The Food and Drug Administration has decided to aid foreign baby formula makers in remaining on the U.S. market for the long term in a bid to diversify the highly consolidated industry, the Biden administration’s latest effort to remedy shortages.
The agency has been working with overseas manufacturers for more than a month to bring FDA-approved formula into the United States to counter a nationwide shortage spurred by a major factory closure earlier this year, as well as monopolistic practices in the industry. The FDA began using enforcement discretion in May to determine which overseas companies could legally market their products in the U.S., provided the products are deemed safe and pure.
MISSISSIPPI’S LAST ABORTION CLINIC TO SHUT ITS DOORS THURSDAY
“These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage,” said FDA Commissioner Robert Califf and Center for Food Safety and Applied Nutrition Director Susan Mayne.
“Given that success, the FDA has determined that a more streamlined pathway that leverages information we have received for the products for which we are temporarily exercising enforcement discretion would help provide for the long-term availability and marketing of many of them,” they added in a written statement.
The FDA will develop a new framework to help foreign formula makers secure long-term authorization to market their formula in the U.S. by streamlining the approval pathway and creating a point of contact at the agency for companies to rely on for guidance about the regulatory process.
“This is similar to a practice commonly used by other FDA centers that has resulted in novel medical therapeutics entering the U.S. market in a more efficient manner. The FDA hopes to encourage more entrants into the market, including new domestic firms,” the agency said.
Several outside factors led to the current shortage, which has been brewing for about a year. COVID-19-related supply chain disruptions, such as difficulty sourcing raw materials and absenteeism due to illness, generated shortages last summer. The shortages worsened and peaked in February with the closure of Abbott Nutrition’s manufacturing plant in Sturgis, Michigan, over reports of contaminated products that sickened a handful of infants.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
Only four companies — Abbott, Perrigo, Nestle SA, and Mead Johnson — control 90% of the U.S. supply of formula and losing one of them was a disaster for U.S. supply. Abbott’s facility reopened in early June following an extensive review by the federal government but closed again two weeks later due to severe thunderstorms that caused flooding inside the plant.
