In an effort to diversify the business after the shutdown of the main domestic facility caused a widespread shortage, the Biden administration is attempting to assist overseas producers of infant formula stay on the American market for the long term.
On Wednesday, the Food and Drug Administration made plans to assist foreign manufacturers who have shipped supplies to the United States to fill the gap in supply get long-term permission to market their infant formula in the country.
As a result, customers will have more options and supply will be more robust to present and upcoming shortages. The agency will offer a mechanism for manufacturers temporarily selling in the United States to comply with current regulatory standards so they may remain on the market.
Additionally, to facilitate the application process and offer producers a single point of contact for navigating the regulatory framework, the FDA will organise meetings.
Dr. Robert Califf, the FDA commissioner, and Susan Mayne, the head 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."
The United States has attempted to increase the supply of infant formula after regulators in February closed a Michigan facility managed by Abbott, the country's largest producer of infant formula, due to safety concerns. The plant stopped again in the middle of June when severe weather caused damage to it, but it reopened on June 4 after the firm agreed to further cleaning and safety standards.
After intense thunderstorms and torrential rains stormed through southwestern Michigan on June 13, the corporation said it needs time to examine the damage and disinfect the factory once more.
President Joe Biden approved the use of the Defense Production Act in May, allowing the FDA to relax federal import limits and providing federal backing to bring baby formula from abroad into the United States.
The equivalent of 43 million 8-ounce bottles of infant formula will have been imported into the United States by this coming Sunday, according to the White House, and the FDA has approved the importation of 400 million 8-ounce bottles.