Martha M. Leon Fernandez
Associate Editor
Loyola University Chicago School of Law, JD 2024
This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.
Concerns about the quality of the baby formula
The FDA’s decisions have a large-scale impact on all types of consumers. The agency is tasked with protecting the public and providing federal oversight over all foods, including baby formula. Baby formula, in particular, is highly regulated to ensure infants’ proper nutrition, growth, and development. In the U.S., Abbott Laboratories and Reckitt Benckiser Group are two major companies that dominate 80% of the national baby formula market. Prior to this year, the U.S. produced 98% of the infant formula it consumed. One of the FDA’s chief concerns with the production of baby formula is large-scale bacterial contamination. Specifically, powdered formula can harbor cronobacter – a bacteria that, at its worst, can lead to sepsis, meningitis, or even death in newborns and those with weakened immune systems.
Concerns that large-scale bacterial contamination occurred arose in the fall of 2021 when four infants died after ingesting baby formula produced in Abbot Lab’s Michigan plant. Shortly after the FDA received a complaint from a confidential informant in October, they began their investigation into the deaths of these four infants, leading to a major recall of 5 million units of powdered baby formula by Abbot Labs, and the shutdown of their Michigan plant in February 2022. Subsequent investigations by Abbot Labs and the FDA failed to find a definitive link between the deaths of the infants in February and the Michigan plant. However, the FDA identified the recall and the plant shutdown as major factors in the baby formula supply shortage.
Other contributing factors
For many baby formula manufacturers, sunflower seed oil is a key ingredient, and Ukraine has been the number one exporter of this oil. However, since the Russian invasion of Ukraine, the shipments had not been arriving regularly. The invasion, coupled with the closure of Abbott’s Michigan plant, and the recall of a large quantity of their formula, has resulted in a severe baby formula shortage.
Manufacturers have considered a number of solutions, such as exporting from other countries and even rewriting formula recipes to use a different oil. Notably, the FDA would have to approve recipe changes and undergo safety testing on animals. As a result, this process could take months and would not provide a quick or cost-effective solution to this pressing issue.
How was the shortage addressed?
At the onset of the pandemic, the FDA was concerned about baby formula shortages because only a handful of facilities produce it, and two key companies dominate the national market. By the fall of 2020, the FDA sets up “21 Forward” a food supply chain monitoring system that allows the agency to monitor disruptions related to COVID-19 and baby formula.
The FDA also requested additional resources from Congress in its budget proposal for 2022 to increase staff and expand research on harmful toxins in food and formula.
Since the closure of Abbott’s Michigan plant in late February 2022, the FDA took affirmative action to combat supply shortages. In May 2022, they relaxed restrictions on imports of foreign baby formula, leading Congress to suspend tariffs on baby formula ingredients and ready-to-sell baby formula.
Additionally, the FDA reports that domestic manufacturers are currently providing weekly updates on production, and there are 18.9 million cans of formula shipped from abroad. Moreover, the FDA plans to permit the marketing of foreign baby formula through October 2025 while they meet regulatory compliance. They are in the midst of developing a new framework that will help foreign baby formula manufacturers to stay U.S. market, with the goal of strengthening the supply chain to avoid another shortage. To help them meet the regulatory compliance standards, the FDA would provide technical assistance to companies seeking to import or sell formula in the U.S. by holding meetings and issuing guidelines outlining how to meet the FDA requirements.
The FDA has also been working with national companies like ByHeart, which is seeking to expand its baby formula manufacturing facility from one plant to three. There are other relatively new brands in the U.S. that are hoping to work towards solving the shortage.
Cynicism over the FDA’s report
The FDA’s internal review provided a number of reasons why the FDA responded to the shortage in this manner. However, there is skepticism about some of these findings, and many are saying that the FDA is not doing enough to address systemic problems exposed by the February shutdown of the Michigan plant.
One of the findings cited indicated that there needs to be an increased scientific understanding of Cronobacter, in order to be able to provide the proper oversight. However, observers push back on this finding stating that Cronobacter has had multiple outbreaks that sparked concern in 2001, 2011, and 2019 and it has been investigated each time. The report also claims that the FDA’s inferior process and overall confusion over how to handle complaints delayed their response to addressing the complaints filed against Abbott. There is incredulity over this finding since Congress disclosed in May 2022 that the FDA was aware of the whistleblower’s report when it was sent in October 2021. This led some to believe that the slow response was not due to confusion or subpar processes but instead due to COVID-19 concerns at the plant. The report also stated that the FDA did not have control over supply chain issues and shortages of critical food products, and there is not sufficient staff to carry out its mission. However, critics point out that the FDA could have eased formula labeling requirements for foreign baby formula products before mid-May to ameliorate supply concerns.
It was shortsighted for the FDA to shut down the production of a vital baby formula plant without taking concurrent measures to ensure a stable supply of similar products from other domestic or international producers. Now, six months later, consumers are still dealing with baby formula supply issues when the shortages could have been avoided altogether.