Author: ashwagandhastandards

  • ASA Member Explains Testing Methods, Quality and the Problem With “Total Withanolides”

    ASA Member Explains Testing Methods, Quality and the Problem With “Total Withanolides”

    August 29, 2026: on Logan Talks Health, Blake Ebersole, co-founding member of the Ashwagandha Standards Alliance, discusses ashwagandha quality, plant-part controversies, testing methods, analytical transparency and why a percentage such as “5% total withanolides” may not tell consumers what they think it does.


    An edited transcript of this interview is found below:

    Logan:
    Why don’t we start with a bit about yourself and how you became so interested in botanical quality?

    Blake:
    I’ve always been interested in natural medicines. My dad’s side of the family is Pennsylvania Dutch Mennonite, and they always used home remedies. You’d smell apple cider vinegar every time you walked into my grandparents’ house, along with Epsom salts.

    I was first exposed to supplements when I was in seventh grade. I was walking to wrestling practice, saw a GNC, and they promised I’d get ripped. I thought, “Yeah, I probably need that.” So I bought Ripped Fuel from Twinlab, which at the time contained a lot of ephedrine.

    That was my first experience with supplements on my own, other than Flintstones vitamins. I remember thinking, “Holy shit, supplements can really knock you off your feet.”

    Later, I worked in food and was always interested in food and nutrition, so supplements became a natural fit.

    I started in the industry on the supply-chain side, learning how ingredients are made, how plants are grown and sourced, and how extraction works. I was responsible for quality, so I saw what was actually being produced and sold into the market.

    For roughly the past 10 years, I’ve worked with brands and manufacturers to make sure they’re buying the right ingredients at the right level of quality, while also helping with product development, formulation and related work.

    It’s a somewhat hidden part of the industry. Most people don’t know where saffron is grown, how it’s extracted, where it’s processed, or how somebody determines whether a product is actually 100% saffron.

    Adulteration has existed for as long as humans have traded valuable goods. The spice trade has always had dilution—adding a little less of the expensive material or mixing something in to increase margins because you think nobody will notice.

    That culture can exist because policing is expensive and time-consuming. Regulators have limited resources for testing, so to a significant extent the industry operates in a self-regulatory environment. People in quality, laboratories, suppliers and brands all have to help establish expectations for appropriate testing and transparency.

    That’s why things like sharing certificates of analysis and explaining testing methods matter. We now have better opportunities for transparency and communication than we had before.


    Logan:
    Ashwagandha appears to be facing possible restrictions or bans in some European countries. What do you think about that? Do you think it’s safe?

    Blake:
    I’ve been following this for some time. I’ve worked with ashwagandha for almost 20 years.

    Whenever something becomes popular and develops into a very large market—and ashwagandha is estimated to be roughly a $1.5 billion market—you start seeing the problems associated with rapid growth.

    You get opportunists coming in. Some diluted materials. Others use analytical methods that can make their product appear more potent or stronger than competing products. You see many of the same games that occur with other expensive or high-value botanicals.

    A group of us who have worked on the ashwagandha production side for many years started discussing these issues a couple of years ago. That became the Ashwagandha Standards Alliance. More recently, we’ve been working with scientists reviewing the larger body of evidence.

    When you look at approximately 130 clinical studies and more than 30 safety and toxicology studies involving different forms of ashwagandha root and leaf, the overall evidence supports safety.

    When something is consumed at the scale of billions of doses, some people are inevitably going to become sick or seek medical care while also taking that product.

    A multivitamin provides a useful analogy. There are many adverse-event reports involving multivitamins in the United States, but that doesn’t necessarily mean the multivitamin caused the event. Multivitamins are simply consumed by a very large number of people.

    That’s an important perspective when looking at adverse-event reports for ashwagandha as well.

    It’s good that systems exist to collect these reports, but they need to be interpreted in the context of the overall evidence, including the safety and toxicology studies conducted on different forms of root and leaf.

    When I look at the science overall, I don’t see evidence of a general safety problem.

    There has also been a major controversy around plant part, particularly claims that ashwagandha leaf is inherently toxic. I don’t see a safety signal supporting that conclusion either.

    What gets obscured by that debate is the underlying quality problem: opportunists entering a growing market, manipulating testing methods, misrepresenting products, diluting materials or failing to disclose what they’re actually selling.

    Sometimes products don’t identify plant part at all. The label simply says “ashwagandha extract.” If the plant part isn’t disclosed, the consumer is none the wiser.

    It’s a fascinating example of how a complex botanical ingredient can be simplified and gamed for short-term commercial advantage.


    Logan:
    I’ve seen this whole root-versus-leaf debate, and it sometimes looks like a marketing differentiation: “The leaf is bad. We’re pure root. You don’t want the leaf.”

    What is that based on? Is there evidence that leaf is worse or dangerous?

    Blake:
    That’s what makes the situation interesting.

    Companies developing products legitimately often spend years developing the ingredient, putting it through clinical studies and conducting safety studies.

    Some of the established root-and-leaf products have more research behind them than many other botanical ingredients we routinely discuss. They’ve also been marketed globally for 10 years or more, giving us substantial commercial experience.

    Looking at those data and that experience, I don’t see a reason to conclude that leaf itself presents a general safety problem.

    Another issue is how ashwagandha is classified.

    Traditionally, it isn’t simply consumed as an unrestricted conventional food in every population. Most modern clinical and safety studies are geared toward the way a supplement would be consumed.

    If you try to treat something as a conventional food, you may need to consider unrestricted consumption by children, pregnant women, nursing women and other populations.

    Keeping it in a supplement framework allows appropriate directions, warnings and restrictions to be used on the label.

    There are also competitive issues underneath these regulatory debates. Companies can have commercial reasons for positioning another type of product as unsafe while portraying their own as preferable.

    That’s why the discussion has to come back to evidence.


    Logan:
    Another way to get the system right is testing. For people listening, where does the United States Pharmacopeia fit into this?

    Blake:
    Testing across the supplement industry is often a black box, and that creates opportunities for gaming.

    One example is “lab shopping.” A company can send the same material to several laboratories and then gravitate toward the laboratory or method that gives the result it wants.

    USP has methods for ashwagandha potency and identity. Ideally, having a common method gives everybody an apples-to-apples reference.

    Companies can also use proprietary methods. There’s nothing inherently wrong with that. But the method needs to be appropriately validated, disclosed where necessary, and reproducible. Another qualified laboratory should be able to perform the method and obtain comparable results.

    If somebody says, “You can’t have our method and nobody else can replicate our result,” that becomes a serious quality and GMP concern.

    This matters when a company claims a certain percentage of withanolides. If the analytical method is being used to inflate the apparent strength of the product, but nobody can see or reproduce the method, the number becomes almost meaningless.

    You can end up with a competition where everybody wants to claim 5% withanolides.

    But then you look at the economics and chemistry and ask: Does the mass balance make sense? If producing a genuine material at that concentration should cost substantially more than the selling price, you have to ask questions.

