Biden must demand timid FDA act as baby-formula shortage grows even worse

Half a year in, the baby-formula shortage keeps getting worse with no end in sight. Unlike the global semiconductor and grain shortages, the formula shortfall is an America-only phenomenon. This means the solution can be found here at home.

But by focusing on importing limited amounts of Food and Drug Administration-approved foreign formula, President Joe Biden is addressing only the problem’s symptom, not the root cause. He needs to cut the ridiculous red tape that’s keeping store shelves bare.

Baby formula has a 30% out-of-stock rate — higher than when parents began panicking months ago and stratospheric compared with the typical 5% to 7% pre-pandemic.

The shortage was precipitated by Abbott Nutrition’s February recall after five infants came down with severe infections after consuming formula produced at the company’s Sturgis, Mich., plant. An FDA inspection found unsanitary conditions and other violations, leading Abbott to recall the formula and halt production. The infection-causing bacteria were not found in the Abbott formula, though.

Baby formula
As of now 80% of all US baby formula comes from two companies.
Getty Images/Brandon Bell

Usually, a recall wouldn’t cause such severe disruption. But the US baby-formula market is extremely concentrated: 80% of all formula comes from just two companies, one being Abbott, which had 48% of the market when the recall started. The company also dominates the formula purchased for the US Department of Agriculture’s Women, Infants, and Children program, holding government contracts in 34 states and the District of Columbia.

Because of its market dominance, there were bound to be repercussions once Abbott recalled formula and halted production at one of its largest plants. Action was needed to prevent a shortage, especially for babies who require a specialized formula for survival. But rapid action was not taken.

The FDA reports that “the U.S. normally produces 98% of the infant formula it consumes.” That’s partly thanks to tariffs of up to 17.5% on imported baby formula that put foreign competitors at a distinct competitive disadvantage. Few even bother going through the FDA’s approval process. With a massive shortage in such a large market, however, many foreign companies began wanting to sell to the United States but needed FDA approval to do so.

Despite the urgency, the FDA took three months to issue guidance on relaxing restrictions on foreign formula. And even after that May guidance, approval still requires extensive documentation and analysis — so the FDA is still causing delays.

Indeed, Reuters reports foreign formula companies Nature’s One and Holle are ready to ship massive amounts of formula, but “they may be waiting a while” due to the FDA’s “slow responses.”

Parents desperate for formula don’t have the luxury of time.

These delays are unacceptable, and Americans deserve to know why the FDA has been so slow and unresponsive. Advocacy group Americans for Prosperity recently submitted a Freedom of Information Act request for documentation on the FDA’s mishandling of this matter. Perhaps what AFP uncovers will shed light on the reasons the FDA did not respond more quickly.

Fortunately, Congress is taking action to break down barriers for foreign suppliers. In May, lawmakers passed the Access to Formula Act to let WIC programs buy alternative formulas. Last month, they passed legislation to waive all tariffs on formula temporarily. But all that will be for naught if the FDA doesn’t speed up its approvals.

The FDA’s primary concern, as it should be, is safety. But while foreign formulas may not have gone through the agency’s approval process, they are regulated by the European Commission. Pediatrics professor Bridget Young notes that the European Commission’s formula regulations are stricter than ours, including bans on certain added sugars.

Baby formula
Foreign formulas are willing to ship off their products but the FDA’s slow response is delaying the process and becoming a pain for parents.
Reuters/Bing Guan

A 2019 study found that among popular European brands, “all formulas except one met the [examined] FDA nutrient requirements.” The problem? “None met all FDA label requirements.” These foreign formulas are healthier than many domestic brands and meet nutritional requirements, yet the FDA shuts them out of the US market because of labeling.

The FDA’s response has been bureaucratic, timid and slow. In a time of crisis, it should have been an easy call to grant Emergency Use Authorization to formulas approved abroad without another onerous and drawn-out process. In May, FDA Commissioner Robert Califf told lawmakers that “some decisions in retrospect were not optimal.” No kidding.

And now it’s August, and the FDA still won’t budge.

Given the FDA’s poor track record on COVID testing, baby formula and the monkeypox vaccine, Americans are right to wonder whether the FDA is up to the job. Reforming the agency to speed approvals while maintaining safety can’t wait; it’s a matter of life and death.

Marion Mass is a Philadelphia-area pediatrician who trained at Duke University Medical School and Northwestern University and the co-founder of Practicing Physicians of America.

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