In an effort to diversify the company following the closure of the primary domestic facility, which produced a significant shortage, the Biden administration is aiming to assist overseas producers of infant formula in remaining on the American market in the long term.
The Food and Drug Administration announced measures on Wednesday to aid international manufacturers who have transported supplies to the United States to address the supply gap in obtaining long-term approval to market their infant formula in the country.
Customers will have more options as a result, and supply will be more resilient to current and future shortages. The agency will provide a framework for firms temporarily selling in the United States to meet current regulatory standards and continue on the market.
Furthermore, the FDA will organise meetings to ease the application process and provide producers with a single point of contact for navigating the regulatory system.
The FDA commissioner, Dr. Robert Califf, and Susan Mayne, the director of the agency's Center for Food Safety and Applied Nutrition, said in a statement that "The need to diversify and strengthen the U.S. infant formula supply is more important than ever."
After regulators halted a Michigan facility managed by Abbott, the country's largest maker of infant formula, in February due to safety concerns, the United States has moved to improve the supply of infant formula. The factory was shut down again in the middle of June due to weather damage, but it reopened on June 4 when the company agreed to stricter cleaning and safety measures.
After severe thunderstorms and torrential rains swept through southwestern Michigan on June 13, the firm stated that it need additional time to assess the damage and cleanse the factory.
In May, President Joe Biden authorised the use of the Defense Production Act, allowing the FDA to remove federal import restrictions and providing federal support for the importation of baby formula from other countries.
According to the White House, the equivalent of 43 million 8-ounce bottles of infant formula will have been imported into the United States by this Sunday, and the FDA has cleared the importation of 400 million 8-ounce bottles.