    Regulators may not prioritize that situation if they don’t consider it an immediate safety issue. That means the industry, laboratories, brands and buyers have to scrutinize it.


    Logan:
    It’s essentially a company saying, “We’re going to mark our own homework. Nobody else can mark it, and we’re not going to tell you how we marked it because the method is secret.”

    Blake:
    Exactly.

    If you’re putting a compositional number on the label, it needs to be something that can be verified.

    A lot of finished-product companies are simply putting a number on the label because the ingredient supplier told them that number. They may not be independently verifying it.

    Laboratories also play a role because some of this testing is effectively a black box.

    Sometimes reports don’t show the chromatographic peaks or identify exactly which withanolides are being quantified. Then you compare that result with a USP-based analysis and the reported withanolide content can be dramatically different.


    Logan:
    That’s what I’ve seen. Some laboratory reports don’t quantify which withanolides are being tested. Put them alongside a United States Pharmacopeia test and the results can look completely different.

    Blake:
    Right.

    It’s important to understand that two analytical methods can measure a group of compounds differently. It’s common in botanical raw-material specifications to see potency reported using two or even three methods, with different expected results.

    The USP method measures a defined group of compounds. Other researchers and suppliers have used techniques such as NMR and broader chromatographic characterization to look at a larger fingerprint.

    Companies may spend significant amounts of money developing those methods and generating the evidence needed to support them.

    Reference standards are another bottleneck. If you’re trying to quantify a particular compound, you ideally need an appropriate chemical reference standard. If that reference isn’t available, is prohibitively expensive, or can’t be obtained in sufficient purity, it becomes much harder for independent laboratories to reproduce the method.

    That’s part of the role of pharmacopeial methods: to establish methods that are practical and broadly usable.

    Ashwagandha contains a large number of withanolides and withanosides. We’re still trying to understand those compounds and how different extracts reflect the underlying root or plant material.

    Then you get into fingerprinting.

    If the botanical starting material shows a fingerprint containing many peaks, but an extract shows only two or three dominant peaks, what happened during processing?

    Now you need to look at the fingerprint and ask: Is this root? Is it leaf? What is the potency? What was concentrated or removed?

    It becomes a puzzle.


    Logan:
    The pharmacopeial method obviously doesn’t capture every withanolide.

    But if you’re a supplier developing an ashwagandha ingredient with a different profile, surely you would want to share enough about your testing method to demonstrate that you’re actually meeting your label claim.

    Blake:
    You would.

    But there can be a commercial problem.

    Suppose you’ve historically labeled your ingredient using one number, and then improved testing shows that the old number isn’t directly comparable to the new one. How do you change the number while simultaneously claiming that the ingredient has remained the same all along?

    That becomes especially important when clinical research is involved.

    You need to connect the commercial material being sold today with the material that was actually used in the clinical studies.

    If you materially change the manufacturing process, you have to ask whether those clinical studies still apply to the product in the same way.


    Logan:
    So companies can change the process used for the commercial material compared with what was used in the studies?

    Blake:
    It can happen. Processes are modified for efficiency, cost reduction or other reasons.

    Maybe you remove a manufacturing step and save money.

    But one of the original purposes of standardized botanical extracts was to help protect against exactly this kind of variability—to establish that a product maintains particular characteristics rather than simply being whatever came out of an extraction process.

    There are also ways to dilute botanical extracts without adding an obvious foreign adulterant.

    For example, you can take exhausted botanical material left over after extraction, grind it and blend it back into the extract. Think of grinding up spent coffee grounds and putting them back into a coffee extract.

    The material technically originated from the same plant, but you’ve diluted the extract with material from which many of the soluble constituents have already been removed.

    Then people wonder why that ingredient is so inexpensive.

    This isn’t unique to ashwagandha. Similar practices can occur with many botanical extracts.

    A lot of this is hidden, even though people working in botanical supply, production and quality know these practices exist.


    Logan:
    I love the fingerprint idea.

    If we’re conducting research on an ashwagandha extract, ideally the study would publish its fingerprint or withanolide profile.

    Then you could say: This specific ashwagandha preparation was studied for stress or anxiety and produced these results.

    In theory, a consumer could look for a product with a similar profile and have more confidence that it resembles the studied ingredient. You might also discover that different withanolide profiles produce different effects.

    Blake:
    Exactly.

    If a clinical study isn’t linked to the actual composition of the material, your ability to determine whether another product reproduces that material is limited.

    Of course, suppliers don’t necessarily want to publish every detail of their manufacturing process or fingerprint because they don’t want competitors copying them. That’s understandable.

    Natural products can be difficult to protect through patents. If a company invests substantially in developing an ingredient, it doesn’t want somebody else simply knocking it off.

    But if you withhold too much compositional information from a clinical publication, you create another problem: nobody can determine what was actually studied.

    There can also be a legitimate evolution in testing. Maybe the manufacturing process hasn’t changed, but the analytical method improves and now measures more withanolides.

    That brings us directly to the phrase “total withanolides.”

    When someone says “total withanolides,” the first question should be: Which withanolides?

    What are the individual compounds being included in that total?

    If one company’s “total withanolides” consists of seven compounds and another company’s consists of 20, those numbers aren’t necessarily apples-to-apples.


    Logan:
    And they could potentially have different biological effects.

    Blake:
    Potentially.

    You also have to ask whether an extract is representative of the botanical material it supposedly came from.

    If a root has a complex fingerprint containing 20 or 30 relevant peaks and an extract has only two or three, what does “full spectrum” mean in that context?

    Is two or three peaks “full spectrum”? Or should a full-spectrum product more closely reflect the broader fingerprint of the starting material?

    Those are legitimate questions.

    The problem is that companies often don’t publish their chromatograms or analytical methods. Occasionally you can find them in studies, but often you can’t.

    Ideally, we would have official monographs and agreed reference methods. Then everybody could point to the same benchmark.

    When those connections aren’t being made, it can start to feel like the Wild West.


    Logan:
    It’s almost as though companies are trying to create intellectual property out of the chemistry. They don’t want to reveal enough information for the product to be recreated.

    Blake:
    That’s part of it, and it isn’t entirely their fault.

    Natural products are difficult to patent. If you’re a company investing heavily in developing an ingredient, you don’t want another company copying it immediately.

    The problem comes when somebody competes by creating something different but uses analytical claims that make it appear equivalent or superior.

    Then you’re trying to compete against somebody whose numbers may not be comparable to yours.


    Logan:
    Your website says the Ashwagandha Standards Alliance wants to see analytical harmonization. What do you mean by that?

    Blake:
    Analytical harmonization can mean several things.

    To me, one practical starting point is for everybody to use at least one common reference method.

    For example, your specification could include the USP method as one line item. Then, on another line, you could include your own proprietary method.

    Now we at least have one apples-to-apples reference point, even if companies also use additional methods.

    Maybe the USP method gets updated in the future to include more compounds. But using multiple potency methods isn’t unusual in botanical products. We’ve seen similar approaches with other herbs such as ginkgo.

    The concept isn’t new.


