FDA refuses to say when America's largest formula plant will reopen

[Auburnfan91 1,407]

Why is biggest baby formula plant in US STILL shut down after three months? Abbott says plant is safe and was not responsible for bacteria that killed two kids - but FDA refuses to reopen it as parents across US struggle to feed their babies

By Natasha Anderson For Dailymail.Com

Published: 13:54 EDT, 10 May 2022 | Updated: 17:07 EDT, 10 May 2022

 

The biggest baby formula supplier in the U.S. has denied its Michigan plant is responsible for the deaths of two children despite the FDA closing it down.

The plant was shutdown nearly three months ago after a bacterial infection caused the deaths and other serious illnesses.  

In mid-February Abbott Laboratories issued a nationwide baby formula recall and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products.

An Abbott spokesperson told DailyMail.com Tuesday that 'thorough investigation' by the U.S. Food and Drug Administration (FDA) and Abbott revealed 'infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility'.

However, despite the findings of the investigation, the plant remains shuttered nearly three months later, fueling the nationwide baby formula shortage.

The FDA - which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis - has refused to say when the plant can resume operations.

Abbott claims they are 'working closely with the FDA to restart operations' at the plant, with the spokesperson noting: 'We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall'.

The FDA told DailyMail.com it was holding discussions with 'Abbott and other manufacturers to increase production of different specialty and metabolic products' but refused to say when the Sturgis plant could reopen.

The formula shortage, which has become a national crisis, was triggered by supply chain issues, but spiked with the closure of the Abbott plant.

Abbott alleges that none of the formula distributed to consumers tested positive for Cronobacter or Salmonella.

The manufacturer claims the FDA and Abbott officials both tested retained products for the bacterias and yielded negative results.

Abbott notes no trace of Salmonella was found at the Sturgis plant and the Cronobacter that was found in environmental testing during the investigation was in non-product contact areas of the facility.

The company alleged the traces of Cronobacter at their plant have 'not been linked to the two available patient samples or any other known infant illness.'

February's recall, which is isolated to powder formulas, including Similac, Alimentum and EleCare, manufactured only at the Sturgis plant has significantly disrupted the supply chain.

The nationwide share of out-of-stock baby formula hit 40 percent in April. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.

As shelves across the country meant to carry baby formula remain largely barren, retailers including Target, CVS and Walgreens are limiting the amount of formula consumers can purchase.

Concerned parents, especially those whose children have unique medical and dietary needs, have expressed feelings of hopelessness and are calling on the government to take action to 'ensure critical, life-sustaining supply chains don’t break down.'

However, an Abbott spokesperson alleged the recall 'does not include any metabolic deficiency nutrition formulas, Abbott’s liquid formulas or other Abbott nutrition powders or brands.'

The company is reportedly 'doing everything it can to address the infant formula supply shortage across the U.S.' This includes 'prioritizing production of infant formula products to help replenish the supply in the market' and shipping products in from overseas.

Last month, the FDA announced it had 'no objection' to Abbott releasing limited quantities of nutrition products 'to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas'. 

The manufacturer, which was permitted to supply consumers with the speciality formulas on a 'case-by-case basis,' claims no formula being distributed has tested positive for bacteria. 

Abbott phone representatives have also been telling parents the FDA is 'holding back' metabolic formula made during the recall period, which is why the current supply hasn't gone out, Politico reported.

The FDA, disputing the company's allegations, issued a statement to the newspaper on Saturday reading: 'The FDA has not delayed the release of any specialty and metabolic infant formula products and the agency strongly disagrees with this characterization of events. 

'The agency has been working with Abbott since the Feb. 17 recall on ways to resume production. These are complex discussions, but from the beginning the agency has been committed to making these infant formula products, including specialty and metabolic products, available again as quickly as possible.' 

Despite the Abbott's efforts, Americans are still struggling to feed their children.

