More Than 150,000 Pounds of Baby Formula Delivered to Houston

More than 150,000 pounds of baby formula was delivered to Houston, Texas, via Germany by plane Sunday as part of President Joe Biden’s “Operation Fly Formula” to address a nationwide baby formula shortage, KHOU-TV reported.

The amount is enough to provide for 1.5 million bottles.

The shipment will be distributed to Target, Walmart, Kroger, and other retailers across the United States via a Nestle distribution center in Fort Worth, Texas.

The shortage stems from the closure of an Abbott Nutritional formula plant in Sturgis, Michigan, in April after the Food and Drug Administration issued a warning to consumers not to use certain powdered infant formula produced there.

The Department of Justice alleged that formula manufactured at the plant was “adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.”

The FDA in January inspected the facility and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies.

Biden in May directed his administration to use Defense Department aircraft to pick up formula from overseas that meets U.S. health and safety standards.

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Flooding Shuts Crucial Baby Formula Plant Days After Reopening

Abbott Laboratories said late Wednesday it has stopped production of its EleCare specialty formula after severe storms and heavy rains in southwestern Michigan flooded areas of its plant in Sturgis.

The company, which has notified the U.S. Food and Drug Administration (FDA), said the incident will likely delay production and distribution of the infant formula for a few weeks.

The temporary closure of the plant comes a week after Abbott reopened its Sturgis plant to alleviate an acute nationwide shortage of baby formula that sent parents scrambling for supplies.

The plant shutdown and Abbott’s recall of infant formula products in February deepened the supply shortage in the United States, with global companies like Neocate maker Danone SA bringing baby formula products into the U.S.

The company began a recall after reports of bacterial infections in children who had consumed the formula made at the plant.

But Abbott, the biggest U.S. supplier of powder infant formula, including Similac, said it has enough existing supply of the baby formula until new products are available.

“Abbott has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available,” it said in a statement.

In a series of tweets on Wednesday night, FDA Commissioner Robert Califf said Abbott and other producers continue to make formula at “higher-than-average rates.”

“This means that the total amount of formula available, even before the Sturgis plant is back in production, exceeds the demand for formula prior to the recall,” Califf tweeted.

Abbott said it will resume production of EleCare once the plant is re-sanitized and added that it will work to restart production of Similac “as soon as possible.”

FDA’s Califf said once Abbott establishes a plan, the agency will be back in the facility to ensure the company can restart quickly. 

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U.S. Receives 190,000 Pounds of Baby Formula From Australia

The United States on Sunday received 190,000 pounds, or “95,000 tins,” of baby formula from Australia, offering some reprieve to families who have been struggling to feed their infants over recent weeks.

According to ABC News, a deal was struck between Bubs Australia and American grocers Kroger Co. and Albertsons Companies to make the import under the direction of Operation Fly Formula.

“We extend our thanks to our retail partners, who will (endeavor) that our products quickly get to retail shelves in the States and stores in most need with the highest stock-out rates,” said Bubs CEO Kristy Carr.

Sunday’s shipment of formula touched down in Los Angeles. It is one of two entering the United States this week from Bubs. The second will arrive Thursday in Columbus, Ohio.

The two shipments combined will bring approximately 4 million 8-ounce bottles, or 380,000 pounds, of baby formula to Albertsons’ and Kroger’s shelves beginning June 20.

“There’s nothing more stressful than the feeling you can’t get what your child needs,” President Joe Biden stated at a virtual meeting with his administration and formula manufacturers on June 1. He added that his administration would use “every tool available” to refill shelves quickly.

Last month, Biden invoked the Defense Production Act, a wartime bill used by the executive branch, to manage the shortage so suppliers could get the necessary formula ingredients to manufacturers.

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Report: Abbott Labs, FDA Knew of Complaint 1 Year Before Baby Formula Shortage

A whistleblower-based report alleges that Abbott Laboratories and federal regulators were warned of potential issues at a Sturgis, Michigan, food manufacturing plant in early 2021 — roughly a full year before a contamination incident forced a plant shutdown and eventually contributed to the nation’s baby formula shortage.

According to The Wall Street Journal, a former Abbott employee filed an OSHA whistleblower complaint in February 2021 with the Department of Labor, and cited a number of operational concerns about what apparently took place at the Michigan plant.

Also in February 2021, the Labor Department then shared the whistleblower complaint with Abbott and the Food and Drug Administration, asserting that the plant had failing equipment in need of repair and potentially released formula without adequate evidence that it was safe for consumption. 