    Logan:
    But those additional methods still need to be transparent enough that we can understand what they’re measuring and which peaks they include.

    Blake:
    Correct.

    Even USP is limited in which compounds it currently measures, so there’s room to go deeper.

    Then you get into another question: Are the marker compounds we happen to measure actually the biologically important compounds?

    Just because a compound is predominant, easy to measure, or has interesting activity in an in-vitro experiment doesn’t necessarily mean it alone determines the clinical effect.

    If you concentrate particular withanolides while excluding other constituents, does the resulting extract behave differently?

    That’s an entirely different scientific discussion.

    When you look across roughly 130 clinical studies involving a wide range of preparations—root, root-and-leaf, water extracts and other extraction systems—you see positive results across many preparations.

    That tells us there is clearly something meaningful happening with the botanical.

    The safety evidence is also there. So when evaluating the plant overall, you have to consider the complete body of work.


    Logan:
    And ashwagandha is consumed by millions of people. If it were causing a very large safety problem, you would expect to see a signal.

    Blake:
    Exactly. We’re talking about enormous numbers of doses consumed globally.


    Logan:
    What regulatory changes would you like to see for ashwagandha?

    Blake:
    I don’t necessarily think major new regulations are what’s needed.

    Ashwagandha is already legally marketed under different regulatory frameworks in countries including Canada, South Korea, Italy and many others.

    The bigger issue is enforcement.

    If regulators don’t have the resources to aggressively police misleading labels or unfair competition, then industry stakeholders have to take more responsibility for addressing those issues.

    I think we need to resolve the misinformation around plant part and get back to the fundamentals:

    What compounds are being measured?

    What process was used?

    What is the composition of the extract?

    What safety evidence and clinical evidence are actually tied to that particular extract?

    It is certainly possible for an unscrupulous supplier to use inappropriate processes, concentrate certain constituents from leaf and then misrepresent the resulting material as root.

    Standards should address that.

    But don’t describe a quality and authenticity problem as though it is inherently a plant-part problem.


    Logan:
    You could have products that are all called ashwagandha but, in theory, have very different chemical compositions.

    Blake:
    Absolutely.

    Historically, a common specification for ashwagandha root extract was around 1.5% withanolides by HPLC.

    But those older specifications weren’t necessarily tied to USP or another harmonized method.

    Different root extracts, root-and-leaf extracts and solvent systems could all be sold under what appeared to be the same 1.5% specification.

    That was 20 years ago.

    Now you see 2.5%, 5% and other variations.

    There can be many different things going on behind those numbers even though the products look similar on the front of the label.


    Logan:
    So, in some cases, people are essentially manipulating the chemistry to reach the number they want to put on the label.

    Blake:
    That’s the incentive.

    To a consumer, 5 looks stronger than 2.5, and 2.5 looks stronger than 1.5.

    That higher number becomes a marketing tool.

    But the ingredient supplier and the finished-product brand have different responsibilities.

    Ultimately, the brand owner is responsible for what goes on the finished-product label.

    If the supplier is located halfway around the world, recovering losses or pursuing litigation after something goes wrong can also be extremely difficult.


    Logan:
    I’m seeing some brands remove 5% claims from their labels.

    Blake:
    Yes.

    If you look historically at labels, you can find brands that appear to have removed those claims. One possible reason is that they weren’t able to reproduce the claimed result under the testing they were using.

    Other brands may continue with the claim.

    This issue is familiar to a lot of people who have worked behind the scenes in ashwagandha quality assurance and manufacturing.

    They’ve faced the dilemma: “The specification says 5%, but our laboratory isn’t getting 5%.”

    You can call it a deviation for a while, but eventually you have to address the discrepancy.

    Either the claim changes, the testing issue gets resolved, or somebody decides to ignore the discrepancy.


    Logan:
    And carries on as normal.

    Blake:
    Right.

    These are also growing pains of a rapidly expanding category. We’ve seen similar issues with green tea extract, turmeric extract and other popular botanicals.

    The positive thing is that the quality problems we’re discussing haven’t translated into the level of serious adverse-event reporting you might expect if ashwagandha itself presented a major safety problem.

    But consumers can still be cheated.

    If a label says you’re getting a particular amount of withanolides and the product doesn’t actually contain that amount under a defensible method, then the consumer isn’t getting what the label suggests.


    Logan:
    Do you think the enormous demand required to support a $1.5 billion market contributes to the problem?

    Companies suddenly need huge quantities of ashwagandha. Maybe that creates pressure to change growing practices or manufacturing simply to produce enough material.

    Blake:
    Definitely.

    The market has grown extremely quickly over the past decade.

    Small farmers have entered the market. Small processors, medium-sized processors and large processors have all entered. Almost everybody in India involved in botanical extracts seems to offer some type of ashwagandha.

    Leaves are somewhat richer in some withanolides and are generally less expensive than root.

    That creates an economic incentive to use more of the plant.

    In India, the term panchang can refer to use of the whole plant. From a traditional processing or agricultural perspective, people may reasonably ask why stems and leaves should simply be discarded.

    Historically, extracts have been made in different ways.

    As botanical identity testing improved, laboratories became better able to distinguish plant parts. Larger and more sophisticated suppliers generally adapted to those expectations.

    Smaller suppliers may not always conduct the same level of laboratory testing.

    If an identity test costs a few hundred dollars per sample, a small supplier may decide not to perform it and instead rely on whoever supplied the raw material.

    That’s why the problem has so many layers.

    You peel back one layer and find another.


    Logan:
    At every level of the supply chain, there’s another opportunity for something to go wrong.

    Blake:
    Exactly.

    The companies involved in the Ashwagandha Standards Alliance include organizations that have processed and sold ashwagandha globally for 20 years or more.

    They’ve seen these problems firsthand.

    They also see opportunistic products entering the marketplace, competing unfairly and potentially damaging the reputation of the entire ashwagandha category.

    There are also consequences to simplistic regulatory actions.

    If, for example, leaf is broadly prohibited, that can affect farmer income and remove value from a plant part that is already used in established commercial products.

    Then you put more pressure on the remaining supply, potentially creating additional incentives for shortcuts.


    Logan:
    So a restriction could actually increase supply pressure and potentially incentivize more trickery.

    Blake:
    Exactly.

    And established brand names aren’t automatically immune from quality problems either.

    The goal of the Alliance is to establish better standards, correct misinformation and make sure the public discussion is scientifically sound.

    We don’t want companies unfairly competing by misleading consumers.

    And we don’t want quality problems to become a scandal that damages the entire botanical.

    Consumers aren’t necessarily going to remember which plant part, supplier or extract was implicated. They may simply conclude, “Ashwagandha isn’t worth the risk.”

    That would conflict with the broader scientific record showing that ashwagandha is a generally well-established and well-studied botanical.


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

    Blake:
    I wish I had a short answer.

    That’s part of the problem we’re trying to solve.

    In my head, I have a list of red flags and green flags that buyers can look for, and I think turning that into consumer guidance would be useful.

