A crash program to streamline U.S. imports of infant formula has worked so well, the FDA will make it permanent, said agency leaders on Wednesday. The program, which began in May when domestic supplies ran low, has resulted in shipments from nine countries of enough formula to fill 400 million 8-ounce bottles.
“These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage,” said FDA commissioner Robert Califf and Susan Mayne, director of the FDA’s Center for Food Safety. “Given that success, the FDA has determined that a more streamlined pathway … would help provide for the long-term availability and marketing of many of them.”
The agency said it intended to issue a “guidance” document in September for companies that want to continue to supply formula to the U.S. market.
On May 16, the FDA said it would exercise discretion through Nov. 14 on the sale of formula that was manufactured overseas or made in the United States for export. There could be some leeway in labeling, such as the order in which nutrients are listed, it said, but minimum nutrient requirements would not be waived. Ordinarily, 98 percent of the formula consumed in America is made domestically. The closing of a mammoth Abbott Nutrition plant in Michigan constricted U.S. supplies in the spring.
“Many of the companies providing these formula products have expressed interest in continuing to serve the American market permanently,” said the FDA. The imports would create more supply resiliency and reduce the risk of relying on too few domestic sources, it said.
To keep the imports flowing, the FDA said, it also would provide a single technical assistance contact for formula makers, making it easier for them to navigate the regulatory process. It would also hold meetings this summer to gather ideas from formula makers on how to “provide a pathway to long-term, uninterrupted marketing for safe and nutritious formula.”
Meanwhile, the White House announced the 15th mission under its Operation Fly Formula, which uses aircraft under contract to the Defense Department to speed shipments of formula to the United States. The new mission, with flights on July 17 and 22, would bring 200,000 pounds of formula to New York City from England.