FDA issues warning letters to three infant formula makers after finding violations

The Food and Drug Administration has issued warning letters to three makers of infant formula — ByHeart Inc., Reckitt/Mead Johnson Nutrition, and Perrigo Wisconsin, LLC — after finding significant code violations during recent inspections at their facilities over the past several months.

The agency exercised oversight of each company as it conducted recalls in December, February and March to remove formula potentially contaminated with Cronobacter sakazakii from the marketplace.

Despite the warning letters, the FDA is not currently advising parents or caregivers to throw away or avoid buying any particular infant formula. The agency said it is not aware of any product already on the market with confirmed contamination. It believes prior recalls successfully removed potentially contaminated batches of formula from stores.

A bottle with infant formula and powder.
A bottle with infant formula and powder.

“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," he said.

“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities," Prater said. "These letters are a reflection of this enhanced oversight."

In December ByHeart had a voluntary recall of its ByHeart Whole Nutrition Infant Formula. In February, Reckitt had a voluntary recall of several batches of its ProSobee 12.9 oz. Simply Plant-Based Infant Formula. And in March, Perrigo had a voluntary recall of several lots of its Gerber Good Start SootheProTM Powdered Infant Formula.

Growing supply of formula

The U.S. infant formula supply is healthy, with in-stock rates at 85% or higher since the beginning of 2023, according to the agency.

That's a major change from early last year, when a severe shortage of formula led to empty shelves and had parents scrambling.

The shortage was driven in part by the closure of one of the largest manufacturing plants in the United States — owned by Abbott Nutrition in Sturgis, Michigan — after a voluntary recall of some of its products. Preexisting pandemic-related supply chain issues and the concentration of the market among three main companies, resulting in a lack of competition, also contributed.

To address the shortage, the Biden administration developed Operation Fly Formula, which imported formula on dozens of flights into the U.S.

Must perform sanitation activity

The FDA said it issued the warning letters to the three manufacturers on Wednesday to reinforce to them "the importance of instituting and maintaining appropriate corrective actions when they detect pathogens."

The manufacturers must investigate to determine the root cause of any prior contamination and perform cleaning and sanitation activities, the FDA said, and evaluate their cleaning and sanitation practices, schedules and procedures before releasing formula.

Cronobacter sakazakii is a germ found naturally in the environment, according to the Centers for Disease Control and Prevention. The germs can also live in other dry foods, such as powdered milk, herbal teas and starches.

Cronobacter germs can cause sepsis, a dangerous blood infection, and meningitis, a swelling of the linings surrounding the brain and spinal cord.

Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking, and the agency will assess the companies’ actions.

In November 2022, the agency released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. The agency has started to hire staff to create a team of infant formula investigators and an Office of Critical Foods to strengthen regulatory oversight of infant formula.

This article originally appeared on NorthJersey.com: Makers of recalled infant formula get FDA warning letters