In order for brands and manufacturers to be able to meet regulatory compliance, and create safe and effective botanical products, herbal identity testing is critical. Confirming botanical genus, species, and plant parts is an art, as well as a science. Wilson talks to Elan Sudberg, CEO of Alkemist Labs, on how the process works.
Welcome to another episode of Herbal Explorations. We're going to discuss the importance of herbal identity testing in the herbal supply chain with my long time friend Elan Sudberg, the CEO of Alkemist Labs, the biggest little plant ... the biggest little, what is the line? I'd obviously ...
Elan Sudberg (00:25):
The biggest little lab in the industry. We can just leave it at that.
The biggest little lab in the dietary supplement industry. I don't know why the plant. Maybe I was already thinking about all the identity and plants we want to be discussing today.
Elan Sudberg (00:40):
We literally started and grew up in the industry together. I'm so proud of all the things he's done on the identity testing front. Elan, tell us a bit about yourself and Alkemist.
Elan Sudberg (00:49):
Sure. So first thank you, Wilson, great honor. And you're right, we were both born into this industry. I think my first day was as two cells and then four cells and then eight and so on. Father was a chiropractor and acupuncturist and had a line of herbal supplements, so that was my foray into the industry. But when I was about 17, I started doing some testing for the supplements that he was making, the tinctures, and basically started a lab for our own manufacturing facility, which was very, very small scale, nothing exciting, and started to fail some incoming raw materials.
And our vendors asked questions and we answered them and then we got more questions. And then they had us test some samples and we sort of became a testing lab and pivoted a year or so afterwards. And the tincture business doesn't exist, just we make it for ourselves in the background. But since then, 20 almost 25 years later, I've got a little over 40 employees in a 21,000 square foot lab, focusing on plant and fungal identity purity and potency for the dietary supplement, pharmaceutical, psychedelic, you name it, industry.
Yeah, literally I remember us coming down and it was just a real family affair. Let's just put it that way.
Elan Sudberg (02:07):
And now it's multiplied and definitely still family owned and a lot of values are there.
Elan Sudberg (02:14):
But no longer the small, intimate company that we all started with.
Elan Sudberg (02:18):
Correct, exactly. It's morphed a little bit, but all is good. So it's all great.
Yeah, let's get down to business. How important is clarity and specs when it comes to plant identity testing? A lot of times I see things, clients get things that are failed. But it could be just that they didn't submit the sample properly, right?
Elan Sudberg (02:40):
For example, if someone says, "I want to test ginseng or ashwagandha." Is that sufficient or do you need something more detailed than that?
Elan Sudberg (02:48):
Well, plants have friends and families, so different species. We always need the species. Specs are really important though. When we receive samples with no specs, we do ask the client for specs. When they don't have specs, that's very telling where position is on GMPs because the last I heard specs are pretty important.
A lot of the industries, as you know, deal with extracts. And if you send us an extract, which is a chemical extraction of some sort of a plant, we need to know data on that. Because if you extract your ginseng with ethanol and water and we don't know that, we can't compare it to the right stuff and in turn it will fail. So specs are really critical for testing it the right way and getting the answers that are accurate. Common problem and common you see in the industry, the 43s and the warning letters are common for not having specs.
Yeah. And I think it's clear. It's when you test for something, do you want to test for the root, the root and the leaves or the leaves? What the heck are we looking at?
Elan Sudberg (03:48):
Well, yeah, exactly. Well, ashwagandha, as an example, a lot of leaf material floats into the root material to fortify the phytochemical profiles. But we've got really simple tests that can differentiate between the two species or the two plant parts. Many folks don't realize that's what's happening. Good news is it's still the same plants, so you're not necessarily being adulterated with another species, but the plant parts could be an issue if your label claim doesn't specify that. And it comes down to basically, what you put in the label should match what's actually in the bottle because otherwise you can get into trouble.
Yeah. It's a lot of what you're paying for and what is the intended purpose?
Elan Sudberg (04:25):
If you're doing a standardized extract, maybe it doesn't matter what plant part it comes from.
Elan Sudberg (04:30):
But if you're doing a more of a full spectrum approach, wow. You got a really different kind of efficacy.
