Question Period Note: Infant formula shortage

N/A

• The Abbott manufacturing facility in Sturgis, Michigan was closed on February 17 due to possible bacterial contamination and has been gradually resuming production since July 1. The supply of specialized formulas, including dietary products for people with rare metabolic diseases and formulas for infants with food allergies, will remain limited until this facility returns to its full production capacity. In addition, the supply of regular infant formula seems increasingly affected as the situation persists.
• Our government has taken necessary actions to address the shortage.
• Health Canada published an interim policy to facilitate the temporary importation of products to mitigate the shortage.
• Health Canada has issued a range of relevant information to the public, healthcare professionals and pharmacists to help them navigate the shortage.
• Health Canada engaged with manufacturers on an ongoing basis. Although limited, the supply should remain stable for the coming months.
• Health Canada will continue collaborating with various stakeholders to manage the limited supply until the situation has fully stabilized.

IF PRESSED ON THE DURATION OF THE SHORTAGE…
• Abbott’s Sturgis plant had resumed production on June 4. However, operations were halted again on June 15 after severe thunderstorms caused flooding in the plant. The plant reopened on July 1. It is estimated that it will take several months before the plant is back to its regular production capacity.
• The Department is working with manufacturers to maintain a continued supply of specialized products for Canadian families over the coming months. Health Canada will continue coordinating the supply with manufacturers and our provincial and territorial counterparts until the situation has fully stabilized.

IF PRESSED ON ADDITIONAL ACTIONS THE GOVERNMENT SHOULD TAKE…
• Given the serious nature of this situation, we have been working closely with stakeholders to proactively resolve barriers that could compromise access to products as the situation evolves.

Recall of Abbott products and plant closure
A recall of certain Abbott brand powdered infant formula was issued on February 17, 2022, after cases of infant illness caused by Cronobacter and Salmonella bacteria were reported to the U.S. Food and Drug Administration (FDA) between September 2021 and January 2022, including one fatal case associate with Cronobacter sakazakii. Another fatal case linked to this bacterium was reported about a week after the recall. No cases of illness linked to the recalled formulas were reported in Canada.
• Cronobacter is not commonly linked to human disease. In rare instances, it is associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (septicemia), especially in newborns.
• Salmonella usually causes short-term symptoms such as fever, headache, vomiting, nausea, abdominal pain and diarrhea. However, young children, pregnant women, the elderly and people with weakened immune systems can develop more severe and sometimes fatal symptoms.

Recalled products were from the Abbott manufacturing facility in Sturgis, Michigan. Although five strains of Cronobacter were found in the production plant, none of them was an exact match for the patient samples.

The recall includes regular and specialized infant formulas including metabolic and hypoallergenic products. Only powdered formulas were affected by the recall. Liquid ready-to-feed formulas and liquid concentrate have not been recalled and are safe.

The Sturgis facility in Michigan is a key supplier for many countries including the United States (US) and Canada. Most of its production was destined for the US market and the rest to more than 30 countries. Its closure is creating a global shortage of these products, although the North American market appears to be most affected. Other manufacturers have increased their production capacity, but it is not possible to fully compensate the volume usually produced at the Abbott Sturgis facility. There are currently no facilities manufacturing infant formula in Canada.

Abbott’s Sturgis plant had reopened on June 4 but closed again on June 16 due to flooding from a severe storm. The plant resumed production again on July 1. Production will gradually increase, focusing initially on specialized formulations. It is anticipated that it will take several more months for this plant to return to its full production capacity.

Specialized formula
The shortage of specialized formula is concerning because it affects a more vulnerable population who depend on them. Specialized products include metabolic products for people with rare metabolic disorders and hypoallergenic formula for babies with allergies.

Metabolic products:
• Metabolic products are used for the treatment of inborn errors of metabolism that result in the inability to metabolize specific amino acids, carbohydrates or fatty acids.
• Approximately 2000 Canadian patients (infants, children and adults) currently require metabolic products; while the incidence of metabolic disorders is relatively low (1 in 30,000 to 1 in 200,000 newborn babies, depending on the disorder), these products are essential to the survival of affected individuals.
• Metabolic products are used only under medical supervision and are not available at retail. In Canada, they are obtained through the National Food Distribution Centre, a non-profit organization solely dedicated to the distribution of metabolic products. They work in close collaboration with registered dietitians and health care professionals and apply just-in-time inventory management for the whole country.
• Patients using metabolic products are particularly affected by the shortage, because there are few or no equivalent products, and switching metabolic formulas can cause problems with palatability and gastrointestinal intolerance.

