From HerbMentor.com, this is Herb Mentor Radio.
You're listening to Herb Mentor Radio on HerbMentor.com. I'm John Gallagher. My guest today is Roy Upton. Roy has been practicing professionally as an herbalist since nineteen eighty one. Trained as an Ayurvedic, Chinese, and western herbalist, he is founder and executive director of the American Herbal Pharmacopoeia.
A past president of the American Herbalist Guild serves on the committee of revision for the US pharmacopeia and the botanical expert advisory committee of groups like the American Botanical Council, visiting faculty for many schools and a staff herbalist for planetary herbals. Roy is also a member of the standards committee of the American Herbal Products Association, and that's just the tip of the iceberg.
The, the American Herbal Pharmacopeia is on the web at herbal dash a h p dot o r g. Roy, welcome.
Oh, thank you, John.
And Roy, you know, is that the best place online for folks to check out your work, you know, after the interview if they wanna if they wanna read more about you? Because you seem like you do a lot of stuff there.
So Yeah.
We were I have to wear a lot of hats. I mean, many of us in the Arab world do. But, yes, that would be the best place to look at the work of the, American Herbal Pharmacopeia, which takes a great deal of my time.
So, yes, that's a good link.
Now, a lot of folks listening may not know what the herbal American Herbal Pharmacopeia or what pharmacopeia is. So could you explain that?
Sure.
Basically what a pharmacopeia is is a organization that helps to establish standards of identity, purity and quality for whatever product category you're addressing. So in this case, herbal products.
It actually came about through legislative efforts.
I don't know if you remember in the early 1990s when FDA was rattling the sabers talking about taking herbs and vitamins off the market And at that time, we got the dietary supplement health and education act passed and that kept supplement on the market.
And part of the conversation was well, how do you guys know what you have? How do you tell one green leaf from another green leaf? How do you tell one bark from another bark?
Mhmm.
How do you tell the quality? What about microbial contamination, heavy metal contamination? What about side effects, contraindications?
Do you know what dosage you're supposed to be using?
All the people had the same questions seem all the legislator people and regulatory people seem to have the same questions and what it arose to me was that we had no comprehensive source for that source for that information in the United States. This is what a pharmacopeia typically does is brings this information together.
Unfortunately, our United States Pharmacopeia which is the official document for drugs, official standard setting organization for drug products.
They had left herbs behind in the 1950s, right. And everything got replaced by chemical synthetic medications.
And we had lost a lot of the knowledge about the standards of identity, the standards of quality, the quality, the standards of purity, when should we pick an herb, how should we dry it so that we don't fry all the constituents that give it its medicinal activity.
What do we know and what do we don't know about this botanical.
A lot of that stuff had been lost really.
You know, it only in existence in counterculture, small counterculture groups who studied herbal medicine, but it wasn't widely known and certainly wasn't compiled in a manner that regulators or legislators or industry would consider to be credible. You know, you could go to an herbalist in Santa Cruz and say, oh, what do I use Echinacea for and how much should I take?
Well, then you have you have to trust that person.
But it doesn't give any independent credibility to that body of information. So what a pharmacopeia does is what we do is we bring all this information together and then we have it reviewed by experts, some additional plant experts all over the world that include herbalists, naturopathic physicians, pharmacists, medical doctors, pharmacologists, toxicologists, chemists, botanists.
And at the end of the day, when we have developed one of these what we call monographs, it represents the most comprehensive and complete body and critically reviewed body of information on that botanical that exists anywhere in the English language.
And FDA uses them, NIH uses them, traditional herbalists use them, University researchers use them, the industry uses them to help establish their own internal quality control standards.
So that's what that's the basis of what we do with the American Herbal Pharmacopoeia.
And and does that somehow intersect then with the US pharmacopoeia? Like, is this is this satisfying their needs?
Like, Oh, go ahead.
I'm sorry.
So I'm just wondering as far as legislatively, is that a response to what had happened before? Or is this like a preparation also to be ready for when something like comes up again like a bill like that idea? Or or or does this somehow intersect to build to rebuild the herbal part of a US pharmacope or are they just not interested?
No. It does it does all of the above actually. Initially, USP wasn't doing any work on the herbal products. The year after we were formed, they brought the idea of getting back But at the end of the day, the gentleman who was the Executive Director of USP at the time, Jerry Halpert, he's a pharmacist, He really convinced them that, hey, we need to be in this botanical sector because it's a growing sector. And if USP doesn't do it, AHP or some other P is going to do it, so we better be here. So literally a year after we formed as an organization to do this work, they decided to get back into the botanical monograph world.
I'm actually there's no real intersect though I'm a member or was a member of the chapter of revision for for USP. So we have worked close in some ways, but in other ways they tend to go off on their own and say well we have to create our own standard because we want our standard to be the standard throughout the entire world. We don't want somebody to say I want to follow an AHP standard or European pharmacopies standard.
But we do have collegiate collaborations with USP.
What it really does goes to the second part of what what you said. This helps to rebuild the foundation of what we should know about our herbal medicines. And it also is a foundational work for when something comes up. So for example, recently we finalized the monograph on the IRB Skullcap. Anybody who knows IRB knows Skullcap is a great nervine, good for sleeping, good for nervous exhaustion and it's extremely safe.
Unfortunately, in the European market, Skullcap and in the American market, Skullcap gets mixed up with another herb called Germanda.
And Germanda can cause liver toxicity.
