Putting Ashwagandha Risk Warnings into Scientific Context

April 28, 2025

Ashwagandha Faktencheck: Studien zwischen Risiko und Realität

April 28, 2025

“German Federal Institute for Risk Assessment warns about Ashwagandha” or “Winter cherry: Federal institute warns about Ayurvedic remedy Ashwagandha” such headlines unsettle many people. Perhaps you as well. But what do the mentioned Ashwagandha risks really mean. This article shows you what the underlying assessments actually state and why raw material quality and dosage are crucial.

Such headlines are designed to generate attention, not to inform you in a sober and scientifically sound way. They deliberately use the so called negativity bias, our natural tendency to react more strongly to potential dangers than to neutral information. The resulting feeling of uncertainty motivates many people to click in order to calm the concern that was triggered.

Such headlines spread quickly. They appeal to a basic feeling we all know: the fear of unintentionally harming your health. However, it is worth looking behind such statements. What was actually assessed. Which data form the basis. And what does that specifically mean for you.

The key question is: How significant are the truly documented Ashwagandha risks and under which conditions do they occur.

Understanding Ashwagandha Risks

Ashwagandha, botanically Withania somnifera, is a plant with biological activity. In clinical studies, mainly standardized root extracts in dosages between 300 mg and 600 mg were investigated over 8 to 12 weeks. Among other things, changes in certain stress related parameters were observed.

Biological activity means that a substance can influence processes in the body. This generally requires that potential side effects are systematically examined. The crucial point, however, is whether documented Ashwagandha risks occur frequently, reproducibly and clearly dose dependently, or whether they are isolated events under heterogeneous conditions.

Ashwagandha Risks According to the Federal Institute

The German Federal Institute for Risk Assessment refers to possible health risks. Among others, the following are mentioned:

Individual reports of liver damage in temporal association with intake
Gastrointestinal complaints
Possible hormonal effects
Lack of systematic long term data

Important for interpretation is the following: No statistically confirmed evidence of frequently occurring severe liver damage at usual dosages in healthy adults is presented. The assessment is largely based on individual case reports and scientific uncertainties.

Study Situation on Ashwagandha Risks

Australia 2024:

12 reported cases of liver problems
7 with possible association
4 without other identifiable cause
Classification as very rare risk
16 cases of partly strong gastrointestinal reactions

These data show documented individual cases. They do not show a clearly reproducible pattern of typical dose dependent organ damage under usual use.

Denmark 2020:

Uncertainties regarding possible hormonal effects
Animal data with effects at very high dosages
Individual international liver case reports
Classification as not sufficiently safe food

No statistically relevant accumulation of severe side effects in the general population was identified. The decision was based on a precautionary regulatory assessment under uncertainty.

France 2024:

Individual documented liver cases
Very different product compositions
No clearly defined risk dosage

Here as well, product heterogeneity was central, not a consistent toxicological pattern.

Raw Material Quality and Dosage in Ashwagandha Risks

A central aspect that is often insufficiently considered in public discussion is product variability.

Plant part
Ashwagandha products may consist of root, leaf or combinations. Leaves may contain higher concentrations of certain constituents than the root. In many assessments, however, Ashwagandha is discussed in general terms without consistently differentiating by plant part.

Dosage
In clinical studies, mostly 300 mg to 600 mg standardized root extracts were examined. In documented case reports, however, the specific dosage or extract type used was not systematically analyzed.

Thus, two key influencing factors, namely raw material quality and dosage, were not consistently differentiated in the public presentation of Ashwagandha risks.

Ashwagandha Risks and Denmark

The food law classification in Denmark is based on the precautionary principle. Background factors were uncertainties regarding hormonal effects, animal data at high dosages and individual international case reports.

This decision does not mean that a statistically relevant number of severe side effects was identified in the general population. It means that regulatory uncertainties were evaluated strictly.

What Ashwagandha Risks Specifically Mean

The available data show:

Rare liver reactions in individual persons in temporal association
Partly pronounced gastrointestinal complaints
Biologically plausible hormonal effects

Not shown were:

Regularly occurring severe liver damage at usual dosages in healthy adults
A consistent dose dependent risk pattern with standardized root extracts
A statistically relevant accumulation of severe side effects in controlled studies

Our Quality Strategy at ASPRIVA

We use exclusively a pure root extract produced with a water based process. The extract is standardized to at least 5% withanolides and contains 0.06% withaferin A. Every batch is laboratory tested. This ensures that no leaf material is included, the composition remains reproducible and the dosage is traceable. This precise differentiation is essential when Ashwagandha risks are to be assessed realistically.