Hypoallergenic products:
• Regular infant formula will typically contain intact proteins, although some products may also contain partially hydrolyzed proteins for babies with intolerances and gastrointestinal discomfort. Hypoallergenic formulas contain extensively hydrolyzed proteins (for mild allergies) or are amino acid based (for severe or multiple allergies). Symptoms of allergy include digestive disturbances that may affect infant growth. Cases of severe allergy can result in an anaphylactic shock.
• Up to 2-2.5% of infants have food allergies, with an estimated 1.2% suffering from allergies to milk protein. Considering the birth rate and the breastfeeding rate in Canada, it is estimated that this represents between 3,000 and 6,000 Canadian infants potentially using hypoallergenic formula.
• However, product usage is believed to be much higher for a variety of reasons. For instance, extensively hydrolyzed products are readily accessible and may be preferred over regular formulas by parents of infants with colic or other mild digestive problems. Other factors include the reimbursement of some extensively hydrolyzed formula in some provinces, noting that an allergy diagnosis may be challenging (there may be self-diagnosis supported by a subsequent medical opinion based on reported symptoms).
• With the closure of the Abbott Sturgis plant, a popular Abbott formulation (Similac Alimentum) has been sold out since April 20, which has significantly increased the demand for hypoallergenic formulas from other manufacturers.
• The supply of hypoallergenic formula reached a low point in June. Since that time the shortage has largely subsided and is now replaced by a limited but stable supply.
• Health Canada has recommended that hypoallergenic formula be accessed only at the pharmacy counter during the shortage to help manage the supply and to facilitate the distribution of products imported under the Interim Policy.
• Certain manufacturers informed us of their intention to return some of their products to shelves in pharmacy and retailers starting in late October. Only formulas that have bilingual labelling may return on store shelves, at the discretion of the manufacturer. Some products imported during the shortage under the Health Canada Interim Policy do not meet bilingual labelling requirements; these will continue to be available for order at the pharmacy counter while supplies last, even after the policy expires at the end of December 2022. Bilingual labels are available on Health Canada’s website and from the pharmacist.

Regular formula
• Regular infant formula continued to be available on shelves during the shortage. While individual products may sometimes be out of stock, alternate formats or comparable products from other brands are usually available.
• Health Canada has been receiving signals in October that the supply of regular infant formula is now more sensitive than it was earlier in the year. Some manufacturers are indicating that they are having difficulty meeting the current demand. The extension of the interim policy will help bolster the supply of regular infant formula to help mitigate a potential shortage of these types of formulas in early 2023.

Additional pressures
The closure of the Abbott Sturgis facility has occurred in a context where manufacturers were already facing supply issues for certain ingredients due to the pandemic, including a shortage for some of the materials needed to make the plastic components of their packaging.

More recently, sunflower oil (a key ingredient in many infant formulas) is in short supply due to the conflict between the Russia and Ukraine, which are the largest exporters for this commodity. One manufacturer producing infant formula for the Canadian market indicates that the supply of sunflower oil cannot be guaranteed beyond this summer and the oil blends in their products must be modified as a result. An ingredient substitution is considered a major change and it must undergo pre-market assessment as per Division 25 of the Food and Drug Regulations. Health Canada is currently working with manufacturers to accelerate the pre-market assessments for more than thirty (30) products.

Health Canada actions to mitigate the shortage:
Health Canada has been taking strong action in two key areas: supply and distribution as well as communications.

Supply and distribution
• Health Canada implemented an interim policy on March 10 to facilitate the importation of equivalent infant formula from countries with similar regulatory standards to Canada. The list of products suitable for importation is included in the interim policy and is updated regularly. Our experts conduct a safety assessment of each product before adding them to the list. These products are safe to use, even if they differ from products available on the Canadian market in terms of labelling or composition. Bilingual labelling provisions continue to apply.
• The Department is monitoring the situation very closely, for both metabolic products and hypoallergenic formulas to understand the status in terms of product availability across the country. We are gathering information from distributors (for hypoallergenic and regular formula) and from the National Food Distribution Centre (for metabolic products).

