A new approach to toxin regulation - The Next #60

Flipping the FDA's approach, the MAHA movement, and opportunities around The Great American Poisoning

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

I have never been so bullish that we are going to make America healthy again.

At the federal level, I think RFK and the incoming nominees for FDA/NIH/CMS are all very aware of our crippling chronic disease crisis. They’re legitimately the first incoming administrators of my lifetime who are even mentioning the chronic disease crisis.

State leaders are also starting to get behind the MAHA agenda:

https://x.com/SarahHuckabee/status/1866862637105176797

My hope for 2025 is that we have federal and state leaders start to make noise on all things MAHA, and a coalition of voters continue to form around this issue.

And the end of the day, if Americans demand change, it can and will happen. Americans are tired of the poisoning, the corrupt guidelines, and a system that makes them sick (and profits from their illness). My hope is that with enough grassroots energy, and state and federal leadership willing to take on the corruption and abuse that’s making Americans sick, we can make a big difference this year.

There’s a tremendous amount of work to do, including getting the incoming nominees confirmed. But I do have hope that the genie is out of the bottle: Americans are aware of the chronic disease crisis and activated to do something about it.

Frankly, I thought it’d take decades more for this issue to come to the political forefront. I plan on doing everything I can to ensure that real change happens. If you’re excited by the mission to end chronic disease, drop me an email - we need talented people to help in the fight, and there’s a lot of opportunity to make a difference in 2025.

💪 What’s new

Imagine you want to introduce a new chemical into the American food system: let's call it Chemical X. What would you need to do to start spraying it on food?

The answer might surprise you: basically nothing!

Under current FDA regulations, companies can self-determine that their chemicals are "Generally Recognized as Safe" (GRAS). No testing required, no approvals needed. Just fill out some paperwork, pinky promise the FDA that it's safe, and you're good to go. Regardless of the chemical, this compound will now end up in the food/water/products of millions of Americans!

Now imagine that you want to introduce a new pharmaceutical drug. You'll need years of clinical trials, hundreds of millions to fund clinical trials, and extensive documentation of both safety and efficacy. The FDA will scrutinize every detail before letting you sell a single pill, no matter what you’re selling (or who you’re selling to).

This regulatory framework is completely backwards. The FDA applies intense scrutiny to drugs that people take for specific illnesses, while allowing virtually unlimited chemical exposure through our food, water, and environment.

You may be dying of a rare disease, and yet the FDA will not allow you to take - of your own volition - a potentially life-saving drug that’s in year 3 of clinical trials. You can’t opt-in to a potentially life-saving treatment.

On the flipside, when it comes to regulating the 80,000+ novel chemicals in our environment (97% of which have never been tested for safety), you cannot opt-out of having your food sprayed with Atrazine, or covered in glyphosate.

Let's look at how these two systems actually work. For pharmaceuticals, the FDA requires:

1. Extensive pre-clinical testing and toxicology studies

2. 3 phases of clinical trials involving thousands of participants

3. Post-market safety monitoring

All at an average cost of $985 million, and 7-10 years of development. This approach leads to fewer than 14% of drugs that begin clinical trials getting approved, and in even the best-case scenarios, an incredible amount of slowness.

Meanwhile, for food and environmental chemicals:

1. Companies can self-determine safety

2. No requirement for safety testing (or even informing the FDA in many cases)

3. Post-market action only if obvious harm is proven (it took 60 years for the FDA to respond to obvious indications of trans fat harms)

In this absurd system, the same government agency that requires a decade of testing for a headache pill lets companies dump untested chemicals into our food supply without batting an eye.

This causes real consumer harm.

Remember BPA? It was used in everything from baby bottles to food containers for decades, before independent research proved it was disrupting our hormones. Even today, its replacements (BPS, BPF) haven't been properly tested for safety. We're basically running a giant uncontrolled experiment on the American public (which I wrote more about in my piece on our insane approach to chemical regulations).

