The UK could be the next country to clamp down on Ayurvedic superfood ashwagandha.
The government’s Food Standards Agency (FSA) has issued a call for data from stakeholders to build up an evidence package, which will inform any future risk management advice.
Companies who manufacture, process, distribute, use, sell or import food supplements containing the herb are encouraged to participate.
The FSA is also requesting the involvement of experts, trade organisations, international organisations, local authorities, consumers and those undertaking relevant research.
Ashwagandha (Withania somnifera) food supplements have soared in popularity thanks to their association with stress and anxiety relief, promoting sleep and boosting focus.
Also known as Indian ginseng or winter cherry, ashwagandha roots have been used for centuries in Asian cultures and Indian traditional medicine systems.
The FSA’s call for responses opened 8 July and will close 2 September 2024, with interested parties requested to send evidence to ashwagandha-callforevidence@food.gov.uk.
The UK agency indicated it was especially interested in receiving:
- Information/data on the safety assessment of food supplements containing ashwagandha, including toxicological testing and relevant toxicological data;
- Any testing that has been carried out that informs the safety and stability ashwagandha in its proposed use;
- Any scientific evidence used to support claims being made;
- Any sourcing information and specifications of the plant part material used;
- The final product’s full list of ingredients (including ratios/percentages) and specification. This also includes any available information on levels of contaminants in the final product;
- Information on the types of products on the market and which are the most prevalent;
- Any information on the specialised formulation that is intended to modify the absorption or metabolism of the supplement, eg, nanoformulation;
- Any relevant information regarding the manufacturing process, including control processes used, such as testing for pesticides, contaminants, etc; and
- Consumer information to better understand the audience. Any information specifically related to consumption/sales to pregnant women or children.
Ashwagandha industry responds
The UK’s move follows a 2023 ashwagandha ban in Denmark.
The results of several risk assessments of ashwagandha in dietary supplements, carried out by the Technical University of Denmark (DTU) in 2020, led the Danish Veterinary and Food Administration (DVFA) to decide it was impossible to establish a safe lower limit for intake.
Risk assessments conducted through literature reviews have shown association with effects on thyroid hormone levels and reports of thyroid toxicity; hypoglycaemic effects; and potential liver toxicity.
Sweden and Finland are now also considering banning ashwagandha as a supplement ingredient.
Poland, meanwhile, has set maximum levels for daily intake at 3g per day, and France, like the UK, is evaluating the potential risk of including it in supplements.
However the DTU report underpinning Denmark’s decision has come under criticism, most recently from a white paper published this month in the Journal of Ayurveda and Integrative Medicine.
The five Indian academics authoring the new report, titled ‘Danish ban on Ashwagandha: Truth, evidence, ethics, and regulations’, said the original DTU report “does not seem to be peer-reviewed”, while “the credentials of the authors, funding sources and conflict of interests are not disclosed”.
They added: “Although the mandate from DVFA is on ashwagandha roots, it draws conclusions from studies on whole plants, stems, leaves, fruits/berries clearly irrelevant to this case.”
The authors further noted that because the DTU report could influence the decisions of more countries, India’s Ministry of Ayush, which regulates the educational standards of the Indian Systems of Medicine and Homoeopathy colleges in the country, has released an Ashwagandha Safety Dossier 2024, presenting “robust scientific evidence on [the] safety and efficacy of ashwagandha roots”.