Ashwagandha testing tricks, explained by Blake Ebersole: the full interview

I was checking out your YouTube. It looks pretty cool. You're tackling some good subjects. I'm a chemist by training, and so I've been doing testing of materials for like twenty years. It's great that you post the COAs and do all that stuff.

I've not been in the industry as long, probably year five or six now, but in the time I have been in, I've just been shocked at the results of the testing. I've only really been posting the YouTube stuff these last six, twelve months, but I think there's a lot of stuff that needs to come out, man. People are buying this stuff and just have no idea what's really in there. Why don't we start with a bit about yourself and how you became so interested in botanical quality?

Sure. I've always been interested in natural medicines. My dad's side of my family always used home remedies, because they're Pennsylvania Dutch Mennonite, so you'd smell apple cider vinegar every time you walked in my grandparents' house, and Epsom salts. But I got exposed to supplements for the first time when I was in seventh grade. I was walking to wrestling practice and I saw the GNC, and they promised that I'd get ripped, and I was like, yeah, I probably need that, being a wrestler. So I bought Ripped Fuel from Twinlab, with the high ephedra, and that was my first experience with supplements on my own, other than Flintstones vitamins. At the time I thought, holy shit, supplements can really knock you off your feet.

Later on I worked in food, and was always very interested in food nutrition, so it was kind of a natural fit. I started in the industry on the supply-chain side, understanding how the ingredients are made, how the plants are grown and sourced, and the extraction. I was responsible for quality, so I saw what was being produced and sold on the market. And then the past ten years I've been working with brands and manufacturers to make sure that they are buying the right types and the right level of quality of ingredients, and obviously helping them as well with product development and formulation.

It's kind of a hidden part of the industry. Nobody really understands where saffron is grown, or how it's extracted, or where it's made, or how it's tested to make sure it's a hundred percent saffron versus not. Adulteration has been around for as long as humans have. The spice trade has always had dilution, basically diluting the material because you're trying to increase your margins by a little bit and nobody will notice. You're not killing anybody here; just fudge the calculation, or add a little bit less, saves us a little money, nobody will ever know. That's the culture that's always been around, because policing it is expensive and time-consuming. The FDA has what, fifty million dollars; they don't have money to spend on testing.

So it's basically a self-regulatory environment now, where people like you and people like me all have to try to set standards for what testing should be, and the transparency, and sharing the COAs and things like that. It's an exciting time to finally have options for transparency and communication that we didn't have before. We're in a really good time now to share what we know, because we have this experience and we have all these test reports.

Especially over the past ten years with Amazon, you've had so many low-cost providers, and they're putting in whatever amounts because they know the risk is low. In the US, the FDA doesn't care about whether you're hitting label claims. They just care about whether your product is safe. They're underfunded and they can only focus on safety issues. So we have so many people that don't meet the label claim on their stuff, and it's an Amazon problem, because anybody can be a seller, right?

Yeah. And it's a race to the bottom, it feels like. Amazon will want to push the cheapest product, because that's probably what will get the most people to buy it. So everyone in the supply chain is incentivised to essentially cut costs wherever they can. I think that's the big part of the problem.

That's right.

So ashwagandha, they're considering banning it in some countries here in Europe. What do you think about that, and do you think it's safe?

I've been following this for some time, and I've been working with ashwagandha for almost twenty years now. The interesting thing is, whenever something gets popular and very big as a market, and ashwagandha is estimated to be a 1.5 billion dollar market now, then you have the problems of a market growing. You have opportunists coming in and diluting their stuff, and you have other people who are fudging the method and trying to show that they have higher potency or higher strength of their product than others. You have all the typical games that can be played, and are played, with other high-value botanicals. You have lots of people trying to come in and make some money off of it.

So a group of us who have been on the ashwagandha production side for many years got together and noticed this a couple of years ago, and then more recently worked with scientists who were reviewing all of the information on ashwagandha, and we're waiting to see what is going to be the final result of the hundred and thirty clinicals and the thirty-plus safety studies on ashwagandha root and leaf. The basis is that it is safe.

