When the president feels it necessary to invoke the Defense Production Act so that American babies can get safe formula, we’ve arrived at a place both oxymoronic and moronic.
The horrifying and tragic aspects of the formula debacle (that, to be clear, has not just affected babies — more on that later) have been well-documented, not least by the meticulous reporting of Helena Bottemiller Evich at Politico — you should read her work. Meanwhile here’s a timeline:
- September 2021: A Minnesota baby is hospitalized for 22 days with a rare Cronobacter sakazakii infection, which can cause deadly meningitis or sepsis. The infant had consumed powdered formula from Abbott’s Sturgis, Michigan, formula plant. Coincidentally, the U.S. Food and Drug Administration conducts a routine inspection of the plant this same month but finds nothing consequential enough to warrant regulatory intervention. By mid-January 2022, the FDA will receive reports of four sick infants and two deaths attributed to C. sakazakii.
- Oct. 19, 2021: A whistleblower sends a 34-page document outlining a litany of negligent and shady practices at the plant, including poor sanitation, falsified records, release of untested formula and retaliation against employees (like the, uh, whistleblower) who dared to speak up. “[T]he common thread,” the complainant writes, “was and is to conceal the reality of what is taking place at the Sturgis site.” Frank Yiannas, the FDA’s deputy commissioner for food policy and response, will later say that he did not see the whistleblower complaint for four months.
- December 2021: The FDA interviews the whistleblower.
- Jan. 31, 2022: The FDA inspects the Sturgis plant. It finds five distinct strains of Cronobacter.
- Feb. 17, 2022: The FDA warns consumers not to use certain formula products from the Sturgis facility. Abbott voluntarily halts production at the plant. Robert Califf is sworn in as FDA commissioner.
- May 16, 2022: Abbott enters into a consent decree with the FDA outlining the steps necessary to resume production and maintain the plant. Abbott asserts that there is “no conclusive evidence” linking its formula products to the sick babies.
- May 18, 2022: President Biden invokes the Defense Production Act to prioritize availability of formula ingredients. He also announces the launch of Operation Fly Formula, i.e., the use of commercial aircraft to retrieve overseas supplies of formula. A member of the White House Domestic Policy Council will later acknowledge that the shortage was not elevated to a “top level crisis” until early May.
- May 19, 2022: Califf testifies at a House Appropriations subcommittee hearing but declines to answer questions in detail citing the FDA’s ongoing investigation.
- May 24, 2022: The U.S. Federal Trade Commission launches an inquiry into factors that caused the shortage, and how and whether families were taken advantage of during it.
- May 26, 2022: At a Subcommittee on Oversight and Investigations hearing, Califf calls the conditions at the plant “shocking” and “egregiously unsanitary,” citing pooled water and a leaking roof. He also concedes that the FDA’s response was “too slow” and that certain agency decisions along the way were “suboptimal.” A few days later the FDA announces the pending import of 1.3 million cans of Gerber formula from Mexico beginning in July 2022.
- June 4, 2022: Per the mid-May consent decree and ongoing remediation efforts, Abbott re-opens the Sturgis plant.
- June 10, 2022: Newly released documents reveal that the FDA has investigated the possible deaths of up to nine infants who consumed formula made at the Sturgis plant.
- June 15, 2022: Abbott halts production at the Sturgis plant in the wake of severe thunderstorms and flooding. The company says that, as a consequence, production and distribution of its EleCare specialty formula will likely be delayed for “a few weeks.” Other specialty and metabolic formula production will begin after EleCare production resumes.
Woof. That’s a whole lot of bad behavior, incompetence and playing catch-up to process, even for the cynics among us who’ve come to expect such things from both corporate America and the government agencies charged with overseeing it.
Cause and Effect
In hindsight, it’s easy to see the awful harmonic convergence of circumstances and wrongheaded decisions that led to months of empty shelves. Others have written about these things in much greater detail, but very briefly, the salient issues include: toxic — both literally and metaphorically — conditions at the Sturgis plant exacerbated by a lack of oversight during the pandemic; concentration in the formula industry, with four companies controlling over 90 percent of the U.S. market and Abbott suppling all formula for 34 state nutrition programs, thereby harming families least equipped to deal with a shortage; and dysfunctional, siloed bureaucracies at both the FDA and the White House. Baby formula is also difficult to manufacture, it’s highly regulated (or supposed to be), and significant tariffs discourage imports. All of this adds up to an appalling lack of rainy-day provisions for catastrophic events like the Abbott fiasco. Somehow U.S. infrastructure includes a strategic petroleum reserve harboring half a billion barrels of oil, but when a single baby formula plant gets shut down, suddenly millions of families are left to fend for themselves.