So you have these reports out there of skullcap causing liver toxicity, but it wasn't skullcap. It was Germanda.
So, what we do is we provide the test, we say this is what it looks like, tastes like, smells like, this is how it grows, this is how you differentiate the species in the field, this is how you differentiated macroscopically, microscopically, chemically, and here are the tests that you need to perform to make sure that you really have Skullcap.
And that was in anticipation of FDA one day coming knocking on the industry's door saying you guys can't use Skullcap anymore because it causes hepatotoxicity. And you're like what? And we're like we can give them a dossier now that says, yeah, we understand that there are reports of Skullcap causing hepatotoxicity, but here's the full story. And here are the testing methodology. So you can leave Skullcap alone and just make sure the company selling Skullcap are performing appropriate tests.
So it's preemptive in that way.
Oh, okay. And and and you and you say these dossiers. Now I noticed on the on herbal dash ahp dot org you actually, sell these correct in PDF form for people and that supports the organization.
Right.
Great. That's great. That's good to know. So people wanna do further study and see what's going on out there, they can do that. And do you find that with, with the intersection with the US pharmacopeia and people in that world that, are is there a, is there still a growing, like warming up to, that realization of working with botanicals? Or is it still or is or is it really like that, you know, that evil conspiracy people imagine going on behind the scenes where, you you know, yada yada yada kind of thing. You know what I mean?
Yeah. Sure. No.
I think that the train has left the station on botanical medicines being integrated into the fabric of the society.
It's not, you know, all warm and fuzzy of course.
But look at what we have. You know, fifteen years ago, maybe twenty, we had very little intersect with regulators. It was all it was actually all confrontational, right. It wasn't progressive or collaborative at all. Today you have the Office of Dietary Supplements, you have the Office of Alternative and the National Center for Complementary and Alternative Medicine who's doing and funding research on herbal medicine materials.
You have various medical groups from Harvard, Beth Israel, Tufts, Universities of Arizona that all over the country you have medical institutes and universities who have integrated medicine programs or botanical research centers that are being funded by the government.
We didn't have that fifteen, twenty years ago. And you have many much more, again twenty years ago all of the books were written by herbalists or by ghostwriters, just writers who wanted to sell a book, but they didn't really know a lot about herbs, but thought it was a popular subject. And there were kind of alternative books. Well now you have a plethora of academically generated books from pharmacists, medical doctors, naturopathic physicians, actual clinical practicing urban clinically practicing herbalists.
So, you get a much higher level of quality of herbal information now than we did in the past.
So, it's out of I think that like I said the trains left the station, the market continues to grow, the integration of herbal products into people's lifestyles continues to grow, traditional Chinese medicine, Ayurvedic medicine continues to grow in popularity, naturopathic medicine every year, the natural health movement is graduating you know a few hundred to a few thousand, holistic health practitioners.
You got acupuncture, traditional Chinese medicine and mind body medicine that we didn't have twenty years ago. So it's out the gate. It's still going to be some growing pains. There'll still be little battles to fight. But I think by and large, the war has been won if if I could put it in those terms.
We no longer have to convince ourselves that there's validity for us existing so okay so now what I want to do is then get into some questions from some people on herb manager because for those folks, they are, for most of them anyway as far as I know.
They're people like me who are your basic home herbalists and they they try to follow what's going on out there in the world in the news and see and and think about that how that inner how that relates to them. And sometimes the news that they hear can cause confusion or fear.
And, I thought a good place to start with some questions that we had in from folks about some of recent, European regulations, especially in the UK.
And, now I could just go and ask questions that came in but something tells me you probably have just to share your knowledge about because if I just start out by saying well, some some of the questions, for example, you know, legal standings of herbalists in the UK, what did they enjoy versus herbalists in the US? And and and and then do the changes that are happening there in the UK is that gonna happen here and how does that affect the home herbalists that sort of thing can you just kind of go there or do you want me to go question by question?
No, that's fine.
Okay. First off there's in the UK there's a legal basis for herbalist to practice herbal medicine that was on the Royal Decree and it would take a Royal Decree to overturn that. So today in the UK, it is legal for a person to actually practice herbal medicine.
And what I mean by that is I mean herbal medicine meaning they can, you know, somebody can go to them, they can perform whatever diagnosis they perform, they can prescribe whatever herbs they want to prescribe for whatever condition and they're not going to run the risk of practicing medicine without a license. There are some restrictions. So there's certain things like a certain number of infectious diseases that they shouldn't be treating and they have a responsibility to report when they see certain infectious diseases.
They're not supposed to treat, Bright's disease or any, you know, that type of kidney disease.
They're not supposed to practice veterinary medicine. So there are certain restrictions they have but they don't need a license to practice herbal medicine.
That's very different than in this country.
There is no legal basis in any state to actually practice herbal medicine separate from having a naturopathic or an acupuncture or a medical license or a chiropractic license in some states.
There are some states that have had what are called Health Freedom Acts that allow for herbal health care consultants to practice but not practice medicine under those health care bills.
You know you can say I'm an herbalist.
You come to me.
I'm gonna give you recommendations on your health, but I can't. I'm not a doctor. I can't treat disease. I can't diagnose disease.
I can't tell you to get off of medications, and I'm going to recommend that you see your doctor if you have any questions. So there's a difference. You know, we can practice quote unquote herbal health care. We can't practice herbal medicine legally.
If we do, we engage in diagnosis and treatment or prevention of disease then we are practicing medicine that violates state medical practices acts.
