Danny Jones Podcast - #187 - Ex-FDA Executive Warns Big Pharma is Banning Health Supplements | Daniel Fabricant

Episode Date: May 29, 2023

Daniel Fabricant, Ph.D served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years. Today Dr. Fabricant is CEO and President of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. EPISODE LINKS https://www.npanational.org https://twitter.com/drfabricant FOLLOW DANNY JONES https://www.instagram.com/jonesdanny https://twitter.com/jonesdanny JOIN OUR KULT: https://bit.ly/koncretepatreon OUTLINE 0:00 - Introduction 2:30 - Healthcare in the US 7:55 - How the FDA works 14:33 - Patents / Branded drugs 24:00 - Daniels role at FDA 33:29 - NAC 36:27 - NMN 41:42 - FDA tried to make fish oil a prescription drug 43:24 - Is David Sinclair trying to monopolize NMN? 51:04 - Peptides 1:02:56 - Cannabis & CBD 1:14:32 - Testosterone therapy for men 1:18:50 - FDA pandemic response 1:31:07 - Creatine 1:34:10 - Cancer vaccines 1:40:33 - Universal health care Learn more about your ad choices. Visit podcastchoices.com/adchoices

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, it was a division then. It's under, that one. It's 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, was a college athlete. So it started there, went to grad school, 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 an guy named Norman Farnsworth there, who's the godfather of pharmacognacy, an interesting word. Pharmacognacy 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, or drugs, there were grants at the time because DeShay, 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 I&Ds and things like that. My advisor was up there in years, and he's like, well, you go to D.C. and you learn how to do that stuff because I've done to do this for too long. And so kind of got thrown to the wolves, at least to the FDA piece. That wasn't, 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 health care goes, we pay more for health care 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 the number three cause of death in the U.S. after heart disease and cancer is pharmaceutical drugs. Does that sound right? Sounds about right, yeah.

We're also one of the things that it ties into that, and it'd be interesting. 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 and pharmaceuticals.

I believe so, yeah. Wow. Yeah. So why is it that we spend more money on health care 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 health care outcomes. Why is that? Good question.

Selfishly. Kevin, where I work from, a lot of it's how we eat, a lot of its 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 it's a lot of it's systematic. You know, we can sit here and rail on the fact that people see their doctor on average for eight, what's it, eight minutes is the visit, the average visit. You know, 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 if you see someone for eight minutes a day, you know, when you go have an appointment, you're not really. Especially if those doctors are seeing like a hundred 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? health care. 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, in their training, 16 hours. Yeah. So how is it the, where's that message going to come from to eat better, to do better? And if you take, I used to teach pharmacology. It, when I was in university, like 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 in 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, like, educating their doctors and students in colleges? And, you know, and like how much attention they pay to,

like, food diet versus supplementation versus pharmacology? Not a ton, but enough to, enough to see. that there are enough to see that there's a clear difference in terms of what's considered healthy and what's not right like I think I think other cultures are much like they have a better concept of what a healthy diet is right they I think they have it's kind of more cultural it's more in ingrained if you will whereas here we're always looking to 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 U.S. as far as like where we, where we are on like the global spectrum

of health care 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 like take control of their own health. Yeah. I mean, that's the one thing. We do lead the way in. It's, it's kind of a, 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, 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 TCHM. Really? Yeah. 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.

What where is China land on like this? What is their health care system? Like how good is the health care in China and how what is their like 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 it's hugely dependent on 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. But I think part of that. too is they see oh wait you know what high fructose corncy or people like that in united states let's start putting that 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 uh rewinding the clock where you know you've seen an increase in life expectancy and more rural folks i think because you have had some fortification of the diet and things like that prior they didn't have right no

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. It's regulated. You'll always hear dietary supplements aren't regulated.

Nothing could be further from the truth. 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 in FDA works on isn't 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 what the one crime.

