The adjusted regulations give regulators the ability to clear formula from overseas as long as they meet certain safety and nutrition requirements.
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Distributors that don’t normally sell infant formula in the United States should consider applying under the streamlined rules, said Dr. Robert Califf, head of the U.S. Food and Drug Administration (FDA).
“I strongly encourage all those who are or could manufacture infant formula products quickly and safely, including those who do not currently sell in the U.S., to help us increase the supply of products, which may serve as the only source of nutrition for many infants,” Califf said in a call with reporters.
The agency is planning to prioritize applications from companies that have the largest volume available and can meet safety and nutritional thresholds as regulators try to fix the formula supply shortages.
Executives of any companies that think they might be able to meet the FDA’s requirements will be able to talk with regulators about the requirements. Labeling is preferred in English and allergens should be listed.
“We’re not requiring any relabeling. What we are asking companies to do is to come to us with the information they have available about product they have, what the labeling is, what the nutritional value is, about the inspectional history of their manufacturing facilities … and then our goal is to try to identify those that are the highest priority for us and identify companies that could bring in safe, nutritionally adequate product most rapidly,” said Susan Mayne, the director of the FDA’s Center for Food Safety and Applied Nutrition.
It will likely take weeks to get imported formula on shelves in the United States, officials said. The administration views the easing of restrictions as a temporary measure until the normal supply chain—98 percent of the formula sold in the United States is typically produced domestically—stabilizes.
The guidance is in place for 180 days.
The move “is something to get us through this period,” Califf said, though it could lead to some changes down the line as officials mull whether imports should play a larger role in the market.
Officials also hope that companies that produce formula in the United States for export choose to sell the product on the domestic market after seeing the new, temporary flexibilities.
The shortages stem from the shutdown of an Abbott Nutrition plant in Sturgis, Michigan in February, months after a whistleblower alerted federal officials of problems there.
The plant was investigated for a connection to Cronobacter infections in infants. Samples collected from the facility detected the bacteria, according to a complaint filed by U.S. prosecutors this week, with inspections revealing substandard conditions. But none of the bacteria was detected in the formula itself, and Abbott says no evidence connects its formula to the illnesses in infants.
The plant could reopen in the coming weeks, though Abbott has said it will take up to two months after production resumes for its product to get to store shelves.
