Ashwagandha Under Fire: Quality, Science, and the Fight Against Misinformation

Ashwagandha has become a billion-dollar category, and with that growth has come scrutiny, regulatory noise, and a wave of misinformation that threatens to undermine an herb with thousands of years of traditional use and over 130 clinical studies behind it.

In this episode, ITC CEO Len Monheit sits down with Blake Ebersole, founder and president of NaturPro Scientific, to unpack what's really happening with ashwagandha. From the Indian Ministry of Commerce's export ban on leaf products to European regulatory flags and concerning case reports, Blake breaks down why most of these issues trace back to quality failures, and not the plant itself.

They dig into the tension between traditional Ayurvedic use and modern botanical science, why withaferin A being present in both leaf and root doesn't make either unsafe, and how the supply chain, from supplier to contract manufacturer to brand, too often fails consumers and the category. Blake also shares the work behind the Ashwagandha Standards Alliance, a coalition of responsible suppliers working to get ahead of the crisis with science-backed, transparent practices.

Connect with us on LinkedIn or visit us at itcstrategy.com

Transcript

SPEAKER_01 0:10

Good day. My name is Len Monheit. I'm the CEO of Industry Transparency Center, ITC. And with me today is Blake Ebersol. And Blake is the founder and president of Nature Pro Scientific. Blake, welcome and glad to have you here with me.

SPEAKER_00 0:24

Great to be here, Len, and great to see you again. Yeah, it's uh it's been a while, but uh yeah, I was been looking forward to this all week, actually.

SPEAKER_01 0:33

That's great to hear. And I know we usually see each other at the events, but we're between events, and uh no, it's good to be able to pick up conversation, especially one that is relevant for a hot issue that it represents, and that's the fear and the news and noise that's happening surrounding Ashwagandha these days, and it's really a global issue. Why don't you quickly give us a little bit of background and where the current status is, and then we'll set up for a little bit of a deeper dive.

SPEAKER_00 1:04

Sounds great. Well, you know, we've all heard of Ashwagandha by now, and and you know, what started it you know 20 years ago as you know, somewhat of a popular herb just blew up. And and you know, now it's more than a billion-dollar industry. And just like with any growing industry or growing product, there's growing pains, right? And and you have uh challenges. And and we're talking about uh both a plant that's been traditionally consumed for thousands of years, uh, but we're also about talking about something that has a lot of quality going into it and a lot of nuance around production and what is actually in this thing. And and then you have different companies making different extracts and different versions and doing different clinical trials. And so, you know, sometimes the messaging that that comes across to the consumer, to the industry gets oversimplified and we miss some of the nuance. And so um, you know, it leads to misinformation sometimes. And so what I'm trying to do is, you know, we formed a group uh with several responsible uh Ashwagandha suppliers called Ashwgandha Standards Alliance. And this started about three or four years ago. Uh Trish Flaster, uh my colleague on this project and myself uh started to hear from uh a lot of uh Ashwagonda brands and suppliers um about some of the challenges and things that they are hearing, you know, is uh, you know, do we have quality problems? And now we have um uh reports from Europe around uh potential bans of Ashwagonda leaf products. And you know, most recently we have um uh the Ministry of IOSH in India uh uh putting an export ban on on the leaf, but not the root, which is kind of unprecedented, you know, considering that there's dozens of safety studies and and and many clinical studies on on good, legitimate roof root and leaf products. And so here we are today, and and we're trying to you know really educate and and get down to the root of well, what are the ish issues? And at its base, it's it's really a quality lesson. Like what are what are the quality assurance practices that should go into an ashwagonda product? And uh how do we prove the safety and how do we support our claims that we use to sell a product? And so, you know, we see ashwagandha as kind of a microcosm of of uh of uh many of the issues that other ingredients face as well. And so uh you know, it's really exciting to kind of be at this time, but it's also a little bit scary. You know, how do we how do we cut through the misinformation? How do we uh make sure that uh products are safe and high quality? And how do we make sure the right information gets gets uh all the way down to the consumer?

SPEAKER_01 3:54

And I've been a st a student of some of the principles of Ayurveda for many, many years that presented at the World Ayurvedic Congress back a long time ago. And this is an interesting tension point globally, but especially out of India, because you have the Ayurvedic practice governed by the Ministry of Ayach. And that's traditional use, goes back thousands of years, and it's it's ingrained in ethnobotany and traditional medicines, and then you have this contrary approach, which is the modern botanical nutraceutical type of industry, which seeks to identify a marker compound and extract and standardize to a marker or a series of markers. So that's part of this issue. And you do you want to comment a little bit on that tension point?