The Similac maker is the leading supplier of milk formula in the U.S. with a market share of about 42 percent in 2021, followed by British consumer goods firm Reckitt Benckiser with a nearly 38 percent share, according to Euromonitor data.

About 40 percent of baby formula products were out of stock across the the nation last month. 

While all parents are feeling the impacts of the disruptive supply chain, those whose children have special medical needs say they are worried about sustaining their kid's nutrition.

'If this doesn’t get fixed soon, I don’t know how my son will survive,' Phoebe Carter, whose five-year-old son has a rare digestive and immune system disease and relies on formula for all of his nutrition, told Politico. 'I just can’t stress that enough.'

Carter is rallying concerned parents and caregivers in an effort to put pressure on Congressional leadership to address the shortage by facilitating formula production at other plants.

The outraged mother, who has created a website to organize caretakers, slammed national leadership, claiming they would take action if America's upper echelon were being directly impacted by the formula shortage.

'If, God forbid, a family member of President Joe Biden or Jeff Bezos or someone influential had one of these diseases, this crisis wouldn’t have made it to Day Two,' she argued. 'Because no one understands this issue and knows it’s happening, there’s no hope for us — that’s how it feels.'

Due to his condition, an allergic exposure causes Carter's son debilitating pain that can last anywhere from a few days to weeks. 

He was placed on an amino acid formula, which provides 100 percent of his nutrition, after all other treatments failed. 

Carter said the formula, which breaks proteins down to their most basic form, put his disease into remission within two months.

Unfortunately, Abbott's Sturgis plant is responsible for the manufacturing of 75 percent of all amino acid formulas in the U.S. Although her son's formula, prescription brand Neocate, is produced by Nutricia, she is unable to get the product for her child. 

Carter claims the recall and shutdown has forced an increase demand of other brands and there 'just isn’t enough overall supply to keep up.'

Neocate, issuing a statement on its website, confirmed the company's supply is very strained, alleging the Abbott recall and the search for replacement formulas has 'created unprecedented demand for amino acid-based formula products.'

'While we are taking urgent measures to get more products into the market, current product availability is low and, in some cases, you will see that our products are out of stock,' the statement said. 

Experts allege the shortage is greatly impacting patients with metabolic, gastrointestinal and allergic disorders. 

The most common metabolic disorder, Phenylketonuria, approximately affects 17,000 people nationwide. 

Another disorder, MSUD, is estimated to impact 2,000 Americans and is 'so severe' that amino acid formula is the 'only means of survival' for those with the condition. 

'Children, babies and adults throughout the world are suffering because of this,' Columbia University faculty member and dietician Karen Reznik Dolins argued. 

'I’ve never seen anything like this ever in my career,” echoed dietitian Leah McGrath. 'If babies are not getting what they’re supposed to be getting, or they’re getting less than, or there’s just the trauma of switching back and forth to different formulas, this has really long term implications in terms of their health and their growth and development, as the first 1,000 days of life are known to be the most crucial.' 

A coalition of metabolic patient organizations recently probed its communities about the impacts of the formula shortage and claims it received more than 50 alarming messages.

'Please help us. We are in a place of desperation,' one parent reportedly wrote. 'I cannot begin to explain the stress that accompanies the fear of running out of a product that is essential for the brain health of my children.

'I have been in a panic over this shortage.'

Abbott, in response to the crisis, told Politico it opened a special phone line last Friday to 'field requests from patients for the metabolic nutrition formulas.'

'We’ve also been engaging with doctor groups and health care professionals. We’ve received dozens of inquiries and are coordinating with metabolic centers and healthcare professionals to fulfill requests based on need and on a case-by-case basis,' a spokesperson said.

'We understand that every patient who relies on these important products has critical needs and we are working diligently to provide product as needed.'

Brian Dittmeier, Senior Director of Public Policy at the National Women, Infants, and Children (WIC) Association told DailyMail.com in a statement Tuesday that the 'unprecedented scope of this infant formula recall has serious consequences for babies and new parents.'