Elan Sudberg (04:39):
Right. And as long as the specs say that, some folks don't have a concern over certain plant parts, for example, or even dirt or filth that we see. There's acceptable limits of everything, and some folks have specs for that, some folks don't.
And going back to something slightly different, what do you think is the importance of orthogonal testing to approach identity testing and what percentage would you say of the industry is doing a truly orthogonal approach to make sure we have what we have.
Elan Sudberg (05:13):
Yeah, orthogonality is critical. It's a phrase that I believe comes from geometry, multi-faceted or multi-sided. But used in industry really means testing things multiple ways. So the orthogonal approach that we use here is identity with macroscopy, looking at it with your eyes, which is how it was done originally, organoleptic smelling and tasting fracture, all that data goes into the macro identification. Microscopic analysis, looking at the cells under the microscope. And then HPTLC, so looking at the phytochemical profile.
That orthogonal approach is really solid for the identity of plants. You can take it further and add a fourth leg to a three-legged stool of orthogonality, and do HPLC or PC and start measuring particular compounds of interest that lead towards efficacious or efficacy. And then last, of course, you want to make sure there's no heavy metals or poisons or pesticides or anything there. So the purity testing is that last but really critical step to testing.
To answer your question, a lot of folks in the industry really stop with just the ... they do the purity, making sure, obviously, it meets the specs for pesticides and metals, micro biological, which are the killers of those products. But they don't do a great job on identity and potency. Some folks use things that are like triquarter, cell phone based software to scan things that will give you an identity data point, but not very accurate.
So they have made sure the pesticide metals are not too bad or they've made sure it looks kind of like the plant that they're interested in and they leave it at that. But you're missing data on potency. How strong is it? What's the caffeine level in your green tea, as an example. And then do you even have the right species? Doesn't matter about pesticides when you're basically selling the wrong species. So orthogonality is huge. It's something we've been following since the very beginning of the lab.
Yeah, I was first exposed to that term by Dr. Joseph Betts in one of his talks and it makes a lot of sense. You got 80% certainty from one method, 70% another, and now by doing these methods you've sort of buttressed your certainty about the identity and potency of a plant. And talking about potency and identity, how important do you think is the pair identity testing with potency testing? Meaning if we're looking at a chemical, we're confirming there's caffeine. It meets a level of caffeine that's required, but heck, do we know this caffeine comes from coffee, green tea or whatnot? So is it something that people should do with extracts, should they always be looking at identity paired with efficacy or how is that dealt with?
Elan Sudberg (08:10):
Sure. So I guess the example in this question is that you can take a peach out of season. You go to Georgia in the summer and grow a peach, and that is the definition that your standard of what a peach should be, full of flavor. And the flavor is a chemical profile, which could be measured, but you measure with your tongue and your brain, and you say, "This is a good peach." You then head over to a big box retailer in the winter and buy a peach and the peach is bigger than normal and has a second peach inside of it and it doesn't rot on your countertop for months.
But technically by genetic analysis, it is still a peach. But when you bite into it, it has a different flavor, different texture. And that's ultimately what you're seeking when you eat peach is not necessarily the nutrient content, but the flavor. And so if you only do identity and don't actually measure the phytochemical profile of your products or plants, you could be selling kind of duds. They could be legally allowed to be called whatever they're called, but are they good? And good could be defined in a number of ways if you know efficacy and compounds.
You brought up caffeine from sources. It's very difficult to determine where the caffeine in that example came from. Caffeine's in a few plants. So green tea, quarana, your mate. And so, you could get a green tea extract that's fortified with synthetic caffeine. You can get a green tea extract which has the normal amounts of caffeine in there from the green tea. As a chemist, I think caffeine is caffeine. It should be pure. It doesn't really matter where it comes from.
Your labels should state where it comes from because you're being disingenuous if you're not sharing that your material was fortified with caffeine. The good news, there are labs that can test synthetic versus natural phytochemical profiles. Not something we do here at Alkemist, it's something we're looking into for later expansions, for sure. That to me comes down to more of a legal issue, whether you state that your stuff is synthetically derived and fortified versus not. As far as efficacy and safety, my position as a chemist is that caffeine is caffeine is caffeine in regards to where it comes from.
