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Under the leadership of U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration (FDA) plans to increase testing of baby formula products as part of Operation Stork Speed.
HSS announced on March 18 that the FDA is working on a set of actions and initiatives that will focus on the quality of baby formula such as the nutrient review process and increasing testing for heavy metals and other contaminants.
“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,” Kennedy stated in a press statement. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”
The team at Consumer Reports, a nonprofit consumer organization, tested 41 baby formulas and found lead in nearly all the formulas. According to their tests, lead levels ranged from 1.2 ppb to 4.2 ppb, which is below the FDA’s “Closer to Zero” goal. However, Consumer Reports experts believe those levels are still too high.
According to the FDA, the most serious effects of lead exposure can happen during times of “active brain development.” High levels of exposure to lead in infancy, and early childhood can lead to neurological effects such as learning disabilities and behavior difficulties.
“The FDA is deeply committed to ensuring that moms and other caregivers of infants and young children and other individuals who rely on infant formula for their nutritional needs have confidence that these products are safe, consistently available, and contain the nutrients essential to promote health and wellbeing during critical stages of development and life,” stated Acting FDA Commissioner Dr. Sara Brenner.
Operation Stork Speed will also encourage companies to create new infant formulas and find ways to inform consumers about formula ingredients.
While the FDA does not approve infant formulas, baby formula manufacturers must notify the agency before marketing a new formula. FDA staff reviews these notifications to confirm if the new formulas meet federal nutrition, labeling, and other requirements. If a product does not meet the requirements, the FDA can classify the formula as contaminated, or misbranded and has the authority to take enforcement action.
Experts at Consumer Reports also tested all the formulas for Per- and polyfluoroalkyl substances or PFAS, often called “forever chemicals,” because they can exist in the body for a long time, PFAS are human-made synthetic chemicals that have been used in consumer products since the 1950s.
Consumer Report experts found some of the thousands of PFAS compounds in nearly all the baby formulas they tested. However, experts noted that many of the PFAS compounds found were less widely understood than the compounds whose health risks are more widely recognized.
In the coming months, the FDA will start the nutrient review by issuing a Request for Information to begin “the first comprehensive update and review of infant formula nutrients by the FDA since 1998.” The agency is also collaborating with the National Institutes of Health (NIH) and other scientific institutions to address research gaps regarding short- and long-term health outcomes associated with formula feeding.