The FDA has launched a program, titled Operation Stork Speed, to help ensure the safety of infant formula. The Food and Drug Administration’s action comes as Consumer Reports releases findings on heavy metals and other contaminants in infant foods. The FDA’s program — aspects of which are already required by… Continue Reading Food Policy & Law, Consumer Reports, heavy metals, infant formula, Operation Stork Speed Food Safety News
The FDA has launched a program, titled Operation Stork Speed, to help ensure the safety of infant formula.
The Food and Drug Administration’s action comes as Consumer Reports releases findings on heavy metals and other contaminants in infant foods.
The FDA’s program — aspects of which are already required by law — includes beginning a nutrient review process. The Consumer Reports findings show that some infant formula contains harmful levels of arsenic and lead.
With Operation Stork Speed, the FDA plans to increase testing for heavy metals and other contaminants. Actions within the program will take several months to initiate.
“The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients,” according to the FDA.
The FDA action follows a fatal 2022 outbreak of cronobacter infections linked to infant formula. That outbreak spurred Abbott Nutrition to recall its infant formulas, including the popular brand Similac. The recall sparked a nationwide shortage of infant formula that saw many store shelves empty for weeks. Parents reported driving for hours to find the needed formula to keep their babies alive.
The FDA plans to:
- Start the nutrient review required by law by issuing a Request for Information in the coming months to start the first comprehensive update and review of infant formula nutrients by the FDA since 1998
- Increase testing for heavy metals and other contaminants in infant formula and other foods children consume
- Encourage companies to work with the FDA on any questions regarding increased transparency and clearer labeling
- Communicate regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
- Collaborate with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan
The Consumer Reports study
In addition to testing infant formulas for heavy metals and arsenic, Consumer Reports tested for per- and polyfluoroalkyl substances (PFAS) and found the substances in almost all formulas it tested. It also found one formula with both bisphenol A (BPA) and Acrylamide.
“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,” said James Rogers, director of product safety testing at Consumer Reports.
“Our tests found that some infant formulas had concerning levels of arsenic and lead that could pose health risks for young children. The good news is that most of the samples we tested did not pose these risks, demonstrating that it’s possible to produce baby formula without these dangerous contaminants and that safer alternatives are widely available.”
Consumer Reports shared its findings with the FDA before the agency’s announcement of its new program. The group expressed concern that the FDA might not have the staffing required to implement Operation Stork Speed.
“It’s very encouraging to see the FDA issue this announcement after Consumer Reports shared our findings about contaminants in infant formula,” said Brian Ronholm, director of food policy at Consumer Reports.
“We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is provided adequate resources and staffing to actually follow through with these promises.”
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.
“At a time when many federal agencies like the FDA are facing staffing cuts, it is critical for HHS Secretary Kennedy to make sure the FDA has the resources necessary to ensure that all infant formula is free of dangerous levels of harmful contaminants,” Ronholm said.
Specific findings from Consumer Report’s (CR) testing
Consumer Report’s food safety team tested 41 different powdered infant formulas, including popular Enfamil and Similac, new startups, popular store brands, and imported formula brands, to find out if they contained dangerous heavy metals and other contaminants. Among CR’s key findings:
● Arsenic: CR found the highest levels of inorganic arsenic in Abbott Nutrition’s EleCara Hypoallergenic (19.7 ppb) and the second highest in Similac Alimentum (15.1 ppb), also made by Abbott. By comparison, the EPA limits inorganic arsenic in municipal drinking water to 10 ppb. While most of the formulas CR tested had arsenic levels below levels of concern, eight formulas were over CR’s risk level and two more were very close to it. Inorganic arsenic is the most toxic form of arsenic and is a known carcinogen for people of all ages. It can contaminate groundwater as well as soil and the food that grows in it.
● Lead: CR found lead at some level in 34 out of the 41 formulas tested, ranging from 1.2 ppb to 4.2 ppb, with the highest level found in Neocate Hypoallergenic. None of the formulas tested had levels that exceeded the Maximum Allowable Dose Level (MADL) set by California, a metric CR chose for its tests to ensure child safety. However, 18 of the formulas had lead levels that made up 50 to 100 percent of the MADL. Exposure to lead can have profound neurological effects on babies. Lead can contaminate food through the soil it is grown in or through water used for irrigation.
● PFAS: Many of the PFAS compounds CR found in its tests are less widely understood than “legacy PFAS” chemicals whose health risks are well known and for which the EPA has set limits in drinking water. CR did find PFOS, one of the older PFAS compounds, in several models of formula. But CR only tested one sample from each brand, so more testing is needed to definitively say which brands have PFAS and which ones don’t.
● BPA and Acrylamide: CR found BPA and Acrylamide in just one formula: Enfamil’s Nutramigen, which is a commonly recommended alternative to cow’s milk formula for babies sensitive to milk protein. Research has found that BPA can leach out of plastic into food and that it is an endocrine disruptor in humans. Acrylamide is a byproduct of a chemical reaction that occurs during the manufacturing process and is classified by the EPA as a likely carcinogen.
(To sign up for a free subscription to Food Safety News, click here)
