Daniel Fabricant, former FDA director, exposes how the agency weaponizes drug laws to ban supplements like NMN and CBD, protecting pharmaceutical profits while ignoring decades of safe use. He details how politicized oversight stifles self-care, causing market crashes in CBD and forcing platforms to remove legal products despite no safety data. Fabricant argues that requiring clinical trials for natural deficiencies eliminates essential nutrition, urging citizens to demand better doctor education and congressional action to restore balance between innovation and public health access. [Automatically generated summary]
Transcriber: CohereLabs/cohere-transcribe-03-2026, WAV2VEC2_ASR_BASE_960H, sat-12l-sm, script v26.04.01, and large-v3-turbo
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Supplement World vs Pharmaceuticals00:15:17
So, you worked for the FDA for how many years?
From 2011 to 2014.
And what was your role at the FDA?
I was the director of the dietary supplement programs there.
So, there was a division then.
It's under.
Mark that one.
Sorry.
Jump a little bit here.
It was a division.
Now it's an office, about 26 people in charge of dietary supplement policy for the whole country and getting involved in enforcement, directing inspections, you name it.
How did you get into this world of medicine and supplements and all this stuff?
You know, I guess it started as a college athlete.
So it started there.
Went to grad school at the University of Illinois trying to discover drugs from plants.
Most people don't realize the majority of our drugs, especially cancer drugs, actually come from plants.
So I started under a guy named Norm Farnsworth there, who's the godfather of pharmacognosy an interesting word.
Pharmacognosy is one I've never heard of.
Yeah, it's basically the study of medicines from plants, right?
That's kind of where we get everything from Chinese medicine, et cetera, and so forth.
But went there, and instead of working on cancer drugs, there were grants at the time because Duché, which was the law which authorized dietary supplements, was new.
And NIH had botanical centers of excellence.
And so we got one of those grants and kind of just fell into it.
There was a lot of regulatory stuff at the time because we were doing clinical trials.
So we had to get, you know, past INDs and things like that.
And my advisor was up there in years and he's like, well, you go to DC and you learn how to do that stuff because I've done this for too long.
And so kind of got thrown to the wolves, at least to the FDA piece.
That wasn't really what my background was.
It was really as a chemist.
It was a pretty good chemist, but then kind of got switched into more of the regulatory political space just by virtue of.
That's what was needed.
Right.
There's a couple stats here that I'll read them off.
I don't, correct me if I'm wrong on any of them, but in the United States, as far as healthcare goes, we pay more for healthcare than anywhere else in the world.
We have the highest level of chronic disease in the world.
We consume more pharmaceutical products than any other country in the world.
And we're the number, and the number three cause of death in the US after heart disease and cancer is pharmaceutical drugs.
Does that sound right?
Sounds about right.
Yeah.
We're also one of the things that ties into that, and it'd be interesting.
Um, We're one of two countries that allows for direct marketing, direct advertising pharmaceuticals to people.
New Zealand, I think, is the other one, right?
Sweden.
Sweden.
Really?
Yeah.
They allow that.
They allow advertising in pharmaceuticals.
I believe so, yeah.
Wow.
Yeah.
So, why is it that we spend more money on healthcare than any other country in the world, yet we have some of like, I think we're like in the 70 something.
We're like number 70 something in the world as far as like healthcare outcomes.
Why is that?
Good question.
Selfishly, given where I work from, a lot of it's how we eat, a lot of it's nutrition, a lot of it's staying healthy.
A lot of it is that.
I think you're seeing.
It's interesting.
I think you're seeing a move towards self-care.
One of the things we see with dietary supplement users, they actually have better health outcomes long-term.
So that's something we're very proud of.
Seem to be more informed on health care, more willing to take matters into their own hands, which I think is better.
I think a lot of it's systematic.
We can sit here and rail on the fact that people see their doctor on average for eight minutes is the average visit.
There's a lot of that that goes into it.
There's not a lot of people don't care how much you know until they know how much you care.
For eight minutes a day, you know, or when you go have an appointment, you're not really.
Especially if those doctors are seeing like 100 people a day.
Right.
They can tell you to eat better, quit smoking, quit drinking, whatever the issue is, and you're going to go, I saw this guy for eight minutes.
It has literally zero impact.
Yeah.
When I go to see my primary care doctor like once a year, he's always just like interested to talk to me because he says he sees probably like 40 to 50 people a day and they're all in there like 70, like from 70 years old to 90 years old.
Yeah.
And it's just like, it's a lot of work.
Well, I think there's that, and there's also to that point, I think we spend more kind of in the, there was a statistic, I don't know how valid it is post-COVID, but that we spent more than any country per capita in the last six months of life, right?
Healthcare.
We spend a lot at the, you know, kind of end stage.
So that's important.
And then for us, I think what's really important is the average doctor gets only 16 hours of nutrition, including dietary supplement education in their training.
16 hours.
Wow.
Yeah.
So how is it that, where's that message going to come from to eat better, to do better?
And if you take, I used to teach pharmacology when I was at the University of Illinois graduate school, you know, they always had grad assistants help teach.
You know, they take, I don't know, probably, 130, 140 hours of pharmacology versus 16 hours of nutrition.
So, right, within medical school.
So, yeah, you think about it that way, it's a big difference.
How much attention do you pay to what other countries do as far as educating their doctors and students in colleges and how much attention they pay to food and diet versus supplementation versus pharmacology?
Not a ton, but enough to see that there's a clear difference in terms of.
What's considered healthy and what's not, right?
Like, I think other cultures are much like they have a better concept of what a healthy diet is, right?
I think they have it's kind of more cultural, it's more ingrained, if you will.
Whereas here, we're always looking to, well, what does a doctor say?
And now it's, well, what does Dr. Google say, right?
So, versus looking kind of internally.
Yeah.
Also, recently, I don't know how, I don't know like what the trend has been over the last 50 years in the US as far as like, Where we are on the global spectrum of healthcare versus other countries.
But it seems like now there's a lot more open information on the internet, like on YouTube, about there's people like Huberman that talk about stuff and how people can basically take control of their own health.
Yeah.
I mean, that's the one thing.
We do lead the way.
It's real disparate because we lead the way in self care.
Other countries want to follow what we do in terms of self care, in terms of access to, you know, because we do, you know, it's interesting.
The irony is because we have access to.
Pharmaceuticals in some ways that other countries don't.
We also have access to other things, right?
Huge, huge issue for our industry, for the dietary supplement industry, is we kind of have an FDA that always wants to pull access back.
Meanwhile, if you look around, that's not what people in this country want.
That's not what people want globally, right?
They want access to multivitamins.
They want access to omega 3s.
They want access to botanicals in a different way than maybe their traditional medical cultures have around the world.
Like in China, you're seeing a huge growth of dietary supplement use.
Now they still have TCM.
Oh, yeah.
Yeah.
It wasn't always available at retail.
And it's, Quite expensive at retail.
Most of the market in China has been traditionally multi level marketing or direct sales.
Now you're seeing retail starting to open up and people really, there's a demand.
Where does China land on like this?
What is their healthcare system?
Like how good is the healthcare in China and how, what is their life expectancy or their overall?
I know here there's like more obese people than anywhere in the world.
It's probably not like that in China.
I know they have a big problem with like people being malnourished, not being able to have food, but it really depends on city versus rural.
It's hugely.
Dependent on the economy, too.
Yeah.
And they do, I mean, they do have some challenges with obesity.
I don't think that's, you know, but I think part of that, too, is they see, oh, wait, you know what?
High fructose corn syrup, people like that in the United States.
Let's start putting that in some food here, too.
So I think when you're seeing those changes, it makes a huge difference.
But, you know, if you look at the fortification programs in some of those countries where they started adding vitamins and things like that, you've seen, it's interesting.
It's almost a rewinding the clock where, you know, you've seen an increase in life expectancy in more rural folks, I think, because you have had some fortification of the diet and things like that.
Prior, they didn't have.
Right.
Okay, so you worked at FDA for three years under Obama.
Yes.
How does, can you give me just like a broad 30,000 foot view of the basics?
Like explain to me, like I'm a 10 year old, how does the pharmaceutical and supplement world work?
Oh, well, okay.
So the supplement world works different from the pharmaceutical.
We put people, there are laws, there are good laws.
We put people in jail when I was there.
FDA still has the ability to do that.
So you don't sell everything that FDA works on.
Is it misbranded?
So is it truthful and not misleading?
If it's not, if you're trying to mislead people or you're telling things that are false, that's a That's the one crime.
And the other crime is is the ingredient adulterated, right?
Have you debased the material in any way, whether by economic fraud?
You hear all the time about olive oil not being olive oil.
That's adulteration.
Also, adulteration can be do you know if this is safe or not?
And yet you introduced it to the market.
So, those are kind of the principles that at least the dietary supplement area is around.
Similar to pharmaceuticals.
Pharmaceuticals have to be proven safe and effective, though, before going to market, with some exceptions.
So, adulteration is saying it's something that it isn't?
That's misbranding.
Adulteration would be debasing the material in some way, devaluing the material in some way, whether for economic gain or that could potentially harm somebody.
If you introduce something loaded with E. coli, that's adulterated, right?
Okay.
While you may eat some E. coli, it's not a food.
So you generally can't put that in the diet.
Okay.
What about the pharmaceutical world?
Like I said, those generally have to be proven safe and effective.
It's about anywhere.
And the fast track can move it up to about two years, but it's a 15-year runway.
You start with preclinical studies for pharmaceutical in phase one, phase two.
Then a dose ranging or phase three.
And then if you get approval, there's usually some sort of post market surveillance study, too.
Is it true that 50% of FDA's budget is funded by pharmaceutical companies?
I think it's more than that.
More than that.
I think it's closer to 72, 73 now, all in.
What does that mean?
Well, they have a different.
So it's a user fee, basically, right?
So it's a user fee.
So that's where they can hire staff to pay attention to those.
Files they work closely with the pharmaceutical companies to review their documents, to review their studies, to get approvals, and it's a pay for.
Hmm.
So now they're still part of FDA.
A big part of FDA is appropriated through Congress, through our tax dollars.
It's a public trust, right?
FDA was started by a guy named Harvey Wiley, kind of poison squad after the jungle and the poisonings in the stockyards in Chicago.
And so, but it's changed quite a bit since then.
It was the Pure Food and Drug Act.
Now it's a lot of people say that food shouldn't even be at FDA anymore, which is interesting.
Yeah.
How much attention do they put into food?
Based on what we've seen over the past 24 months with things like what happened with infant formula, I think that kind of question.
Yeah.
Can you explain what happened with infant formula?
Yeah.
There was a bacteria that was found with some manufacturers that shouldn't be there, and the agency knew about it and did nothing, effectively, is what the story is, and just kind of said, okay, it'll be fine.
It'll work its way through the system, and it didn't.
And some kids got really sick, and it led to a huge shortage of infant formula because basically, everything that was on the shelves had to be brought back, recalled, you know, whether for retesting or for destruction.
And that certainly created a number of problems for people.
Was that Johnson Johnson who made that, or was that a different product?
Am I thinking of a different product?
It was a division of Abbott.
Abbott, that's what it was.
That's what it was.
Yeah, yeah, yeah.
And there are some versions of the story where there might not even have been the contamination.
It might have just been more of FDA's errors.
And I think that's really the challenge, is, you know, what's the best thing the agency does?
The agency was started, you know, kind of back to that poison squad, to inspect and test, right?
To go into facilities, make sure that facilities are.
Sanitary, there aren't processes that could damage the products and randomly test.
And when they don't do that, like FDA didn't visit that facility for a long, long time, you kind of go, what is it they're doing then?
Yeah, they're supposed to be like the arbiter of safety when it comes to all this stuff.
And it seems like they've just become like the worst part of human nature has infected the FDA, similar to the way it affects the other industries like defense and.
Everything else.
It's become politicized.
Your food and your drugs are incredibly politicized now, which that was really, you know, it's part of the reason FDA actually is a third tier agency in the cabinet, president's cabinet.
They're not, they don't report, no one at FDA reports directly to the president.
They report to the secretary of HHS.
And that was by design to keep them apolitical.
The opposite has happened effectively in the past 20 years.
Can you explain how that's changed over the last 20 years?
Well, I think what's happened is people have pushed down the people they want politically into the under organizations, right?
So it was never a, You have folks that are at FDA for life.
I don't want to get into the deep state stuff or any of that stuff, but you have folks that are there for life.
And it's like there's really not a lot of checks and balances on that because, one, the more political, the higher political levels are in and out pretty fast, right?
And they'll set an edict forward and then they'll be gone two years later.
