Four years ago, I wrote two posts with titles I meant: “Mr. Abbott, you are going to face criminal sanctions” and, a few weeks earlier, “Mr. Abbott, you are going to jail for manufacturing tainted infant formula.” I was wrong. Not about the facts — about the willingness of this Justice Department to do anything about them.
The Wall Street Journal reported last night, in “The Baby Formula Probe Produced a Pile of Evidence. Then the DOJ Dropped the Case,” that the Department of Justice spent years building a criminal case against Abbott Laboratories over the Sturgis, Michigan plant — the same plant where Cronobacter sakazakii was found on equipment, where a former FDA official told Congress five strains of the bug were present and the facility was “out of control,” and where four babies who drank Abbott formula got sick and two of them died. According to the Journal, some prosecutors believed they had the evidence to charge. Some supervisors thought it was a good case. They were looking at a misdemeanor under the Food, Drug, and Cosmetic Act and a separate count for misleading the government, and they were weighing charges against at least one individual.
Then the people at the top closed it. Instead of a charge, Abbott gets to claw back some of the money it earned selling formula through federal nutrition programs — a civil settlement whose terms, naturally, weren’t revealed. A DOJ spokeswoman explained that this Justice Department “does not believe in regulation by prosecution.”
I want to sit with that phrase for a minute, because I have been quoted in this very article saying the quiet part out loud. When the White House issued its May 2025 executive order on “overcriminalization,” I said it brought a sigh of relief to CEOs across the country — because the threat of criminal exposure is precisely what kept people in the food business on their toes. I wasn’t being cute. I was describing how deterrence actually works.
I walked through the law when that order came out, and I’ll say it again here. Section 333(a)(1) of the FDCA is one of the few true strict-liability crimes in federal law. The government does not have to prove a guilty mind. If a food is adulterated and it moves in interstate commerce, the crime is complete — and under the responsible-corporate-officer doctrine, the executives who had the authority to prevent it can be held to answer. That is not a loophole. That is the deal Congress struck in 1938 because babies’ lives can depend on whether a powder is made in a clean plant or a filthy one. I wrote in December that we still need the risk of criminal sanctions in food poisoning cases. The Abbott non-prosecution is the first big proof of what happens when you take that risk off the table.
There are two details in the Journal’s reporting that should make every parent’s stomach turn. First, even if DOJ had wanted to prosecute, the office that does this work — the Consumer Protection Branch — was being disbanded as a cost-cutting measure, the same branch that put away the executives behind the Peanut Corporation of America salmonella outbreak. Second, one of Abbott’s defense lawyers — a former deputy attorney general — reportedly urged the incoming administration to overhaul that very office and strip it of its ability to bring criminal cases at all. Read those two sentences together and ask yourself who is writing the rules now.
We have seen this movie before, and the credits still haven’t rolled. Ten people died in the Boar’s Head Listeriaoutbreak. A year and a half later I’m still asking where the Boar’s Head investigation went — and the government’s own refusal to release records, on the ground that they were compiled for a law-enforcement purpose, is the loudest confirmation we have that someone with a badge was once looking hard. “Once” is doing a lot of work in that sentence.
Yes, Abbott denies the link. The company points out that no unopened, distributed formula tested positive, and that CDC’s sequencing of the two available infant samples didn’t closely match the plant strains. FDA, for its part, still calls what was found at Sturgis a serious concern, because plants like this one are among the most likely sources of contaminated formula. And the civil case the government did bring — joined by 31 states — alleged that Abbott knowingly fell short of manufacturing standards and ran a culture of concealment at Sturgis. Knowingly. Concealment. Those are not the words of a clerical error. Those are the words you build a criminal case around — the case DOJ decided not to bring.
I litigate the infant formula cases that land downstream of decisions like this one. Right now my firm represents families of babies hospitalized with botulism after ByHeart and Nara formula, and I’ve spent this spring writing to Secretary Kennedy, to FDA, and to the Senate HELP Committee asking Congress to put real teeth back into formula safety. Here is the through-line. When the criminal threat disappears, the only accountability left is a civil check — and a civil check is just a cost of doing business. It gets passed along, written off, and forgotten by the next quarter. It does not keep anyone up at night. It does not keep anyone on their toes.
I have tried to steer clear of politics on this blog. But there is nothing political about saying that a company whose plant sickened babies should have to answer to more than its accountants. The Journal got the headline right: there was a pile of evidence. What’s missing isn’t proof. It’s the will to use it.
We live in interesting times.
