National Hypoallergenic Infant Formula Shortage

Advisory Alert

June 14, 2022

*Cette information est seulement disponible en anglais.

To: Local Health System Partners


Tools to support health care professionals and families during this national shortage

Current situation

Canada is experiencing a shortage of hypoallergenic infant formula. This problem is the result of the unexpected closure of a major North American manufacturing facility operated by Abbott Laboratories in Michigan. This has particularly affected specialized infant formulas, which are often used as the primary source of nutrition for infants with metabolic disorders, severe gastrointestinal diseases, and allergic intolerance.

Tools for health care providers

A national clinical decision tree entitled, Use of Specialized Infant Formula during a Shortage (PDF), has been recently developed to support health care providers across the country guide treatment decisions, and to support families and caregivers to make appropriate formula choices while rationing the use of specialized infant formulas. Health Canada facilitated bringing experts together from a broad community of health care stakeholders for its development, including Canadian Pediatric Society, Canadian Pharmacists Association, Food Allergy Canada, Canadian Society of Allergy and Clinical Immunology, Dietitians of Canada, Hospital for Sick Children and McMaster Children’s Hospital.

The decision tree offers specific guidance to health care providers when counselling families, discussing safe alternatives, and conserving limited national supplies of specialized formulas. This resource is also available in French.

Furthermore, Alberta Health Services has created the Typical Formula Consumption Amounts: Healthy Term Infants (PDF) tool for health professionals which can be used in tandem with the decision tree.

Information to share with concerned parents and caregivers

To facilitate your discussions with concerned parents and caregivers, Health Canada has published the webpage, Information for families during the shortage of formula for infants with food allergies.

A fact sheet which includes a description of infant formulas affected by the shortage, tips about what to do and what not to do during the shortage, a recommendation to speak to a health care provider, and useful information on possible alternative approaches and products is available to download on the Health Canada webpage in English and French. In addition, many hyperlinks are provided to further guide parents, including links to other related Health Canada webpages and to the list of products approved for importation under the Interim policy on the importation and sale of infant formulas, human milk fortifiers (HMF) and dietary products for the treatment of inborn errors of metabolism to mitigate shortages (Health Canada).

The Interim Policy was published to facilitate the importation of infant formula to mitigate the effects of the shortage. Annex A of the policy specifies which products can be imported during the shortage. The list continues to be updated as the situation evolves, and we encourage you to consult Annex A regularly.

Products imported to mitigate the effects of the shortage are safe, even though their composition or labelling may be different from what we normally see on the Canadian market. They come from countries that have similar standards to ours, and Health Canada completes a safety assessment before adding them to the list.

These formulas will be available in pharmacies. They will be kept behind the counter to better control inventory and reserve them for babies who need them most. Pharmacists will be able to order them through their typical distribution channels. Appendix A of the Interim Policy contains links to translated label information when imported infant formula does not have bilingual labeling.

Inventory of highly hydrolyzed and amino acid-based formulas remain very low across the country. This situation is likely to continue for several weeks despite the recent resumption of production at the Abbott plant in Michigan.


Original Signed By

Dr. Penny Sutcliffe
Medical Officer of Health and Chief Executive Officer

NOTE: All Advisory Alerts are found on our website.

This item was last modified on June 14, 2022