Why American formula is toxic - The Next, #63

And why I'm skeptical of nutrition science

Hi there, and welcome to The Next - my take on health, wellness, and company building.

In the last few years I’ve founded 3 health brands (Kettle & Fire, Perfect Keto, Surely non-alc wine). I’m now working on Truemed, which allows health and wellness brands to accept HSA/FSA funds. Previously, I worked in tech and had no experience in CPG, DTC, or any other 3-letter industries.

If you missed past episodes, I recommend checking out The Great American Poisoning, my manifesto on what’s going on with our chronic disease crisis. Otherwise, let’s dive in!

🆕 What’s new

Remember when eggs were terrible for you, then suddenly they weren't? Or how fat was killing you, then it wasn’t (and now might be again)?

Lately, I've been wondering about how we create knowledge in complex systems like nutrition and biology. And questioning whether our current gold standard - the randomized controlled trial (RCT) - is the best way to understand what is (and is not) healthy.

I’ve written about this before, but “following the science” will necessarily miss out on harms caused by novel compounds. If you waited for "evidence-based" recommendations, you would have been smoking cigarettes until the 1970s, eating trans fats until 2003, and guzzling fluoride until recently. In that time, you could do a lot of harm to yourself!

I love evidence. But I struggle with the way that some people (especially in the health space) will only believe something if it’s “evidence-based”, ie has multiple RCTs. Seed oils couldn’t possibly be bad: there are studies that say so!

In a complex system like the human body, it’s extremely hard to isolate cause and effect. RCTs are better designed for interventions (like pharmaceuticals) that are a single intervention that creates a measurable outcome. They're extremely poorly suited for interventions that affect multiple systems within the body.

Food isn't a single compound with a single effect - it's a complex mixture of compounds that interact with thousands of systems simultaneously. How could you possibly design a placebo-controlled study for, say, the effects of eating ribeye steak? You can't give someone a "placebo steak” (though it does sound delicious).

I disagree with the RCTs-at-all-cost crowd in a few ways.

First, they often fail to acknowledge that our studies are often not very good! They’re frequently biased and influenced by funding sources. For example, most of our heart disease models (that blame cholesterol and saturated fat, and have informed public health policy for 50+ yeears) come from a Harvard professor who was paid $50,000 by the sugar industry to demonize fat.

This crowd also tends to overlook the replication crisis: the fact that a huge portion of published studies simply don't replicate. A recent meta-analysis found that only 50% of landmark cancer biology studies could be fully or partially replicated.

Secondly, RCTs give people the false sense that we "know" a thing. We run a few animal + human studies, see no active harms, and conclude that a novel chemical or ingredient is totally fine.

However, most trials are designed to measure just a few things. As I wrote in our insane approach to regulating chemicals, RCTs are measure changes over a certain period of time (say, 5 years) for specific concerns (like GI effects). If none are found by the end of the trial, well, sounds like seed oils are good. Put ‘em in everything!

This approach works for a lot of things. But what it will miss is any sort of unexpected, unmeasured, long-term impact to health or another system that the trial designers didn’t consider.

Consider this: if we had a compound in our food system that caused cancer in 30% of people after a decade of repeated, small exposure... we would have literally zero way to detect it. No RCTs, no regulatory processes, no tests - nothing in our current system would identify such a compound.

That example might sound extreme, but it's entirely plausible given the compounds we've found that act in similar ways.

Lastly, RCTs miss the entire concept of relativity. Some humans will be able to digest rice, and others won’t. Some single-target meds could work for someone, and totally fail another. There really aren’t “laws of physics” for every human body. The body is a complex system that is different per person, and even different for the same person in different environments.

This is an important point. RCTs attempt to control and placebo everything. But with something like nutrition, it is literally impossible to control all the variables in such a complex system.

Let’s take light, for example. It seems that light can impact glucose modulation and change the way your body handles food. Yet as far as I know, there has never been a single nutrition study that has controlled for light exposure.

