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Baby formula shortage update overview:
- Who: The U.S. Food and Drug Administration is exploring options that would allow baby formula imports to continue from outside the United States after the nationwide shortage ends.
- Why: Currently, the FDA only allows overseas baby formula manufacturers to sell their products inside the United States through Nov. 14.
- Where: The baby formula shortage has affected consumers nationwide.
The U.S. Food and Drug Administration (FDA) is exploring ways for baby formula manufacturers to continue selling their products in the United States once the current shortage ends.
The FDA previously said it would temporarily allow baby formula to be imported into the United States up to Nov. 14 as a way to help alleviate a nationwide shortage that left parents scrambling to find ways to feed their babies, Reuters reports.
New guidance scheduled to be released in September will provide overseas manufacturers with instructions on how they can fulfill the requirements needed to continue selling their baby formula in the United States, according to the agency.
The nationwide baby formula shortage began after Abbott Nutrition was forced to shut down its Sturgis, Michigan plant following the death of two babies who consumed its Similac PM 60/40 baby formula.
The FDA first warned consumers on Feb. 17 not to use certain Similac, EleCare and Alimentum powdered infant formulas originating from Abbott’s Sturgis plant after they were linked to multiple infants illnesses in addition to the two deaths.
The agency received four separate consumer complaints with three related to cronobacter sakazakii infections and one in regard to a salmonella newport infection.
“All four cases related to these complaints were hospitalized, and cronobacter may have contributed to a death in one case,” the FDA said in an alert at the time.
(Photo Credit: Ken Wolter/Shutterstock)
As of June 22, the FDA says it has “reviewed and investigated” a total of 129 consumer complaints regarding Abbott baby formula products with 119 of them occurring after the company’s voluntary recall on Feb. 17.
Abbott ultimately made an agreement with the FDA, including allowing an outside expert to come in to ensure the company is in compliance with health regulations, which allowed it to reopen its Sturgis plant on June 4.
The baby formula manufacturer said when announcing its reopening date on May 24 that it expected its product to be available to consumers by on or around June 20, CNN reported at the time.
Formula shortage exacerbated when Abbott closed plant days after reopening
Flooding from severe storms forced Abbott to close the Sturgis plant down again only days after it resumed production at the facility.
“These torrential storms produced significant rainfall in a short period of time — overwhelming the city’s stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant,” Abbott said in a statement on June 15.
The U.S. Department of Agriculture also made an attempt to help diminish the nationwide shortage by urging state agencies and baby formula manufacturers Gerber and Rickett Mead Johnson to be flexible on their contracts.
Being flexible on their infant formula contracts would allow Women, Infants and Children (WIC) participants to purchase brands which, depending on their location, would not normally be available to them.
“Responding to the infant formula shortage has been – and will continue to be – a team effort,” Agriculture Secretary Tom Vilsack said in a statement on May 25. “WIC families are depending on us for the vital nourishment their babies and children need to thrive. We cannot let them down.”
Have you been affected by the baby formula recall? You may qualify to join a free Similac, Alimentum and EleCare formula recall lawsuit investigation!
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