Ashwagandha KSM-66: ANSES opinion and contraindications
Ashwagandha has been the best-selling plant in the supplement aisle for three years, and it is also the one on which a French authority has most recently commented. In April 2024, ANSES published a risk assessment opinion concerning it. This text exists, it is public, and it changes the way this plant should be advised — including when it is sold. Here's what it says, what the KSM-66 extract is exactly, and who should stay away from it.
Ashwagandha KSM-66, what is it?
Ashwagandha, Withania somnifera, is a Solanaceae whose root is traditionally used in Ayurvedic medicine. It belongs to the same botanical family as the tomato, potato, and belladonna — a family that, as the latter reminds us, produces active molecules.
KSM-66 is a trade name, not a synonym for ashwagandha. It designates a patented root extract, standardized to 5% withanolides, obtained by an extraction process that its manufacturer claims is free of chemical solvents. It is the most used extract in published protocols, which explains why it is found everywhere on labels.
The important detail: not all ashwagandha extracts are equal, and the difference is not cosmetic. Another common patented extract, Sensoril, is standardized to a higher level of withanolides and includes the leaf in addition to the root. However, the leaf is richer in withaferin A, a steroidal lactone whose cytotoxicity is described in in vitro studies. The plant part used and the standardization rate are therefore not just label details: they are two products with different profiles.
The detailed composition, withanolides, and doses used in research are covered in our article on KSM-66 ashwagandha extract. The page you are reading focuses on safety and the ANSES opinion.
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Nutriting nuAshwagandha is an organic ashwagandha root extract in vegetable capsules. One capsule provides 300 mg of KSM-66® extract, standardised to 5% withanolides, i.e. 15 mg...
What does ashwagandha do, and what are we allowed to say about it?
No health claims are allowed in Europe for ashwagandha. None, on any grounds: neither stress, nor sleep, nor anxiety, nor testosterone, nor sports performance.
This is not unique to this plant. Claims concerning botanical substances have been in a pending status at the European level since 2010: they have been neither authorized nor definitively rejected, and in practice, they cannot be used. A seller who writes "anti-stress ashwagandha" or "reduces cortisol" is simply violating Regulation 1924/2006.
The word "adaptogen," which you will see everywhere, also has no regulatory value. It classifies a family of plants derived from a research tradition; it does not describe a recognized effect.
What research has actually measured — salivary cortisol, perceived stress questionnaires, sleep parameters, hormonal markers, over durations of six to twelve weeks — falls under protocols, not promises. We have reported this in detail in the dedicated article, without drawing any guaranteed effects.
What does the ANSES opinion on ashwagandha say?
This is the core of the matter, and it is what distinguishes ashwagandha from most plants in the aisle: here, an authority has spoken.
In its opinion of April 19, 2024, on the risks associated with the use of Withania somnifera preparations in food supplements (request 2021-SA-0077), ANSES reports the following elements.
Reported cases
The French nutraceutical surveillance system recorded reports of adverse effects associated with ashwagandha-containing supplements during the period 2009-2023. The described effects are mainly digestive — diarrhea, vomiting — as well as drowsiness, fatigue, and skin manifestations. Two reports stand out due to their severity: one case of acute hepatitis and one case combining macroscopic hematuria and kidney failure. The WHO international pharmacovigilance database records a significantly higher number of cases, with the same profile of digestive and liver damage.
A note on methodology, because it is important not to overinterpret: these reports do not measure frequency. They list reported cases, whose imputability to the product is evaluated on a case-by-case basis. They do not say how many people out of a hundred are affected. But they are sufficient to identify the organs to monitor.
Concerns raised
ANSES highlights concerns related to possible genotoxicity, suspected endocrine disrupting effects — particularly on thyroid function and fertility — as well as liver damage, cardiac damage, and sedative effects on the central nervous system. Effects on fetal development are also among the points of vigilance.
Recommendations
The agency recommends systematic control and qualification of the composition of the plant raw materials used, calls for additional toxicology work, and invites consumers to report ashwagandha intake to their doctor due to possible interactions with treatments.
We sell this plant, and we relay this opinion. These two things are not contradictory: they are the condition for the advice to be worth something.
Who should not take ashwagandha?
The list below includes the populations for whom ANSES advises against the consumption of supplements containing ashwagandha:
- Pregnant and breastfeeding women. This is the most consistent point, also found in traditional monographs.
- People under 18 years of age.
- People with an endocrine disorder, particularly thyroid dysfunction or hyperandrogenism.
- People with liver disease or heart disease.
- People taking central nervous system depressants — anxiolytics, hypnotics, sedatives.
To this is added a common-sense rule that we apply at the counter: if you are taking medication for your thyroid, whatever it may be, ashwagandha is not a purchase to make without first discussing it with your doctor. This is the most frequently mentioned interaction point and concerns many people.
