ByHeart took the baby formula world by storm back in 2022 by being the first U.S.-made infant formula brand (with globally sourced ingredients) to use organic, grass-fed whole milk, not skim.

In this post, I’m taking a closer look at ByHeart’s ingredients, how it compares to other baby formulas and its drawbacks.

ByHeart Baby Formula Backstory

Back in 2016, three companies owned approximately 90% of the infant formula market. Mia Funt and Ron Belldegrun were frustrated with the lack of innovation and decided to develop a better baby formula. They recruited a team of doctors, pediatric researchers, and seasoned formula experts and created an infant formula recipe entirely from scratch. (This is a big deal—ByHeart is the first new infant formula manufacturer in the U.S. in 15 years.)

They conducted the largest clinical trial of a new infant formula brand in 25 years, not only comparing their formula to a commercial infant formula, but also comparing it to breast milk.

The final recipe is an easy-to-digest infant formula that does not contain corn syrup, maltodextrin, soy or palm oil.

Their Whole Nutrition Infant Formula received the Clean Label Project Certification and the highest-tier “Purity Award.”

Where is ByHeart Made?

ByHeart’s headquarters are in New York City, and their end-to-end manufacturing facilities are in Pennsylvania, Iowa, and Oregon.

Is ByHeart formula organic?

No. The primary ingredient is organic grass-fed, whole milk and includes other organic ingredients like their prebiotics and lactose. However, ByHeart intentionally adds proteins that are found in breastmilk (like alpha-lactalbumin and lactoferrin) which are not considered fully organic by the USDA.

ByHeart prides itself on its sky high standards, and is the only U.S.-made infant formula brand (with globally sourced ingredients) brand to win all three Clean Label Project awards. Their main goal is to always combine certified-clean ingredients with the highest-quality nutrition.

Is ByHeart formula FDA approved?

The FDA does not “approve” any infant formulas, but rather, requires formula manufacturers to be registered with the FDA in order to be sold in the United States and products must be deemed adequate in meeting the FDA’s safety and nutritional requirements.

The FDA requires the finished product to contain 29 essential nutrients at or above specific levels. Product must also undergo comprehensive testing to ensure it meets all safety regulations.

ByHeart meets all of the FDA’s safety and nutrition requirements, and their facilities are FDA-registered.

The Clean Label Project team independently tests for heavy metals (Total Arsenic, Cadmium, Lead, and Mercury) and over 400 of the most commonly used pesticides, including glyphosate, and plasticizers (including BPA, BPS, and phthalates). Additionally, ByHeart’s internal quality control program screens for more than 700 contaminants.

Comparison to Other Popular Baby Formula Brands

ByHeart is a premium brand, so it’ll be in the same camp as brands like Earth’s Best, Happy Baby, Bobbie, Kendamil, Similac Organic, and Bubs Organic. The main standouts for ByHeart are its use of organic, grass-fed whole milk, its patented protein blend that features an 80:20 whey-to-casein ratio, a soy-free recipe, and its end-to-end U.S. manufacturing with globally sourced ingredients.

✅ Whole Milk

ByHeart is the only U.S.-made infant formula to include organic, grass-fed whole milk. (Most companies use skim with added fats. ) Kendamil also uses whole milk but they are manufactured in the U.K.

✅ 80:20 whey to casein ratio

Cow milk has a whey to casein ratio of 20:80 so most baby formula companies adjust this ratio to be closer to the 60:40 ratio of mature human breast milk. ByHeart’s whey to casein ratio is 80:20, with the intention of being gentle on a baby’s digestive system. This ratio is also much closer to the whey to casein ratio found in early breast milk.

✅ Soy-Free formula

ByHeart does not contain corn syrup, GMOs, or palm oil, which are common in many mainstream formulas. It is also free of soy, which is still found in some premium brands (this is often important to parents who have a sensitivity or allergy to soy).

