RFK Ordered The FDA To Review Baby Formula In The US

In March, Health and Human Services (HHS) Secretary Robert Kennedy announced the implementation of Operation Stork Speed, an initiative designed to ensure ongoing quality, safety, and nutritional adequacy of infant formula in the U.S., as well as shoring up the resilience of domestic formula production. This is the first re-evaluation of formula nutrients since 1998.

“The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” Kennedy said in a statement. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”

Among the initiatives tasked to the FDA, under the leadership of Marty Makary, Operation Stork Speed seeks to review the nutritional requirements of infant formula; increase testing for heavy metals and other environmental and manufacturing contaminants; promote clearer labeling and reassess allowable marketing claims for formula; and promote scientific research on formula feeding regarding short-and-long-term health outcomes.

Earlier today, Makary gathered a panel of experts for what he categorized as a “true listening session” to improve formula options and manufacturing in the US.

“As you know, moms want to see more options for formula. They want to see formula options without seed oils, they want to see formula options without corn syrup, they want to see formula options without added sugar,” he discussed in his introductory statements. “And some of those are already on the market, and then other spaces we, as a regulatory body, can help facilitate some of that innovation.”

Indeed, many infant formulas do not contain corn syrup, and many that do contain corn syrup do not solely rely on corn syrup as a carbohydrate. Corn syrup (also referred to as corn syrup solids) are a simple, corn-derived sugar called glucose and is different from high fructose corn syrup (HFSC) — a combination of glucose and fructose, a naturally occurring sugar found in fruits. Glucose provides necessary carbohydrates for infants who cannot consume or digest the primary carbohydrate present in most infant formulas (and breast milk), lactose. There is no infant formula in the U.S. that contains HFSC.

Seed oils — which are currently viewed skeptically by many in the so-called MAHA movement — are a source of necessary fat in infant formula which can only be found in seed oils, fruit oils (olive oil, palm oil) or cow’s milk fats. They are also present in European formulas, which are often touted as superior to American-made infant formula.

Still, there have not been many innovations within the formula space for decades, and Makary points out that the U.S. is overdue for re-examining the possibilities that might be available in this vital space.

“In my view, the field of medical science does not stay stagnant for 26 years in any space, and it’s hard to believe that is the only sort of enlightened moment that we’ve had in understanding how best to nourish children,” he said, continuing, “We have to acknowledge that we all want the same thing: there are no malicious actors and we have to see the best in everybody. And this should not be an us versus them with any stakeholder group or any innovator, developer, or company out there. This is an expert forum to ask how can we think collectively about what’s best for some of the most vulnerable in our nation.”

Over the course of two hours, panelists discussed how infant formula formulation, production, and supply chains might be improved or at least expanded to provide parents with more options. Many highlighted the disaster of formula shortages during the Covid-19 pandemic when many families scrambled to find food for their babies after one of the few large producers of infant formula — European regulations, as well as Canadian and Australian models, were brought up as avenues to examine and learn from, but most of the experts cautioned that such regulatory paradigms should not simply be adopted whole cloth.

Many panelists highlighted the need for improved regulations on formula marketing. Michael Goren, Vice Chair of Research and Professor of Pediatrics at the Keck School of Medicine at the University of Southern California observed that over the past few decades, carbohydrates (sugars) not found in breast milk have been added to infant formula. While he concedes that this is sometimes necessary, particularly for preterm infants who cannot digest lactose, or babies with particular health conditions, lactose is the better choice for carbohydrate in formula.

“Lactose is the sole carbohydrate, energy source, in breast milk … [glucose] is a very different type of sugar and it’s handled quite differently in the body,” he explained. “Advertising and marketing claims based on the concept of lactose intolerance in babies [has prompted] gentle formulas, or marketed towards fussy babies, but actually the fact is that almost all full-term babies can digest lactose.”

Overall, the panel was far from repudiation of American-made infant formula that some, perhaps, had expected from this administration.

“The most important thing I think everyone has to take home, for the public, is that the infant formula that’s sold in the United States is produced safely, is used safely, helps babies grow safely, and has been associated with tens of millions of babies safely making to through infancy,” said Steven Abrams, a doctor and professor of pediatrics at Dell Medical School at the University of Texas at Austin. “What we’re trying to do here is to improve it … no one should take home the idea that one has to get formula from another country, another part of the world for safe and effective infant formula. In fact, many options are already there and our goal is simply to improve what’s already an effective product.”

It is unclear how the various initiatives suggested, from increased inspection and research, will be accomplished as the HHS budget and staff face tremendous cuts, but a commenting period from scientists and other researchers will be ongoing through September 11 of this year.