    There are established branded ingredients whose specifications and testing I’ve personally reviewed and where I have confidence in the documentation. That doesn’t mean a product needs to use a branded ingredient to be good. There are excellent non-branded suppliers as well.

    In general, though, I tend to look for suppliers and brands with a long track record and substantial experience.

    If somebody is claiming 5% total withanolides, I would ask more questions.

    I would want to see the certificate of analysis and understand the methodology used to reach that 5%, because it’s a relatively high specification and can be difficult to reproduce depending on the method.

    Five percent is definitely a claim where I want to know more.


    Logan:
    And even if you have a COA saying 5%, it can’t simply show unquantified peaks. You need to know what was measured and how the laboratory reached that number.

    Blake:
    Exactly.

    This should ordinarily be handled during supplier qualification, but even a sophisticated consumer or buyer could ask for the HPLC chromatogram showing the peaks.

    A supplier making that kind of claim should know exactly what you’re asking for and should be able to provide appropriate analytical documentation.

    In a truly transparent industry, representative chromatograms generated using standardized methods would be readily available.

    But that’s often where the sausage gets made, so companies can be reluctant to disclose it.

    Still, there are suppliers that have completed the validation work and are willing to say, “Here are our results. Send the material to another qualified laboratory using the same method, and you should get comparable results.”

    We need more of that.


    Logan:
    We need more companies like that on planet Earth.

    Blake:
    We’re working toward it.

    The industry is moving in that direction. More companies are sharing test results and quality documentation.

    In the United States, for example, cannabis companies in some states have been required to make certificates of analysis available.

    The supplement industry could learn something from that model.

    Imagine if companies made a third-party COA available for every finished-product batch. Consumers and customers could look at the testing and see what was actually measured.

    That would improve transparency significantly.


    Logan:
    I think that should be the law: a third-party COA for every batch, available to consumers, showing the dosage and the quantified compounds.

    Blake:
    That’s close to my ideal world, and I think we’re moving in that direction.

    Testing itself doesn’t have to be mysterious.

    You send the material to a qualified laboratory and obtain the report.

    If you built quality into the product in the first place—selected appropriate ingredients, qualified the supplier and understood your specifications—the laboratory result shouldn’t come back as a surprise.

    For companies that know what they’re doing, testing is verification.

    Problems arise when quality wasn’t built into the product at the beginning and people start trying to figure out how to make the test result work after the fact.


    Logan:
    At that point, they can be in a difficult position. They’ve sent the product to a laboratory and effectively demonstrated that an expensive batch may be mislabeled.

    Blake:
    Exactly.

    And it happens more often than people realize because testing can come relatively late in the process.

    Then somebody says, “We can’t just throw this batch away. What do we do?”

    Sometimes the temptation is simply to sell it anyway.

    As a quality professional, I’ve advised against that many times. I didn’t always get my way.


    Logan:
    Blake, this has been a fascinating conversation and extremely helpful. I think people are going to find your experience really interesting.

    Thank you very much for your time.

    Blake:
    Absolutely, Logan. It was great being with you. These were excellent questions, and it’s refreshing to have a conversation with somebody who understands the issues we’re talking about.

    Thanks for having me.


    Editor’s note: This interview has been lightly edited for length and clarity. Verbal fillers, repetitions and false starts have been removed, and obvious transcription errors have been corrected. The speakers’ substantive comments and intended meaning have been preserved.

  • ASA Expands Global Membership Initiative as Kerry Group Joins Coalition

    ASA Expands Global Membership Initiative as Kerry Group Joins Coalition

    Growing global coalition brings together leading companies and experts working to advance science-based standards, transparency and public trust in ashwagandha


    Boulder, Colorado — August 18, 2026 — The Ashwagandha Standards Alliance (ASA) today announced the continued expansion of its global membership initiative, with Kerry Group, a global leader in sustainable nutrition, joining the Alliance.  

    The addition of Kerry comes as ASA expands membership among global responsible suppliers, brands, manufacturers, laboratories, researchers and other stakeholders throughout the global ashwagandha value chain.

    Kerry joins ASA’s other Founding Executive Members: Sabinsa Inc., Cepham Inc., Arjuna Natural USA, Botanical Liaisons, LLC, and NaturPro Scientific, LLC. Together, the members are helping build a broader industry coalition around responsible stewardship of the ashwagandha category.

    “Ashwagandha has become one of the world’s most important botanical ingredients, and the issues surrounding it are bigger than any one supplier, brand or market,” said Blake Ebersole, co-founding member of the Ashwagandha Standards Alliance. “Kerry brings significant scientific, regulatory and global market experience to the table. Their participation is another important step toward building the broad, credible coalition this category needs.”

    Building on collaboration in Europe

    Kerry has already participated in efforts aligned with ASA’s mission. In July, ASA recognized Kerry and the Safeguard Ashwagandha initiative for presenting scientific evidence directly to policymakers at the European Parliament in Brussels, as European authorities consider the regulatory future of ashwagandha.

    ASA has emphasized that the future of the category depends not only on communicating safety evidence, but also on addressing legitimate industry responsibilities, including truthful plant-part and potency labeling, appropriate specifications, validated analytical methods, GMP compliance, traceability and responsible public communication.

    “Kerry’s decision to join the Alliance builds on the kind of collaboration we believe is essential,” Ebersole said. “Companies can compete commercially while still working together on the scientific and quality foundations that affect everyone.”

    Kerry’s participation comes as ASA continues its global membership initiative and invites additional responsible stakeholders to take part. Membership is open to ingredient suppliers, finished-product brands, manufacturers, testing laboratories, research organizations, consultants, clinicians, trade organizations, educators and other professional stakeholders with an interest in responsible botanical science, quality, transparency and public trust.

    ASA is intentionally agnostic to plant parts and commercial ingredients. The Alliance does not exist to promote one product, supplier, analytical method or commercial position. Instead, it seeks to create a common scientific foundation around quality, identity, safety, analytical testing, labeling and responsible communication.

    The Ashwagandha Standards Alliance was established as a collaborative, science-anchored initiative focused on advancing the integrity of ashwagandha ingredients and consumer products globally. Its work is organized around six core priorities:

    • Education — providing clear, science-based information for industry, regulators and the public;
    • Safety — evaluating and communicating the broader body of scientific evidence concerning ashwagandha;
    • Quality — supporting authentic products, responsible sourcing, accurate labeling and appropriate documentation;
    • Analytical harmonization — encouraging fit-for-purpose specifications and validated analytical methods;
    • Transparency — promoting open communication around composition, testing, sourcing and scientific evidence; and
    • Public trust — helping preserve confidence in ashwagandha through responsible industry stewardship.

    “The Alliance becomes stronger when participation extends across the value chain,” Ebersole said. “Those who formulate and sell ashwagandha consumer products should be involved in the same conversation as the companies producing standards-setting ashwagandha ingredients.”

