Science and Tech


FDA warns baby formula manufacturers over federal violations

Three companies were given 15 days to submit corrective plans to avoid future formula shortages.
Baby drinking formula from a bottle.
Posted at 3:33 PM, Aug 31, 2023

The U.S. Food and Drug administration has issued warnings to three manufacturers of baby formula over violations of safety regulations.

The agency announced Wednesday that it had sent letters to ByHeart Inc., Mead Johnson Nutrition, and Perrigo Wisconsin, LLC. after inspecting their facilities over recalls of some of their products. Regulators said the letters are a follow-up meant to reinforce the importance of instituting and maintaining appropriate actions when they detect any pathogens that may contaminate product.

"Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns," said Donald Prater, acting director of the FDA's Center for Food Safety and Applied Nutrition. "The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage."

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Similac infant formula on display on a store shelf.

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The letters require the companies to commit to extensive sanitation and cleaning regimens, launch investigations into potential contaminations, and reevaluate their sanitation policies. All three companies were given 15 days to establish corrective plans in accordance with the FDA review.

"In addition to around-the-clock regulatory work, the FDA remains steadfast in upholding the commitment to unify and strengthen the FDA Human Foods Program," the agency said in a statement. "This new vision comes as a result of the agency’s review of findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, at the request of the FDA Commissioner, following the agency’s infant formula supply chain response."

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Similac Alimentum Hypoallergenic Infant Formula, imported from Puerto Rico, is for sale at a Stew Leonard's grocery store

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The health warnings come after a year of disruptions and shortages in the baby formula industry that left shelves empty across the U.S. and families struggling to find what they needed to fulfill their babies' nutritional needs. The FDA said stock rates of formula in the U.S. have been at about 85% or higher since the beginning of this year.