FDA announces Operation Stork Speed to strengthen oversight on infant formula after CR shares its testing results with agency
YONKERS, NY – A new Consumer Reports investigation of infant formulas found that some of the products tested contained potentially harmful levels of arsenic and lead. CR also found per- and polyfluoroalkyl substances (PFAS) in almost all the infant formulas tested and one that contained both bisphenol A (BPA) and Acrylamide. Fortunately, most of the baby formula in CR’s tests did not contain concerning amounts of contaminants and chemicals.
“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, PhD, 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.”
One day after CR shared its test results with the FDA, the agency announced Operation Stork Speed to “enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.”
“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.”
CR’s investigation is part of its Toxic-Free Kids’ Food campaign, which aims to encourage policymakers and manufacturers to protect children from harmful dyes, heavy metals and chemicals in their food. CR launched a petition today calling on Health and Human Services Department Secretary Robert Kennedy, Jr. to ensure that the FDA has the staffing and resources necessary to keep harmful contaminants out of infant formula.
CR’s food safety team tested 41 different powdered infant formulas, including well-established formulas like 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.
What Consumers Should Do:
- Keep these test results in perspective: Environmental pollutants are pervasive in our food supply and all of the contaminants CR detected in formula have been found in breast milk, food, and water in previous studies.
- Talk to your pediatrician: If you’re concerned about CR’s test results and are thinking about switching the formula you feed your baby, talk to your pediatrician first.
- Never try to make your own formula or offer alternative foods: Getting the right concentrations of nutrients, electrolytes, and fluid in formula is crucial, and virtually impossible to do at home, experts say.
- Use clean water to mix your powdered formula: The EPA sets limits on contaminants in tap water for most of the country, but not every part of it. If you drink water from a well, for instance, that water is not regulated by the EPA. So it’s a good idea to get well water tested for heavy metals and PFAS before using it. You can contact your local health authorities with questions, and if you have concerns about environmental pollutants particular to your area, consider using bottled water or investing in a filtration system.
“Parents shouldn’t have to worry that the infant formula they are feeding their newborn might contain toxic chemicals that could endanger their young child’s health,” said Ronholm.. “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.”
Media Contact: Michael McCauley, michael.mccauley@consumer.org