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In May of 2025, the FDA announced a new review of infant formula nutrients called “Operation Stork Speed.” The FDA periodically reviews its formula regulations (the last time was in 1998), so this isn’t an unusual or concerning step, although Operation Stork Speed has gotten more media attention than past reviews. As is customary, there is an open period for comments; you can submit your own public comment here, which closes in September, after which the scientific review will begin. Based on this review, the FDA may change some aspects of their guidelines around infant formula nutrients, or they may not.
The idea of this review, while not new, is wrapped up in a much larger discussion of formula safety in recent years. The formula shortage in 2022, which started with recalls at a manufacturing plant, combined with rhetoric against formula ingredients (especially seed oils) from the Make America Healthy Again movement, has generated a lot of worry.
The core question: How much of this is founded in reality, and how much is misinformation?
Note: One issue that comes up over and over again is the “breast milk versus formula” debate, which I have covered extensively. (TLDR: The benefits of breast milk are short-term and overstated; formula is also an excellent option for feeding babies, and you should do what works for you and your family.) With that out of the way, I am going to focus on safety and ingredient issues.
A (very) brief history of infant formula
Historically, before the invention of formula, if a mother was unable to breastfeed, there were limited options for feeding infants. Having another woman nurse the child (sometimes called a wet nurse) was the most likely to result in survival. Animal milks — cow, goat, sheep — were sometimes used, but rarely successfully. The main problem is that these milks are not, on their own, sufficiently digestible by infants, and they do not contain the appropriate nutrients.
The first infant formula was developed in the late 1800s, and 1915 saw the first development of something close to the current infant formula. This product was based on cow’s milk (like most modern formulas) but with the milk processed to make it more digestible (diluting the protein content, adding more whey) and with added components. Since 1980, infant formula in the U.S. has been regulated by the FDA, following several safety issues in the 1970s, including a case in 1979 in which formula deficient in chloride caused illnesses and several deaths.
The last 100 years of formula development have focused mainly on making formula as close as possible to breast milk, assisted by an evolving understanding of breast milk components. For example, many formulas now add human milk oligosaccharides, a type of sugar thought to promote immune function.
Fully replicating breast milk is challenging, probably impossible, given that the composition of milk differs by person and changes over time even within a person. However, infant formulas have advanced considerably over time.
What does formula regulation look like, and how might it change?
The FDA strictly regulates the nutrient components of infant formula (for details, see this very in-the-weeds page). For a large number of nutrients and vitamins, they indicate a maximum and a minimum. Example: infant formula must contain between 1.8 and 4.5 grams of protein per 100 calories; it needs at least 0.5 ppm of zinc, and on and on. The FDA regulations imply both minimum and, in some cases, maximum amounts and also some ratios. They also have a lot of rules on labeling.
For this reason, the nutrient composition of all infant formulas in the U.S. is extremely similar. Where they differ, in some cases, is the ingredients that make up these nutrients. Different kinds of milk (say, cow versus soy) have different nutrient profiles, so they need different additions to hit the nutrient requirements.
The two most common formula brands in the U.S., Similac and Enfamil, have not only very similar nutrients but also very similar ingredient lists. Smaller formula brands and specialty formulas sometimes have different ingredients. This could involve using sunflower versus safflower oil or using organic rather than conventional ingredients. There is no concrete evidence to suggest these different ingredients lead to different outcomes.
The FDA does not “approve” infant formulas, but new formulas must be sent to the FDA for nutrient review before being marketed. If they are marketed without this review, they may be subject to enforcement action, including warning letters, recalls, civil suits, and fines. As with other foods, the FDA can also recall infant formula if there is a health risk (these would be listed here and likely covered extensively in the media).
So, what will Operation Stork Speed do, exactly? In making changes to infant formula regulations, the FDA could change the required nutrient profiles (adding more, changing amounts) or require new additions to infant formula. They could also limit the inclusion of particular ingredients in the formula, although their regulations generally have focused on nutrient balance. At this point, we have no clear sense of their specific agenda, nor do we know precisely who or how they will do the review.
Your questions on ingredients and safety
Many people are worried about changes to formula regulations because they have concerns — or feel confused — about the state of ingredients and safety in formula right now. When I asked you to share your top questions about formula, many of them revolved around these topics. I’m going to address your most common questions to help clarify these concerns and provide some context.
Are seed oils bad? Why are they in formula, and will the FDA remove them?
Over the past few years, we have been hearing a lot about seed oils (cooking oils like canola, safflower, sunflower) and their possible negative health effects. However, there is little or no good evidence to suggest seed oils have harmful health impacts. Therefore, the premise of this concern is flawed; seed oils are fine.
In addition, there is a good reason seed oils are in all infant formula, which is that they provide a source of fatty acids that are necessary to mimic breast milk (and are therefore required by the FDA).
It is extremely unlikely that the FDA would limit seed oil use in formula because it is necessary to mimic breast milk, and there are no viable alternatives.
Why is high fructose corn syrup in formula?
It isn’t.
Most infant formulas do not contain anything in their ingredient list that even looks like corn syrup. The carbohydrates contained in formula come from the sugars in the milk, which is typically the first ingredient.
Some lactose-free formulas contain corn syrup solids, which are not the same as high fructose corn syrup. They are carbohydrates derived from corn; these carbohydrates are necessary when it is not possible to have milk-based sugars. (Corn-based versions are preferable to sugar because they are more easily digestible and generally better tolerated by infants.)
Are European formulas better?
