The Infant Formula Shortage: An Avoidable Crisis

KEY TAKEAWAYS

• Parents have struggled to find baby formula, a situation that became a crisis in the spring when a large manufacturing plant closed. 
• The Biden administration ignored the warning signs and ultimately made the crisis worse through its repeated failure to act. 
• There remain many unanswered questions about why the Biden administration failed to prevent this crisis and how it intends to make sure this doesn’t happen again. 

All year, parents have been struggling to find formula to feed their babies. Well before the crisis made headlines in the spring, there were warning signs the Biden administration refused to heed. The Biden administration’s bureaucratic blundering created a nationwide crisis, with empty shelves and angry parents demanding answers.

Biden Administration Let a Shortage Become a Crisis

Source: Senate HELP

empty shelves

Early this year, the Food and Drug Administration began investigating consumer reports related to four infants who were hospitalized after consuming baby formula manufactured by Abbott. Out of an abundance of caution, in February, the company initiated voluntary recalls of certain infant formulas and temporarily stopped production at its Sturgis, Michigan, plant. At the time, the Sturgis plant produced an estimated 20% of formula in America, and the closure and recalls exacerbated what was already a shortage of formula due to supply chain issues. Since at least January, the media had been reporting empty store shelves and parents in a panic about finding food for their babies. In early February, before the recall, the nationwide out-of-stock rate for formula was 26%. At the end of the next month, it was 30%, and by late May it was 70%.

An investigation by the Centers for Disease Control and Prevention found that the sealed infant formula containers produced in the Sturgis plant contained none of the strains of the bacteria that made children sick, but there were other traces of those strains in the children’s homes. The CDC found no link between the bacteria harming children and the plant production. The CDC ended its investigation on May 14, and Abbott resumed production at its Sturgis facility in June. Less than two weeks later, severe storms and flooding closed the plant again. The plant reopened in July after a three-week shutdown. Earlier this month, the nationwide out-of-stock rate stood at 30%.

Biden administration’s BOTCHED response

The infant formula shortage did not happen overnight. There were indications throughout the COVID-19 pandemic that supplies were running low and that the shortage was getting worse. Rather than addressing the issue with appropriate urgency, the Biden administration and the FDA stalled. During the pandemic, the FDA sent its workers home and decided to conduct only “mission critical” inspections. It did not do a single inspection at Abbott’s Sturgis facility between September 2019 and September 2021.

Despite knowing about the formula shortage for months, the Biden administration either failed to recognize it was a problem or was incapable of acting until there was a full-blown crisis. President Biden grumbled that he was unaware there was a formula shortage until April, even though manufacturers had been warning the FDA since late 2021 that they were facing a shortage. It wasn’t until May – when the national out-of-stock rate was over 40% – that President Biden finally invoked the Defense Production Act to increase production and began using commercial flights to import formula from overseas. Similarly, FDA waited until May to take steps, such as waiving labeling and other regulatory requirements, to increase formula supply.

The FDA branch that oversees baby formula failed to consider the effects of recalls and shutting down manufacturing capacity. As former FDA Commissioner Scott Gottlieb said in May that the regulatory scheme at the FDA is “stringent enough that it does create obstacles to getting into the market for new entrants … But, at the same time, it doesn’t provide stringent enough oversight of the resulting oligopoly – three companies control 80% of the market – to ensure that there’s no snafus that can cause shutdown of those facilities.” As a result of FDA regulatory barriers, high tariffs, and government purchases through the Special Supplemental Nutrition Program for Women, Infants, and Children, among other factors, the formula market has few competitors, making it very vulnerable when something goes wrong.

It took far too long for the administration to recognize what parents and the formula industry had been trying to tell them. It also has taken too long for the administration to acknowledge what went wrong and what it is doing to make sure this kind of shortage doesn’t recur.

• What steps is the FDA taking to improve its inspection program, especially for critical products like infant formula?

• Has anyone at the agency been fired over the failure to deal with the shortage before it became a crisis?

• When can parents expect shelves to be fully stocked again?

• Will the FDA make permanent the temporary measures allowing formula to be imported from other countries?

• How should oversight of formula be reformed to ensure that these problems don’t happen again?

For American families trying to find food for their babies, the administration’s actions were long overdue. Now it’s time for some answers to parents’ questions.