US permits import of more powdered milk, domestic factories reopen

Matthew Perone and Zeke Miller Associated Press

Washington — Following attacks from parents and politicians, President Joe Biden’s administration will relieve the national shortage of powdered milk on Monday, including the reopening of the country’s largest manufacturing plant and increased imports from abroad. Announced measures.

The Food and Drug Administration said it is streamlining the review process to help foreign manufacturers begin shipping prescriptions to the United States.

“The FDA expects that measures and measures with infant formula makers and others will mean that supplies are in progress or on the shelves,” FDA Commissioner Robert Caliph told reporters.

Caliph said the United States prioritized companies that could provide the largest cargo and quickly documented that their formulas were safe and met US nutritional standards.

The import announcement came shortly after regulators announced that they had reached a contract allowing Abbott Nutrition to reopen a plant based in Sturgis, Michigan, which had been closed since February due to pollution problems. I did. The company must overhaul safety protocols and procedures before resuming production.

Neither procedure has an immediate impact due to tight supply, and many parents are looking for infant formula online or in food banks.

Abbott said it would take eight to ten weeks for new products to begin arriving in stores after the FDA’s approval. The company had not set a schedule for resuming production.

Imports into the US supply chain can take months, officials said. Even before the latest changes, FDA officials have said that infant formula imports have already increased by more than 300% since last year.

The announcement on Monday was previewed last week by the White House, which has relied on the FDA and formula makers to quickly find ways to mitigate the shortage. Anger over this issue quickly snowballed, handing the Republicans a new issue for use against President Biden prior to the November elections.

The shortage is due to a February recall by Abbott, which exacerbated the ongoing supply chain disruption among formula makers and reduced the shelves of many stores across the country. Due to the shortage, retailers such as CVS and Walgreens are limiting the number of containers customers can buy in a single visit.

Abbott’s voluntary recall was caused by four diseases reported in infants who ingested infant formula from plants in Michigan. All four babies were hospitalized for a rare type of bacterial infection and two died.

After six weeks of inspection, FDA investigators published a list of issues in March, including loose safety and hygiene standards, and a history of bacterial contamination in some parts of the plant.

Chicago-based Abbott emphasizes that the product is not directly related to bacterial infections in children. Bacterial samples found at the factory did not match the strains collected from the baby by federal investigators. The company has repeatedly stated that it is ready to resume production until the FDA’s decision is made.

Former FDA officials say it takes time to fix the types of problems found at Abbott’s factories, and infant formulas are being scrutinized more than other food facilities. Companies need to thoroughly clean facilities and equipment, retrain staff, and repeatedly test and document pollution-free.

As part of the FDA’s new import policy, regulators said companies need to provide factory inspection documents.

According to pediatricians, milk powder produced in Canada and Europe is similar to that in the United States, but traditionally 98% of the supply of infant formula in the United States is produced domestically. Companies looking to enter the United States face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.

San Diego’s father, Stephen Hyde, had been prescribed Abbott, but faced the dire task of finding a prescription for his medically fragile daughter who had to switch to recalling other brands and subsequent shortages. I faced it.

Zoie Hyde was born 19 months ago in a rare life-threatening condition where he had no kidneys and needed dialysis and a feeding tube until he was heavy enough for a kidney transplant.