FDA inspectors subsequently uncovered a host of violations at the Abbott Nutrition plant, including bacterial contamination, a leaky roof and lax safety protocols. 

A year later, the Sturgis plant closed after the FDA began investigating four bacterial infections among infants who allegedly consumed powdered formula from the plant. 

Two of the infected babies reportedly died

It’s worth noting, however, that no completed investigation has submitted any concrete evidence linking the infant deaths to formula produced in the Michigan plant; and Abbott maintains its innocence regarding whatever caused the infections, which apparently involved different bacterial strains. 

The FDA has undergone scrutiny for taking so long to close the plant last year, and then renegotiate its opening in 2022.

The rationale: If Abbott had been cleared of any wrongdoing with the four infant infections, then why weren’t plant managers allowed to resume making formula in due time?

Agency leaders recently told Congress they had to enter “a legally binding agreement with Abbott” to ensure that all the problems were fixed. 

An Abbott spokesperson recently told the Journal, “We investigated the federal OSHA complaint and have not been able to confirm the allegations.”

An FDA spokesperson also told the media outlet: “We know there have been various questions about the timeline of events leading up to the FDA’s warning and Abbott’s recall of products manufactured at their Sturgis facility.

“Our top priority right now is addressing the dire need for infant formula in the U.S. market, and our teams are working day and night to make that happen.”

The White House has taken heat for the baby formula shortage fallout, including President Joe Biden, who acknowledged last week that he wasn’t made aware of the national shortage until April — about two months after word spread of the Abbott plant shutdown.

“I became aware of this problem sometime in early April, about how intense it was. We did everything in our power from that point on,” Biden said in a White House roundtable discussion with formula manufacturers. “I don’t think anyone anticipated the impact of the shutdown of one facility.”

In the same meeting, however, a few speakers said they understood how the shutdown could have an immediate impact on formula availability.

“We were aware of the general impact that this would have,” said Robert Cleveland, a senior vice president at Reckitt, when responding to a question from Biden about whether the company was surprised the Abbott plant’s closing had “this profound effect immediately.”

“We knew, from the very beginning, this would be a very serious event,” Cleveland said.

Upon hearing about Abbott’s shutdown, Cleveland immediately contacted Reckitt’s retail partners, such as Target and Walmart.

Cleveland’s primary goal then: helping the retailers order all the available inventory on hand and push stock from distribution centers to stores. 

The Sturgis plant’s reopening is expected to improve supplies in the coming weeks.

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Biden’s Use of Defense Production Act Draws Republicans’ Scorn

President Joe Biden’s repeated use of the Defense Production Act, a decades-old law that grants the president broad authority to increase the manufacturing output of critical items in a national emergency, has drawn the scorn of Republicans.

According to The Hill, the DPA has been a tool used in the Trump administration since the start of the COVID-19 pandemic, but Biden has been using it for other issues not pressingly related to national security.

Recently, the Hill reports Biden used the DPA to boost the production of goods used in the manufacturing of solar panels. While environmentalists and climate activists hailed the move as a bold step in combating climate change, Republicans saw it as overstepping the law’s provisions.

Sen. Pat Toomey, R-Pa., criticized Biden, saying he abused a law originally designated for defense purposes. The law, first authorized in 1950 as a response to the Korean War, gave the president and executive branch the authority to order businesses to focus on the production of a needed good.

Jerry McGinn, executive director of the Center for Government Contracting at George Mason University’s School of Business, asked, “When you get out of a national security space or something like pandemic response, the more that people are going to say, ‘Is this appropriate?'”

“It’s not surprising,” he added. “Republicans are going to criticize a Democrat or vice versa. But the authority’s very clear, it’s got to be essential for national defense, and are solar panels essential for national defense? So that’s where we have the debate on this.”

But the White House has said invoking the DPA for solar panel production is an important first step toward the administration’s clean energy goals.

White House press secretary Karine Jean-Pierre told reporters on Monday that the “steps we’re taking today are in response to an urgent need of — to grow the domestic clean energy economy and strengthen U.S. energy security. They are part of the president’s multipronged approach to accelerating the transition to a cleaner, a clean energy future made right here in America.”

Biden has also invoked the DPA to speed up the production of baby formula amid a nationwide shortage. Earlier this year, Biden also used the DPA to boost production of electric vehicle batteries — a motive in alignment with his administration’s agenda to make electric cars account for half of all new vehicle sales by 2030.

