Stork speed is ongoing.
The initiative, published in mid-March by US Health and Human Services Secretary Robert F. Kennedy Jr., charges the US Food and Drug Administration, which leads the first comprehensive update and review of infant formula nutrients since 1998.
“We’re going to make prescriptions for American toddlers the world’s gold standard,” Kennedy said in an Instagram post about the initiative.
The latest information on the Formula is stated by Dr. Thomas Brenna, professor of pediatrics, chemistry and human nutrition at the University of Texas at Austin’s Dell School of Medicine. Brenna is a member of the new FDA review panel on infant formula meetings in Washington on Wednesday. The group has met once online, and this will be their first face-to-face meeting.
The FDA’s final comprehensive review, published in 1998, “I sought a reevaluation of fatty acids in infant formulas within five years for all the research that was being done in the 1990s. I was one of the people doing them,” Brenna said. “And here we are in 2025. There’s a lot of discussion there.”
Dr. Roger Clemens, a faculty member of the Global Medicine Program at Keck School of Medicine at the University of Southern California in Los Angeles, said the panel stocks experts who have been investigating the nuances of infant formula nutrition for many years.
“I have 50 years of experience myself, some others are close. So I’m sure I have 500 years of experience with this group in areas of real importance, such as carbohydrates, fats, proteins, amino acids, and more.”
“We hope that the public will also make comments. All public comments are scheduled for September 11th, and we hope that hundreds of people will tell us what is in their minds,” he added.
The rise in backlash against using seed oil to provide fat is one of the 30 nutrients federal guidelines must include in infant formulas, built among Kennedy’s American healthy movements and several anti-additive food activists and social media influencers.
“Seed oils are one of the most unhealthy ingredients we have in our food,” Kennedy told Fox News last fall, adding that seeds are “related to all kinds of very serious illnesses, including inflammation throughout the body that affects our health.”
But reality is much more subtle than that, especially when it comes to prescribing for toddlers, said Brenna, a pediatrician who spent decades studying omega-6 and omega-3 fatty acids.
“Many health concerns stem from how heavily the oil is processed,” Brenna said. “Some people suggest moving from seeds to palm oil, not from seeds, but in a way, they are treated more strictly than seed oil.
“I think we should focus on gentle ways to extract all the oils because they need to be processed to use,” he said.
Choosing the right source and amount is important, Brenna said, as about 47% of the calories in infant formulas must be from fat.
As present, federal guidelines require minimal levels of 30 nutrients, including major vitamins, minerals and fats, proteins, and linoleic acid. Only 10 nutrients have been set to a maximum level.
Omega-3 fatty acids docosahexaenoic acid, or DHA, and plant-based alpha-linolenic acid, or important lipids for infant brain development, such as ALA, were not part of federal guidelines. (Many formula manufacturers have added DHA since 2001 under the FDA’s “generally recognized as safe” or GRAS designation.)
“We are one of the only countries in the world that do not require a variety of fats in infant formulas,” Brenna said. “Everyone else is updating their standards and we’re sitting still.”
Another area of concern is the types of carbohydrates used in “sensitive” or “moderate” infant formulas sold to parents who are concerned about lactose intolerance.
“Lactose, a natural sugar, is the only source of carbohydrate energy in human breast milk,” says Golan, who is also the program director for nutrition and obesity at the Saban Institute at Children’s Hospital Los Angeles.
However, the 1998 guidelines do not require lactose to carbohydrates added to infant formulas, nor do the types of carbohydrates that parents should list on the label for their choice, Goran says.
“Many formulas for babies on sale today are made with glucose-based corn syrup solids rather than lactose,” he said. “This is all based on this myth that (so-called) “slow” infants have lactose intolerance.
Many nutritionists believe that corn syrup is processed like sugar by the body, but a new, unpublished study by Golan and his team considers that view.
The 6-month-old baby wore a glucose monitor for three days to see how blood sugar reacted to the corn syrup-based formula compared to babies with breast milk and traditional lactose sweet formulas. An overview of that study will be presented during the panel meeting on Wednesday.
“We showed that giving those babies to corn syrup just makes the blood sugar overdrive,” Golan said. “However, infants who drank traditional lactose-based formula had similar glucose levels to those breastfed babies.”
A study by researchers at the Children’s Hospital of Los Angeles has found that babies who have been sweetened with corn syrup “can eat up to 60 grams of sugar per day.
In another study published in 2023, researchers at the Children’s Hospital also found that babies given the corn syrup-based formula are 10% more likely to become obese by the age of four.
“High levels of dietary sugars can affect brain development, memory and learning performance in children,” Golan said.
In terms of safety, many parents remember the lack of decontamination at the infant formula manufacturing plant owned by Abbott Nutrition, which contributed to a serious shortage of infant formula in 2022.
An FDA inspection determined that Abbott was negligent after the company recalls some Simirack, Alimentum and Elecare formulas made at its manufacturing plant in Sturgis, Michigan. The recalled prescription was associated with severe Chronobacter Sakazakii and Salmonella infections in five infants. Two babies with Chronobacter infection have died.
There are other safety issues to consider, Clemens said.
“We want to look beyond traditional safety and a lot of topics come to mind,” he said. “We need to address new pathogens in the food supply. We recommend looking at more than bacterial contaminants and looking at viruses and fungi.”
Furthermore, the US has not set standards for heavy metals. Clemens said:
A recent consumer report survey found studies on arsenic levels and lead in some samples of 41 infant formulas, but the majority of reports on heavy metals focus on baby foods. In 2021, a council survey found that major baby food manufacturers were deliberately selling baby food that had broken down with an astonishing level of toxic metals.
Keeping your child’s formula progress up to date, said Dr. Stephen Abrams, a review panel member and neonatologist, and Dr. Stephen Abrams, a professor of pediatrics at the University of Texas’ Dell School of Medicine, Austin.
“If you talk about oils, new carbohydrate sources, and even new protein sources, you need a more efficient method to get more efficient methods, such as clinical trials,” Abrams said.
“The FDA has never fully addressed the issues of inaccurate labeling in the formula market, false marketing claims, or anything like that,” he added.
Another issue is providing additional support for the rise in donor milk programs in the US. According to the American Academy of Pediatrics, breast milk is best suited to the health of a baby, and mothers who cannot or cannot breastfeed should have the option to obtain the milk from their donor, Abrams said.
“With one exception, these milk banks are all nonprofits and need additional support to grow,” he said. “There’s a lot of donor milk out there and the US is not close to its ability to support the milk bank itself.”
Other concerns will be raised by other members of the review panel on Wednesday. Still, parents shouldn’t take a review as a sign that the US formula market is either confused or harmful to young children, Abrams said.
“It’s not that there’s a risk to the infant formula we sell today, but our regulations are for ’80s ceremonies that are no longer on sale,” he said. “We need an update.”