Abbott infant formula shortage occurred when FDA inspectors detected Cronobacter sakazakii bacteria (triggers sepsis, inflammatory responses, and meningitis, which causes the tissues surrounding the brain and spinal cord to swell) sickening 4 infants of which 2 died. Abbott voluntarily withdrew product & shutdown production in Feb 2022 to fix manufacturing problems caused by failing to maintain sanitary conditions in the plant, has remained shut fir 3 months, and covered up problems to pass FDA inspections. After the 1st child became sick a whistleblower FedEx’d detailed reports to the FDA which was slow to act (2 months to review, 1 month to inspect, 1 month to communicate with Abbott).
US infant & medical nutrition supplies were already under pressure due to supply chain issues before the bacterial infection. Abbott has suffered from staffing & global supply chain problems
Covid 19 pandemic
War in Ukraine
Abbott passed previous routine FDA inspections (Sep 2021) but a whistleblower had contacted top FDA officials (Oct 2021) after the 1st infant became sick with specific allegations of food safety concerns months before the recall, reporting lax cleaning practices & purposely falsified records to keep FDA from learning about serious issues related to the plant’s own system for checking for bacteria in formula according to House Appropriations Chair Rosa DeLauro during a budget hearing on Capitol Hill when disclosing the whistleblower report stating ,
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility,” DeLauro said. “I am equally concerned that the FDA reacted far too slowly to this report.”
“Hard copies of the disclosure were sent via FedEx to senior food safety officials and other leaders at FDA (acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, associate commissioner for Regulatory Affairs and Catherine Hermsen, assistant commissioner of the agency’s Office of Criminal Investigations).”
“(Regarding Oct whistleblower FedEx to FDA) the agency (FDA) did not interview the whistleblower until December. FDA didn’t inspect the plant until Jan. 31. Formula was recalled Feb. 17.”
“(Abbott) dismissed (the whistleblower) due to serious violations of Abbott’s food safety policies.”
“After dismissal, the former (Abbott) employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities. Abbott is reviewing this new document and will thoroughly investigate any new allegations.”
In addition to the serious questions raised about Abbott Nutrition’s food safety practices, revelations of an early whistleblower warning reinforce concerns about leadership and decision making on food issues at the FDA.
Problems reported by whistleblower:
1) current and former employees are “fearful of retaliation” where Abbott is the largest & highest paying employer
2) plant officials “knowingly” falsified records leaving off key information from paper compliance records that are difficult to retrieve
3) ongoing problems with ensuring that its powdered formula cans were fully sealed. powder would get into the can seams “thereby jeopardizing the integrity of the seal and product safety
4) employees altered the plant’s testing process so that empty cans were tested instead of sealed cans containing the product
5) questionable practice was never disclosed or referenced in records that came to his (employee) attention. The employee has reason to believe that the questionable practice has not ceased and has not been disclosed to FDA officials.
6) 2019, a batch of the plant’s infant formula tested positive for “micros,” according to the document. It doesn’t specify which bacteria was found, but formula is routinely tested for Salmonella and Cronobacter. Plant officials decided that instead of destroying the entire batch, they would destroy the most suspect part of the batch and then release the rest of it into the market without conducting additional testing to ensure it wasn’t contaminated.
7) infant formula was released commercially without supporting documentation to suggest it was compliant and safe for consumption.
8) During FDA’s routine 2019 inspection of the Sturgis plant, company officials were “worried what the FDA would find about the micro batches. Throughout the audit, [quality assurance] leadership kept [quality systems] staff apprised. One member of management stated that the FDA was on the ‘right trail.’ She even volunteered that she was amazed that the FDA was unable to discover what occurred with the micro batches. Once the FDA audit was over, staff and department managers congratulated each other on a successful FDA audit.”
FDA is "helping" Abbott optimize processes & production schedules by:
1) expediting review of notifications of manufacturing changes
2) Using FDA Forward food supply chain continuity system
3) Expediting certificates of already permitted products from abroad into the US
3) streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records.