Yeah, I agree that it looks the same structurally and everything else. I think the key is the labeling. Because most people in our industry were selling supplements and not beverages, necessarily. We don't state, there's 10 milligrams of caffeine. We usually state the source of caffeine. So in your example, you can get sugars from a lot of different things or caffeines from a lot of different things.
But if you put that on the label now, you have an identity issue. Sure, you're delivering the caffeine, but from a different source, and it brings up different issues. So I think back to that, you need to know the people who are providing you the ingredients and have traceability in the supply chain to know that the source is really, like you said, green tea or coffee or whatever it is. And making sure that, and testing is a way to verify the work you do before you receive the ingredient by the ingredient. It doesn't stand by itself. It's part of the whole puzzle.
Elan Sudberg (11:27):
Correct. And for your case with a company like New Herbs, your company stands on the foundation of thousands of years of data. And so back when herbs were being explored and used, they weren't extracting one chemical from it to treat ailments. They were taking an extract or some sort of mixture and using all the chemicals together. For me, I can drink espresso right before bed and go right to sleep. But if I drink yerba mate before bed, I'll be up for hours. So it's not just caffeine that does the trick, it's the xanthene family in that example that keeps me up, whereas coffee has less xanthene. So if you're focused on one particular compound in an extract, you're basically pharmaceuticalization a plant, which is not bad. It's just not the original way that herbal medicine was brought to us, as in your case with New Herbs, thousands of years of traditional use.
Yeah. I think a lot of it just becomes, are we talking about the full spectrum and all the things out of the plant? And plants are so complex. If I said, "Hey, Elan, what's all the chemical constituents in ginseng?" And despite almost 50, 60 years of scientific, deep diving, we still haven't scratched the surface of every single component in Chinese ginseng. So I think there's the whole plant as the usage of the application of the whole plant versus more of this constituent versus the biomedical approach. And even though Chinese herbs have been used for a thousand years, it's constantly evolving. And what I mean by that is, for example, you might have noticed when we send stuff to you or stuff comes through your lab, it looks different than it looked five, 10 years ago. And the reason why is, well, we no longer use sulfites. We no longer use other things and we have better preservation technologies. So we don't need to use sulfites. We don't need to cut it a certain way. So now it's a lot of it, the way that we cut and process it is a little bit different than originally even 10, 15 years ago. So if you don't change specs and you said you want Angelica sensesis slices, and all of a sudden you're getting whole roots or chunks, it is the right thing, absolutely correct. But it doesn't meet your spec and that's why these specifications and quality systems and purchasing are living documents in that you always have to keep working on and there's no such thing as a perfect solution.
Elan Sudberg (14:16):
Right. Wilson, mentioned something that triggered me for your relationships. Like when you have these specs, you have these relationships with vendors. Whether it's your vendor supplying you the herbs, knowing what you need and what is right for your company and also your testing lab. The relationships are really critical to have so that you can work together to produce that final product that works for the consumer. And as an example back to New Herbs, you're collecting herbs from a series of farmers that have been working with you and your family business for a long, long time. They know exactly. But as you mentioned, the times are changing and the sulfites or the preservatives or the preservation techniques are changing and adapting along with all the technology that we have.
Yeah, and it's teamwork. It's really me working with my farmers, producers and knowing that, okay, this is what we need to do to get the best quality material given today's technology and then communicating that to my customers downstream and then communicating to you as a testing lab so that we're all on the same page. And I'll give you a perfect example, the reasons we no longer need sulfites for a lot of the herbs that we process is because we're processing them within two to three days of harvesting using machine drying or other kind of techniques that instead of traditional sun drying or when the sun is available, we're going to go get a good dry. It's no longer our grandparents or maybe our great grandparents way of doing things, pull out of the ground, put it in the sun and pray.
Elan Sudberg (15:51):
Right, exactly, exactly. But you've carried those traditions on to adapt them to, as safety specs, change and needs change, you adapt those to match the needs of your clients, which is why New Herb is still a successful company in this industry.
Well, thanks. Thanks. What's the one thing that keeps you awake at night in the industry, when it relates to testing and what people are doing or aren't doing? Like, "My God, why don't more people do this?" Why can't they sleep?
