"If I have to feed formula, at least it should be the best formula, right? My friend used European formula, and her baby thrived on it. Should I do the same? Are European formulas cleaner? Why do American formulas have all this extra junk and chemicals?"
Recently a patient’s mom brought a can of formula with her to the appointment. They had recently switched to this European formula because they were worried about chemicals in the US formula. She had made changes in her skincare product purchasing based on a desire for cleaner products, and her concern about how skincare products are regulated in the US had extended into concern about regulation of infant formula.
So, how do infant formulas in the US stack up against the formulas available in the EU? How do FDA regulations compare to the EU formulas? Are the ingredients really different? What does it mean for a formula to be “Euro-inspired” or “Euro style”? Is it worth spending 3-10x the money on these formulas?
What does it mean for American formulas to be “full of chemicals”?
The easiest way to evaluate the claim about chemicals is to compare ingredients side by side. Are there a lot of extraneous ingredients after you account for what’s required nutrition-wise?
The job of formula is to deliver nutrition. That nutrition is comprised of macronutrients (protein, fat, carbohydrates) and micronutrients (vitamins and minerals).
Formula is also made to try to be as close to breastmilk as possible. (You’ll notice every formula advertised that it is “modeled after breastmilk.”) To that end, other ingredients include probiotics (good bacteria) and prebiotics (food for the probiotics). As other components of breastmilk are identified, formula manufacturers try to add them to formula too, so that formula-fed babies can also benefit (and they can distinguish themselves from competitors).
Everything is chemicals. Every substance can be expressed with a chemical formula. Most substances have more than one name, and the technical name can look scarier or more artificial. Cyanocobalamin is a chemical – vitamin B12. Ferrous sulfate is a chemical – iron. All formulas will have a list of chemicals in their ingredient list. So does breastmilk. Breastmilk actually has more chemicals than formula, because it contains immune cells like antibodies and cytokines, hormones like leptin and ghrelin, and growth factors.
Because infant formula is potentially an infant’s sole nutrition, it’s really important to get this right. That’s why the FDA regulations define the minimum (and maximum, in some cases) amounts of the macro and micronutrients. The EU regulations don’t necessarily have the same ranges, but they have ranges for the same things.
Don’t take a random blogger’s word for it though — go to the source(s). Here are the FDA regulations and a direct link to the sub-section on nutrient requirements and the EU regulations.
For more information about FDA regulation of infant formula, check out this post.
For more information about the FDA recall of the European formulas for insufficient iron, check out this post.
Here are the ingredients lists from three different formulas. Try to guess which is a US formula and which is a European formula.
- Desalinated whey powder, vegetable oils (palm, rape, sunflower), lactose, skimmed milk powder, palm kernel fat, starch, potassium chloride, calcium salts of orthophosphoric acid, sodium citrate, calcium carbonate, oil from the microcarbon algae Schizochytrium sp., choline bitartrate, oil from Mortierella alpina, magnesium carbonate, inositol, L-phenylalanine, L-tryptophan, L-tyrosine, vitamin C, potassium citrate, nucleotides (cytidine-5′-monophosphoric acid, sodium salts of uridine-5′-monophosphoric acid, adenosine-5′-monophosphoric acid, sodium salts of inosine-5′-monophosphoric acid, sodium salts of guanosine-5′-monophosphoric acid), taurine, iron bisglycinate, zinc sulfate, vitamin E, niacin, pantothenic acid, copper sulfate, biotin, thiamine, manganese sulfate, vitamin D, vitamin A, vitamin B6, riboflavin, potassium iodate, folic acid, vitamin K, sodium selenate, vitamin B12
- Skimmed milk, whey product, vegetable oils (palm oil, rapeseed oil, sunflower oil), Starch, galactooligosaccharides from lactose, calcium carbonate, LCP oils (fish oil, vegetable oil from M. alpina), potassium chloride, L-tyrosine, vitamin C, L-tryptophan, iron sulfate, zinc sulfate, vitamin E, stabilizer lactic acid, natural Lactic acid culture (Lactobacillus fermentum hereditum) , Niacin, pantothenic acid, Copper Lysine Complex, Vitamin A, Vitamin B 1, vitamin B 6, manganese sulfate, potassium iodate, vitamin B 2, sodium selenate, folic acid, vitamin K, biotin, vitamin D, vitamin B12
