In use for over 3,000 years, the popular Ayurvedic herb (aka Withania somnifera) has been used in supplements for years, with touted benefits including its ability to improve muscle strength, thyroid function, cardiorespiratory endurance, blood sugar levels, and boost fertility.
In the last few years, it is increasingly being incorporated into functional food and supplement products thanks to its potential cognitive health benefits, with inclusion in products aiming to support sleep and relieve stress.
Because there are no harmonised EU rules on herbal extracts as food supplements (unlike for vitamins and minerals), it is up to national authorities to decide whether a product is safe, and which category it falls under (ie. whether it is a food supplement or medicinal product).
And recently botanical preparations are coming under increasing scrutiny and a growing number are being added to the list of substances prohibited, restricted, or scrutinized.
Danish risk assessment extended to other EU countries
As with a number of botanical supplements, the potential risks of consuming Ashwagandha have been discussed for a long time, with some of the purported side effects of this herb including stomach upset, liver damage, and very low blood sugar levels.
As a result of these concerns, in 2020, the Technical University of Denmark (DTU) carried out several risk assessments of the plant in dietary supplements. The conclusion of these was that the root or extract of the root can have a negative effect on thyroid hormones and on sex hormones. The team concluded it is not possible to establish a lower safe dose of the ingredient.
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”.
As a result, other Nordic countries are considering following Denmark, using the same assessment.
For example, after a number of Swedish products with high levels of ashwagandha were banned in Denmark, the issue has become topical in Sweden.
IADSA also noted in its news bulletin this month that Finland is considering a ban on ashwagandha, based on the Danish ban.
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) also revealed in its ‘Nutrivigilance 2020-2021 Activity Report’ that expert appraisals were being initiated into the risks associated with the use of turmeric, Garcinia cambogia, and Ashwagandha in food supplements.
Meanwhile, 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.
Amongst the uncertainty, companies are being advised that the primary responsibility for ensuring that food is safe for consumers lies with them. The Swedish Food Agency states on its website: "Companies that want to release products with ashwagandha on the market could demonstrate that the products are safe, for example by conducting or referring to studies themselves".