Some consumers in the U.S. swear by formulas made in Europe. Many of these formulas (for example, Holle) are not registered with the FDA and must be imported from Europe. This lack of FDA registration limits its oversight on possible recalls. There are some European formulas that meet FDA requirements, but they can occasionally be difficult to find.
Some parents prefer these formulas over those produced in the U.S. because the EU puts more stringent regulations on ingredients in the formulas. While the U.S. largely focuses on nutrient profiles, the EU also regulates the particular ingredient inputs. They require at least a certain share of calories to come from lactose, for example. Some European formulas, but not all, use whole milk rather than skim milk, replacing some plant-based fats with milk fats.
Does any of this mean they are “better”? This is not a well-defined question. There is no reason to think formulas made in the U.S. are dangerous or lead to bad outcomes for babies. In this sense, there isn’t much of a “better” margin. And, in practice, the actual ingredients in most of these formulas are extremely similar.
Goat milk vs. cow milk vs. some other milk?
Milk-based infant formula can be made with either goat or cow’s milk. There are no goat-milk-based formulas produced in the U.S., although some European formulas do use goat milk. There isn’t any clear reason to prefer one or the other; a baby with a reaction to cow’s milk is likely to also react to goat’s milk. The primary reason we typically use cow’s milk is that it’s a lot cheaper.
For infants who cannot consume cow or goat milk proteins, soy or other options may be available. These formulas tend to be more expensive but can be lifesaving for infants with severe reactions to milk protein. Infants with a reaction to milk protein are also at a higher likelihood of reacting to soy, so it may be necessary to experiment with different options depending on your child’s allergy.
Can I make my own formula?
No. To turn milk into formula, it needs to be processed to change the nutrient profile to better match breast milk. Then it needs to be combined with other nutrients, fats, and proteins. Online recipes to make your own formula are unlikely to hit these profiles. Making your own formula is subject to significant safety concerns, both about contamination and about a lack of nutrients. Put simply, this is dangerous.
But how do I know that formula is safe?
The FDA regulates formula the same way it regulates other foods, with periodic checks, inspection of production facilities, and monitoring of any adverse reports. This is how we keep the food supply safe in general and formula, too.
Closing thoughts
I am not concerned about the safety and efficacy of infant formula in the U.S. Like the vast majority of parents in the U.S, I used some formula with both of my children. The nutrient profile regulations are strong, and we know that formula is used by millions and millions of babies every year.
I do, as an economist, have some concerns about market structure. Infant formula is unusual among food products in being (a) required for survival for part of the population and (b) having no substitutes. In addition, in the U.S., most formula is produced by one of two companies. This all combines to put us at risk for situations like the formula shortage in 2022, when families had very real fears about being able to feed their children.
Having a heavily concentrated industry for a product of this type may be a mistake. The FDA has engaged in some long-term planning on how to make the industry more resilient, but I think this needs more focus. In the end, the safety of babies is more likely to be impacted by generating more competition in the formula market than by obsessing about seed oils.
The bottom line
- The FDA enforces nutrient guidelines for infant formula, making all major U.S. brands nutritionally similar and safe. Concerns about ingredients like seed oils or corn syrup are largely based on misinformation.
- While it has drawn media attention, this FDA review is part of a routine process to evaluate and potentially update formula nutrient requirements, with no current cause for alarm.
- Though some European brands use different ingredients or stricter input regulations, there’s no strong evidence that they lead to better outcomes than FDA-regulated U.S. formulas.
- With just two companies dominating U.S. formula production, shortages like the one in 2022 exposed structural vulnerabilities. Strengthening market resilience may have more impact on infant well-being than fine-tuning ingredient debates.
A correction was made on July 24th, 2025: An earlier version of this article used the term “lactose” instead of “milk protein” and did not mention that infants with a reaction to milk protein are also at a higher likelihood of reacting to soy. It also incorrectly stated that only one brand of EU formula is available in the US. There are multiple.
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This paragraph is a little bit inaccurate: For infants who cannot consume cow or goat milk proteins, soy milk or other options may be available. These formulas tend to be more expensive but can be lifesaving for infants with severe reactions to lactose.
some babies react to cows milk protein (and sadly there is often cross reactivity with soy and goat protein in these babies as well), so they typically need an extensively hydrolyzed formula like alimentum or nutramigen (these formulas still have cows milk protein but it is more broken down, so most babies with cows milk protein intolerance can tolerate them). This is not an issue with lactose at all, which is a sugar, but rather the protein. Fortunately most babies grow out of it. – MD mom of a kiddo with CMPI
I thought that read a bit wrong too! Thanks for explaining. I have a baby with CMPI as well.
Thank you for addressing this! I am a pediatric dietitian and work with a lot of babies with CMPA/CMPI. There’s a lot of misinformation out there about soy formula being an acceptable alternative to cow milk protein (it’s not). ParentData Team – can you update this information in the article?
Thanks, Glynnis — we have updated this!
My pediatrician suggested that the “closest formula to breastmilk” was Similac 360 Total Care Sensitive Infant Formula Powder. But the first ingredient is corn syrup (though not high-fructose corn syrup) which totally turned me off. For those formulas that do include corn syrup, is it bad?
https://www.similac.com/products/baby-formula/360-total-care-sensitive-powder/20-1-oz-tub.html
I think this is because you’re looking at “sensitive” formula, which is different in its composition for babies who don’t tolerate milk well. Per the article, “Some lactose-free formulas contain corn syrup solids, which are not the same as high fructose corn syrup. They arecarbohydrates derived from corn; these carbohydrates are necessary when it is not possible to have milk-based sugars. (Corn-based versions are preferable to sugar because they are more easily digestible and generally better tolerated by infants.)”