Whereas the folks at kind of the base level, they operate somewhat freely to do what they want.
And I think a lot of times their personal politics comes into play and they're not accountable to those because the, The people at the levels above just go in and out pretty quick.
And so in some ways, they've become independent from some of it having to answer politically, but they're making it up as they go along.
I mean, they've been defiant, especially on the food side.
There was a Reagan-Udall review, which actually is a third-party kind of a foundation that looks at FDA consistently.
They looked at the foods program and tobacco program, and they found that the food program at some point just stops answering Congress.
And it's like, well, wait a second.
Congress has oversight over FDA.
Congress funds FDA.
That's who they have to answer to.
And FDA just wouldn't answer on some of the food stuff.
So, really?
Yeah.
So that's a challenge, right?
It's like, how do you bring them into a place where they go, wait, I swore an oath to protect American life, to help, you know, to protect babies in the case of infant formula and make sure things are going right?
That's concerning, to say the least.
How do patents affect certain things like pharmaceutical drugs and other things like that?
And how is FDA involved in that?
Yeah, that's a great question.
Patents are.
Pharmaceutical IP, I would say to the agency, is those are crown jewels, right?
They think pharmaceutical IP is, in a lot of ways, their reason for existing, right?
FDA works hand in hand with somebody who did a lot of research to get a blockbuster drug to market, and they get user fees for it, like we said, 70% of the user fees.
So they're protecting their investment, right?
Who gets the user fees?
FDA does.
Okay.
So, like I said, so that IP drives those user fees, right?
That IP around, hey, I have a potential blockbuster drug.
And I'm going to bring it to market.
I need to have, I'm paying you to make sure you review things in a timely manner because the quicker I get to market, the longer my patent life, the better off I am.
Patent Life and Exclusivity00:03:58
But the patents don't the patents drive up prices like astronomically?
They certainly can.
You know, and usually that's what happens.
Branded drugs are obviously cost a lot more than generics.
And, you know, you have a runway on your branded before it even can become a generic, right?
You get 17 years effectively plus or minus, you know, however long the approval process took.
So in that 17 year window, you know, Would you rather get to marketing year two or year 13?
Right.
So, do other countries have these patents with drugs like this?
There's definitely material protection.
I mean, there is in other countries.
I think the challenge here is you really do have that direct correlation.
And I'm not saying that user fees are always a bad thing, it makes people accountable.
We need blockbuster drugs in some ways, we need new developments, we need innovation.
Right.
At the same time, when you see an article like there was in Bloomberg on Monday that said, hey, there are drugs that were fast tracked that are still making claims that were never authorized.
That's when you go, well, wait a second.
Where's the check and balance there?
And that seems to be done just to kind of like, oh, hey, you know what?
You paid us a user fee.
We fast tracked it.
And, hey, do what you want to do, which is people should kind of scratch their heads and go, well, wait a second.
Right.
But the patents themselves, these people are able to get 20 year monopolies on certain drugs.
Doesn't that completely stifle innovation?
It can.
It can.
What happens, interestingly, what happens now more and more is somebody looks to extend the patent life by way of adding it with another drug or making another claim for it.
Right.
So if you have a patented drug and it's about to come off patent and you combine it with another therapy, you see this a lot of times in cholesterol reduction, things like that, then you get even more patent life and more exclusivity.
So you're seeing that a lot.
You know, I think that's one of the challenges that's out there right now is where are we?
And it's part of the reason there's all this battle about, and it sounds like insulin prices are going to come down, but it seems like there's all these battles, you know, about pricing, about open market, about the marketplace.
And, I think those are good discussions.
It's definitely more front facing than it was before.
I think, in some ways, though, and especially for our industry, I think what we're seeing for the dietary supplement industry is you're seeing that process, that patent process or the IND process being used to keep others out of the market, which wasn't the intent.
The intent was you're going to file an IND, you're going to have the IP.
Are you going to develop it?
If you're not going to develop it, okay.
How are you still able to block someone out from the market indefinitely?
That's a problem.
Is there any.
Is there any, do you see any sort of like hope or do you see any, are you optimistic at all of this changing or being fixed some way?
Because there's obviously glaring problems in this thing, and you say it wasn't their intent for this to happen.
But do you see any way, is there anyone pushing for this to be changed or?
I mean, I think patent reform generally is tough, right?
Because it always gets into tort reform, which no one ever wants to touch.
What's tort reform?
Sue somebody and when you can't, like what's what it's the basis.
I think when it comes to IP right now in the country, we have a very big divide between tech, cell phones, if you will, and biosciences.
Biosciences need more protection.
Tech, they'd rather have an environment where you can effectively steal from one another because the technology is different every six months, too.
I think it's important that people have time to develop life-saving therapies, etc.
Don't get me wrong, but I think there's got to be a little more specificity on it.
It can't be kind of this zero-sum game, and you know, that's.
I think contributed to the bit of the challenge.
For our industry, I am hopeful because I think you're seeing more and more products that walk in two worlds, products that are both drugs and at lower levels may have a physiological effect, not a pharmacological effect, but a physiological effect.
What is the difference there?
Pharmacological usually is drug receptor response, right?
Walking Two Worlds00:04:03
You may have something like niacin, right?
You take a lot of niacin, it helps to smooth the vasculature in a way that it prevents coronary vascular disease, heart attacks, et cetera.
Niacin at a lower level you need for cellular functioning.
So, these are the sort of cellular metabolism.
And so, different levels, very different levels.
Different amounts.
Different amounts, different outcomes, different use.
And so I think more and more you're seeing that.
You're going to see more of that with peptides, with live microbials, with, you know, you name it.
Certainly cannabinoids touch into that too because you've got drug approvals and CBD.
But that dosage is about anywhere from a gram to two grams a day.
And it's important because it works on kids who have seizure disorder, right?
Which is they used to have to take very hard.
CBD is.
CBD does.
Yeah, the drug.
The drug.
Yeah.
And, you know, they used to have to take really harsh drugs to deal with that seizure disorder.
Yeah.
But that's not why folks in the supplement space or the food space want to use it.
They want to use it because people may occasionally have trouble falling asleep, or they may, you know, maybe after a hard workout, it really works well for them for recovery.
Those are total different endpoints.
So, and they make energy drinks or they make drinks with CBD in them too.
Yeah.
Yeah.
They've got those to help you, I guess, you know, kind of.
I always wonder too, because there's so many products out there and they like slap these little labels at the bottom of their can that'll say, like, you know, this much CBD.
I always wonder, like, Is that bullshit?
Like, is that really in there?
Well, this is the whole point of FDA, right?
It's like we've come full circle in a short time.
FDA should be out there inspecting and testing.
Instead, they throw up their hands and they go, we don't know what to do because there's this drug, even though there's a part of law where FDA can say, hey, just because it was a drug first, we can still allow it as a food or supplement.
And like you said, the product's already out there.
Like the horse has left the barn.
So they might as well get in front of it and say, look, we've evaluated this scientifically.
If you're going to use it as food or supplement, like one of those beverages, you don't exceed this much a day.
Like we tell people, hey, You know, you'll see on caffeinated products, like you may want to keep it below like 400 milligrams a day.
You've seen some of those things.
You know, not to be used under 18, those sorts of things.
You haven't seen any of that from FDA.
They just keep going, oh, we don't know what to do.
And meanwhile, like you said, there's a proliferation of products in the market and a proliferation of misinformation, if you will, because they're not being inspected, they're not being tested.
And that's really what needs to happen more than anything.
Because there's really no big incentive for them to do that.
Is that right?
For FDA?
Yeah.
I mean, I think that there is.
But again, they feel like and there's no repercussion.
Well, they feel like well, there isn't a repercussion.
You're right.
Nobody has taken them on.
It's interesting.
You have so many states and so many members of Congress who have programs where they're like, hey, farmers, rip up your tobacco fields, plant hemp, and there's going to be a marketplace for you.
That was about 10 years ago.
That marketplace still isn't, if you will, in FDA's line of thinking, regulated.
And so that's hurt, right?
Like, I think about five years ago, CBD was about $4,000 a kilo.
Now I've heard stories as it's down to about $100 a kilo.
So that's crushed those farmers, absolutely crushed them, just economically in terms of the value of their crops.
Because they had tobacco crops and they changed them to hemp?
Yeah, there's a lot of states that funded those programs.
And so they grew hemp and there was kind of this gold rush.
Like I said, the price of CBD got up to about $4,000 a kilo.
And then without a government framework to regulate it as a food or supplement, it crashed quickly and now is down to about $100 a kilo.
Interesting.
And the whole Delta 8 market came to be by FDA in action, realistically, because I mean, you've heard the stories about Delta 8 and it proliferating everywhere.
Delta 8 is effectively the CBD biomass that somebody smart somewhere figured out, wait, if I cook this, it's not as good as Delta 9 THC, but it's not bad, and I can sell it for more than $100 a kilo.
So, you know, it's a very interesting kind of model that's sprung out from FDA's inaction.
Huh.
Because you didn't have Delta 8.
Some people say it exists in a plant, but it's in such minute quantities.
You know, it's a very small plant metabolite that I don't know that anyone felt a sizable effect of it.
The Delta 8 Market Boom00:14:37
Biologically, before.
Delta A is a type of THC, right?
Yes.
Yeah, that's right.
Okay.
So, and is there any of that in CBD?
Well, a very, very, very minor, minor, like minor mouse.
But if you apparently, I think if you heat it, use some sort of soft acid, and then you create, you know, you convert CBD to Delta 8, and now you're seeing that sold alongside, you know, basically in dispensaries and things like that as a get high product, which is not the industry I represent.
Right, right, right, right.
So, okay, let's go back to your role at the FDA when you were at the FDA.
Can you share, like, some of your experiences as the director?
Of the division of dietary supplementation and the different programs you worked on, and like what specifically you had to deal with?
We had the first injunction for GMP violations, which was big.
So, GMP is good manufacturing practices.
Good manufacturing practices ensure a baseline of quality of how a product is made.
And there was a firm that really wasn't adhered to, had no quality parameters in their facility at all.
They just made something, they didn't know what was in it, they didn't know if it was contaminated, they didn't know anything.
And so, we were able to use the law to shut them down, which was a big thing at the time.
It was the first time it had been used.
And the GMP laws are – you have GMPs in pharmaceuticals, medical devices, foods.
It's a standard – GMPs are a standard in the U.S., but this kind of quality standard, quality by design standard, is fairly uniform throughout the world in terms of making health products for people, that you have to have a minimal quality standard.
And this was something that came about only when you – first started working for the FDA?
It was in, there were some pieces in motion.
So the GMPs were, it took the FDA, so the GMPs were authorized in 1994.
It took the FDA until 2008 to get them out.
So yeah, the first enforcement didn't happen until my watch.
The inspections were ongoing, but the first time a firm got shut down for it was under my watch.
We pushed on that hard and made sure that that happened because it was a firm that wasn't, at least at the time, wasn't interested in complying with the law and having some assurances to consumers that things were made in a quality manner.
Okay.
What about like dietary supplementation or anything or any other programs?
Well, some of the big ones we worked on was, I don't know if you remember DMAA.
No.
DMAA was a pre-workout ingredient at the time, which was very popular, but it was questionable.
It actually used to be a drug, and it was questionable whether or not it was found in nature.
And so that was one of those where we had to demonstrate it wasn't found in nature and it could potentially lead to health issues.
And so that was a big one that was on the market.
Who was claiming it was found in nature?
A few different people.
The company at the time was called, the big seller company at the time was called USP Labs.
And they had a recently, I think in 2020, the case against them finally closed the government.
I mean, obviously when I left the government, the case kept going, but I think the government finally closed the case against them.
I think some of their executives served time and had to pay a fine.
So that was a big one just because it was this whole construct of, hey, this is found in nature.
Not really.
It was kind of a, it had a, it, The molecule itself, a lot of people think, and again, there are studies on both sides of the fence, think it has amphetamine like behavior, which shouldn't be in your foods, right?
So that was kind of the particular challenge with that particular issue.
Then the company had another issue.
The government was shut down in 2013.
I had a daughter.
My daughter was young at the time, she was about a year and a half, and they shut the government down.
So we all go home on October 1st, right?
And the fiscal year, September 30th, they tell me, the head of this Center for Food says, You're not essential.
I was like, great.
I don't want to be essential.
I get a call the next day.
There was an outbreak in Hawaii of non hepatic liver injury from another one of this same company's products.
And so I had to go in.
We had to work the case.
Case and by the end of the month, we were able to get that product off the shelves.
Through we started to work on mandatory recalls, actually, the first time FDA was going to use mandatory recall, and then we pulled it back.
