US infant formula maker to restart production at key factory, first step towards easing shortages

Infant formula maker Abbott said on Monday it had reached a deal with U.S. health regulators to restart production at its largest domestic plant, though it will be well over a month before any new product is shipped from the site to help alleviate the nationwide shortage facing parents.

Under the agreement, Abbott must work with outside experts to upgrade its standards and reduce bacterial contamination at the Sturgis, Michigan, facility that the Food and Drug Administration has been investigating since earlier this year. The deal, which is up for review by a federal judge, amounts to a legally binding agreement between the FDA and the company on the steps needed to reopen the plant.

The agreement was filed in court by the US Department of Justice, on behalf of the FDA.

After production resumes, Abbott said it will take six to eight weeks before new products start hitting stores. The company has not set a timeline for restarting manufacturing, which must be approved by the FDA.

The FDA is expected to announce additional measures on Monday to allow more foreign imports into the United States to address supply issues.

It comes as US President Joe Biden’s administration faces intense pressure to do more to ease the shortage that has left many parents searching for baby formula online or at food banks.

Reminder of the already tight offer

The Abbott factory came under intense scrutiny earlier this year after four infants fell ill with bacterial infections after consuming formula from the Michigan factory. Two of the babies died.

A woman helps distribute formula during a Saturday formula drive in Houston. Parents looking for infant formula are finding themselves on empty supermarket and drug store shelves, in part due to ongoing supply disruptions and a recent safety recall. (David J. Phillip/Associated Press)

In February, the company halted production and recalled several brands of infant formula. These steps reduced supplies that were already strained by supply chain disruptions and parent stockpiling during COVID-19.

The shortage has led retailers like CVS and Target to limit the number of containers customers can buy per visit and has forced some parents to trade and sell formula online.

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Outrage over the issue quickly snowballed and gave Republicans a new talking point to use against Biden ahead of November’s midterm elections.

Abbott is one of four companies that produce about 90% of US formula, and its brands account for nearly half of that market.

After a six-week inspection, FDA investigators released a list of issues in March, including lax safety and health standards and a history of bacterial contamination in several parts of the plant.

Chicago-based Abbott stressed that its products were not directly linked to bacterial infections in children.

The bacteria samples found at his factory did not match the strains taken from the babies by federal investigators. The company has repeatedly said it is ready to resume manufacturing, pending an FDA decision.

Abbott Laboratories manufacturing plant in Sturgis, Michigan. The company has reached an agreement with US health authorities to restart production at the plant. (Brandon Watson/Sturgis Journal/Associated Press)

Former FDA officials say fixing the kind of problems found at Abbott’s plant takes time, and infant formula facilities face more scrutiny than other food facilities. Companies must thoroughly clean the facility and equipment, retrain personnel, and repeatedly test and document that there is no contamination.

Announcement expected on formula imports

On Monday, FDA Commissioner Robert Califf told ABC News that an announcement was forthcoming regarding the importation of infant formula from overseas.

The key issue is making sure the instructions for the formula are in languages ‚Äč‚Äčthat mothers and carers can understand, he noted.

Pediatricians say infant formulas produced in Canada and Europe are roughly equivalent to those in the United States. But traditionally, 98% of the infant formula supply in the United States is made domestically.

Companies seeking to enter the United States face several major hurdles, including stringent research and manufacturing standards imposed by the FDA.