Whenever something is consumed billions of doses a year, every year, you're going to have a small percentage of people who happen to be sick at the same time, or happen to seek medical care. It's similar to a multivitamin. There are lots of adverse reports of multivitamins, especially in the US from the serious adverse event reporting system. That's not because the multivitamin is causing the problem; it's that it just so happens that people who are seeking medical attention happen to be taking it, because it's so popular. That's an analogy of what we're seeing with ashwagandha. We saw it with other herbs. The good thing is there's a system for catching these reports, but it's also important to keep it in perspective, especially when we have close to thirty safety and toxicology trials on different forms of ashwagandha root and leaf, and it shows excellent safety. We have all the traditional use as well. You look at the science and you say: there is no safety issue here.

And in fact, when we talk about plant part, there's this big controversy around plant part and whether the leaf is toxic. There's the root-only people that want people to believe that the leaf is toxic, when it's really not. There's no signal for that either. But what it's all masking is that underneath there's this quality issue of all these opportunists coming in and trying to fudge the method, and trying to misrepresent their product, or dilute it and pad their margins. We have people representing different processes that are not well disclosed on their packaging or on the label. Sometimes they're not labelling plant part at all and just calling it ashwagandha extract. Nobody's ever the wiser, because we just don't state the plant part. You see all these little different ways that people can game the system. It's almost a fascinating look into how a complex ingredient can be gamed, or turned into a short-term profit-margin-padding type of thing.

I've seen this whole root and leaf thing, and it seems to be just a marketing differentiating thing: the leaf is bad, we're pure root, you don't want the leaf. What are they basing that off? Is there any evidence that the leaf is worse, or in any way dangerous?

Well, no, and that's the interesting thing too. The people who are doing it legitimately, they're developing it over several years, they're putting it through clinical studies, they're putting it through safety studies. The leaf people have more research on their product than many other herbs or ingredients we're even talking about. And then they've been marketing these products for ten or more years, so they have all the customer feedback from it being sold around the world, and there are no serious adverse events reflected in those reports either. As I look at it now, there's no reason to think that there's any safety issue.

Now, obviously, ashwagandha is traditionally used on an irregular basis. It's not considered a food, right? That's where some of the controversy is now as well. Even though ashwagandha safety and clinical studies are shorter-term and geared more towards the supplement type of use, there are some people who are trying to pigeonhole it as a food. And you question: well, foods must be consumed by children and pregnant and nursing and all those things. Unless we have all this data on those populations, then we'll keep it as a supplement, because then you can have those types of warnings or restrictions on the label.

At the same time, some of the people gaming the system on the potency are also trying to game the system by marketing it as generally recognised as safe, GRAS. In the meantime, everybody else is playing it safe and conservative and calling it a supplement. Whether this ever sees pushback, because now ashwagandha is found in foods. There's a lot of business, competitive activity going on to position certain other products as unsafe, to protect a competitive position or business position.

Other ways you could game the system is testing. What is the United States Pharmacopeia, for the people listening?

Testing across all supplements is often a black box, and that system is easy to game too, because you have lab shopping, where companies will send the same sample out to different labs and then pick the lab that gives them the result that they want. And then the other part is, USP has a potency method for ashwagandha and also an identity method. Ideally we would all follow this method and then we'd be talking apples to apples. But some people have their proprietary method for strength. The idea is, well, that's okay under the law, but you have to disclose the method and it has to be replicable. You have to be able to get the results in another lab. Sometimes they're saying, well, you can't have our method and you can't replicate it. That becomes a problem. That's illegal against the GMPs.

And that's the type of thing that we see often too: a deliberate effort to falsely inflate your strength claims so that you can appear to be stronger, and nobody can reach your level with withanolides, for example. But you're fudging your method.

And you won't disclose how they're doing it.