And the other crime is, is the ingredient adulterated, right? Have you debased the material in a 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 areas around. Similar 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 aim or that could potentially harm somebody. If you introduce something loaded with e-coli, that's adulterated, right? Okay. You don't, 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, it has to be, 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. I think it's more. 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? And that's, yeah, 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. 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, oh, 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 story. shortage of entered 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 and Johnson who made that? Or was that a different, am I thinking of a different product? It was a division of Abbott. Abbott, that's what it was. Yeah. That's what it was. Yeah. And there are some versions of the story where there might not even been the contamination.

It might have just been more of FDA's errors. And I think that's really the challenge is, you know, 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 the 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? If you love diving into culture and comedy, like on Danny Jones podcast, playoff hockey is right up your alley. NHL on T&T has the best coverage,

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Yeah, they're supposed to be, 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, as 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 can you explain how that how that's changed over the last 20 years well i think what's happened is you people have pushed down the people they went politically into the the under organizations right so it was 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 there that are folks that are there for life and it's like um there's really not a lot of checks and balances on that because one the more political the more 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 um they they operate somewhat freely to do what they want and i

think a lot of times their personal politics comes into play and you don't you're not account they're not accountable of those because the people at the levels above just go in and out pretty quick. And so in some ways, they're, they've become independent from some of it having to answer politically, but they're, they're making it up as they go along. I mean, they've been defiant, especially on the food side. They 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. 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 to 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? That's... Who is 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. But the patents, don't the patents drive up prices, like, astronomical 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 market a year two or year 13? Right. So do other countries have these patents with drugs like this and with? There's definitely material protection. I mean, there is an other countries, I think the challenge here is, is you really do have that direct correlation. You know, 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, wait a second, where's the check and balance there? And that's, 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 more, it's definitely more front-facing that 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 I&D process being used to keep others out of the market,

which wasn't the intent. The intent was, you're going to file an I&D, 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, 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.

Right. But, but do you, do you see any way, is, 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? Tort reform basically torts of when you can 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, we have a 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, et cetera. 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? 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, etc. Niacin at a lower level you need for cellular functioning. So these are the certain cellular metabolism.

And so different levels, very different levels. Right. 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 harsh. CBD is. CBD does. Yeah, the drug, the drug. Yeah. And, you know, they used 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 one.

to use it. They want to use it because people maybe 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, right. And they make energy drinks or they make drinks with CBD in them. Yeah. Yeah. They've got those to, um, to help you, I guess, you know, kind of. I always wonder to because there's so many products out there. Yeah. And they like slap these little 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 on 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. Like you said, the product's already out there. Like the horses left the barn. So they might as well get in front of it and say, look, we've evaluated it 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, there's 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 any repercussion. You're right. That 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 law, in the 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 hear 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 were,

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, it got up, the price of CBD got up to about $4,000 a kilo. And then without a government frame, 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 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 biologically before. Delta 8's 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, very minor, like minor mouths. 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, alongside, and basically in dispensaries and things like that as a, you know, 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, 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's 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, had no quality parameters in their facility at all. They'd just make 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. You know, GMPs are a standard in U.S., but, you know, this kind of quality standard, quality by design standard is fairly uniform throughout the world in terms of making, you know, health products for people that you have to have a minimal quality standard. Right.

And this was something that came about. out 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, DMA. No. DMA 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 leave 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 time was called USP Labs. And they had a recently, yeah, they, 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 their executive served time and had to pay a fine. So that was a big one just because it was this this whole construct of, hey, this is found in nature. Not really. It was kind of a, it had it, 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? We don't

you sell. So that was, that was kind of the particular challenge with that, that particular issue. Then the company had another issue. The government was shut down. of 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 that the head of the Center for Food says, you're not essential. I was like, great. I don't want to be essential. I get to call the next day. There was an outbreak in Hawaii of non-hypatic liver injury from another one of this same company's products. And so I had to go in. We had to work the 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. 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 we, you know, they can go into your facility. They have pretty broad authority. They can go to 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 to law, which if you want to watch somebody make, you know, make their product, what's better than that? And kind of FDA's reticence to do that in some areas, I think 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, specifically dietary supplements, they're more interesting in 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 an an acetyl-sustine. 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 bronchie. 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. in the 90s before DeShay came in. So before there was even a definition of dietary supplement, NEC was sold in a capsule, people took it, use it. So you'd 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 a safety? 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. said, you know, and so you spent a lot of time doing this kind of, like I said, this paper dance of here are 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 substance 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. Say there you go. You're our problem, no. 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 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 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's it 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 as a farm IP.

