The editors of the Washington Post have a plan for fixing the infant formula shortage:
The simple solution, from the outset, would have been to import more formula from abroad, from places such as the European Union, Britain, Canada, Australia and Japan. The U.S. Food and Drug Administration announced Monday that it was streamlining its review process so that foreign manufacturers could begin shipping more formula into the United States. That should have happened weeks ago. The FDA also reached a deal with Abbott on how to reopen the shuttered factory in Michigan.
The situation is still dire. Supplies of formula have been 40 percent out of stock, and it could take two months before it is widely available again. On Wednesday, the White House took the much-needed steps of announcing “Operation Fly Formula†to speed up foreign formula imports by using Defense Department air cargo contacts and invoking the Defense Production Act to speed delivery of ingredients to domestic formula producers.
As with most crises, the families that are the hardest hit are low-income households that can’t afford to pay high prices or drive around to multiple stores and families that have children with special medical conditions. At a minimum, states should work with manufacturers to suspend requirements forcing moms on the Women, Infants and Children (WIC) program to buy only specified formulas with government vouchers.
Disappointingly — albeit predictably — demagogues have been feasting on the fears of babies going hungry. Republican lawmakers and their backup choir on right-wing media have been stoking outrage with false claims blaming the shortage on stocks being set aside for the babies of undocumented immigrants. And there are some who are trying to shame mothers who don’t breastfeed.
The nation needs a full and rational accounting of this mess and the troubling questions about why it took so long for the FDA to look into the Abbott plant after a whistleblower came forward in October. Longer-term, we should open the U.S. market up to more imports from abroad. The trade deal the Trump administration struck with Canada and Mexico that made it even harder to import formula from Canada has had unintended consequences. In the 21st century, the United States should be capable of feeding the smallest and most helpless among us.
I don’t think they’ve actually thought it through very well. As has been pointed out around here, importing infant formula from small countries that produce formula almost exclusively for domestic consumption, e.g. Canada, is at best a very short term solution and at worst is just moving the problem from a U. S. one to a Canadian one. The United States is a very big country. I’m not convinced that Canada or Ireland is in any position to compensate for a 40% shortfall here in the U. S. which is what is being reported.
They also might want to consider why the FDA has the regulations it does on infant formula. If they don’t preserve the lives or health of American babies, they shouldn’t exist. If they do preserve the lives or health of American babies, they should not be lifted even temporarily. I don’t see any middle ground.
In addition you might want to consider this analysis at BIG by Matt Stoller. Mr. Stoller sees the problems as unforeseen consequences of FDA regulations conjoined with Department of Agriculture policies. Consider the bar chart at the top of this page. It represents the market share of the companies that dominate the infant formula market in the U. S. In case you’re wondering about Nestle, while it doesn’t have much market share here, it does have an enormous slice of global marketshare.
That’s not the working of the market you see in operation there. It’s a consequence of the way the Food Supplemental Program for Women, Infants, and Children (WIC) works. Winners of bids in each state are guaranteed a statewide monopoly on infant formula sales under the program in that state. WIC accounts for about half of all infant formula sold. Contract winners have an enormous competitive advantage.
“why the FDA has the regulations it does on infant formula. If they don’t preserve the lives or health of American babies, they shouldn’t exist. If they do preserve the lives or health of American babies, they should not be lifted even temporarily”
When I looked into baby formula a while back — the understanding I got is formula is extremely regulated to prevent perverse incentives.
For example, the nutritional content of formula specifies what must be in formula and within a very tight limit, the amount. That’s to prevent marketing a brand is better it contains Y% more of X (which may not actually benefit the baby). Or even worse, it has ingredient X with no evidence it benefits babies. And regulations on how it is manufactured must be very strict to prevent the cause of Abbot’s shutdown — bad formula that killed 2 babies.
If the shortage had not happened, the Abbot plant’s issue would be a national scandal by itself. In other countries, Abbot would be under the equivalent of FBI investigation.
That doesn’t actually resolve the conundrum. Competition is not a “perverse incentive”. If a range of acceptable values for each nutrient is acceptable, that’s what the regulation should say.
My understanding is that they don’t actually know what killed the two babies. They suspect the Abbott plant but aren’t actually certain. Further, the FDA has shown little sense of urgency in the matter.
