On Wednesday, the Food and Drug Administration was to announce plans to help foreign producers who have shipped supplies to the United States, under emergency approval to address the deficit, obtain long-term marketing authorization his formula in the United States (Ted Shaffrey, Associate). Press)
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WASHINGTON – Biden administration is trying to help foreign baby formula manufacturers stay in the U.S. market long-term, in an effort to diversify the industry after the closure of the largest domestic plant caused a shortage across the country.
The Food and Drug Administration on Wednesday announced plans to help foreign producers who have shipped supplies to the United States, under emergency approval to address the deficit, secure long-term authorization to market their formula to the United States.
The agency will offer a way for producers temporarily selling to the U.S. to meet existing regulatory requirements so they can stay in the market, offering consumers more options and making supplies more resilient to current and future shortages.
The FDA will also host meetings and offer producers a single point of contact to work through the regulatory system to make the application process more efficient.
“The need to diversify and strengthen the supply of infant formulas in the United States is more important than ever,” said FDA Commissioner Dr. Robert Califf and Susan Mayne, director of the Center for Food Safety and Applied Nutrition. agency, in a statement. “The recent shutdown of a major infant formula plant, coupled with unforeseen natural weather events, has shown how vulnerable the supply chain has become.”
The United States has tried to increase the supply of infant formula after regulators closed a Michigan plant run by Abbott, the nation’s largest infant formula manufacturer, in February over safety concerns. The plant reopened on June 4 after the company committed to additional disinfection and safety protocols, but closed again in mid-June after bad weather caused damage to the plant.
The company said it needs time to assess the damage and disinfect the factory again after heavy storms and heavy rains that swept southwest Michigan on June 13th.
In May, the FDA eased federal import regulations to allow the baby formula to be shipped to the U.S., and President Joe Biden authorized the use of the Defense Production Act, providing federal support to achieve foreign formula in the US.
The White House said that next Sunday, its efforts will have brought 43 million equivalents of 8-ounce bottles of infant formula to the U.S. and the FDA has authorized the equivalent of 400 million 8-ounce bottles to import them in the US.
“Infant formula is an essential food product that is the only source of nutrition for many babies in American companies and their manufacturing facilities must meet strict FDA standards to ensure that the formula is 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 temporary enforcement discretion policy will expire in November, but the administration says it will renew it if necessary to ensure internal supply.
“Today’s FDA announcement will help ensure that the infant formula supply market is less vulnerable to future supply shocks and provide families with the confidence of constant access to a variety of safe infant formulas.” said White House spokesman Kevin Muñoz.
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