FDA Urges Increased Imports Of Infant Formula To Meet Shortage

The U.S. Food and Drug Administration or FDA has urged infant formula manufacturers to import infant formula products to the United States to meet the ongoing severe supply shortage.

In order to further increase the availability of infant formula in the country, while protecting the health of infants, the regulator announced a guidance outlining increased flexibilities for the global manufacturers. This will help companies who do not normally distribute their infant formula products in the U.S. to do so efficiently and safely.

The FDA now said it would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries.

It also may provide flexibilities to those who manufacturer infant formula products domestically for export and may be able to increase further domestically produced product for the U.S. market.

The FDA urged such companies to submit information to quickly evaluate whether the product can be used safely and whether it provides adequate nutrition.

The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest. The FDA is already in discussions with some manufacturers and suppliers regarding additional supply.

The agency said the move is part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it.

The U.S. normally produces 98 percent of the required infant formula in the country, with the rest is imported from Mexico, Ireland and the Netherlands.

The country started facing reduced supplies of infant formula in February after Abbott Nutrition, the largest U.S. infant formula manufacturer, closed its plant in Sturgis, Michigan and recalled its most popular powder formulas, including Similac, Alimentum, and EleCare, after reporting bacterial infections and related deaths in babies.

Meanwhile, U.S. President Joe Biden recently announced steps to combat baby formula shortage in the country after meeting with retailers and infant formula manufacturers.

Amid the nationwide formula shortage, Abbott now has reached an agreement with the FDA to restart production of baby formula at the company’s plant in Sturgis, Michigan, subject to court approval.

The FDA noted that it had already implemented a streamlined process to facilitate the importation of infant formula at U.S. ports of entry so that formula coming from abroad can be dispersed quickly throughout the country.

For the year-to-date period, imports of infant formula are up more than 300 percent from last year.

FDA Commissioner Robert Califf said, “We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”

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