UK FSA opens call for ashwagandha safety data due to “potential health risks”

11 Jul 2024 --- The UK’s Food Standards Agency (FSA) requests stakeholder views on ashwagandha supplements to build an evidence package for future risk management advice. The organization underscores its awareness of “potential risks to health from consuming ashwagandha in food supplements.” 

The FSA is seeking evidence to support its request for a risk assessment on the botanical from the country’s Committee on Toxicity. This evidence will determine whether a safe level of ashwagandha for use in food supplements can be established and assess the risk associated with consuming ashwagandha-containing supplements. 

The call is open until September 2 for food business operators, experts in the field, trade organizations, international organizations, local authorities, consumers and those researching a topic related to this call for evidence.

Specifically, the FSA encourages companies that manufacture, process, distribute, use, sell or import ashwagandha-containing supplements to participate. 

Health risks 
Ashwagandha (Withania somnifera) is used in traditional remedies and is increasingly popular as a food supplement to relieve stress and anxiety, promote sleep and boost focus. 

The FSA highlights that risk assessments in literature reviews have shown “association with effects on thyroid hormone levels and reports of thyroid toxicity, hypoglycemic effects and potential liver toxicity. ”

After a 2020 safety assessment, the botanical has been prohibited in Denmark. The Finnish Food Safety Authority is deliberating whether to follow the Danish decision. 

The UK has not established or set limits for ashwagandha’s use in supplements. For all other food uses, ashwagandha plant parts are considered “unauthorized novel foods,” companies that want to include the botanical in foods other than supplements need authorization before introducing them to the UK market. 

Earlier this year, Nektium-backed research highlighted ashwagandha’s anti-stress benefits and product safety. However, the study’s authors cautioned there were no systematic clinical studies to examine the plant’s potential acute or chronic toxicity. 

Requested evidence 
The FSA has set up a list of evidence it would like to receive. This includes “any available data on the safety assessment of food supplements containing ashwagandha,” such as toxicological testing and data. 

Moreover, the organization would like to receive data on testing on ashwagandha’s safety and stability and scientific evidence to support claims. 

It would also like to learn more about sourcing and manufacturing of the botanical, its extracts and supplements. Additionally, the FSA would like to receive the complete list of ingredients and specifications for final products and “any information on the specialized formulation that is intended to modify the absorption or metabolism of the supplement.” 

Finally, the organization requests consumer and market information, such as market or sales data on ashwagandha-containing supplements and “any other pertinent information or issues concerning these products.”