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Infant formula manufacturer, FDA agree on plant reopening

Karissa Welshans

May 17, 2022

As the baby formula shortage continues to worsen in the U.S., Abbott and the U.S. Food and Drug Administration (FDA) have entered into a consent decree to soon reopen the company’s infant formula plant in Sturgis, Mich. The plant was voluntarily closed in February after four infants became ill, two of which eventually died. The infants, all with Cronobacter infections, had consumed formula from the Sturgis plant, but investigations have since revealed the particular strain was not found in the plant.


As part of the agreement, FDA and Abbott determined the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.


"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility," said Robert Ford, chairman and chief executive officer of Abbott. "We know millions of parents and caregivers depend on us, and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."


Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. The company would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves.


Abbott has been working on corrective actions since the FDA inspection and submitted a response and corrective action plan to FDA on April 8. Even before its formal response, Abbott had begun working to implement improvements and take corrective action. Some of these actions included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility. Abbott immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection. The company has also been making upgrades to the plant.


Abbott further reported that after a thorough investigation by the company as well as by FDA and the Centers for Disease Control and Prevention (CDC), there is no conclusive evidence to link Abbott's formulas to the infant illnesses and deaths. Still, the company said it is further strengthening its processes and using advanced technologies to enhance sanitization procedures, product tracking and monitoring as well as training protocols for employees and visitors.


"Our safety and quality processes meet even the toughest scrutiny, and we're committed to continuously improving our processes and protocols," said Ford. "Nutrition is fundamental to Abbott and to our goal of improving the lives of more than 3 billion people by decade's end. We intend to set the standard for the industry, raising the bar on both safety and quality."


Efforts to support formula supply


Since the recall, Abbott said it has taken numerous measures to mitigate the supply shortage. Specifically, it has focused on production in its Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers.


Abbott has been working with the U.S. Department of Agriculture (USDA) and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. Abbott said Friday it 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. Additionally, the company has:


  • Air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.

  • Prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed and ramped production at our other U.S. manufacturing site in Casa Grande, Arizona, for powder infant formula.

  • Offered an increased number and value of coupons available for all infant formula products, including Similac liquid ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.

  • Been running other facilities at full capacity to help replenish the supply in the market.

Formula maker Reckitt Benckiser told Reuters this week that it is ramping up production by 30% and Nestle said it was flying formula in from overseas to help alleviate the supply shortage.


On Friday, the USDA urged states to take advantage of flexibilities the department is offering in the Special Supplemental Nutrition Program for WIC, to help families get the safe formula they need.


“We’re acutely aware that the ongoing recall has left many parents and caregivers concerned about access to formula and how they will feed their babies,” said Agriculture Secretary Tom Vilsack. “Our team is committed to the health and safety of all Americans and is calling on states to act immediately to offer maximum flexibility, information, and support to WIC participants. Meanwhile, USDA will continue the work we started in February, working not only within our department, but across the federal government, suppliers and partners to end this infant formula crisis as quickly as possible.”


On Monday, the FDA outlined increased flexibilities regarding importation of certain infant formula products to further increase the availability of formula across the country. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.


“The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert Califf, M.D. “Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely. We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”


The U.S. normally produces 98% of the infant formula it consumes, with the primary source of imports coming from trading partners in Mexico, Ireland and the Netherlands. However, given the production and distribution issues that have led to reduced supplies of infant formula in some parts of the country, the FDA has outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. It also may provide flexibilities to those who manufacturer infant formula products domestically for export and may be able to increase further domestically produced product for the U.S. market.


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