And they don't want to address the issues that would effectively have a diminishing return on farm IP, I think they think. I 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 they're thinking. Yeah, it's money thinking. Yeah. So what was the reason they drew that line in the same 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 to Bronkey. 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. 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 that's 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 says? Dechae. Dechae. Okay. So amendment to the food drug cosmetic down. Right. So 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 is right with the world. Except then we drop our law. and about two weeks later, they do the same thing with NMN. NMN is a, some people think, an equivalent of niacin. So nicotinamide, my nucleotide. 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, I take it every day. I took it before this podcast. It's great. 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 and 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 yeah David Sinclair if you scroll down about half through the article it talks about like David Sinclair he first went on Joe Rogan's podcast started talking about all these anti-aging compounds and MN was one of them and he specifically called it a supplement yes number of times um and

And it's great right up, by the way, if I can give a quick shout out to Mike Roberta and the guys are Price Pluck. Great right up by them. They covered, they went deep on it. Keep going down. You'll see the photo or you see like a video clip of Davidson Clare. You got to keep 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 and 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 FTAs. Like, no, thanks. Easy there, killer. Yeah, right, exactly. Those are like, you know, kick those out, right? And they should be kicked out. They don't fit into the construct, right? I mean, you're really talking about things in the diet, things in nature, you know, people want to use as foods to supplement their diet.

So, anabolic steroids aren't found in nature? I mean, they are, but you don't they? They make them from yams, don't they? They used to make them from horse urine. Pregnant horses. Yeah, premarine is pregnant merry urine. So there's a... That's nature. Not quite food, though, you know. 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, it's a very blurry line.

It can be. But in some ways, yes and no. I guess I'm, I'm biased because I've administered a law. It's like, I think it's pretty clear. But I understand for, 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 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 of that use being approved of here, I guess, is might. 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 or 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 know. You want to take the prescription fish oil.

Usually those are taken by people who have 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 they, FDA actually wants to like completely take fish oil off the supplement market. They tried. They tried. So they tried, they used the, it's interesting, they use the International Trade Commission to try that. They try to complain and they tried to,

It was an interesting argument because they tried to usurp FDA's jurisdiction on this. It was Amerin, the product of Vasepa. So they tried to say, look, this is, you know, 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 are 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. yourself in the industry's favor in that look there was no way on god's green earth people you know people been talking about eating fatty fish for the fats for the omega three's for 60 years now right you know 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 but i think it gets back 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 it would make the general population people like 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 you're not going to go to the doctor, right? I mean, so that's the challenge you're running into, especially with 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 word, but there's definitely a lot of friction there. So, but back to our good friend, David, Sinclair. Yes, David Sinclair. So 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 sits,

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, after he goes, oh, we change our mind. You can't be a dietary ingredient. Whoa, wait, where do 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 does? 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 I&D, 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 i and d went in anywhere and fda won't tell you when that i and d was effective so you go and you start looking at pieces and one of the things in the story is if you go to clinical trials dot gov there was a study on a supplement that on an nmn supplement that had um 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, MIB 626 versus NMN.

So they changed it to look like it was. Oh, yeah, yeah, yeah. Scroll down a little bit. There's actually, I think there's screenshots of that on here where they actually show, they pull 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 I, indeed, to do a supplement trial. That doesn't make it a drug. but you submitted the I and D.

