FDA sends warning letters to three infant formula manufacturers

The US Food and Drug Administration (FDA) has revealed that it has sent warning letters to three infant formula manufacturers in the US following inspections of their facilities over the last several months.

The infant formula manufacturers that have been approached by the FDA include ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. The agency has said that the warning letters are for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

According to the FDA, at the time of each inspection, it issued “inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace”.

As part of its announcement, the FDA has highlighted that is “does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time”.

“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. 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,” continued Prater.

FDA unveils national infant formula market strategy

The agency has said that is “not aware of any distributed product where contamination was confirmed” and has explained that it believes that the recalls were effective in removing the potentially contaminated batches of product from the market.

In addition, the agency has noted that “these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market”.

Explaining the reasoning behind the warning letters, the FDA has said that it is issuing the 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”. As part of this, the firms must make sure that they thoroughly conduct root cause investigations and perform subsequent cleaning and sanitation activities.

The FDA has also stated that the firms also need to “properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product”.

ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC company will have 15 working days to respond to the FDA to explain what corrective actions they are taking, with the FDA explaining it will then will assess the adequacy of the companies’ corrective actions in the agency’s review of the responses and during the FDA’s next inspection of each facility.

“During these inspections the agency will verify proper implementation of appropriate corrective actions taken by each company,” the FDA explained.

Previously, in November 2022, the agency released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. Since then, as part of that strategy, the FDA has been working with Congress to strengthen its regulatory tools and increase funding to oversee the infant formula industry and has also worked with the US Centers for Disease Control and Prevention (CDC) to support the Council of State and Territorial Epidemiologists’ decision to add invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List.

The FDA has said the it has started to establish a “dedicated cadre” of infant formula investigators and an Office of Critical Foods. It has claimed that “both of which will strengthen the regulatory oversight of infant formula” going forward.

When approached for a comment, a spokesperson from Mead Johnson Nutrition (Reckitt), told New Food: “At Reckitt/Mead Johnson Nutrition, the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality.

“The FDA’s communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections. We take this very seriously and have been in an ongoing dialogue with the agency regarding our commitment to ensure that our manufacturing represents the highest standard in the industry.”

The spokesperson continued: “There are no safety or quality concerns with any Reckitt / Mead Johnson formula. Parents and caregivers can rest assured, our products can be used with confidence, and they don’t need to do anything differently when shopping or feeding their infants.

“Infant formula safety is our top priority, and we are confident in the rigor of the programs we have in place to ensure the safety of every infant formula product we ship.”

New Food has approached all three infant formula manufactures in question for a comment.