Same with hormones, or one’s microbiome. We know that hormones change with the seasons (and even the time of day), and we know that one’s hormones have a huge impact on how one digests and uses food. Yet - again - I don’t know a single set of nutrition RCTs that attempt to control for hormones, time of year, individual microbiome composition…

With a complex system like nutrition or human biology, I think two approaches make sense:

1. The Precautionary Principle - This means relying on ancient wisdom and eating what your ancestors ate. Yes, a novel food additive might not be harmful (but it also might be)! Whereas steak is highly unlikely to kill you, given that humans have been eating steak for millennia.

2. Subjective experience - Aka “try things and see how you feel”. People often don’t appreciate that you can learn a lot just from seeing how you feel! This, of course, has limits: you’ll feel amazing on day 2 of a 3 day fast, but probably don’t want to fast forever. But in many ways, if you feel good on keto, on carnivore, or on the honey diet… just try it!

This approach means combining a macro ancestral lens with deep attention to your own individual responses. RCTs are this third approach that often aren’t a good lens to make decisions - studies contradict each other constantly, and they completely ignore the subjective experience (which is frankly ridiculous in the health domain).

How you feel after eating certain foods, how your energy levels change, how your sleep is affected - these are all measurable outcomes that matter enormously but get discarded because they're "just subjective."

I understand why people crave simple, binary statements like "this is good and that is bad." But the reality of complex systems is that they rarely yield to such simplistic thinking. Knowledge (unfortunately) is often much more relative than we want to think, and diet is a perfect example.

This is messy and harder than just following the latest headline about what the “evidence” says. But it's also more likely to lead us to actual health and well-being.

I’m still trying to figure out where I land on this topic. It’s the most important topic of all - how do we create knowledge as humans? - and I’d love to improve my thinking on this topic as it applies to health!

I thought of this meta-question after my conversation (rant?) with the CEO of David Bar here - https://x.com/zachranen/status/1904620313092252085

💪 Health stuff

Let’s look at this product:

What you’re looking at is the ingredient list for the best selling baby formula in America.

Yes, you read that correctly. The primary ingredient in the most popular baby formula is corn syrup. Sugar, soy oil, and safflower oil also are among the top 5 ingredients.

Infant formula in the US is so bad it’s hard to believe. Not just the ingredients (though those are about the worst I could imagine), but also the history of formula companies, and the fact that the FDA practially mandates the above ingredients are included in formula.

Let’s dive in to what I think may be among the worst products harming Americans health: infant formula.

The baby formula industry has an insanely dark history that’s hard to believe. In the 1970s, Nestle aggressively marketed formula to mothers in developing nations by basically scaring them. They literally had sales reps dress up as nurses, and approach new moms to convince them that formula was superior to breast milk. They would then provide free samples just long enough for mothers' natural milk to dry up, forcing dependency on their product. They convinced mothers that formula was more "Western" and "modern" than breastfeeding.

The results were catastrophic. Mothers who couldn't afford enough formula would dilute it to make it last longer, leading to malnutrition. Many lacked clean water to mix with the formula, causing life-threatening diarrhea and infections. By some estimates, literally millions of infants died as a result of these practices.

I don’t know what to call this other than evil. Big Food has reps push a high-margin (but nutritionally bereft) product to millions of new mothers, millions of babies die, Nestle keeps moving on.

The formula companies use other tricks to spur demand for their candy formula products. For example: you know the growth charts your pediatrician uses to tell if your baby is underweight or overweight? For decades, they were created by the formula industry!

As Dr. Robert Mendelsohn, a renowned pediatrician and early critic of the industry, discovered, these charts were deliberately manipulated to list above-average weights for each age group. This meant many perfectly healthy breastfed babies would appear "underweight" compared to formula-fed babies (who tend to be heavier).

Worried parents would hear: "your baby is in the 25th percentile for weight. We might need to supplement with formula." What they weren't told was that breastfed babies naturally grow at different rates than formula-fed ones, and being in the 25th percentile is completely normal.

