Episode Summary
Today, Élan Sudberg, CEO of Alkemist Labs, joins CHPA's Duffy MacKay for an in depth discussion of herbs and botanical testing. Herbs are an important and growing category for dietary supplements, foods, and even cosmetics. When herbs are further processed into botanical dietary supplements, they can be complex products that require extra care in sourcing, manufacturing, and testing. Learn more on today's episode of CHPA Chat.
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Anita Brikman: Just ahead on today's CHPA Chat, lessons from the lab, a deep dive into herbal and botanical testing, from echinacea to the shroom boom. Here we go.
Speaker 2: Welcome to CHPA Chat, conversations in the consumer healthcare industry.
Anita Brikman: Hello everybody. Today we're taking a little bit of a walk on the wild side. Actually, we're talking about herbs and botanicals that are an important and growing category for dietary supplements, foods, and even cosmetics. Herbs are grown in the wild and harvested globally, and they have their own quality challenges. When herbs are further processed into botanical dietary supplements, they can be complex products that require extra care in sourcing, manufacturing and testing. To lead this discussion, I'm going to turn over the CHPA chat hosting chair to our senior vice president of dietary supplements at CHPA, Duffy MacKay. Hey Duffy.
Duffy MacKay: Hi Anita. Thank you so much for having this important topic on today's podcast.
And I have the pleasure to have as a guest today, Elan Sudberg. And Elan is the CEO of Alkemist Labs, and he owns a passionately committed contract testing laboratory that specializes in plant authentication and botanical ingredient identification. And I've known Elan for maybe over a decade, he's not only a CEO of a lab, but he is a real thought leader in the space and he takes a place in a lot of the leadership and FDA engagement. So it's a real pleasure to speak with Elan today about some of the unique things he's learned and lessons learned from the lab. He's got decades of experience. The lab, I believe it was handed off from your father, is that correct, Elan?Elan Sudberg: Correct, correct. We started it together in 1997, but obviously I was 17, so yeah, handed off by him for sure.
Duffy MacKay: But 1997, just a few years after DSHEA was passed. First of all, tell me a little bit about Alkemist Labs and what makes you all unique.
Elan Sudberg: So we are a father and son owned business, which I think is rare. I don't know if there's any others. We consider ourselves the biggest little lab in the industry because we're 43 people strong, which is tiny compared to the enormous goliaths that dominate the field. But I think what makes us most unique is the fact that we focus only on plants and fungus and we have done so since the very beginning, and plan to continue with that focus.
Duffy MacKay: That's excellent. And I know both the category of plants, what we sometimes refer to botanical medicine, always been a strong growing category, but also now fungus. Fungus and mushrooms seem to be one of the new hot ingredients. And I know there's lots of questions around that, so it's good to see that you've expanded there.
Anita Brikman: I have a question about that because I've seen mushrooms in all these super foods on Amazon and everywhere, people swearing by them for alertness, helping your skin, just these wonder ingredients. Is that true, Elan?
Elan Sudberg: It's the shroom boom. It's funny that to see things that have been around for thousands of years become cool again because mushrooms have been around for millions of years, probably or longer, who knows? And being used in our society for a long time, it's just been re-popularized again. And to answer your question, there's an enormous amount of benefits that lie in the fruiting bodies, in the mycelium masses of these organisms
Duffy MacKay: And I'll just add to that for a long time, people that are in, that utilize dietary supplements, plants and fungus, mushrooms have been well known for the strong activity in immune and really helping the immune system, your shiitakes and maitakes. But lately we're really looking at mushrooms for other things like keeping people, as you said, energizing, nutritive and other things. And so we are starting to see more and more science. But this is where Elan becomes really relevant.
When you have a category that was relatively unpopular and all of a sudden it becomes popular and you're reading about it online and you're seeing thought leaders and folks start to talk about it, what happens is demand will go up, and often the supply chain takes a while to catch up. So this creates an opportunity for adulteration or people to use a different inexpensive form of a mushroom and try to call it one of the more important ones. And so this brings us to plant identification and where Elan really plays a role. So talk a bit about what you do in identity testing that might be different than say your average lab that works with vitamin C and magnesium and zinc.