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Abbott Reopens Michigan Plant Amid Nationwide Baby Formula Shortage

Abbott Laboratories said on Saturday that it has reopened its baby formula production plant in Sturgis, Michigan, taking a step toward alleviating an acute nationwide shortage that has sent parents scrambling for supplies.

The company said it will begin production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20.

The Food and Drug Administration (FDA) said on May 19 that the plant was on track to open within one or two weeks.

The facility will open after meeting initial requirements agreed to with the FDA as part of the agreement Abbott entered into on May 16, the company said.

The plant shutdown and a recall of infant formula had deepened a supply shortage in a nation where, according to federal data from 2020, less than half of babies were exclusively breast-fed through their first three months.

Roughly 73 percent of baby products are out of stock nationwide as of May 22, according to data firm Datasembly.

Empty shelves show a shortage of baby formula in San Antonio
Empty shelves show a shortage of baby formula at a Target store in San Antonio, Texas, on May 10, 2022. (Kaylee Greenlee Beal/Reuters)

Abbott started a recall in February after reports of bacterial infections in children who had consumed the formula made at the plant.

The FDA’s inspection of the Sturgis facility revealed “shocking” results such as cracks in vital equipment, a lack of adequate hand-washing and evidence of previous bacterial contamination.

Abbott has said there is no evidence to link its formulas to the illnesses, while the FDA’s inspection found bacteria in environmental testing and not in the product samples.

The FDA subsequently entered into a consent decree agreement that gave it oversight of Abbott’s actions to address problems at the plant.

Before the recall, Abbott controlled 40 percent of the infant formula market, including Similac, but the market share of other companies such as Reckitt Benckiser Group PLC has grown since then.

Even after the plant reopens, it may take weeks before formula supplies are back to normal, FDA Commissioner Robert Califf has said.

Global companies that make baby formula such as Neocate maker Danone SA are bringing products into the United States after the country’s health regulator relaxed its import policy.



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Abbott Restarts Baby Formula Plant Linked to Contamination

Abbott Nutrition has restarted production at the Michigan baby formula factory that has been closed for months due to contamination, the company said Saturday, taking a step toward easing a nationwide supply shortage expected to persist into the summer.

The February shutdown of the largest formula factory in the country led to the supply problems that have forced some parents to seek formula from food banks, friends and doctor’s offices.

Abbott said it initially will prioritize production of its EleCare specialty formulas for infants with severe food allergies and digestive problems who have few other options for nutrition. The company said it will take about three weeks before new formula from the plant begins showing up on store shelves.

“We will ramp production as quickly as we can while meeting all requirements,” Abbott said in a statement.

The plant’s reopening is one of several federal actions that are expected to improve supplies in the weeks ahead. President Joe Biden’s administration has eased import rules for foreign manufacturers, airlifted formula from Europe and invoked federal emergency rules to prioritize U.S. production.

Abbott closed the Sturgis, Michigan, factory in February after the Food and Drug Administration began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died. The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains.

FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols. The FDA has faced intense scrutiny for taking months to close the plant and then negotiate its reopening. Agency leaders recently told Congress they had to enter a legally binding agreement with Abbott to assure all the problems were fixed.

Abbott’s February recall of several leading brands, including Similac, squeezed supplies that had already been strained by supply chain disruptions and stockpiling during COVID-19 shutdowns.

The shortage has been most dire for children with allergies, digestive problems and metabolic disorders who rely on specialty formulas. The Abbott factory is the only source of many of those products, providing nutrition to about 5,000 U.S. babies, according to federal officials.

Abbott is one of just four companies that produce about 90% of U.S. formula. The company’s recalls and shutdown triggered a cascade of effects: Retailers have limited customer purchasing to conserve supplies and parents have been told to switch brands to whatever formula is in stock.

FDA Commissioner Robert Califf recently told lawmakers it could be about two months before formula supplies return to normal levels. The agency has waived many of its regulatory requirements to accept more formula from the United Kingdom, Australia and other nations.

U.S. manufacturers, including Reckitt and Gerber, have also stepped up production, running plants 24/7 and sourcing more formula from alternate facilities.

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Biden to Meet With Baby Formula Makers on Alleviating Shortage

U.S. President Joe Biden will meet with major infant formula manufacturers on Wednesday as his administration presses ahead with efforts to boost imported supplies to help ease a nationwide shortage.

The meeting comes multiple global suppliers are seeking U.S. approval to ship in the critical infant food as Biden’s administration seeks to accelerate what it has dubbed Operation Fly Formula to help fill store shelves.