Communication
• The Department has proactively taken on a facilitator role to promote information sharing since the beginning of the shortage. This includes sending targeted information to the healthcare community and caregivers as well as the development of several communication products for the public, healthcare professionals and pharmacists to help them navigate the shortage. In addition, we have contacted various associations to raise awareness and explore ways to reduce or eliminate barriers to providing rapid and fair access to product.
• Many communication materials were developed by Health Canada:
o Information for the public include a public advisory and a detailed fact sheet for families, with two separate social media campaigns to further emphasize key messages and reach a broader audience. In addition, information about the shortage was posted on Service Canada screens across the country between July 1 and August 31.
o Information for healthcare professionals include a clinical decision tree jointly developed by a broad community of healthcare stakeholders to guide treatment decisions and help families make appropriate choices while rationing the use of specialized infant formulas.
o Information for pharmacists were developed to help them order hypoallergenic formula during the shortage and answer questions from the public.

The situation in the United States
On May 12, President Biden directed his administration to work urgently to ensure that infant formula continues to be safe and available during the Abbott recall. He recommended the simplification of product offerings to increase the speed and scale of production, the cracking down on any price gouging or unfair market practices related to sales of infant formula, and increased supply through importation. The United States Congress also investigated the shortage.

On May 18, President Biden invoked the Defense Production Act (DPA). On June 2, Health Canada met with officials from the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services, which is responsible for administering the DPA. ASPR confirmed that the DPA was being used to prioritize the acquisition of additional raw material to infant formula manufacturers to bolster capacity. ASPR is not directing where the infant formula is going and there were no indications that the measures under the DPA would result in a cessation of U.S. infant formula exports to Canada. Both Health Canada and ASPR have committed to keeping each other abreast of developments as the shortage evolves.

Media presence
The shortage has been receiving media attention in the United States since early May. In Canada, coverage has been sporadic. Media focused initially on understanding measures taken domestically to alleviate the effects of the shortage, including efforts to import products to Canada, and questioning the absence of domestic production of infant formula (see section on Canada Royal Milk, below). This summer, Canadian news stories were around the challenges faced by families when trying to access specialized formula. Some media reports were positive and reiterated key information published by Health Canada. More recently, stories have focused on the frustrations experienced by parents who must often switch regular formula as more popular products are out of stock.

Canada Royal Milk
Canada Royal Milk (CRM) owns a production plant in Kingston, Ontario, that manufactures fortified cow milk powder, whole goat milk powder and skim goat milk powder that may be used in fortified milk products for adults and for infant formula production. These products are not for the Canadian market and are exported to other countries including China. Contrary to certain media reports, CRM does not produce infant formula.

CRM cannot sell infant formula on the Canadian market until the company receives pre-market approval from Health Canada. The company met with Health Canada to discuss information requirements to support a pre-market submission to produce and sell infant formula in Canada. [Confidential information: On May 31, 2022, Health Canada received a submission from CRM for the sale of an infant formula product in Canada. The review is underway.]

• The Abbott manufacturing plant in Sturgis, Michigan is an important supplier and its closure in February affected the availability of infant formula in Canada and elsewhere.
• In Canada, this resulted in a shortage of specialized products for people with rare metabolic diseases and for infants with food allergies.
• Health Canada published an interim policy on March 10 to facilitate the importation of equivalent products from other countries. To date, the importation of 46 specialized products has been authorized pursuant to the interim policy and the list is updated regularly. The interim policy is in effect until December 30, 2022 and will be extended until December 31, 2023.
• Health Canada has mitigated the impact of the shortage by permitting the importation of products from countries with similar regulatory requirements, convening regular stakeholder (provinces, territories, manufacturers, distributors, health professionals, non-governmental organizations) meetings, developing communication materials for the public and for the healthcare community, monitoring supply, and assisting with equitable distribution.
• The supply of formulas for infants with allergies reached a low point in June. Since that time the shortage has largely subsided and is now replaced by a limited but stable supply.
• Since the spring, formulas for infants with allergies could only be accessed at the pharmacy counter to help manage the supply. Certain manufacturers have decided to return some of their products to shelves at pharmacies and retailers as of late October. It is anticipated that the current supply will continue meeting the needs of Canadian families for the coming months.
• Metabolic products are not available to the general public. Their supply is very limited and is managed by specialized distributors in close collaboration with healthcare professionals caring for patients with metabolic disorders.
• Abbott’s Sturgis plant reopened on July 1. Production will gradually increase over the coming months, initially prioritizing specialized products.
• Health Canada has been receiving signals in October that the supply of regular infant formula is now more sensitive than it was earlier in the year. The extension of the interim policy will help bolster the supply of regular infant formula to help mitigate a potential shortage of these types of formulas in early 2023.