So they went into this initial report and they literally changed every single place that NMN or NMN was mentioned and they changed it to, what did you say? MIB 626, I think. And why did they do that? Because that's the name of their drug. They filed the I&D 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, 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 NAC. effectively. So NMN is essentially like if you take it in a concentrated dose from what I guess for my my grasp of understanding of what it does is essentially is kind of like an anti-aging drug, cellular on the cellular level, right? So David Sinclair has built up a huge following when it comes

to anti-aging and sleep and all that kind of stuff like he's like discovered the fountain of youth And couldn't he essentially sort of like market some sort of drug, 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 this sort of movement you usually see for Blockbuster drugs being developed by that company. Right. Like by now you would think they'd be in the next stage of phase, you know, the next phase 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 don't, I'm not aware of them answering those particular issues with dose ranging and those sorts of things. and also 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 there telling you're sure? 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. He's 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 recognizes safes. A company can do a, and actually FDA sued for the rights for 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. Uh-huh. That's why. That's why right. They can determine safe for use in human food. That was done, at least for our understanding, before that I&D.

So in some ways, the race to market was, one by the food side versus the drug side. So, you know, this is, 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 just 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 nicotamide riboside actually has an NDI, got a good day letter, and is on the market. So yeah. What is that used for? Same, same, same. It's on, it's, it's, it's, they interconvert. What is like the lowest hanging fruit people use that for health-wise? 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, is there are going to be more ingredients that are going to come to market.

Peptides. Peptides are being studied for both day and day out use as, you know, nutritional products, but also as, you know, therapy. for everything from cancer to Alzheimer's. There's all sorts of peptide trial. What is a peptide? Can you explain to me? Like I'm like 12? It's smaller than a protein, larger than amino acid. Does that? So it's a specific link of amino acids that has a general, that generally once it gets into circulation, it has a, you know, a direct biological effect. It's effectively, you know, and I'm not a peptide expert, so forgive me crudeness. And if you get, If you get mail on this, you know, telling 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. Okay. 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 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 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 i you know i and these on all of them and people can never sell them as a food or it's 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 chat gpt four and he like basically like the vet said we got to put your dog down there's no help helping him and he typed in all of his dog symptoms on chat chbt and the chat chabit

t like suggested what to do what to give him and what to feed him and it literally brought his dog back 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 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 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 farm 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 are this, 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 pull 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. Right. 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 submitted 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 at some platforms. Some are still up in selling it because it isn't final agency action. And I think that's what's interesting. But Amazon has pulled it. Amazon has pulled it. And who knows why. You know, we've certainly reached out to them. We haven't heard anything back, which is unfortunate.

it. But that's another thing for people to consider when they, you know, where they're purchasing products because I think for Amazon, they, you know, 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 browning points. I don't know. But there, it's odd in that it kind of goes around due process, right? Is 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 do 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. So I think that that's some of the challenges. How do you, how do you, you know, an FD,

like on NAC, that hurt that part of the industry economically for a while. Right. Right. Did FDA pay anyone back on that? No. There was no, you know, there was no restitution on that. There was no, you know, they certainly didn't pay our court costs and anything like that to, you know, to file a lawsuit and anything else. But I think that's the reality.

And it's a bit of a, 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 for this industry is that 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 is you really deadlocked 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 if 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, well, 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 name of your organization? Natural Products Association. National Prox. NPA national.org. Never lost to FDA. And it's not because we sued them on everything. We were very selective, very targeted.

And so there were some banding together by companies. I think what you're seeing, though, is you're seeing when DeShay passed, FDA, not FDA, a Congress got more male 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. So, 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, you know, I don't want to sue them because something bad could have. You've already lost. Right. Right. I mean, it's a, it's a terrible premise because you're really, 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. That's a good point. Yeah. It's, uh, it's an interesting. time. We want more folks involved. We have a good, a good group of people involved on the

NMN thing, but more folks should be involved. A lot of folks are interested in NMN. 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 100, 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. Metro biotech is his company. Okay. It's historically called a supplement in pharmaceutical outfits own clinical trials. So what's his company, Metro Biotech? 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 principles.