Perhaps the craziest aspect of this whole situation is that American regulations actually mandate unhealthy ingredients in formula. The Infant Formula Act of 1980, passed in response to nutritionally inadequate formulas making babies sick, incorporated outdated nutritional science from the 1970s.

These regulations require that at least 2.7% of formula calories come from linoleic acid—the problematic fat found in seed oils. This makes it literally illegal to sell formula in America without seed oils, despite mounting evidence that these oils contribute to obesity and metabolic dysfunction.

I've spoken with several physicians who believe this requirement is a root cause of America's childhood obesity epidemic. Seed oils impair mitochondrial metabolism and promote fat storage from infancy. A systematic review of the research shows that formula-fed babies experience "excessive and rapid weight gain" compared to breastfed infants.

Though the Secretary of Health and Human Services has the authority to update these guidelines as science evolves, they haven't done so in decades. Which makes RFK’s recent push for Operation Stork Speed wildly, important and exciting!

Breast milk is a marvel of evolutionary design, and the more I learn about it the wilder it is. It contains antibodies that protect infants from disease, stem cells that help with development, and even contains proteins and fats that infants cannot digest in order to attract beneficial bacteria that can help colonize the baby’s gut better!!

No formula can replicate this complexity. Breast milk contains over 1,000 proteins, whereas formula typically contains around 30. The composition of breast milk even changes throughout a single feeding and as the baby grows. Breast milk is even diurnal, and morning milk contains compounds that help the baby wake up, while milk at nighttime contains melatonin to aid in sleeping.

Studies consistently show that breastfed babies have higher IQs, lower obesity rates, fewer allergies, and better immune function than formula-fed babies. For mothers, breastfeeding reduces the risk of breast cancer, ovarian cancer, and postpartum depression. For those who struggle with breastfeeding, there are milk banks and companies like It’s My Leche doing great (but admittedly weird!) work.

Today’s formula is poisoning infants, and pretending that corn syrup and soybean oil is a reasonable substitute for the most complex and health-promoting product that humans can consume. Fixing our formula (and encouraging breastfeeding) should be an urgent public policy.

😌 Dope stuff on the internet

Some of my favorite things since the last newsletter (note: I don’t get paid to recommend anything here):

• 📰 Article - I found this post on a potential fundamental error in biology quite fascinating. New and different ideas are interesting, and required for knowledge to progress. If we are wrong about one of our core beliefs in biology, well, that would be a big deal!
  

• 📚 Book rec - I’ve been increasingly interested in the work of Ivan Illich recently. He’s a wildly interesting philosopher, thinker, and I think his worldview is extremely relevant in today’s day and age. If you’re interested, I’d recommend starting with his classic book Medical Nemesis.
  

• ⌚ Cool product - I’ve recently been enjoying Jacob Bar in the office, and am a big fan of their clean ingredients. Though still my all time favorite bar has gotta be the Perfect Keto peanut butter bar 😅
  

• 🎵 Music - I didn’t know until this month that Above and Beyond has a live orchestral version of some of their most popular songs. It’s incredible: Satellite especially did it for me.
  

• 🏀 Random - I’ve written before about the GRAS loophole that allows companies to self-attest that a completely novel ingredient is safe, even if it hasn’t undergone significant safety testing.
  Well, it seems like RFK is taking a hard look at GRAS and is going to make some changes. Great for American health, terrible for Big Food and ag companies. Exciting!
  

• 🔥Hot take - I think David Bars are bad, and wrote about that here. Maybe it’s just me, but it seems unlikely that taking a seed oil, processing it further, and then calling that compound EPG (and saying because your body doesn’t digest it, it doesn’t count calorically) seems… not great?
  

• 🙋‍♂️ Ask - A team I invested in is working on Toku, a natural, non-statin alternative to lowering your risk of heart disease and improving your lipid markers. I’ll have more to say about Toku in future episodes (there’s some crazy stuff around statins and Alzheimers, for example), but if you’re interested sign up for the waitlist and trial they’re running!

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Another 30 days spinning around the sun. Hope you’re enjoying this brief slice of time we have - see you in a month 👋

• Justin