The FDA Announces Baby Formula Plan: “Too Little Too Late,” Experts Say

On March 28, just ahead of the House Oversight and Accountability Committee meeting to investigate the 2022 months-long and life-threatening baby formula shortage, the FDA announced that it finally had a plan to address future baby formula shortages. The agency, however, also said that many contributors to the shortage were “beyond the purview of the FDA.”

“While we stand here today, more than a year since the recall, it is my view that the state of the infant formula industry today is not much different than it was then,” Frank Yiannis, who resigned as the FDA’s deputy commissioner of food policy and response in February of this year, said during his testimony to the committee on Tuesday. “The nation remains one outbreak, one tornado, flood, or cyberattack away from finding itself in a similar place to that of February 17, 2022.”

Yiannis also addressed the lag time between when the initial complaint was filed and when the formula shortage was actually addressed, but offered no reason for the delay.

“Clearly, I really wish, and I should have been notified sooner, so I could have initiated containment steps earlier. Had that happened, I believe we might not be here today,” Yiannis said. “Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened.”

For many experts, the plan for the formula shortage is long overdue. But whether the actions taken are enough to prevent future crises is another question.

“We need a supply chain that is secure, from a product quality [and] safety perspective, resilient, responsive, and adaptable. The proposals have done something about product security, but the rest, not so good,” said Steven Melnyk, Ph.D, a professor of supply chain management at Michigan State University who Fatherly spoke with in 2022 about the initial shortage.

What Is The FDA’s New Plan To Prevent Another Formula Shortage?

In a new 27-page report, the agency outlined steps it took to address the shortage over the last year and laid out its plans to rectify existing issues and bolster the resilience of the formula supply chain from manufacturing facilities to supermarket shelves.

The plan is made up of two distinct stages, actions the agency will take immediately and a more robust strategy (yet to be fully announced) that will roll out in 2024.

The immediate changes include:

• Annual food safety inspections at all formula plants.
• Enhanced training for formula inspectors.
• Improved and strengthened communication with existing and potential formula manufacturers and distributors.
• Improved monitoring of the entire formula supply chain, including raw materials, in-stock rates, sales data, and potential disruptions of supply chain logistics.

The agency also plans to work more closely with the USDA to ensure that the needs of the Special Supplemental Nutrition Program for Women, Infants, and Children program, the largest purchaser of formula in the U.S., are met and that families in need get the formula they require. The full plan can be found on the FDA website.

What Are Experts Saying About The FDA Plan?

Not all experts agree that the new FDA plan is robust enough to address the risk of future shortages, however. One of the major contributors to last year’s shortage was the high tariff the U.S. charges on baby formula imported from foreign countries. The tariff means that many companies cannot profit by importing, so the U.S. market remains at risk.

“I miss a clarion call, indeed a call with any strength, to abolish [tariff] barriers,” Gary Hufbauer, a nonresident senior fellow at the Peterson Institute for International Economics, told Fatherly. “Instead, the report offers a mealy-mouthed justification for tariff-rate quotas, even after explaining the high capital costs that restrict entry to the industry. The net result is to ensure business as usual — a highly concentrated domestic market, with the danger of future shortages that entails.”

Another issue, according to Melnyk, is the way the U.S. infant formula supply chain is set up.

“We have a system that is characterized by bottlenecks (i.e., the concentration of production in a few facilities)... The actions taken by the FDA are bothersome for two reasons: they are specific to the events that affected supply in 2022, and they have not done anything about the bottlenecks.”

According to Melnyk, the proposed strategy is based solely on what happened in 2022 and does not take into account alternative problems that could plague the system in the future.

“What we have learned from the events of 2020-2023 is that supply chains can be impacted by numerous different factors, many of which we had never considered before — e.g., the blockage of Suez Canal in March 2021 by the [Ever Given] — who could have predicted this?” Melnyk explained. “Consequently, one thing that many supply chain managers have learned is to start planning for the unexpected.”

The 2022 Baby Formula Shortage, Explained

Last year’s devastating formula shortage started in part due to the closure of a major formula production plant in Sturgis, Michigan. The plant, owned by Abbot Pharmaceuticals, one of the country’s largest formula producers, paused production after whistleblower complaints were filed in 2021 regarding cleanliness and sanitation practices. The complaint was not addressed until one year later, in February 2022, after several babies became infected with the dangerous Cronobacter bacterium from drinking formula the plant produced.

After the Sturgis shutdown, Abbott issued several recalls, which in turn severely limited the amount of formula available to families. Not only are there very few formula producers in the United States, but Abbott also controlled more than 40% of the formula market, per one Vox estimate in 2022. And, to make matters worse, because of the U.S.’s stringent import policies regarding formula, it became almost impossible for other countries to bolster our supply or for parents to order formula directly from overseas manufacturers.

The ubiquitous “supply chain issues” experienced in many sectors post-pandemic were partly to blame, and manufacturers and distributors struggled to keep store shelves stocked with brands not affected by the recall or plant closure.

By June 2022, it was reported that at least nine infants had died after consuming the contaminated formula. The Sturgis plant was closed for five months to address sanitation issues, during which time families around the country struggled to find enough formula to feed their infants.

Are There Any Other Current Baby Formula Recalls?

Abbott Pharmaceuticals isn’t the only formula company to have issued recalls. Most recently, Reckitt, producer of the popular formula brand Enfamil, issued a recall in February 2023, warning that as many as 145,000 cans of ProSobee Simply Plant-Based Infant Formula could be contaminated with Cronobacter.

The company issued the recall in conjunction with the FDA. “We are committed to the highest level of quality and safety, and it is for this reason that we have taken this extraordinary measure,” Reckitt said in a statement on its website. “The health and safety of infants is our highest priority.”

For more information on the recall and the batch numbers involved, visit the FDA website.