U.S. to allow more imports of baby formula, reopen key plant to ease shortages
Abbott plant in Michigan was shut down earlier this year after 4 babies became ill
Under fire from parents and politicians, U.S. President Joe Biden's administration announced steps Monday to ease a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.
The U.S. Food and Drug Administration (FDA) said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.
"The FDA expects that the measures and steps it's taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward," FDA Commissioner Robert Califf told reporters.
Califf said the U.S. will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and compatible with U.S. nutrition standards. The policy is structured as a temporary measure, lasting six months.
The announcement came shortly after regulators said they'd reached a deal to allow Abbott Nutrition to restart its plant in Sturgis, Mich., which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.
Neither step will have an immediate effect on tight supplies that have left many parents searching for formula online or in food banks.
After getting the FDA's OK, Abbott said it will take six to eight weeks before new products begin arriving in stores. The company didn't set a timeline to restart manufacturing, which must be cleared with the FDA.
Getting imports into the U.S. supply chain will also take several weeks, according to administration officials. Products from Australia, New Zealand and the U.K. are expected to meet the standards needed for importation.
But regulators said national industry data shows most U.S. stores, on average, still have 80 per cent of their formula inventory in stock. They suggested some of the empty shelves seen in recent days may be due to panic buying by parents.
Monday's announcement was previewed last week by the White House, which has been leaning on the FDA and formula makers to quickly find ways to alleviate the shortage. Outrage over the issue has quickly snowballed and handed Republicans a fresh talking point to use against Biden ahead of November's midterm elections.
Recall squeezed already strained supply
Abbott's plant came under scrutiny earlier this year after four infants became sick with bacterial infections after consuming powdered formula from the Michigan factory. Two of the babies died.
In February, the company halted production and recalled several brands of formula. Those steps squeezed supplies that were already strained by supply chain disruptions and parents stockpiling during COVID-19.
The shortage has led retailers like CVS and Target to limit how many containers customers can purchase per visit and forced some parents to swap and sell formula online.
Abbott is one of just four companies that produce roughly 90 per cent of U.S. formula, and its brands account for nearly half that market.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from the babies by federal investigators.
But FDA officials pushed back on that reasoning Monday on a call with reporters — their first time publicly addressing the company's argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.
"Right from the get-go, we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two," FDA's food director Susan Mayne said.
Fixing problems will take time
Former FDA officials say fixing the type of problems uncovered at Abbott's plant takes time, and infant formula facilities receive more scrutiny than other food facilities. Companies need to exhaustively clean the facility and equipment, retrain staff, and repeatedly test and document there is no contamination.
As part of the FDA's new import policy, regulators said companies would need to provide documentation of their factory's inspections.
Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the U.S. But traditionally, 98 per cent of the infant formula supply in the U.S. is made domestically.
Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.