- jimK 05/13/2022
The fact that the supply line for baby formula collapsed because just one supplier needed to stop operations to fix production problems highlights the fragility of supply lines generally due to the ongoing consolidation of suppliers into fewer and fewer large scale suppliers. In this case, the industry’s consolidation has resulted in supply line disruptions that are more than just inconvenient, they are medically hazardous.
While consolidated suppliers can exploit economies of scale to cut costs, they are also able to increase prices because they have less competitive pressures. Also, they can effectively minimize the ability of innovators to develop new and better processes because profitable mega suppliers have little incentive to introduce new methods and independent innovators do not have access to prices available to established mega suppliers who can exploit economies of scale.
Certainly, there should be a rebalancing of critical supply chains to so that real capitalistic competition can keep critical supply chains more robust and less fragile to disruption due to issues with a singular supplier. Also, it can reduce profiteering possible when a few mega suppliers have little competitive pressures and encourage innovators to take the risks needed to introduce more productive and cost effective methods. What specifically that balance point should be needs to be carefully evaluated, especially for products critically needed and those medical products with life or death consequences for some.
Even though the right ‘balance’ may be difficult to pin down a move in the right direction would be any policy that can restore pure capitalistic free market competitive pressures (with no ability of crony capitalists to simply buy political favor in lieu actually competing for market share), and a large enough supplier base that would feel the need to explore innovative solutions.
This is more of a hidden problem than many might realize. For example, a few years back all of the acetaminophen used in the US and in many other countries was produced (and I presume, still is) by a singular manufacturing plant in Philadelphia. Acetaminophen is used as a primary ingredient in a phenomenally large number of brand name over the counter and prescribed medical products required by people in the US and around the world -much of whom are critically dependent on this singular supplier of acetaminophen.
The chemical processes used to produce acetaminophen are multi-step industrialized chemical processes that involve some potentially hazardous intermediate chemistry and require physically separate ‘wet’ and ‘dry’ plants, because the intermediate chemicals of the separate plants are very reactive with each other to the point of being explosive.
These factors help explain why there is a solitary US manufacturer and the risk to the use and availability of many prescribed and needed medications. Even just encouraging this manufacturers to build a redundant production facility elsewhere in the country would minimize the supply chain risk. My knowledge of this comes from a few years back and I cannot say whether or not foreign manufacturers have increased. Even so, it is illustrative of the issues.
Another supply line disruption occurred in the seventies when the only US dynamite production line blew up. I lived something like 30 miles from it in Virginia and watched the windows shake from both the sound of the blast and even the overpressure minutes later. This delayed a lot of civil engineering cut and fill operations, mining operations, demolitions and some military military applications, and led to a much broader use of ammonium nitrate as a somewhat less effective but more readily available and safer alternative for many of these applications.
The point is that critical supply lines are corrupted and put at risk by consolidations of industry suppliers who can benefit from lower costs using economies of scale, can raise or even manipulate prices because they have little competition and suppress innovation because the market entry prices are more than innovative risk takers can afford.
Critical supply chains are made more fragile and less robust by the consolidation of suppliers and this can have disastrous consequences for medically required life saving or life protecting supplies. For this reason alone, these critical supply chains need to be ‘rebalanced’ to enable more pure and sustained capitalistic free market pressures to establish the robustness needed to assure that there are no catastrophic disruptions due to issues with a singular solitary supplier.
- Brian 05/13/2022
I'm appalled at how those on the right think that the very small number of immigrants getting the formula in the reserved supply is giving to them don't deserve to live.
We know you don't really care about babies, especially babies of color, but you have reached a new low.
- Robert J. 05/24/2022
Looks like the Feds looked the other way as this industry consolidated to just three major producers essentially a monopoly market with Abbott being the prime problem at its Sturgis, MI plant. It's time to break up these monopoly markets and to enforce more rigor in product testing. Allowing imports (tested) would help ease shortages.
The infant formula shortage problem started in 2020 with pandemic-driven YoYo demand (stockpiling, then not buying until stockpile used, then large demand for more). In addition FDA Food oversight has always taken a backseat to drug oversight which was paused in 2020 and part of 2021 and just restarting at the time the whistleblower submitted the report to FDA.
