Operation Stork Speed Prepares to Overhaul U.S. Baby Formula Guidelines

Operation Stork Speed was launched last March to bring U.S. infant formula standards into the modern era. During their first six months of life, many infants get some or all of their calories from formula, but federal rules governing what goes into those bottles haven't been updated in decades. This spring, the U.S. Food and Drug Administration plans to release a report that reviews contaminants in formula and required ingredients.

Most guidelines around infant formula date back to 1985, with only some minor amendments thereafter. The results of the FDA review are expected to be unveiled in April. The report will likely include a nutrient review of ingredients, such as fatty acids, as well as new safety protocols to minimize contaminants and prevent the type of outbreaks that have caused recent formula shortages and recalls in the U.S. and abroad.

Unlike the European Union and Australia, the United States has not set maximum allowable levels for any environmental contaminants in baby formula. This includes, for example, lead, tin, cadmium, arsenic and others. Recent reports have shown that nearly half of the powdered formulas on the U.S. market contain detectable levels of lead or arsenic.

While these metals are often trace amounts found naturally in the environment, the administration is looking to set much stricter limits. The Health and Human Services secretary has said the regulations are based on old science that fails to account for modern health concerns.

Some of the more controversial goals championed by the Make America Healthy Again movement — such as removing seed oils — may have hit a wall of scientific and industrial reality. Manufacturers and pediatricians point out that these oils provide linoleic acid, an essential fat that is also found in breast milk. Swapping them out without a clear, safe alternative could disrupt the delicate balance of infant nutrition, they warn.

A string of high-profile formula recalls has fueled the push for change. Recently, major infant formula brands have had issues with bacterial contamination, reminding parents and policymakers that the supply chain remains fragile.