FDA reaches deal with baby formula factory to resume production after closure over safety issues

Abbott Nutrition, the maker of Similac and other popular baby formulas, said Monday it has come to an agreement with the Food and Drug Administration to fix safety issues at a Sturgis, Mich., factory that has been shuttered for more than three months, contributing to a nationwide formula shortage.

The agreement represents a first step toward resolving a problem that has sent parents scrambling from store to store to find sustenance for their infants. But questions remain about what precisely the FDA will require of Abbott and the Sturgis facility operations before reopening is approved.

The company has previously said that once the FDA has signed off on the fixes, it will take two weeks to restart production and another six to eight weeks to get the product back on shelves.

FDA Commissioner Robert Califf said on the “Today” show on Monday that he felt “very comfortable” that the Sturgis plant would reopen in two weeks and that the shortage would be resolved by the end of the year.

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards,” Califf said in a statement late Monday.

“This is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” said Robert Ford, chairman and chief executive of Abbott, who noted that the shortage was also exacerbated by a voluntary recall by the company of formula that had been possibly tainted by a bacteria that sickened two babies and killed two others. The FDA has not proven that the Sturgis plant was the source of the contamination, the company has said.

“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,” Ford added.

According to the FDA statement, a proposed consent decree between the FDA and Abbott Nutrition and three of its top executives was filed in the U.S. District Court for the Western District of Michigan. The proposed consent decree must be approved by the court. “Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law,” the statement said.

The consent decree “allows the company to get back in operation. Given what has happened so far, the FDA is going to scrutinize everything Abbott does. There will be inspectors there. They will want to see batches to determine that problems will not recur,” said Carl Tobias, a law professor at the University of Richmond.

A protracted shortage affects low-income Americans the most, since half of baby formula is purchased by recipients of a food assistance program benefiting poor mothers and young children. Many more months of a shortfall would disproportionately impact low-income families.

“The FDA is working closely with Abbott to bring the facility back online safely,” White House press secretary Karine Jean-Pierre told reporters Monday afternoon. “That is the key here, safely.” She said the administration is also “moving as quickly as possible” to bring in more formula from overseas.

On a call Monday night, Susan Mayne, the director of the Center for Food Safety and Applied Nutrition at the FDA, said the agency would approve new types of formula from foreign and domestic sources on a case-by-case basis. It is already in discussion with producers, she said, to explain what is needed in terms of a review of ingredients, testing results and inspection history.

And on Friday, the White House announced the possibility of invoking the Defense Production Act to produce baby formula amid the shortage. But supercharging production of formula is no easy feat.

Most formulas are made from a mix of protein concentrate from cow’s milk, rice starch, corn syrup and oils. They are sold ready to drink and in powdered forms that must be reconstituted with water.

Because the minimum amounts of fat, protein, calcium and a number of vitamins is so stringently regulated, as many babies get 100% of their nutrition from formula for the first six months of life, a limited number of manufacturers have the ability to produce it effectively.

About 90% of the infant formula supply in the United States is produced by four major companies: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. To make up for the Sturgis facility shortfall, Abbott has prioritized infant formula production at its other plant in Columbus, Ohio, converting other liquid manufacturing lines into making liquid Similac, and has brought in millions of cans of product from its Ireland production facility.

Perrigo has stepped up production to ship 37% more formula in the past three months than during the same period last year, and Gerber is running formula factories at capacity to accelerate product availability to retailers and online.

Still, grocery store shelves have dipped, retailers are rationing popular brands and parents have traveled miles to locate formula for their infants.

Members of Congress have expressed frustration with both Abbott and the FDA, with Republicans also singling out the broader Biden administration for criticism over the formula shortage.

“Months ago, I called for the FDA to take action on this looming crisis, and the Biden administration failed to provide a timely, substantive response,” Rep. Elise Stefanik, R-N.Y., said in a recent statement.

House Appropriations Committee Chair Rosa DeLauro, D-Conn., said she received a lengthy report from a former Abbott employee who registered a litany of complaints about conditions at the Sturgis plant with the FDA last October.

But the agency did not interview the whistleblower until late December, DeLauro said at a hearing in April. The FDA began its inspection at the plant on Jan. 31, and the recall was issued on Feb. 17, according to FDA documents.

“Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves?” DeLauro said at the hearing.