So, wow, because the company got rid of all of it, so it was an interesting issue.
Yeah, it seems like there's probably a lot of issues with some of the like stuff that's supposed to fire you up or like zip you up, like energy drinks and like stimulants.
Well, there can be, there are also a lot of really good manufacturers.
The big thing though, this is the key thing is.
FDA should know first.
They should be the ones, right?
Like that's why we're paying the tax dollars is they should know first.
They should be out there going, okay, we've seen these facilities.
We understand.
They can go into your facility.
They have pretty broad authority.
They can go into your facility at any quote-unquote reasonable time.
Now, they're not going to be coming by at midnight, but if they want to go to your facility and they want to have access to your records, they have it by the letter of the law, which if you want to watch somebody make their product, what's better than that?
And kind of FDA's reticence to do that.
In some areas, I think it is concerning.
That's really where they add the most value.
And instead, they've kind of gotten off on this specific to our commodities, because dietary supplements, they're more interesting and kind of paper arguments than actually boots on the ground.
Like lawsuits?
Well, yeah, like what we've seen with, you know, we had to sue them on NAC.
They told us NAC, which was in the market for 30 plus years.
What is NAC?
It's N acetylcysteine.
It's an amino acid found in broccoli, found all over the place.
It was approved as a drug in the 60s for.
inhalational.
It opens up the bronchi.
Now that's a different administration than swallowing it and having it dissolve in your stomach and work its way through your system.
And because of that, FDA then says in 2020, now the drug was approved in the 60s, I think 1963.
There are records we gave to FDA that it was sold as a supplement in oral form in the 90s before DeShea came in.
So before there was even a definition of dietary supplement, NEC was sold in a capsule.
People took it, used it.
So you have 30 some odd years of safety.
In 2020, they told us, nope, not allowed anymore.
And you go, wait a second.
What's the issue?
Is there safety?
FDA said this?
Yeah, FDA said this.
And they go, we're like, well, what's the issue?
Is there a safety issue?
Because if there is, then we need to work with you guys to address it.
No, not a safety issue.
Okay, so what's the issue?
Well, we don't think it fits the category.
It's like, well, it's an amino acid, you know, and so you spend a lot of time doing this kind of, like I said, this paper dance of here are our arguments.
They come up with counter arguments, which, you know, from our side, it's like a little thin.
But then, you know, it progresses and it progresses to them.
Denying people to export it because they're saying, well, you're exporting an illegal drug and so forth.
And so it's like, okay.
So now you're interfering with the business.
Then Amazon delists it, right?
Which really hurt part of the business because unfortunately, I think our space, the dietary supplement space, has given away a lot of land to Amazon, whether intentional or not.
You know, everyone's got to use it to sell, but I think there's so many.
I use Amazon to buy all my supplements.
There you go.
You're our problem though.
Yeah, right.
No, but, you know, and look, a big part of our membership are mom and pop retail, right?
We've heard from so many mom and pop retailers because.
Someone goes in there and they go, Hey, what does this do?
And the mom and pop retailers are knowledgeable.
They've been doing this for 20 years, 30 years.
And they tell people, and then they never see that person again because, just like you said, then they go, Wait, I can just buy it on Amazon.
And now I know which brand I like.
I know which brand to take.
I know what ingredients I like.
And they just go to Amazon.
That's fine.
It's a choice in the marketplace.
But it gave Amazon the ability to basically, in this instance, and with NMN, which we'll touch on too, it gives them the ability to effectively, FDA never has to.
Really, render a scientific or legal opinion, they can just go, We don't like this, and Amazon will stop selling it.
And that is like Amazon is like the waterfall for everything.
It's a category killer, it's an ingredient killer, it's an industry killer.
So that, and FDA knows that, you know, and that's where, that's where the game is right now versus like, okay, if there's not a safety concern, if it occurs in nature, we're not making disease claims.
We're not saying this is used to treat asthma.
People are using NAC for healthy metabolism for, you know, a number of, there's a number of studies and probably, probably over 200 clinical trials, good clinical trials on NAC as a supplement.
So it's not like there hasn't been research done to show the effects.
So the fact the agency just wants to go, nope, line in the sand, can't be both a drug and a supplement.
You go, wait a second, how does that work?
Right.
You know, it's this whole concept of if something occurs in nature, I get that if somebody finds something in nature nobody found before and develops it for IP as a blockbuster drug, they should have first right to the marketplace.
I think that makes sense.
But the notion that that should forever be locked out of other uses, especially as a food or supplement, people clearly ate it before.
That doesn't make any sense.
If you find a minor component of broccoli, right, that no one found before, and let's say someone develops it and it works against prostate cancer and it works well, great.
But let's say lower levels of that ingredient have a function that, you know, helps you with urinary tract infections, right, which you can have a food do.
We have that cranberry juice, right?
So it should never be allowed to be used for those purposes as well, right?
It's kind of backwards.
And that's why, like, when you brought up the farm IP thing, it really.
That's what drives the agency is the pharma IP, and they don't want to address the issues that would effectively have a diminishing return on pharma IP.
I think they think.
I think they think if it has another path to market, that's going to reduce the value of the pharma IP, which I think it's pretty flawed thinking, but that's clearly their thinking.
Yeah, it's money thinking.
Yeah.
So, what was the reason they drew that line in the sand with NAC?
Still don't know to this day.
Still don't know to this day.
You know, we can speculate there were some studies, interestingly, early on.
Shouldn't we be able to get this information?
Good question.
We'll go deep on that.
There were some thoughts because there were trials looking at NAC for COVID because it opened the bronchi.
So there were some folks that thought there was someone at work trying to brand a drug with NAC for COVID applications.
Okay.
So that was one theory.
Again, that's completely, we're going to go completely tinfoil hat or whatever.
Black helicopters.
Black helicopters.
Right.
But that was one theory.
You know, again, we don't know to this day.
So we sued them.
To hopefully find out, and they ended up selling us out of court because they didn't want us to get discovery and everything else.
So they gave us what we want.
They brought it back to market with enforcement discretion, which they'd never done before.
They'd never said, okay, fine, you can sell it as a supplement too, which they did effectively.
Now we want them to write a regulation.
There's a regulation in the law that allows for FDA to take something in its pharmaceutical and allow its sale as a supplement or a food.
Okay.
They've never used that in 29 years of this law being in place.
Which law is this?
DeShe.
DeShe.
Okay.
So, Amendment to the Food, Drug, Cosmetic Act.
Right.
By the end of this, you're going to be a food, drug, cosmetic expert.
But so they gave us what we want, and Amazon put it back on, and all's right with the world.
Except then we drop our lawsuit, and about two weeks later, they do the same thing with NMN.
NMN is a, some people think, an equivalent of niacin.
So nicotinamide mononucleotide.
Right.
And say that 10 times fast, right?
Right, right, right.
No, so I'm very familiar with NMN.
I, Verso, the company that Daniel Meyer has, I love it, I take it every day.
I took it before this podcast.
It's great.
It's a, It's a precursor to NAD, which is like cellular energy and anti aging and supposed to like keep you young and keep yourself healthy, like regenerate yourselves, right?
I mean, look.
And it became popular from, we should go deep on the NMN stuff.
So, it became popular originally when it was already obviously discovered.
I think somebody won a Nobel Prize over discovering it.
And then this is the article.
David Sinclair, if you scroll down about halfway through the article, it talks about David Sinclair.
He first went on Joe Rogan's podcast, started talking about all these anti aging compounds.
NMN was one of them, and he specifically called it a supplement.
Yes, a number of times.
And it's a great write up, by the way.
If I can give a quick shout out to Mike Roberto and the guys at Price Plot, great write up by them.
They covered it, they went deep on it.
Keep going down.
You'll see the photo or you'll see like a video clip of David Sinclair.
You got to keep going.
Firing through that, man.
You're going to have to hit that wheel hard.
Yeah, there we go.
No, it's faster.
You're going to see his face.
You'll see Sinclair's face.
Yeah.
Yeah.
And now he wants to keep it out as a supplement.
Nope, that's Jeff Duncan.
That's our buddy from South Carolina who wrote FDA a letter.
There's Warren Hatch.
It's about halfway through, Michael.
Yeah, it's interesting in that they, you know, the most interesting piece.
Right there.
Yeah, there it is.
You don't have to play it right now, but.
The most interesting piece in all of that is FDA after the fact on NMN.
They did.
So we have what's called a new dietary ingredient notification provision.
It's not pre-market approval, but it's pre-market notification.
We have to give the agency safety data before going to market, 75 days, and they look at it and they go thumbs up or thumbs down, or they can say, nope, this isn't a dietary ingredient, which, you know, people have submitted things like steroids over the years to try to sell them a dietary supplement, and FDA's like, no, thanks.
Easy there, killer.
Yeah, right, exactly.
Those are like.
Kick those out.
They should be kicked out.
They don't fit into the construct.
You're really talking about things in the diet, things in nature people want to use as foods to supplement their diet.
So, anabolic steroids aren't found in nature?
They are, but you don't get them.
They make them from yams, don't they?
They used to make them from horse urine.
Pregnant horses.
Yeah, premarin is pregnant, merry urine.
That's nature.
Not quite food, though.
Right, right, right.
But long story short, they don't fit in that the definition is smart because the definition is really vitamins, minerals, amino acids, you know, botanicals.
It's not like, hey, something to completely.
It effectively draws the cut of are you trying to basically sell a pharmaceutical in the diet, right?
Like that's kind of the cut.
It's a bit of a.
It's a very blurry line.
It can be.
Blurry Lines Between Drugs00:12:31
But in some ways, yes and no.
I guess I'm biased because I've administered the law to me.
It's like.
I think it's pretty clear, but I understand for a lot of folks, they look and they go, well, wait a second.
Why can I say, like, supports, like, there are drugs that support strong bones, so, but I can say it for calcium and vitamin D, right?
You know, so I get that there's some confusion there at the same time.
Something like a steroid really works on the only time medically you take a steroid is when you're having an injury, right?
There's a lot of other reasons, though, aren't there?
Like, isn't it in other countries, don't they?
I think specifically in Europe, I could be wrong on this, but I heard that testosterone is prescribed for like ADHD or ADD.
It might be.
It very well might be.
I don't know if that use is being approved of here, I guess.
Here we just hop them up on amphetamines.
There's that too, right?
Yeah, you raise a good point.
Yeah, but I think that the common sense way the law is applied is hey, these are things we find in the diet or find in a plant and aren't at a level where we're trying to.
We can change the structure of function of the body, right?
Calcium builds strong bones.
Back to that again.
Right.
But we can't say, hey, this hits, you know, this will reduce A1C and you'll, you know, you won't have a cardiovascular incident, right?
We generally don't say it.
But though we do say, hey, fish oil promotes healthy cardiovascular function.
Okay.
I do get that some people say it's a distinction without a difference, but I think there is a difference.
I think the difference is, look, we're not trying to replace a medicine.
We're really trying to go, look, this is really more a lifestyle change.
You want to take the prescription fish oil.
Usually those are taken by people who've already had a stroke or heart attack versus you want to cut that off at the pass.
You want to be more preventative.
Here you go.
And the main difference is just the amount of it you get with the prescription.
That's the amount – the pharmaceutical company, I think, will say that the purity is different.
They may be right on some aspects of that.
I don't think there's that significant a difference, but again – I think Daniel was telling me that FDA actually wants to completely take fish oil off the supplement market.
They tried.
They tried.
It's interesting.
They used the International Trade Commission to try that.
They tried a complaint, and they tried to – it was an interesting argument because they tried to usurp FDA's jurisdiction on this.
It was Amarin, the product of Vicepa.
So they tried to say, look, this is clearly being used to – Basically, as a substandard drug, and FDA doesn't know what they're doing.
It was kind of an interesting argument.
It failed.
People have been eating fish and people have been eating fish for fish oil for longer than the drug's been approved.
So that kind of came to play.
That actually IP part came to play somewhat in the dietary supplement industry's favor, in that, look, there was no way on God's green earth people have been talking about eating fatty fish for the fats, for the omega 3s for 60 years now.
So that was one of those where it was tougher for them to kind of go, no, it was a drug first.
It should be a drug only.
But I think it gets back to that.
And how much harder would it be for people to get their hands on it that way?
Like, it would be so much more difficult.
It would make the general population, people that possibly can't afford to go to a doctor every year, they would not be able to get their hands on it.
But the medical establishment go, What do you mean?
You're not going to go to the doctor.
What's your problem?
Why are you not going to go to the doctor?
Right.
I mean, so that's the challenge you're running into, especially with the self care movement, right?
Is you're running into someone's going to, there's a winner and there's a loser, right?
