FDA Will Help Overseas Baby-Formula Makers Keep Selling in U.S. Beyond Shortages

The FDA said on Wednesday it would develop a new framework to help the global makers of formula stay in the U.S. market.

The change could help strengthen the formula supply chain after it was found to be vulnerable to disruptions. It could also be a boon for manufacturers overseas that have been eager to enter the U.S., while injecting more competition into the concentrated market.

Abbott Laboratories

and

Reckitt Benckiser Group

accounted for roughly 80% of infant and toddler formula sales in the U.S. last year, according to market-research firm Euromonitor.

Under the plans, the FDA would provide technical assistance to companies seeking to enter the U.S. infant formula market and hold meetings this summer with companies that import or sell formula to help determine what additional steps should be taken to ensure uninterrupted marketing of products.

In September, the FDA intends to issue guidelines outlining how companies that have been allowed to sell their products in the U.S. temporarily could meet FDA requirements to continue to supply infant formula.

“The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the U.S. market better understand their options to continue producing and supplying formula to the U.S. in the weeks, months and years ahead,” said FDA Commissioner

Robert Califf

and

Susan Mayne,

director of the agency’s food division.

Baby formula started to experience shortages because of supply-chain disruptions caused by the pandemic. The shortages worsened after the temporary shutdown last February of an Abbott plant in Sturgis, Mich., that makes Similac and other products following reports of contamination.

The shortages exposed the vulnerabilities in the more than $4 billion U.S. market for baby formula, The Wall Street Journal reported.

A combination of tight regulations restricting international brands from entering the market with the federal government’s role as the biggest formula buyer, through the Women, Infants and Children supplemental nutrition program, limited competition and the flexibility needed to overcome the recent shortages.

The federal government has been flying in formula made overseas to help ease shortages, while Abbott’s Sturgis plant restarted manufacturing last month under FDA oversight.

The U.S. government “is working with manufacturers around the clock to ensure parents have the formula they need to feed their infants. We will pursue all available options until we have stabilized the infant formula supply in the U.S.,” said Health and Human Services Secretary

Xavier Becerra.