-2022 Bilingual label on product
Similac® Alimentum® with 2'-FL, 946 mL Hypoallergenic Infant formula (Extensively Hydrolyzed) Abbott Nutrition United States 28-Apr-2022

English label on product and on this page

French label on this page

Enfamil® Nutramigen® liquid concentrate, 384mL Hypoallergenic Infant formula (Extensively Hydrolyzed) RB /Mead Johnson United States 09-May-2022

English label on product and on this page

French label on this page

Aptamil® Pepti 1, powder 400g Hypoallergenic Infant formula (Extensively Hydrolyzed) Nutricia Netherlands 15-June-2022

English label on this page

French label on this page

Aptamil® ProExpert Pepti, powder 400g Hypoallergenic Infant formula (Extensively Hydrolyzed) Nutricia Brazil 15-June-2022

Portuguese label

English label on this page

French label on this page

Modilac® Expert Rice powder 400g Hypoallergenic Infant formula (Extensively Hydrolyzed) Laboratoire Modilac® Poland 15-June-2022 Bilingual label on product
EleCare® powder 400g Hypoallergenic Infant formula (Amino Acid-based) Abbott Nutrition United States 10-Aug-2022

English label on product and on this page

French label on this page

EleCare® Jr powder 400g Hypoallergenic Infant formula (Amino Acid-based) Abbott Nutrition United States 10-Aug-2022

English label on product and on this page

French label on this page

Kirkland Signature for Babies Sensitive to Lactose Infant Formula Iron Fortified Milk-Based Powder (1.36kg) Regular Infant Formula PBM Nutritionals LLC United States 02-Dec-2022 Bilingual label on product
Kirkland Signature Omega+ Infant Formula Iron Fortified Milk-Based Powder (1.36kg) Regular Infant Formula PBM Nutritionals LLC United States 02-Dec-2022 Bilingual label on product
Parent's Choice Gentle+ Iron Fortified Milk-Based Infant Formula Powder (942g) Regular Infant Formula PBM Nutritionals LLC United States 02-Dec-2022 Bilingual label on product
Parent's Choice Omega+ Iron Fortified Milk-Based Infant Formula Powder (992g) Regular Infant Formula PBM Nutritionals LLC United States 02-Dec-2022 Bilingual label on product
Similac® Advance® powder (352 g) Regular Infant Formula Abbott Nutrition Ireland 21-Dec-2022

English label on product and on this page

French label on this page

Modilac Précision 1 powder (700 g) Regular Infant Formula Laboratoire Modilac® France 31-Jan-2023 Bilingual label on product
Modilac Précision 2 powder (700 g) Regular Infant Formula Laboratoire Modilac® France 31-Jan-2023 Bilingual label on product
Enfamil® A NeuroPro powder {890 g (2 x 445 g) box, 587 g tub and 204 g sample can} Regular Infant Formula RB /Mead Johnson United States 12-Jan-2024 Bilingual label on product
Kendamil®
Iron Fortified Milk-Based Infant Formula, powder (800 g and 1,049 g)
Regular Infant Formula  Kendal Nutricare Canada Ltd United Kingdom 29-May-2023

English labels on products

1,049 g English label on this page

1,049 g French label on this page

800 g English and French labels to follow

Kendamil® Organic
Iron Fortified Milk-Based Infant Formula, powder (800 g)
Regular infant formula Kendal Nutricare Canada Ltd United Kingdom 13-July-2023

English Label on product

English and French labels to follow

Kendamil® Goat
Iron Fortified Goat Milk-Based Infant Formula, powder (800 g)
Regular infant formula Kendal Nutricare Canada Ltd United Kingdom 13-July-2023

