FDA Launches ‘Operation Stork Speed’ to Improve Infant Formula Safety, Including Contaminant Testing
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The U.S. Food and Drug Administration (FDA) is launching “Operation Stork Speed,” which is an effort to better ensure the ongoing quality, safety, nutritional adequacy, and resilience of the U.S. infant formula supply.
Advocacy group Consumer Reports says that FDA announced Operation Stork Speed one day after it shared with the agency the results of independent testing showing some infant formula samples to contain potentially harmful levels of certain contaminants. Although Consumer Reports expressed approval about the new FDA initiative, the group is also calling upon the U.S. Department of Health and Human Services (HHS) to ensure FDA is adequately resourced to deliver on its promises.
Operation Stork Speed will include actions such as:
- Beginning the first comprehensive update and review of infant formula nutrients by FDA since 1998, starting with the issuance of a Request for Information in the coming months
- Increasing testing for heavy metals and other contaminants in infant formula and foods commonly consumed by young children
- Extending the personal importation policy, which allows U.S. citizens to personally bring or ship into the country certain foreign products that are not for sale on the domestic market
- Encouraging companies to work with FDA on any questions regarding increased transparency and clear labeling
- Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
- Collaborating with the U.S. National Institutes of Health (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.
FDA is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. The announcement of Operation Stork Speed follows FDA’s publication of a long-term strategy to increase the resiliency of the U.S. infant formula market, released in January.
HHS Secretary Robert F. Kennedy Jr. (RFK Jr.) says Operation Stork Speed is in alignment with his “Make America Healthy Again” agenda.
Consumer Reports Raises Concern About Contaminants in Some Infant Formulas, Questions Whether FDA is Adequately Resourced to Deliver on Operation Stork Speed
Consumer Reports lauded the stated objectives of Operation Stork Speed, noting that the agency announced the new initiative just one day after the group shared with FDA the results of its own investigation of contaminants in infant formula.
“We look forward to seeing the details of how they intend to implement the plan, and we hope FDA is provided adequate resources and staffing to actually follow through with these promises,” said Consumer Reports Director of Food Policy Brian Ronholm. Following the announcement of Operation Stork Speed, Consumer Reports launched a petition calling on HHS and Secretary Kennedy to ensure that FDA has the staffing and resources necessary to keep harmful contaminants out of infant formula.
As part of its Toxic-Free Kids’ Food campaign, Consumer Reports tested 41 different powdered infant formulas, including well-known formulas like Enfamil and Similac, new startups, popular store brands, and imported formula brands, to discern whether they contained toxic heavy metals and other contaminants. Although the majority of samples tested did not raise any red flags, certain formulas contained toxic heavy metals arsenic and lead, per- and polyfluoroalkyl substances (PFAS), bisphenol A (BPA), and acrylamide.
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More specifically, the highest levels of inorganic arsenic were found in Abbott Nutrition’s EleCara Hypoallergenic formula at 19.7 parts-per-billion (ppb), followed by Similac Alimentum (also manufactured by Abbott) at 15.1 ppb. By comparison, the U.S. Environmental Protection Agency (EPA) limits inorganic arsenic in municipal drinking water to 10 ppb. While most of the formulas Consumer Reports tested contained arsenic at non-concerning levels, eight formulas exceeded and two formulas came close to meeting Consumer Report’s “hazard quotient,” determined by Consumer Reports to be the level at which no adverse health effects would be expected to occur (based on a three-month-old infant of average size eating an average amount each day).
Additionally, Consumer Reports found lead at some level in 34 out of the 41 formulas tested, ranging from 1.2–4.2 ppb, with the highest level found in Enfamil Nutramigen at 4.2 ppb, followed by Neocate Hypoallergenic formula at 4.1 ppb. None of the formulas tested had levels that exceeded the Maximum Allowable Dose Level (MADL) set by California, the metric chosen by Consumer Reports as its standard for ensuring child safety. However, 18 of the formulas had lead levels at 50–100 percent of the MADL.
Consumer Reports also tested the formulas for per- and polyfluoroalkyl substances (PFAS). Many of the PFAS found in the samples were lesser-understood PFAS compounds—as opposed to “legacy PFAS” chemicals, for which the health risks are understood and for which EPA has established maximum limits in drinking water. Perfluorooctane sulfonate (PFOS), a legacy PFAS, was found in several formulas, however.
Finally, BPA and acrylamide (a likely carcinogen) were found in one formula, Enfamil’s Nutramigen, which is a commonly recommended alternative to cow’s milk formula for babies sensitive to milk protein.