- Skimmed milk, whey powder (partly demineralised), vegetable oils (palm oil, sunflower oil, rapeseed oil), maltodextrin, lactose, skimmed milk powder, skimmed milk powder, fish oil, calcium carbonate, Mortierella Alpina oil, choline bitartrate, potassium chloride, sodium chloride, vitamin C, ferrous sulphate, zinc sulphate, L-tyrosine, L-tryptophan, copper sulphate, vitamin E, vitamin A, sodium selenite, vitamin D, niacin, manganese sulphate, pantothenic acid, vitamin B, vitamin K, folic acid, biotin, vitamin B, vitamin B, potassium iodate
- Nonfat Milk, Lactose, High Oleic Safflower Oil, Whey Protein Concentrate, Soy Oil, Coconut Oil. Less than 2% of: C. Cohnii Oil, M. Alpina Oil, 2′-Fucosyllactose, Short-chain Fructooligosaccharides, Beta-Carotene, Lutein, Potassium Citrate, Calcium Carbonate, Ascorbic Acid, Soy Lecithin, Potassium Chloride, Magnesium Chloride, Ferrous Sulfate, Choline Bitartrate, Choline Chloride, Ascorbyl Palmitate, Salt, Taurine, Inositol, Zinc Sulfate, Mixed Tocopherols, d-Alpha-Tocopheryl Acetate, Niacinamide, Calcium Pantothenate, L-Carnitine, Vitamin A Palmitate, Copper Sulfate, Thiamine Hydrochloride, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Manganese Sulfate, Phylloquinone, Biotin, Sodium Selenate, Vitamin D3, Vitamin B12, Calcium Phosphate, Potassium Phosphate, Potassium Iodide, Potassium Hydroxide, and Nucleotides (Adenosine 5’-Monophosphate, Cytidine 5’-Monophosphate, Disodium Guanosine 5’-Monophosphate, Disodium Uridine 5’-Monophosphate).
- Nonfat Milk, Lactose, High Oleic Sunflower Oil, Whey Protein Concentrate, Soy Oil, Coconut Oil, Galactooligosaccharides. Less than 2% of: C. Cohnii Oil, M. Alpina Oil, Beta-Carotene, Lutein, Potassium Citrate, Calcium Carbonate, Ascorbic Acid, Soy Lecithin, Potassium Chloride, Magnesium Chloride, Ferrous Sulfate, Choline Bitartrate, Choline Chloride, Ascorbyl Palmitate, Salt, Taurine, m-Inositol, Zinc Sulfate, Mixed Tocopherols, d-Alpha-Tocopheryl Acetate, Niacinamide, Calcium Pantothenate, L-Carnitine, Vitamin A Palmitate, Copper Sulfate, Thiamine Hydrochloride, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Manganese Sulfate, Phylloquinone, Biotin, Sodium Selenate, Vitamin D3, Vitamin B12, Calcium Phosphate, Potassium Hydroxide, Potassium Iodide, and Nucleotides (Adenosine 5’-Monophosphate, Cytidine 5’-Monophosphate, Disodium Guanosine 5’-Monophosphate, Disodium Uridine 5’-Monophosphate).
Ready for the big reveal? Formulas 1, 2 and 3 are European, and 4 and 5 are American.
- [DM Babylove Anfangsmilch 1]
- [Hipp German Stage 1]
- [Holle Organic 1 (Germany)]
- [Similac Pro Advance Powder]
- [Similac Pure Bliss]
Virtually all of these ingredient lists are identical. The spelling of ‘soy’ vs ‘soya’ could be a giveaway, but that’s hardly a substantial product difference.
Because all the formulas need to have the essentials covered, the only real differences are where the fats come from, the number of features, and any additives for formulation.
Interestingly, even though corn syrup is an ingredient people love to hate, the only formulas with maltodextrin were European formulas. Maltodextrin is a sugar that is almost always derived from corn.
Corn, Sucrose, and “other junk”
Human milk is lower in protein, higher in carbohydrates and higher in fat than cow milk. That means if we’re starting with a cow milk base, we need to add carbohydrates and fat in order to make it appropriate for a human. Those carbohydrates need to come from somewhere.
In all regular dairy formula — and in breastmilk — those carbohydrates come from lactose.
There is a formula that some people use for infants that is not approved as an infant formula that uses rice syrup as the carbohydrate. I don’t have anything against corn syrup, but even if I did, I don’t know that rice syrup is better. (Rice syrup has historically been worse because of the high arsenic content of rice, but the manufacturer is now taking great effort to use rice that is not high in arsenic.) This formula is used for regular feeding, so it’s rice syrup vs lactose, not rice syrup vs corn syrup.
It is not special to not have corn syrup in a regular dairy formula. It is typical.
What about sucrose?
“The EU bans adding sucrose to baby formula!”
