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Amid shortages, FDA allows Abbott to release baby formula from facility after recall

Abbott-Alere-Acquisition
Posted at 2:05 PM, May 11, 2022
and last updated 2022-05-11 14:05:12-04

As recalls and supply chain issues have combined to cause shortages of infant formula, the Food and Drug Administration said it is taking steps to alleviate the shortage.

Among the measures, the FDA said it will not object to allowing formula made at a Sturgis, Mich. Abbott plant to be released. In February, Abbott recalled products made at the facility due to possible contamination.

While getting the Michigan facility back up and running could help alleviate some of the shortages, Abbott said it will take some time to get it back up and running.

“We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage,” Abbott said. “Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.”

Abbott issued the recall and closed the facility after two infants died and two others were treated for cronobacter. Abbott released findings on Wednesday saying that there is no evidence to link their formulas to these infant illnesses.

The FDA said products from the facility could be released to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis. The FDA said it’s working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

“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. “Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA.”

The White House addressed the formula shortage on Tuesday, saying the FDA is working toward streamlining the movement of formula. 

“What the FDA is doing -- which, while they are independent, they are part of the administration -- is taking a number of steps to address,” White House press secretary Jen Psaki said. “That includes working with major infant formula manufacturers to ensure they’re increasing production, because part of this issue is, of course, making sure there is stock on the shelves -- right? -- and working with the industry right now to optimize their supply lines, product sizes to increase capacity, and prioritizing product lines that are of greatest needs.”

In response to the shortage, a number of retailers have placed limits on the amount of formula that can be purchased. 

The New York Times reported that CVS and Walgreens are limiting customers to three baby formula products per purchase. Target is limiting online purchases of formula to four items per transaction.

Abbott said it is tripling its production of Similac Ready-to-Feed formula compared to last year.