SPEAKER_00 4:49

That's right. And so, you know, many people split the traditional use and separate it off from the modern and the scientific use when in fact they're actually combined together. They should be considered, you know, relatively one and the same and part of the total picture. And so, you know, we can't uh just say that um, you know, only traditional use has has stated this. Um we also have to consider what modern science has has uh developed as well. You know, one of the challenges we always have with the traditional use arguments is yeah, there's such a rich history there, um, but just because something hasn't been uh recorded or documented well doesn't mean that it didn't exist or it wasn't used. And so, you know, there's this kind of misconception that ashwagandha leaf was uh never consumed when that's not really the case. And so even in uh many of the older texts, you they're talking about the whole plant, uh they're talking about leaf uh use for for acute conditions. And actually, when you look at uh going back thousands of years, ashwagandha wasn't just grown and used in India, it was grown and used across the Mediterranean and in Africa, uh across Africa and and other parts of Asia as well. And so, you know, we're lacking a lot of these texts, you know, many of these cultures didn't uh write things down very well, but but you know, knowing what we know now, we have this traditional use, and now we have the modern and the modern view and the scientific data to support safety, to support efficacy. And so we can't just separate off uh uh tradition versus modern. It's it's both of these together to create the totality of the picture here.

SPEAKER_01 6:36

And the marker compounds traditionally for Ashwagandha are with analydes, uh with a Farin A, I think is the primary one that people talk about. And they're different in the leaf and the root as far as their concentrations. But if you think about it more holistically, the entourage environments are going to be dramatically different, so the physiological effects are going to be somewhat different, and then you have preparation on top of that. So you've got a lot of variables, and then you have modern analytical techniques with thresholds of detection that are examining zero, so you've got a lot of tools and a lot of opportunity for confusion.

SPEAKER_00 7:21

That's right. And and so you know, oftentimes it gets very confusing because there's so much to it. But what many people happen to miss is that uh looking at the molecular structure of Withoferrin A, it's actually the parent compound or skeleton to many of these other uh with analydes and and also uh uh uh with anicides as well. And so because this uh because withferin is in the leaf, it's in the root, it's in the stem, and it's this parent compound, it's it's basically intrinsic to uh the health properties of the plant. Now, you know, there is partial truth in saying that, yeah, it's in slightly higher amounts in the leaf, but that doesn't automatically mean that it's unsafe or that we should uh we should reject it or or stay away from it. And so I think, you know, just like with any myth or misinformation, there's it comes from a bit of truth, but then that gets manipulated uh sometimes for you know to for commercial interests or or to gain a competitive advantage. Um but it's important that we stick back to the science because otherwise we're just listening to you know whatever the market or whatever uh you know commercial interests want to say. And and here we are, we could be destroying an entire market for root and leaf because uh consumer doesn't necessarily remember which plant part is is supposed to be safe versus unsafe. So we're always looking at you know what what are the unintended consequences of following a more commercial narrative rather than uh following science?

SPEAKER_01 8:57

And that's a conundrum in our industry because it's the marketing ultimately that sells products, it's the quality in the science that creates the trusted environment. Sometimes they're disconnected, all too often they're disconnected, which is unfortunate. But that is part of the problem.

SPEAKER_00 9:13

That's right. And and so, yeah, it's you know, there has to be a counterbalance, which is what ITC does, does great for you know for so many things, is provide that kind of counterbalance to you know to the type of misinformation and and misconceptions that are out there, because uh ultimately we you know we have to find the truth somewhere and we have to follow the science. And when the science is there, for Ashwagonda, we have 133 uh uh clinicals that have been you know reviewed and and and uh put into meta-analysis. We have dozens of safety papers on the different plant parts. It's like it you know, this plant doesn't deserve the the negative attention or or the the kind of uh you know misinformation that that that is being given to it.

SPEAKER_01 9:59

Now, in the United States, and I mean our audience is going to be global, at least hopefully. Um but in the United States, you got mandatory adverse event reporting, and presumably signals would have been realized in the North American marketplace. I know that there's also similar mechanisms in Australia, and and I mean, and Australia did have a flagged issue uh several months ago. Um, but what's the adverse event situation in in the United States? I mean, is there what has been the history there?