Didn't he tweet something that he had nothing to do with it? He may have. I don't. I don't. I don't think that's the case, though, because I think there's prior, 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 under 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 of 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 20, 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 2 to now Schedule 5. 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 scheduled on so long as it's 0.3% or less of THC. Okay. Okay.

So you've got it decriminalized 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 and as a food or supplement. 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. It's 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. 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 the same. So, 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. You have. have this growth in the marketplace so confusing yeah it really is no but the bigger thing is this is it's this drug exclusion criteria once again is you people ate hemp prior to the drug being developed

right i think we know that yeah CBD has always been in hemp right we know this too um as well as the other cannabinoids now i'm not saying again that if somebody develops them as a drug you can't um 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 and more power. So they want to lump CBD supplements in with vaped products. with everything and have this cannabis center. And 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. Center for Tobacco products took about 10 years for them just to get up and running when they got that authority from Congress. And it has not exactly been a success.

I mean, they keep saying vape products aren't regulated. Meanwhile, every, you see more and more vapes stories. Everywhere. Right. And so 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, you know, combustion products probably are tougher on your body than non-combustion products, right? More than likely in terms of, you know, 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 that's kind of where things are with that we filed a citizen petition on that as well they denied it in January of this year they said 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 done, 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. you. 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 a thousand pages of company safety data that showed a safe level. And they go, man, 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 the problem we're having. And a lot of people are talking. And 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. I think they're dispersed a lot. 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, you know, 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 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's 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 could in 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 as 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 or tobacco kind of like bought out all the vaping companies? I forget what company. It was a, or was it the ad agency or something? They bought some of them. I know that.

I think the bigger thing is this is, you know, you've got, you've got a very different set of rules and foods and dietary supplements than you do on tobacco. Right. They really can't make claims in the tobacco world at FDA because there's no. So for foods and dietary supplements and drugs, you're always on what's called kind of the risk benefit continuum, right? Everyone has to eat foods. Some foods, if they provide a benefit, you can claim that benefit, right? Vitamin D, calcium, et cetera, for dietary supplements, structure function claims.

Promotes healthy metabolism, promotes healthy gut function. You know, those are, but you have to prove it. You have to have substantiation, but you can make those claims. On tobacco, like, I don't know, I may be dating myself here, but they used to say on certain cigarettes contains, you know, 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's, 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 that's the irony in all this, right? Is FDA is a public health agency. And for them, they throw up their arms 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 makes me very pessimistic about marijuana ever becoming legalized in the country. I mean, I think there are 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 that takes kind of the, you know, all the money laundering, the wire fraud, mail fraud, some of that off, 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, um, 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 they drive. Like a credit union because they can't use, 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. issue is 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? 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 various. They're trying to control that more. They're worried about, I think, you know, since when? When have they, 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.

And it's like, 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. But FDA at the time goes, well, we don't have authority over accompanying 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 it's, 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 give 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's 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. So we'll see how that plays out. Yeah, because it's such a, it's such a simple, it's such a simple compound that can help people in so many different ways. Like there's 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, you know, if you're a guy who's a low testosterone, that can lead to all sorts of things like heart disease and everything else. But you can get this cheap testosterone that cost, you know, less than 50 bucks a month or whatever that can help these things. And 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 things critical for us. We tell people all the time is get get those tested, get know what those are. Those are, you know, incredibly important, especially vitamin D. I mean, vitamin D was, you know, it's interesting. Vitamin D was one of the biggest, um, biggest cohorts for COVID mortality, was vitamin D status. And so we, you know, it's, it's, uh, it's important. And we know other governments actually told people and I think the UK was sending people vitamin D. Right. Because 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've got to be careful with what you say. But for something that's approved as a drug, the rules are different. I mean, for nutritionals, the rules are. You've 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 performed 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, so many other factors was a bit poor time. 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, you know, we tried to be helped. any way possible because I think early on nobody knew what was happening and everyone was just like look and our board was great they were like what do we do to help right yeah I think that's the biggest thing is like why why during a pandemic are we when people are just trying to say healthy why are you going to start looking at ways to you know I'm not of the belief that the the universe of dietary supplements and nutritional 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, is 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 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'd go, you know, gyms were, 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 store. strip mall and an ice cream store would be open but the supplement shop would be closed and it was it kind of it didn't get viral but it certainly got a lot of attention where people like what what's going on here so macdonald was open yeah yeah and so we we had a bit of a head butted with the governor out there in

