US diversifies infant formula industry to avoid shortages

WASHINGTON – The Biden Administration seeks help foreign baby food makers remain in the US market for the long term, in an effort to diversify the industry after the closure of the largest domestic factory caused a nationwide deficit.

The Food and Drug Administration is due to announce plans on Wednesday to help overseas manufacturers who have shipped supplies to the United States, with urgent approval to address the shortage, to gain long-term approval to market their formula in the U.S. bring.

The agency will provide a way for producers selling temporarily in the US to comply with existing legal requirements so they can stay in the market, give consumers more choice and make supply more resilient to current and future shortages.

The FDA will also host meetings and provide manufacturers with 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 infant formula supply in the US is more important than ever,” said FDA Commissioner Dr. Robert Califf, and Susan Mayne, the director of the agency’s Center for Food Safety and Applied Nutrition, in a statement. “The recent closure of a major infant formula factory, exacerbated by unforeseen natural weather events, has shown how fragile the supply chain has become.”

The US has been trying to increase baby food supply after regulators shut down a Michigan plant run by Abbott, the largest domestic baby food manufacturer, in February over safety concerns. The factory reopened on June 4 after the company committed to additional decontamination and safety protocols, but was closed again in mid-June after severe weather caused damage to the factory.

The company said it needs time to assess the damage and re-decontaminate the plant after severe thunderstorms and heavy rains swept southwestern Michigan on June 13.


In May, the FDA eased federal import regulations to allow baby food to be shipped to the US, and President Joe Biden authorized the use of the Defense Production Act, granting federal aid to get formulas from overseas to the US.

The White House said its efforts by Sunday will have brought 43 million 8-ounce bottle equivalents of infant formula into the U.S.

“Baby food is an essential nutritional product that is the sole source of nutrition for many babies in US companies, and their manufacturing facilities must meet strict FDA standards that ensure the formula is both safe and nutritious,” said Califf and Mayne. “These standards are necessary to protect our children and will not be sacrificed for long-term considerations.”

The FDA’s policy of temporary enforcement release expires in November, but the administration says it will extend it if necessary to ensure domestic delivery.

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