None of the methods can be disclosed, so nobody even knows how these numbers are reached. It becomes a pissing contest: I want to hit five percent withanolides. Well, you can't do it, because to do that it would cost two hundred dollars a kilo versus they're selling it for whatever, sixty or seventy. So it's like, well, the mass balance doesn't add up. But until somebody does some kind of legal action, the FDA is not going to step in, because they don't consider it a safety issue.

That is super interesting. So it's essentially a company saying: we're going to mark our own homework, no one else can mark our homework, and we're not going to share with you the method by which we mark our own homework. It's a secret. It's just ridiculous.

That's right. Sometimes people come up with their special method to measure the withanolides. Well, if we're going to put this number on the label, it has to be replicated and repeated so it can be verified. But a lot of companies are just throwing the number on the label because that's what the supplier said, and they're not verifying it through a method of their own. And certain labs are part of the deal too, because they're the ones keeping it all private and doing their black-box thing. Well, who's enforcing on the labs, right?

And often with these labs, they won't share the peaks, so they don't quantify in the reports what withanolides they're testing. And you put it next to a United States Pharmacopeia test and the withanolide level is completely night and day.

That's right. And it's important to know that two different methods can measure the same group of compounds, but just in different ways. It's very common to see raw-material specs, especially botanical specs, where it's potency by two or three different methods, and it's expected to be different results. The USP method only includes a small number of compounds, whereas others have done the NMR and everything to characterise the full fingerprint. These companies spend a lot of money to invest in developing the method so they can prove it.

And then generating reference standards, that's the other bottleneck. If a pure chemical reference of that same compound that you're measuring isn't available, you can't buy it, or it's too expensive, then nobody can run the method, even though it might count more. That's why USP's role is to make a generally acceptable method. There are more than a hundred withanolides and withanosides that are in ashwagandha. So they're trying to push the envelope to see, okay, what are these compounds? And then, does the extract reflect the root powder or the root material? That's the next thing. So then you're counting peaks. Somebody only has two peaks, versus the fingerprint is twenty peaks. Well, what happened there? Now we've got to look at the fingerprints of withanolides for all these different materials and try to understand, number one, is it leaf versus root, and number two, what the potency is. Trying to figure it all out is like a puzzle.

The pharmacopeia method doesn't record the full hundred withanolites, right? I think you said it's seven. But I kind of feel like it's on the supplier. If you are developing an ashwagandha product that has a different withanolide profile to the USP method, then surely you would want to share the testing method that you've got, to prove to the world that you're meeting your label claims.

You would, but it would unravel all of the labelling that you have under the previous number. So that's the question: how do you change a number on a material that you claim has been the same the whole time? Because you have to link this material you're selling to what was used in the clinicals. If you change the process from what was used in the clinicals, well, the clinicals don't apply to your product anymore. But sometimes companies will change their process on the material they sell versus the material that was used in the study, because of process improvement, or they're trying to lower cost, or whatever it is.

Shave some process off and save a bit of money.

The idea of standardised herbs was to protect against all this gaming of the system that can be done by saying, whoa, this is a concentrated extract, and trying to get a lot of money out of it, versus diluting in the straight powder, or extracted, exhausted material. People blend that in. That's called the marc. That's how you can also dilute it without adding anything external. You grind up the exhausted coffee grounds, basically, and then you put them back into the extract. Like, yeah, here it is. And everybody wonders why your price is so cheap, because, well, shit, you're basically putting waste back into the product.

This is not just ashwagandha. It's many other extracts; this is how it's done in extracts, to game the system and also come in at lower cost. A lot of this stuff is very hidden, but we're trying to bring it out more to the light. There are many people that know about these practices.

I love the idea of the fingerprint. If we're going to research a plant, say ashwagandha, then it should be published in the studies: the fingerprint, the withanolide profile. So then we can say, right, this ashwagandha was studied for stress, for anxiety, and it had these results. Consumers, in theory, if they could find a product with that withanolide profile, would have so much more confidence that what they're buying is going to have those results. And you might then find that a different withanolide profile actually has different benefits in the body.

