Just a year after the U.S. experienced a formula shortage due to numerous recalls, the Food and Drug Administration (FDA) issued warning letters to three infant formula manufacturers this week.[1]
ByHeart, Mead Johnson Nutrition (which makes Enfamil) and Perrigo (which makes Gerber Good Start) each received a notice. The FDA issued them "to help ensure that the industry is producing infant formula under the safest conditions possible."
This may raise some questions about what exactly the warnings mean for you. If your family relies on formula from one of these companies, it's understandable to wonder what you should do now. Here's what doctors want you to know about this news — and why it's okay to keep buying and using formula like you have before.
What did the FDA's formula warning say?
The letters stem from "inspections of these facilities over the last several months," the agency explains. Basically, the FDA visited these companies' factories and exercised regulatory oversight during recalls (in December 2022, February 2023 and March 2023) to remove potentially contaminated products from the marketplace.
The inspections looked for Cronobacter, a type of bacteria that can live in dry foods like powdered infant formula and can cause serious infections in babies.[2]
The FDA now wants each company to share exactly what it's doing to prevent contamination problems from happening again so that parents can feel confident that what they're buying is safe.
Importantly, the agency does not recommend that caregivers throw out or avoid purchasing any particular infant formula right now.
What does the FDA's warning mean for you?
Ultimately, these warnings don't directly affect you or your baby, says Gina Posner, M.D., a board-certified pediatrician at MemorialCare Orange Coast Medical Center in Fountain Valley, California, and a member of the What to Expect Medical Review Board. "They're basically just telling the formula companies that they should make sure this doesn't happen again," she says. "You don't need to throw away your current formula. It's just telling the companies, 'Hey, you need to be on your toes.'"
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The letters put pressure on all formula producers — not just the three who received letters — to ensure they're being as safe and careful as possible with their manufacturing processes, says Robert Hamilton, M.D., a board-certified pediatrician at Providence Saint John's Health Center in Santa Monica, California.
It's totally understandable if you still have concerns, but experts agree it's safe to buy and use formula as you normally do.
"The formula itself is still fine, as per the FDA," reassures Jamie Alan, Pharm.D., Ph.D., an associate professor of pharmacology and toxicology at Michigan State University.
What does the warning mean for the future?
The last time there was a major issue with formula, it led to a massive shortage across the country.[3] In 2022, Abbott — the maker of Similac, Alimentum and EleCare powdered formulas — recalled formula made in its Sturgis, Michigan, plant due to potential Cronobacter contamination.[4]
That recall and its cascading effects led to supply problems before President Joe Biden invoked the Defense Production Act in May 2022 to speed production of infant formula.[5]
But the FDA and outside experts both stress that this is not the same thing. "This should not cause formula shortages," Dr. Hamilton says. "This is an indication that maybe the FDA is looking at formula production and safety more carefully."
Hopefully, the warnings will ultimately make formula an even safer option. "Companies know the FDA is watching out and they're cracking down on violations," Dr. Posner says. "They don't want infant deaths or sickness from formula to happen again."
You should feel comfortable purchasing available formula as you typically would, Dr. Hamilton advises. "In terms of the actual purity of formula on the market, if the FDA feels comfortable that products are safe, parents should feel comfortable, too," he says.
The bottom line: Keep purchasing formula from brands you know and trust. The FDA's actions will help ensure that powdered formula remains a safe feeding option for your baby. "This is an internal issue companies are dealing with," Dr. Hamilton says. "They will not want this to become a bigger issue."
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