FDA launches Operation Stork Speed to improve infant formula safety

In response to growing concerns about the safety of infant formula products, the US Food and Drug Administration (FDA), under the leadership of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, has announced Operation Stork Speed.

This new initiative aims to ensure that infant formula remains safe, reliable, and nutritious for the millions of American families who depend on it.

The announcement follows a Consumer Reports investigation, which uncovered potentially harmful levels of heavy metals, including arsenic and lead, in some popular infant formula brands. As concerns grow, the FDA is stepping up its efforts to maintain the safety, nutritional adequacy and availability of formula, especially for vulnerable infants.

HHS Secretary Kennedy said:

Helping every family and child get off to the right start from birth is a critical part of our mission to Make America Healthy Again.”

A response to growing consumer concerns

The Consumer Reports investigation, which tested 41 different infant formulas, found traces of concerning chemicals, such as arsenic, lead, PFAS, BPA and acrylamide in some products. While the majority of formulas tested were deemed safe, certain brands contained higher levels of toxins that could pose long-term health risks.

James Rogers, PhD, Director of Product Safety Testing at Consumer Reports, expressed his concern:

Millions of parents rely on infant formula during the first important months of their babies’ lives and deserve access to safe, healthy and nutritious products.”

He pointed out that, while not all formulas tested had dangerous levels, some did contain heavy metals that could be harmful to infants’ development.

The investigation’s findings come at a time when parents are increasingly concerned about the safety of products they rely on for their babies’ nutrition. This has prompted the FDA to act swiftly and launch Operation Stork Speed, a set of initiatives aimed at addressing these concerns.

Key actions under Operation Stork Speed

Operation Stork Speed outlines several key actions designed to ensure that infant formula continues to meet the highest standards of safety and nutritional value. These include:

• Comprehensive nutrient review: The FDA will initiate its first comprehensive update of infant formula nutrient standards since 1998, marking a significant step forward in ensuring formula quality.
• Expanded testing for contaminants: The agency is increasing testing for heavy metals, including arsenic and lead, and other harmful substances across infant formula and children’s foods.
• Enhanced labelling transparency: The FDA is working with manufacturers to improve formula labelling, making it easier for parents to understand what’s in the products they’re feeding their children.
• Collaboration with scientific bodies: The FDA is teaming up with the National Institutes of Health (NIH) and other research organisations to address gaps in scientific knowledge regarding formula feeding and its long-term health effects.

Acting FDA Commissioner, Dr. Sara Brenner, reassured parents and caregivers:

Whether breastfed, bottle-fed or both, the rising generation must be nourished in a way that promotes health and longevity over the course of their lives.”

The science behind the concerns

Consumer Reports found that some formulas contained inorganic arsenic, which is the most toxic form of arsenic. Abbott Nutrition’s EleCara Hypoallergenic and Similac Alimentum contained some of the highest levels of arsenic, at 19.7 ppb and 15.1 ppb, respectively. This is concerning since the US Environmental Protection Agency (EPA) limits inorganic arsenic in drinking water to 10 ppb due to its carcinogenic properties.

Lead was also detected in 34 out of 41 formulas tested, with the highest levels found in Neocate Hypoallergenic. While none of the formulas exceeded California’s Maximum Allowable Dose Level (MADL), many formulas had lead levels that approached or exceeded 50 percent of the MADL. Lead exposure, especially in infants, can cause neurological damage.

The investigation also uncovered traces of PFAS — chemicals linked to potential health risks — including BPA and acrylamide, both of which can have endocrine-disrupting and carcinogenic effects. Although Consumer Reports stressed that many formulas did not contain dangerous levels of these chemicals, the presence of such substances raised significant concerns about the manufacturing processes behind baby formula.

What happens next?

The launch of Operation Stork Speed is a crucial step in addressing these concerns and ensuring that the infant formula industry prioritises safety and transparency. Consumer Reports has welcomed the FDA’s announcement but emphasised the need for sustained oversight and resources to make these changes a reality.

On March 18, Consumer Reports launched a petition calling on Health and Human Services Department Secretary Robert Kennedy Jr. to ensure that the FDA has the staffing necessary to execute Operation Stork Speed.

Looking forward

As Operation Stork Speed unfolds, parents and industry professionals alike will be closely monitoring the FDA’s efforts to meet rising demands for safer, more transparent, and higher-quality infant formula. The health of future generations at stake, the initiative aims to ensure that every parent feels confident in their baby’s nutritional start.