Also, a warning sign, because it is rarely written: in case of unusual fatigue, jaundice, dark urine, or abdominal pain while taking ashwagandha, stop and consult a doctor. These are the signs that should make you think of the liver.
If your reason for buying is sleep or nervous tension, two aisles are based on more solid regulatory foundations: magnesium, which has authorized claims for normal nervous system function, and melatonin, for which a sleep claim is indeed authorized. This is a difference in status, not a commercial preference.
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Trained by JP Ashwagandha KSM-66 - Stress, Resistance & Recovery
TrainedByJP Ashwagandha KSM-66 is a supplement in vegetable capsules providing 600 mg of ashwagandha root extract (Withania somnifera) per capsule, standardised to 5% withanolides, i.e. 30...
How to read the label of an ashwagandha extract?
The part of the plant. This is the first line to look for, and the one that the ANSES opinion makes decisive. "Root" does not have the same profile as "root and leaf". A label that does not specify this does not allow you to know what you are buying.
The withanolide content. This is the standardization benchmark, expressed as a percentage. A KSM-66 extract is standardized to 5%. A higher titration is not a guarantee of superior quality: it is a different product, often obtained differently and sometimes from another part of the plant.
The quantity of extract per capsule, not the quantity of "equivalent plant". Both figures circulate and they do not mean the same thing. A capsule announcing "5,000 mg equivalent plant" actually contains a few hundred milligrams of extract. The important figure is that of the extract, associated with its titration.
The name of the patented extract, if any. KSM-66, Sensoril, Shoden: these names refer to identifiable processes and specifications. An anonymous "ashwagandha extract" offers no traceability, and the ANSES opinion insists precisely on the qualification of the raw material.
What the label should not say. "Anti-stress", "reduces cortisol", "improves sleep": these mentions are prohibited. Their presence does not prove that the product is bad, but it proves that the manufacturer treats regulations with nonchalance — which is rarely a good sign for the rest.
This is the same reading requirement that we apply to shilajit, another traditional product where the origin of the raw material weighs more heavily than the advertised dosage.
What should not be expected from ashwagandha?
It is not an anxiolytic. Anxiety that interferes with daily life is treated by a doctor, and self-medication with a plant often delays proper management.
It is not a sleeping pill. The ANSES opinion also mentions sedative effects among the points of vigilance, which is not the same as a benefit.
It is not a hormonal stimulant. Studies have measured hormonal parameters, on limited numbers; ANSES, on the contrary, evokes suspected endocrine disrupting effects. Claiming otherwise would be dishonest in both senses.
It is not a muscle-building product. In this area, proteins, training, and sleep do the work, as detailed in our article on muscle recovery.
And it is not a harmless product because it is "natural." This is precisely the shortcut that the ANSES opinion contradicts.
Frequently asked questions about ashwagandha KSM-66
Is ashwagandha dangerous?
It is not harmless. ANSES, in its opinion of April 19, 2024, reports cases of digestive and skin adverse effects, drowsiness, as well as a case of acute hepatitis and a case of kidney damage, and raises concerns about genotoxicity and possible endocrine disruption. It advises against consumption for several populations, listed above.
Is ashwagandha banned in France?
An agency opinion is not a ban: ANSES assesses risks and recommends, it does not regulate. Supplements containing ashwagandha are still marketed in France. However, the opinion clarifies who they are not recommended for, and it is this list that must be read.
What is the difference between KSM-66 and Sensoril?
KSM-66 is a root extract standardized to 5% withanolides. Sensoril combines root and leaf with a higher standardization. The leaf is richer in withaferin A, a molecule whose cytotoxicity is described in vitro. These are two different products, and the plant part should normally be on the label.
What are the side effects of ashwagandha?
The most frequently reported are digestive — diarrhea, vomiting — with also drowsiness, fatigue, and skin reactions. Liver damage has been reported, more rarely but more seriously.
Can ashwagandha be taken with thyroid medication?
ANSES advises against consumption for people with thyroid dysfunction. If you are being treated for your thyroid, the question should be asked to your doctor or pharmacist before any purchase, and not to a seller.
How long can it be taken for?
Published protocols most often cover six to twelve weeks. There is no safety data on prolonged use, which in itself is a good reason not to get into continuous intake.
Does ashwagandha cause weight gain?
Nothing links this plant to body weight, and no claims exist in either direction. A capsule of extract does not provide significant calories.
Should it be taken in the morning or evening?
Protocols distribute intake according to the parameter studied, often in the evening for studies on sleep. As drowsiness is among the reported effects, it is better not to start a course of treatment on a morning of driving.
It's a product we prefer to sell having had the conversation, and not just the click: our store in Vendargues, about ten minutes from Montpellier, is made for that, and the list of contraindications from ANSES is applied as is. Online, the ashwagandha section and our article on diet and stress revisit the levers that don't depend on any capsule.
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