Wednesday, Sep 21, 2022

Baby Formula Crisis Roils the Nation

 

As countless infants across the country face the risk of malnourishment as a result of the baby formula shortage crisis, millions of outraged parents are demanding answers from the Biden Administration.

Explanations about “supply-chain glitches,” “inflation” and the sweeping recall of baby formula by manufacturing giant Abbot Nutrition, have failed to pacify Americans who are being forced to put their babies to sleep hungry.

The crisis has united people in fury over the harm being done to the most helpless, vulnerable segment of the population.

About 75 percent of the country’s babies rely on store-bought formula, a NY Post article reported.  Parents of these infants have been driving desperately from town to town, city to city and even out of state in search of formula.

“The problem has been brewing for months,” Rep. Michael Waltz, R-Fla. affirmed in a televised appearance. “It touches me personally—I have a four month old son. Since the day he was born, finding formula for him has been a struggle. Family members, relatives and friends have been scouring stores to help us.’

“America is not a Third World country,” Rep. Waltz said. “That this is happening is shameful and rests squarely on the shoulders of the Biden Administration.”

Baby Formula Linked to Infants Falling Ill, Dying

The product recalls that heightened the formula shortage resulted from FDA plant inspections in 2019 and 2021, as well as information concerning several babies hospitalized in Minnesota, Ohio and Texas with bacterial infections.

These illnesses were linked by the CDC and FDA to the consumption of powdered infant formula produced by Abbott, one of the nation’s largest manufacturers of baby formula, including Similac and specialty metabolic formulas EleCare and Alementum. Two of the sick infants died.

As it turned out, “the FDA and CDC were well aware of dangerous contamination in the Abbott plant many months earlier,” reported the New York Post. “From Sept. 2021 to February 2022, the CDC received reports of “cronobacter bacteria” cases in several infants” in the aforementioned states.

Cronobacter infection, although rare, can cause severe, life-threatening infections or meningitis. They can be deadly in newborns in the first days or weeks of life, according to the Post article.

There were warning signs about Abbott’s products prior to these outbreaks.  After an inspection in 2019, the FDA cited Abbott for failing to test an adequate amount of formula to assure that it met “the required microbiological quality standards.”

Then, in September 2021, the FDA returned to Abbott and found that the company failed to “maintain a building used in the manufacture of infant formula in a clean and sanitary condition.”

Around this time, “the FDA was warned by a whistleblower at the plant that Abbott was falsifying records, releasing untested formula into the market, and failing to adequately clean and disinfect the plant,” the NY Post article details.

The production of baby formula requires the most exacting sanitary standards; infants’ lives depend on this level of vigilance. Yet the FDA was allegedly slow to respond to the whistleblowers’ allegations. An investigation was eventually opened, took several months to complete and ultimately substantiated the whistleblower’s claims, according to FDA documents.

In its March 2022 recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant,” the Post article reported, although not in the powdered formula itself. “A review of the firm’s internal records also confirms the company’s destruction of product due to the presence of [this bacteria].”

The company says it halted production of its own volition. Other sources say it was ordered to do so by the FDA.  Abbott also claims that genetic sequencing of the cronobacter bacteria did not match that of the diseases found in the infants, a position disputed by the FDA.

In any case, the impact of the recall was felt immediately across the nation.

The abrupt shuttering of the country’s largest baby formula manufacturer left store shelves bare, families struggling to find safe alternatives for their infants, and the FDA and the Biden Administration scrambling for excuses for their months of inaction.

FDA Slammed For Dragging Its Feet

House Appropriations Chair Rosa DeLauro, D-Ct., told Politico that the delay in halting production at the Abbot facility was inexcusable; the recall should have happened immediately before other babies were endangered.

She also slammed the FDA for “dragging its feet” after their investigation of Abbott’s Michigan facility. DeLauro cited the whistleblower’s report she herself had made public in October, and pledged to scrutinize the entire issue in upcoming hearings.

“Parents are desperate. I want to hold the bad actors whomever they are accountable,” DeLauro said.

The congresswoman has scheduled a public hearing for the upcoming week with FDA Commissioner Robert Califf, and has invited the head of Abbott to come and testify “about what they did do and what they did not do.”

‘I’m looking at a company that has put profit over people, and it’s plain wrong. The company was aware of the failure and they attempted to hide that information from the FDA, and the FDA just dragged their feet in making this public,’ she fumed, according to The Center Square.

Others have torn into the FDA and the Biden administration for not having worked out a strategy for generating adequate baby formula supplies to replace those that were recalled.

Congresswomen Elise Stefanik and Ashley Hinson of Iowa, both Republicans, sent a sharply worded letter to the FDA Commissioner, calling on the agency to provide a clear timeline for when baby formula inventory is expected to be sufficiently restocked.

They also demanded a long-term plan to minimize supply chain disruptions for baby formula.