SPEAKER_00 10:33

Well, you know, it's it's to be expected when something is consumed uh billions of times per year, there's going to be a certain segment of uh of reports of of negative things. And uh many times those reports um are only associated with, say, the supplement or Ashwalgandha in this instance. Um, but so many times it it could be coincidental based on the law of averages. Um, you know, people get sick sometimes, or they get food poisoning, or uh they have a bad reaction, or they have an undiagnosed health condition. Um in many cases, these uh the reports that we've seen from Europe and uh from other places, uh you know, you see pictures of of what's actually being uh what was associated with a case report, and it's it's basically a Ziploc bag, or it's uh it's it's not something that you would recognize as being being a commercial product. And so, you know, one of the challenges, limitations we have from these case reports is um they might report what was on the label, but they don't ever actually send it to a lab to determine, okay, was it contaminated with heavy metals, or was it, you know, was it accurately labeled? And so everybody goes off of what was on the label. And so um, you know, recently there have been a number of uh of uh systematic reviews that were published in and phytotherapy research where they reviewed the entire evidence uh and they didn't see any smoking gun. So whether that be plant part, um uh whether that be uh uh dosage or or certain things, um, they they couldn't attribute it to any one thing. Now, what they could attribute it to to the most part, you know, reading between the lines, is uh, you know, uh brands and and products that appeared to not to have a history of of mislabeling or uh don't appear to be uh have been made by GMPs, well that that that is somewhat of a smoking gun. And so really it's an argument for hey, um if everybody is is uh adhering in quality practices and GMPs using materials that have uh already been studied in safety studies, we know that they're uh uh accurately labeling products, they're disclosing uh ingredient suppliers are disclosing all the facts and the specifications uh transparently to the brand, and that's making it to the consumer. Well, those are the safe products, right? So it's it's more of a quality uh issue than a plant part issue, uh is is what the evidence is saying now.

SPEAKER_01 13:09

And that makes sense. And back to the uh back to the case studies and case reports, correlation is night causation, and the data is a little bit of a mismishmash of a bunch of, I mean, there's a lot of mess in there, and to try to attribute single soul cause among some of those case data reports is really, really problematic. So the the quality problem is now coming to a head in Ashwagandha, but the quality problem, as you and I well know, has been an issue for as long as we both have been in this industry. Right. Is it getting better?

SPEAKER_00 13:50

Absolutely. You know, um, you know, you can you can't discount the fact that you know GMPs were uh for supplements were were incorporated in 2010. Uh, you know, there were several years where where brands and suppliers had to ramp up and start to do testing. So yeah, compared to where we were, you know, 15, 20 years ago, we're we're we're we're so much better. But that doesn't mean we're anywhere near perfect. And so, you know, as a consultant, I I work for brands and manufacturers who are sourcing ingredients like Ashwagonda. And so I so I see in real time actually what they're missing from the picture. And sometimes it's not their fault because they don't know, they're they're not experts in Ashwagonda or or you know many of these ingredients. So they're relying on the word of their supplier. Well, if the supplier is trying to uh pad their margin or or uh take shortcuts on testing, well, they're never you know they're never the wiser because they don't know what what the what the specification for ashwagandha is supposed to be. And so you know it's even gotten to the point where uh a supplier might um uh put something on the specification, but nobody can replicate the method that they're using. And so so you know it looks good on paper, but then when you you know send it to uh an independent lab, you you can't you can't replicate the result. And so you know a lot of brands and manufacturers, they're still taking the word of the supplier instead of you know independently testing the entire spec themselves. And so, you know, that this is one example of of the types of gaps that we still see um you know when it comes to this. And it's you know, we say trust but verify, but you know, I've always I've always tried to turn that into you know verify, then trust, because you know, you don't earn the trust until you actually do the verification, you know, because it's it's real easy to uh to pull one over on people when when they don't really know what they're buying.

SPEAKER_01 15:48

And I'm gonna interject with a little bit of a pet behavior. You you said that suppliers may be a culprit here. I'm gonna also argue that the contract manufacturers often can be the culprit and be where the transparency is lacking, and whether they will inadvertently or purposefully switch out an inferior ingredient. And the brand is just buying sometimes ignorantly an ingredient and using the guidance of the contract manufacturer, their formulation team, um, their uh their technical team, and the right questions may not be asked at the right places in the supply chain.

SPEAKER_00 16:27

That's right. Yeah, it's some of it is willful ignorance and and others is is um, you know, we we don't want to know what we don't want to know. Um and so so yeah, oftentimes it oftentimes it's the brand's fault. They go to the to the contract manufacturer and say, hey, this has to be a certain price. And then the manufacturer's like, well, we don't get the business until we find the ingredient, find the ashwagandha that that that meets the cost requirements. And so they're that's the number one thing they're looking for, then is okay, passing through uh passing the test on the cheapest ashwagandha ingredient they can find. And and you know, they don't know anything about plant part. But yeah, we we see things like lab shopping, you know, like uh somebody will send a uh sample to Alchemist and they'll fail it. Well, they're not gonna give up there, they're gonna find another lab who's gonna pass it, and and they might keep doing that and until they find a lab that passes. And so so that is uh you know, I see that as fairly common too is hey, we're already invested in this formula, the cost structure, the everything. Well, if if something fails during during scale up, well, we're gonna push through it. We're not gonna just you know turn back now.

