Chris Wilford
Associate Editor
Loyola University Chicago School of Law, JD 2026
In March, the FDA announced Operation Stork Speed in response to a Consumer Reports investigation which found traces of toxic chemicals in baby formula. Secretary of HHS, Robert F. Kennedy Jr., has directed the FDA to begin several new initiatives and increase the scrutiny of testing to find ways to have better access to safe baby formula. Operation Stork Speed will begin a comprehensive review of the nutrient list that is currently approved by the FDA and increase labeling transparency with industry. Although created in response to the Consumer Reports findings, a ProPublica investigation published on April 4th has led to concerning claims about unsanitary practices within an Abbot Labs factory. The same Michigan-based factory that shutdown in 2022, after reports of infant hospitalizations and deaths due to this facility’s formula, causing a nationwide shortage. Given the added issues with the factory, if done correctly, Operation Stork Speed could begin to solve the safety issues that have recently plagued the baby formula industry.
Consumer Report and creation of Operation Stork Speed
Consumer Reports tested 41 types of powdered baby formula for numerous chemicals including arsenic and lead. Over half tested positive for some level of toxicity. The FDA announced Operation Stork Speed just one day after receiving these results. Specifically, the FDA will increase testing for heavy metals and other contaminates and extend the personal importation policy. Extending the personal importation policy allows people to import, for personal use, things otherwise not approved by the FDA or for sale in the United States. By extending the personal importation policy, the FDA’s hope is that this eased policy will become an attractive alternative source of safe baby formula, alleviating some of the demand for domestic production.
Abbott Labs factory in Sturgis, Michigan
ProPublica’s investigation into unsanitary practices at the formula factory has raised concerns over the fact that there might be tainted baby formula. Whistleblowers claim that the factory in Sturgis is taking shortcuts when it comes to testing, that they do not seal leaks immediately allowing for bacteria to grow, and they do not take all necessary microbe tests while doing maintenance. Additionally, employees have felt pressure from management to increase production and have seen other employees who complained or reported issues face retaliation. There was even a report about an employee using cardboard found next to the trash rather than a portable pump to redirect the flow of coconut oil into a tank that was then used in formula. This is not the first time the Sturgis facility has been in trouble. Sturgis was the infamous facility that had to fully shut down and recall all products in 2022 due to very similar charges to the accusations they are currently facing. The shutdown sparked a nationwide shortage of baby formula due to the high concentration of manufacturing and that there are only a handful of factories in the United States that are responsible for all domestic production-before the 2022 shutdown. The Sturgis facility produced as much as 41% of the nation’s baby formula, but as of 2024 it produces closer to 20%.
The FDA’s response
Abbott Labs has been under a consent decree with the FDA since the incident in 2022. The facility in Sturgis has undergone at least 10 separate inspections since entering the consent decree, including a multiweek review (that took place when the alleged cardboard incident took place). Almost none of the inspections resulted in action needing to be taken. However, one inspection from December of 2022 noted many of the things being claimed today by present and former employees: not taking all the necessary tests, not swapping for microbes while cleaning or preforming maintenance, etc. Yet, the FDA came under immense fire for its response to the initial warnings about the 2022 incident as being slow and ineffective at preventing the crisis. The Office of Inspector General found numerous deficiencies with the FDA procedures that were focused on “procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.” For the current violation being alleged at the Sturgis facility, the FDA has yet to comment on any investigations or protective measures it’s taking.
An opportunity to make actual change
Many have speculated on how enforcement with the FDA will change under the Trump administration and specifically under RFK Jr’s “Make America Healthy Again” initiative. It is concerning that the FDA is claiming that it will increase inspections while simultaneously trying to cut the workforce by thousands. But there is an opportunity to make a lasting change if the administration is willing to do more than a surface level response to the issues at hand. Between the 2022 crisis, the Consumer Reports investigation and the new allegations about the Sturgis facility, it is obvious there are issues with the manufacturing processes of baby formula. It is also likely that the Sturgis facility is not making the necessary strides for it to be a consistently safe place to make baby formula. The Trump Administration has the tools to fix this – increased inspections, testing and more stringent penalties are easy starts. Yet the administration has sent mixed messages on how vigorously they will pursue the issue. Any food born pathogen for baby formulas is potentially deadly and as shown only a few years ago, any shutdown causes massive panic and shortages. With proper planning and policy, hopefully through the guidance of Operation Stork Speed, maybe that can change.