That's right. Whatever clinical you're publishing, if it's not linked to an actual composition of material, then you're limited on information on whether it's being reproduced. Obviously suppliers don't want to put their whole process and fingerprint in there, because they don't want people to copy as well. But at the same time, if you hide or don't disclose composition information in your clinical, you're leaving yourself open to a lot of problems.

It's very interesting to see, okay, maybe it's the same process, but you improve the method over time for testing it, to include more withanolides. That's the thing: when you say total withanolides, well, what are they? What are the individual compounds? Then we can talk apples to apples. But if one person's total withanolides is seven compounds and the other's is twenty, that's not apples to apples.

It could have completely different effects in the body.

You do question. The root is the traditional part; it's got, whatever, thirty peaks or twenty-five peaks in it. Then you see an extract with only two or three peaks. How is that extract representative of the raw material? So then you're like, okay, well, what is full spectrum? Is full spectrum two or three peaks, or is it twenty-five peaks? How can you trust people saying full spectrum when they only have two or three peaks?

People don't show their chromatogram or their method often. Sometimes you can find it in the studies, but oftentimes it's not published. Ordinarily we would have a monograph, some official monograph, USP for example, and then you reference that and everything's easy peasy. But when we don't make these connections and we don't have the good references people are using, then it's like the Wild West, almost.

It's like they're trying to create intellectual property out of chemistry. They don't want to reveal it so that their product can't be recreated.

That's right. And it's not all their fault, because natural products are hard to patent. As a brand owner, you're investing all this into developing this ingredient; you don't just want everybody else to start copying it, because that happens all the time. That's why people don't want to invest, because somebody will just knock it off, or unfairly compete. You could create something different, but then you're talking apples to oranges on your stats, and then it's like, how do we compete with somebody who's lying, right?

It says on your website you want to see analytical harmonisation. What do you mean by that?

Analytical harmonisation could mean different things, but to me it means that everybody's using common methods, or at least one common method. So on your specification, include the USP method. You have that as the reference number, and then on a second line item you can have your own proprietary method. That's how we at least build on harmonising apples to apples, even though there are some oranges thrown in there. We have enough apples to compare because we have a common method, the USP method. That's the best that we have at this time. Maybe the USP method will be updated in the future to encompass more. But this is traditionally how it's been done with these extracts: you list as many potency methods as you think are reliable and then let everybody else figure it out. We did it with ginkgo; we have the two methods for ginkgo. It's not like nobody's ever heard of what the solution is before.

But those methods have to be transparent. We have to be able to see what they're recording and what peaks they're measuring.

That's right.

Even USP is limited in terms of which compounds it's looking at. So we do need to dig deeper and say, okay, what are these specific marker compounds? And then you say, well, is it just these marker compounds that are the active ones? That's a totally different question. Just because these are the predominant compounds, and we know from in vitro mechanism work that they have certain activities, if you concentrate just the withanolides to a certain extent and exclude other compounds, does that change the effect of the product? That's getting into a totally different discussion at that point. But it's an interesting one.

With a hundred and thirty clinical studies on a wide range of preparations, root only, root and leaf, water extract, not water extract, and all of them have positive results, you say, okay, there is something there, obviously. And when you look at the safety, the safety's there too. So how do you argue with overall plant safety, considering the body of work?

And it's consumed by millions of people. You would know if it was really causing problems.

Billions of doses per year around the world. Yeah.

What regulatory changes would you like to see with ashwagandha?

I don't think there are any changes needed. It's already legal in Canada, South Korea, Italy, all these countries. I think enforcement. If the FDA doesn't have the money to enforce unfair competition or false labels, then that's got to be an industry or a competitor thing. It fits in well with all the different regulatory programmes it's sold in around the world, just like many other herbs. It's got the safety, it's got the efficacy. So I think we just have to figure out the plant part, resolve the misinformation on that side, and then go back to the basics: what compounds are we measuring, what is the process, what is the composition of the extract, and then what safety and clinical ties to that extract.