The infant formula demand problem spans 2 administrations driven by the pandemic, and the FDA problem spans multiple decades and administrations as food oversight has been neglected in favor of drug oversight at FDA
1) Formula Demand YoYo
-Spring 2020, people stockpile formula.
along with toilet paper
-after stockpile gone demand increased
-YoYo demand throws off production
- Early 2022 increased births
-decline in breastfeeding rates
(mothers returned to work?)
2) FDA Food Oversight failures - while FDA is responsible for 80% of US Food Supply, FDA which is run by doctors is focused on drug oversight and most of oversight is dedicated to drugs. Due to Covid shutdowns even drug oversight was halted in 2020 and part if 2021 and was just starting backup when the infant formula problem surfaced due to a whistleblower.
- Jim2423 05/12/2022
This is just another case where our government could care less about it's citizens safety. Our government enjoys spending money in manufacturing weapons to destroy people. But cries the blues in spending money for our safety. Our government has created an Energy Department that has not produced one watt of electrical power production. Department of Education, which needs no explanation. It shows through our local public school systems failing. Department of Homeland Security which just produces jobs for the average person just barely above minimum wage. And projects every traveler as a terrorist. Our food industry have taken advantage of Congresses lapse in spending to enforce food industry to provide safe food products for consumers. Due to a lack of hiring inspectors, and enforcement procedures. Baby Formula is just one of many contaminated food products. Contaminated farm problems, contaminated medicines, contaminated dairy products, contaminated meat products, now baby formula. How about reducing your military budget and protect your citizens. Or do these companies donate big money into your campaign coffers? So you can turn a blind eye.
- John 05/13/2022
The absolute best thing a mother can do for a child to help improve neural growth and sound physical growth is to breast-feed. Hands down. I know some women can't, and they need to have access to baby formula but every mother they possibly can and should do it it will pay off greatly in the long run in the health of the baby.
- Bobbie 05/14/2022
Mothers should be breast feeding and not relying on baby formula. If it is needed let's get it to those moms and babies.
- Linda 08/08/2022
This shortage, along with many other we are currently suffering, are the result of the shortedness, poor planning, profit-chasing by the manufacturers. They merge companies, then consolidate operations in fewer plants. Then they cut the stocks on hand to fit the "just in time" model of warehousing. All of this leaves us vulnerable to anything that disrupts the supply chain. All to increase profits! Then they cry to the federal government for aid to rectify the problems they themselves caused! It is unfair that we, as customers and taxpayers must keep paying the costs of Corporations' pursuit of profits!
- ednablount 06/29/2022
I understand the formula shortage became due to the supply chain shortage caused by COVID. Even though there are steep tariffs on getting formula outside of the US, I do not see what other choice we have WE cannot have hungry babies. Now with Roe v. Wade being overturned our infant population will increase and you will have mothers who cannot or do not want to breastfeed.
- Watcher202 06/16/2022
It's a shame what the federal government is doing to us citizens.
It's time they answer for their traitorous behavior toward US citizens.
- Jim2423 06/02/2022
This is monopoly controlled. Our Food & Drug told the factory to clean up your process. Employees complained about their unsanitary operation. Being baby food was not a big money maker. They shut down. Congress where were you, on break. This is a monopoly and should be busted. States are just as bad, only allowing just a few baby food companies to sell their products in their state. Shame on our elected, do nothing, officials.
- DaveS 05/20/2022
192 heartless republicans voted against a bill to ease the baby food shortage, but blame Biden for not getting anything done? Sure sound like the norms for republican Russia party!
- Rebekah 05/19/2022
This is criminal. Babies lives are at stake. The executives of Abbot Labs should be jailed for malfeasance. The Emafil factories should be seized and run by the workers on behalf of all children.
- Mindy 05/19/2022
I would love to know why Jack Bergman hates babies. Why did you vote against helping babies, Jack? Why do you hate your constituents with babies so much? Why do you want babies to starve? Why are you so morally bankrupt?
