RFK Jr. Targets Infant Formula Industry as FDA Tightens Rules

livewell
March 19, 2025
Noah Bennett

The U.S. Food and Drug Administration (FDA) has recently initiated Operation Stork Speed, a sweeping initiative to enhance safety protocols for infant formula, including expanded heavy metal testing and a long-overdue review of nutritional standards.

“The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said HHS Secretary Robert F. Kennedy Jr.

A Look into the Initiative

The move follows heightened scrutiny of FDA infant formula regulations and recent findings of contaminants in some products, while Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. intensifies pressure on manufacturers to prioritize transparency and safety.

Key Developments in Infant Formula Oversight

The FDA’s plan marks the first comprehensive update of infant formula nutrient requirements since 1998, with a Request for Information set to kick off the review process.

The agency will also ramp up infant formula testing for heavy metals like arsenic and lead. Furthermore, the contaminants highlighted in a recent Consumer Reports study found concerning levels in some baby formula products.

The FDA further aims to collaborate with industry stakeholders to improve labeling clarity and address research gaps on long-term health outcomes linked to formula feeding.

The Current Emphasis

FDA infant formula regulations now also focus on resilience in supply chains, a critical focus after the 2022 cronobacter outbreak tied to Abbott Nutrition’s Similac, which triggered nationwide shortages.

Acting FDA Commissioner Sara Brenner, MD, MPH, underscored the agency’s commitment: “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for families and children who rely on them”.

RFK Jr.’s Industry Scrutiny

Kennedy, a vocal advocate for stricter food safety standards, has positioned infant formula as a priority under his “Make America Healthy Again” agenda.

In a statement, he stated the need for “continuous safety, nutritional adequacy, and resilience” in the FDA infant formula supply chain. His office has scheduled meetings with executives from major manufacturers, including Abbott Laboratories (Similac) and Reckitt Benckiser (Enfamil), though details remain undisclosed.

The Critics Take

Kennedy’s push aligns with his broader efforts to overhaul food oversight, including proposed reforms to “generally recognized as safe” (GRAS) regulations.

Critics, however, note potential challenges in implementing these measures without adequate FDA staffing, a concern raised by Consumer Reports after sharing its findings with the agency.

Industry and Consumer Reactions

While baby formula giants like Abbott and Reckitt have not publicly commented, their stocks dipped slightly following the announcement. Meanwhile, newer entrants like Bobbie Labs are capitalizing on the demand for cleaner options, launching the first USDA Organic Whole Milk infant formula in the U.S. market.

Consumer advocacy groups welcome the FDA’s infant formula testing expansion but stress the need for actionable results. Brian Ronholm, director of food policy at Consumer Reports, urged the agency to “follow through with these promises” and address staffing gaps.

The Broader Implications

The FDA’s actions reflect growing public awareness of infant formula safety, driven by high-profile recalls and studies revealing contaminants. With nearly half of U.S. infants partially reliant on formula by six months, according to CDC data, the stakes are high.

While Operation Stork Speed signals progress, its success hinges on sustained collaboration between regulators, manufacturers, and researchers to ensure baby formula meets nutritional and safety benchmarks.