'Assurances from manufacturers that production has ramped up have not yet translated to new product on the shelf. Each day that this crisis continues, parents grow more anxious and desperate to find what they need to feed their infants,' the statement said.

'Unlike other food recalls, shortages in the infant formula supply affects a major – or even exclusive – source of nutrition for babies. Inadequate nutrition could have long-term health implications for babies. Supply shortages are particularly acute for infants who require specialty formulas to address allergies, gastrointestinal issues, or metabolic disorders; adequate substitutes with other brands may not be easily identifiable.

'Every day, we hear from parents who are hurt, angry, anxious, and scared. The lives of their infants are on the line. It is time for answers and accountability as we all work to improve the supply and ease the worries of parents enduring this national crisis.'

The FDA told DailyMail.com its priority was to ensure recalled products remained off shelves while they worked with manufacturers to find alternative baby formulas.

'Following the Feb. 17 FDA warning, Abbott’s voluntary recall and decision to voluntarily cease production to address significant issues that could impact the quality of the product, the FDA has been working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands,' a spokesperson said.

The authority, in a recent budget document, asked Congress to give the agency new authorities to prevent a critical shortage from occurring in the future. 

'No law requires manufacturers of infant formulas or essential medical foods to notify FDA when they become aware of a circumstance that could lead to a shortage of these products,' the agency penned, noting it would like to see new protocols requiring companies to notify the FDA of anticipated supply chain interruptions.  

White House press secretary Jen Psaki said Monday the Biden administration is working with manufacturers to ensure baby formula makes it back on empty shelves as frantic parents work to ensure their children are fed.

'Ensuring the availability of these products' is a 'priority' for the FDA, Psaki said at her daily press briefing, noting 'they're working around the clock to address any possible shortage.'

It is unclear if the administration's response will include need requirements for manufacturers, as the FDA requested. 

 

https://www.dailymail.co.uk/news/article-10801581/FDA-refuses-say-baby-formula-plant-reopen-despite-companys-claims-facility-safe.html

 

This has been brewing for months. The fact that the government had no plan B in place and have just allowed the shortages to get worse tells you all you need to know.

Edited May 14, 2022 by Auburnfan91

[icanthearyou 4,462]

The governments role in the economy should be more reflective of social concerns than concerns for private profit.

[Auburnfan91 1,407]

The government should invoke the defense production act to produce more formula and help with the shortages if they're not going to reopen the formula plant soon.

[TexasTiger 12,811]

“But the F.D.A. said it had initiated an on-site inspection of the plant in which environmental samples tested positive for Cronobacter. Inspectors have also uncovered potential manufacturing problems, and a review of internal records revealed the company’s past destruction of product because of bacterial contamination, the agency said.”

https://www.nytimes.com/2022/02/18/us/baby-formula-recall.html

[autigeremt 6,569]

Why would Democrats care about living babies outside the womb no more than those inside the womb?

 

.... I couldn't help myself. 

[icanthearyou 4,462]

1 hour ago, autigeremt said:

Why would Democrats care about living babies outside the womb no more than those inside the womb?

 

.... I couldn't help myself. 

I have always wanted to take you seriously but, you will not allow it.

[autigeremt 6,569]

1 hour ago, icanthearyou said:

I have always wanted to take you seriously but, you will not allow it.

🤦🏼‍♂️ 

[TexasTiger 12,811]

https://jabberwocking.com/it-sure-looks-like-abbott-is-the-bad-guy-in-the-abbott-infant-formula-scandal/

[jj3jordan 2,040]

18 hours ago, icanthearyou said:

I have always wanted to take you seriously but, you will not allow it.

Why the non answer?