So those that's the those are the two main differences between the UK and United States with regards to the right to practice.
What's happening in the UK is secondary to a broader piece of legislative initiative throughout the entire European Union.
The only reason why it seems to be affecting the UK more is because they have a body of herbalists that can actually legally practice where in France and Germany and Belgium and all these other countries, you don't.
They don't have the same rights for herbalist to practice herbal medicine. They don't even have strong herbalist organizations in many countries who can fight you know and stimulate what's going on in the UK, the opposition to the implementation of this European Union directive.
The UK is unique in that it has a very strong body of herbal practitioners. So now they're up in arms now that they see what's coming down the pike.
And it's interesting. It doesn't have anything to do with them practicing per se. It has to do with them being able to access herbal medicines.
That's where the rub is. It's not with their ability to practice. It's their ability to access the herbal products that they need because that's what the European directive was about.
So so so who is behind like in this be in this EU directive, like is it industry pharmaceutical industry behind it pushing that?
Not initially. No. It has nothing to do with that.
Remember the European Union came together, what, fifteen years ago Yeah. Or twenty or something to have a an international currency called the Euro. Right. Instead of, you know, every country having different currency.
Well they also had to look at every other aspect of of law and work to harmonize the laws across the European Union. So if you had certain laws on herbal products in Switzerland, well that wasn't applicable to Germany, France, and and all the other countries and vice versa. So what they had to all do is come together and say we need to harmonize our medicine laws, we need to harmonize our trade laws, we need to harmonize our food laws so that we can have free trade throughout the European Union. Free and consistent trade throughout the European Union because you don't want to get arrested in France because you're selling a product that's illegal there because it was made in Germany.
So they developed what was called a traditional medicines directive and every country interestingly already had had what was called a traditional medicines model, which meant that herbal products could be allowed to state what they were good for. So valerian is used for sleeplessness, right? Or echinacea is used for colds.
And they had very specific language as you know, Skullcap has traditionally been used as fill in the blanks. And every most of the countries had this, but they regulated their products differently and it was a great model until they tried to harmonize. It was a great model. So France was very open.
Germany interestingly was very open.
Other countries were very restrictive on what types of claims would be allowed on products And again, remember as a juxtaposition against the American market, we can't say that stuff on our products. Right. Now we can say valerian promotes a healthy night's sleep. Echinacea supports a healthy immune system, right?
But we can't say it's for colds, we can't say valerian, it's for sleeplessness because that turns the product into a drug. Got it. Okay. So the European Union directive was really only about harmonizing the laws of the manner in which herbal products are regulated throughout the European Union.
The problem came in is because what I said, most of those countries do not have organized bodies of practicing herbalists except for the UK and the and the UK people were asleep when the European Union directive was developed because they're kind of only tangentially in the EU. Right? They're kind of their own little island sitting off on the side, you know, whereas France, Belgium, and Germany, and Switzerland, and Austria, they're all sitting in the same neighborhood.
Right? So so the the UK people were kind of off in their own world not realizing it. Because because the herbalist Wait a minute. Yeah. The herbalists were not organized, so they were not at the table in the conversations.
So so in order to come up with these standardizations, these other European countries, they they're just deciding, well, just, you know, to make it easy, nobody can access it. Is that what they're saying?
Oh, no. Not at all. No. They wanna promote free access. No. They want to promote open access, but at the same time, you'll have, again, you'll have a strict comp country sit like right now Germany is a very strict country. You'll have a strict company like country like Germany saying the only indications that can be on these herbal products are those that have been supported by double blind clinically, you know, placebo controlled trials.
Or they say only herbs, that have an established use for thirty years in the European Union or they come again, they come up with different parameters.
So what's happening is then countries then, if I get this right, who have more lax laws over the years are are seeing, oh, wait a second. You guys are trying to make things strict like they were in other countries in my country.
Yes. But what they what the European directive did and supposedly did was kind of flatten that conversation. So those the the strict company countries didn't get everything they wanted. The lax countries didn't get everything they wanted, but they came up with something that they all said they could live with. But the missing piece of the remember that has to do with products.
The missing piece of all of those puzzles was that there was no body of practicing herbalists represented in the conversations because most of those countries don't have the herbalists. So now that the UK herbalists, the professional herbalist community in the UK realizes what the European Union directive means to them as practitioners, now they're involved in the conversation. Now they're up in arms. But in the initial, you know, phase of developing these directives, nobody once stood up and said, hey, how are we going to deal with traditional Chinese medicines here? Wait a minute, how are we going to deal with traditional Ayurvedic medicines? Wait Wait a minute. How are we gonna deal with the fact that these herbalists practice legally in the UK, but we don't have any other practitioners in Italy or France or Belgium or wherever.
And Right? You know, and all along They were at the table.
And and all along, no grassroots type herbalists, like, in the in Europe or the UK ever really saw what was going on or just there Right. Is there not a movement?
No. It was there was complete, complete ignorance of what was going on.
And frankly they didn't, you know, a lot of counter remember a lot of counterculture people they're like, oh, that doesn't apply to me, that doesn't apply to me, that doesn't apply to me. And so they don't get involved politically. They don't get involved in a regulatory scheme. They don't they don't pay attention to what's happening in international law and how it might impact them or their patients.
And unless you are proactive in doing something like that, when this stuff comes down the pike and all of a sudden you realize, wait a minute, what's gonna happen in June when this directive becomes into effect? Yeah. I didn't know that. I mean, I heard about this five years ago or, actually, you know, the European directive goes back almost ten years. Uh-huh. So this is not a new thing.