2,2 g/100 kJ 3,3 g/100 kJ
(9 g/100 kcal) (14 g/100 kcal)
8.1. Only the following carbohydrates may be used:
— glucose syrup or dried glucose syrup,
— pre-cooked starch (naturally free of gluten),
— gelatinised starch (naturally free of gluten).
8.2. Lactose [did not copy this section but you can read it in the original]
Sucrose may only be added to infant formula manufactured from protein hydrolysates. If added, the sucrose content shall not exceed 20 % of the total carbohydrate content.
Glucose may only be added to infant formula manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).
8.5. Glucose syrup or dried glucose syrup
Glucose syrup or dried glucose syrup may be added to infant formula manufactured from cows’ milk or goats’ milk proteins or infant formula manufactured from soya protein isolates (alone or in a mixture with cows’ milk or goats’ milk proteins) only if its dextrose equivalent does not exceed 32. If glucose syrup or dried glucose syrup is added to these products, the glucose content resulting from glucose syrup or dried glucose syrup shall not exceed 0,2 g/100 kJ (0,84 g/100 kcal).
The maximum glucose amounts laid down in point 8.4 shall apply if glucose syrup or dried glucose syrup is added to infant formula manufactured from protein hydrolysates.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0127#d1e32-11-1
While it’s true that we don’t have rules against using sucrose as the carbohydrate, none of the regular dairy formulas do, so it’s not an issue. We don’t have rules against elephants in the formula either, but all our formula is elephant-free.
Regular formulas are just that.
Special formulas include:
- formulas with proteins somewhat broken down. These are sometimes advertised as “gentle proteins” or “partially hydrolyzed” and pictured as tiny teddy bears. For example, Enfamil GentleEase, Enfamil Reguline, Gerber GentlePro, Similac Pro-Total Comfort
- formulas with intact proteins but reduced lactose — eg Similac Pro-Sensitive
- formulas with fully or extensively broken-down proteins, “fully hydrolyzed,” “extensively hydrolyzed,” “hypoallergenic,” “HA” — eg Nutramigen, Alimentum, Gerber HA.
- formulas where the proteins have been broken down all the way to the amino acids, “elemental,” “amino acid” eg Elecare, Neocate, Essential Care Jr, PurAmino, Alfamino
Formulas with reduced lactose obviously can’t use lactose as their carbohydrate source. Formulas with hydrolyzed proteins are also typically trying to have lower lactose levels, so that’s the point where you start to see corn syrup solids being used — they still need a carbohydrate. (The exception is Hipp HA, which does use lactose.)
A word on soy-based formulas: most babies who have a protein sensitivity to dairy also have a sensitivity to soy. Someone must still use it, because they still make it. And if you want to read my take on goat milk-based formula, see my prior post on choosing formula.
There are many other worlds of specialty formula, including those for babies with fat malabsorption, premature or low birth weight babies (higher calorie, different mineral composition), and babies with inborn errors of metabolism. Carrageenan is another ingredient found only in highly processed specialty formulas in order to achieve certain technical properties:
To build viscosity which both helps stabilize the sedimentation of dense components such as insoluble calcium and phosphorus salts, as well as slow the upward migration of fat which is less dense.
Without carrageenan added for stabilization, infant formula would be more likely to produce insoluble sediments or creaming (separation of fat)
As carrageenan allows for optimal physical properties when forming an emulsion, to manufacture infant formula that contains hydrolyzed protein as without carrageenan oil would separate almost immediately.Codex Alimentarius Commission, 23 – 27 November 2015
These formulas are by definition highly processed, highly specialized, highly technical products. They are miracles of modern medicine that allow babies to survive and thrive who are not able to consume ‘regular’ food. Carrageenan is not found in regular formulas.
Manufactured in Vermont
When you hear “Manufactured in Vermont,” what do you imagine? What feelings does that evoke? Pastoral farmland? Ben and Jerry’s? What about “Manufactured in Ohio”?
Formula manufacturers are trying to evoke certain feelings in order to sell their product over other products. There are lots of feelings involved in infant feeding. Feelings of guilt, mostly. American motherhood involves a lot of guilt.
There is one single contract manufacturer of formula in the US: Perrigo.
Perrigo makes every single store brand of formula: Target, Walmart, Kroger/QFC, Costco. And they make Bobbie. And Burt’s Bee’s infant formula (honestly I didn’t even know Burt’s Bees had wandered into marketing formula). Perrigo has plants in Vermont and Ohio.
So, yes, it’s manufactured in Vermont. But so is the Target/Walmart/QFC/Costco formula. That’s just where the manufacturing plants happen to be.
The thoughtfully sourced dairy? It’s the same dairy that’s in the Target/Walmart/QFC/Costco formula.
