FDA sends warning letters to three infant formula manufacturers over federal violations

The Food and Drug Administration (FDA) sent warning letters to three infant formula manufacturers over violations of federal safety regulations, the agency announced Wednesday.

ByHeart, Mead Johnson Nutrition and Perrigo Wisconsin were issued letters after FDA inspections of their facilities as they implemented limited recalls of some of their products over health concerns regarding the bacterium Cronobacter sakazakii, which can be found in dry foods.

The agency said the letters are not tied to current recalls and that products from the companies currently on the market don’t pose a risk to consumers.

“The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations,” the agency said in a statement.

The letters mandate that the companies commit to extensive cleaning and sanitation regiments, conduct investigations into the contaminations and reevaluate company sanitation policies. The companies have 15 working days to create corrective plans for FDA review. The agency will also evaluate the “adequacy” of the companies’ responses when it next inspects their facilities.

“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,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition. 

“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious,” he continued.

The health warnings come after a year of shortages in the baby formula market in 2022. The FDA said stock rates of baby formula are at about 85 percent nationwide since January.

That shortage was caused by a combination of health concerns, supply chain woes and a lacking FDA response, an internal agency investigation found.