“As moms ourselves, we know the stress this is causing in so many households,” the Congresswomen wrote. “The infant formula shortage is yet another example of how this administration’s supply chain crisis is harming working families. This crisis has now come home to America’s kitchen tables, as families do not know how to feed their children.”

“Bare-Shelves-Biden’s failed policies have created a panic for families by failing to address a baby formula shortage,” Stefanik said. “Hardworking parents are already paying the price for Biden’s inflation and supply chain crises. They can’t wait weeks for formula.”

“As a new mother,” Stefanik wrote, “I sounded the alarm on this earlier. After the Biden Administration did absolutely nothing to address this crisis, I’m continuing to bring the concerns of parents to the highest levels by demanding answers from Biden’s FDA to address this crisis.”

“Working families are already worried about how much their groceries are going to cost because of inflation, and now, parents have the added stress of not knowing if the baby formula they need will even be in stock,” Congresswoman Hinson wrote. “The Biden Administration must prioritize fixing supply chain disruptions and getting baby formula back on the shelves.”

Damage Control

With the formula shortage generating a firestorm across the country, the White House and the FDA began an urgent effort at damage control.

“I’ll answer the baby formula question because all of a sudden it’s on the front page of every newspaper,” a rattled President Biden told news correspondents early this week. “This is a process we are working on very, very hard. There is nothing more urgent on our plate right now.”

The White House announced steps to ease the shortage, including reopening Abbot Nutrition, the largest domestic manufacturing plant, and increasing imports from overseas.

The Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the United States, reported the Miami Herald.

FDA commissioner Robert Califf said the U.S. will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are compatible with U.S. nutrition standards. The policy is being presented as a temporary measure lasting six months.

The imports announcement came shortly after FDA officials said they’d reached a deal to allow Abbott Nutrition to restart its Michigan-based plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production. In addition, Abbott must regularly consult with an outside safety expert to maintain production.

After getting the FDA’s approval this week, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company has not set a timeline to restart manufacturing.

“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage,” Abbott CEO Robert B. Ford said in a statement after the agreement with the FDA was reached.

Getting imports into the U.S. supply chain will also take several weeks, according to administration officials. Products from Australia, New Zealand and Great Britain are expected to meet the standards needed for importation.

“Pediatricians say baby formulas produced in Canada, Europe and Israel are roughly equivalent to those in the U.S. But 98 percent of the infant formula supply in the United States has traditionally been produced by less than a handful of domestic companies—Abbott Laboratories, Reckitt Benckiser Group PLC and Nestlé Gerber business. These companies control a $4 billion market.

Overseas companies seeking to enter the United States face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA, in addition to high regulatory taxes and demanding safety rules that include labeling guidelines, reported the Miami Herald.

“These longstanding rules have vastly reduced imported baby formula, exacerbated the current crisis, and are central to officials’ efforts to ease the shortage,” the article said.

Once the import restrictions are loosened, we believe these and other ongoing efforts will help dramatically improve the supply in the United States in a matter of weeks,” the FDA’s Califf said.

But critics say the loosening of import restrictions should have happened months ago, and the timeline announced by Califf— “a matter of weeks”—is highly unrealistic. According to Senator Marsha Blackburn, R-Tenn., the American people are fed up.

“Whether in Ukraine or Afghanistan, whether it is inflation, the tax hikes, the open border, the out-of-control spending, this baby formula issue, the American people have had enough,” she declared on American Reports.

“For this to become a crisis situation, when they could have launched an “Operation Warp Speed” for baby formula if they truly cared–it is unacceptable. Americans have had it with this administration.”

‘The Recall Was in February–Why Has It Taken So Long?’

Some Democrats have tried to defend the Biden Administration’s handling of the crisis, insisting the president had been working on the problem “from day one.”

In a CBS Face The Nation installment, host Margaret Brennan pressed Transportation Secretary Pete Buttigieg, a Democrat and former presidential nominee, about why it has taken the Biden administration “so long” to respond to the baby formula shortage.

“I know the president said more action is coming, but this has been ongoing for months,” Brennan said. “Supply chain issues already and then this one plant, Abbott [shut down]. Whistleblower in September…then the recall in February. But now it’s May! Why has it taken so long? And why did the president seem to say it was new information to him?”

Brennan quoted Biden’s comments last week when he responded to media questions about the shortage. The president said that had the administration been “better mind readers,” they could have acted on the problem earlier, implying the shortage had taken him by surprise.

Buttigieg challenged that statement, insisting the Biden administration had acted from “day one,” by having the Abbot plant shut down.

“We are here because a company was not able to guarantee that its plant was safe. And that plant has to shut down,” he said. Brennan questioned the Transportation Secretary further, saying that it was “the federal government’s job as regulators to help ensure that such a crisis does not happen.”