    Organizations and professionals interested in participating in the Alliance can learn more about its mission, principles, membership categories and current activities at: https://ashwagandhastandards.org/join-the-alliance/

    About the Ashwagandha Standards Alliance

    The Ashwagandha Standards Alliance is a coalition of responsible stakeholders working globally to advance science-based standards, transparent disclosure and accurate public communication for ashwagandha ingredients and finished products.
    The Alliance works to strengthen industry and public understanding through practical education shared scientific dialogue, and clear expectations for ashwagandha quality, safety and labeling.

    Its goal is to foster a stronger foundation of consistency, accountability and public trust while keeping the global conversation around ashwagandha grounded in more than 150 clinical and safety studies.

    About Kerry
    Kerry Group is a world leading provider of taste and nutrition solutions for the food, beverage and pharmaceutical markets. It innovates with its customers to create great tasting products, with improved nutrition and functionality, while ensuring a better impact for the planet. Kerry’s leading consumer insights, global RD&A team of 1,300+ food scientists, and local manufacturing footprint in 34 countries enables it to co-create with its customers across over 150 markets. Kerry is driven to be its customers’ most valued partner, creating a world of sustainable nutrition. For more information, visit www.kerry.com.

    Media Contact: 
    Kandice Randal, Kandice Rae Communications

  • ASA Supports Safeguard Ashwagandha at EU Parliament Meeting

    ASA Supports Safeguard Ashwagandha at EU Parliament Meeting

    July 16, 2026

    The Ashwagandha Standards Alliance thanks Safeguard Ashwagandha and Kerry Group for their presentation of science on Ashwagandha directly to policymakers at the European Parliament in Brussels.

    The meeting brought together scientists, regulatory experts, industry leaders and retailers as Europe considers a possible formal assessment of ashwagandha, known as Article 8.

    At the meeting, Dr. Thomas Brendler presented a review covering 131 clinical trial reports and toxicological assessments. A central conclusion was that the safety concerns repeatedly cited by authorities are not supported by the full body of current evidence.

    The primary challenge is not safety, but compliance problems that the regulations are already established for.

    As Alliance co-founding member Blake Ebersole shared with meeting participants, “What we are dealing with is not a question of safety, but a question of quality, standards and proper labeling.”

    Ashwagandha Standards Alliance Recorded Statement by Blake Ebersole in EU Parliament, Brussels July 14, 2026

    “While it’s true that some ashwagandha products are mislabeled as to plant part — in order to reach a number on the label — regulations already require accurate plant part and potency labels.”

    The Alliance supports rigorous safety evaluation, GMP compliance, truthful plant-part and potency labeling, appropriate warnings, meaningful chemical characterization and evidence that applies to the actual product being sold.

    “Safeguard Ashwagandha and Kerry deserve credit for moving the global discussion toward a harmonized, truthful and evidence-based approach.”

    ——-

    Full transcript of ASA presentation in EU Parliament follows:

    My name is Blake Ebersole, and I’m a co-founding member of the Ashwagandha Standards Alliance, which stands for the science and quality of ashwagandha products worldwide. 

    Ashwagandha is a botanical that’s not just used traditionally for thousands of years in India and across the Mediterranean and Africa. It also has more than 130 human and safety studies published on various forms – including extracts from the root and aerial parts of the plant, including the leaf. 

    The safety evidence for ashwagandha is based on scientific standards for other established supplement ingredients. In fact, ashwagandha has more safety trials than many of the herbs and some of the foods we commonly consume. 

    For a botanical consumed by humans on the scale of billions of doses per year, it’s been subject to relatively few reports of serious adverse events. So let’s put ashwagandha in perspective to other commonly consumed supplements. In the U.S. for example, we see that multivitamins are the most commonly reported supplement for serious adverse events. That’s not because of any inherent issue with multivitamins – but because they are so frequently consumed.  The law of averages dictates that anytime someone seeks medical assistance, they are often also taking a multivitamin. But no one claims the multivitamin caused the health issue. 

    The science supports that is the case here with ashwagandha, where most of the adverse events were reported on root, if only because it is the plant part that is ore popular. Yet, out of the relatively few case reports documented, we see a pattern of mislabeling and poor quality that existing regulations already address, but which are sometimes unevenly enforced. 

    The purpose of the Ashwagandha Standards Alliance is not to dismiss safety concerns, but to ensure that these concerns are evaluated with scientific rigor in an objective manner, and with needed perspective from the supplements category as a whole. 

    Some have raised questions about whether plant part may be an issue. While it is true that some ashwagandha products are mislabeled as to plant part to reach a number on the label, regulations across developed nations already require accurate plant part and potency listing.

    Further, ashwagandha root and leaf products with clinical and safety trials are already legally sold in many countries, including the U.S., Canada, Australia, New Zealand, China, Spain, Italy and France. These countries have approved certain root and leaf products based on the strong science and excellent record of safety they bring to consumers. 

    What we are essentially dealing with is not a question of safety, but a question of standards, quality and proper labeling. 

    We need to be asking, what material is being sold, made by which process and quality practices. And at what dose, and for which population.

    That is why the Alliance fights for enforcement of current regulations, which includes Good Manufacturing Practices and truthful labeling, including appropriate label warnings as found on many supplement products.

    When products meet current requirements, regulators and consumers can evaluate them rationally. When the rules are not followed, uncertainty increases.

    The Ashwagandha Standards Alliance is working to support objective evaluation and communication on the abundant science already published, adhering to established regulations for quality and labeling, and enforcement against products which don’t meet these existing standards. 

    Our request is simple: evaluate ashwagandha based on evidence and GMP’s, not on subjective and irrational criteria. 

    Address real quality issues where they exist. Require accurate labeling and expect GMP compliance. Demand transparency from industry.

    But don’t confuse the need for consistent standards with alarmist and irrational responses that conflict with measured, evidence-based approvals in many other nations.

    Ashwagandha is already regulated responsibly while preserving access to properly manufactured, accurately labeled, and scientifically supported products.

    The path forward should be based on the facts and the infrastructure already in place, that used successfully for a wide array of supplements. 

    Thank you for your consideration.

    Reference: Ashwagandha armed with critical safety data as industry anticipates Europe-wide assessment, by Nikki Hancocks, Nutraingredients.com, July 16, 2026

    Get involved with the Alliance today: https://ashwagandhastandards.org/join-the-alliance/

  • Ashwagandha Standards Alliance Responds to India’s Ministry of AYUSH, Launches With Global Membership Initiative 

    Ashwagandha Standards Alliance Responds to India’s Ministry of AYUSH, Launches With Global Membership Initiative 

    A broad coalition of responsible stakeholders invites global participation as regulatory debate over ashwagandha leaf underscores need for clarity and evidence-based review.

    FOR IMMEDIATE RELEASE

    Boulder, Colorado — June 23, 2026 — The Ashwagandha Standards Alliance (ASA), a broad coalition of responsible stakeholders working globally to advance science-based standards and accurate public communication for ashwagandha ingredients and consumer products, today announced the launch of its global membership initiative.

