In February of this year, the FDA issued a warning to consumers that it was investigating complaints of cronobacter and salmonella infections in four infants who had consumed powdered baby formula from Abbott Nutrition’s Sturgis, Michigan processing plant. Abbott then recalled the products in question, and has yet to restart production at the plant, causing the ongoing baby formula shortage in the US.
As more information unfolds about the events leading up to the recall and the conditions at the Sturgis plant, we are reminded of the important role that whistleblowers play in protecting public health and safety. In 2019, FDA inspectors learned that there was cronobacter in finished products produced at the Sturgis plant and that the company had inadequate testing practices, but did not take any regulatory action against the plant. Neither the FDA nor the Michigan Department of Agriculture and Rural Development inspected the plant again until September of 2021, when the FDA inspected the plant and found unsanitary conditions such as workers handling raw materials without adequately washing their hands. The FDA did not test for cronobacter or other pathogens in the plant.
The next month, a former quality assurance worker at the Sturgis plant sent a 34-page report to various FDA officials alleging that Abbott falsified testing records, tested empty cans rather than finished products for bacteria, sold untested products in a batch where cronobacter was found in other products, hid information from FDA inspectors about the presence of bacteria, had inadequate cleaning procedures, and retaliated against employees who complained about these regulatory violations. The FDA interviewed the whistleblower in December and inspected the Sturgis plant at the end of January, this time taking samples to test for bacteria. The test results came back positive for cronobacter, although the strain was different than the strains of cronobacter found in the infected infants—by then the FDA had received at least four complaints that infants who consumed Abbott powdered formula had fallen ill, and one had died. On February 17, the FDA issued its warning to consumers. The whistleblower’s report likely played a key role in ensuring a second inspection of the Sturgis facility, and is being used by federal lawmakers to push for improved oversight of the FDA to prevent such lax inspection and regulation of food producers in the future.
Whistleblower Protections in the Food Manufacturing Industry
Employees of food manufacturers who witness regulatory violations and raise concerns about them to their employer or to the government have legal protections. The Food Safety Modernization Act prohibits food manufacturers, processors, transporters, and distributors from retaliating against employees who refuse to violate the Food, Drug, and Cosmetic Act or who report violations of that Act to the federal or state government. Other whistleblower protections may apply as well. For example, the Abbott whistleblower report alleges that Abbott’s false public statements may have misled investors about its financial status, and that the company may have violated the terms of its government contracts, through which Abbott receives federal dollars to supply formula at a lower rate through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). These allegations could implicate the Sarbanes-Oxley Act, which prohibits shareholder fraud, and the False Claims Act, which prohibits fraudulently obtaining payment from the federal government. Both laws have anti-retaliation provisions designed to protect employee whistleblowers. If you believe you have suffered retaliation for raising concerns about food safety, shareholder fraud, or fraud in government contracting, you can contact an attorney for legal advice.