Elan Sudberg (16:27):
I got asked this question from someone else the other day and I said that when I was a kid, I never had the desire to be a cop or police officer, but justice has always really been a driver for me. I just hate cheaters. I just hate, hate cheaters in all aspects of politics, in business or banking or whatever it is. That drives me crazy, seeing folks grow in success by taking shortcuts or cheating. So this company brings me lots of joy and fulfillment because we're not catching cheaters so much, but we are. Our customers send samples to us and with COVID, the supply chain has changed quite a bit and everyone's had to find new vendors and requalify vendors. So we've been able to help our clients adapt to the supply chain issues by making sure everybody's buying the right stuff.
So to your question, what keeps me up at night is the people who are wiggling through not doing the right thing or taking the least expensive route or the bare minimum. The GMP has been out for a long time. They're pretty specific about what we should do and how to do it, but they do leave a little bit of room for ambiguity. So people can interpret things and use tri quarters and light boxes and things to identify plants, and that's basically a test. And the FDA says, "Yeah, that's adequate."
And then poor quality materials are perpetuated throughout the industry. And again, the worst thing, I said the other day that Alec Baldwin has killed more people than the entire dietary self industry in all of my years of playing here, which is about 25, and working in it. And so the industry is very safe. The worst things that happen, or the least bad worst thing is that the product doesn't work very well. And that's because of folks taking shortcuts in quality control. Of course the worst thing that could happen is someone gets sick and dies. But like I said, that doesn't happen in our industry and hasn't happened for a long, long time.
Yeah. And especially if we add a word to your statement, legal dietary supplements.
Elan Sudberg (18:28):
We're not drugs masquerading as dietary something.
Elan Sudberg (18:32):
Correct. But even then, there's not a lot of deaths. I haven't heard about them. So even with the APIs sneaking into garbage products and garbage brands, it's a very safe industry pushing very safe products. But still, folks are cheating and it drives me crazy because brands like yourselves and our other best clients are spending the money to do the testing with the right methods and the right technology, and their competitors in some cases are not. And so they can achieve lower price points on the shelves. They can get their products out faster. And that's what keeps me up at night. That kind of cheating bothers me to where I want to just fight for my clients, make sure they have the right results as fast as possible.
Yeah. I think cheating
Elan Sudberg (19:21):
Is Horrible. And I think the other thing that keeps me up at night is now that with FSMA, with the food safety modernization act, there's a lot more emphasis on microbials. And I feel like we're over treating things.
Elan Sudberg (19:41):
It's like, "Hey, what's your five log reduction plan?" Like, "Well this is a fruit. 99% of the time, unless you've got bad harvesting techniques and it falls on the ground and you pick it off the ground, microbials aren't an issue." But we're treating everything. And I'm interested in seeing, what I would like to know, maybe one day offline we'll figure it out, try to do a little guesstimation, is like how many people have retest potency after sterilization?
Elan Sudberg (20:19):
Oh, interesting. Yeah.
You hit it with heat or you hit it with steam or whatever legal method it is, there has to be some degradation. Right?
Elan Sudberg (20:29):
Correct. Yeah. We've experienced that just in the identity of materials, that they passed identity first, then they were treated for sterilization. And then like you mentioned, phytochemical profiles change and no longer match reference materials. And again, back to that relationship that we have with our clients and you with yours, we go back to our clients, we talk about it when something fails. And they say, "Well, we treated it with this." And we'd say, "Oh, okay. That's probably it." Good brands always keep being retained. So before you treat it, there should be a portion of that product removed, kept aside, so that you can test it before and then also after and come up to that conclusion without it being some sort of mystery. But yeah, there's a lot of treatment on these plants and that absolutely does affect analytical results in the lab.
Yeah, which is not surprising at all. Because if you think about it, I'll give you an example. In Chinese Pharmacopia, there's a thing called Deon or rehmannia. There's raw rehmannia and
there's cooked rehmannia, which is processed rehmannia, two different chemical constituent profiles, as you know. And if you treat it raw, it's going to become cooked. I mean every time we see it. And that's going to be an issue on your label if you put raw rehmannia and you're actually using cook rehmannia in this instance. And I think you have to know the herbs. You have to know what you're getting into and what you're doing to them and really do a deep dive and understand it and work with partners that really understand the herb and herbal material in order to get a quality product out there.