And it seems more and more on the medical side, they're at least losing some control in that regard and they don't like it.
And I think that that's where a lot of the, I don't know if controversy is the right word, but there's definitely a lot of friction there.
But back to our good friend David Sinclair.
Yes, David Sinclair.
So he goes everywhere.
He wrote a book too, right?
Yeah, he wrote a book and says take NMN supplementation.
Also, so here's where it got interesting.
So a company submits an AKL or submits the NDI, the new dietary ingredient notification.
Okay.
They get an AKL, which is a good day letter.
They say, go to market.
We like your safety data.
Go nuts.
Great.
They tell everyone, we got the AKL.
They were the first ones.
And to this day, they're the only ones.
Six months later, FDA, and this goes back to the question of what happened.
Six months later, FDA goes, oh, we changed our mind.
You can't be a dietary ingredient.
Whoa, wait, where did this come from?
Well, we came up, we discovered new information.
What do you mean you discovered new information?
You're supposed to do, when that ingredient comes in, you're supposed to do those checks.
Is it being trialed as a pharmaceutical?
Is it, you know, what?
Have they ever done that before?
Never, never.
Where they came back and said no?
Never.
Never.
And also, they don't technically have the statutory authority.
The statutory authority, like we talked about, derives from is it adulterated or is it misbranded?
They haven't said the product is adulterated.
They haven't said that, hey, this product is unsafe.
It's made unsafe.
They actually said they like their safety data, right?
So you have to have a reasonable expectation of safety for a new dietary ingredient.
The firm already met that.
FDA said, you meet that, go to market.
Now they're going to come back and go, well, we didn't know there was previously an IND.
So the IND, once again, for the drug to move it ahead as a drug, kicked it out.
What's interesting in that is.
You can't search when that IND went in anywhere, and FDA won't tell you when that IND was effective.
Effective.
So you go and you start looking at pieces.
And one of the things in this story is if you go to clinicaltrials.gov, there was a study on a supplement that, on an NMN supplement that had, that was submitted prior to the NDI, but it was on a supplement.
Then after the fact, they changed it to say, what was it, MIB626 versus NMN.
So they changed it to look like it was on a supplement.
Scroll down a little bit.
There's actually, I think there's screenshots of that on here where they actually show, they pulled up the reports.
Keep going.
You'll see like it's a, is this it right here?
Where all these redactions are?
All the redactions.
So basically.
Zoom in on that.
Yeah.
So they go from, hey, it's a supplement.
We're doing a supplement trial.
And some universities require a supplement, require an IND to do a supplement trial.
That doesn't make it a drug, but you submitted the IND.
So they went into this initial report and they literally changed every single place that NMN was mentioned and they changed it to, what did you say?
MIB 626, I think.
And why do they do that?
Because that's their drug.
That's the name of their drug they filed the IND under.
Okay.
So that way they can keep it out of the market.
They also removed any mention of the term dietary supplement, right?
Which was everywhere.
Yeah.
Initially.
Right, right.
So this is where you scratch your head and you go, okay, come on.
And also, here's the bigger problem.
Do we think, and, you know, David Sinclair is a very wise researcher, very well respected.
I'm not going to talk about that, but these guys are not necessarily.
I mean, I have a hard time seeing where they're going to develop a blockbuster drug with NMN, right?
So what's the point other than to block people from the market as a supplement or as a food, which is a bit problematic.
And we know NMN is in the food supply, right?
Now, once again, to our earlier, okay, maybe people didn't discover it and say, hey, eat your frosted flakes for NMN content, right?
Like you say, eat it for, you know, carbohydrates or vitamin D or vitamin A.
But at the same time, it was there.
And so they're effectively trying to use this part of the law to keep it out.
Of the supplement food supply indefinitely, which doesn't really make a lot of sense.
So we're in the same place we were on NEC, effectively.
So NMN is essentially like if you take it in a concentrated dose, I guess from my grasp of understanding of what it does, is it essentially is kind of like an anti aging drug on the cellular level, right?
Sure.
So David Sinclair has built up a huge following when it comes to anti aging and sleep and.
All that kind of stuff.
He's discovered the fountain of youth.
Couldn't he essentially market some sort of anti aging drug and make a ton of money doing that?
I think that's the goal, but I think that you haven't seen the sort of movement you usually see for blockbuster drugs being developed by that company.
By now, you would think they'd be in the next stage of clinical trials and so on and so forth.
That doesn't seem to be what's going on here.
Don't they have some clinical trials going?
They do, but I'm not aware of them answering those particular issues with dose ranging and those sorts of things.
So what that indication would be.
FDA has never approved a drug for, there's no anti-aging drugs on the market.
So that would be a pretty, to break through that, like to get that claim for a drug, that's going to be a pretty high bar.
Like what are those endpoints for anti-aging?
Are people living longer?
Are their telomeres shorter?
How do you test it?
Right.
What's the actual, what gives you that claim, right?
So that's the challenge versus what we do know about NMN is it's in the diet.
It promotes cellular metabolism.
It reduces, if you will, Some cellular metabolic injury, which I think is, you know, we can equate that, if you will, with anti-aging or something along those lines, right?
That's kind of, but I think that this whole construct of it can't be a supplement and we can't know when it was excluded from the market is even more ridiculous.
Adding fuel to the fire, there's actually a self-grass, which is another way of going to the market, generally recognized as safe.
So you see that on food ingredients all the time, like caffeine.
Self-grass?
Yeah, grass.
So generally recognized as safe.
A company can do a, and actually FDA sued for the rights for a company to do this.
A company can get a panel together and, under scientific procedure, have toxicologists review the ingredient and determine that it's safe for use in human food.
That's my favorite.
They can determine it's safe for use in human food.
That was done, at least for our understanding, before that IND.
So, in some ways, the race to market was won by the food side versus the drug side.
So, you know, this is one of those challenges.
We'll see as this plays out.
you know, is the intent by FDA to tell people they can only sell it as a food and then not sell it as a supplement?
I mean, it's really bizarre.
It's just a very, it's an odd duck, and it goes back to that kind of construct of FDA is you can't have something that walks in both worlds.
You know, there's not a safety problem.
They've said that with NMN.
There's no safety issue there.
They're not seeing like people aren't having liver injury or any sort of problems.
So what's the actual, other than protecting the IP, what's the goal of FDA here?
And that's the part that nobody wants to talk about.
Isn't NMN just basically another form of vitamin B?
A lot of people think that.
A lot of people think it's an equivalent to niacin.
It's a better form of niacin.
There's also talk about nicotinamide riboside, which is on that pathway too, similarly.
And nicotinamide riboside actually has an NDI, got a good day letter, and is on the market.
So, yeah.
What is that used for?
Same, same.
They interconvert.
What is like the lowest hanging fruit people use that for health wise?
Same as NMN.
Nicotinamide riboside, same as NMN.
Okay.
So it's kind of, it fits in that kind of anti aging space, if you will.
I think the bigger challenge, though, is this is the tip of the spear there are going to be more ingredients that are going to come to market.
Peptides.
Peptides are being studied for both day in, day out use as nutritional products, but also as therapeutic for everything from cancer to Alzheimer's.
There's all sorts of peptide trials.
What is a peptide?
Can you explain to me, like I'm like 12?
It's smaller than a protein, larger than an amino acid.
So it's a specific link of amino acids that has a general. that generally once it gets into circulation, it has a direct biological effect.
It's effectively, and I'm not a peptide expert, so forgive my crudeness.
And if you get mail on this, tell people to shut me up, they might be right.
But it's basically using amino acid residues, so a link of specific amino acid residues to behave at a specific receptor or a receptor ligand, much like a drug would, like a small molecule drug would.
But it's an amino acid-based.
You know, those are the building blocks versus proteins are very long and, you know, so much depends on folding proteins, things like that, and how they act biologically.
Whereas peptides are usually shorter chain and there's much more of a direct short term effect.
Peptides and Biological Effects00:14:24
Peptides usually don't make it through the gut, but with improvements in technology, now they do.
So they can be used orally versus before they were primarily used in injectable, which is different from my industry.
We don't we don't inject anything into you dietary supplement.
You got to take, you know, take in orally.
But I think you'll see if FDA, if you will, wins on NMN developments like that, where do they go?
Like they can't, you know, you really are blocked out of the market then because there's no reason why somebody wouldn't take.
Especially with AI now, you could effectively model a molecular space, file nuisance INDs on all of them, and people could never sell them as a food or as a dietary supplement.
So, wow.
Right.
So, so much for innovation.
Yeah.
Did you hear that there was a guy whose dog was dying and he used like ChatGPT 4?
And he like basically, the vet said, We got to put your dog down.
There's no helping him.
And he typed in all of his dog's symptoms on ChatGPT and the ChatGPT like, suggested what to do, what to give him and what to feed him, and it literally brought his dog pack to life.
I wouldn't doubt that that, you know.
I think you're going to hear more and more stories like that these days.
And it goes to the self-care thing too.
Right, if people don't, when you're faced with that sort of dire consequence, you're going to try to find an alternative right, you know, and it's not always that dire consequence, it may be something as much as like hey, I gained a few extra pounds, or you know, I don't feel as I don't, I don't have as much energy as I used to, and so, you know, folks are going to look, um and so Versus.
There's got to be a general recognition by FDA that there are ingredients that are going to walk in two worlds, and there isn't always a bright line.
And so how do you distinguish between the two?
That's really kind of where we are.
And they don't seem to want to go there because of that, like you mentioned, that pharma IP piece is, you know, that's the crown jewels to them.
They don't want to do anything that upsets that apple cart.
So what stage are you in with this battle with the FDA over NMN?
And what is the status of NMN like on Amazon and different websites?
Even Shopify.
Yeah, Shopify pulled it.
Amazon pulled it as well.
And they all kind of pulled around the same time, which was odd.
Back to the black helicopter thing.
Yeah.
You know, we haven't seen what's, you know, from the agency, there's final agency action.
They actually will take a legal action or stipulate some sort of legal position.
They haven't done that to this point.
To this point, all they've done is respond to NDIs saying, we don't believe it's a dietary ingredient because of this drug exclusion criteria.
So, We like to think that's final agency action.
The agency doesn't.
We probably wouldn't be able to have any sort of judicial relief on that because they could go, hey, this isn't final agency action to a judge and it would get quashed.
So, what we've done, and identical to what we did on NAC, we started with a citizen's petition.
So, a citizen's petition is we're trying to compel FDA to a specific course of action.
In this case, reverse their decision on NMN or, similar to NAC, allow for it in the marketplace, pretty much identical to what they did on NAC for NMN.
That process takes 180 days.
We submit it on March 6th.
So it becomes ripe, if you will, for the courts on September 6th.
So that would be probably the first chance we would get to say, hey, Your Honor, this is final agency action if folks were motivated to go there.
So that's kind of the state of play of things right now.
Like we said, platforms have pulled it, some platforms, some are still up and selling it because it isn't final agency action.
And I think that's what's interesting too.
But Amazon has pulled it.
Amazon has pulled it, and who knows why.
We've certainly reached out to them.
We haven't heard anything back, which is unfortunate.
But that's another thing for people to consider when they're purchasing products.
Because I think for Amazon, who knows?
They probably have to keep parts of the government happy too.
And so if they can go, look, we're a good corporate citizen.
We took this off without even final agency action, maybe that gets them some brownie points.
I don't know.
But it's odd in that it kind of goes around due process, right?
FDA has not rendered a legal opinion.
You know, no different than if you got pulled over for driving too fast and, you know, no car company would sell you a car anymore.
And it's like, well, I haven't even been to court on this yet, right?
Right, right, right.
You know, there's no like, what's the basis?
Well, you got pulled over.
And it's like, okay.
You know, that's kind of the challenge.
It just keeps shit in limbo for a long time.
Yeah.
And the limbo is economically, and again, FDA knows this, the limbo, anytime you deal with the government, there's an old joke that when you get, you know, when you have a legal entanglement with the government, you are innocent till proven bankrupt.
And I think that some of that applies here, right?
Wow.
Yeah.
And that a lot of companies, especially small mom and pop companies that are selling online, probably can't survive without that Amazon exposure or that Shopify exposure.
Some of them can't.
Yeah.
Some of the platforms can't.
Some of the brands can't.
So I think that that's some of the challenge is how do you, you know, an FDA, like on NAC, that hurt that part of the industry economically for a while, FDA's actions.
Did FDA pay anyone back on that?
No.
There was no restitution on that.
They certainly didn't pay our court costs and anything like that to file a lawsuit and anything else.
But I think that's the reality.
And it's interesting.
Other industries, pharmaceutical industries, sues FDA frequently.