When they’re selling it with a byline of “Made in Vermont” they’re selling on the emotion associated with a wholesome Northeastern state. But Ohio can look pretty pastoral too.
Formula is big money, so the organic brands are out to convey feelings of small, family operations.
Happy Baby Organics is Nurture, Inc. Their parent company is Danone.
Plum Organics is part of Campbell Corporation.
Burt’s Bees is a brand of The Clorox Company.
Similac is a brand of Abbott Laboratories.
Enfamil is made by Mead Johnson, which is now owned by a British firm called Reckitt. Founded in 1895, it had been owned by Bristol-Myers-Squibb between 1967 and 2009 until it was spun off into an independent company, then bought by Reckitt Benckiser in 2017.
Nestle owns Gerber. They acquired Pfizer Nutrition in 2012 — Pfizer made brands like SMA and S-26, which had been Wyeth brands, before Pfizer bought Wyeth Nutrition in 2009. These brands are bigger outside the US. In the US, Gerber formulas are either hydrolyzed or extensively hydrolyzed — none are ‘regular’ dairy formulas.
Features vs Extra Ingredients
I was curious about the actual differences in the ingredients between various formulas, so I made a giant grid and labeled each ingredient with its purpose.
Protein – whey protein concentrate, nonfat milk (same as skimmed milk), whey product, whey powder, demineralised whey, whey protein.
Fat – coconut oil, high oleic (sunflower or safflower) oil, soybean oil, rapeseed oil, palm oil
DHA – algal oil / Crypthecodinium Cohnii Oil, schizochytrium sp. oil
ARA – Mortierella Alpina Oil / vegetable oil from M. alpina (long chain polyunsaturated fatty acids)
Enfamil NeuroPro has a whey protein-lipid concentrate (from milk), which is a source of MFGM (milk fat globule membrane). This is a breastmilk-like additive/feature.
A note about palm oil: in all the ingredients I’ve seen formulas claiming to be free of, this is the only one that actually gives me pause. Palm oil is used as a fat source in order to mirror the palmitic acid content of breastmilk, but palm oil as a primary fat source in formula can cause decreased absorption of fat and calcium. This can lead to firmer stools, and more seriously, decreased bone mineral density (Koo, 2003). The Earth probably cares if it’s sustainably sourced or not, but baby bones don’t care.
- Kirkland – no palm
- Similac Pro-Advance – no palm
- Bobbie – no palm
- Parents Choice (compares to Enfamil) – palm olein
- Parent’s Choice (compares to Similac Pro-Advance) – palm olein
- Plum Organic – palm olein or palm oil
- Happy Baby Organic – palm olein or palm oil
- Enfamil NeuroPro – palm olein oil
- Hipp German Stage 1 – palm oil (long chain polyunsaturated fatty acids)
- Holle Stage 1 (cow) – palm oil
- Aptamil First Infant Milk – palm oil
- Bebevita Anfangsmilch 1 – palm oil
- Milupa Milumil Anfangsmilch 1 – palm oil
Koo WWK, Hammami M, Margeson DP, Nwaesei C, Montalto MB, Lasekan JB. Reduced Bone Mineralization in Infants Fed Palm Olein-Containing Formula: A Randomized, Double-Blinded, Prospective Trial. Pediatrics. 2003;111(5):1017-1023. doi:10.1542/peds.111.5.1017
Lactose across the board.
Except Holle Organic German Stage 1 has maltodextrin as well.
The formulas are very consistent with vitamins, so I’m only going to note the exceptions.
Holle German Stage 1 doesn’t have a riboflavin (vitamin B2) ingredient listed. The label claims to meet the riboflavin requirement. I wonder if the four listed milk/milk powder/whey products provide for the riboflavin? I emailed the company but haven’t heard back. Bebevita Stage 1 also doesn’t have riboflavin listed.
Hipp German Stage 1 doesn’t have a choline product listed. All the other formulas use choline chloride or choline bitartate to provide choline. The EU provides a choline requirement only for formulas made from hydrolyzed proteins. The FDA requires 7 mg per 100 calories.
Hipp and Holle German Stage 1’s also don’t provide inositol, nor does Bebevita Stage 1. Inositol is provided to support brain growth. The EU provides an inositol requirement only for formulas made from hydrolyzed proteins. The FDA requires 4 mg per 100 calories.
Many of the formulas don’t provide lutein, which is not required, so it would be considered an added feature. Lutein a carotenoid that’s related to vitamin A and thought to help prevent certain eye diseases. Beta-carotene, another carotenoid, is also only found in some of the formulas.