All this time, the UK herbalists or the acupuncturists or the Ayurvedic people could have been opening dialogue with the European Union regulators at any time to say, you know what, we know about this European Union directive. There are certain things you guys didn't really think about that impact ourselves, our practice and our patients in our communities, we'd like to we'd like to have formal conversations with you. They didn't do that. Nobody did that in the European Union. Nobody did that in the UK. They just heard about the European directive, yawned about a little bit, and went back to doing whatever they do.
So so here's here's then where it goes from here because I'm sure you more than anyone have seen them all coming through. And use and I showed you some of the questions ahead of time coming through. And where this leads people to start to think, and I've seen emails on it, is that we've got, oh, big conspiracy theories about what people are trying to do about herbal medicine and how this is then gonna come to the US and eventually lead to us not being able to grow or wildcraft certain herbs. Now, you know, to me now that I hear what you're saying, all that and what people are saying seems pretty ridiculous. Is that true or is there is there any basis?
No. There's always a little bit of truth in everything. So when something is and there's always conversations that get mixed.
So the thing about illegal to grow your own herbs and stuff like that, that has nothing to do with the European Union directive. That has to do with the food safety bill that was just passed in Congress a couple of weeks ago.
And the part of the food safety bill basically says that if you're going to buy or sell, I mean, if you're gonna sell any commodity you grow, you have to be registered. You have to be a registered food producing facility because they are so paranoid about all this E. Coli crap. Mhmm. You know, with Burger King and spinach from Watsonville Farms and contaminations that you hear about.
And there's and that's all of course also driven by this fear in a homeland security you know they can attack our food supply thing, you know, so we have to make sure that all our food suppliers are registered, certified or whatever eyed, you know. And so that's where that fear comes from.
It doesn't prevent people from growing what they want. It just puts burden on people that want to sell like at a farmers market whether it's a tincture product or whether it's an apple, right? It doesn't matter. That's where that conversation comes in and people mix up those conversations.
The reality on the international spillover, I. E. The ability potential for international law to come knocking on North American soil. That's always a potential because just as we had NAFTA, just as we had GAAP, just as we are part of the you know codex elementarius and we have been for forty years, there's always the chance for the US to somebody to develop a trade agreement, a treaty that says, yes, we will harmonize with your laws.
Right. That's not gonna happen in the short run.
That could happen in the long run. It won't Right now, there's nothing in the European Union director or what's happening in the UK that can possibly affect the US with regards to dietary supplements because the dietary supplement category protects access to all of these things that were on the market when the act was signed and that would have to be overturned and if if Congress would try to overturn that and actually there are Democrats that would love to see that overturned, This country would freak out again and kick their butts like we did the last time.
We always win those battles.
The place we'll lose is if again, if the democrat if if if we don't keep our house in order and there are more people that are alleged to die of Ephedra or there keeps there continues to be reports of supplements being spiked by conventional drugs in like the herbal Viagra pills or people dying from taking weight loss, herbal supplements, or people companies making outrageous cancer claims Mhmm. You know, on their astragalus or something.
If we don't clean up our act as an industry, as a profession, these are the things that are going to work to whittle away and erode our rights to these products.
That's the basis of what we try to do with the American Herbal Farm and appears to say this is what we know, this is how much you should take, this is how you tell you got the right stuff, this is how you tell if it's good quality, this is how you tell if it's pure, this is the test you can perform whether you're an herbalist collecting it in the field, a farmer growing it in your backyard, somebody selling it at an herbal bazaar or a farmer's market or if you're Pfizer developing an herbal drug. This is what we know about this herb, this is how you do it, this is how you ensure the identity, purity, quality and potency of this and this is the dosage contraindications, this is what it does in pregnant women, this is what it does with regards to drug interactions.
Here is everything you need to know to use and make this medicine safely. Mhmm. That's what we have to promote throughout our whole community. And it doesn't matter whether you're a traditional herbalist picking it at home.
If you're picking it out in the field, you better know that you're picking the right stuff. Mhmm. You better know that you're not picking it, on a lead smeltering mine, where you had all these tailings one hundred and fifty years ago, because the plants are gonna be sucking up too much lead or too much cadmium or arsenic or something like that. You better know that you should wash your hands before picking or while you're processing after you went to the bathroom.
Right? There are some basic things you have to do in order to make a safe and effective medicine that's that's that you are willing to give to a patient.
And that's what happens in a lot of third world countries. They don't have the same hygienic practices or they are harvesting herbs right next to roads or they're harvesting herbs in industrial areas that used to be mining areas.
And unless you have a way to know the quality of your material, you don't know what you're doing. And then as a as a practitioner, Because that because that's what's going to get FDA or somebody knocking on our door faster than anything else. It's going to be first, it's going to be us hurting somebody.
And the second is telling somebody, oh, yeah, we can cure your cancer. Don't take your chemotherapy drugs. Don't take your cardiovascular medicine. Throw your statins out.
So you're saying that Right. You're saying that, that pretty much like things will continue to go as they are in the US at in the moment, but it really always depends on the responsibility of those in the industry.
You know, all it takes then is, you know, like I said, one one breakout of something or one, you know, or or irresponsible claims or things like that for the FDA to go to make changes.
So Absolutely.
So that's really, I guess, a free market type of way of doing it. It's just more of a self regulation and and Yeah.
