How widespread are fake supplements?

I am dealing with a Consumerlabs issue right now, in fact. I brought some of their reports to Supply Side West in Vegas last week and sat down with the presidents of Ixoreal and Natreon, the companies that make KSM-66 and Sensoril. The issue is that Consumerlabs is using the USP monograph for ashwagandha testing. I don't blame them for that. That's what they have available. However, it is an older method developed before we knew as much as we do about ashwagandha. I'll explain a bit.

As often is the case with certain extracts from Traditional Chinese Medicine or Ayurvedia, there is a big gap in not only standardizations, but testing methods and standards. The USP monograph is good for some, but woefully inadequate for others. I'll start with ginger. The USP monograph looks for 4 gingerols. However, there are actually 6 ones we are interested in. So the numbers look different on USP results compared to our standardizations. That's relatively easy, though; as you are only adding 2 more standards which are available. So we did our own methods internally to look at those other 2 in addition to the standard 4. I say easy, but I just mean relatively. Going from 4 to 6 is easier than say 8 to 40, for instance. This is something we run into all the time with various extracts. When we say gingerols, bacopasides, withanolides, ginsenosides, etc. we are grouping things together. We have to define what we consider a part of those groups, then we need to actually have reference standards that allow us to quantify them. DO NOT ever trust a quantified HPLC result based off area percent methods. NEVER EVER. You need reference standards to get quantification numbers. Most people don't know this. If you look at an HPLC readout from say a single ingredient, and you see a single peak with a % calculation on it, that DOES NOT mean that's the purity. That's an area percent calculation based off what the UV detector in the HPLC sees. If you don't compare it to a reference standard, you have no idea what the purity is. The UV detector can only see things with a chromophore, and everything has a different response factor. So anyone making claims based off those peaks and area percents are misleading everyone. You need to run your methods on your sample, then run the same methods on a qualified reference standard, then calculate how pure your sample is IN RELATION to the standard. This is also how you sometimes see 102% on assays. That would mean your sample could be more pure than the standard. So let's say Sigma's standard for something is 98%, and you get 102% on your sample. That could mean your sample is 99% pure. Assays are in relation to standards. If you see HPLC/UPLC results that say A%, area%, or %(area), you know you are looking at results NOT compared to a standard. Don't consider those results anything more than just a machine readout. It does NOT mean purity. It is complicated, though. So there are exceptions. Fish oil, for example, can use area percent on a GC-FID because the response factors are known and you are burning the compound to completion. Fatty acid analysis on a GC is okay to do by area percent, but not things on an HPLC/UPLC. I can go into more detail on that later if you want, but 99% of the time area percent is garbage chemistry.

So what does all this mean for ashwagandha and Consumerlabs? Well ashwagandha is not one that has 4 or 6 actives in it. That would be easier, but unfortunately this one is a lot more difficult. There are over 40 withanolides in ashwagandha, with over 300 known withanolides in nature. When you have groupings of compounds in the 40 range, things get tough. So what does the USP monograph look at? Well most people would be surprised, but it only looks at 8. So USP is only looking at 8 of the over 40 withanolides that could be present in ashwagandha. In fact, it's even more crazy than that. The USP method ONLY MEASURES TWO OF THEM, then calculates the others based off known response factors. That's right, the USP method is only really quantifying TWO of the withanolides in ashwagandha, then giving numbers for the other 6 based off math. Why is that? Well the withanolide standards are EXPENSIVE! I spent $3,500 just on the 8 standards alone. However, I wanted to do proper chemistry and quantify them properly. This is also why I bought a $40,000 microgram scale. If I make a stock solution of all 10mg of each standard, that solution might only last a couple months. So I would have to buy a new set of $3,500 standards every few months! That's not economically feasible. So we use our microgram scale to make stock solutions of smaller amounts of the standards when we need them. This is also better for accuracy, as the standard will not degrade like it would in a large stock solution. So this is what we are using to measure the USP subset of withanolides in ashwgandha. Now back to Consumerlabs...

Consumerlabs tested a bunch of ashwgandha products on the market using the standard USP monograph and methods. This means that only two of the withanolides were quantified using a standard, and the total numbers in the results were given based off math and known response factors. It also only listed the 8 withanolides in the USP monograph. Well KSM-66 and Sensoril failed those tests. Why is that? If you didn't know anything about chemistry or ashwagandha monographs, those results might look very bad. The top selling ashwagandhas in the world barely have any withanolides!!! We've been getting a lot of emails about this, which is why I sat down with the presidents of Ixoreal and Natreon, along with Alkemist and a few other Indian manufacturers of ashwagandha, with hard data to get to the bottom of it. KSM-66 and Senoril are patented extracts of very specific cultivars of ashwgandha. Just like you have wildly different things in certain strains of marijuana, you can have the same in other plants. Those are called cultivars. Something being the same species of plant doesn't mean it is the exact same thing. Cultivars can vary drastically from one another. Then you have variables like growth media, growing conditions, harvest time, and extraction methods that lead to very very different end products. So KSM-66 and Sensoril are made from very specific cultivars, using very specific extraction methods, that are standardizing to different withanolides than the USP monograph is looking at. So we are measuring them in the lab in an improper way. Even our internal methods that are more rigorous than the USP methods won't see them, as they are outside of those 8 that we have standards for. So we are working with Ixoreal and Natreon to improve the methods and science behind them to get this data we really need. Natreon is more willing than Ixoreal at the moment. They are giving us reference standards and are helping/paying for us to do lab work on things. Ixoreal is currently wanting us to send off to a couple ISO certified labs they have non-disclosure agreements with. They have given the reference standards to those labs to run the tests. They won't currently give us the standards to use ourselves. I am not too happy about that, as I want to see this shit in MY LAB. So I am going to keep trying to get them to allow us to have some of these reference standards. We sell a lot of both of these companies products, and I think a lot of people trust me to get to the bottom of things using good science. So hopefully they will see that working with me is going to be a good idea in the long run.

Anyway, back to your original question: what do I think about Consumerlabs? Well they are using the standard USP monograph, so their numbers are not "wrong" per se. However, I think we are missing a big picture with ashwagandha. If there are 40 withanolides in there, and we are only measuring 8 of them (really only 2), we are missing a LOT. In Consumerlab's defense, they did contact Ixoreal and Natreon about it, and did change the results to "uncertain" based off that data. So they seem to be somewhat aware of it. I like their system better than LabDoor, for sure. However, it can be done much much better than anyone is doing it currently. I will create a Consumerlab type nonprofit at some point. It really needs to be done. Science is so much more complex than anyone realizes, and sometimes no data is better than bad data. Consumers won't know any better. They see numbers and believe what they are told. For instance, the product that had the highest withanolides on Consumerlabs test, Nature's Way, is actually the WORST! You want to know why? They use much much cheaper ashwagandha leaf in it, which is much higher in withanolides. However, not the ones we want. It's higher in Withaferin A. That's in high concentrations in the leaves, but low in the roots. That's grouped in with "total withanolides," though. So people see the higher number and think better, but it actually shows it is the lowest quality extract in there. You can't get that high in withanolides in the roots alone. You just can't. So the numbers are misleading. Do NOT buy ashwagandha based off the Consumerlabs report. This is one that requires much more complex explanations and testing to really find the true "best quality" on the market. This is going to be the case for a lot of extracts out there, which is why I am working so hard to get this data.