According to the Wall Street Journal (WSJ), the regulator is developing a new framework to allow global baby formula makers to stay in the U.S. market. This framework will involve "technical assistance" to companies wanting to enter the infant formula market. It is planning to hold meetings in the summer with these firms to help determine the necessary steps and ensure zero supply issues.
The FDA also plans to issue guidelines in September 2022 for companies permitted to import or sell infant formula.
"The change could help strengthen the formula supply chain after it was found to be vulnerable to disruptions," said the WSJ, noting that the baby formula shortages "exposed the vulnerabilities in the more than $4 billion U.S. market for baby formula." The publication added that the FDA's proposal "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."
FDA Commissioner Dr. Robert Califf and FDA Center for Food Safety and Applied Nutrition Director Susan Mayne said the agency "expects that [its] 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."
Supply chain snags caused by the Wuhan coronavirus (COVID-19) pandemic caused the initial shortage of baby formula. However, the temporary closure of an Abbott Laboratories plant in Sturgis, Michigan that manufactures baby formula added fuel to the fire.
The February 2022 shutdown and subsequent product recall stemmed from the death of an infant who consumed formula tainted with Cronobacter sakazakii, according to the Centers for Disease Control and Prevention. Operations at the Sturgis plant resumed operations in June 2021, albeit under FDA supervision.
The combination of regulations blocking international brands from entering the market and Washington's role as the biggest formula buyer via the Special Supplemental Nutrition Program for Women, Infants and Children has restricted the flexibility and competition required to overcome the shortages.
Health Secretary Xavier Becerra said the federal government "is working with manufacturers around the clock to ensure parents have the formula they need to feed their infants." He added: "We will pursue all available options until we have stabilized the infant formula supply in the United States."
Importing infant formula from overseas through Operation Fly Formula was among these measures. Back in May 2022, President Joe Biden announced that 27.5 million cans of formula from Australia would be flown in to address supply snags. The formula from Bubs Australia is using goat's milk instead of cow's milk.
"I've got more good news: 27.5 million [cans] of safe infant formula manufactured by Bubs Australia are coming to the United States. We're doing everything in our power to get more formula on shelves as soon as possible," Biden tweeted at the time.
Later, Biden announced additional shipments of formula from the Land Down Under. In a July 6 press release, Washington announced that the two flights would transport infant formula from Bubs Australia to Ontario, California on July 10 and Columbus, Ohio on July 21. The two deliveries, amounting to approximately 318,000 pounds of baby formula from the Australian firm, would be sold "through national and regional retailers."
"Biden launched Operation Fly Formula to speed up the import of infant formula and start getting more formula to stores as soon as possible. By July 10, Operation Fly Formula will have transported more than 43 million 8-ounce bottle equivalents to the United States," said the statement.
FDA.news has more stories about the regulator's actions amid the baby formula shortage.
Watch "American Journal" host Harrison Smith explaining how the FDA shut down the Sturgis plant below.
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