✅ U.S. Manufacturing

ByHeart is one of only five infant formula manufacturers in the U.S. and owns their end-to-end manufacturing.

Similac also owns their own manufacturing in the U.S., Kendamil owns their own manufacturing in the U.K., Bubs owns their own manufacturing in Australia, and Earth’s Best and Bobbie are both made by the U.S. manufacturer Perrigo. Happy Baby won’t tell me where their formula is made, but I’m assuming it’s one of the big three – Perrigo, Abbott, or Nestle.

What are the ingredients in ByHeart?

Ingredient lists are difficult for most people to decipher, but ByHeart has a couple of standouts.

• Organic whole milk (most companies use skim)
• Lactose (instead of corn syrup and maltodextrin)
• Organic vegetable oils (organic high oleic sunflower, organic low erucic rapeseed, organic coconut, organic sunflower)
• Organic galactooligosaccharides (a prebiotic fiber)
• Alpha-lactalbumin (breast milk levels)
• Whey
• Whey protein hydrolysate (partially broken down proteins)
• Lactoferrin (found in breast milk and colostrum)
• DHA algal oil (schizochytrium) (this is an omega-3 fatty acid)
• Mortierella alpina oil (this is an omega-6 fatty acid)
• Vitamin a palmitate, vitamin d3, vitamin E acetate, vitamin k1, thiamine hydrochloride, riboflavin, vitamin b6 hydrochloride, vitamin b12, niacinamide, calcium pantothenate, folic acid, biotin, ascorbic acid, mixed tocopherols, ascorbyl palmitate, l-carnitine, inositol, calcium phosphate, sodium citrate, calcium carbonate, potassium citrate, ferrous sulfate, potassium chloride, magnesium phosphate, calcium chloride, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenate, potassium bicarbonate, choline chloride.

Promising Customer Reviews and Feedback

“I loved the ingredients and the no soy/no GMO/ no palm oil idea. It’s close to European formula I used for my older son.” Target

“After a lot of research I was comfortable with all the ingredients, extremely happy to see this is made in the US and loved that it’s done by small batch processing.” Target

“We really love the ingredients of this formula! We love that it is made with whole milk as the first ingredient, unlike other brands that are made with skim milk and corn syrup.” Target

“Love the ingredients! My baby enjoys it and his poops looked really healthy and normal on ByHeart!” ByHeart site

“The ingredients are the best I’ve ever seen in any formula and it’s made in the US for an accessible price” ByHeart site

Potential Drawbacks or Concerns

• A few parents have observed that it foams after mixing. Some parents have found that mixing with a small whisk or Dr. Brown’s formula mixing pitcher instead of shaking works much better. Note: It is always recommended that you add the formula powder to water while measuring instead of adding water to the powder already in the bottle.
• ByHeart uses many organic ingredients (and is non-GMO) but is not certified organic, which might be important to some parents specifically looking for an organic infant formula.
• It’s a premium formula, so it costs more than some basic brands.

Cost and Availability

If you use the subscribe and save option on the ByHeart site, the cost is $1.63, which translates to $39 a can (which typically lasts a week). ​​Other premium formulas run between $1.25 and $1.70 per ounce, so it’s somewhere in the middle.

If you order from the ByHeart site directly it will be delivered to you directly for the cheapest price. However, if you find yourself scrambling for a can, Target also carries it which is nice as a widely available option.

Conclusion: Is By Heart Worth the Hype?

The formula shortage during the pandemic was a good wake up call that it’s probably not a great idea to have two companies supplying an essential food source for a whole nation.

ByHeart goes above and beyond to create a superior formula at a reasonable price that is easy to access and gentle on new digestive systems.

If you’re looking for a U.S. formula that includes prebiotics, proteins found in breastmilk, is free of soy, and is made with organic-grass-fed whole milk, ByHeart is worth checking out.

You can find ByHeart Whole Nutrition Infant Formula on the ByHeart site.

You might also find this post helpful: Formula Feeding Basics: What to Do and What You’ll Need