Really?
Yeah, quite frequently.
So that's one of the things I think is in some ways good for this industry is that it needs to be more common because it's tougher and tougher to get relief from Congress now.
Congress is.
Pretty well deadlocked.
I mean, we've seen that for how long now?
As you really deadlock Congress, they don't do as much as they used to.
There's not as much, you know, legislation as there used to be.
And so, and for good reason, I mean, just some of the rules of the road in Congress, the fact you've had so much redistricting that you've got pretty safe seats on both sides, which makes it, hey, if I know I'm going to get reelected, why am I going to do anything?
I mean, that's what you see more and more, right?
Yeah.
So, that's really where the, if you will, the, as Wayne Gretzky used to say, that's where the puck's going, right?
Is there's going to have to be on these issues, And people are always like, well, lawsuits are expensive.
Yeah, they are.
But at the same time, if you don't have another, you know, 100% of zero is zero.
And so if you don't have another path forward, that's really where the industry's left is starting to move in those directions more and more.
So I'm sure there's people like you, lots of people like you who are basically helping lead this fight.
And how is this fight against the FDA being funded?
And it seems like, you know, are all of these NMN companies banding together and throwing in money for this, or how does it work?
Some.
So our organization is 87 years old.
Our organization, I can say, and has sued the FDA throughout history, never lost a lawsuit to FDA.
What's the name of your organization?
Natural Products Association.
Natural Products Association.
NPANational.org.
Never lost to FDA.
And it's not because we sued them on everything.
We were very selective, very targeted.
And so there was some banding together by companies.
I think what you're seeing, though, is you're seeing when DeShaye passed, FDA, not FDA, Congress got more.
Than they got for the Vietnam War.
Wow.
Telling people, hey, members of Congress, I want to have access to my vitamins, my minerals, my botanicals.
Don't tread on that.
Don't make FDA treat them like drugs, right?
Worked, worked very well.
30 years, you've seen more and more people use supplements and use them safely.
If you look at side by side of other commodities at FDA, if it's not the safest, it's certainly one of the safest.
You really don't see some of the challenges you may see with other commodities.
And people go, well, wait a second.
Food's the safest thing.
About 150,000 people get hospitalized every year for produce, for norovirus and things like that.
So, right, don't see that challenge with dietary supplements.
So a really strong safety record.
But with that, I think some people have been very successful in the industry.
I think there's some apathy, and we want to see more folks get involved in that level.
And also, I think you have folks that are scared of, well, if I sue the government, aren't they just going to come after me?
It's like, okay, let's play that through.
If I sue the government, aren't they going to come after me and target me?
That's always a possibility.
Can you control it?
No.
But if you have that mentality that if I sue them, I don't want to sue them because something bad could happen.
You've already lost.
Right, right.
I mean, it's a terrible premise because you're basically like, You know, it's like, I don't want to do the right thing because it may affect my livelihood.
And it's like, when's that worked out well in history?
You know, it's just kind of said, you know, and I'm just going to stuff it because, hey, yeah.
So it's a good point.
Yeah.
It's an interesting time.
We want more folks involved.
We have a good group of people involved on the NMN thing, but more folks should be involved.
A lot of folks are interested in MM.
I mean, it really is used very widely.
You know, in some ways, thanks to David Sinclair.
Right.
So, yeah, I got some other bullet points on NMN just because I couldn't remember them, but.
It was called a dietary supplement by more than 100 researchers from around the world.
It was called a supplement for years by the co founder of the pharmaceutical outlet in question.
I'm assuming that's David Sinclair.
Yeah.
Metrobiotech is his company.
Okay.
It's historically called a supplement in pharmaceutical outfits' own clinical trials.
So, what's his company, Metrobiotech?
Yeah, that's the company he's, I think, one of the principals in.
I don't think he's the CEO, but I think he's one of the principals.
Didn't he tweet something that he had nothing to do with it?
He may have.
I don't think that's the case, though, because I think there's been some prior things put down.
So that's our understanding.
And so, you know, I don't know if it's a case of, who knows, maybe people are upset that they didn't make money off of it as a supplement.
Now they're trying to block it from the rest of the market.
I don't know that, like I said, we don't know yet what really the impetus is here.
I guess people can say, well, the impetus is they want to develop it as a blockbuster drug, but it's a little different in terms of how that's going to move forward.
What about cannabis and CBD?
When did this whole thing get on the radar of the FDA?
Good question.
When I was there, I was part of the cannabis working group there in 2013.
So it's been on the radar.
But CBD really became prominent in the market around, what, 2016, 2017?
Something like that.
Around there.
FDA had a big public meeting in 2019 where they said they were going to do something.
It was in May of 2019.
And we're going to do something.
Well, they've proceeded to do nothing.
And they were going to use the existing pathways because people wanted to sell it, as we said, a beverage, a food, or as a dietary supplement.
Now, there was the drug product out there.
The drug product got there.
They got approved, I think, in 2019.
I want to say it was 2019 was the approval.
And then DEAD scheduled it from a schedule.
I think it was a schedule one or schedule two to now schedule five.
I think that was 2019 or 2018.
So you go, wait a second.
Farm Bill passes in 2018 and Farm Bill says, okay, hemp is no longer, you know, not going to be Schedule I so long as it's 0.3% or less of THC.
Okay.
Okay.
So you've got to decriminalize there.
And, you know, FDA has proceeded to, in the past five years, keep going.
We're confused.
We don't know what to do.
Now, other governments have moved ahead.
FSAI, which is the Irish FDA, they've moved ahead with a temporary level.
The UK has moved ahead with a temporary level.
What is a temporary level?
Of how much a day you can take of CBD as a food or supplement.
Okay.
So there are other governments that have moved ahead with allowing it as a food or supplement, but with a recommended upper level.
If people want to go past that.
Is this only CBD or is this marijuana, cannabis?
Only CBD.
Only CBD.
So only CBD, yeah.
So, I mean, other places, I mean, states obviously have their own marijuana law.
Some states, I think 30 states have actual CBD laws on the books.
Mm hmm.
But that's patchwork, right?
I mean, you very rarely get states to agree with each other on kind of the technical aspects.
You know, how are you testing versus how am I testing?
Is it the same?
And also you go state to state.
It's interstate commerce, which is generally federal jurisdiction, right?
So you've got all these kind of moving pieces there.
So with CBD, you have this growth in the marketplace.
It's so confusing.
Yeah, it really is.
No, but the bigger thing is this, is it's this drug exclusion criteria once again.
People ate hemp prior to the drug being developed, right?
I think we know that.
CBD has always been in hemp.
Right?
We know this too, as well as the other cannabinoids.
Now, I'm not saying, again, that if somebody develops them as a drug, you can't have some exclusivity in the market.
But the notion that somehow it should never be allowed on the other path, when, you know, especially with CBD, people aren't talking about using it for seizure disorder.
They're talking about using it for occasional sleeplessness, occasional inflammation from, you know, workouts.
Right.
So it's a total different use.
And yet, The agency keeps going, well, we can't do anything with it.
Now, classic to government, they want a cannabis center.
Of course they do, right?
The government always wants more money, more power.
So they want to lump CBD supplements in with vaped products, with everything, and have this cannabis center.
So let me see if I get this right.
You can't solve the problem for one particular class of good, like a dietary supplement.
So you're going to combine dietary supplements with foods, with animal feed, with vape products, with inhalation products, and that's going to make it easier.
It doesn't make any sense, right?
And it's a delay, too.
The Center for Tobacco Products took about 10 years for them just to get up and running when they got that authority from Congress.
Financial Hurdles for Cannabis00:07:40
And it has not exactly been a success.
I mean, they keep saying vape products aren't regulated.
Meanwhile, you see more and more vape stories everywhere.
Everybody vapes.
Right, right.
And there's an argument to be made public health wise, but because the way they set up the structure on tobacco, combustion products probably are tougher on your body than non combustion products, right?
More than likely in terms of lung disease and those sorts of things.
Right.
There are some studies that stipulate that, but you can't say it under that sort of a combined regime that FDA has on tobacco, which in a lot of ways I think they want that on cannabis because I think they really don't like it and kind of, and they certainly don't like the dietary supplement industry, so they want to kind of use it to take their shot.
So we'll see where this goes.
But that's kind of where things are with that.
We filed a citizen's petition on that as well.
They denied it in January of this year.
Really?
They said the existing pathways weren't adequate.
And it's like, well, wait a second.
You haven't used them.
So we submitted our citizens petition.
We gave them the option.
One of our board members is a company called CBDMD, and they've done these studies in Europe to get – they actually are the – I think they're the only ones in Europe that have gotten through the process, in the UK, that have actually gotten through the process because they've spent a lot of money on big-time science.
And they're supposed to, right?
It's new to the diet, if you will.
So they establish its safety.
Great.
That's what we want.
We were like, FDA, you could review this if you will say you're not going to consider the drug exclusion criteria.
And they said no.
And so you keep hearing from them, we don't have the data.
Well, here you go.
You had company data, probably 1,000 pages of company safety data that showed a safe level.
And they go, meh, we don't want to look at it.
And it's like, how do you get out there in the press and go, we can't use existing pathways?
Well, if you're not even going to review the damn data, what do you do?
So this is a problem we're having.
And a lot of people are talking.
What can be done now, though, that they said that?
This is the question, right?
We really need to find someone in Congress who's willing to push them around on the issue.
And that's the challenge.
Yeah.
Yeah.
Or once again, use the courts.
And I think that's the issue.
And I think the courts are tougher because I think the financial interests in CBD are much more dispersed.
I could be wrong, but I think they're dispersed a lot.
I think you have some interest from some of the tobacco companies, which is ironic when you think about it because they want to say, well, no, see, we've cut our use of tobacco.
We're a safer company, we're a safer product now.
Take that for what it's worth.
Then you have folks who really are very well versed in hemp.
And to the extent they want to line up behind kind of the existing authorities, I'm not so sure.
They may think that they're special or different.
They might be different, but it's still a botanical.
And botanicals we regulate either as a food or dietary supplement, or we regulate them as a drug, with the exception of tobacco.
So you've got to fit in one of those two worlds.
So we'll see.
But yeah, it's going to be either Congress or the courts on this, because otherwise it's just FDA delaying indefinitely.
And back to what we said.
It protects that pharmaceutical IP.
It really does.
It has, that's the net effect of all of it.
Is the pharmaceutical IP, that blockbuster drug for CBD, nobody's technically legally encroaching on its market share.
So, couldn't a company like a big tobacco company sort of like get that patent and sell it that way?
As a tobacco?
It depends.
I mean, it depends.
Well, I guess part of, yeah, I guess as part of that, because wasn't there a big fight with tobacco and like vaping when vaping first came out?
Yeah.
Wasn't there like a big buyout where tobacco kind of like, Bought out all the vaping companies.
I forget what company it was, or was it the ad agency or something?
They bought some of them.
I know that.
I think the bigger thing is this you've got a very different set of rules in foods and dietary supplements than you do on tobacco.
They really can't make claims in the tobacco world at FDA because there's no, for foods and dietary supplements and drugs, you're always on what's called kind of the risk benefit continuum.
Everyone has to eat foods.
Some foods, if they provide a benefit, you can claim that benefit, right?
Vitamin D, calcium.
Etc., for dietary supplements, structure function claims, promotes healthy metabolism, promotes healthy gut function.
But you have to prove it.
You have to have substantiation, but you can make those claims.
On tobacco, I don't know.
I may be dating myself here, but they used to say on certain cigarettes contains 30% less nicotine or tar or whatever.
When FDA took over tobacco, those claims went away because it's a risk or harm reduction type part of the law.
It's a very different part of the law than the rest of FDA.
So it'll be interesting to see if people try to stick.
Cannabis into that part of the law, I think that's an incredibly bad idea, but they might give it a shot.
You can still buy CBD, though, pretty much everywhere in the U.S.
Yeah.
That's the irony in all this, right?
Is FDA is a public health agency.
And for them, they throw up their arms and go, we don't know what to do to protect consumers.
It's like there are products out there now.
You can go inspect and test facilities now and make sure at least there's no contaminants.
At least products aren't loaded with THC.
At least there aren't heavy metals or pesticides.
And they're not doing that.
And that's the bigger, I think that's the bigger letdown for everybody.
How can you sit there and go, we're worried about safety when you've done nothing?
Yeah, it's disheartening.
Yeah.
And this, this makes me, Very pessimistic about marijuana ever becoming legalized in the country.
I mean, I think they're going to leave a lot of it up to the states.
I think broadly, federally, yeah.
I mean, federally, there's a few hurdles.
