The Biden administration is trying to help foreign baby formula manufacturers stay on the United States market for the long term to diversify the industry after the closure of the largest domestic plant triggered a nationwide shortage.
The Food and Drug Administration (FDA) announced plans on Wednesday, July 6, to help overseas producers that have sent supplies to the U.S. under emergency approval to address the shortfall and secure long-term authorization to market their formula in the country.
The agency will provide a way for producers temporarily selling in the United States to meet existing regulatory requirements to stay on the American market, providing consumers with more choices and making supplies more resilient against current and future shortages, NPR reported.
The U.S. needs to diversify its infant formula supply
To make the application process more efficient for foreign formula makers, the FDA will also host meetings and provide them with a single point of contact to work through the regulatory system.
FDA Commissioner Dr. Robert Califf and Susan Mayne, the agency's Center for Food Safety and Applied Nutrition director, said that the need to diversify and strengthen the U.S. infant formula supply is more critical than ever. They added that the recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown how vulnerable the supply chain has become.
The U.S. government has tried to boost the supply of baby formula in the country after regulators shuttered a Michigan facility run by Abbott Nutrition, the largest domestic manufacturer of baby formula, over safety concerns back in February. The Sturgis plant reopened on June 4 after the company committed to additional sanitizing and safety protocols, but the facility closed again in mid-June after severe weather caused damage to the factory.
The FDA eased federal import regulations in May to allow the baby formula to be shipped to the United States. President Joe Biden also authorized the use of the Defense Production Act, providing federal support to get formulas from other countries into the U.S., according to Politico.
Read Also: Georgia Mom Who Could Not Find Formula for Her Twins Overwhelmed by Donations From Strangers
Temporary enforcement discretion is set to expire in November
The White House announced that by this coming Sunday, July 10, its efforts will have brought 43 million 8-ounce bottle equivalents of infant formula into the United States. The FDA has also cleared the equivalent of 400 million 8-ounce bottles for import into the country.
Califf and Mayne said that infant formula is an essential food product that is the sole source of nutrition for many babies in the United States. They added that companies and their manufacturing facilities must meet rigorous FDA standards that ensure the formula is both safe and nutritious, and these standards are necessary to protect the children and will not be sacrificed for long-term supply considerations.
The agency's policy of temporary enforcement discretion is set to expire this coming November, but the Biden administration said it would renew it if necessary to ensure domestic supply, according to CNN.