Because it is possible that some unscrupulous suppliers could be using crazy solvents and concentrating withanolides from leaf and then calling it root. We want to make sure we address those people as well, and that standard. But certainly don't paint it to be a plant-part issue when it's actually a quality issue, right?

Super interesting that you could have essentially the same thing, same ashwagandha, but they could in theory have very different chemical makeups and respond very differently.

That's right. We have limited information. For example, a common standardisation for ashwagandha root extract was always 1.5% by HPLC. But it was never graded to USP or anything like that. So many different extracts of root and leaf and different solvents were all sold under that same 1.5 spec. That was twenty years ago, and so now you have 2.5%, you have 5%, and then you have different variations of that. There could be lots of different things going on there to get what appears on the front to be the same product.

Right. So they're essentially manipulating the chemistry to get the result they want, so that they can put a number on a label. It looks stronger.

That's right. Because a number looks higher: five is higher than 2.5 or 1.5 for a consumer. So the consumer buys it because it has a higher number. And the supplier doesn't care. They're like, okay, well, if somebody will buy the material, that's not our responsibility; that's whoever the brand owner is. That's the other untold thing about the supply industry. We're partially responsible if there's a recall or something like that, but you're responsible for what goes on the label as well, and it's usually the brand owner that has to deal with all of it. And if you're buying from India or China or wherever, good luck recouping any loss or litigation at that point.

I'm seeing some brands remove 5% claims from their labels as well. They just don't want to deal with having to meet the standard.

That's right. When you look on the dietary supplement label database, you can see some brands have removed it, because it appears maybe they weren't able to replicate those results, and then other brands maybe are still just rolling with it. Many people know about this common issue, because the ashwagandha industry is 1.5 billion dollars; it's touched a lot of people in our industry. Especially people who have worked on the back end, on the QA and production side, they've had to deal with this dilemma of: hey, it says five percent, but that's not what our test is telling us the results are. So okay, we can call it a deviation. We can only do that for so long until we have to deal with this and say, hey, we're either going to take it off the label or we're going to ignore it, right?

And just carry on as normal.

Right. It's growing pains of a product that's fast-growing. We saw it with other things, like green tea extract and turmeric extract, to an extent. The good thing is, for the most part, whatever problems we have in quality haven't washed out to more case studies or more serious adverse event reports than we would expect based on the amount that's consumed. But a lot of consumers are getting cheated on whatever they think they're getting. They're not getting whatever milligrams of withanolides is on the label; they're getting whatever is in the product. And placebo effect, maybe it helps some people as well.

Do you think the huge supply that must be required to do 1.5 billion dollars' worth of ashwagandha a year has something to do with it? They're seeing incredible demand for their product, and they've got to find a way to meet that demand, and perhaps it's changes in the process and in the way they grow the plant to just get the numbers out.

That's right. It's grown so fast over the past ten years. There have been so many small farmers getting into it, small processors, medium-sized processors, large processors in India. Everybody who does extracts does some kind of ashwagandha. But the issue is, the leaves are slightly richer in withanolide content, but they're also cheaper than root. That's why it's easy for people to use the whole plant. In India they call it panchang, which is whole plant: stems, everything. Why would you waste stem and leaf? Were you just going to throw it away? Traditionally many extracts are made this way. But then, when we started to do better identity testing, the labs could point out whether there was leaf in it. So that self-corrected for most of the bigger suppliers. But the smaller suppliers, they're not sending it to the lab. They're just selling it as is, and not going through the typical process that some of the bigger and more responsible companies are doing. It costs two hundred dollars to send a sample to the lab to get it ID tested, or two fifty or whatever. Why would you do that, when we're buying it from somebody where everything looks good? It's like an onion. You peel back one layer and then you find the next, and you're like, wow, this is fascinating how all this works.