Though it sounds like, I mean, what's interesting now is with all the different financial products, I think some of the, I think whether it's through kind of a coin or a crypto or some other financial mechanism, I think there are ways now that you can, it may not be insured in an FDIC bank, but it seems like folks have come up with ways to bank on it, you know, which is interesting.
You know, the markets, the financial markets kind of found a crack in the dam.
I don't know how that'll play with the capital markets and getting investors and things like that, but it does seem like there's some movement banking wise without Congress doing what they needed to do banking wise on it.
So that may change things a bit.
How does that affect drug legalization, like for marijuana?
Well, if you were legally transferring money across state lines now, like if it's a legal vehicle to transfer money across state lines, that takes kind of the, you know, All the money laundering, the wire fraud, mail fraud, some of that off the plate.
By using like cryptocurrencies?
Could be.
Could be crypto, could be different, you know, different financial products.
But I know that folks feel like there are ways to stabilize that through the use of different electronic financial products.
Oh, interesting.
Yeah.
Because like now what they have to do with these dispensaries is they have to have these like Brinks trucks come and pick up the cash and they drive it to the, where do they drive?
Like a credit union because they can't use it.
Yeah, they can't use an FDIC bank.
So yeah.
Yeah.
It's interesting.
Whereas I think, People have really thought about it long and hard.
Not that they found a way around it, but they kind of found a way through with different, you know, who knows.
But the bigger thing is this, is it shouldn't be, this shouldn't be as complicated an issue as it'd become, right?
There's really the thumb on the scale on a lot of this in terms of kind of, in specific, less so on THC because that's not my space.
But on the CBD space, it's just there's really, there's no reason why that part of banking, right?
Compounding Pharmacy Risks00:09:04
Like there's no reason there should be a prohibition on that part of banking, on industrial hemp.
I mean, Farm Bill should have removed that.
So it's an odd, it's odd, very odd.
And what is going on with, I also heard that there's something going on with testosterone therapy where they're trying to ban telemedicine clinics from prescribing testosterone to guys with low testosterone or different variants.
Yeah.
They're trying to control that more.
They're worried about, I think, you know.
Since when?
When did that come on their radar?
I don't know.
I don't, you know, it almost seems like it's funny because so much of that, I think, Remember during COVID, everyone was pushing telemedicine?
And it's like, use telemedicine for everything.
Don't go see your doctor.
And now it's like, no, come see your doctor.
So it almost seems reflexive in that regard.
It's like there's that wanting to bring back, you know, hey, we've got control over this.
You can't do this by telemedicine.
You can't, you know, you can't basically have an online presence to self-prescribe yourself to need HRT, whereas a few years ago, it seemed to be fine.
Yeah, and there's lots of like, so there's these telemedicine clinics that are everywhere.
There's hundreds of them.
And they basically, they'll like call somebody up on the phone.
They'll fill out a survey, tell them how they're feeling.
They have to get their blood work done.
They analyze their blood work and say, hey, you can get this much testosterone or whatever, and we'll send it to you.
We'll mail it to you.
Right.
But they get it from these like compounding pharmacies, right?
Yeah.
Does the FDA inspect these compounding pharmacies?
They're supposed to.
And the FDA, a while ago, actually, when I was at the agency, you had the compounding pharmacy in Mass where people died of some bacterial and fungal contaminants.
This was 10 plus years ago.
Yeah.
But FDA at the time goes, well, we don't have authority over compounding pharmacies when actually it was kind of shown that they do.
So they do.
Compounding pharmacies do have some leeway, and it's usually through state licensure.
But they're still, if they're producing anything in a batch type manner, which some of this is produced in a batch type manner, right?
They're not just making specific for you.
They're making, okay, they're going to make a batch of 60 and folks that meet that diagnostic, then they'll get them out.
Then it would be FDA's jurisdiction.
I imagine most of the production is done that way.
So in those cases, FDA would have jurisdiction over the quality and those sorts of things.
So, yeah, it's an interesting, it is interesting, though, considering that, yeah, during COVID, everything was, no, telemedicine, telemedicine, telemedicine.
And now it's, nope, you got to, yeah.
Yeah, it's very odd.
Well, like you said, the technology is there.
I mean, I think the diagnostics to some degree of telling someone what their hormone levels are are, and again, this isn't my area of expertise, my area of oversight, but it is interesting in that you seem to have, you know, was fine a few years ago and now it's not.
We'll see how that plays out.
Yeah, because it's such a simple compound that can help people in so many different ways.
There are so many different diseases and conditions that having proper hormone levels can fix, whether you're a woman or you're a man, depending on what.
If you're a guy who has low testosterone, that can lead to all sorts of things like heart disease and everything else.
But you can get this cheap testosterone that costs less than 50 bucks a month or whatever that can help these things.
If you just maintain and pay attention to what your blood work and your testosterone levels and your vitamin levels and all this stuff, it's very easy to do if you can pay attention to it.
Yeah, the vitamin level thing is critical for us.
We tell people all the time is get those tested, get know what those are.
Those are incredibly important, especially vitamin D.
I mean, vitamin D was, you know, it's interesting.
Vitamin D was one of the biggest cohorts for COVID mortality with vitamin D status.
And so we, you know, it's, it's, It's important and we know other governments actually told people and I think the UK was sending people vitamin D whereas that wasn't kind of the strategy here which was interesting So yeah, I mean with the technology with getting tested and combining those You know you got to be careful with what you say But for something that's approved as a drug it's the rules are different.
I mean for nutritionals the rules are you got to be very careful and not say hey if you have low levels of vitamin D You need this much to avoid disease you can't say that but you do need to say hey your levels are low.
Here's what you need to get back to an optimal or You know, worthwhile level.
Right.
What did FDA do specifically during the pandemic?
Would you say they did, would you say that they did perform well during the pandemic?
Or how would you analyze how they responded to everything during the pandemic?
Well, I mean, we had NAC during the pandemic, so that was kind of, that's, yeah, having a fight on the NAC thing when folks are worried about, you know, so many other factors was a bit poor timing.
I think our biggest concern was inspections.
was the delay or ceasing of inspections.
We understand that people didn't want to go out and do inspections, go to facilities.
We worked really hard with the White House to make sure dietary supplement manufacturers were deemed essential.
That was important that they stayed open.
We actually even wrote letters saying, look, if you need extra production to produce whatever hand sanitizer, we're happy to use our facilities to do that.
So we tried to be helpful in any way possible because I think early on, nobody knew what was happening.
Everyone was just like, look, and our board was great.
They were like, what do we do to help?
Yeah, I think that's the biggest thing is like, why during a pandemic are we, when people are just trying to stay healthy, why are you going to start looking at ways to, you know, I'm not of the belief that the universe of dietary supplements and nutritionals should be completely unlimited, but I do believe it's an expanding universe, not a contracting universe.
And whereas I think the agency took the opportunity to go, nope, we need to contract the universe.
And I think that's kind of at the core of whether it's NMN, CBD, NAC.
I think that's at the core of those issues, they want to contract what folks have access to.
One of the things that disturbs me is that I don't know if it was FDA or NIH, but they owned like 50% of some of these vaccine patents, like the Moderna patent, for example.
I think NIH owned like 50% of these Moderna patents, and they were like buying up all these vaccines, and they actually had them, and they needed to get rid of them.
And people were encouraged to.
Not to talk about supplements and stuff like that.
And don't talk about that.
That's bullshit because we really need to be focusing on the vaccines because that's what's really going to help people.
Now, we had states actually, three states, and Massachusetts shut everything down.
So we weren't unique.
They shut down all stores for about two weeks.
And we fought, but we were Massachusetts.
That wasn't going to happen.
What was interesting is Nevada shut down specifically supplement stores and health and wellness stores.
There was a great.
So it was interesting.
Some of the pretty large bodybuilding community out there.
And so they go.
You know, gyms were closed, some gyms were closed, some gyms were open.
It seems like some folks were kind of like sneaking folks in the gyms, which I think is kind of cool.
But they would go and take pictures at a strip mall, and an ice cream store would be open, but the supplement shop would be closed.
And it was, it kind of didn't get viral, but it certainly got a lot of attention where people were like, What's going on here?
So McDonald's was open.
Yeah, yeah.
And so we had a bit of a headbutt with the governor out there in Nevada, like, What are we doing here?
Right.
Because it was, It's like, well, wait a second.
Why is your order to shut down something where people are trying to stay healthy versus, you know, it was a weird time.
And it was weird what people made into a priority versus, you know, we knew vitamin D was really important.
We knew zinc was really important.
And, you know, we tried to make sure folks had options there.
And, you know, another scary thing is like they discouraged practicing doctors.
From talking to each other and actually like talking about what works with patients and what doesn't work with patients.
They were unable to experiment with any sort of like therapies or any sort of things to prevent COVID.
It was just like all these big agencies just pushing one thing on everybody.
And when you look at their close ties with pharmaceutical companies, that gets really scary, especially when you have the hindsight of looking at the opioid crisis and some of these things like these patents and.
And all this stuff.
And a lot of these things, like I told you, I read that Dr. Fauci book by Robert F. Kennedy, and he talks about how they specifically tried to shun some of these medicines like hydroxychloroquine and I think ivermectin, and they pushed them out to all these other countries, like the third world countries could get them, but we couldn't get them.
Diet Science and Supplements00:03:53
Yeah.
Well, I think, you know, you see, and you bring up OxyContin, we always get told in the supplement industry, well, you guys aren't regulated because, you know, you aren't, you don't go through the drug approval process.
And the drug approval process is apparently perfect, except it's not, except we've seen challenges.
We've seen challenges with, you know, with OxyContin and with other things.
And, you know, again, I think the whole concept of a natural product is, look, you know your milk every day.
Has enough calcium and vitamin D to help a kid build strong bones.
You know that.
You don't need to clinical trial that.
Like, we know that.
The science is well established.
Right.
So, if you took everything in the industry and required a, you know, required a phase one, two, three type approval, would you have what, about 20 products, 30 products, probably?
I mean, with the cost with everything else.
So, the economic aspect comes in, but the bigger thing is these are things from the diet.
These aren't most, the majority of the industry is things from the diet.
Probably, you know, 80% of the country uses a supplement every day, and probably.
One third of that is people using a multivitamin, multimineral supplement, you know, these things that we don't get enough of in the diet anymore.
You know, we have, you know, you see frequently people have low vitamin D status, low magnesium status, things like that.
Okay, where are they going to get it from?
We're like, well, just, and the argument back is always, we'll eat a better diet.
Okay.
So with all the demands on time now, which are much greater than they were 20, 30, 40 years ago, where's that going to happen?
And so it's what do they say?
At that point, they kind of get quiet.
But I mean, you look at, you know, we always look at the dietary guidelines, right?
And the dietary guidelines for the first time ever kind of said, well, hey, supplementation can be good.
But there's some walking back of that, too.
The dietary guidelines also for a long time told us that, you know, don't eat any fat in the diet, too.
Where it's like, well, that turned out to be not such a good recommendation.
So the food pyramid was basically upside down on purpose.
What is the history of the food pyramid?
It was like paid for by, I forget what company.
I want to say it was like Kellogg's or something.
But there was some, maybe you can look it up.
Who paid for the original food pyramid?
I don't know if you've ever heard anything about that.
No, I haven't.
This might be a black helicopters thing, but I heard that there was like a big food manufacturer that actually sponsored and paid for the traditional food pyramid that has basically bread at the bottom of it.
They're saying that the foundation of a meal is bread.
It's like the very top was eggs, right?
That don't eat too many eggs, right?
The food pyramid is a.
There we go.
Well, this is like the standard definition based by Wikipedia.
I'm looking for the tinfoil hat.
He's looking for the tinfoil hat.
Yeah.
We got to get that one going.
No, but I mean, I think that's the question is there's.
Search for like who really came up, who really developed the food pyramid?
Something like that.
Sorry, what were we saying?
No, it's interesting, though, because, and I think this is kind of where the issue comes back to.
We started off with doctors only get about 16 hours of nutritional education, including supplements.
So.
There's so much good information out there now that folks are going to hear things that sound fishy and go, wait a second, I eat eggs every day and my cholesterol is great.
But I mean, now it's, you know, all you hear about with people talking now that we have this like open information and open dialogue on the internet and YouTube, you have people talking about like all the benefits of high fat, low carb diets.
And like one guy I've had in here multiple times, Dr. Dom D'Agostino, has like studied, he's been funded by the DOD to study ketogenic diets for Navy SEALs.
Social Media Health Trends00:06:51
For their oxygen toxicity seizures.
Okay.
So, when the seals dive and they use the little rebreathers, they could get oxygen toxicity seizures.