And that's what I'm I'm a very strong proponent of self regulation, of self policing our own communities.
And I'm not talking about from a draconian perspective. I'm talking about from an education perspective. You know, if we're teaching somebody how to identify herbs in the field, then that lessens the risk of Skullcap getting mixed up with germanor and somebody getting a toxic liver. If we, if we know that, there's a chance that comfrey can cause veno occlusive disease in the developing fetus of a pregnant woman who might be using it for an upset stomach, then it's good for us to tell a patient that. So that a baby is not born with veno occlusive disease because of comfrey for example, which I don't believe that it causes but there's evidence that suggests that it can do that. So why don't you choose something out? You can choose any number of other digestive supporting herbs that don't have the compounds that potentially cause liver toxicity.
So this is where we have to, you know, be open to challenging our own paradigms.
And looking at the world of botanical information that's out there not just what we believe from some teacher or something we read or something we have experienced even ourselves.
Right.
We have to look at the broad body of information that an experience that exists in the world.
So so really, I mean, it's a pretty volatile thing. And if people are listening to this, they're probably people who are learning how to harvest their own herbs and make their own remedies, which are always safe to do. You know, I mean, people can I'm sorry. Let me take that back. I mean, that that that that, you know, they can always do, but then people also get concerned because people also purchase herbs and raw herb material. And I think a lot of this comes down and say, yeah, you know, I can go and pick my own nettles, but my all you know and and for my herbal infusions that I'm gonna make.
But at the same time it's like, oh my gosh, if I need more nettle, am I gonna be able to buy it in the US? Right. And, and I guess the answer is we'll see.
No. No. The answer is a definite yes.
Oh, okay.
There's nothing that's gonna ever that's gonna prevent us from buying nettles unless for some reason, there's some body of evidence that comes out that says metals is gonna cause your big toe to fall off.
Right. Right. Right.
You know, all that it's giving rise to some kind of microbial outbreak.
Right.
And then they might not take it off the market, but what they would do is they would require for it to be sterilized. Right?
Irradiated, ethylene oxide, steam sterilization, you know, they they recommend just like they do with spinach. Mhmm. And strawberries.
Right? That's one of the reasons why strawberries are irradiated.
And one and they started to talk about radiation of spinach and go to the kill e coli.
So they don't necessarily take it off the market. They just impose restrictions so that somebody else doesn't get sick. Right. But the thing that stinks about it is that they'll do this based on single events.
Right.
You know what? Stuff happens, you know, and we can't legislate and regulate just because something might happen.
Right? If if you always had E. Coli outbreaks in spinach, then throughout the world or throughout the country, then you have to say well there's something wrong with our harvesting and growing and fertilization practices and change that, Right? Don't regulate spinach out of existence.
Clean up the process. Mhmm. So that we're not, you know, if if one event happens every once in a while, big deal. Mhmm. You know, and unfortunately, yes, some people will die from that, so it's a big deal for them.
But from a broad perspective, if it only happens, you know, rarely, and you use the event to improve your your handling processes, you don't have to legislate stuff out of existence. Mhmm.
Okay. Okay. I I see. I guess so so is there you know, then then all in all, when you hear these emails and things going around about like, you know, well the codex this or that or the big pharma and all this, then it's really not as much of that as those kinds of rumors and whatnot are saying out there.
No. Those will be generated predominantly by a few people who some of whom go in and attend these meetings and some who don't. Mhmm. And and you'll have I've had people that have been at the meeting.
Right? Mhmm. And the more flamboyant and conspiratorial of the people that were there, they come back saying the sky is falling and the other ones come back saying, I didn't hear any of that that this guy is saying. I don't know where he's projecting, where he's getting that information.
Yes. This one guy said that, but anybody has the right to ignore an opinion. It doesn't mean that's policy.
And see what I mean? At the end of the day, it's a process of figuring out how do we represent everybody's opinion around the table. And you'll have some opinions that say, we want these regulated as drug peer. No, you know, no questions asked period.
End of story. Mhmm. It doesn't mean that that carries that at the end of the day. Mhmm.
That's one person's opinion.
Okay. Okay. Okay. This is that's as as far as, you know, with all the regulation and and, you know, relation to Europe and what people and those fears and stuff, that's very comprehensive. I appreciate that clarity.
Something that that comes up for people, next is that, you know, and and folks listening to submitted questions. I'm kinda like looking through them and I'm just kind of, you know, fusing them together into the general ideas because of the amount of time that we have today.
But, so I may not ask it directly, but, you know. So anyway, you know, what what comes up for people then when they hear these and they and you said like they cross lines, you know, here here there's this European EU thing versus the Food Safety Act and then there's the good manufacturing, practices and and everything.
And and and you could speak to that but in with through the lens of not necessarily like, maybe if you want to through like someone who's more of a herbal consultant or quote, you know, kind of practitioner. But you know, most folks here, like, I'm I'm getting questions like, you know, everything from people wondering if it's what's okay for them to share in words online and giving herbal advice from a forum or social networking site. Like, people I've been emailing saying, is it okay? Is it legal for me to give advice to, a friend on Facebook about a cold, you know, or a hurt knee. You know, you get you get that of people asking questions like that and being confused because they might wanna have a little herbal advice column on their blog or something like that, you know. Do they so so so they wonder about the, you know, disclaimers and can I do that?
Let's start with that, and then I'll move to more of some questions with products that people have.
