How ByHeart Sold Americans on Its Whole Milk Baby Formula
Hi, it’s Anna in Virginia. Before botulism, ByHeart made a lot of claims about its infant formula. I took a closer look. More on that in a moment, but first ...
ByHeart has touted its infant formula, now embroiled in a nationwide botulism outbreak, as a “patented protein blend” that “gets closest to breast milk.”
The company’s website highlights that it’s made from whole milk and free of soy, palm oil, corn syrup and a list of other wellness buzzwords. While some parents may gravitate to this pitch simply because they want to feed their babies what they perceive to be a more natural diet, ByHeart also paid for a clinical study in 2021 that it claims shows babies have less gastrointestinal distress and more efficient growth using its product.
Let’s dive in to that study.
On gastrointestinal issues, ByHeart says babies who drink its formula have fewer spit-ups than those that received a different, popular formula. At its widest interval, ByHeart-fed babies spit up 2.5 times in a week compared with 3.5 times for those on the other formula.
ByHeart also says babies on its formula had softer stools. Though it’s unclear how the consistency was measured, the difference is seemingly minimal.
ByHeart also says its formula supports more efficient weight gain. What does that mean? Well, the study shows ByHeart-fed babies drank less formula and gained the same amount of weight over 24 weeks as those on the other product. It’s not clear how much less ByHeart babies drank, but the company claims that less formula means less exposure to protein.
“Protein overfeeding in early infancy is hypothesized to impact endocrine and metabolic programming contributing to negative outcomes including diabetes and childhood obesity,” according to the study.
A review of 16 studies on the topic published in Advances in Nutrition in 2021 shows this possibility but also concludes that “the totality of evidence remains inconclusive.”
ByHeart launched in 2022 as the US was trying to recover from a nationwide formula shortage sparked by contamination concerns at Abbott Laboratories, which makes Similac. While the shortage is now long over, ByHeart made inroads with its wellness marketing just as Health and Human Services Secretary Robert F. Kennedy Jr.’s Make America Healthy Again campaign took hold.
HHS announced “Operation Stork Speed” in March, which launched a comprehensive review of infant formula ingredients. ByHeart sent in its thoughts on this review in September. One of its main points was that the FDA has set too high of a bar for assessing the safety of novel ingredients.
“FDA’s focus has been on the theoretical risks of novel ingredients, which has the consequence of hindering innovation due to a lack of clearly defined and realistic safety parameters,” ByHeart wrote. “New ingredients and formulations should be evaluated through a broader, more holistic lens that includes consideration of functional outcomes and potential benefits they may offer, along with safety.”
No one knows yet what caused the contamination of ByHeart’s formula with the bacteria that causes botulism, but Susan Mayne, the former head of the FDA’s Center for Food Safety, wrote on her Substack: “I hope this most unfortunate outbreak is a wakeup call to the administration to recognize that microbial food safety is every bit as important as chemical food safety.” — Anna Edney