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The baby formula crisis may leave a permanent mark on the international market

The FDA wants to create a process to allow formula manufacturers in other countries to sell their goods in the U.S. — and help head off future shortages

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Illustration by Zoë Petersen, Deseret News

Baby formula manufacturers in other countries who stepped in to ease the formula shortage in the United States may find there’s a place for their products on American store shelves after the crisis ends.

The U.S. Food and Drug Administration announced this week that it plans to grant long-term authorization so that formulas from other countries that won temporary approval during the crisis can earn authorization to continue selling in the U.S. It’s a move officials say will help prevent future baby formula shortages.

The plan, which was announced in a joint statement by FDA Commissioner Dr. Robert M. Califf and Susan T. Mayne, who directs the Center for Food Safety and Applied Nutrition, will also simplify the path to approval so that more infant formula makers can participate in the U.S. formula market in the future.

“The need to diversify and strengthen the U.S. infant formula supply is more important than ever,” they said. “The recent shutdown of a major infant formula plan, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become.”

Meanwhile, the White House on Wednesday announced the 14th Operation Fly Formula mission. This one is set to bring in the equivalent of more than 4.7 million 8-ounce bottles of formula from Australia’s Bubs. The flights will land in Ontario, California, on July 10 and in Columbus, Ohio, on July 21. The imported formula will be available through regional and national retailers.

Empty shelves and panicked parents

Parents have been scrambling to find formula for several months as supply chain issues and stockpiling of infant formula crashed up against a voluntary formula recall and the closure in February of the nation’s largest formula manufacturing plant.

Abbot Nutrition’s Sturgis, Michigan, facility was closed after the bacteria cronobacter sakazakii was found in the facility, then reopened again in June after the company met the terms of a consent decree. But the plant unexpectedly closed just days later after it sustained major damage from a severe storm.

Other factors likely piled on to these issues, deepening the crisis, experts said. Demographic Intelligence’s chief information officer, Lyman Stone, told the Deseret News recently that trends like a drop in breastfeeding played a role in creating the shortfall.

Demographic Intelligence provides U.S. birth forecasts and fertility analytics for businesses that have an interest in birth trends. One of its surveys identified three underreported issues that made the baby formula market volatile.

One of the issues was stockpiling and hoarding similar to what happened with toilet paper early in the pandemic. Others were a “widely fluctuating” number of births and a decrease in how many women breastfeed their babies.

As births dropped in the pandemic, formula manufacturers adjusted formula production downward. When births rose as the pandemic progressed, it put pressure on the existing formula supply. And not only did fewer women breastfeed, but they also seemed to breastfeed for a shorter duration during the pandemic, both of which bolstered the need for formula to feed those babies or supplement feedings and put pressure on the supply.

Tackling the shortage

Government officials — including the Biden administration and members of Congress — have tried to find solutions to the challenge of how to adequately feed the youngest, most vulnerable people in America, including children with special dietary needs who require hypoallergenic and other specialty formulas.

The White House said that in addition to importing formula through its Operation Fly Formula, the federal government has addressed the formula shortage by invoking the Defense Production Act so that raw materials can be diverted to aid in manufacturing formula, by working directly with retailers and manufacturers to increase the formula supply and by cutting red tape to increase imports. Federal officials have also made it easier for the Women, Infants and Children supplemental nutrition program to waive rules so that families who use the program have more formula brand options. And government agencies have cracked down on price gouging.

Additionally, on a case-by-case basis — and subject to greater product testing — Abbott Nutrition has been allowed to release some of the cans of its EleCare amino acid-based formula plant that were produced at the Sturgis plant before the closure. Those receiving the formula are described as “needing urgent, life-sustaining supplies of this specialty formula, the White House said.

Some of the steps to address the shortage have been taken by members of Congress. Sen. Mike Lee, R-Utah, for example, sponsored the FORMULA Act, passed by unanimous consent in the Senate. There’s a minimum 17.5% tariff on baby formula imports, and the act suspends that for 90 days to give families affordable access to a range of safe, reliable baby formulas that have been imported from countries that have safety standards similar to those in the U.S.

Lee has also proposed suspending restrictions so that families participating in the Women, Infants and Children program can buy any formula brand they can find in WIC-approved stores.

“My FORMULA Act represents needed relief for the countless Utah moms and dads who are struggling to feed their babies during what doctors are calling ‘the worst crisis of their careers,’” Lee told the Deseret News. “While I am thrilled the FORMULA Act unanimously passed the Senate, I am hard at work negotiating with House and Senate colleagues to get this and other provisions to help Utah families feed their babies passed into law. I am fully committed to ending this crisis and ensuring nothing like this dangerous shortage ever happens again.”

The FORMULA in the bill’s title stands for Fixing Our Regulatory Mayhem Upsetting Little Americans.

The FDA plan

The FDA plan unveiled this week has three parts, according to Califf and Mayne. The agency intends to:

  • Create a single technical assistance contact for companies wanting to market their infant formula in the U.S.
  • Meet with companies that have already imported, sold or distributed their formula here under the FDA’s temporary authorization to discuss what they would have to do so they can continue on a more permanent basis once the formula shortage ends.
  • Create a pathway to make that happen. The agency promises that it will issue guidance in September to help those who have temporary authorization so they can continue supplying formula.

“Ensuring that the youngest and most vulnerable individuals have access to safe and nutritious formula products is a top priority for the FDA,” read the statement from Califf and Mayne. “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.”

The temporary authorizations that simplify bringing in outside formula during the baby formula shortage are slated to expire in November, though the Biden administration says it will extend them, if needed. The FDA plan could make that unnecessary.