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ByHeart's Market-Changing, Innovative New Formula: Full Review!

baby formula byheart formula review infant formula organic organic formula Mar 23, 2022
can of ByHeart infant formula sitting on a kitchen counter with baby in background placing hand on formula canister lid and parents in background

Y'all, I have been waiting with bated breath to write this review and I am SO excited that the moment is finally here! 

I'm thrilled to introduce you to ByHeart, a brand new formula company that is leveling up innovation and quality in the U.S. formula market. Pay attention as this new formula is one-of-a-kind in a few key ways!

Read on for:

  • An overview of the brand 
  • The key differentiators in ByHeart's formula from other products in the market
  • The benefits shown by ByHeart's groundbreaking large-scale clinical trial (the first of its kind in over 25 years!)
  • Who could be a good fit for this formula (and who may not be)


The Background on ByHeart

ByHeart was founded 5 years ago by a brother and sister duo who are parents and have experience in both the healthcare and business development sectors. After living through the challenges that many of us face with feeding our babies, they set out to create a brand-new formula from the ground up focusing on quality and safety at every level. Here's what this looks like:

Vertically-Integrated Manufacturing

Most parents don't know that there have only been three stand-alone infant formula manufacturers in the U.S. for decades. These include Mead-Johnson (which produces Enfamil), Abbott (which produces Similac), and Nestle (which produces Gerber). Another company, Perrigo, produces store-brand generic formulas and is co-manufacturer for smaller brands like Burt's Bees and Bobbie.

ByHeart recently became the 4th vertically-integrated, stand-alone manufacturer for infant formula in the U.S.! This means that they control absolutely every step of the manufacturing process from ingredient sourcing to production safety to packaging and shipping. By keeping the entire process ("farm-to-formula") in-house, ByHeart eliminates extra variables and can ensure that every part of the process meets their strict standards.

Closer to Breastmilk Ingredients

ByHeart completely reworked the recipe for infant formula, removing ingredients that have long been considered essential (looking at you, soy oil!) and adding ingredients that hadn’t been used in U.S. infant formulas. 

Why? To create a formula that better mirrors the composition of breast milk in order to confer more of the benefits typically seen in breastfed babies. Don't worry, we're going to cover the recipe in detail below!

Sustainable, Quality Production

ByHeart created their Planet-First Policy with a focus on making their production as environmentally friendly as possible. First, their all-metal container is infinitely recyclable and the scoop is as well! They rely on regenerative agriculture from local farms to source their organic ingredients and have created a small-batch blend process that requires half the steps of traditional processing. This also allows them to maintain high levels of ingredient quality!

Let's talk about those ingredients, yes?


A Closer Look at the Recipe

ByHeart's formula is markedly different from anything else available in the U.S. today. Let's break down some of the key differences in their recipe and why these features are so exciting!

Nutrients from Whole Milk 

Did you know that every other cow milk-based infant formula in the United States uses skim milk? ByHeart is the first and only FDA-registered infant formula to use whole milk as the base! Some features that make whole milk a great choice:

  • Good cholesterolWhile cholesterol often gets a bad rap, good cholesterol (known as HDL) is important! Whole milk is a great source of HDL which helps promote efficient brain growth.
  • MFGM - You might be familiar with milk fat globule membrane, or MFGM, as it's found in a few other formulas as an added ingredient. By using whole milk, ByHeart's formula naturally contains MFGM! This membrane promotes the development of a healthy gut microbiome. You can learn more about MFGM here.
  • Reduced need for vegetable oils - One of the biggest benefits of using whole milk is that the milk fat provides essential fatty acids. Historically, formulas have relied on vegetable and seed oils to provide these fatty acids. By retaining the fat in the whole milk, ByHeart was able to craft a well-rounded fatty acid profile without the use of soy oil and palm oil. Instead, their organic oil blend includes sunflower, rapeseed, and coconut oils. 

No Soy!

This is a HUGE deal, especially for parents who have been importing from Europe in order to avoid soy or for babies with sensitivities or allergies to soy.

Every other formula in the U.S. outside of Neocate (a specialty elemental formula for babies with severe allergies) uses soy in some form, typically soy oil. ByHeart is able to leave out the soy oil because of the essential fatty acids provided by whole milk fat and other vegetable oils.

A note on soy...

Please remember that soy oil is different from soy protein, and both soy oil and soy lecithin have had the protein removed. Soy protein is what those with allergies typically react to, and is also the source of concern among some parents (particularly as it relates to phytoestrogens in soy protein). While the AAP and other agencies have strict criteria for when a soy protein-based formula should be used, they do not make any judgment about the use of soy oil in formulas. I personally have no qualms about its use though I know some parents would prefer to avoid it entirely. ByHeart provides parents with this option.

