RFK Jr. is investigating infant formula. Here’s what’s at stake

Operation Stork Speed is underway. Announced in mid-March by US Health and Human Services Secretary Robert F. Kennedy Jr., the initiative charges the US Food and Drug Administration with leading the first comprehensive update and review of infant formula nutrients since 1998. “We’re going to make American infant formula the gold standard for the world,” Kennedy said in an Instagram post about the initiative. The update on formula is long past due, said Dr. Thomas Brenna, a professor of pediatrics, chemistry and human nutrition at the Dell Medical School at the University of Texas at Austin. Brenna is a member of the new FDA review panel on infant formula that is meeting in Washington on Wednesday. The group has met once online, and this will be the first in-person meeting. The FDA’s last comprehensive review, released in 1998, “called for a reevaluation of the fatty acids in infant formula within five years because of all the studies that were going on in the 1990s; I was one of the people doing them,” Brenna said. “And so here we are in 2025, and much needs to be discussed.” The panel is stocked with experts who have been investigating the nuances of infant formula nutrition for years, said panel member Dr. Roger Clemens, a faculty member in the global medicine program at the Keck School of Medicine at the University of Southern California in Los Angeles. “I myself have 50 years of experience, and several others are close, so I’m sure we have 500 years of combined experience in this group in areas of genuine significance, such as carbohydrates, fats, proteins and amino acids,” said Clemens, who also served as a scientific adviser to Nestlé USA for over 10 years and is a consultant on medical nutrition. “We hope the public will comment, as well. All public comments are due on September 11, and we hope hundreds of people will tell us what’s on their minds,” he added. Revisiting the source of fats in formula A growing backlash against using seed oils to provide fat, one of the 30 nutrients that federal guidelines say must be included in infant formulas, has been building within Kennedy’s Make America Healthy Again movement and among some anti-additives food activists and social media influencers. “Seed oils are one of the most unhealthy ingredients that we have in foods,” Kennedy said in an interview with Fox News last fall, adding that seed oils are “associated with all kinds of very, very serious illnesses, including body-wide inflammation, which affects all of our health.” However, the reality is much more nuanced than that, especially when it comes to infant formula, said Brenna, a pediatrician who’s spent decades studying omega-6 and omega-3 fatty acids. “A lot of the health concerns stem from how heavily the oils are processed,” Brenna said. “Some suggest moving to palm oil, which is not from a seed, but in some ways, it’s processed more harshly than seed oils. “All oils must be processed to be used, so I believe we should be focusing on milder ways of extracting all of the oils,” he said. About 47% of calories in infant formula must be from fat, so choosing the right sources and amounts is key, Brenna said. As they currently exist, federal guidelines require minimum levels of 30 nutrients, including key vitamins, minerals and fats, proteins and linoleic acid, an essential fatty acid the body cannot make on its own. Only 10 nutrients have set maximum levels. Important lipids for infant brain development, such as the omega-3 fatty acid docosahexaenoic acid, or DHA, and the plant-based alpha-linolenic acid, or ALA, have never been part of the federal guidelines. (Many formula makers have been adding DHA since 2001 under the FDA’s “generally recognized as safe” or GRAS designation.) “We’re one of the only countries in the world that doesn’t require a range of fats in our infant formulas,” Brenna said. “Everybody else has been updating their standards, and we have been sitting still.” Consider source of carbohydrates in formula Another area of concern is the types of carbohydrates used in some “sensitive” or “gentle” infant formulas marketed to parents concerned about lactose intolerance, said Dr. Michael Goran, a professor of pediatrics and vice chair for pediatric research at the Keck School of Medicine at the University of Southern California, who is also on the review panel. “Lactose, which is a natural sugar, is the only carbohydrate energy source in human breast milk,” said Goran, who is also program director for nutrition and obesity at the Saban Research Institute at Children’s Hospital Los Angeles. However, the 1998 guidelines do not require the carbohydrates added to infant formula to be lactose, nor are the types of carbs