The United States Food and Drug Administration (FDA) has reached an agreement with Abbott Nutrition for a plan to resume operations at the latter's infant formula facility located in Sturgis, Michigan.
The decision was announced on Monday and comes as welcome news to frustrated parents who were struggling to find the formula on shelves across the region. However, it could still be several weeks before they are able to see relief.
Abbott and the FDA
Abbott said that the agreement it made with the FDA lays out "the steps necessary to resume production and maintain the facility." However, it noted that the processes and operations are still subject to court approval.
The company said that when the FDA gives the official green light, it could begin operating again at the site within two weeks. It also noted that it would take six to eight weeks after that before the product is back on shelves.
In a statement, the chairman and chief executive officer of Abbott, Robert B. Ford, said that the company's number one priority was getting infants and families the high-quality formulas they need. He said that the situation was a major step toward reopening the Sturgis facility that could potentially ease the nationwide formula shortage, as per ABC News.
Abbott Nutrition is estimated to be one of only four companies that control 90% of the market and is an industry that was already dealing with supply chain issues before federal inspectors found evidence of a deadly bacteria at the Sturgis plant and forced it to close down.
However, the company has maintained that there was still no conclusive evidence linking its formula to four infant illnesses that resulted in two deaths. In a statement, FDA Commissioner Bob Califf said that the administration wanted to take a more intimate look at what caused the nationwide shortage of formula beyond the Sturgis plant.
According to the Associated Press, United States President Joe Biden's administration announced the new steps to ease the nationwide formula shortage on Monday. The decision comes after criticism from parents and politicians and includes the reopening of the largest domestic manufacturing plant and increasing imports from overseas.
Nationwide Formula Shortage
The FDA said it was also streamlining its review process to make it easier for foreign manufacturers to begin shipping formulas to the country. Califf noted that the agency expected that the measures and steps taken would result in more and more supply moving forward.
The commissioner said that the U.S. will now prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and meet U.S. nutrition standards.
On the other hand, the situation with Abbott came after the company's staff were allegedly "unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants."
The agreement between Abbott and the FDA requires the manufacturing company to hire a qualified expert to oversee various improvements at the Sturgis facility moving forward. The company has been in a race to replenish stocks amid the crisis that Republicans have used to criticize the Biden administration, the New York Times reported.