Abbott set to reopen production facility as US scrambles with infant formula shortages

17 May 2022 --- Infant formula producer Abbott is set to reopen its infant formula plant facility in Sturgis, Michigan, US, two weeks after receiving clearance from the US Food and Drug Administration (FDA). This move is being implemented as part of a consent decree with the FDA that details the necessary steps to reopen the site for production, including meeting the FDA’s food safety standards.

“Our priority is getting infants and families the high-quality formulas they need. This is a major step toward re-opening our Sturgis facility to ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” says Robert Ford, chairman and CEO at Abbott.

Abbott’s site was previously closed due to five environmental subsamples being positive for Cronobacter sakazakii, linked to reports of illness and one death. The company also voluntarily recalled the products made at this site.

According to the company, the Centers for Disease Control and Prevention found no evidence of a link between Abbott formulas and baby illnesses after its inquiry.

FDA calls on public to stay calm
The FDA’s commissioner, Robert Califf, provided insight into how the FDA will ensure the production site is safe and meets industry standards.

After the decree has been followed, Abbott will begin producing EleCare, Alimentum and metabolic formulas first, with Similac and other formula production later.“Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” says Califf. “The public should rest assured that the agency will do everything possible to ensure that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which US consumers have come to expect.”

According to Abbott, the decree is subject to court approval. Following the decree with the FDA, it could take approximately six to eight weeks for the formula to be accessible in stores. 

Addressing infant formula shortages
This move was implemented during the current infant formula shortage in the US, which the FDA is attempting to solve.

“We recognize the hardships parents and caregivers have faced in obtaining infant formula. The FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation,” Califf explains.

Considering the importation of infant formula, the FDA recently released guidance that provides additional flexibility regarding importing certain infant formula products to increase infant formula availability across the US while maintaining child health.

Yesterday, NutritionInsight reported on US president Joe Biden’s measures to tackle infant formula shortages as the market now has reports of “predatory behavior” in the market. This move from Biden follows the online market price increases due to infant shortages in stores.

Formula manufacturers and importation
Abbott will continue to import formula from an FDA-registered facility in Ireland.The agency encourages infant formula manufacturers worldwide to take advantage of these options.    

Califf explains the action paves the way for companies who do not usually distribute their infant formula products in the US to do so efficiently and safely.

“We are hopeful this call to the global market will be answered and that 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,” he says. “With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit US stores in weeks.”

The FDA adds that it is also taking a look at increasing flexibility of the supply of infant formulas developed by manufacturers across the US and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.

To increase infant formula supplies and protect the health of infants, the FDA issued guidance to infant formula manufacturers to temporarily exercise enforcement discretion, on a case-by-case basis, for specific requirements that apply to infant formula. 

The guidance will be in effect until mid-November and the FDA will evaluate whether any extension is necessary.

Edited by Nicole Kerr

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