Yeah. In the first case, you have protection on the freedom of speech, freedom of press, constitutional amendment protection. Okay. So with the with the pure and unadulterated and non commercial conveyance of information, Mhmm.
You can do that.
Now, there also there are also lines that court precedence as drawn in the sand. Right? So for example, if you are a friend, if you are an herbalist and you are giving your friend advice on hold, then that's there's absolutely no problem with that whatsoever.
Now it might be a little different if you just charge a friend, a three hundred and two fifty dollars or hundred and twenty five dollar consultation fee, because now they've engaged at a business practice of practicing medicine.
It becomes further complicated if you've then said let me send you or why don't you go ahead and going to treat. You've one established that you're going to treat this person for disease. You're going to charge them for that information and you're going to make them buy a product that you said is gonna treat their disease. So then you just made a drug claim.
So you see it where the lines are crossed. And also there also might be a place where you would run awry if you were a person developing like an anti cancer blog. And you were saying, listen, everybody that's listening to me like Rush Limbaugh, don't take your chemotherapy. They're they kill you.
Don't take a radiation. They're gonna fry your immune cells, and you need your immune cells to fight the cancer.
Take astragalus.
Right. Take reishi mushroom. Mushroom, take legustrum, take echinacea, take whatever the herbs that I'm saying you should take and throw away all your conventional drugs. Somebody's gonna come after you from practicing medicine without a license and really giving bad advice.
Then that's complicated more if you say, look at all my immune supportive products that are great once you throw away all your conventional drugs.
Okay?
So lines, there are different lines in the sand.
But for the most part, individual expressions, friend to friend, non business to non business are protected on the freedom of speech, freedom of press. You can write anything you want in in a book. You can write anything you want in an article.
And, again, remember this.
Freedom of of speech protects truthful speech.
Right? Right. The stereotypical thing, you can't run into the movie theater and yell fire if there's no fire.
So similarly, you can't be going out there proclaiming, I got the cancer cure if it's not true. Freedom of speech does not protect lies, exaggerations, or anything like that.
Wow. So what you're saying has to be truthful, not misleading.
Okay. Okay. And then how do people who are like who get trained in various herbal, you know, skills and then wanna be an herbal consultant, rather, a, either in person or over online or something. How do they how do they do that legally?
You don't.
As a well, as a consultant, you can.
As a to to do practice herbal medicine, you can't unless you're a licensed naturopath, acupuncturist, chiropractor, or medical doctor. Mhmm. So you can be an herbal consultant. Anybody can consult. I can be a automotive consultant. I can be an aerospace consultant.
Recommend. Exactly. No. No. If you are recommending, if you are charging somebody Mhmm. And you are recommending something for the treatment or or prevention of disease, then you are actively engaged in the practice of medicine.
You switch it around. You don't have to be an herbal medicine practitioner, but an herbal consultant. An herbal health care consultant and say, no, I can't treat you high blood pressure, but I can help you to promote a higher level of cardiovascular health.
Got it. You see the difference? Yeah. I do. I do. And You're still gonna give Hawthorne.
Alright. Right.
Still gonna give vitamin e and magnesium and coq10 and l carnitine.
Mhmm. Right? Mhmm. But it's for cardiovascular health, not for essential hypertension.
Mhmm. So that's how you can do it. Act as a health herbal health care consultant legally, but it doesn't allow you to diagnose. Well, how do you know you have essential hypertension? And then you pull up the stethoscope.
Well, you're not now diagnosing. You just engage in the practice of disease.
What if well, you said about like charging and stuff like that.
What if someone comes up to me and says, John, I've got, you know, this situation and, you know, what should I do to you know, just like a friend or something. And then like you said freedom of speech and all you do truthful this and that but still if they're asking me advice and I'm telling them something and what if it goes wrong and then they turn around with, you know, can someone sue somebody?
Yes. Absolutely. You can sue in this country, we can sue anybody for anything. It doesn't have to have any merits whatsoever.
We can sue anybody for anything. And that's where that's where the rubber meets the road is that, yeah, you have the freedom to tell them whatever you want and they have the freedom to say, hey, I took that stuff and it caused me to have runs the runs for three days and that put my heart in to cardiac arrhythmia. I thought I was gonna have a heart attack. What kind of advice are you giving me, John, you know, and how many other people are you hurting every day?
Mhmm. I'm gonna put an end to this. You you know, and then they sue you. And again, that's where I mean about us being as skilled as we possibly can.
Mhmm. And knowing what our limitations are, knowing the both our clinical limitations as well as our legal limitations, and ethical limitations. If there's something that we don't know, oh you really need to go see this acupuncture, this Nature Path, this integrated medical doctor, or this whatever because I don't know that. And to be able to say, no, you know what, I don't know enough about that specific thing to give you some sound advice from my experience.
I could study it up for you. If you want me to take a look at it and give you some basic recommendations tomorrow, I will. You understand that? Yeah.
That's that's the dance. It's a dance that we have to play if Right. If we wanna do it legally. And even if you're not charging, you brought up the issue of of charging and not charging.
Actually, practicing medicine without a license thing doesn't have a a clause that says you have to charge for it. Again, it goes back to somebody says, hey, you guys, I got the cancer cure to beat all cancer cures. Throw your stuff out. Throw your medications out.
Take my stuff.
Even if they didn't charge you for that advice, they're still practicing medicine without a license and the medical people are gonna come after you and say, okay, you're making all these claims. First, we think you're practicing medicine without a license. Second, we don't believe you have like the one guy the last guy that got whacked on doing something like this, he's in jail for twenty five years because he hired an actor to act as a doctor to tell people that this thing is gonna be good for their diabetes. Well, he's spending twenty five years in jail and had to pay three million dollars.