English Label on product

English and French labels to follow

Enfamil® A NeuroPro, Ready-to-Feed, 59 mL and 237 mL Regular infant formula RB /Mead Johnson United States 12-Jan-2024 Bilingual label on product
Enfamil® A NeuroPro Gentlease powder, 862 g (2 x 431 g) box, 553 g tub and 204 g sample can Regular infant formula RB /Mead Johnson United States 12-Jan-2024 Bilingual label on product
Enfamil® A NeuroPro Gentlease, Ready-to-Feed, 59 mL and 237 mL Regular infant formula RB /Mead Johnson United States 12-Jan-2024 Bilingual label on product

Products listed below are for the treatment of hereditary metabolic conditions and are used only under strict medical supervision. These products are not available in pharmacy or in retail. The National Food Distribution Centre manages their distribution in collaboration with the healthcare community.

Table 2: Products imported for medical use
Product name Condition Manufacturer Country of origin Date added to list
WND 1 UCDFootnote * RB /Mead Johnson United States 10-Mar-2022
WND 2 UCDFootnote * RB /Mead Johnson United States 24-Mar-2022
MMA/PA Anamix® Early Years MMA/PAFootnote * Nutricia United Kingdom 10-Mar-2022
OA 1 MMA/PAFootnote * RB /Mead Johnson United States 10-Mar-2022
OA 2 MMA/PAFootnote * RB /Mead Johnson United States 24-Mar-2022
IVA Anamix® Early Years IVAFootnote * Nutricia United Kingdom 10-Mar-2022
LMD IVAFootnote * RB /Mead Johnson United States 10-Mar-2022
HCY 1 Homocystinuria RB /Mead Johnson United States 10-Mar-2022
HCU Anamix® Early Years Homocystinuria Nutricia United Kingdom 10-Mar-2022
GA 1 GAFootnote * RB /Mead Johnson United States 10-Mar-2022
GA 1 Anamix® Early Years GAFootnote * Nutricia United Kingdom 10-Mar-2022
MSUD Anamix® Early Years MSUDFootnote * Nutricia United Kingdom 10-Mar-2022
TYR Anamix® Early Years Tyrosinemia Nutricia United Kingdom 24-Mar-2022
Locasol® Hypercalcemia Nutricia Germany 10-Mar-2022
Calcilo XD® Hypercalcemia Abbott United States 10-Aug-2022
Cyclinex®-1 UCDFootnote * Abbott United States 10-Aug-2022
Cyclinex®-2 UCDFootnote * Abbott United States 10-Aug-2022
Glutarex®-1 GAFootnote * Abbott United States 10-Aug-2022
Glutarex®-2 GAFootnote * Abbott United States 10-Aug-2022
Hominex®-1 Homocystinuria Abbott United States 10-Aug-2022
Hominex®-2 Homocystinuria Abbott United States 10-Aug-2022
I-Valex®-1 LMDFootnote * Abbott United States 10-Aug-2022
I-Valex®-2 LMDFootnote * Abbott United States 10-Aug-2022
Ketonex®-1 MSUDFootnote * Abbott United States 10-Aug-2022
Ketonex®-2 MSUDFootnote * Abbott United States 10-Aug-2022
Phenex®-1 PKUFootnote * Abbott United States 10-Aug-2022
Phenex®-2, Unflavoured PKUFootnote * Abbott United States 10-Aug-2022
Phenex®-2, Vanilla PKUFootnote * Abbott United States 10-Aug-2022
Pro-Phree® Protein-free Abbott United States 10-Aug-2022
Propimex®-1 MMA/PA Abbott United States 10-Aug-2022
Propimex®-2 MMA/PA Abbott United States 10-Aug-2022
Tyrex®-1 Tyrosinemia Abbott United States 10-Aug-2022
Tyrex®-2 Tyrosinemia Abbott United States 10-Aug-2022
ProViMin Protein-Vitamin-Mineral Module Abbott United States 10-Aug-2022