- Matthew 05/15/2022
So we have a national baby formula shortage while we at the impending announcement of the Supreme Court ruling overturning womens Heath care rights. That makes sense--it's right on par with the Evangelical White Christians hypocritical "Pro-Life" ideology that they only give a shit about life when it's in the womb because once it comes out--they don't give a damn about it. It's amazing the legal monopoly we have given these 4 companies to this market. There are good regulations that protect workers, the community, and the planet; than we have bad regulations that allow a monopoly to be a monopoly. For instances, most states have an agreement with a baby forumla company, that makes a woman on WIC only get that companies formula with NO SUBSTITUTIONS if the brand is out of stock. That should not be. But hey, why help parents of young children WHEN WE CAN HELP MASS SHOOTERS GET ALL THEIR MASS SHOOTING ASSAULT RIFLES, BULLETS, AND ARMOR!!! Because the American Nazi Party truly believes in sanctuary of guns over life!!!
To my third reich "reps" Risch and CRAPo, stop your pro life hypocrisy and just HELP THESE FAMILIES!!! I know it's asking a lot of two individuals that want to rot in hell and support mass shooters right to mass shoot.
- Charles 05/15/2022
Congress can mandate increased production.
The USA needs more manufactures. Abbott needs competion.
Some of you doubt because your mainstream media won't show you that illegal immigrants are receiving pallets of baby formula at the border while America children's parents see empty shelves.
New York Post:
Border detention center looks stocked with baby formula despite shortage
By Callie Patteson and MaryAnn Martinez
May 12, 2022 | 12:49pm
Rep. Kat Cammack shared pictures of “pallets” of infant formula at the Ursula Migrant Processing Center in McAllen, Texas on her Twitter and Facebook pages Wednesday.
“The first photo is from this morning at the Ursula Processing Center at the U.S. border. Shelves and pallets packed with baby formula,” she wrote in a tweet accompanying side-by-side photographs of full and bare shelves. “The second is from a shelf right here at home. Formula is scarce. This is what America last looks like.”
Cammack’s office shared several additional images supposedly from the same location with The Post on Thursday.
He, as a Border Patrol agent, just took in pallets, pallets of baby formula for all of the illegals that are crossing into the United States,” Cammack said.
Border Patrol facilities across the southern border of the US are stocked with infant formula, Brandon Judd, the president of the union that represents Border Patrol agents told The Post.
“If [the Biden] Administration was not encouraging vulnerable women and children to put themselves in the hands of dangerous cartels, by incentivizing illegal immigration through the catch and release program, then the formula that is currently overstocked at the border patrol facilities could go on the shelves,” Judd told The Post Thursday. “I am certainly not saying we should not care for those in our custody. We should.”
Cammack urged her constituents to call their Democratic leaders and “demand that the administration take action on putting the baby formula back on the shelves for American kids.”
This from Politifacts.
baby formula for babies held at the border is a legal requirement
IF YOUR TIME IS SHORT
A 1997 legal settlement requires border officials to provide adequate food and water, among other things, to children who have been detained. For infants, that can mean providing baby formula.
The Biden administration would be breaking the law if it did not have a supply of formula and other food for people detained in government facilities
- Dennis 05/15/2022
Yes, I am concerned the Politicians ordered the companys to stop production, Like they did with Oil.
- Guy 05/15/2022
These idiots knew back in October that there may be an issue. Another major issue that is only addressed when there is public outrage.
- Adel 05/15/2022
All I can think of is, who wants to kill the babies? Who is behind this strange thing that is happening now?
- DaveS 05/14/2022
First of all, where is the competition in industries? You got monopolies that only make one product you need for your child! You got corporate greed making record profit at the expense of the American people. The oil and gas industry, the food distribution industry plus others are the ones organizing and driving the prices up on all products, plus the basic cost has stayed the same or gone down!
- Jean 05/14/2022
Am I concerned about the baby formula shortage? Indeed, for what it says about rampant corporate consolidation -- and the many many years of federal government failure to take and enforce anti-trust measures.
- Bret 05/14/2022
Personally not concerned, but generically. . . I'm 60 years old, the oldest of 3 kids and none of us was ever given formula. We nursed and moved over to cow’s milk and cereal and we all turned out healthy. How did humans ever survive without formula? This is pointing out a bigger problem.