Every level of the supply chain, there's more room for trickery.

The people in my group, the Ashwagandha Standards Alliance, are companies who have been processing ashwagandha for twenty or more years and selling it globally. They have this experience, and then they see what's going on with these opportunists, and it's unfairly competing, and it's setting a bad name for ashwagandha. If India restricts leaves, well, that takes away thirty percent of the farmers' income, or whatever percent that was, and then they're hurting everybody in the process, where the leaf is already an established part of ashwagandha product.

So it just puts even more pressure on the supply and then incentivises more trickery.

That's right. And even a brand name isn't immune to the trickery as well. It's not just the small producers. Our idea is: we set standards, we correct misinformation, we make sure that everything we're saying is scientifically sound, so people can't unfairly compete, or misdirect, or falsely mislead consumers about the label. Because if there's suddenly a scandal in ashwagandha and it starts to leak out to consumers too much, then people are not going to remember which plant part or which product is safe or not safe. They're going to say, hey, it's not worth the risk. But what the science is saying is that there's minimal to no risk, because it's such a safe and well-established herb. It's very helpful. So overall there is no problem, when other people are making it out to be one.

My last question. How can consumers spot a good ashwagandha product?

I wish I had a short and quick answer for you, but that's the issue that we're dealing with right now. In my head is a list of tells, and red flags versus green flags, and I think that would be a useful type of information. Obviously, certain branded ingredients for ashwagandha: Sensoril, Shoden and Shagandha are three brand names where I've personally reviewed their specs and their testing, and everything is going well. That doesn't exclude other suppliers who don't have branded ingredients as well. But in general I go after the suppliers and the brands who are more legacy, who have had enough experience to know whether or not to list that. And then anyone talking about five percent withanolides, I would ask to see the COAs, I would ask to see the methodology for reaching that five percent, because it's a fairly high amount to achieve, and it's difficult to replicate. So the five percent is definitely one that I'm always wanting to ask more questions about.

And if you have got a COA for a five percent, it can't just be unquantified peaks. What have you measured to reach that number?

Even as a consumer, obviously this should be done in supplier qualification, but you ask for the HPLC chromatogram with the peaks on it. They should know what you're talking about, and they should be able to show that to you. In a truly legit world, where we're fully transparent about what's in our supplements, a chromatogram with a standard method would be freely available on people's websites. But no, that's where the sausage is made, so people don't want to disclose that stuff. Some companies will disclose that. There are suppliers who have gone through the validation and say, hey, this is our results, send it to any lab that can do the method and they'll get the same results, and then everybody's happy.

We need more companies like that on planet Earth, don't we?

We're working towards it. I think you're working towards it, and that's something I've tried to tell people to do for a long time. In the US, the cannabis companies have had to post their COAs by matter of state law. Supplements need to catch up with the weed folks here in the US.

I think that should be the law. You should have to post a COA from a third-party lab for every batch you make, and consumers can then ask for that COA and see the dosage, see the peaks that are quantified, and that would just make everything so much better.

It would. That's my dream world, and it's moving that way. There are more companies doing it. That's the future. It's not rocket science. You send it to the lab, you get the test report. You should be like, okay, we put all the quality in, we know what ingredients we picked; the test report shouldn't be some surprise or guess. And it isn't, for those of us that know what we're doing. But some people go to extreme measures because they didn't put the quality in in the first place, so then they're caught trying to figure out the test method later.

They want to figure out the test method later, but then they're also in a spot, because they've sent the product to a lab and they've basically just proved an entire batch is mislabelled. So they've got an expensive problem to solve.

That's right. And it happens more often than you think, because that part comes last, and then the company's like, well, we can't just trash this. We can't reprocess it. What the fuck do we do with it? Well, we roll with it. It happens all the time. As a quality person I've advised against that, but oftentimes I don't get my way, right?