What does that look like? No bueno. What the forensic timeline above obscures is the most vexing and frustrating thing about the shortage: its consequences beyond the immediate tragedy of dead children. Retailers like Walgreens and CVS that still have formula have limited how much customers can buy. There’s been price-gouging on eBay. Mothers of babies who can safely consume breast milk have found themselves pumping day and night; some have substituted juice for formula. Families have rationed and diluted formula. Some have made their own, despite doctors’ and the FDA’s pleas not to. Elsewhere, parents of extremely premature babies have had to drive from store to store in a desperate quest to find adequate nutrition for their fragile newborns.
Have You Seen Me?
As I mentioned earlier, the shortage has not just affected babies. Thousands of children and adults with rare genetic diseases are not able to metabolize certain amino acids (the building blocks of protein). Maple syrup urine disease is one such condition (the disease gets its name from the peculiarly sweet smell of the affected babies’ diapers and earwax). MSUD patients lack a functioning enzyme complex that allows them to break down the so-called branched-chain amino acids (leucine, valine, and isoleucine). When the disease was discovered in 1954, MSUD babies almost always died in a few days or weeks; their mothers would breastfeed them and that influx of protein would cause their brains to swell dramatically. Eventually doctors developed specialty formulas lacking BCAAs (especially leucine, which is neurotoxic in excess) that kept MSUD patients alive and, for the most part, healthy. Today Abbott is a major supplier of such products and, importantly, of ingredients used by other companies to make formulas for metabolic patients.
The shortage has forced MSUD families and their healthcare providers to improvise. Karen Reznik Dolins is a registered dietician who is also the research lead for the MSUD Family Support Group and mother of an adult daughter with MSUD. Dolins reported that as of late May, her 28-year-old daughter Hannah had not received a formula shipment in over three months, although Abbott recently sent her a two-week emergency supply. Hannah relies on it for more 85 percent of her nutritional intake. Dolins is even more concerned by the prospect of an agonizingly slow resumption of supply. Even before the June 14 announcement of a further delay, she said that per Abbott, new formula might not begin shipping again until August.
In recent weeks I’ve heard similar frustrations from physicians and nurses at several specialty clinics in Pennsylvania, Ohio and Indiana that treat MSUD and other rare metabolic diseases that are relatively common in Amish and Mennonite patients — patients who require formula. Clinical geneticist Zineb Ammous, medical director of the Community Health Clinic in Topeka, Indiana, said, “It’s been terrible.” She is thankful that the CHC’s dietician recognized the implications of the Sturgis plant closure early and was able to stock up on medical foods for their metabolic patients. Pediatrician Holmes Morton, founder and medical director of the Central Pennsylvania Clinic in Belleville, Pennsylvania, called the shortage “…a huge mess. How does a formula company run out of metabolic formula? For more than two months we were creating metabolic formulas from scratch using amino acid mixes, sugar, starches, and coconut milk.”
And nurse practitioner Donna Robinson of the Clinic for Special Children in Strasburg, Pennsylvania, has watched her patients’ lives get completely disrupted. “I have spent hours upon hours trying to find formula for our MSUD and [glutaric aciduria type 1] patients, working with our primary metabolic formula company to determine what products are available, speaking with patient families, keeping staff updated, and re-writing prescriptions and diets. We were really struggling to find product to use; [we’ve had to] change diets constantly to accommodate what we could get for our patients.”
She and Dolins both noted that switching brands, even if the ingredients are ostensibly the same, can have real downsides. “My biggest problem right now,” said Robinson a couple of weeks ago, “is finding Neocate formula for one baby who has MSUD and also a milk protein intolerance. He did not do well on another elemental formula; Neocate is what he’s done well on. And [as of early June] I can’t find any.” Neocate is made by Nutricia, not Abbott. But since the Abbott recall, demand for Neocate has tripled. In late May, the FDA announced that an additional 500,000 cans of Neocate would be arriving from Europe by late June.
Meanwhile, for these patients there are no alternatives — they can’t make their own, they can’t just opt for fruit juice, and they can’t rely on someone else’s prolific breast pump. As Hannah Dolins recently told Insider, “I’m 28 years old. I am not ready to die…I need my formula to live.”
As with the ongoing epidemic of mass shootings, the formula crisis has revealed our shameful inability to protect some of the most vulnerable among us — in this case newborns and sick people.
Is there a silver lining? If one squints hard enough, maybe. The last few months have seen communities — like the MSUD community — connect (or reconnect), share what they have, and help each other via social media and telephone. On a macro scale, one hopes that both the executive branch and formula makers will learn from a teachable moment that never should have been necessary. To finish the job will take humility, planning, creativity, legislation and, probably, a whole lot of litigation.
The only upside of a screaming baby is that at least everyone’s awake now.
Misha Angrist is associate professor at Duke University’s Social Science Research Institute and a senior fellow in its Initiative for Science & Society. The views expressed in this column are those of the author and do not necessarily reflect the views of Duke University or Public Health Watch.