Buttigieg’s response was that America was a “capitalist country” and that “the government does not make baby formula, nor should it. Companies make formula.” That facile answer ignored the most basic responsibility of government to prioritize the sustaining of human life, especially of babies and children, its most vulnerable population.

*****

‘Contaminated Baby Food’ Lawsuits Filed Against Manufacturers

The baby formula shortage is far from the only issue surrounding the baby food industry in recent times. In 2021, dozens of contaminated baby food lawsuits were filed against manufacturers after toxic heavy metals were found in their products, reports Legal Examiner.

Also, in the last year, there have been several lawsuits by parents whose premature babies contracted necrotizing enterocolitis (NEC), a serious and often fatal disease, after consuming cow’s milk-based formula. NEC can affect the intestines of premature infants after being fed this type of formula.

The lawsuits have been filed against two manufacturers; Abbott Laboratories, the makers of Similac, and Mead Nutrition.

The plaintiffs in the NEC baby formula lawsuits allege the manufacturers hid the risks of NEC and sold their products as safe infant-feeding options.

Amid concerns over safety and the shortage of baby formulas, Americans are also distraught over the hike in baby formula prices, despite the lack of availability. According to one report by CBS News, parents have seen the average cost of baby formula increase 18 percent over the last 12 months.

*****

A Tractor Trailer Full of Baby Formula

“Back in November, the Biden administration closed down Abbott without a plan to make up the 43 percent market share of baby formula which that manufacturer provided. They should have had a strategy in place to counter the coming shortages,” Rep. Kat Commack, R-Fla., said in a Fox News appearance.

“So, again, typical Biden administration – no plan, no contingency planning. Yet just today, I’m getting word from Border Patrol agents that there is a tractor trailer full of pallets of baby formula sitting in that warehouse [for babies of illegal migrants].

Commack’s remarks pointed to a third reason for the formula shortages across the United States.

The Biden administration’s botched border policies are pitting U.S. babies against migrant infants in detention during the nationwide formula shortage, a top immigration expert, Andrew Arthur of the Center for Immigration Studies, told the NY Post.

Arthur said the failure to stop the flow of immigrants across the border is contributing to the baby formula crisis. And it’s expected to worsen when the Biden administration lifts Title 42, a regulation implemented during the Trump administration that directs border agents to turn migrants away at the U.S. border, to stem the spread of Covid-19.

“The Biden administration’s failure to adopt policies to deter illegal migrants is the reason for both the surge in drugs, and the fact that DHS is having to buy formula while the supply of it dwindles in the United States,” Arthur explained.

“DHS is having to store up massive quantities of baby formula to provide for the infants who with their parents are currently in custody. On top of this, Border Control is anticipating a massive wave of new illegal migrants who will surge to the border once [Title 42] expires,” the immigration expert said.

That is expected to happen at the end of May, although numerous congressional and court actions have been taken to extend Title 42, without a clear outcome as of yet.

Border Patrol Agent: ‘You Will Not Believe This!’

Rep. Kat Cammack released photos showing pallets of baby food believed to be at a migrant processing center. Describing them, she said, “The first photo is from this morning at the Ursula Processing Center at the U.S. border. Shelves and pallets packed with baby formula. The second is from a store right here at home where shelves are half-empty and formula is scarce.”

“This got sent to me by a Border Patrol agent this morning who said, ‘You will not believe this. They’re receiving pallets of baby formula at the border.’”

“This man,” continued Cammack, “has been a border patrol agent for 30 years and he has never seen anything quite like this. He’s a grandfather and he’s saying that his own kids can’t get baby formula.” She urged Americans to pressure the administration to extend Title 42 given the influx of migrants who are expected to end up in custody when it expires.

“Call your Democratic members of Congress and tell them that you want them to put pressure on the administration to keep Title 42 in place, to take the baby formula that they have basically siphoned out of the supply chain and put it back in the stores for American kids,” she urged on social media.

Cammack added that she had been to the border three times, had held in her arms children of illegal immigrants, and has seen firsthand how these children are often exploited by “coyotes.” These are gangsters who take exorbitant payment to lead immigrants across the border, often abusing them in the process.

Meanwhile, Republican Indiana Rep. Jim Banks sent a letter to DHS Secretary Alejandro Mayorkas and DHS Secretary Xavier Becerra demanding to know how much formula the government had purchased for migrants in recent months.

“It doesn’t matter where they are from or what citizenship they hold, no child deserves to suffer from lack of food. America is the greatest, most compassionate, most generous country on earth,” Banks said. “When the violent cartel coyotes, encouraged by the Biden administration, smuggle babies across our open border, we will not let them go hungry.

“However, the American people struggling to feed their children deserve to know,” he said, “how much baby formula has been purchased by the Biden administration in response to the worst border crisis in history – a catastrophe of the Democrats’ own making.”

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