On Monday evening, baby formula producer Abbott announced that it had reached a conclusion with the Food and Drug Administration, paving a way to reopen a factory in Sturgis, Michigan. This year, the factory had shut down, resulting in the prevailing shortage.
The company confirmed that it had entered into a decree with the FDA. The agency and organization agreed on the benchmarks needed to resume production and ensure the facility meets safety guidelines.
FDA officials said late Monday that if a court allows the agreement, the Michigan site could resume in two weeks.
The site would initially offer specialty metabolic formulas EleCare and Alimentum, followed by Similac and, consequently, another procedure, remarked the official FDA.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward reopening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely reopen the facility,” said chairman and CEO Robert B. Ford.
During a CNN interview, FDA commissioner Dr. Robert Califf had offered a rosy timeline for resuming the facility. He has forecasted that once a deal was struck, the factory could re-function and continue production formula within two weeks and be back to normalcy after a few weeks.
However, Abbott said that things would not go at a very fast pace.
Once it starts to, Abbott says that it will begin producing the formulas.
While the U.S offers 98% of the formula consumed here, currently, it imports a small amount from Mexico, the Netherlands, and Ireland.
Califf, along with Susan Mayne, the FDA’s director of the Center for Food Safety and Applied Nutrition, and FDA deputy commissioner Frank Yiannas, informed reporters that organizations that want to take advantage of any “flexibilities” should give information to the FDA which would analyze if the foreign formulas offer “adequate information.”
The lack is becoming a significant financial crisis for many families, principally low income. Since WIC is not yet enabled to handle online shopping and several families cannot find eligible formulas in store, some are to use the benefits of the Supplemental Nutrition Assistance Program or pay out of pocket, which “puts stress on the rest of the household,” remarks by senior director of public policy Brian Dittmeier, at the National WIC Association, the nonprofit advocacy arm of WIC.