SPEAKER_01 17:41

Yep. So I mean, obviously, with with our company name ITC, the middle word transparency is key to our ethos and what we believe. And I think that these issues need to be wisely brought to the surface and argued with a basis in the science. And so advocating and what you're doing, Blake, is absolutely right on and consistent with our our ideals here at ITC. And then the other aspect is the category responsibility and category stewardship that you're using is very similar to what we've done in a couple categories where we've taken investment. And the mission is basically to make sure that the category grows responsibly. So it sounds like that's part of the premise behind the Ashwagon Equality Alliance, but you started this before there was really an issue. So kudos to you, but now it's found a need for it in being that transparent architect with some information.

SPEAKER_00 18:37

That's right. And you know, really, you know, founding on the um the type of approach or the type of idea that you guys uh you know really did first, it was hey, a group of us got together and started complaining about the problems that we saw. And then maybe, maybe we weren't really serious until until you know the problem really just was right in front of us. And so we do have this, you know, in this industry kind of a reactive versus a proactive approach. But yeah, you know, um uh now so many livelihoods are based on Ashwagonda, uh, from the farmers on through the processors to the brands and everything. Well, if if that demand dies away, well, you know, you know, what's the farmer gonna do now? I guess he can grow corn or something. Um, but but you know, it the you know, it takes it it took so much effort to build a market, and and we can't just let it get thrown away or or or you know destroyed by a misinformation. And so, you know, kind of you know uh you know, protecting not only the the integrity of the market, but the value of it and everybody who's involved in it, that's that's part of what we're trying to do here. And and really, you know, from my own personal point of view, well, if if we saw a safety issue or if I personally saw a safety issue and everything's being published, I wouldn't be as excited at you know protecting this because then I'd say, well, maybe there is some validity to it. But but you know, as it appears now, there you know, it's it's really one of those things that it's such a helpful herb. It has safety for you know the billions of doses that that people consume it for. Um and and you know, there's there's not much, not many things that that are uh helpful for the people that take it as as as ashwagand itself. And so, you know, we want to honor this traditional herb. We don't want to just throw away all the all all the achievements and advancements that that have gotten us this far, all the investments in research. Um, you know, 130 clinicals, it's like, well, you know, how many herbs have 130 clinicals by by this point? It's like, you know, so much knowledge we have, uh, let's use it now and let's preserve it.

SPEAKER_01 20:50

Oh, absolutely. And uh it's uh it's a good it's a good mission, and uh it's a good uh it's a good mission to be on. We also though live in a very litigious environment. And getting this the getting the facts straight to be able to provide at least a defense to the plaintiff's attorneys seems like a responsible thing to do. Um what's your message for the plaintiff's attorneys, other than this is safe, stay away?

SPEAKER_00 21:21

Well, um unlike many other things you could take to court, um, you know, you they were gonna have to fight against quite a lot of data that uh runs contrary to uh whatever they're trying to prove. And so um, you know, it's easy to pick on, say, lead levels or um, you know, what have you, uh food poisoning, uh undeclared allergens, things like that. But uh uh they're gonna have a hard time uh proving a case for safety um, you know, just based on the the evidence that we have so far. Now, obviously that changes when uh you can prove a uh a product um hasn't been labeled correctly or may have undeclared contaminants or adulterants. And so luckily we do have this type of testing where um, you know, testing capabilities where, hey, if it is a legitimate concern, then hey, you know, then then let the law work its course. But you know, let's not target the products that have no safety concern, that are rigorously tested and and high quality, because uh that that seems a little unfair to me.

SPEAKER_01 22:35

Absolutely. Okay, so we're we're drawing to a close here. Um when will you think that the alliance has been successful or is it already successful? And what's your parting message?

SPEAKER_00 22:48

Well, we're just getting started, and so we have uh a core group of founding members. Uh Sabenza, uh Cephum, and Arjuna Naturals are some of the key ones, but we have lots of interest from uh brands, uh manufacturers, uh media, and there's lots of interest to you know, try to do the right thing here. And so uh I would say we haven't even uh touched the surface yet of what the potential is. Um and so so yeah, I think we're just at the beginning here. Um, you know, again, we've been talking about it for a while, but now we're actually putting it in action. And so I think you know, my parting message would be um, you know, follow the science. Um and and once you have enough science, then stick up for it and take responsibility for it. Um, you know, keep your objectivity and you know, don't contribute to the misinformation or the myth until you actually know what the answers are.

SPEAKER_01 23:48

Wise words. Okay. Blake, thank you very much for being with me today.

SPEAKER_00 23:52

Thanks, Len. It's been a great time talking and uh yeah, look forward to the next one. More to come. Absolutely. Thanks.