What I’m saying is the regulations don’t care very much about competition — they prioritize health and safety first, second and third (as they should).
Competition can create incentives that risk safety / health. Not only on substandard production (efforts to cut costs), but adding extra ingredients that could be not beneficial / harmful.
As to the FDA; I honestly don’t know what’s going on inside. They were super fast to approve the mRNA vaccine, killed (tens/hundreds of?) thousands in laggardly approving boosters, and is the last developed market to approve a “traditional platform” vaccine.
“My understanding is that they don’t actually know what killed the two babies. They suspect the Abbott plant but aren’t actually certain. Further, the FDA has shown little sense of urgency in the matter.”
That’s pretty much all they know. A simple search of articles (scraping the wheat from the chaff):
You can find the FDA report. Abbott discovered the bacteria in question in September of last year. The FDA report is dated Jan 31, 2022, so they knew by then. An FDA official was quoted as saying the bacteria was not one that would initiate immediate action.
Three senators wrote a letter to the FDA in February inquiring about its actions. The FDA sat around for several months. Neither the lawmakers or the FDA apparently thought through the implications of a shutdown.
There clearly is no definitive link between Abbot formula and the sick babies. (They look at genetic sequences of contamination strains and the babies. Apparently different.) On the other hand, there is no clear exculpatory evidence either. As one technically oriented person who was interviewed said – we probably will never really know.
And in a head shaker, one article covering the story was calling for massive finished product testing, as opposed to process equipment testing. The poor dear. But hey, a journalism major.
And everyone is pointing their finger elsewhere. Maybe time to get all the liars in the same room.
So yes, all we really know is that the FDA dragged their feet and the cause of the baby sickness is undetermined.
I think we must be hearing different versions of the story. Yes, it started in September but the FDA did follow up inspection in February(?) and cultured bacteria. Abbott knew they were under the gun and didnt clean up the plant.
I thought lifting the regulations was talked about because they might bring in EU or NZ formula. By reputation those places have quality measures as tight or tighter than we have. Lifting the regs so that we could import formula from Germany where the value of some nutrient is 0.00001% different than ours is OK with me.
Steve
This is the version that I think holds up best:
Here is the FDA Inspection report, dated 1/31/22, as I said.
https://www.fda.gov/media/157073/download
Note Observation 1. B in the 9/25/19 – 2/20/22 timeframe: bacteria identified “during sister swabbing with FDA.”
That phrasing is not clear to me so I tried to be charitable and assume it was on Abbot to not have reported. But the FDA may have been aware as early as late 2019.
It doesn’t make Abbott or the FDA look good.
However, as an investor in an industrial bakery, familiar with food regulations, a former process engineer in a real live volume production environment, and having read the commentary of tech types on the specifics of FDA related testing in the baby formula setting, the notion of perfection is ludicrous on its face. Is your hospital germ free, steve? Didn’t think so…….
I think a rational person should be able to live with the notion of a non-zero risk, cost benefit analysis view of food and drug production. I think the issue here is, when the FDA decided to bring the hammer, or Abbott decided to do it unilaterally, what the hell did people think would happen?
That’s the disfunction of government. And its on Joe’s watch. He could always resign if the pressures of the day are too much for his delicate old bones. So Joe should just take his medicine, STFU and address issues, and stop pointing fingers. Pointing fingers seems to be his core skill. He is a politician of the worst stripe; a Senator. A leader or executive? Not in this universe or this lifetime.
It’s okay with me, too. My point was that the regulations should be change permanently to allow them.
Here’s why I think the regs on imports will only occur on an emergency basis (besides the fact of the size of the American market).
Imagine the Abbot plant issue wasn’t in Michigan but in Ireland. If the end result was babies got sick and died; the outrage at the FDA for allowing formula it didn’t have full jurisdiction in inspecting would be tremendous.
In addition in practice there is no such thing as an enforceable international civil code of law.
” the notion of perfection is ludicrous on its face. Is your hospital germ free, steve? ”
No, but the places that need to be sterile are tested and kept sterile. We dont have standing water in those areas. I am assuming that the other manufacturers are tested in the same way and are not having issues.
Steve