nevada it's like what what are we doing here right because it was it's like well wait a second why are you why is your order to shut down something where people are trying to stay healthy versus you know it was weird it was a weird time and it was weird what people made into a priority um versus you know we knew vitamin d was really important we knew zinc was really important um and you know we tried to make sure folks had options there and you know another scary thing is like they discouraged like 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 all this stuff. And a lot of these things, like I told you, I read that Dr. Fauci book by Robert Faginty. He talks about how they specifically tried to like 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. 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 don't go through the drug approval process. been the drug approval process is apparently perfect, except it's not, except we've seen challenges. We've seen challenges with, you know, with OxyCon 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 a 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 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 multivitin, multi-mineral 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? Well, we'll 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, uh, what do they say? At that point, they kind of get quiet. 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. It's like, well, that turned out to be not such a good recommendation. 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 were 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 like sponsored and paid for the traditional food pyramid that has basically bread at the bottom of it. The same foundation of a meal is bread at the very top was eggs. right you have to only too many eggs right the food pyramid

is a well this is like the standard definition based by Wikipedia I'm looking for the I'm looking for the tinfoil hat he's looking for the tinfoil yeah

we gotta get that one going no but I mean I think that's the question is there's who really search for like who really came up who really developed the food pyramid

something like that sorry what were saying no it's interesting though because And I think this is that 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, they're 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 we have this 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 Degistino has like studied, he's been funded by the DOD to study ketogenic diets for Navy SEALs for their oxygen toxicity seizures. So when the seals dive and they use the little rebreathers. Yeah. They can 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, into what is the name of the disease where people have seizures? 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, which is fascinating. And that's the interesting piece.

is 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 into worlds, that won't hold up under that paradigm either because, you know, people are going to respond differently something at a higher dose versus a lower dose. And again, if these are things that we're already in the 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. 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, 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, they need to. I mean, we have platforms that. They can go to our website, click on take action. It goes to 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.

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 health care and their wellness. You know, not that, again, I'm not advocating that people delay the treatment of disease.

I'm not saying that there's not an importance to, you know, 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, the people that use supplements has grown from, you know, 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. People, 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 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, it's so cheap. Like, could you imagine if they try to do something like this

with creatine? It actually is happening on the state level. States are looking at, it's funny, we've been fighting. So we talk a lot about federal. We talk about FDA. We fight battles on the states too. And the states are interesting right now is 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 held striped. And they, your whole premise is that dietary substances are leading to eating disorders. And so specifically in the, you know, body building 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 is 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 like, oh, yeah, the creatine, it's making me have body dysmorty. Meanwhile, creatine has been studied for 40 years. It's like the most studied. It really is. Yeah. 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 it. Atterol? It might be. We've, we've. looked at I forgot which ones we looked at I have to I have to go back and check my notes but we looked at and we foyered um we did Freedom 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 they always it's funny they always start with well you know because of social media and it's like well is 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 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 population could ever achieve. And people are measuring themselves to that standard. So that's where it's interesting is 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% percent. 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 a song on how much press the issue gets. So 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. What is, do you know what cartoon?

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, I heard that it's, it's basically, it's a type of cell or gene therapy that they can do where they take the cancer cells or take 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 rate on cancer. Not familiar with it. I mean, you know, I wonder what. these big agencies 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 natural products world.

