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White House Accelerates Response to Baby Formula Shortage

May 12, 2022 by Dan McCue
White House Accelerates Response to Baby Formula Shortage
A sign telling consumers of limits on the purchase of baby formula hangs on the edge of an empty shelf for the product in a King Soopers grocery store, Wednesday, May 11, 2022, in southeast Denver. Parents across the country are struggling to find baby formula in stock in stores because of supply chain disruptions combined with a massive safety recall. (AP Photo/David Zalubowski)

WASHINGTON — President Joe Biden on Thursday directed his administration to “work urgently” to respond to the major baby formula shortage that has forced families across the United States to rely on others with leftover supplies to swap or sell to get the nutrition they need for their youngest members.

In addition, White House officials said, the president spoke with retailers and manufacturers, including Walmart, Target, Reckitt and Gerber on Thursday, to discuss ways they and the federal government can work together to help more families gain access to infant formula.

The shortage in formula is the result of supply chain disruptions caused by the coronavirus pandemic and a voluntary recall initiated on February 17 by Abbott Nutrition after concerns were raised about bacterial contamination at its facility in Sturgis, Michigan.

According to findings released in March by federal safety inspectors, Abbott failed to maintain sanitary conditions and procedures at the plant.

Abbott is the largest infant formula manufacturer in the country. At least four infants fell ill and two died after they allegedly ingested tainted formula.

In a written statement on its website, Abbott said it began its recall after receiving four complaints about an environmental bacteria, Cronobacter sakazakii, found in infants who consumed formula from the plant. 

“The facts about what was learned about the cases of Cronobacter have not been widely communicated,” Abbott said. “After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.”

The statement went on to say:

  • Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
  • All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
  • The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically:
    • Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
    • In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
    • Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
    • The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

 

With supplies growing ever scarcer, retailers have been limiting what customers can buy, and pediatricians and other members of the health care community have been directing concerned parents to contact food banks and other facilities that might have formula to spare.

According to the White House, several federal agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Commerce and the U.S. Trade Representative, have been working “diligently” to address the shortfall in formula production while the Michigan plant remains offline.

Among the steps the administration has taken, White House officials said in a conference call with reporters Thursday afternoon, is working with other infant formula manufacturers to increase production, expediting the import of infant formula from abroad, and calling on both online and in-store retailers to establish purchasing limits to prevent the possibility of hoarding. 

“As a result of these efforts, more infant formula has been produced in the last four weeks than in the four weeks preceding the recall — despite one of the largest infant formula production facilities in the U.S. being offline,” a senior administration official said.

Still, officials said they realize many families remain concerned about the availability of infant formula, especially those who depend on specialty formulas for which the Michigan facility is a key supplier. 

According to the White House, 20 different specialty formulas are used by about 5,000 infants as well as some older children and adults with rare metabolic diseases, and Abbott Nutrition is the only supplier for some of these formulas.

Among the steps to address the crisis President Biden announced Thursday was a call to manufacturers to simplify product offerings to increase the speed and scale of their infant formula production, stabilizing the overall volume of formula available in the market. 

At the same time, the USDA is working with states to make it easier for vulnerable and low-income families to purchase the formula they need with their Special Supplemental Nutrition Program for Women, Infants, and Children benefits, a federal program similar to food stamps. 

Specifically, the department is urging states to allow WIC recipients to use their benefits on a wider variety of products so that if certain sizes or types of formula are out of stock, they can use their benefits on those that are in stock. 

At the same time, the department is urging states to relax their requirements that stores keep a certain amount of formula in stock. This will offer relief to retailers and allow companies to manage inventories to meet demand, White House officials said. 

The administration is also stepping up efforts to crack down on those who may be price gouging or otherwise engaging in unfair trade practices during the shortage.

Under normal circumstances, the United States produces about 98% of the infant formula it consumes, with trading partners like Chile, Ireland, Mexico and the Netherlands making up the rest.

In the coming days, White House officials said, the Food and Drug Administration will announce new steps to increase the amount of infant formula products coming from abroad.

Earlier on Thursday, Rep. Abigail Spanberger, D-Va., said in a statement that she’d spoken directly to White House Chief of Staff Ron Klain about the ongoing formula shortage and that the two had discussed “all possible avenues for getting formula back on the shelves so that parents who rely on it know they will be able to feed their babies.”

“We discussed tariff relief, initiating new and immediate imports and the possibility of using the Defense Production Act. Any plan released by this administration must make sure that formula is stocked on our shelves for all Virginia parents, crack down on price gouging, and increase imports of formula from abroad. Quick action is needed, and the White House must take decisive action. In the longer term, I am pursuing legislation to ensure we don’t face this challenge again.”

Abbott has said that once it gets FDA approval, it could restart production at the Michigan plant within two weeks.

When that happens, it will reportedly begin by restarting production of EleCare, Alimentum and metabolic formulas, and then phase in production of Similac and other formulas. 

Once production begins, it will likely take six to eight weeks for the formula to arrive on store shelves.

In the meantime, Republicans on Capitol Hill and the campaign trail are expected to continue to try to raise the political heat on the White House.

On Thursday, Senate Republican Leader Mitch McConnell, R-Ky., called the infant formula shortage “outrageous and unacceptable.”

“This problem has been developing in slow motion for several months now, but the Biden administration has been characteristically sluggish and halting in response,” McConnell said. “The FDA knew about the initial recall. The administration should have foreseen these supply shortages. But the Biden administration has been too slow and passive about getting production back up and running. Both Republican and Democratic senators have demanded answers from the administration and gotten none.

“The same Biden administration that overruled nonpartisan FDA scientists on vaccine policy cannot now hide behind the FDA and pretend they’re powerless. The president and his team must get a hold of the situation fast and do right by America’s moms, dads and babies,” the Republican leader said.

In its latest statement, dated May 11, Abbott Nutrition acknowledged the recall “has worsened an already existing industry-wide infant formula shortage in the U.S.” and said “we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves.”

“We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas,” the company said.

Dan can be reached at dan@thewellnews.com and @DanMcCue

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