    ASA was formed to strengthen industry and public understanding and support a more consistent, evidence-based approach to ashwagandha products. The Alliance will focus on practical education, shared scientific dialogue, and clear expectations for quality, safety, analytical methods, transparency, labeling, and responsible communication.

    “Ashwagandha has earned confidence around the world. Our job is to help keep the conversation grounded in facts, not fear, and to support standards that match the importance of this plant in global health and wellness,” said Blake Ebersole, co-founding member of ASA.

    The membership launch comes at a critical moment for the global ashwagandha community. Public discussion of ashwagandha has become increasingly polarized, while regulatory interpretation and consumer communication remain inconsistent across markets. 

    ASA’s goal is to create a credible voice for ashwagandha quality and science, and to offer a collaborative platform for organizations and professionals who share a common interest in responsible marketing of ashwagandha products.

    Membership information and application are available at ashwagandhastandards.org/join-the-alliance.

    A science-led Alliance for all stakeholders

    ASA’s work is centered on six priorities: education, safety, quality, analytical harmonization, transparency, and public trust. Within these priorities, the Alliance is focused on truthful labeling, traceable sourcing, appropriate specifications, validated testing, GMP-aligned manufacturing, and evidence-based interpretation.

    The Alliance is not a marketing coalition or a trade group built to defend one commercial position. It is intended to be a globally credible, scientifically grounded, structurally independent initiative built around a simple principle: ashwagandha deserves standards and honesty equal to its global use.

    “We are working across the global regulatory and supply chain,” said Trish Flaster, co-founding member of ASA. “The point is to support disciplined expert review, transparent dialogue, and clear public education.”

    ASA’s response to Ministry of AYUSH shows why standards matter

    Recent AYUSH and FSSAI actions in India concerning ashwagandha leaf have underscored the need for a clearer distinction between adulteration and truthfully labeled ashwagandha ingredients supported by appropriate quality and safety evidence.

    In April, ASA supported industry efforts that led to successful interim stays from the Karnataka High Court regarding the FSSAI advisory seeking to restrict the use of ashwagandha leaves in commerce. 

    ASA views the judicial stays as an important opportunity for a fuller legal, scientific, and regulatory review before broad restrictions are allowed to affect compliant and transparent manufacturers and responsible brands. ASA’s update on the Karnataka High Court stay is available at ashwagandhastandards.org/high-court-stays-fssai-advisory-banning-ashwagandha-leaves-in-supplements.

    In June, ASA prepared an analysis and response to the Ministry of Ayush’s Counter Affidavit to the Karnataka High Court stay on the leaf ban. This response concluded that the Ministry’s actions did not provide a transparent risk assessment sufficient to support a blanket prohibition on all ashwagandha leaf material.

    ASA’s responses emphasize that the issues raised by the Ministry support the need for global regulatory enforcement of Good Manufacturing Practices and product mislabeling. 

    “Undeclared substitution of plant part should be taken seriously,” Ebersole said. “But we shouldn’t conflate this with the real issue being ignored – truthfully labeled, GMP-manufactured products should be evaluated on what evidence supports their safe use.”

    A practical path forward

    ASA encourages a framework that protects consumers and preserves public trust without reducing  botanical quality to a slogan. 

    By supporting transparency and stakeholder collaboration, ASA aims to strengthen confidence in ashwagandha among suppliers, brands, retailers, regulators, researchers, health professionals, media, consumers, and the farmers who cultivate the crop.

    “Science-based standards help to create a stronger path toward product quality and public confidence,” Flaster said. “This is the foundation ASA is working to build with members across the global ashwagandha community.”

    Membership invitation

    ASA invites suppliers, brands, manufacturers, testing laboratories, researchers, clinicians, trade organizations, media professionals, educators, consumers, consumer-facing stakeholders, and other responsible participants to join the Alliance. 

    Founding Member benefits include early access to Alliance communications, meetings, strategy discussions, and recognition in Alliance communications as appropriate by membership category.

    Founding Executive Members also participate in shaping standards, communications and policy for ashwagandha.

    About the Ashwagandha Standards Alliance

    The Ashwagandha Standards Alliance is a coalition of responsible stakeholders working to advance standards, transparency and communication for ashwagandha globally. 

    For more information:

    ASA Response to India Actions: https://ashwagandhastandards.org/wp-content/uploads/2026/05/Technical-Rebuttal-for-Recent-Claims-Regarding-Ashwagandha-Leaf.pdf

    About ASA: https://ashwagandhastandards.org/about/

    Join ASA: https://ashwagandhastandards.org/join-the-alliance/

    ASA Founding Charter: https://ashwagandhastandards.org/wp-content/uploads/2026/06/ASA-Founding-Charter.pdf

    Media Contact:

    Blake Ebersole

    Founding Member

    Ashwagandha Standards Alliance

    blake@npscientific.com

  • Join the Alliance Now

    Join the Alliance Now

    Ashwagandha has become one of the most widely used botanical ingredients in global health and wellness.

    But growth has exposed some problems, and the public conversation has become misguided.

    Meanwhile, important questions are sometimes ignored. When we argue about plant part, the serious questions are missed:

    ❓ Was the product accurately labeled?

    ❓ Was the fingerprint representative of ashwagandha?

    ❓Were allergens and contaminants tested?

    ❓Were the test methods valid?

    ❓Was the product made under real GMP controls?

    ❓Did the ingredient actually match the material used in the safety or clinical study used to substantiate it?

    The answers to these questions are what paints the quality picture for ashwagandha — and any other botanical too.

    That is why the Ashwagandha Standards Alliance is opening membership to the broader global community of responsible ashwagandha stakeholders.

    We are not a marketing coalition or a trade group built to defend one commercial position.

    We are intended to be a globally credible, scientifically grounded, structurally independent alliance built around a simple principle: Ashwagandha deserves standards equal to its global use.

    Our goal is to create a unified voice in the marketplace for scientific standards, and to build a shared, credible, science-based platform to create a bright future for ashwagandha.

    ASA is being formed as a collaborative, science-anchored initiative dedicated to advancing the global integrity of ashwagandha through:

    • Evidence-based safety review
    • Analytical harmonization
    • Transparent quality practices
    • Responsible communication
    • Truthful labeling
    • Regulatory dialogue
    • Public education

    Our mission is simple:

    A credible voice for ashwagandha quality and science.

    The Alliance exists to advance science-based education and foundational standards work for ashwagandha products. Our focus is to support informed decision-making and education for government, industry, and consumers.

    By encouraging responsible communication and transparent quality standards, the Alliance helps strengthen the confidence in ashwagandha products that it has earned.

    Membership is open to suppliers, brands, manufacturers, laboratories, researchers, clinicians, trade organizations, educators, media professionals, and other stakeholders who believe ashwagandha deserves standards equal to its global use.

    Founding members will have opportunities to participate in technical discussions, working groups, education efforts, draft publications, stakeholder briefings, regulatory updates, and public communication initiatives.

    Because the future of ashwagandha should not be shaped by panic, selective science, hidden agendas, or sloppy testing.

    It should be shaped by people willing to do the work.