Elan Sudberg: As I mentioned before, we started as just a plant identity lab and for a number of reasons. One, because we were actually serving my father's tincture line. As a chiropractor, acupuncturist and herbalist he had a line of tinctures, herbal tinctures, alcohol, water-based. And we started doing our own quality control for those incoming raw materials, identifying, just making sure we had the right ingredients. Started failing materials, and the vendors asked us to test new batches and we ended up doing more lab testing than production and shifted over to lab testing. Identity testing is a nuanced thing. We all can identify a strawberry at the market, but if you powder that strawberry, how do you know it's strawberry versus powdered cherry and powdered... And then if you then extract it, it becomes even more difficult as the data gets diluted. So we just have an affinity for plants. I've always loved them as has my father. And we stayed there.
Also, with the HPTLC identity testing, it was a function of the money we had. My father cashed in a mutual fund. I took bar mitzvah money, literally, and we put that towards some lab equipment. And what we could afford was the identity testing equipment. And so at that time, the industry was very excited about CSI-like equipment and expensive, very sensitive equipment. We stayed low-tech, something that had been around for a hundred years and focused there. And then when the GMPs, the good manufacturing practices came out 10 years later after we started, identity testing was paramount. And we happened to be in the right place at the right time, 10 years early, but managed to stay there for 10 years successfully and became very popular very fast.
Duffy MacKay: That's worth a moment. So identity testing, Elan, you mentioned you can recognize the strawberry with your eyes. And so when you're a food manufacturer, there's no requirement that you do identity testing. The strawberry shows up on the pallets, you say "Strawberries are here" and then you go ahead and make your strawberry product. But with a dietary supplement, if you get a strawberry extract, you have a hundred percent responsibility to identify that material. It has to stay in quarantine until you've done a valid test. Give me a couple examples of where people can get fooled by doing the wrong identity testing.
Elan Sudberg: So when the FDA came out with their GMPs, the good manufacturing practices in 2007, they didn't specify what methods to use. They said use scientifically-valid, not validated, but scientifically-valid methods. And to me that was underwhelming. They could have done more and better. And so basically they said, "Use science, best of luck. We'll see you in court." And so there are really great people in this industry and really great companies doing really great things. And of course there always will be cheaters in every single industry, whether it's lawn furniture to milk or to dietary supplements. And so it is possible to use inferior or substandard testing technologies that don't require chemists or people with any sort of degrees of any sort. They're lab in a box and you plunge a probe into a sample and it gives you some data and it really does a poor job at catching adulterants.
With the strawberry example, one could add starch or sawdust or all various inert fillers. That's the least bad. It's just not going to be as good. No one's going to get sick. Strawberries don't have poisonous cousins, as do some of the other botanicals in our industry. It's rare there'll be a health issue with adulterated strawberry, just be poor quality and you'd be losing money. But there are some botanicals in this industry that do have closely related species that are in fact poisonous. I do worry about the inferior technologies not catching those.
It's still very, very important to check the identity of your starting ingredients and you're in the middle because a lot of companies have ingredients sent to one company to make it to do one thing and then they encapsulate and they... Lots of chain of custody hence. So testing it throughout the process is really critical to make sure you end up with a product that, one, works, and two, is safe.
Duffy MacKay: And also, so we talked a little bit about the importance of identity testing, but you mentioned one of the risks is that the product wouldn't work and therefore that brings me the idea of potency or activity level. Where some of the plants when we put the label together, we have the botanical, we put a certain amount of metric weight, a hundred milligrams of the herb in there, but we're also looking for an active constituent at a certain levels. There's expectations, whether it be hypericin levels or one of these other active constituents. For years of identity testing, you've expanded into potency testing. Tell us a little bit about that transition.
Elan Sudberg: Yeah, we've been very comfortable with just doing, is it or is it not echinacea angustifolia root? And that's what we were experts at for a long time. But due to really customer demand, which has really driven almost all of our expansion, there's not a lot of choices in labs. And as I mentioned, we're the biggest little one.