Similac® Special Care® 20 Premature

English label on this page French label on this page

Formula for infants born premature Abbott United States 5-Oct-2022

Similac® Special Care® 24 High Protein Premature

English label on this page French label on this page

Formula for infants born premature Abbott United States 5-Oct-2022
PKU Periflex® Early Years PKUFootnote * Nutricia United Kingdom 02-Dec-2022

Similac® Special Care® 30 (59mL)

English label on this page

French label on this page

Human milk fortifier

Note: product is labelled as ready-to-feed, however is used in Canada as a human milk fortifier. Preparation instructions and indications for use as a human milk fortifier to be provided to healthcare providers

Abbott United States 14-Dec-2022

Similac® With Iron 24 (59mL)

English label on this page

French label on this page

High energy infant formula Abbott United States 14-Dec-2022

Enfamil® 24

English label on product and on this page

French label on this page

High energy infant formula RB /Mead Johnson United States 14-Dec-2022

Enfamil NeuroProTM Enfacare®

English label on product and on this page

French label on this page

Formula for infants born premature RB /Mead Johnson United States 14-Dec-2022

Enfamil® Premature 20 Cal/fl oz

English label on product and on this page

French label on this page

Formula for infants born premature RB /Mead Johnson United States 14-Dec-2022

Enfamil® Premature 24 Cal/fl oz

English label on product and on this page

French label on this page

Formula for infants born premature RB /Mead Johnson United States 14-Dec-2022

Enfamil® Premature 24 Cal/fl oz High Protein

English label on product and on this page

French label on this page

Formula for infants born premature RB /Mead Johnson United States 14-Dec-2022

Enfamil® Liquid Human Milk Fortifier Standard Protein

English label on product and on this page

French label on this page

Human milk fortifier RB /Mead Johnson United States 14-Dec-2022

Enfamil® Liquid Human Milk Fortifier High Protein

English label on product and on this page

French label on this page

Human milk fortifier RB /Mead Johnson United States 14-Dec-2022

Enfamil® Water

English label on product and on this page

French label on this page

Hospital nutrition product RB /Mead Johnson United States 14-Dec-2022

Enfamil® 5% Glucose in Water

English label on product and on this page

French label on this page

Hospital nutrition product RB /Mead Johnson United States 14-Dec-2022

Enfamil® Enfalyte

English label on product and on this page

French label on this page

Hospital nutrition product RB /Mead Johnson United States 14-Dec-2022

Similac® 360 Total Care® Sensitive (59 mL)

English label on this page

French label on this page

Hospital nutrition product Abbott Nutrition United States 21-Dec-2022

Similac® 360 Total Care®(59 mL)

English label on product and on this page

French label on this page

Hospital nutrition product Abbott Nutrition United States 31-Jan-2023

Similac®Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
(24 x 5 mL)

English label on product and on this page

French label on this page

Hospital nutrition product Abbott Nutrition United States

14-Feb-2023

Nestlé® Good Start® Plus 1 (89 mL bottle)

Bilingual label on product

Hospital nutrition product Nestlé Canada Inc. United States 22-Mar-2023

Similac® Alimentum® (59 mL)

Bilingual label on product
Hospital nutrition product Abbott Nutrition United States 29-May-2023
Footnote 1

WND: waste nitrogen disorder, UCD: urea cycle disorder, MMA/PA: methylmalonic or propionic acidemia, OA: organic acidemias, LMD: leucine metabolism disorders, IVA: isovaleric aciduria, HCY/HCU: homocystinuria (or hypermethioninemia), GA: glutaric aciduria type 1, MSUD: maple syrup urine disease, PKU: phenylketonuria.

Return to footnote * referrer

Manufacturers or importers of infant formula, HMF, or metabolic products wishing to add products to the list in Appendix A may contact the Bureau of Nutritional Sciences, Food Directorate via email at: bns-bsn@hc-sc.gc.ca.

Note that all other applicable Canadian laws and regulations remain in force, including those related to import (e.g. licensing) and food safety (evidence of meeting Canadian food safety controls).

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