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EU regulatory update on ashwagandha

Article-EU regulatory update on ashwagandha

© iStock/Azay photography EU regulatory update on ashwagandha
Ashwagandha has enjoyed a boom in popularity in recent years. But with EU member states instigating recalls and risk assessments, could this botanical’s bubble be about to burst?

An adaptogenic herb with an ancient history

Ashwagandha, or Withania somnifera, is an adaptogenic herb with a long history of use in Ayurvedic medicine, where it is used to treat conditions including rheumatism, digestive issues, insomnia, and joint inflammation. Most research has focused on the therapeutic effects of the root extract.

In recent years, it has exploded in popularity as a dietary supplement, with indications such as relieving stress and anxiety, promoting sleep, and boosting focus.

However, concerns have been raised over the safety of ashwagandha, with several European countries ordering recalls and risk assessments, according to industry experts.

Ashwagandha under scrutiny amid uncertainty over safe intake limits

In 2020, the Technical University of Denmark (DTU) carried out several risk assessment of ashwagandha in dietary supplements and decided that, based on the available data, it was not possible to establish a safe lower limit for intake. Scientists concluded that the root or extract of the root can have a negative effect on thyroid hormones and on sex hormones. Germany made a similar assessment.

Luca Bucchini, managing director at Hylobates Consulting, a scientific and regulatory consulting company, said ashwagandha was under growing scrutiny from EU member states.

In particular, Denmark has taken a very aggressive stance against the plant, based on risk assessment, ordering recalls and seizing products that are sold, even online, to Danish consumers,” he told Vitafoods Insights.

Danish risk assessment extended to other EU countries

Danish authorities have used the EU’s Rapid Alert System for Food and Feed (RASFF) to flag dozens of products containing ashwagandha that were being marketed online, judging the breach to be “potentially serious”. Examples of these Danish alerts included products being sold to consumers via DanishUK, and German websites although ashwagandha is authorised in the UK and Germany.

After several Swedish products containing high levels of ashwagandha were banned, the Swedish Food Agency ruled last year that the Danish risk assessment could also be applied in Sweden – although it is up to different municipalities to decide on individual cases.

“[Sweden] is giving similar advice, based on the potential for effects on sex hormones and thyroid hormones,” Bucchini added. “Sweden is less aggressive in enforcement.

But these concerns are shared by authorities elsewhere in Europe, too.

© iStock/iantphotoEU regulatory update on ashwagandha

It is speculated that Finland may take a similar approach,” he said. It is possible that these Nordic countries will raise the issue at the EU level in order to achieve a ban of the plant at the EU level.

Concerns based on very precautionary framework

Asked whether there was a possibility that ashwagandha could be banned in the EU in the future, Bucchini said: “Other member states have restrictions on the plant, such as France, which limits the sales to pharmacists, or Poland [...]. Germany had expressed concerns through risk assessment."

Polish authorities have established maximum levels for ashwagandha, stating the root powder could be used at a maximum amount of 3 g per day and that the maximum withanolide content may not exceed 10 mg in the recommended daily portion of the product, while Germany's Federal Institute for Risk Assessment (BfR) featured ashwagandha in a 2013 report although the botanical extract can be sold there.

So this traditional plant may face limitations in the near future, unless the scientific concerns, based on a very precautionary framework, are not dispelled," Bucchini said.

But he added:It should be noted that member states with most experience with botanicals, and a less important herbal medicine industry, do allow the plant.

In order to defend ashwagandha, this is certainly the time to act, in terms of scientific evidence and assessment, and to explain that a proportionate approach is needed.


This article has been amended to clarify that UK and German ashwagandha products were the subject of RASFF alerts that were issued by Denmark, not by British or Danish authorities, and to add information regarding Poland and Germany.