Elan Sudberg (22:12):
I agreed hundred percent. Yeah. Back to the first question we talked about, the spec, if you give us rehmannia and you don't tell us it's treated or raw, it may not match because we're going to have to compare it to both raw and cooked rehmannia reference materials. But that's the kind of stuff that we need to know and some players in the industry know that that's important. Some folks just ask for rehmannia and get whatever they got for the price point they wanted. They didn't even know if they got raw or cooked and they moved it along the industry, won't test out correctly and there'll be problems the whole way through.
Yeah, or they pay twice for testing.
Elan Sudberg (22:43):
Exactly. And whoops, we forgot to tell you.
They ask for rehmannia. You chose raw and they weren't clear and it failed, and you go, "Why?" And they went back to the vendor and said, "Hey, you asked for rehmannia. My standard rehmannia is cooked rehmannia. Go back to Alkemist. Go pay for the cooked rehmannia and do it again." Right?
Elan Sudberg (23:00):
That's classic. That happens a lot. More than we realize. Exactly when things fail, a good lab will go back and work with the client and say, "Why do we think this is failing?" Not to test into compliance, but just to get to the bottom of it. Because a lot of times there's an explanation like we just discussed.
Yeah. I think testing into compliance is definitely something I know you would never do. But there's a difference between working with your client and if the client's receptive, now they're going to write on their spec, raw rehmannia or cooked rehmannia, whatever the case, whatever they need. And when they submit the sample next time, they're going to write the right thing in as well. So that's being on the same page. I think alignment is really key. Not to take up too much more of your time, but any exciting news of Alkemist news in 2022? And if not, you know.
Elan Sudberg (23:55):
Yeah, yeah. No, I've got some tricks up my lab coats. First thing is we are expanding this year. We're bringing on metals, pesticides and digital solvents. Those are all validated. Equipment in. Trained staff. Ready to launch next year. Be a big splash and disruption. We'll be also adding micro biological services early next year as well, so full service by maybe Q1, end of Q1. So that's one.
Two, next generation transparency, something I've been working on for many, many years, seven, to basically try to get my clients to share their results. Be proud of your lab. Be proud of your data. You spend a lot of money on quality. Share it. My next marketing campaign, so that's starting to take some traction. And then lastly, the psychedelic industry is something that cannot be ignored and Alkemist Labs have the DEA schedule for 1, 2, 3, and four. And so we can actually legally federally test various very, very strong medicinal plants and fungus. And we're starting to work with some interesting legal clients as well to make sure they have the right material.
Elan Sudberg (25:01):
Talk about disruption, there's a $20 billion Prozac industry that will be disrupted by some mushrooms in the very near future, and we're hoping to be an ancillary part of that. So exciting expansion and exciting branding and exciting another field that we're going to be helping industry, which is just all great. So 2022 is going to be a very busy and fast growing year for Alkemist Labs.
Wow, thanks for sharing. I'm so excited about you becoming a full service lab and making my life a lot easier.
Elan Sudberg (25:33):
And the psychedelic part about it, wow. That's amazing. We definitely have to touch bases about that and pick your mind about what that landscape looks like in relation to the herbal product industry and the fungus and all this stuff.
Elan Sudberg (25:51):
It's going to all merge.
... the edges, and we're all coming together as one big happy family.
Elan Sudberg (25:57):
Yeah, well you saw the hemp industry came up, made a big splash. Now it kind of calmed down. Now seeing the ingredients start to combine as we all predicted, you'll start to see your adaptogens and your hemp products put together. And I have a feeling that you'll start to see
that with the psychedelic industry once they find a foothold, and you'll start to see all the other 2000 medicinal herbs we've been playing with for years get married to some other new exciting ones in the near future. So, it's going to be exciting.
Great. Can't wait for 2022, then. And thank you, Elan, for your time and have a wonderful holiday.
Elan Sudberg (26:28):
Likewise, thank you.