Yeah. Last big breakthrough was tax all, 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. That's my academic background. Right, right, right. some of the biggest discoveries we had are from from plants and so um hopefully there'll be more of that is um as you know i got to think with the technology a lot of times especially the modeling now with you know i don't know if it's AI i don't know what it is but but

you know basically manipulating that sort of learning path right like okay maybe the compound was trialed in the wrong cell culture or wrong you know wrong cellular target versus you know what's available now or what what our understanding is now. So yeah, I think you'll see more of that. I think, I hope so. You know, there's, 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, 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.

Well, or it's convenient. I mean, I think convenience is it. I think the time is the issue is I think we don't encourage people to make it a priority, right? As we work, work, work, work, work, produce a product versus, you know, having, you know, it goes back to, I think, I think 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? 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. Right. You know, I mean, that's, that's, you know, 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, you know, be careful of where you take that information 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, you know, diabetes or something like that.

But then, you know, if there's something, 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 this is all lifestyle and diet. You can definitely fix this. Don't, 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, and this, 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. You know, 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, is 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 critical, it's more critical than ever that people have to get involved, is people do have to get, people, nobody wants to get involved politically to shape these things, but you have to. There's a saying in D.C. that if you're not, 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 know, you have to be sympathetic to that, or at least empathetic to that. But not getting involved to have, you know, when it comes to your ability to, you know, what is it you can, you know, 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? You know, 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, you know, 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? You know, we just had an issue with infant formula, infant formula availability. I mean, they're flying in planes from Europe to bring us infant formula. He doesn't have any. That's wild.

Right. And but people, like, they forgot about it. And you go, wait a second. No, no, no, no, no. This has to be fixed for the future. Like, what systems are in place to ensure this isn't going to happen again? Or at least there are some sort of, you know, know, there's some sort of guidance to people that are, okay, how do I know, like, 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 form. You know, nobody knows that. That's not what makes the news. It's what should make the news. Right. 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? Wow, that's a tough, you guys have me a tough question. A little outside the scope of my job. I think universal health care is tough. Well, it's interesting to hear your opinion.

Just from your experience in working in the FDA and working with all people you do. Yeah, universal health care is tough, I think. I think there's so many issues. I've seen, and I have my biases. I have some friends who, I'm a big fan of the, I'm a big fan of the doctor-run hospitals, of the doctor-owned hospitals, you know, where they're, their share. It's not just like, oh, hey, I built some, you know, 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? You know, I think ultimately that's the frustration people generally have when they encounter an institution, right, or, you know, a medical center, a government agency is there's, there's a lack of care by that institution, whether it's a government agency, whereas if it's like diffusion of responsibility. I'm a big fan of small business, right? And this makes, you know, you can have a big hospital run like a small business. I think that that's, you know, I think

ultimately, I don't want to say that's what everybody wants, but I think if, 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. Oh, are you still doing this? Why? You know, 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 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. Really? Yeah, you see it from,

if you look at different medical societies, they'll have positions on supplements like don't, 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 know you don't know what's in them 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 processing online there 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. The 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?

That's okay if for the 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 you know you kind of you kind of dissed me with that answer right like you didn't you didn't I wanted to know something about this I went to you as the authority and just basically one you showed you weren't knowledgeable and two you just dismissed it out of hand you weren't you didn't listen to it at all and I think that that puts a lot of people off right and there's also there's like executives of drug companies that

are like going to visit these doctors and like taking them out to dinners and stuff like that and trying to get them to prescribe more of their more of their drugs. And, you know, even the doctors are financially incentivized because they get, they make more money to prescribe certain things than others. No, I think, I think that's, you know, and again, you're, you're talking about an institutionalized approach. Right. Right. I think so much of this has been institutionalized where it's like people have their, you know, 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 right it's not a meritocracy of of of health care 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 you know 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 a challenge it may be a difficult challenge but okay like you know that's a 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

