The Food and Drug Administration is taking steps to improve the supply of baby formula available on store shelves.
One of the first steps was to begin allowing the Abbott manufacturing facility in Sturgis, Mich. to release supplies of certain specialty and metabolic formulas on a case-by-case basis.
“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,” said FDA Commissioner Dr. Robert M. Califf, in a news release. “Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA.
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Neonatal Intensive Care Unit Registered Dietician Desha McNeair at Children’s Hospital of Georgia said that will benefit a relatively small number of patients.
“It’s a renal formula for kids with kidney issues, and then metabolic formulas. So, those are very few and far between,” she said. “They’re releasing them because the kids who cannot attain those formulas are at risk of needing hospitalization, because they can’t tolerate anything else. So that’s why it’s on a case-by-case basis and only for patients in dire need.”
The beginning of the crisis traces to supply chain issues connected with COVID-19. Then in February 2022 the FDA warned consumers not to use certain powdered formulas from Abbott, one of the largest manufacturers of baby formula.
Abbott initiated a voluntary recall of Similac, Alimentum and EleCare and posted information on its website saying, “Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.”
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On May 16, the FDA released guidance on increasing flexibilities regarding importation of some products.
Califf encouraged infant formula manufacturers to take advantage of the opportunity when the announcement was made on Monday.
“Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely. We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants,” he said.
McNeair said then FDA will still need to examine the formulas before releasing for sale in the U.S.
“Formulas from other countries are not as regulated. So, FDA cuts would probably have to look over all the formulas and make sure that they meet our standard,” she said.
Califf said he expects the products will quickly meet the agency’s safety and nutrition standards. Those that do could be available in U.S. stores in a matter of weeks.
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Projections are it could be upwards of three more months before the supplies of infant formulas are back up to normal levels.
McNeair said estimations on when the Abbott plant will resume production have been changing every day.
“But even if they opened it today, it’s going to take another six to eight weeks before they can get that formula on the shelf. So regardless, we’re looking at exactly another two or three months,” she said.
McNeair and the FDA continue to strongly advise against parents trying to make a homemade formula using information found through a simple Internet search.
She explained formula is highly regulated, designed to ensure all the components are correct and can meet the nutritional needs of the child. One formula she found did not have the necessary 20 calories per ounce because it did not contain enough fat for a baby’s developing brain.
Dana Lynn McIntyre is a general assignment reporter for The Augusta Press. Reach her at dana@theaugustapress.com
