FDA to Allow Baby Formulas Intended For Other Countries to be Used in the United States

Baby Formula Shortage baby formula US Food and Drug Administration Robert Califf Abbott Nutrition

By Joel Brussels , Parent Herald May 17, 11:41 am

Photo: (Photo : JIM WATSON/AFP via Getty Images)

The U.S. Food and Drug Administration made a huge announcement on Monday, May 16, saying that it is working on allowing baby formulas intended for sale in other nations to be diverted to the United States in an effort to boost supplies on store shelves here in America amid ongoing domestic shortages.

When asked by CBS News whether Americans struggling to find baby formula should be able to buy alternatives from European manufacturers, FDA Commissioner Robert Califf said that one of the things they worked on continuously over the weekend was putting forth a set of rules that would enable the use of formula that was intended for other countries in the United States.

The agency's chief explained some complexities in implementing this ruling, saying, "You can imagine that it's really important that we make sure that the constituents, remembering that formula has over 30 different constituents that have to be in the formula, and also that the instructions for use are in English, or a language that the consumer can understand, because mixing up the formula, getting the right formula for the infant is critical."

Pressure building on Biden administration to address baby formula shortage

Califf said in a separate interview that he expects further details on the plan to be released by the FDA by the end of the day on Monday. When asked about the new measures, Califf said that they should have a big effect over time because they will have access to a lot more baby formula from different manufacturers.

Fox News reported that pressure has been mounting in recent weeks for the Biden administration to take action as out-of-stock rates for baby formula continued to soar nationwide, leaving parents in the United States panicked over empty store shelves.

According to the White House, the federal government has been working nonstop to increase supplies since a major formula plant by Abbott in Sturgis, Michigan, was shut down and recalls were issued in February amid an investigation by the FDA over concerns of bacterial contamination at the facility.

Abbott to re-open Michigan plant soon

Califf said that the Michigan plant could reopen in about two weeks. Abbott Nutrition confirmed that development, saying it has agreed to terms set by the FDA to resume operations at the company's Sturgis facility amid a nationwide shortage of baby formula.

Abbott CEO Robert Ford issued a statement, saying that their number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening their Sturgis facility so they can ease the nationwide formula shortage. Ford added that they look forward to working with the FDA to quickly and safely re-open the Michigan facility.

NBC News reported that under the agreement, the Michigan plant will be required to retain an independent expert to review operations and ensure that it follows the law.