Contaminated Infant Formula: Unsafe, Unpunished, Corrupted

My days of having small children are long past, but my heart breaks for families trying to decide what to feed infants who cannot be breastfed.

Powdered infant formula is the least expensive option.  Unfortunately—and tragically these days—it is not sterile.

Ordinary bacterial contaminants are not a problem.  Pathogens are.

In recent years, there have been all too many illnesses and deaths among infants unknowingly fed contaminated formula.

What got me started was an article in the Wall Street Journal: “The Baby Formula Probe Produced a Pile of Evidence. Then the DOJ Dropped the Case,”

The Justice Department spent years investigating Abbott Laboratories over how it managed a baby formula facility where potentially deadly bacteria was discovered and suspected of causing infant deaths, worsening a national shortage.

Some prosecutors believed they had evidence to criminally charge the company under a law they have used to pursue other businesses for allegedly selling contaminated foods, according to people familiar with the matter. Some supervisors also thought it was a good case, they said. Top decision makers instead closed the probe, the people said, opting for a lighter-touch option: clawing back money the company earned from selling formula through federally funded nutrition programs. The outcome, which hasn’t been previously reported, illustrates how the Justice Department under President Trump has moved away from strict approaches to corporate enforcement and raised the bar for punishing companies. Trump in an executive order last year called for minimizing the use of criminal sanctions, where civil penalties could be used instead.

And then, KFF Health News and USA Today co-published “A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File.”

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry…Under federal rules, if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate. But it doesn’t always have to inform the government agency that oversees the safety of infant formula. A company must complete an investigation and notify the Food and Drug Administration within 15 days only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.” If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

I was curious to know what food safety lawyer Bill Marler, who represents victims of food poisonings, had to say about all this.  Plenty, starting with The Fox Has Been Guarding the Henhouse for Years: Infant Formula Makers Decide for Themselves Whether Baby Deaths Get Reported to the FDA.

The headline finding should stop every parent, pediatrician, and member of Congress in their tracks…Here is what KFF Health News found when it asked the FDA, through the Freedom of Information Act, for every such notification manufacturers had submitted since January 1, 2020: none. The reporters then asked the agency to search all the way back to January 1, 2000. Again: no responsive records.…This is not an academic problem for me. I currently represent families in two infant botulism outbreaks tied to powdered infant formula — the November 2025 ByHeart outbreak that sickened at least 48 infants across 17 states, and the spring 2026 Nara Organics outbreak that so far has sickened three. In those cases, we have dug deeply into the same regulatory framework KFF Health News just exposed…The adverse event reporting system for infant formula is not a system at all. It is an honor code — for an industry that litigation has shown may not deserve it.

On his Publisher’s Platform, Marler writes: Mr. Abbott, You Are Not Going to Jail After All

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….A DOJ spokeswoman explained that this Justice Department “does not believe in regulation by prosecution”….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.

Why is this happening?  500,000 Reasons to Drop a Criminal Investigation

Here is why the families I represent — and every parent who lived through the 2022 [Abbott formula] shortage — should be furious.

Abbott gave $500,000 to President Trump’s inaugural fund. Public Citizen has documented that Abbott was one of 58 corporations facing federal investigations or enforcement that together poured some $50 million into the inauguration…And then there is the stock. As Common Dreams reported this week, the President’s own annual financial disclosure…shows that Trump began buying Abbott stock in late September of last year and picked up roughly $500,000 worth of Abbott shares over the course of 2025. The buying happened while his Justice Department was still sitting on a criminal case against the company.

$500,000 into the inauguration. $500,000 in stock in the President’s own portfolio.

As Marler is careful to say, “No court and no investigator has found that the donation or the stock purchases caused this case to be dropped. What is undisputed is the sequence: the money, and then the vanished prosecution. Whether one caused the other is a question no one in a position to answer has been willing to answer.”

I’d say it sures gives the appearance of conflicted interest if not bribery and corruption at the highest levels of government.

Excuse me, but we are talking about helpless newborn and very young infants here, utterly dependent on formula as their sole source of nourishment.

Cases of contaminated formula may be rare, but they have affected commercial, alternative, and organic brands, and their consequences are devastating (take a look at the case studies in Marler’s letter of support for the Infant Formula Safety Modernization Act of 2026).

Congress needs to pass this act, and right away.  And is needs vigorous enforcement.

Legal slaps on wrists will not stop food safety violations.

In the meantime, the safest formula is the liquid form, pasteurized to kill spores as well as living pathogens.   Otherwise, powdered formula is a risk, a small risk, but finite.  You do not want your infant to be one of the unlucky ones.

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