Ascorbyl palmitate is a fat-soluble version of vitamin C that’s used as an anti-oxidant, as are mixed tocopherols (a form of vitamin E).
Different salts, same provisions.
You can think of a salt like a partnership. It’s a compound that results from the reaction of an acid with a base. Potassium phosphate results from the reaction of potassium with phosphorus. It’s a single ingredient (a salt) that provides for both of those minerals. For salts that provide more than one element declared in the nutrition panel, I picked one place for it to go.
Table salt is the partnership between sodium and chloride. Most formulas have sodium chloride as an ingredient.
- Potassium Chloride
- Magnesium Chloride
- Ferrous Sulfate – iron, sulphur
- Choline Bitartrate – choline
- Choline Chloride – choline, chloride
- Salt – sodium, chloride
- Zinc Sulfate – zinc, sulphur
- Calcium Pantothenate – calcium, vitamin B5
- Copper (cupric) Sulfate – copper, sulphur
- Manganese Sulfate – manganese, sulphur
- Sodium Selenate – sodium, selenium
- Calcium Phosphate – calcium, phosphorus
- Potassium Phosphate – potassium, phosphorus
- Potassium Iodide – potassium, iodine
- Potassium Hydroxide – potassium
These are naturally occuring chemicals. They are the result of chemical reactions between elements.
Soy lecithin is the major emulsifier (though it also provides some choline). Some formulas use monoglycerides for emulsification. One formula uses sunflower lecithin. Emulsifiers allow for components to mix together.
European formula is not inherently safer. They have outbreaks and recalls too.
Here’s a clip from an importer/distributor registered in Washington State:
Again, here are the FDA requirements for infant formula — https://ecfr.federalregister.gov/current/title-21/chapter-I/subchapter-B/part-107
The actual manufacturers of the European formulas are not the ones distributing it in the US. They are not the ones advertising them in the US. The ones advertising are the formula “shoppes” – they are selling a product that they have imported and are illegally distributing. They are the ones trying to convince you that the formula available at the supermarket is not good, not healthy, and not safe, so that you’ll buy the product they’re essentially selling out of the trunk of their car.
Given that these imports are illegal, we also have no idea to what conditions the shipments were subjected along the way. There’s an expiration date, but we don’t know to what extent the nutrients are stable if they sat in a hot shipping container for a few months, for example.
For US-based formula companies that don’t want to go through all the hassle of FDA approval, a common strategy is to pretend to be a toddler formula. Toddler formulas are completely unregulated. (As an aside, most toddlers do not need formula, but can instead transition to whole milk at a fraction of the cost.)
Bobbie was initially recalled because of this strategy, pretending to be a toddler formula while clearly intending to be an infant formula. Also because it lacked adequate iron, did not indicate it lacked adequate iron, and did not provide nutritional information for a number of required nutrients.
Baby’s Only (Nature’s One) continues to do this, and even provides nutritional fact sheets to “share with your doctor” showing it has appropriate infant nutrition.
Designed by Nature formulas were recalled in 2021 because they were not adequate for infants.
Kabrita goat milk formula continuously rides the line, using babies in their visual advertising to suggest using it as an infant formula while still claiming to be a toddler formula.
Sammy’s Milk is another goat milk formula that wasn’t vetted as an infant formula, didn’t contain enough iron, wasn’t tested for serious bacterial contamination, and was subsequently recalled.
The purpose of regulation is to assure the safety of the product. Given the number of inadequate formulas that have been identified and recalled by the FDA, it seems like our regulations are working. Formulas that are sold as infant formulas are assured to have adequate nutrition for human infants to grow in a healthy way.
It is substantially more expensive to illegally import Euro formulas than to buy formula domestically.
Costco Kirkland Signature ProCare runs $0.07 per prepared ounce. That’s about $50 per month to fully formula feed.
Bobbie, the FDA-compliant “Euro style” formula runs $0.23 per prepared ounce.
Hipp German Organic Stage 1 at one of the formula stores advertising on Google runs $0.70 per prepared ounce ($35 per box, with the unit price decreasing slightly if you buy 8 or 12 packs at a time). Another store charges $40 per box, for a prepared cost of a breathtaking $0.85 per ounce.
That means these formulas are at least TEN TIMES the cost of Costco formula.
But there are other costs associated with this practice, too.
Families who import formulas are doing so because they’ve been made to feel like the food available locally is dirty or inadequate. When they go to such lengths to buy formula, when they run low or run out, they feel desperate. They can’t just go to the supermarket and buy formula, because they’ve been convinced that locally-available formula is bad for their baby. That stress is significant. It’s horrible to feel like you don’t have what you need to feed your baby.
Not worth it.