With the new framework, the agency plans to strengthen the supply chain by “reducing the risk of reliance on too few production facilities” in the U.S.
The two closures of Abbott Nutrition’s Sturgis, Mich., plant — the first time after a contamination breach in February and the second after a severe storm flooded parts of the factory in June — proved “just how vulnerable the supply chain has become,” FDA Commissioner Robert Califf, MD, and the director of the Center for Food Safety and Applied Nutrition, Susan Mayne, PhD, co-wrote in a press release.
The proposed timeline:
1. The FDA will elect or hire a technical assistance contact to handle global companies’ requests to fuel the U.S. supply.
2. The agency will meet with the overseas manufacturers this summer to discuss “long-term” steps.
3. Further guidance is expected to be released in September.
As of July 6, the U.S. has imported enough formula for more than 400 million 8-ounce bottles from nine countries, according to the press release. With Operation Fly Formula, the White House has mobilized more than a dozen international flights since May to address the shortage, with planes flying from countries including Germany, Switzerland, Mexico and England.
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