required to be listed on the label so parents can choose, Goran said. “A great many of the infant formulas sold today are made with glucose-based corn syrup solids and not lactose,” he said. “Which is all based on this myth that (so-called) ‘fussy’ infants have lactose intolerance, which really is not a concern for most babies.” Although many nutritionists believe corn syrup is processed like sugar by the body, new unpublished research by Goran and his team counters that view. Six-month-old babies wore glucose monitors for three days to see how their blood sugars responded to corn syrup-based formula, compared with babies on breast milk or traditional lactose-sweetened formulas. A brief of that research will be presented during the panel’s meeting Wednesday. “We showed that when you give those babies corn syrup, it just makes their blood glucose sugars go into overdrive,” Goran said. “But the infants who drank traditional lactose-based formula had glucose levels similar to breast-fed infants.” An analysis of the nutrient component of corn syrup-based and lactose-based formulas by researchers at Children’s Hospital Los Angeles found that babies drinking formulas sweetened with corn syrup “could consume up to 60 grams of added sugar a day — the equivalent of two sodas worth of sugar,” according to a brief on the study. In a separate study published in 2023, Children’s Hospital researchers also found that babies fed corn syrup-based formulas were 10% more likely to be obese by age 4. “High levels of dietary sugar can have an impact on children’s brain development and memory and learning performance,” Goran said. Updates to safety concerns When it comes to safety, many parents remember the lack of decontamination at an infant formula manufacturing plant owned by Abbott Nutrition that contributed to severe shortages of baby formula in 2022. The FDA inspection determined that Abbott was at fault after the company recalled several lots of Similac, Alimentum and EleCare baby formula made at its Sturgis, Michigan, manufacturing plant. The recalled formulas were linked to serious Cronobacter sakazakii and Salmonella infections in five infants. Two babies with Cronobacter infections died. There are other safety issues to consider, said Clemens, who is also past president of the Institute of Food Technologists and the International Academy of Food Science and Technology. “We want to look beyond traditional safety, and a number of topics come to mind,” he said. “We need to address emerging pathogens in the food supply. I’m going to suggest we look at more than bacterial contaminants and consider viruses and fungi, as well.” Nor has the US set standards for heavy metals, Clemens said: “Yet tests find arsenic and lead in formula and baby foods.” A recent Consumer Reports investigation found concerning levels of arsenic and lead in some samples from 41 infant formulas, but the majority of the reports on heavy metals have focused on baby foods. In 2021, a congressional investigation found that leading baby food manufacturers knowingly sold baby foods with alarming levels of toxic metals. Bring infant formula into the 21st century Keeping up-to-date with advances in infant formula means those changes need to be tested via the scientific process, said review panel member and neonatologist Dr. Steven Abrams, professor of pediatrics at the Dell Medical School at the University of Texas at Austin. “If we’re going to talk about novel ways of putting together oils, novel carbohydrate sources and even novel protein sources, there has to be a more efficient way to get those vetted, such as in clinical trials,” Abrams said. “Nor has the FDA fully addressed issues of inaccurate labels, false marketing claims and things of that sort in the formula market,” he added. Another issue is providing additional support for the growing number of donor breast milk programs in the US. Breast milk is still best for a baby’s health, according to the American Academy of Pediatrics, and mothers who can’t or don’t want to breast feed should have the option of obtaining that milk from donors, Abrams said. “Except for one, all of these milk banks are nonprofits and need additional support to grow,” he said. “There’s a lot of donor milk out there, and the US is nowhere near maxed out on its capacity to support the milk banks themselves.” Other concerns will be presented Wednesday by other members of the review panel. Still, parents should not take the review as a sign that the US formula market is in disarray or in any way harmful to infants, Abrams said. “It’s not that there’s a danger in the infant formula we’re selling today, but our regulations are for formulas from the ’80s we no longer sell,” he said. “We are in dire need of an update.”