East Paris
Kentwood, Michigan
May 23, 2022
What follows is a Holman Jenkins opinion piece from Saturday’s WSJ. I appreciate that opinion writers write to agitate some of their readers; he really got to me this time.
While reading it I was reminded of Stephen Covey’s description of being on a subway with misbehaving kids. His message was we make assumptions and have biases that we need to factor into our analysis of a situation.
Jenkins doesn’t like regulation. I got that. He’s saying regulators (the pejorative “bureaucrats) have a zero-risk tolerance. I don’t know — and neither does he — what facts led the FDA to shutdown the Abbott plant. I’ve giving the FDA the benefit of the doubt until I learn more.
The real issue is that all parties — Abbott, the FDA, and Abbott’s competitors — must have known there would be a shortage of formula given the plant was shutdown. Why aren’t we holding Abbott accountable for not doing something to procure formula yo fill the hole. Why aren’t we holding its competitors accountable for not trying to fill the hole. I still believe the shortage is not the FDA’s responsibility to fill. That’s freaking socialism!
People make mistakes. Maybe the FDA was unwarranted in shutting down the plant. We don’t know. Regulators have a tough job. They get no thanks for keeping us safe. Jenkins‘ argument is a slippery slope. If not the regulators, who do we turn to to keep us safe.
BTW, I get all the constraints — monopoly, tariffs, labeling. Was anybody sounding an alarm that unless the FDA relaxed those parameters we would end up where we are.
Sorry — I stored this angst up for 48 hours. Do we have too many regulations? Yes. Which ones should we get rid of is a tougher question. For those we are going to keep, we need to give the agencies the resources to enforce them.
One Bad Choice and a Baby Formula Shortage A blinkered view of the risks led to a blinkered decision that endangers thousands of families.
By Holman W. Jenkins, Jr. May 20, 2022 6:20 pm ET Baby formula is a target of shoplifting rings. Its supply has been disrupted by Covid lockdowns. Its pattern of demand has been thrown for a loop by pandemic-spawned changes in retailing and baby-making. Add the fact that half the U.S. supply is consumed by welfare recipients, who are limited by regulation to a choice of three manufacturers. Add federal rules that make it hard to relieve a domestic shortage by importing foreign-made supplies.
And still the shocking baby formula crisis of 2022 is not an occasion for your perfect storm metaphors: The key factor that overwhelms all others is a government decision in February to force a factory shutdown and product recall on an Abbott Labs plant in Michigan.
The four cases of Cronobacter sakazakii infection in infants that the government cited could not be traced to the factory’s products. No contaminated baby formula was found; Cronobacter was identified on the factory grounds but lacked a genetic match to samples from affected infants. A considered response might have been to keep the factory running and carefully check its output for contaminated formula, but that’s not the response the Food and Drug Administration chose and thereby hangs a tale.
As one textbook puts it, Cronobacter is a “one product-population problem”—the product is powdered infant formula; the population is newborns, especially low-birth-weight newborns.
A bacteria common in the environment and resilient to boot, with unusual resistance to arid conditions, Cronobacter typically causes disease only in the elderly and immunocompromised. The big exception is very young infants—2 months or less or with compromised immunity—who can develop deadly complications like sepsis and meningitis. Cronobacter’s natural reservoir is uncertain but the bacteria are readily found on plants, in soil, on meat, cheese, fruits and cereals, in sewage, in herbal teas, etc. A 2014 U.S. government study found specimens on the premises of 38 of 55 U.S. facilities for making powdered milk, with 4.4% of 5,671 “swabs and sponges” testing positive. Though contamination in factory-sealed products has rarely been found, unlike more expensive liquid versions of baby formula, the powdered variety has proved impractical to sterilize.
In the U.S., contamination in the home is clearly the big risk, “after you open the container,” as the Centers for Disease Control and Prevention puts it. Cronobacter has been found on lids, scoops and bottles and in stored water. For parents of infants in the vulnerable categories, the CDC urges mixing powdered formula with water heated to 158 degrees Fahrenheit before serving the cooled solution to an infant. To make matters more complicated, incubation of Cronobacter is estimated to take at least four days and sometimes as long as 21, so a parent’s anecdotal intuition that a specific formula may be involved is not much to go on. Only one state, Minnesota, tracks Crononbacter infections. The CDC says it receives reports of two to four infant cases a year but has no idea of the true incidence and points to recent evidence suggesting mild infection may not be uncommon among all age groups. With this context in hand, especially a lack of evidence that the factory was the culprit, a conclusion is hard to resist: In shutting down the Abbott plant, the FDA was acting from a zero-risk mentality in its own bailiwick—protecting infant formula from factory contamination—with zero regard for costs and risks that would be somebody else’s problem. These include a nightmare for parents and a risk of malnutrition for thousands of newborns, particularly those in need of doctor-prescribed formulas that only the Michigan factory produced.
When have we heard this story before? Almost daily during the Covid crisis, from government agencies and politicians who made blinkered decisions more in their own narrow interests rather than in the interests of the public broadly considered. Recall the FDA’s self-protecting perfectionism that delayed lab and later at-home testing for Covid long after other countries had them.
The media are often unhelpful in this regard. “Follow the science” can serve as a smokescreen for avoiding the science, often complex and uncertain, in favor of partisan stereotyping and narratives of villains and heroes. In recent days, the FDA has continued rationalizing its behavior with a labored and showy “settlement” that will allow the Michigan factory to reopen; because the Defense Production Act became a “thing” to the media during the Covid crisis, the Biden administration on Tuesday invoked the DPA and dispatched military-affiliated air carriers to deliver foreign-sourced baby-formula supplies. Congress held hearings on Thursday. We may be witnessing only the beginning of the political circus to flow from a single act of questionable judgment by the FDA.