Baby Formula Makers and FDA to Discuss Shortage With Lawmakers
Officials from the Food and Drug Administration and from the major formula manufacturers are expected to testify before the House Energy and Commerce Committee’s oversight and investigations subcommittee about their attempts to address the short supply. The Energy and Commerce panel oversees the FDA, which regulates baby formula.
Rep.
Frank Pallone
(D., N.J.), chairman of the full committee, said, “The focus of this hearing will be on better understanding the causes of the shortage, what has been done to increase production and supply thus far, and what more still needs to be done to ensure access to safe formula across the nation.”
Rep. Cathy McMorris Rodgers (R., Wash.), the top Republican on the full committee, said she was “hoping to get answers for parents about: Why wasn’t more done?”
Formula maker Abbott Laboratories’ facility in Sturgis, Mich., was shut down earlier this year due to the discovery of bacteria. It is expected to reopen in June.
Photo:
jeff kowalsky/Agence France-Presse/Getty Images
The FDA’s discovery of bacteria at an
Abbott Laboratories
plant in Sturgis, Mich., prompted the company in February to recall some products and shut down the plant, worsening formula shortages. Abbott has said it aims to reopen the plant during the first week of June.
Christopher Calamari, Abbott’s senior vice president for U.S. nutrition, is expected to tell the committee the company is taking steps to be able to supply more formula to the U.S. by the end of June than it was producing in January before the recall. He is also expected to testify that Abbott is averaging six to eight flights a day carrying 132,000 cans of formula into the U.S.
The hearing is the latest in Congress on the short supplies of a crucial baby product, which have left some store shelves empty, triggered an outcry from parents and prompted the Biden administration to try to address the problem.
Some families rely on formula to feed and provide nutrition to their babies. Stocks started running short in 2020 after the Covid-19 pandemic disrupted supply chains.
Starting last year, four infants were hospitalized with cronobacter bacteria infections after consuming Abbott formula, and two died. Abbott has denied that the cronobacter infections were caused by contamination at its plant.
The Centers for Disease Control and Prevention said genetic testing on the bacteria strains in two of the hospitalized infants didn’t match the bacteria discovered at the plant. This month, Abbott reached agreement with the FDA on the steps needed to reopen the company’s Michigan plant under agency supervision.
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What’s the solution to the formula shortage? Join the conversation below.
FDA Commissioner
Robert Califf
is expected to defend his agency’s handling of the original bacteria investigation as well as the shortages that followed. “We lost confidence that Abbott Nutrition had the appropriate safety and quality culture and commitment to fix these problems quickly,” he said in prepared testimony.
The FDA also found that Abbott didn’t have contingency plans for producing its specialty formulas, which some infants with metabolic disorders rely on.
Formula makers have said it could take months to eliminate the shortages. Meanwhile, the White House has arranged for Defense Department commercial aircraft to fly in formula that meets U.S. standards from overseas.
The Biden administration also said it would use the Defense Production Act to make sure formula makers have the ingredients they need to increase production.
Also, the FDA temporarily eased baby-formula import rules to permit the distribution of more products to the U.S.
—Peter Loftus contributed to this article.
Write to Liz Essley Whyte at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Officials from the Food and Drug Administration and from the major formula manufacturers are expected to testify before the House Energy and Commerce Committee’s oversight and investigations subcommittee about their attempts to address the short supply. The Energy and Commerce panel oversees the FDA, which regulates baby formula.
Rep.
Frank Pallone
(D., N.J.), chairman of the full committee, said, “The focus of this hearing will be on better understanding the causes of the shortage, what has been done to increase production and supply thus far, and what more still needs to be done to ensure access to safe formula across the nation.”
Rep. Cathy McMorris Rodgers (R., Wash.), the top Republican on the full committee, said she was “hoping to get answers for parents about: Why wasn’t more done?”
Formula maker Abbott Laboratories’ facility in Sturgis, Mich., was shut down earlier this year due to the discovery of bacteria. It is expected to reopen in June.
Photo:
jeff kowalsky/Agence France-Presse/Getty Images
The FDA’s discovery of bacteria at an
Abbott Laboratories
plant in Sturgis, Mich., prompted the company in February to recall some products and shut down the plant, worsening formula shortages. Abbott has said it aims to reopen the plant during the first week of June.
Christopher Calamari, Abbott’s senior vice president for U.S. nutrition, is expected to tell the committee the company is taking steps to be able to supply more formula to the U.S. by the end of June than it was producing in January before the recall. He is also expected to testify that Abbott is averaging six to eight flights a day carrying 132,000 cans of formula into the U.S.
The hearing is the latest in Congress on the short supplies of a crucial baby product, which have left some store shelves empty, triggered an outcry from parents and prompted the Biden administration to try to address the problem.
Some families rely on formula to feed and provide nutrition to their babies. Stocks started running short in 2020 after the Covid-19 pandemic disrupted supply chains.
Starting last year, four infants were hospitalized with cronobacter bacteria infections after consuming Abbott formula, and two died. Abbott has denied that the cronobacter infections were caused by contamination at its plant.
The Centers for Disease Control and Prevention said genetic testing on the bacteria strains in two of the hospitalized infants didn’t match the bacteria discovered at the plant. This month, Abbott reached agreement with the FDA on the steps needed to reopen the company’s Michigan plant under agency supervision.
SHARE YOUR THOUGHTS
What’s the solution to the formula shortage? Join the conversation below.
FDA Commissioner
Robert Califf
is expected to defend his agency’s handling of the original bacteria investigation as well as the shortages that followed. “We lost confidence that Abbott Nutrition had the appropriate safety and quality culture and commitment to fix these problems quickly,” he said in prepared testimony.
The FDA also found that Abbott didn’t have contingency plans for producing its specialty formulas, which some infants with metabolic disorders rely on.
Formula makers have said it could take months to eliminate the shortages. Meanwhile, the White House has arranged for Defense Department commercial aircraft to fly in formula that meets U.S. standards from overseas.
The Biden administration also said it would use the Defense Production Act to make sure formula makers have the ingredients they need to increase production.
Also, the FDA temporarily eased baby-formula import rules to permit the distribution of more products to the U.S.
—Peter Loftus contributed to this article.
Write to Liz Essley Whyte at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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