And what they did was they experimented on putting them on these really low carb ketogenic diets, and it would completely get rid of the seizures.
Interesting.
So, he's like parlayed that into what is the name of the disease where people have seizures?
Epilepsy.
Epilepsy, yeah.
So, he's been studying that on epilepsy patients and completely eradicated all seizures from these epilepsy patients by putting them on a strict ketogenic diet.
Yeah, it's fascinating.
And that's the interesting piece everybody wants the personal aspect now, and their technology is coming online to be personal.
So that's kind of where this fallacy that you have compounds that walk in two worlds won't hold up under that paradigm either, because people are going to respond differently to something at a higher dose versus a lower dose.
And again, if these are things that were already in a diet, I just don't understand the utility other than to protect that pharma IP.
I mean, that's really the only clear line you can draw in all of this as to why things are.
Kind of kept out of one side of the market.
How come?
I mean, the pharmaceutical companies, they've, I think I heard this quote from Robert Kennedy.
He said that they've literally paid out, they've killed more, they kill more kids every year from pharmaceutical drugs, from like overdoses, than in the entire Vietnam War every single year for the last 20 years.
How can nothing be done about that?
And they pay billions of dollars, like they just get sued for killing these things, like what was the name of that drug?
Was it Vioxx or something?
A drug that they were sued for, they killed like 70,000 people and there was a big lawsuit and they made like, these numbers are way off, but they made something like $60 billion on the drug.
And then by the time they got through the lawsuit, all they had to do was pay out like $10 billion in damages or something like that.
And they got away.
They still made a profit, right?
They profited like $50 billion still.
And they just keep doing that.
They can keep getting away with it even with these big billion dollar lawsuits.
Well, the good news is, like on NAC, NMN, and CBD, one thing we've really had and made a focus is.
If folks want to see these things available and continue to be available as a supplement, you know, and continue to be available for self care, they can write their members of Congress and they need to.
I mean, we have platforms that can do that.
They can go to our website, click on take action.
It goes through the firewalls and they can say, look, I want to have access.
Why is the access being restricted?
You know, there really isn't a good reason.
And so people can still make their voice heard, which is, you know, I don't want people to feel powerless.
I don't want to feel people like, okay, there's just this monolithic industry that's just going to wipe out the other side of the world.
I don't think that's right.
I think people want, like I said, I think people really want.
That ability to self govern their healthcare and their wellness.
Again, I'm not advocating that people delay the treatment of disease.
I'm not saying that there's not an importance to pharmaceutical development.
We're not saying that at all.
But there's got to be this pathway is the structure works.
I mean, the people who use supplements have grown from probably less than half the country to now about 80% of the country since 1994.
And the reason for that is products are used safely, there's efficacy.
So, people are deriving a benefit.
And, you know, why should that be, you know, why should things be precluded from that that clearly intentionally can fit in the space?
Right.
You know, why should the options be restricted because somebody wants to just block the way for the sake of blocking the way?
Yeah, it would suck to see this happen with like a lot of the great supplements that are out there right now.
Like, I think one of the most basic ones is even like creatine.
Creatine has so many.
So many positive benefits for so many different things when people take it.
And it's so cheap.
Like, could you imagine if they try to do something like this with creatine?
Well, it actually is happening on the state level.
States are looking at it.
It's funny, we've been fighting.
So, we talk a lot about federal, we talk about FDA.
We fight battles in the states, too.
And the states are interesting right now, there's a group out of Harvard, and everyone thinks Harvard, wow, they know what they're doing.
They let me in there, so it's not that great.
But this group called Striped, and their whole premise is that dietary symptoms are leading to eating disorders.
And so, specifically in the, you know, A bodybuilding or muscle building area, and then weight management, fat loss, things like that.
And their whole premise is it's for the kids, which is always a great premise.
People love that premise.
Oh, hey, we're protecting the kids, the kids, the kids, the kids.
Okay.
Who's going to argue against that?
And they usually bring in a kid who had some eating disorder issue and says it was the supplements.
Okay.
Now you're not going to, you're never going to say, okay.
Like what type of supplements?
That's the problem, they're never descriptive.
But you're seeing because it does touch on, they're saying like in males, it's body dysmorphia, you know, so something like creatine is actually directly.
Being attacked because people are like, oh, yeah, the creatine, it's making me have body dysmorphia.
Meanwhile, creatine has been studied for 40 years.
It's like the most studied.
It really is.
And the safety record is wonderful.
And this whole notion that somehow it's leading to eating disorders, there are pharmaceuticals that actually do lead to eating disorders, right?
People develop anorexia, bulimia from certain pharmaceuticals.
We've never seen.
Adderall?
It might be.
We've looked at, I forgot which ones we looked at.
I have to go back and check my notes.
But, We looked at and we FOIA'd, we did Freedom of Information Act requests on FDA on adverse events and dietary supplements and eating disorders since 2019.
There hasn't been one.
Not one.
Wow.
So, right.
So, this whole premise, it's like, well, it's protecting the children.
And they always go, it's funny.
They always start with, well, you know, because of social media.
And it's like, well, is the problem social media or is the problem dietary supplements?
Because it's kind of, you know, yeah, especially now with the AI, you see unhealthy people.
Pictures on social media, right?
You see pictures of, oh, hey, look, someone created a body that no one could ever, like, you know, like 0.001% of the population could ever achieve.
And people are measuring themselves to that standard.
So that's where it's interesting it's just, it's, the issue gets attention.
The dietary supplement issue gets a lot of attention in press.
And these folks at the state level, 45% of Congress in Washington, D.C., once served in a state house or a state senate.
And so they are doing anything they can to springboard, if you will, their careers up.
And so The issue gets press.
I mean, it does.
It's always amazing to me, having done this for so long, how much press the issue gets.
Empowering Personal Choices00:09:50
What about can we talk about cancer for a little bit?
Sure.
I heard that some of these vaccine companies were talking about developing a cancer vaccine.
They've been looking at cancer vaccines for a long time.
Really?
Yeah.
Do you know what CAR T therapy is?
Not familiar with it, no.
Okay.
I was hoping you did.
I don't really know much about it either.
But I heard that it's basically a type of cell or gene therapy that they can do where they take.
The cancer cells, or take the cells out of your body, they manipulate them somehow and they put them back in your body and it, like it has had like 99.9 effective effective rate on cancer.
Not familiar with it, I mean I, you know, I wonder what these big agencies are, are thinking about or planning when it comes to cancer and like when we can develop something for cancer.
I mean, there's been a lot of drugs developed over the course of years, like I said, especially from the natural products world.
Um yeah, last big breakthrough was taxol, which was actually from a plant.
So, you know, I'm a big proponent of natural product drug discovery programs.
I think they, you know, I'm biased though.
It's my academic background.
Right.
But some of the biggest discoveries we had are from plants.
And so hopefully there'll be more of that.
I got to think with the technology, a lot of times, especially the modeling now, I don't know if it's AI, I don't know what it is, but basically manipulating that sort of learning path, right?
Like, okay, maybe the compound was trialed in the wrong cell culture or wrong cellular target versus what's available now or what our understanding is now.
So, yeah, I think you'll see more of that.
I think, I hope so.
You know, there's a lot of the technology is growing so fast that it's like, how do all the pieces fit together?
Right.
Yeah.
I mean, the people you got to worry about is just the people that don't pay attention to it and the people that need the guidance, right?
Like, I would have to say that's probably most of the country people don't give a shit about what they eat.
They just eat whatever they can because it's cheap or it's convenient.
I mean, I think convenience is it.
I think the time is the issue, I think we don't.
encourage people to make it a priority, right?
As we work, produce a product versus, you know, having, you know, it goes back to, I think, I think it goes back to where we started is like, where are you getting your information from and why?
Yeah, health is not, you know, even now, all the debates we have and even the way like you look at obesity and discussion about obesity, it's weaponized.
It's not like, hey, what's the challenge?
Like, what's the actual root cause?
It's always weaponized politically, right?
I'm not telling people to, you know, I'm not telling people that they shouldn't find value in themselves, but I think when things are at odds with your health, right?
Like things that could harm you.
And that's not, I mean, that's inappropriate to weaponize on any level.
You know, I mean, that's really the thing.
And that's why it is important that people get their levels of things checked.
They are on top of, there's no excuse to be, Not knowledgeable about your health.
There really isn't, especially in this day and age.
That's critical.
And especially if there are institutions that aren't knowledgeable about your health, be careful of where you take that information in from.
Yeah, because there's a big difference between somebody who has some sort of genetic disorder where they can't control their obesity or their metabolism or if they have diabetes or something like that.
But then if there's a way you can get some sort of Baseline check and figure out look that you don't have any of these disabilities.
This is all lifestyle and diet.
You can definitely fix this.
Don't make it something, don't promote that kind of lifestyle.
You have to promote the kind of lifestyle that's going to better yourself and other people and help you live longer.
Like you said, the whole thing about convenience is a big problem and people not having time to pay attention to it or having time to cook their own food or know the difference between.
Olive oils and seed oils.
Seed oils are a huge problem.
There's a lot of discussion on that right now.
I think, look, it goes.
Here's the thing our knowledge is always changing.
We know that now.
And as it pertains to what we choose in terms of self care, I think it's more critical than ever that people have to get involved.
Nobody wants to get involved politically to shape these things, but you have to.
There's a saying in DC that if you're not.
At the table, you're on the menu.
I think so many people have kind of just walked away, and I understand there are more crunches on people's time than ever that you have to be sympathetic to that, or at least empathetic to that.
But not getting involved to have options when it comes to your ability to, what is it you can, and not that there shouldn't be checks and balances in place.
There should be safety checks and balances in place.
You want FDA to inspect and test, right?
I mean, could you imagine what would happen if everybody who used a supplement wrote Congress and said, hey, Congress, FDA needs to up their inspections?
Even the infant formula thing, I don't think you saw the kind of outcry that really could have shaped things for the better, which is, and that's where you got to.
And you've got a great platform to tell people to get involved and to not be apathetic and get out there and say, hey, look, what's going on?
We just had an issue with infant formula, infant formula availability.
I mean, they were flying in planes from Europe to bring us infant formula because we didn't have any.
That's wild.
Right.
But people, they forgot about it.
And you go, wait a second.
No, This has to be fixed for the future.
What systems are in place to ensure this isn't going to happen again?
Or at least there's some sort of guidance to people that, okay, how do I know?
How is it I know that FDA is actively testing and inspecting?
Like, are they going to tell us, like, hey, we inspected this many infant formula?
You know, nobody knows that.
That's not what makes the news.
It's what should make the news.
Right.
Do you think that the landscape with the FDA and all these agencies and general health in the country would benefit from a universal health care system?
That's a tough question.
You guys are going to be a tough question.
A little outside the scope of my job.
I think universal health care is.
Well, it's interesting to hear your opinion just from your experience and.
Working in the FDA and working with all the people you do.
Yeah, universal healthcare is tough, I think.
I think there are so many issues.
I've seen, and I have my biases.
I have some friends who I'm a big fan of the doctor run hospitals, of the doctor owned hospitals, where they're shareholders.
It's not just like, oh, hey, I had to build some hours for another insurance company.
It's like, no, no, we're a self contained unit.
I think there's more, I think people care more that way, which I think is ultimately what's lacking, right?
I think ultimately that's the frustration people generally have when they encounter an institution or a medical center, a government agency is there's a lack of care by that institution, whether it's a government agency.
Whereas if it's it's like diffusion of responsibility.
I'm a big fan of small business, right?
And this makes you can have a big hospital run like a small business.
I think ultimately, I don't want to say that's what everybody wants, but I think if this level of care is there, I think people want that.
I think people want bedside manner.
I think they want to have a real conversation with their doctor.
I don't think they want to just see the checklist.
Okay, did you do this, this, this, this, and this?
Are you still doing this?
Why?
Or in the case of our industry, I don't think people want to see a doctor where they go, hey, and it's no fault of the doctors per se.
The doctor only has 16 hours of nutrition information.
And they go, hey, doc, there's this new supplement I want to take.
Oh, no, no, don't take those.
Right?
I think that's the response by a lot of the medical community is don't take those.
And really, yeah, you see it from, if you look at different medical societies, they'll have positions on supplements like don't use them ever and things like that.
And you go, okay, that's.
The problem with that is you, one, the only thing you guarantee is that person's still going to keep doing that behavior.
They're just not going to tell you anymore as the doctor, right?
They're going to go, okay, I can't tell this, you know, this guy or girl that I, yeah, I like these supplements.
I use these supplements because they told me not to use them and it's, you know, you don't know what's in them, blah, blah, blah.
