WASHINGTON — The Biden administration is trying to help foreign infant formula makers stay in the U.S. market for the long term, in a bid to diversify the industry after the closure of the nation’s largest factory sparked a shortage in national scale.
The Food and Drug Administration on Wednesday announced plans to help foreign producers who sent supplies to the United States, as part of an emergency approval to address the shortfall, obtain long-term clearance to market. their formula in the United States.
The agency will provide producers temporarily selling in the United States with a way to comply with existing regulatory requirements so they can stay in the market, giving consumers more choice and making supplies more resilient to current and future shortages.
The FDA will also host meetings and provide producers with a single point of contact to work through the regulatory system to make the application process more efficient.
FDA cites need to diversify formula supply
“The need to diversify and strengthen the U.S. supply of infant formula is more important than ever,” said FDA Commissioner Dr. Robert Califf and Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the agency, in a press release. “The recent closure of a major infant formula factory, compounded by unforeseen natural weather events, has shown how vulnerable the supply chain has become.”
The United States has been trying to increase the supply of infant formula after regulators shut down a Michigan plant in February run by Abbott, the nation’s largest infant formula maker, over safety concerns. The factory reopened on June 4 after the company pledged to apply additional disinfection and safety protocols, but closed again in mid-June after bad weather caused damage to the factory. .
The company said it needed time to assess the damage and re-disinfect the plant after severe thunderstorms and heavy rains swept through southwest Michigan on June 13.
Biden used the Defense Production Act to get a formula from overseas
In May, the FDA relaxed federal import regulations to allow infant formula to be shipped to the United States, and President Joe Biden authorized the use of the Defense Production Act, providing federal support for transport preparations from abroad to the United States.
The White House said that by next Sunday, its efforts will have brought 43 million equivalent 8-ounce bottles of infant formula to the United States and the FDA has cleared the equivalent of 400 million 8-ounce bottles. to import into the United States.
“Infant formula is an essential food product that is the sole source of nutrition for many babies in the United States. Companies and their manufacturing facilities must meet rigorous FDA standards that ensure 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 FDA’s discretionary temporary application policy is set to expire in November, but the administration said it will renew it if necessary to ensure domestic supply.
“Today’s announcement by the FDA will help ensure that the infant formula supply market is less vulnerable to future supply shocks and provide families with the confidence of consistent access to a variety of formulas. infant formula,” White House spokesman Kevin Munoz said.