In an effort to diversify the baby formula U.S. market, the Biden administration is making strides to help foreign makers stay on the shelves.
The need to diversify and strengthen the supply chain is more important than ever, the Food and Drug Administration (FDA) said.
“The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become,” the agency said.
Abbott Laboratories, one of the largest manufacturers of formula in the United States recalled Similac, Alimentum and EleCare powdered infant formulas in mid-February.
Before the recall, Abbott controlled 40% of the infant formula market. The recall resulted in empty store shelves across America and retailers putting limits on how much formula a person could buy.
Abbott in Michigan re-started on June 4 but shut down two weeks later because of severe weather damage. It has yet to reopen after repairing damage, cleaning and sanitizing.
On Wednesday, the FDA announced plans to help overseas producers, which have sent supplies to the United States under emergency approval to address the shortfall, secure long-term authorization to market their formula in the U.S.
The FDA said it will provide a way for producers temporarily selling in the U.S. to meet existing regulatory requirements, so they can stay on the market, providing consumers with more choices and making supplies more resilient against current and future shortages.
In addition, the FDA will host meetings and provide foreign producers with a single point of contact to work through the regulatory system to make the application process more efficient.
“Ensuring that the youngest and most vulnerable individuals have access to safe and nutritious formula products is a top priority for the FDA,” the agency said.
In May, the FDA eased federal import regulations to allow baby formula to be shipped to the U.S., and President Biden authorized the use of the Defense Production Act, providing federal support to get formula from overseas into the U.S.
The FDA eased federal regulation “on a case-by-case basis” in order to address “the temporary shortage.”
The White House said that by July 10, Operation Fly Formula will have transported more than 43 million 8-ounce bottle equivalents to the U.S.
The agency maintains a list of manufacturers that have been given “enforcement discretion” in order to increase the supply of baby formula in the United States.
“Infant formula is an essential food product that is the sole source of nutrition for many babies in the U.S. Companies and their manufacturing facilities must meet rigorous FDA standards that ensure the formula is both safe and nutritious,” Califf and Mayne said. “These standards are necessary to protect our children and will not be sacrificed for long-term supply considerations.”
The enforcement discretion is in effect until Nov. 14, but the administration says it will renew it if necessary to ensure domestic supply.
“Today’s announcement by the FDA will help ensure the infant formula supply market is less vulnerable to future supply shocks and will provide families with the confidence of steady access to a variety of safe infant formulas,” said White House spokesman Kevin Munoz.
The Associated Press contributed to this report.
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