A Proprietary Protein Blend

Another major innovation that ByHeart brings to the table? A patented protein blend that more closely mirrors the composition of early breast milk. We're about to get technical! Here are the highlights to understand what makes ByHeart's protein blend so different:

  • 80% whey to 20% casein protein ratio: This is the same whey:casein protein ratio that we see in colostrum (early breast milk)! This makes for an easier-to-digest product that is gentle on new tummies. Most formulas with added whey protein stick with a 60:40 ratio which is that of mature breast milk while others only include the 20% whey that naturally occurs in cow milk. More whey makes a formula easier to digest!
  • Breastmilk levels of alpha-lactalbumin whey: Did you know that there are various types of protein found within whey? The protein type that makes up the largest percentage of breastmilk whey is called alpha-lactalbumin, or alpha-lac for short. Alpha-lac comprises roughly 22% of the proteins found in breastmilk and only 3.5% of those found in cow milk! An important component of breastmilk that contributes to increased tryptophan levels (hello, sleepiness!) and gut and immune function, ByHeart's formula is the only in the U.S. to include this protein at breastmilk levels.  
  • Partially-hydrolyzed whey: ByHeart's protein blend also includes whey protein hydrolysate; this means the whey protein is partially broken down for ease of digestion. This is similar to many gentle and sensitive formulas, though ByHeart has the added benefit of using 100% lactose for the carb source unlike many sensitive formulas on the market. 
  • Lactoferrin: You might have heard of this one before! If not, lactoferrin is another type of protein that exists in high concentrations in colostrum/early breast milk. Lactoferrin is known to help support immune system development. Additionally, lactoferrin helps with iron transport and absorption.


Clinical Trial Results

As a "science-forward" company, ByHeart conducted the largest infant formula clinical trial in more than 25 years. A clinical trial is required by the FDA before a formula is introduced with a substantially different recipe or using an ingredient that hasn't been used before (in this case, whole milk). This is required in order to demonstrate the formula’s safety and efficacy.

ByHeart's trial enrolled nearly twice the number of participants that the FDA requires and included 3 different participant arms: a ByHeart arm, a conventional formula arm, and an exclusively breastfed arm. After following participants for 6 months, ByHeart was able to analyze data (collected via stool test, blood test, and parent reporting) to evaluate outcomes in the following areas:

  • Stool frequency and texture
  • Spit-up frequency
  • Gas 
  • Fussiness (hours of crying per day)
  • Growth 
  • Sleep (measured by blood serum levels of tryptophan)

I'll let them share the full details here, but overall I was VERY impressed with how closely their formula led to outcomes similar (and in the case of reflux, even better!) than outcomes seen in the exclusively breastfed group. Their goal was to create a closer-to-breastmilk formula that provides similar-to-breastmilk benefits, and the research shows that they have.


Is ByHeart a Fit for Your Family?

There's a lot to be excited about with ByHeart entering the formula market… but that doesn't mean it's going to be the right choice for every family or every baby. Let's take a look at some of the factors that influence whether or not I'd recommend ByHeart for an individual family:

I would recommend ByHeart for:

  • Families who want a soy-free, palm-oil free formula
  • Families who are formula feeding from day one
  • Families who need a gentle or sensitive formula but want to maintain 100% lactose as the carb source
  • Families who want something “clean” (ByHeart is Clean Label Project certified and a Purity award winner!)
  • Families who are comfortable ordering exclusively online
  • Families who are using European formula and want to eliminate the risks that come with importing
  • Families who are supplementing (2 or more bottles a day)

I would not recommend ByHeart for:

  • Families who currently have a formula that is working for them and that they feel good about (I never recommend switching if what you’re currently using is working well)
  • Babies with cow milk protein allergy/intolerance
  • Families who want a 100% organic product
  • Families who need a reduced lactose product
  • Families who want a formula with A2 milk
  • Families who want to be able to purchase their formula in-store
  • Families who want or need a lower price point (ByHeart rings in at $0.21 per fluid ounce)
  • Families who want or need a ready-to-feed formula
  • Families who are supplementing less than 2 bottles a day (as you might not get through the entire container in the required one-month-after-opening time frame) 


Want to Try ByHeart? Don’t Miss Free Shipping!

I can’t WAIT to hear what you all think and how your babies take to this formula!

Interested in trying it out? If you subscribe to a personalized Feeding Plan, ByHeart will send you two cans to get started and will tailor your delivery based on baby’s age and how much they drink. The best part? You’ll always get free shipping!

I know you might have questions given how new this recipe is. Stay tuned for a ByHeart Q&A on Instagram next week!


NOTE: Some of the hyperlinks on this page are affiliate links. This means I may receive a small commission for recommending them. This is at no additional cost to you!