And then the most recent expansion is into contaminants like pesticides, heavy metals, which also is required by law. So now again, by popular demands and begging requests by our clients, we've expanded into those testing. So it's identity, purity and potency now is what we offer for all the plants and fungi.
Duffy MacKay: In looking at all those different lab samples, anything interesting you're finding? Any patterns? Anything?
Elan Sudberg: It's funny when there used to be cold and flu season and then weight-loss season. In summer months, people would be preparing for a cold and flu season because the winter month's coming and so on and so forth. And so we would see spikes in contamination, adulteration of those particular ingredients. Sometimes by accident because people are picking materials in the fields and they're not always PhD botanists, something gets in there. But also dilutions, things that are diluted with starch.
Nowadays, obviously it's still cold and flu season, it's been that way for about three years. And so we had a run on the cold and flu or the immune-related botanicals and ingredients and mushrooms. And so as a result we saw a lot of elderberry adulteration. Again, no one put poison in it and sold it as elderberry, it was more like cut with half starch or cut with half malted out because the supply chain was so challenged that the unscrupulous decided to continue selling it.
And then again with the mushrooms being a very helpful in the immune sector, those have blown up or boomed as I said earlier.
Anita Brikman: But as a consumer, how do I tell? How do I know what I'm getting?
Elan Sudberg: How you tell is you look for brands that are transparent, we all have to be compliant with these rules. Testing is not a new thing and it shouldn't be a new offering by the products in this industry. They should all be doing it already. The push is really to show the brands to the consumers that actually go the mile, the extra step to do all the testing that's necessary by sharing the fact that there is regulations behind this industry and there are results showing that this is good quality material. It's a fairly new movement, it's moving slowly. But I do believe it's the next step because as we said, we aren't allowed to say our products do much. There's regulations about what we can claim in our industry. So you can sell product, you really can't say it does work, but what you can do is talk about the quality of your product at least and defy those rhetorics that were not regulated or sell garbage because that's not the truth.
Duffy MacKay: Anita, I think Elan is very, very close to the supply chain and looking at it, and I think your question is a little more for the unknown consumer that just wants to walk into the store and pick a product and doesn't want to belabor. And I think at the top level, you buy from retailers that and trust. All of these retailers are recognizing that they have to do their due diligence. And so the major retailers in the area of dietary supplements have their own programs where they're actually evaluating the facilities and the lab and the testing.
Always have a consumer looking for claims that are too good to be true. If the products making crazy promises, pause, talk to your healthcare provider. Supplements shouldn't be over promising that way. They shouldn't have outrageous names like Rhino Believer and things like that. When you're working with mainstream brands, they have a reputation that they're trying to protect. Some will go as far as using a third party seal to point to the fact that they're going to all these efforts. Some of the brands rely on their own brand reputation as their seal. They say, "Hey look, we are a household name. Any product we're putting out, whether it's herbal, toilet paper or contact lenses, we're putting our brand on it, so we're going to do our due diligence."
Elan Sudberg: I do like to tell people that quality costs money. Our customers spend a lot of money with our lab and other labs. So if you're at the store shelves and you see a product, the same product but different brands, and one's $7 and one's 40, there's generally some truth behind that. Now, there's also brands that are like 80, celebrity endorsed some crazy branding like that, which also... So you just got to watch out for the extremes on both ends.
Duffy MacKay: So one of the things I've noticed, I actually got a call from a colleague that was admiring another company and he said, "I'm really admiring how they're sharing their certificates of analysis." And so for Anita, for your sake, once you do the lab, what the lab will typically do is put their results, which will include what test was done, the test results, and includes the method they used. And this is nerdy getting into the weeds stuff, but as Elan mentioned, a lot of different methods are allowed. So for example, when you're testing an identity of botanical, and this is funny, there's something called organoleptic testing. What that is is you taste it and you smell it. That's the test. So if you just ordered a whole bunch of-
Anita Brikman: I could do that.