Right.
When the actuality is, who knows?
They may have, you know, they may have done the research and they may know all about, you know, companies now post some of their manufacturing processes online.
There's some really state-of-the-art stuff out there that people know about.
And that guides people's purchasing decisions.
And if you go to a doctor who isn't as knowledgeable and you go, hey, what about this?
Did you see the study?
And this doctor's like, nope, don't do any of it ever.
It's kind of like when your parents would tell you why.
And, you know, when you're young, I told you so.
Well, outside of your parents, that's the only person that's kind of a right answer for, right?
Like that's okay if their parents are doing it.
But when, you know, someone in an institution does it, it's a little, it generally long term tends to have the opposite effect of intended.
People are going to go, I'm going to do that anyway and probably go further because it's like, you didn't give me.
You kind of dissed me with that answer, right?
I wanted to know something about this.
I went to you as the authority, and you just basically one, you showed you weren't knowledgeable, and two, you just dismissed it out of hand.
You didn't listen to it at all.
And I think that that puts a lot of people off.
Doctor Knowledge Gaps00:03:17
Right.
And there's also executives of drug companies that are going to visit these doctors and taking them out to dinners and stuff like that and trying to get them to prescribe more of their drugs.
Even the doctors are financially incentivized because they make more money to prescribe certain things than others.
No, I think that's - again, you're talking about an institutionalized approach.
I think so much of this has been institutionalized where it's like people have their - we have too many institutions picking winners and losers and not empowering people to really look into what's going to work for them and not that they shouldn't listen to it.
Right, right.
And that's what it should be.
I mean, ultimately, I think that's what we all want.
We want to know like we're getting - we started this conversation with - are we getting the best or, you know, we can get at this point in time for what we need versus are we just getting some bureaucratic response to a challenge?
It may be a difficult challenge, but okay.
Like, you know, that's our frustration right now is, you know, like with, like I said, with the reduced inspections and testing, it's like that's important.
I know it may not sound exciting, but it's important.
People need to know that facilities are out there.
you know, out there being inspected.
You know, the one thing I was lucky, like I said, they sent us to, when I was at FDA, they sent us to Harvard for an exec program to learn to be better regulators.
And the one thing it taught me, it made a lot of sense, a guy named Malcolm Sparrow, brilliant guy, if you ever get a chance to read, called Character of Harms, really talks about kind of the regulatory arts, if you will, and how you regulate a space.
And he said, you know, it's a bell curve.
He goes, you've got your regulator and then you've got your field of companies to be regulated, and it's a bell curve.
You want to always move that bell curve to the right to companies are increasing, you know, increasing compliance with the law.
Take an issue like GMPs, like quality.
You always want to make sure that the standards are continuously improving.
So how do you do that?
You do that by the companies that are already on the bell curve and are complying.
You help them further.
You know, you promote the good things they're doing.
But the bigger thing is, you know, are you dealing with the folks that aren't going to comply?
Are you dealing with the folks that really aren't, you know, are, behaving in a way that they shouldn't.
And I think that's the problem now is the focus isn't on, hey, no system is without problems.
But instead of focusing on the problems and trying to solve those one way or the other, we're focused on, and the problems aren't the whole bell curve, right?
The problems are a part of, a very small part of it.
And so instead of focusing on that and dealing with that, we're going to make the whole thing a big problem and then nothing gets done.
And no one has any incentive to move forward because it's all, if you treat everybody like they're, you know, They're the bad guy, you know, or it's a problem, right?
Right.
You know, same thing with that doctor.
If you go to the doctor and go, Hey, doc, I use this supplement, they're like, Don't ever do that.
It's like, What did that person do wrong?
You know, they had a question.
Question.
So I think that's the challenge is there's a lack of a, you know, I call a small business feel or bedside manner, but I think there's a big lack of that right now.
Yeah.
Lobbying and Trade Associations00:04:37
If there's a system that brings that back, all for it.
Right, right.
And it's hard to see right now if there is a way for that to ever happen, at least in my lifetime.
But so again, what can people do to, like you said, they can write to the FDA in regard to NMN?
Well, they can write to Congress in terms of they can write to Congress.
Yeah.
If you go to our website, npanational.org, you can click a button, take action.
It takes 30 seconds.
There are electronic systems that get behind, you know, there are firewalls in Congress.
Like if you try to write them, sometimes you'll get blocked and things like that because they get so much email and things like that.
This will actually get behind the firewall and you can, you know, tell them, hey, I want to have access.
Okay.
What is this?
npanational.org.
Yep.
So right at that little button on the right-hand side, take action.
There's our fly-in, too.
Oh, cool.
You can come to D.C. and meet with your members of Congress.
We set up meetings for folks in the industry.
Oh, way.
Yeah.
Yeah, they get to meet with their senators, their person in the House of Representatives, and tell them about the industry.
Tell them all the good they're doing.
So, yeah, it's a cool thing.
I think we've got about 110 registered right now, which isn't bad.
We haven't done it for four years because of COVID, because you couldn't.
This is the first time we're actually let back into congressional offices without an appointment and someone coming to let you in.
So, it's nice.
It was shut.
It's kind of odd.
It's like, wait a second.
Congress works for the people, but you can't see them.
So, that's gone.
But, yeah, so if you click on the take action button up in the corner, It goes right to a list of issues.
So, if the first one protects NMN access to supplements, and click on that, and so it'll populate a letter.
It'll go to both your, it'll go to your.
And this gets through the firewall.
Yeah, like it's a firewall.
So, this one's going to the secretary of HHS, the president, vice president.
No way.
That's cool.
Yeah.
And so, it gets mail up there.
On NMN, I think our engagement right now is about 50,000 letters, which isn't bad.
We're not a consumer organization.
I mean, we're an industry organization, which consumer organizations, there's some good ones.
We work with one called Alliance for Natural Health.
They do a great job, too.
Their email lists are, you know, pretty extensive on people who use supplements.
And it's great because they really rally folks to go after it.
Has anything like this, any sort of campaigns like this ever worked?
Oh, yeah.
Really?
Oh, yeah.
We've had, we've been to part of some really good ones.
You know, gosh, just last year there was a drive by a senator from Illinois, Senator Richard Durbin, who's a very longstanding critic of the industry, to really institute some pretty.
Pretty bad provisions that would allow for.
We keep talking about this challenge of having Amazon delist things without any sort of due process, right?
What he was proposing would basically put that on, if you will, steroids.
He would make that to where that was kind of the rule of the land.
And so we were able last year, just our group alone, we had over 100,000 emails.
I think that group I mentioned, the Consumer Group Alliance for Natural Health, had almost a million.
So there was a lot of mail going to members of Congress saying, hey, And emails have – you can either have relationships, personal relationships with members of Congress, which is great to try to shape what happens policy-wise.
But the two things they listen to are donations, obviously, which for our industry, we don't have that sort of corporate giving that other industries do.
I'd like to see an increase, but – because ultimately, in D.C., there's 4,000 associations in D.C., right?
So – okay, and that's just associations.
So you figure all the lobbyists, everything else, everyone every day is just fighting for oxygen.
Right.
And so how do you get more airtime with a member of Congress?
Congress.
Well, you know, generally, and it's not like you pay them money, they do what you want, but you, you, you know, you support their campaign for reelection.
You know, you're a friend of their family, if you will, so to speak, in that regard.
So they may, you know, they may listen to you.
They may not, but at least you get the airtime.
But the power of the grassroots is they look at that and they go, wait, if somebody's willing to send me an email, they're probably willing to go out and vote.
So that calculus, they keep real close tabs on that calculus, right?
You go, wait a second.
My district.
You know, I got 100,000 emails.
That's enough to win or lose a congressional district.
Are there any big lobbies in support of the supplement world?
I mean, we're technically, you know, we're a trade association.
We are a C6, which is a lobbying group.
Okay.
But not a lobbying group.
Well, C6 is technically a lobbying group.
Well, C6 is in a trade association, which means you can lobby on issues.
C3s can also lobby, but there are restrictions in the tax code to the amount of time and paying contract lobbyists and things like that.
FDA Accountability Needed00:05:14
So it's different.
But yeah, we're the oldest and largest in the space advocating for the industry, making sure that the supplement industry gets a fair shake.
You know, and compared to other organizations, you know, you look at pharma, I think their budget last year was $500 million.
Ours is about a $3.5 million budget.
So it's a big difference.
Lobbying budget?
No, just total, you know, total budget.
Yeah.
So only $500 million for all of pharma?
I think that's what their budget was.
But that's just noted.
That's not all of pharma.
That's their association.
Oh, just their association.
Just their association.
So that puts it in kind of scale, right?
Right.
That's two orders of magnitude.
Yeah.
That's a big difference.
Yeah.
And look, they, you know, The association per se isn't our enemy.
Our biggest challenge right now is FDA and getting FDA to really look at the industry as having value to human health.
It does.
But I think we've seen a pattern in practice here with trying to exclude things from the market that they don't necessarily see it that way.
Who is in charge of the FDA?
Well, right now the commissioner is a guy named Robert Califf.
Robert Califf.
Yeah, he's been there before.
And so he, you know, I think he has his views on the industry.
Have you ever talked to him about this?
Yeah.
I mean, I think his views are.
How does that conversation go?
It's, you know, there's always going to be the pleasantries, right?
You've got to, you know, everyone's got to.
All warriors in D.C. have a code, right?
But at the same time, you know, you've got to, how you doing?
How are the kids?
All this stuff.
But then you've got to get to the heart of the matter.
I think the heart of the matter is he sees the industry as he's an MD.
And I think he feels like it's interesting because when he, this is his second trip as commissioner, his first trip, He said that the laws are adequate.
This time he says that the laws are – he doesn't feel like the laws are adequate.
And it's like, well, it doesn't feel like the laws are adequate.
For dietary sums to regulate them.
Because I think given his background, he thinks it should be very pharma-like versus the system we're under.
Now, it's interesting in that we do have some very pharma-like procedures.
Like our adverse event reporting is the same as pharmaceuticals, exactly the same.
So if there's a post-market issue, it's the exact same reporting system pharmaceuticals use.
Isn't it VARS?
VARS is for the vaccine.
VARS is only for vaccine.
CARES is the one for SIFSAN.
And the vaccine one is only like, it's like 99.9% unreported.
Well, some people say that.
Yeah.
I mean, the statistics are different, but even if there's underreporting, look at the numbers on that versus the numbers at SIFSAN for dietary supplements.
I mean, the numbers are what are the numbers there?
Very, very small.
There's about mandatory adverse events.
I think there were 4,000 or 5,000 last year.
When I was at FDA, the biggest one we'd get was people choking on a tablet because the tablet was too big for their throat.
Wow.
Which happens when people get older.
It's not like we had ones where people would have their hand cut on a glass bottle.
They drop the glass bottle and, you know, they report that to FDA.
Now, that wasn't the product that caused the problem, but still makes the definition.
But that's the point is the systems, you know, the systems, I think they're more than adequate given the safety record and given the wide usage pattern.
But I think there's this resistance to the commodity because it does on some level.
I think a lot of doctors feel like it takes power out of their hands versus seeing how they can work with it in an integrative way.
It's just hard for me to see any sort of good in pharmaceutical industry.
Well, look, I mean, we all need, look, we do need drugs.
We do, I'm not going to say, I mean, we do, there is a, we need new drugs, we need new antibiotics, we need those things.
Like, you know.
But they need to be more like a post office than they need to be like a giant fucking monopoly.
You know what I mean?
I mean, look, there's a lot of different opinions on there.
I think the bigger thing is with all of FDA.
Like, not, I mean, I don't mean it like socialism.
What I mean is like it needs to be, like there needs to be some sort of barricade between the FDA and these companies.
I think what needs to happen is there's got to be.
Checks and balances.
That's the key thing is the checks and balances.
There's got to be oversight.
You've got to have someone who's willing to come to the table and talk in a reasonable manner.
And it's not just like, hey, this is the most important thing at the agency, so it needs to be the most.
Just because it's the important thing for FDA doesn't mean it's the most important thing for yours and my life or 300 million Americans' lives.
And so I think that that's.
I think the agency really needs to be held accountable and reminded of.
There's a public they serve and how to serve that the best.
And if that's not their interest, okay, fine.
Like other job, but there's got to be that accountability.
And I think you haven't seen, you haven't really seen the agency, the accountability, especially in the food center where dietary sums are resided for some time.
So we'll see what happens.
Right.
Well, Dr. Fabricant, thank you so much for coming on here and sharing this information.
I really appreciate it.
Again, it's npanational.org.
I'll link it below.
Is there any other websites people can go to to follow what you're doing or check anything out?