FDA Infant Formula Safety Initiative Calls on Industry Leaders To Improve Public Recall Alerts

Push comes months after the agency launched Operation Stork Speed to increase testing and oversight of infant formula.

Federal health officials are calling on baby food and infant formula manufacturers to strengthen how they communicate product recalls and safety concerns, following years of scrutiny over the industry’s handling of health risks their products may pose for vulnerable infants.

In a press release issued on July 9, the U.S. Food and Drug Administration (FDA) urged manufacturers to adopt more transparent and timely recall practices to better protect infants and young children from contaminated or unsafe food products.

The call to action follows several high-profile safety lapses in recent years, most notably the recall of Alimentum, Elecare and Similac formula after powdered products from an Abbott facility in Michigan tested positive for Salmonella Newport and Cronobacter sakazakii. 

These dangerous bacteria were linked to at least two infant deaths and multiple hospitalizations. Investigators later found Abbott failed to follow key safety protocols, prompting sharp criticism and a nationwide formula shortage in 2022.

Beyond contamination concerns, the FDA has faced mounting pressure to address other widespread risks, including the nutritional dangers of certain infant formulas and the presence of toxic metals in many baby food products.

As the industry concerns mount, the FDA is now urging baby food and infant formula manufacturers to improve how they communicate product recalls, with a focus on protecting the health and safety of children. Dr. Marty Makary, FDA Commissioner, is emphasizing the need for “radical transparency” and calling on industry leaders to work with the agency to enhance recall messaging and public access to safety information.

In a letter to industry leaders, Makary outlined two long-term goals he hopes to achieve through the FDA’s work with manufacturers:

• Launching a modernized digital platform for standardized industry data submissions, streamlining recall processing and classification.
• Redesigning and digitizing recall documentation to support automated data extraction and AI-assisted analysis.

Makary also announced five short-term goals to improve current processes:

• Developing a centralized, consumer-friendly webpage with recall information, prioritizing infant formula and baby food.
• Reviewing internal and external communication procedures to ensure they meet current public health standards.
• Upgrading the FDA Enforcement Report system to allow better filtering of recall data, especially for high-risk food categories.
• Using focus groups and stakeholder input to improve risk communication.
• Accelerating recall classifications through improved procedures.

According to the FDA, these improvements should promote greater transparency and give parents and caregivers the tools they need to track the safety of products in their homes, helping protect their children’s short- and long-term health.

“At the FDA, we believe that radical transparency in food safety and nutrition actions is key to reducing foodborne illness and chronic disease, setting a strong foundation for lifelong health. It is imperative the food industry and FDA work together to ensure swift, transparent, and effective recall communication, especially for products vital to infant and child nutrition.”

-Martin A. Makary, M.D., M.P.H., FDA Commissioner

The FDA’s push for improved industry cooperation follows the recent launch of Operation Stork Speed, which expanded federal review and testing of infant formula ingredients, including heavy metals and other contaminants in products like Similac and Enfamil.

Infant Formula Health Risks

One area of increasing concern involves cow’s milk-based formula products like Similac and Enfamil, which studies have linked to a higher risk of necrotizing enterocolitis (NEC) in premature infants. 

NEC is a life-threatening gastrointestinal condition that causes inflammation and tissue death in the intestines, often requiring emergency surgery or resulting in death.

As a result of the growing evidence linking NEC risks to premature infants, hundreds of families have filed Enfamil NEC lawsuits and Similac NEC lawsuits against the formula manufacturers, alleging they failed to warn that their products may significantly increase severe gastrointestinal injuries, or even death. As of July 1, more than 740 NEC lawsuits have been consolidated in a federal multidistrict litigation (MDL) in the Northern District of Illinois.

Toxic Metals in Baby Food

Concerns have also escalated around the presence of heavy metals in popular baby foods. A 2021 Congressional report revealed that products made by Gerber, Beech-Nut and Walmart’s Parent’s Choice brand contained elevated levels of arsenic, lead, cadmium and mercury, elements linked to neurological issues, including autism and ADHD.

Despite the findings, follow-up testing has confirmed that harmful levels of metals persist in many of these products.

In response, families across the U.S. have filed toxic baby food lawsuits alleging that manufacturers knowingly sold products with dangerous contaminants while falsely marketing them as safe. As of July 1, at least 180 toxic baby food lawsuits have been centralized in an MDL in the Eastern District of New York.