Public advisory

Shortage of infant formulas for babies with food allergies: what you should know and do

Last updated

Summary

Product
Infant formulas for babies with food allergies and certain medical conditions
Issue
Health products - Supply
Food - Other
What to do

Speak to a health care professional to discuss your baby’s needs and possible alternative products. Do not make homemade formula, use other milk substitutes or acquire infant formula or breastmilk from unknown sources. If you are combining bottle-feeding and breastfeeding, try to maintain your breastmilk supply and consult your health care professional if you need advice on an allergen free diet.

Affected products

Infant formula - manufacturing plant by Abbott Laboratories in the United States.

Issue

UPDATE: June 29, 2022

There continues to be a national shortage of specialized infant formulas for infants with food allergies and certain medical conditions. This includes extensively hydrolyzed formulas and amino acid-based formulas. There is no shortage of regular infant formula in Canada.

While shipments of specialized formulas are arriving in Canada to alleviate the effects of the shortage and will be available through pharmacies nationwide starting the first week of July, supply of these specialized products will continue to be limited throughout the summer. 

Health Canada has been working closely with its provincial and territorial partners and stakeholders to help ensure the fair and equitable distribution of these products.

Parents and caregivers in need of these products are encouraged to speak with their pharmacist. Health Canada has communicated guidance and resources to pharmacists through their professional associations.

What to do: Parents and caregivers should speak with a health care professional, such as a doctor, registered dietitian or nurse, about their baby's needs. They can help recommend possible formula substitutes and how to transition them into your baby's diet.

If your baby does not need specialized infant formula, please don't buy it. Keep specialized infant formulas for babies with allergies and medical conditions.

Visit www.canada.ca/infantformulashortage for more info.

Original Advisory: May 19, 2022

The closure of a large infant formula manufacturing plant by Abbott Laboratories in the United States (manufacturer of Similac®Alimentum)®, has resulted in a global shortage of infant formula. Canada is experiencing a shortage of infant formulas designed for babies with food allergies and certain medical conditions.

There are two types of formulas for babies with food allergies: extensively hydrolyzed infant formulas and amino acid-based formulas. In certain provinces, the supply of these products is not meeting demand.

This can be a distressing situation for parents and Health Canada is doing everything it can to mitigate the situation to provide parents with safe and healthy alternatives. The Department has published an interim policy to recommend enforcement discretion to facilitate the importation of equivalent and safe infant formulas that 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. The interim policy includes a list of products eligible for this policy that is updated regularly.

The shortage of extensively hydrolyzed formulations is putting additional pressure on the limited supply of amino-acid based formulas. Amino acid-based formulas are critical for babies who are at risk of very serious allergic (anaphylactic) reactions. It is therefore critical that consumption of these products be facilitated by doctors only to babies who require them.

Health Canada is monitoring the supply situation and is working with manufacturers to import this product where possible. Other manufacturers have increased their production to quickly provide alternative products and Abbott is working with the U.S. Food and Drug Administration to safely resume production at its facility in the near term.

If additional safety or supply information is identified, Health Canada will take appropriate action and inform Canadians as needed.

What you should do

  • Speak to a health care professional, such as your doctor or pharmacist, to discuss your baby’s needs and possible alternative products and how to transition them into your infant’s diet.
  • If you are combining bottle-feeding and breastfeeding, try to maintain your breastmilk supply and consult your health care professional if you need advice on an allergen free diet.
  • Do not attempt to make homemade infant formula as it can put your baby’s health at risk. Commercial infant formula contains many important nutrients that cannot be created at home.
  • Do not use other substitutes such as cow’s milk, goat’s milk, evaporated milk, soy or rice beverages as they are not nutritionally complete.
  • Do not acquire infant formula or breastmilk from unknown sources, such as online groups or third parties.
  • When purchasing infant formula, reserve specialty infant formulas for those with medical conditions requiring these ones and avoid buying large amounts.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Food - Infant products
Health products
Companies
Published by
Health Canada
Audience
General public
Children, pregnant or breast feeding women
Identification number
RA-64183
Media and public enquiries

Media Enquiries:

Health Canada
(613) 957-2983
media@hc-sc.gc.ca

Public Enquiries:

(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca

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