U.S. parents have struggled to find baby formula in recent months as supplies suffered after a February recall of some formulas by one of the nation’s main manufacturers, Abbott Laboratories, coupled with other pandemic-related supply chain issues.

The Biden administration has relaxed its import policy and invoked the Defense Production Act to help increase available U.S. supplies, which is still expected to take weeks. It has also said it could use federal resources to help transport supplies to retailers.

Two million cans of formula have been sent from the UK, and Australian manufacturers are also preparing to send in more product.

The companies attending the 2:30 p.m. (1830 GMT) virtual meeting to provide an update include ByHeart, Bubs Australia , Reckitt Benckiser Group, Perrigo Company and Nestle SA’s Gerber, the White House said.

Many U.S. parents rely on baby formula. Fewer than half the babies born in the United States were exclusively breast-fed through their first three months, according to the Centers for Disease Control and Prevention’s 2020 Breastfeeding Report Card.

U.S. lawmakers have criticized the Food and Drug Administration for not acting promptly to address the problems at Abbott’s Michigan plant, which is set to reopen June 4.

The agency has said the company, which has the largest U.S. market share for infant formula, did not have a contingency plan to produce its specialty formulas that serve as the only source of nutrition for thousands of babies with metabolic disorders.

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[PREMIERING 3PM ET] Baby Formula and Inflation Crisis—Interview with Ken Paxton

In this episode of Counterculture with Danielle D’Souza Gill, Danielle shines a light on the deep problems Americans in the country are facing: they can’t find baby formula, are paying high gas prices, and are dealing with skyrocketing inflation. She interviews Ken Paxton, attorney general of Texas, about these problems, among others.

* Click the “Save” button below the video to access it later on “My List.”

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FDA Chief: COVID, Mail Mix-up Delayed Action on Baby Formula

The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at a baby formula plant linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and even a missing piece of mail.

FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency’s response by months, including a whistleblower complaint that didn’t reach FDA leadership due to a “mailroom failure.”

Califf testified before a House subcommittee probing the shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies in stores.

Califf told lawmakers FDA’s response was: “Too slow and there were decisions that were suboptimal along the way.”

The FDA and President Joe Biden face mounting pollical pressure to explain why they didn’t intervene earlier to try and address the supply problems. The oversight subcommittee’s ranking Republican quickly zeroed in on the slow response.

“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” asked Rep. Morgan Griffith, R-Virginia. The panel will also hear from three formula manufacturers, including Abbott Nutrition.

The shortage mostly stems from Abbott’s Michigan plant, the largest in the U.S., which the FDA shut down in February due to contamination.

“We knew that ceasing plant operations would create supply problems but we had no choice given the insanitary conditions,” Califf said in opening testimony.

Califf gave the first detailed account of why his agency took months to inspect the plant despite learning of potential problems as early as September.

FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, leading to hospitalization and two deaths.

Califf told lawmakers the FDA began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.

After detecting positive samples of bacteria in multiple parts of the plant, the FDA closed the facility and Abbott announced a massive recall of its formula on Feb. 17.

Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits.

Califf also laid out the agency’s months-long timeline responding to an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records.

Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.

Senior FDA officials eventually received emailed copies of the complaint, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks. A mailed copy addressed to then-acting commissioner Dr. Janet Woodcock has still not been located, according to the FDA.

Political fury over the shortage has landed squarely on the FDA and Califf, the only administration official who has testified thus far on the issue. The problems have quickly snowballed into a political firestorm for President Joe Biden, who has invoked the Defense Production Act and emergency flights to shore up supplies.

Califf is also facing questions about why his agency didn’t anticipate the shortage, given that Abbott’s plant supplies roughly one-sixth of the U.S. formula supply. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11. Califf’s testimony states that his agency does not have the “authority, resources, or dedicated staff” to track supply chain disruptions. He asked lawmakers for new powers and resources to monitor the information.

Behind the shortage are other distinct factors, including industry consolidation that’s made the U.S. formula market vulnerable to disruptions at individual companies.

An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards. After the company restarts production next month it will be able to produce more formula than before the recall, according to prepared remarks from Abbott’s senior vice president, Christopher Calamari.

The company will restate its contention that there is no direct link between its formula and the infant infections investigated by the FDA. Agency regulators have said the small number of cases and incomplete testing data make it hard to draw a direct connection between the illnesses and Abbott’s plant.

Executives from Reckitt and Gerber are also scheduled to testify.

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