[TitanTiger 20,471]

Abbott agrees to consent decree with FDA, could restart plant within 2 weeks, pending court approval

(CNN) The baby formula manufacturer at the heart of a nationwide formula recall said Monday that it has reached an agreement with the US Food and Drug Administration to enter into a consent decree, a legally binding agreement that would require the company to take certain steps in response to violations found at its Sturgis, Michigan, facility. 

If a court approves the agreement, the company says, it could restart the site within two weeks. It would first resume the production of its specialty metabolic formulas EleCare and Alimentum, followed by Similac and other formulas.

After Abbott restarts the site, it will take six to eight weeks for the products to reach store shelves, it said...

https://www.cnn.com/2022/05/16/health/abbott-formula-shortage/index.html

[DKW 86 7,411]

How many deaths and illnesses were linked to that plant?

I have heard only two, but I TRULY HAVE NOT PAID ATTENTION. My family all breastfeed and really could not careless.

 

[Cardin Drake 1,809]

They didn't find any formula that was contaminated.  There were no illness linked to the plant.  The inspection found other issues that the government says Abbott needs to correct.

[Cardin Drake 1,809]

Biden today:

I’m taking two new steps to increase baby formula supply: - Invoking the Defense Production Act to increase domestic production - Launching Operation Fly Formula to use federal planes to fly formula in from abroad We're making sure safe formula gets to all who need it.

There, that wasn't so hard, was it?  Better late than never.  BTW, most people in the 40's and 50's grew up just fine on do it yourself formula. Evaporated milk and a little karo syrup, lol.

[DKW 86 7,411]

Some of us had it used on us in the 60s

[TitanTiger 20,471]

17 hours ago, Cardin Drake said:

BTW, most people in the 40's and 50's grew up just fine on do it yourself formula. Evaporated milk and a little karo syrup, lol.

We know more now.  It doesn't have anything close to the nutrients an infant needs - that they would typically get from breast milk.  Sure, evaporated milk and corn syrup is better than your baby starving, but it's far from a solution.

https://www.truthorfiction.com/a-homemade-baby-formula-recipe-from-1960-is-viral-and-dangerous/

[homersapien 11,354]

On 5/18/2022 at 10:46 PM, Cardin Drake said:

Biden today:

I’m taking two new steps to increase baby formula supply: - Invoking the Defense Production Act to increase domestic production - Launching Operation Fly Formula to use federal planes to fly formula in from abroad We're making sure safe formula gets to all who need it.

There, that wasn't so hard, was it?  Better late than never.  BTW, most people in the 40's and 50's grew up just fine on do it yourself formula. Evaporated milk and a little karo syrup, lol.

Yeah, we also grew up without seat belts. 

Edited May 20, 2022 by homersapien

[icanthearyou 4,462]

This is not a governmental failure, certainly not the failure of a political party.

This is a failure of allowing capitalism to be undermined by the capitalists.  This is economic power using political power to the detriment of society.

If you want capitalism to work well, the capitalists must be regulated by government. 

[Cardin Drake 1,809]

We quit being capitalists a long time ago.  In a capitalistic country, governments and corporations aren't allowed to borrow money at 3% when the inflation rate is 8% (really more like 10% if it was being measured honestly).  I'm not sure exactly when the left went from hating the government to being their biggest cheerleader, but anybody can see the FDA mishandled this and bears a large portion of the blame.

Edited May 21, 2022 by Cardin Drake

[icanthearyou 4,462]

The problem is not how the FDA handled the whistleblower complaint.  The problem is how the manufactures used the FDA to keep imports out of the market.  The market should never been allowed to consolidate to only 3 suppliers.  The real problem is not incidental, it is structural.

There is no government good, government bad argument.  There are two types of regulations.  Regulations that protect society.  Regulations that restrict competition.

The basic problem lies in allowing trade associations, allowing those associations to fund massive lobbying efforts, the lobbyist being allowed to write regulations for the benefit of the major industry players.