Duffy MacKay: If you just ordered a whole bunch of spearmint and it comes fresh, you are allowed to do identity testing where you taste it and you smell it and you have a trained person that says, "Yes, I've evaluated the material, it is spearmint." But as Elan said, when it comes powdered and dried, it becomes a lot harder. So your valid test must be a microscope from a trained professional or HPLC or one of these other methods. So the certificate of analysis is a big transparency piece because it tells you what test method they used. So you can call a bluff if they use a really inappropriate test method. So there's...
A colleague called me and he said, "Hey, have you seen this?" They put a QR code on their bottle, you scan the QR code, it goes right to the certificate of analysis and the consumer can look at. Now the argument is for a lot of consumers that's way over their head. They don't understand the information and blah, blah, blah. But for those who are really trying to go that next level transparency, this is a trend we're seeing and that certificate of analysis, it discloses a lot to the trained professional.Elan Sudberg: There's a brand in our industry, I won't name who, but they've been doing this for a long time. And they devote an entire side of a box or a bottle to this "Type in a lot number into the website and see all the data behind it." And as I understand it, they only have single-digit clicks for that offering, meaning there's only single-digit clicks of consumers who are buying the product, who actually look it up and actually see.
But the fact is, what it does is it gives access to data and the consumers, whether they don't understand an HPLC chromatogram, doesn't matter, the fact the brand, this brand has shown transparency in all the cards versus the other one who has not. Stories might be made up that, well, maybe they're not doing the testing and maybe this brand is, and therefore I'll buy the one that appears safer because here's the transparent testing, even if I don't understand it. It's that ability, that willingness to show it.
Elan Sudberg: What I would also do is also help celebrate the brands that are doing the hard work because there are brands that are not, and they’re competing against the brands that are. And basically it’s not an even playing field. If you’re spending millions on testing and your competitor’s not, you’re going to survive very long if you’re not going to get those sales. And unfortunately the price is a big factor for a lot of consumers. That’s how they make their choices, unfortunately. And I’d love to see that change where quality first is critical and they learn through a very small amount of PR, marketing, education from the brand side of why their product is better because they’re doing all this testing, all this great sourcing and here it all is because we have it, why not share it?
Duffy MacKay: Let me flip this around. Let's say I'm a company and traditionally doing multivitamins, maybe a little protein powder, and all of a sudden I'm like, "I really want to get into this herbs and fungi, and I want to screen some labs and ask them some questions." What kind of questions should I be asking potential labs that I want to work with?
Elan Sudberg: Such a really great question Vitamin C is a very simple molecule. It's all by itself. And so testing vitamin C or caffeine or even some proteins and macronutrients are, I don't want to say, simple, but not as complicated as botanicals because botanicals and mushrooms have many chemicals and we're selling those many chemicals. So my point is that not every lab can just quickly jump over to testing echinacea angustifolia root extracts with water 2% mixed with St. John’s Wort. I just said a PhD worth of work potentially for a new lab. So it is important to know that if you're going to go to a medical professional, you want to go to a specialist, you go to your generalist first, they refer you to a specialist and then you stay with specialists for whatever your ailment might be.
Duffy MacKay: What about accreditations? Is that layered on top of the kind of question.
Elan Sudberg: Yeah, thanks remind me that. Accreditations are really important. There's something called ISO, you've probably all heard of ISO 9000 for manufacturing facilities, but there's something called ISO 17025, which is for lab testing and it's basically you use an accrediting body to come through your entire quality system. They spend perhaps even a week or so looking at every single method. Generally, folks, labs will be ISO accredited for a particular method, so caffeine and green tea with method X, and that would be your accreditation, your scope. We actually have a rare flexible scope. So basically all plants and mushrooms under the sun or in the water by identity testing for those. Because there's so many that we test, we couldn't possibly do 2000 different accreditations.
So using a lab that has gone through the process of getting an ISO accreditation means that you've gone with a more professional, mature operation that has jumped through the hoops to be challenged on every single thing. There's more checks and balances in the process. I do like to add that before we were ISO 17025, we were still a good lab. So just because one's not, doesn't mean they're bad, but if they are, it means good. It means that they've gone through this rigorous challenge testing.