Jeez.
Right? So, you know, he was a promoter. Right? He's not you and me who do this as a living, a mission a mission in life.
Right? This is our philosophical, the basis of our existence is believing in natural medicine. This guy was out to make a buck. He's in jail for twenty five years, but the principle is still the same.
Right. Right.
He was brought to task.
He didn't have the information to back up the claims that he was making. Mhmm. And he's paying the price.
Right. Right. Right. Right. Well, that's great. So I think that for in that in that area, it really covers anyone from just someone who wants to help a friend all the way to somebody who's thinking about maybe consulting and what that's about.
Very few people get very few people get, WACC or this there have been a few, but very few people, healthcare practitioners, get sued or get any kind of legal action taken against them unless it's because a doctor turns them in because they're jealous of professional competition and stuff like that. That's happened.
That's why I'm learning herbs. The only things I ever put out or really focus on are always just, you know, promotes health, you know, just, you know, is is a healthy thing to take or use and general first aid. Just just simple, simple. I don't get into the how to cure chronic stuff. Leave that to the to the experts.
So, so I guess if there's one other area to look at, you know, with the time that we have here is is for those people like, oh, let's say say that I want to go in, you know, I I get it. Because making things like salves and creams and tinctures and oils and tea blends and all is such a wonderful way, you know, for a a growing and an herbalist and wanting to learn and all to to, to learn about what they wanna do because they might have a vision or an idea of, oh, sharing with the community or selling at a farmer's market or selling to their friends, selling at a local store or trading or all these kinds of things because it's a great way to learn, you know, learn about herbs and all through just making products.
And then often what happens is people make these things and realize that they're ending up with so much in their kitchen, they might as well, you know, make some labels and put them on and share with friends or sell them or go to the local farmers market or something. And so, in all these things we've been talking about, what, like, things that should people keep in mind, whether it be the good the GMPs or the Food Safety Act and how that all works?
It's a tricky it's a tricky thing because first off, when you're talking about, bulk herbs, okay, now they're they're classified as foods, not as dietary supplements.
So that's one set of regulations that has to do with producing things in the food grade food grade kitchen and having an address on your label that this was prepared in food grade kitchen.
There was a tincture manufacturer who had to throw away literally throw away dump right in front of the USDA inspector's face about twelve hundred dollars worth of tinctures that weren't made in a food, you know, food grade facility when they made tinctures.
The bulk herbs, they're actually exempt from most GMPs because you could sell lavender as a potpourri, It's not going to be ingested. It's not going to be made into a dietary supplement. There's no claim that's going to be made on it like structured function claim. So that's almost completely exempt. So you could sell the peppermint you grew and then it's up to whoever bought it as to what they wanna do with it. But as far as you are concerned, you're just selling it because it smells good or it looks good or whatever.
When you start making tinctures or capsules or tablets or any kind of pills or serves that are going to be ingested, now you're making either tea blend which is falls on the food or Tincture pills capsules and tablets or syrups. Now you're making a dietary supplement and so the different laws apply all the way from GMPs to food safety to whatever.
When you're talking about salves and oils, well, those aren't going to be internally ingested. So they're not dietary supplements and they're not food so they can either be cosmetic or drugs.
If you have a claim that says this salve is good for cuts, bruises, burns, this and that, you just made it a drug product. If you have, an oil that says put this under your tongue, put this under your nose for colds and flus, you just made a drug product and then drug GMP requirements come in. There are some exemptions with regards to small businesses if you sell less than X amount of a specific product, then you're exempt from, for example, dietary supplement GMPs.
The most important thing is for people to be people to be aware of exactly the class of product they're making and then to go on to the FDA or the FTC or whatever websites and see what laws pertain and regulations per pain to the class of products that they're making. See if they fit into any of the exemption categories.
And be very clear at if they choose not to follow those laws, they do run the risk of eventually being, you know, if they're selling at a farmer's market like I said, USDA inspectors go through farmer's markets all the time and that's how this tincture maker got caught, you know, selling her stuff. And they warned her first. They said, oh, you need an address.
You have to destroy this. And she convinced them, okay, I'll get an address. Can I just keep it in a fix it to the labels? And they said, oh, yeah.
Sure. We'll let you do that. Well, then they came back the next month. She hadn't fixed it and they made her destroy it.
So they gave her a chance.
Right.
And she chose not to comply, so she had to dump her product. So we just have to be aware of what we're making, what laws are appropriate or, that we're supposed to be following, and then choose to follow them consciously or choose to not follow them consciously but do it consciously?
It it's so so this is a that's a pretty big big, big change because it wasn't that long ago where you could just probably go to the farmer's market with your homemade tinctures and things and and and, and it was really easy to do. But now it seems like we are involving commercial kitchens. We have to follow these.
It was always the same. The law was always the same with regards to food products. They were still they just weren't enforcing it because there weren't as many people that were reporting getting sick or there wasn't as much legislative attention paid to this category before. But as the category grows, there's more attention by regulators, there are more attention there's more attention by, congressional people like the whole offender thing.
You know, a guy in New York had a constituent whose daughter died while playing soccer, and they blamed it on ephedra.
So then that guy goes to congress and says, hey, guys. We gotta do something here. We got a problem. And then you got Richard Durbin in Illinois saying, yeah. I don't like this shit either. So let's excuse me. I don't like this stuff either.
