FDA To Investigate Whether Infant Formula Products Provide Enough Nutrition

Agency plans to hold public expert panel on infant formula nutrition in June, amid continuing concerns about the marketing of Similar, Enfamil and similar products, which have driven many mothers away from breast feeding.

Amid years of troubling research, product recalls, and lawsuits highlighting risks linked to certain infant formula products, federal regulators have launched a comprehensive investigation into their nutritional content.

The U.S. Food and Drug Administration (FDA) issued a press release on May 13, announcing the next phase of Operation Stork Speed, which is a federal initiative introduced by Health and Human Services Secretary Robert Kennedy, Jr. to modernize oversight of infant formula and ensure it meets current standards for infant health and development.

The initiative builds on longstanding concerns over contamination, inadequate labeling and inconsistent ingredient quality, and aims to strengthen both safety and nutritional oversight. As part of the effort, the FDA has issued a Request for Information (RFI) to formula manufacturers, which will support upcoming reviews of nutrient content and expanded testing for heavy metals and other potentially harmful substances that have been found in infant formula in recent years.

Officials say the review is the first of its kind since 1998, and comes amid concerns about the recent marketing efforts of infant formula manufacturers, as well as growing evidence that preterm infants fed cow’s milk-based formulas are far more likely to develop necrotizing enterocolitis (NEC), a life-threatening gastrointestinal condition that primarily affects premature babies, compared to those fed human milk.

As a result, a growing number of Similac and Enfamil NEC lawsuits are being filed by families of premature infants, each raising allegations that the cow’s milk-based infant formula products caused their infants to develop NEC, and that these injuries could have been prevented if the manufacturers had provided adequate warnings.

“Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” Kennedy said in the press release. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen.”

The agency claims it seeks to revise nutritional requirements for infant formula using the latest science. The press release indicates the agency will hold a public expert panel on the issue sometime next month.

Information on how to submit a public comment can be found here.

Infant Formula Nutritional Concerns

The announcement follows a massive Abbott Laboratories Alimentum, Elecare and Similac recall issued about two years ago, following the discovery that powdered formula products manufactured at a Michigan facility were contaminated with Salmonella Newport and Cronobacter sakazakii bacteria, which can be dangerous and life-threatening infections.

At least two infant deaths and hundreds of illnesses were reported by parents who fed the contaminated baby formula to their children, and subsequent investigations have revealed Abbott ignored industry safety standards and best practices at its facility for years, endangering infants for the sake of profits.

The review also comes amid growing concerns about the value of toddler milk and toddler drink products. Critics say that the products appear to have no real nutritional value for toddlers.

Abbott Laboratories faces several toddler drink lawsuits over products like Similac Go & Grow, which include high amounts of sugar.