FDA issues “infraction” warning letters to three infant formula producers for “violating legislation”

31 Aug 2023 --- ByHeart, Reckitt/Mead Johnson Nutrition and Perrigo Wisconsin received warning letters from the US Food and Drug Administration (FDA) for infractions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations. After reviewing the companies’ submitted corrective action responses to the FDA’s inspectional observation forms, the agency has concluded that certain areas still require corrective actions. 

The warning letters reflect findings from inspections of the three companies’ facilities that violated legislation. As the warning letters are not associated with current recalls, the agency does not anticipate any impact on the availability of infant formula on the market. 

All three companies conducted recalls to remove products potentially contaminated with Cronobacter sakazakii from the marketplace, the pathogen that played an important role in the 2022 US infant formula crisis. 

“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,” says 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.” 

The FDA does not advise parents and caregivers to discard or avoid purchasing particular infant formula. The agency states that it is unaware of any distributed product where contamination was confirmed, adding that it believes the recalls effectively removed the potentially contaminated batches of product from the market. 

Regulatory process 
The agency explains that warning letters are part of the FDA’s normal regulatory process. They aim to reinforce to the manufacturers the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations. 

For example, the companies must thoroughly conduct root cause investigations and perform cleaning and sanitation activities. Before releasing products, they must also correctly evaluate their hygiene practices, schedules and procedures. 

“Over the last year, the FDA has continued to increase our oversight of powdered infant formula facilities,” explains Practer. 

The warning letters note that companies must take corrective action to ensure future product safety.“These letters reflect 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.”

The companies will have 15 working days to explain to the FDA what corrective actions they are taking. The FDA will then assess the adequacy of these actions by reviewing the companies’ responses and an inspection of each facility, where the FDA will verify the implementation of the corrective actions taken. 

Last week, Nutrition Insight talked to Valio about how food safety issues in the infant nutrition market may make this highly regulated market even more strict. 

Ensuring product safety 
The warning letters are part of the FDA’s new strategy to avert future contaminations and shortages in the infant formula market after last year’s formula crisis. 

The agency has been working with Congress to strengthen its regulatory tools and increase funding to oversee the infant formula industry. 

Moreover, the US Centers for Disease Control and Prevention (CDC) and the FDA supported the Council of State and Territorial Epidemiologists’ decision to add Cronobacter infections among infants under one year old to the Nationally Notifiable Conditions List. This list by the CDC provides comprehensive reporting of diseases in the US. 

The FDA underscores that parents and caregivers should follow manufacturer instructions for preparing powdered infant formula. Heating water to at least 158°F/70°C before mixing it with powdered formula can also help to protect against Cronobacter. 

Earlier research found that during the US infant formula shortage, 48.5% of parents using formula resorted to potentially harmful feeding methods to cope with the deficit. 

Researchers recommend spacing samples over time to catch pathogens like Cronobacter sakazakii rather than random sampling during production. Taking more samples can increase the power to detect contamination, even if the samples are small. 

By Jolanda van Hal