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Bipartisan bill aims to reduce future baby formula shortages

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Companies that make baby formula would be required to have a backup plan to keep their supply flowing in the face of a recall or an emergency disruption if they want to land a government contract to serve families in need under a House bill introduced this week.

The Access to Baby Formula Act — authored by Rep. Jahana Hayes, D-Conn., and with Rep. Michelle Steel, R-Seal Beach, as the original cosponsor — also would give regulators more flexibility to cut through red tape when future disruptions do hit, so they can more quickly get formula back on store shelves. And it would require more notification, such as online bulletins, from state and federal authorities if events likely to trigger shortages take place.

“Families desperate to feed their babies shouldn’t have to face empty shelves because of government mismanagement and overregulation,” Steel said. “This bipartisan legislation will provide certainty for recipients and manufacturers, ensuring this crisis doesn’t happen again.”

The bill includes “minor, but positive steps” toward addressing the issue, said Gustavo Oliveira, a professor of global and international studies at UC Irvine who studies food supply chains and reviewed the legislation.

He noted that success of this proposal depends on a few other factors also falling into place. And he said lawmakers need to tackle deeper issues with consolidation of the food supply chain, and the lack of support for low-income families through things like mandated family leave, to truly safeguard against such shortages in the future.

“That’s a tall order,” Oliveira said, referencing the need for a deeper re-imagining of the way food is distributed and regulated. “But it is ultimately the only real solution beyond these minor steps contemplated in these legislations and executive initiatives.”

As of early May, an estimated 43% of baby formula was out of stock across the United States. That shortage has caused panic for millions of families who can’t rely only on breastmilk for a variety of health or practical reasons.

The shortage was triggered in February when Abbott Nutrition, which makes Similac and other popular formula products, voluntarily shut its Michigan plant and recalled products. At the time, the company faced an FDA investigation over potential contamination that may have caused bacterial infections that led to two infant deaths. The shutdown exacerbated already-existing, pandemic-related supply chain problems that affected, among other things, the ingredients and packaging used in baby formula.

The FDA announced Monday, May 16, that it had reached an agreement with Abbott that will let the company resume production within a couple weeks. And on Wednesday, May 18, President Joe Biden invoked the Defense Production Act to prompt other formula manufacturers to focus on boosting supplies.

But it’s still not clear why it took three months for federal regulators to resolve the issue with Abbot.

Chris Tang, a UCLA business professor and a scholar of global supply chain management, said the FDA “dropped the ball” and should have responded much sooner. That idea also is prompting lawmakers to ask questions, with FDA Commissioner Robert Califf slated to testify before Congress on the topic Thursday, May 19.

Politicians also have proposed a range of solutions to help prevent such an extreme shortage from happening again.

On Tuesday, May 17, Rep. Rosa DeLauro, D-Conn., asked the House through H.R. 7790 to send an additional $28 million in emergency funds to the FDA as a way to help address broader supply chain issues.

Under H.R. 7791, from Hayes and Steel, manufacturers that hope to sell their product to the federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) programs — which help low-income families with kids age 5 and younger — would need to include plans for addressing any disruption without affecting people who receive WIC benefits. Roughly half of the baby formula sold in the United States is purchased through WIC, which means the current shortage is hurting poor families the most.

But rather than take a punitive approach, perhaps by blocking WIC contracts for a formula manufacturer that doesn’t yet have a contingency plan, Tang believes businesses will respond better to a reward system, such as giving preference to bidding companies if they can demonstrate they have a robust plan to avoid supply chain problems.

The second part of the Access to Baby Formula Act would codify the practice of allowing federal and state regulators to waive some rules — such as which products can be sold in U.S. stores and which products can be purchased with WIC benefits — during severe shortages.

Brian Dittmeier, senior director of public policy at the National WIC Association, noted that many of the contingency plans invoked by regulators to backfill recent shortages were available only because of pandemic-related rule changes that temporarily gave regulators power to waive certain regulations. Dittmeier said he supports the element of the bill from Hayes and Steel that would “enshrine” such waivers into law and make them permanent.

But the bill states that the rule waivers would only be allowed if the changes don’t “substantially weaken the nutritional quality” of any products affected by those changes. And Oliveira, of UC Irvine, noted that making such a determination would require “significantly increased inspection, supervision, and enforcement of food safety laws, including more stringent punishments for companies responsible for food safety incidents.”

This shortage started with a food safety incident, after all, amid complaints that the FDA already doesn’t have resources to stay on top of such problems. So Oliveira believes the bill could work only if Congress also boosts support for FDA, such as by approving the additional $28 million requested in DeLauro’s bill.

Tang said a bigger problem that needs to be addressed is that big companies such as Abbott — along with entire industries — have put “all their eggs in one basket” in a way that meant shutting down a single plant has dramatically reduced the national supply of formula.

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Oliveira agreed, saying the country should take steps aimed at “deconcentrating the entire food system.” Such changes, he added, should include a discussion of “anti-trust legislation, improvements in labor rights” and shifting federal subsidies to help smaller companies.

“It is a problem of an extremely concentrated food industry in the hands of a few giant corporations, which are almost not accountable to the government or to the public until a scandal happens,” Oliveira said.

“These measures currently being discussed merely address the immediate crisis,” he added. “But longer term, and more structural solutions, (will) require going far deeper into dismantling this highly concentrated food system.”

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