executive program to learn to be better regulators. And the one thing it taught me and made a lot of sense, a guy named Malcolm Sparrow, brilliant guy. If you're a good chance to read, called Character of Harms, really talks about kind of 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. And 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 right the problems are a part of a very small part of right 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 You know, it's a problem, right? You know, same thing in 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. 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. 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, 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 it. They can write to Congress. Yeah. If you go to our website, MPA national.org, you can click a button, take action. It takes 30 seconds. There are electronic systems that get behind, you know, they're 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? NPA national.org. Yep. So write that little button on the right hand side, take action. There's our flying too. You can come to D.C. and meet with your members of Congress. We set up meetings for folks in the industry. Oh, no way. Yeah. Yeah, they get to meet with their senators, their house, 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 in someone coming to. Oh, wow. So it's nice. It's kind of odd. It's like, wait a second. Congress works for the people, but you can't see them. Right.

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 protect 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, that gets a file. So this one's going to Secretary 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 are 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. Oh, really? Oh, yeah. We've been a 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 bad provisions that would allow for, we keep talking about this challenge of having Amazon delistings 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, yeah, so there was a lot of mail going to members of Congress saying, hey,

You know, and emails have, you know, you can either have relationships, personal relationships with members of Congress, which is great, you know, to try to shape what happens policy-wise. Right. But the two things they listen to were donations, obviously, which for our industry, we don't have that sort of corporate giving that, you know, other industries do. You know, I'd like to see an increase, but, you know, 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 air time with a member of Congress? Well, you know, generally, and it's not like you pay them money, they do what you want, but you, you know, you support their campaign for re-election. 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 air time. But the power of the grassroots is they look at that and they go, wait, if someone, somebody's willing to send me an email, they're probably willing to go on the 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 where we are a C6, which is a lobbying group. Okay. But not a lobbying group. C6 is technically a lobby group. Well, C6 is in a trade association.

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. 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 three and a half million dollar 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. Oh, okay, gotcha. That puts it in kind of scale, right? Right. That's two orders of magnitude. Yeah, that's a big difference. So, yeah. And look, they, you know, they, the association per se isn't our enemy.

Our challenge, our biggest challenge right now is FDA, 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 Kalef.

Robert Kaleaf. Yeah, he's been there before. And so I think he has his views on the industry. Have you ever talked to him about this? Yeah, yeah, yeah. I mean, I think his views... How does that conversation go? It's, you know, there's always got to be the pleasantries, right?

You've got to, you know, everyone's, everyone's got to, all warriors in D.C. have a code, right? But at the same time, you know, you've got to, you get to, how you're doing, how the kids, all the 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 second trip as commissioner, his first trip, he said that, you know, 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 He doesn't feel like the laws are adequate for dietary cells to regulate them Because I think given his background he thinks it should be very

Farma-like versus the system we're under now it's interesting in that we do have some very farmalike 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 very or what is the vairs is for the vaccine There's is only for vaccine cares is the one for SIFSAN and then and the vaccine one is only like it's like it's like 99.9% unreported. Well, some people say that. Yeah. I mean, I, I, the statistics are different, but even if there's under reporting, look at the numbers on that versus the numbers at SIFSAN for dietary supplements.

I mean, the numbers are one of the numbers there. Very, very small. There's about mandatory adverse events. There's, I think there were four or five thousand 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 the throat. Wow. Which was just you know which is fun which happens when people get older. It's not like You know we had ones where people would have their hand cut on you know it was a glass bottle they dropped a glass bottle And you know they report that to FDA now that wasn't the product that caused the problem right still makes 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 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 a 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 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 can't have you've got to have someone who's willing to come to the table and talk in a reasonable manner. Right, right. 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 years in 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. Fabricane, thank you so much for coming on here and sharing this information.

I really appreciate it. Again, it's npa national.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? That's the big one. Thank you so much, Daniel. This was great. And hopefully we'll do this again.

Cool. I appreciate it very much. Goodbye, everybody.