Environmental toxins are also hard to monitor and track! When pharmaceuticals cause problems, tracing cause and effect is relatively easy. Symptoms will often appear within a known timeframe, and causality is usually clear.

With environmental toxins? Their effects can take decades to surface, and it's nearly impossible to prove causation when everyone is exposed to hundreds of chemicals simultaneously. Under today’s regulatory approach, it would be literally impossible to detect a chemical that gave 15% of people cancer after 20 years of repeated exposure.

The key to fixing our regulatory approach is choice. With pharmaceuticals, one makes an informed choice to take them, one where you weigh risks and benefits. But nobody chooses to have PFAS in their drinking water, phthalates in their food packaging, or glyphosate in their beer. We're being exposed without our consent, and in an environment where it’s practically impossible to opt-out of these large-scale chemical interventions.

This regulatory approach is a big reason we are seeing rising rates of cancer, autoimmune conditions, and developmental disorders that correlate strongly with increased chemical exposure. After all, the average American has detectable levels of over 200 synthetic chemicals in their blood. Literally, there has never been a generation of Americans exposed to so many novel chemical compounds.

I’m very hopeful that flipping this regulatory approach is one of the key areas the new administration focuses on. And it’s something we will be advocating for in our work at End Chronic Disease.

🤑 Biz stuff

I went on My First Million to share some startup ideas around health.

Fixing the chronic disease crisis is the biggest opportunity in the US today. When the default outcome is that your average American is overweight, and 8/10 of us will die of a chronic condition, it’s hard for me to think of a bigger opportunity.

I talked about building a modern butcher shop (like my friend Kevin is doing in Austin), helping people improve their home’s health (a la Lightwork), and building a better, root-cause approach to address fertility issues.

At some point, I’ll write a longer piece outlining the many opportunities I see around the chronic disease crisis. If you have thoughts (or are working on something in this area), let me know!

😌 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 - Not an article, but if you haven’t seen it, be sure to check out PlasticList. Nat Friedman paired up with Light Labs to test for plastic levels across a bunch of common products (Indian takeout, Whole Food steak and salmon, etc). The takeaway from this research should be that our food system is compromised. You really have to go to extreme lengths to avoid many of the plastics and other things in everyday items like steak or salmon (even from Whole Foods!).
  A friend and I have been thinking of funding a similar research initiative to test a bunch of other consumer products, as well as specific things in Austin. If you’re interested in getting involved, let me know!
  

• 📚 Book rec - I just finished Breaking History, Jared Kushner’s take on the Trump’45 Presidency, and really enjoyed it. Kushner is an interesting character: a total outsider who joined the government in 2016 and negotiated the Abraham Accords, one of the most consequential foreign policy wins of our lifetime. If you don’t want the book-length read, his recent podcast on Invest Like the Best was also fantastic.
  

• ⌚ Cool product - I’ve been eating a ton of Maui Nui venison sticks the last few months. They’re amazing, and the only wild-harvested product on the market. I went hunting with the Maui Nui team in October, and can’t recommend their operation and ethics highly enough.
  

• 🎵 Music - Another banger - enjoy!
  

• 🏀 Random - This perspective on the “petroleum diet” is a good one. Basically, additives, dyes, and other compounds made from petroleum are everywhere in the standard American diet (sadly). This is just one of the areas I’m hopeful to see major change in ‘25!
  

• 🔥Hot take - On the microplastic topic, be sure to avoid tea bags made of light plastic, as they emit billions (or trillions!) of particles with every cup of tea. Avoiding all of this stuff is so draining, I’d like nothing more than to move to (or build?) a development that was healthy-by-default and did all of this thinking and work for me.
  

• 🙋‍♂️ Ask - My friend is still recruiting for people willing to try a non-statin approach to lowering cholesterol and other lipid markers. Sign up here if interested, I’ll be doing the trial as well!

***

What a year it’s been! Personally, 2024 has been one of the busiest (and most interesting) of my life. Excited to see what the new year brings, and thanks to many of you for following along the last year 👋.

• Justin