 

Edited May 21, 2022 by icanthearyou

[Cardin Drake 1,809]

1 hour ago, icanthearyou said:

 The problem is how the manufactures used the FDA to keep imports out of the market.  The market should never been allowed to consolidate to only 3 suppliers.

 

I couldn't agree more on that part of your post. That's not capitalism either.

[icanthearyou 4,462]

22 minutes ago, Cardin Drake said:

I couldn't agree more on that part of your post. That's not capitalism either.

I hope you can see the structural problem in the rest of the comment.  That is the crucial element in perverting capitalism by way of collusion and corruption.  Money in politics, big corporate money, is nothing but government for sale.  That is inherent corruption.  It is bipartisan but, it is not necessarily equal.

Any form of government can be successful if,,,  the interest of capital and society are balanced.  When either dominates the other there will be suffering.  Total inequity is self-defeating.  You cannot have production without consumption or, consumption without production.

Balance is the answer.  We need to stop thinking simply about economic growth and, concentrate more on the breadth of that growth.  One of the real promises of capitalism is shared prosperity.  We are drifting away from that ideal and, that drift is accelerating.  Money in politics is why.

Relative equality is (maybe was is better) an American ideal.  More importantly, it is (maybe, should be again) a Christian ideal.

Balance is the answer, not corruption and greed.

We need to reform.  AI, automation, the environment will demand it.  We are going to go through a period of unparalleled devaluation of human labor.  The attempts to consolidate power and/or maintain the status quo, will likely make that transition excruciating for our children.

The devaluation of human labor does not have to mean the decline of human existence.

 

Edited May 21, 2022 by icanthearyou

[Cardin Drake 1,809]

I pretty much agree with all of that.  Corruption is out of control.  Wall Street is running the country for their own benefit, and it doesn't matter which branch of the uni-party is in control, because both parties are in bed with the billionaires.  In capitalism, interest rates are controlled by the market, not the government. It starts there, and it ends with bureaucrats collecting "royalties" from the very companies they are in charge of regulating.  And us not even knowing how much they are getting paid and who is paying it.

Edited May 21, 2022 by Cardin Drake

[icanthearyou 4,462]

1 hour ago, Cardin Drake said:

I pretty much agree with all of that.  Corruption is out of control.  Wall Street is running the country for their own benefit, and it doesn't matter which branch of the uni-party is in control, because both parties are in bed with the billionaires.  In capitalism, interest rates are controlled by the market, not the government. It starts there, and it ends with bureaucrats collecting "royalties" from the very companies they are in charge of regulating.  And us not even knowing how much they are getting paid and who is paying it.

Agreed.  I wonder if the credit based ponzi scheme we currently call an economy is what we are really protecting.  Humanity be damned.

[Cardin Drake 1,809]

 I know we don't agree with much politically. But sometimes I wonder if the fact that the powers that be can rely on that is just part of the big plan. We can argue endlessly about whether the democrats or the republicans or the government or capitalism is more at fault for this.  But meanwhile, the big picture is that government and big business have colluded once again to keep all foreign competition out and let 3 large manufacturers have the domestic market to themselves, all to the detriment of the consumer.

We can now return to the regularly scheduled squabbling. 

[icanthearyou 4,462]

22 minutes ago, Cardin Drake said:

 I know we don't agree with much politically. But sometimes I wonder if the fact that the powers that be can rely on that is just part of the big plan. We can argue endlessly about whether the democrats or the republicans or the government or capitalism is more at fault for this.  But meanwhile, the big picture is that government and big business have colluded once again to keep all foreign competition out and let 3 large manufacturers have the domestic market to themselves, all to the detriment of the consumer.

We can now return to the regularly scheduled squabbling. 

Yes but, the partisan squabbling, the social hysteria is the distraction that keeps us from doing anything about what we agree upon.

They got us right where they want us.  Why wouldn't they though.  They own it all, government, parties, media, banks, exchanges, means of production.

I still contend, the real goal is creating inane divisions which keep conversations like the one we are having to a minimum.