News: May 14, 2022: The baby formula shortage is began during the COVID-19 pandemic due to supply chain issues.
In February of this year, one of the largest baby formula makers, Abbot Nutrition Sturgis, recalled several of their popular brands, The following is latest statement from Abbot May 13, 2022:
May 13, 2022
Since the recall, one of our priorities has been to mitigate the supply issues. In particular we’ve been focusing on production in our Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers. Abbott has been working with the USDA and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. Abbott will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.
We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can. Since February:
We’ve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.
We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.
We are offering an increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.
And our other manufacturing facilities are running at full capacity as we continue to prioritize production of infant formula to help replenish the supply in the market.
At the same time, we have been working to address the FDA’s 483 observations so we can restart operations at the Sturgis, Mich., facility. We immediately began implementing corrective actions and subject to FDA approval, we could restart our Sturgis, Mich., site within two weeks.
We are confident that we can continue to produce safe, high-quality infant formula at all of our facilities as we have been doing for millions of babies around the world for decades.
Below is a portion of the FDA Press Release announcing the recall"
For Immediate Release:
February 17, 2022
On Feb. 28, CDC announced one additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at Abbott Nutrition’s Sturgis, Michigan facility. Cronobacter infection may have been a contributing cause of death for this patient. In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant. All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients.
The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakiiI infection. The FDA and CDC informed the firm of these findings and on Feb. 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.
On Feb. 17, Abbott announced that the company initiated a voluntary recall of potentially affected products, including Similac, Alimentum and EleCare powdered formulas manufactured in its Sturgis, Michigan facility. Products made at this facility can be found across the U.S. and were likely exported to other countries as well. Canadian health officials have also issued a recall warningExternal Link Disclaimer. Additional recall information is available on the FDA website. Parents and caregivers can also enter their product lot code on the company’s websiteExternal Link Disclaimer to check if it is part of the recall.
FDA is continuing to investigate and will update this advisory should additional consumer safety information become available: FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022) | FDA.
Below is the most recent FDA Press Release:
FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products
For Immediate Release:
May 10, 2022
Today, the U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility, and Abbott initiated a voluntary recall of certain products. Since that time, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market.
“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,” said FDA Commissioner Robert M. Califf, M.D. “Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”
Prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic including those impacting the infant formula industry. The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S. In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall.
Leveraging all of the tools at its disposal to support the supply of infant formula products, the FDA is:
Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods. The infant formula industry is already working to maximize their production to meet new demands. Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas.
Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs.
Monitoring the status of the infant formula supply by using the agency’s 21 Forward food supply chain continuity system, combined with external data. 21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains.
Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.
Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S
Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records.
Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.
Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.
Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility. In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.
It’s important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers. The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility, among other activities.
The agency continues to advise against making infant formulas at home and encourages caregivers to work with their child’s health care provider for recommendations on changing feeding practices, if needed.
The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.