    Science.
    Quality.
    Transparency.
    Context.
    Trust.

    That’s the work ahead of us

    Join the Ashwagandha Standards Alliance today by completing the Membership Application below — or visiting https://ashwagandhastandards.org/join-the-alliance/

    Alliance Membership Application

  • Supplyside Supplement Journal: ASA sets sights on ashwagandha standards and education

    Supplyside Supplement Journal: ASA sets sights on ashwagandha standards and education

    Thank you to Devon Gholam, Ph.D. and SupplySide Supplement Journal for covering the Ashwagandha Standards Alliance.

    One line in the article captures the problem well:

    “The market and wide variety of available ingredients have led to consumer confusion around ashwagandha.”

    That’s the primary issue.

    Ashwagandha is no longer a small niche botanical. So when any ingredient gets as big as ashwagandha is now, we might expect the growing pains that we’re seeing now

    Different extracts, plant parts, standardizations, safety narratives and regulatory responses.

    Some of that complexity is real.

    But the answer shouldn’t be panic or marketing spin.

    The Alliance is focused on six priorities:

    Education.
    Safety.
    Quality.
    Analytical harmonization.
    Transparency.
    Public trust.

    As the article states, ASA was formed after stakeholders came together to try to clarify the confusion and address some of the challenges and issues around communication of the science.

    Let’s avoid the fear and the slogans, and focus on better standards, better methods, and better context.

    Read the article here:
    https://www.supplysidesj.com/business-resources/new-alliance-sets-sights-on-ashwagandha-standards

  • New Infographic: Ashwagandha Facts, Not Fear

    New Infographic: Ashwagandha Facts, Not Fear

    A Science-Based Guide to Safety, Quality and Labeling for Industry

    The Ashwagandha Standards Alliance has released a new educational infographic, Ashwagandha Facts, Not Fear, to help brands, regulators, practitioners and consumers better understand how ashwagandha products should be evaluated.

    Ashwagandha is one of the most widely used botanicals in the world. It is also increasingly the subject of simplified narratives that do not reflect the full evidence base or the complexity of botanical quality.

    A quality ashwagandha product cannot be defined by a single plant part, a single constituent or a single number on a specification sheet.

    It must be evaluated as a complete product.

    Safety Requires the Totality of Evidence

    Safety evaluation begins by identifying what product is actually being used: the plant part, extract type, dose, biomarker fingerprint, manufacturing process and intended population.

    From there, safety assessment should consider:

    • Human clinical trials
    • Animal toxicology studies
    • Peer-reviewed publications
    • Quality assurance data
    • Dose and exposure
    • Product-specific composition

    This is how responsible evaluation works: characterize the product, assess the dose and exposure, and weigh the totality of evidence.

    Not by fear, marketing or treating all ashwagandha ingredients as interchangeable.

    Ashwagandha Facts Not Fear

    Quality Is More Than Plant Part

    Plant part matters. But plant part alone does not establish quality, safety or clinical relevance.

    A complete quality assessment should also address:

    • Biomarker fingerprint: Is the product chemically representative of the ashwagandha material it claims to contain? Which withanolides are identified on the HPLC chromatogram representing “total withanolides”?
    • Plant contaminants: Has the product been appropriately assessed for heavy metals, pesticides and mycotoxins?
    • Process contaminants: Have risks from allergens, residual solvents, fillers or other manufacturing-related issues been evaluated? Are they being truthfully labeled on ingredients and finished products?
    • Method validity: Are analytical methods validated, replicable and fit for purpose?
    • Independent verification: Can product specifications be reproduced and confirmed?
    • Evidence matching: Does the marketed ingredient actually match the material used in supporting studies?

    The answers to these questions determine whether brands can stand behind their products — and whether consumers can trust what is on the label.

    What Brands Should Do

    Brands selling ashwagandha products have a responsibility to move beyond simplified narratives and verify the total quality picture.

    That means they should:

    • Verify the identity, composition and quality of their ingredients.
    • Match ingredients to the totality of relevant evidence.
    • Confirm that specifications are reproducible using valid analytical methods.
    • Use accurate labeling.
    • Provide standard supplement precautions, including guidance for individuals who are pregnant, nursing or managing medical conditions.
    • Ensure consumers are instructed not to exceed the recommended dose.

    What Consumers Deserve

    Consumers deserve more than reassuring slogans or alarming headlines.

    They deserve:

    • Transparency
    • Realistic claims
    • Meaningful attention to quality and safety
    • Products supported by appropriate evidence
    • Labels that accurately describe what is being sold

    The goal is not to dismiss safety questions. The goal is to evaluate them correctly.

    Building Better Standards for Ashwagandha

    The Ashwagandha Standards Alliance advances science-based education and foundational standards for ashwagandha products. We support informed decision-making by industry, government and consumers through transparent evaluation of quality, safety, methods and labeling.

    Download and share the infographic: Ashwagandha Facts, Not Fear — A Science-Based Guide to Safety, Quality and Labeling for Industry.

    Learn more about the Ashwagandha Standards Alliance at www.ashwagandhastandards.org.

  • ASA Member Commentary on May 18 Article in Nutraceuticals World

    ASA Member Commentary on May 18 Article in Nutraceuticals World

    I appreciate Monday’s ashwagandha article in Nutraceuticals World for the wide range of opinions expressed.

    This article correctly identifies one central scientific issue: that root, leaf, and root+leaf materials may be chemically similar, but are not identical.

    It also points out the variation among legitimate products, and that generic total-withanolide claims are no longer enough.

    And the article provided a sketch of the underlying story that’s still being written…

    ——

    That story is partly about the fact that a plant-part ban doesn’t fix the current problems we face. Of unverifiable specifications, non-replicable test methods, and mislabeling of root-only products.

    That story is about the path already taken that has industry facing the potential for regulatory bans of ashwagandha as a whole — much less the possibility of a root-only standard.

    As Shaheen Majeed explained, a root-only standard would have enormous consequences. It would benefit some responsible suppliers and brands, while harming others. Most of all, it would affect the entire value chain — from farmer to consumer, and could reshape the global category.

    That kind of decision requires transparent processes, a focus on what is or isn’t true — and most of all, conflict disclosure of those leading the ‘root-only standard’ argument.

    Although the trade media has done a fairly good job on reporting on the topic, one key distinction is being missed, which is undeclared adulteration versus declared plant part from legitimate and science-backed products.

    That is, this is not just about the plant part.

    If a product is labeled as root-only water extract, then it should contain nothing but root water extract — no residual solvents or undeclared fillers detected. If not, that’s a quality and safety problem.

    If a product is labeled as root and contains undeclared leaf, then yes, that’s a quality problem.

    If a product doesn’t declare plant part, but is labeled or assumed to be root — that’s also a problem.

    But if a product is declared root+leaf with specifications, toxicology, clinical studies, and defined amounts of the specific marker compounds all aligned — that’s GMP and it’s safe according to the science.

    —–

    The industry should not let plant part become a cover for an oversimplified narrative that hides underlying issues.