So we do have to do something about it. And then before you know it, the Democrats are on tier to regulate just like they do seat belts and, you know, helmets for motorcycles and, you know, they're they're the consumer protectionists of the congress. Right. Right. That's the good and the bad of them. They wanna protect us from everything.
But But herbs are too amorphous and remedies are too amorphous and then they just Not when a girl not when a girl dies on a sock sixteen year old girl dies on the soccer field.
Then they make a meltdown. Exactly. There is nothing amorphous about that. They have to do something about that.
But but I mean I mean they lump it everything together from a hand cream to a ephedra pill.
Absolutely. They have to. I mean, that's that's the government. Right? You can't you're not supposed to arbitrarily regulate one aspect of something and leave everybody else alone. That's unfair. It causes unfair business practices and they have to say, we have to regulate this whole category of goods.
Does does it does it does it does it speaking of hand cream, does hand cream salves body products, they fall under Cosmetics. And and do they have to be done in a commercial kitchen too?
I don't know cosmetic laws. So I do there are laws for cosmetics.
And I got they people need to look that up on FDA, FTC, that kind of site. Exactly.
FTC has to do more with claims than FDA has to do with more more with manufacturing and labeling of products.
Because because the FTC that the claims over all those crazy like acai berry like ads that you saw and everything. Right. I mean that even affected like like, internet sites of all niches and genres because it was those people that suddenly caused the FTC to make people completely change the way things like testimonials and all were done in all markets. So it's amazing.
Yeah. And that's the problem.
As soon as people start pushing the envelope Yeah.
Then they have to push back and say, Hey, you guys, you've gone a little bit too far for our comfort or for what you have evidence for. And so we need to challenge you and you're gonna go after the AIDS and the cancer and the diabetes stance that, you know, for a long time a stance that, you know, for a long time, this has been a sleepy little community.
But geez, now it's spilling over into everything. And you got Dean Adele, and you got, you know, Doctor. Oz, and you got Oprah, and you get all these people now.
Well, she's she's the one that put Asahi on the map. Right? It was Oprah. And, Harold Bloomfield put Saint John's Wood on the map in nineteen ninety eight. So then the Fed say it's no longer a sleepy little community.
Now we get this, you know, these heavy metals and Ayurvedic products coming from India and we have these spiked products from China being sold as herbal Viagra, but they have real Viagra in it, you know. Mhmm. Or we have these, you know, codeine herbal cough syrups from China. Now we have to do something about it because it's no longer a sleepy little community. It's in our face now.
So so, you know, you're finish it to wrap it up Roy. You know, you're a unique individual and that you've been you're in this world and you can see and empathize and understand the clarity of where all this is coming from for people. Because people will might get into this and they're going, oh man, these rules and regulation, the FDA blah blah blah. But at the same time, you know, you're also, you know, a trained herbalist has been doing this a long time like you're you're you're an earthy you you you're an earthy, crunchy herbalist in Origin. Right?
Yes.
And and and at the same time, you're you're you've got your your your your foot dipped in both, you know, in in in both worlds. And so what is your, you know, you know, overall feeling and take about these kinds of rules and regulations being that you can empathize with pretty much everyone who who is, involved here.
That's where I'm a big advocate of self regulation, self education, self policing. Meaning, we police ourselves.
Meaning, you, John, police yourself of what you're doing and how you're doing it and do it to the best of your ability. It doesn't mean I police you or FDA. And don't wait for FDA to police you, but you police yourself. And that would encourage this self regulating, and I really mean self regulating and self policing and ask our own questions. How do I know what species of echinacea I really have?
I bought it from this company. How do they know?
What tests did they perform that gives me confidence that I really have Skullcap and not Germanda?
How do I really know? And if we can ask ourselves those questions and answer them with confidence to ourselves, then we're doing the best we possibly can. My job is to provide the information that people can refer to so that they say, well, let me go see what the American says. Let me go see what the American Oral Products Association says.
Let me go see what the European or the U. S. Pharmacopeia says about what this thing should look like, taste like and smell like. And let me bone up a little bit on my botanical ID to make sure I can get the species and not generically just get to nettles.
Mhmm. Right?
Right. Right. Right.
Wow. And and so Roy, once again, to to do that, and you just mentioned the American Herbal Pharmacopoeia, and to check out what, dossiers and monographs that you have all, you know, prepared. People can access that information at herbal dash a h p dot o r g. And, and I guess that's the best URL, like you said, for people to check all that out.
Yeah. There's tremendous numbers of resources online now.
And and and can I ask you, is there places where, people can see you speak or teach? Are you on this, faculty, with any schools people would know about if they wanna, you know, kinda connect with you personally?
Or it's it's hit or miss.
You know, I go to Wake Forest. I go to Tyssefia. I go to Best Deer. I, with faculty or visiting faculty down at USC School of Pharmacy. So different, you know, it depends on the year. Yeah.
It depends on the year. Well, Roy, it's been an honor and a pleasure. It's been so informative. I I really love to have you back sometime because, you know, we I think I only hit about ten percent of the questions. Yeah.
I know.
But it was so but but but in but it generally, though, I feel really complete. Like, that was really great. That so it was awesome.
I'll actually have a chance to see you. Okay.
Well, we'll we'll see you again, and maybe we'll, we'll get to meet at a conference sometime in the future.
Alright, John. Thank you.
Thank you.
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