Duffy MacKay: I've had an opportunity to visit your lab, really nice facility. Do you get an opportunity to get inside of a lot of our company's labs and compare notes?
Elan Sudberg: Last three years, not so much. But yeah, it's one of my favorite things to do. Whenever I do travel, I try to meet up with a client, whether a manufacturer or another lab. Because lab subcontract to us. And I was just at one... I won't name names, but one of the biggest in our industry, in California, and it was a beautiful, amazing lab. I wish someday to have the equipment that they have. But I'm going to turn it around a little bit. I said, "Look, how much do you spend on testing each year?" And they said, "Millions," very proudly, "Millions." And I said, "How much do you spend on your employees that are in the lab and all the equipment?" "Millions and million." They're so proud. And I said, "What do you do to share that with your consumers?" It was crickets.
Duffy MacKay: [inaudible 00:29:38] to share the information.
Elan Sudberg: To share that, "Hey, we're this big company, we spend several tens of millions on making sure these are the best products," but they've shared not one bit of that. I think it's a value [inaudible 00:29:49].
Duffy MacKay: It's interesting. I have heard the opposite, and this is again not to be challenging, but to bring it full circle, I've heard people say "Quality is the floor, at least with our brand. The expectation is it's there. The expectation is that exactly what's on the labels in the bottle. There's nothing more, there's nothing less. And so therefore we don't think we need to market on that because that's just a given. What we're going to market on as our sourcing, our potency, the clinical trials that we've run."
I think it's a different perspective. You're recognizing that there's a voice out there that likes to say that this is an unregulated industry, those products aren't tested and verified, therefore, buyer beware. And what you're saying is from someone that's been doing this for 20 years, who understands GMPs and understands the obligation to do identity testing, to set specifications, to verify those specifications are met, to make sure the products as pure and free of contaminate, that is required. [inaudible 00:31:01] just black and white required. And so when you're trying to push back against that voice that says you're unregulated, you're like, "Wait a minute, why aren't we out there showing everybody all the stuff we do to test?"
Elan Sudberg: That company you spoke of is a dinosaur and has an extinction coming for them. And I'll say it to their face. I don't know who they are, but [inaudible 00:31:26] I'll call them. I think that we are in the age of information I say because I think we're still here. And people are curious, they're not really curious, but I think they're skeptical. And I think trust is no longer trust but verify. That was a great cute phrase, trust but verify. I say verify then trust. Because it's been a strange few years and before that it's been a strange few years and so on and so forth. I'll say it again that the last value proposition we have in this industry, the dietary supplement industry is quality.
You can do clinical studies and confirm that... And ingredients has some effects. It's very challenging and very expensive and even then we have to be very careful about what we say. But what you can do is brag about the millions of dollars that your company invested in equipment and staffing and testing to make sure you have the highest quality ingredient. I don't know how that wouldn't be a selling point to a consumer versus one who says nothing.
I look at it, I consider myself a marketing guy with a chemistry degree. That's how I identify. And I think that it's like a marketing campaign. You spend 20,000, 200,000, a million dollars in a marketing campaign to say, "Cool, we did it," and then you put it in a drawer of a mid-level employee never to be seen again. And talk about it, bring it to the front because you already spent the money. Didn't you? That's the funny part. You already spent the money on this testing. Now take it out of that closet or take it out of that drawer and share it because it is valuable information in a very skeptical consumer base who is told that we are not regulated. Let's show them that that's not true.
Anita Brikman: Elan, Duffy, I think you guys have enlightened and changed some minds and brought things out into the light out of that mid-level drawer. I think that is a great call to action for all of our listeners on CHPA Chat. Thank you so much for joining us.
Speaker 2: Thank you for joining us here at CHPA Chat. For more information and to hear our entire catalog of shows, please visit chpa.org.
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The views expressed in this podcast are solely those of the speaker and do not necessarily represent the opinions of the Consumer Healthcare Products Association.
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