    And this narrative should not be a default shortcut to “all use of leaf is adulteration”. Those two are not synonymous, and plus they are untruthful and hurtful.

    Because that narrative also means “root-only companies get to define the market.”

    Better standardization, labeling and testing is needed.

    But the nuance needs to be presented, and the policy decisions should be transparent.

    The outcomes should be proportional to risk, arising from rigorous, transparent and consensus-based policy.

    That’s how truth wins out in the end.

    Source: LinkedIn Post on May 21, 2026 by Blake Ebersole, Alliance Founding Member

    Nutraceuticals World Article: https://www.nutraceuticalsworld.com/exclusives/global-implications-of-indias-ashwagandha-leaf-ban/

  • High Court stays FSSAI advisory banning ashwagandha leaves in supplements

    High Court stays FSSAI advisory banning ashwagandha leaves in supplements

    May 19, 2026 — The Karnataka High Court, the highest judicial authority of the Indian state of Karnataka, has issued an interim stay on the enforcement of the Food Safety and Standards Authority of India (FSSAI) advisory that sought to ban the use of ashwagandha leaves or extracts that contain leaf in health supplements. The court’s decision comes in response to petitions filed by industry stakeholders challenging the April 16 advisory, which clarified that only ashwagandha roots and their extracts are permitted under current regulations.

    Petitioners argued that the abrupt restriction bypassed formal regulatory amendment procedures under existing food safety frameworks and would severely disrupt longstanding manufacturing practices. The High Court granted the interim stay specifically to the petitioners involved in the case to provide temporary relief while the legal arguments are considered. The court has scheduled a follow-up hearing for June 8, to allow regulatory authorities time to file their formal objections.

    Source: AHPA

  • Technical Review Paper Drafted on Ashwagandha Safety, Withanolides and Analytical Standards

    Technical Review Paper Drafted on Ashwagandha Safety, Withanolides and Analytical Standards

    The Ashwagandha Standards Alliance has drafted a technical review in internal peer review prior to submission for publication.

    Ashwagandha (Withania somnifera (L.) Dunal) is among the most widely used botanical ingredients in dietary supplements and herbal products globally. Its increasing commercial use has been accompanied by heightened regulatory scrutiny, particularly in relation to isolated reports of hepatobiliary injury and questions regarding the comparative safety of root, leaf, and root–leaf preparations.

    This technical review evaluates the current evidence base for ashwagandha safety, with emphasis on adverse event interpretation, preclinical toxicology, clinical tolerability, plant-part composition, withaferin A, reproductive-risk labeling, and analytical standards for withanolide determination. The review draws substantially on recent comprehensive evaluations published in Phytotherapy Research and places those findings within a quality, regulatory, and analytical framework relevant to manufacturers, ingredient suppliers, finished-product brands, researchers, and regulators. 

    The review concludes that the available evidence does not support a generalized causal association between properly manufactured ashwagandha extracts and serious liver injury at studied dosages. Published case reports of suspected ashwagandha-associated liver injury are important for signal detection, but they are limited by small numbers, incomplete product characterization, lack of quantitative withanolide analysis, absence of botanical-part identification, limited information on extraction methods, and frequent confounding by comorbidities, concomitant medications, pre-existing liver disease, or poorly characterized preparations. 

    In contrast, the broader evidence base includes controlled clinical trials, repeated-dose oral toxicity studies, genotoxicity assessments, reproductive and developmental studies, and long-standing traditional use. Across these evidence categories, a reproducible hepatotoxicity signal has not been demonstrated. Controlled clinical trials have not shown consistent elevations in liver enzymes or serious hepatic adverse events, while preclinical oral toxicity studies commonly report no-observed-adverse-effect levels in the range of 1,000–2,000 mg/kg body weight, corresponding to exposure margins substantially above customary human supplement intakes. 

    The review also addresses the distinction between root, leaf, and root–leaf extracts. Root preparations remain the most extensively studied form of ashwagandha. However, available toxicological and clinical evidence does not demonstrate a distinct safety signal for leaf-containing or root–leaf preparations when such products are authenticated, quality-controlled, and used within studied dose ranges. Current evidence therefore does not support the categorical treatment of leaf material, root–leaf extracts, or elevated withanolide content as inherently unsafe. 

    Withaferin A is considered in detail because of its biological activity and its relatively higher abundance in leaf material. The review emphasizes that in vitro cytotoxicity and pharmacological bioactivity should not be equated with in vivo oral toxicity. Studies of isolated withaferin A and whole ashwagandha extracts have not demonstrated the dose-dependent liver injury, genotoxicity, or systemic toxicity that would be expected if withaferin A were the principal toxicological driver of reported adverse events. Accordingly, withaferin A should be interpreted as one bioactive constituent within a complex botanical matrix, rather than as an intrinsic marker of hazard. 

    The review supports continued conservative precautionary labeling for pregnancy and lactation. This recommendation reflects the absence of adequate controlled human data in these populations and the prudent application of standard dietary supplement risk-management practices. It should not be interpreted as evidence of demonstrated reproductive or developmental toxicity, since the available preclinical data do not establish such a risk. 

    A central conclusion of the review is that ashwagandha safety and quality discussions must be linked to analytical rigor. The term “total withanolides” is not a single uniform measurement. It may vary depending on extraction procedures, chromatographic conditions, reference standards, peak selection, calibration strategy, and the method used to express results. Consequently, numerical withanolide values are not fully interpretable unless the analytical method and reporting basis are clearly disclosed. 

    The review therefore recommends the use of transparent, validated analytical methods consistent with AOAC principles and FDA expectations. Appropriate methods should establish specificity, linearity, accuracy, precision, limits of detection, limits of quantification, and suitability for the relevant botanical matrix. Multi-peak chromatographic fingerprinting should be used as a complementary quality tool to support botanical identity, batch-to-batch consistency, and detection of unintended fractionation or adulteration.

    From a regulatory and quality perspective, the review argues that transparent method validation, accurate labeling, appropriate specifications, and adequate product characterization are preferable to unsupported plant-part prohibitions or single-compound safety thresholds. Narrow compositional restrictions may obscure the central issue: whether the product is authenticated, manufactured under appropriate quality systems, analytically characterized, accurately labeled, and evaluated within a relevant exposure context.

    In summary, the technical review finds that properly manufactured ashwagandha extracts, including root and leaf-containing preparations, have not been shown to present a generalized hepatotoxic risk at studied dosages. The more scientifically defensible path forward is not broad categorical restriction, but improved analytical transparency, stronger quality documentation, validated methods, accurate withanolide labeling, and evidence-based interpretation of adverse event reports.

    For ASA, these findings reinforce the need for public standards that distinguish safety signals from causal evidence, in vitro activity from in vivo toxicity, and marketing claims from validated analytical data. The objective is not to defend every ashwagandha product or every commercial claim. The objective is to support a scientifically credible framework for ashwagandha safety, quality, and labeling.

    To be part of the review and publication of this critical review, consider joining the Alliance as a member.