HHS, FDA Launch “Operation Stork Speed” to Investigate Baby Formula Safety and Nutrition

HHS and FDA announced “Operation Stork Speed” to evaluate the safety and nutrition of baby formula. The announcement came on the same day that Consumer Reports released its results after testing 41 different baby formulas on the market. The organization said about half of the products it tested came back with “potentially harmful levels of at least one contaminant.”

Acting FDA Commissioner Sara Brenner, M.D., M.P.H. said, “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. 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.”

As part of Operation Stork Speed, the FDA will begin the first comprehensive review and evaluation of baby formula since 1998. The agency will increase testing for heavy metals and other contaminants.

Consumer Reports tested the infant formulas for arsenic, but there are currently no established limits for formula. The products with the highest levels of arsenic are made by Abbott Nutrition – EleCare Hypoallergenic came in at 19.7 ppb and Similac Alimentum had 15.1 ppb. Abbott released a statement to Consumer Reports and said it was concerned about the methodology. Heavy metals exist in the environment and “may be present in trace amounts in food products, including infant formula and even human breast milk.”

Consumer Reports developed a hazard quotient, which is a level that is not expected to cause adverse effects for a 3-month-old average-sized infant eating an average amount every day. The organization reports that eight formulas were over the limit, and two more were very close. EPA has a limit of 10 ppb for drinking water, which is the same limit the FDA has for bottled drinking water.

David Carpenter, MD, director of the Institute for Health and the Environment at the State University of New York at Albany, told Consumer Reports that the source of the arsenic could be from contaminated drinking water added to the product before it is dehydrated and packaged.

“There is no excuse for having arsenic in baby food or formula,” Carpenter said. “Absolutely none. The industry should be bending over backward to be certain it’s not there.”

Lead testing found all the products had between 1.2 ppb and 4.2 ppb, which falls below the FDA’s goal. Consumer Reports cited experts who indicate that it is “virtually impossible” to reduce the amount of lead to zero, but at the same time, “there is no safe level of lead exposure.”

Consumer Reports also tested for PFAS and found some forever chemicals in “almost all” of the products it tested. The organization quoted Courtney Carignan, an environmental epidemiologist at Michigan State University, who said: “I don’t think parents can choose their way away from PFAS in their infant’s diet—it’s more of a closer to zero mentality that we need to start taking when it comes to PFAS in food.”

The FDA will also extend the personal importation policy that was broadened to allow individual imports of baby food formula during a 2022 shortage. The European Union has banned corn syrup and other added sugars from all infant formulas. The majority of U.S. baby formulas use lactose as the primary carbohydrate from milk. For hypoallergenic formulas, the primary ingredient is often corn syrup.

Operation Stork Speed also includes a collaboration with the NIH “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.”

Zen Honeycutt and Moms Across America conducted their own study measuring heavy metals in infant formula. Honeycutt appeared on The HighWire in June to share the results with guest host Tracy Beanz. They evaluated 40 different products and tested each baby formula two times. They found all of the samples contained aluminum and lead. 80% had higher levels of lead than the EPA allows for drinking water.

57% of the samples had arsenic, 55% had mercury, and 35% were positive for cadmium. The formula that had the highest level of aluminum contained levels 200x the EPA level allowed in drinking water.

The posted results state, “The top-scoring, least contaminated baby formulas tested were Kirkland ProCare Non-GMO infant formula, Similac Sensitive infant formula, and PurAmino hypoallergenic powder infant formula. The lowest scoring and most contaminated baby formulas tested were Total Comfort Infant Formula, Up & Up Gentle Premium Powder Infant Formula, Up & Up Non-GMO Hypoallergenic Powder Infant Formula, Enfamil Plant-Based Soy Powder Infant Formula.”

The Consumer Reports study also noted that one formula had detectable levels of bisphenol A (BPA) and acrylamide. BPA has been banned for use in baby bottles and infant formula packaging. Acrylamide is classified as a likely carcinogen by the EPA. BPA and acrylamide were detected in Enfamil’s Nutramigen, which is often recommended for children who have sensitivity to milk protein.

In August, The HighWire reported about the Biden administration’s effort to encourage other countries to weaken regulations on baby formula. ProPublica reported evidence of “meddling” in 21 different countries, plus Taiwan, Hong Kong, and the European Union. The campaign to weaken regulations worked in many instances over the course of decades, according to ProPublica.