Call for evidence signals potential changes to UK regulations surrounding use of ashwagandha

Suppliers and manufacturers of products containing ashwagandha must pay attention to potential changes regarding regulation of the herb in the United Kingdom. At present, there are no safe levels established or set limits for its use in food supplements, prompting the UK Food Standards Agency (FSA) to open a call for evidence to help inform any future risk management advice.

Ashwagandha (Withania somnifera) is a herb originally used in ancient Indian ayurvedic medicines, and has continued to be used for thousands of years to relieve stress, increase energy and improve concentration. As natural ‘alternative’ remedies have grown in popularity, ashwagandha is reaching new levels of demand. In fact, the ashwagandha industry is projected to skyrocket from US$53,538,910 in 2023 to US$128,912,320 in 2031 (1). As the use and popularity of ashwagandha continues to rise, governments around the world are evaluating its properties and potential risks.

In April 2023, Denmark made the decision to ban the use of ashwagandha in dietary supplements, stating that it was unable to establish a safe dose. The ban was based on a finding by the Danish Technical University (DTU) that ashwagandha has ‘a possibly harmful effect on thyroid and sex hormones’ (2). Sweden and Finland are considering following Denmark’s lead.

The FSA’s call for evidence follows a request from the Committee on Toxicity to create a risk assessment for ashwagandha. The UK currently has no safe limit established for the use of ashwagandha, and if the FSA’s call for data establishes that limits need to be put in place, stakeholders of ashwagandha food supplements could be affected.

If your company manufactures or supplies ashwagandha food supplements, this is your opportunity to provide research and help inform the regulatory future of ashwagandha. Visit the FSA website for details on the evidence required, as well as submission details. Responses are required by close of September 2, 2024.

For help navigating regulations surrounding ashwagandha, including gaining authorisation as a novel food, please get in touch at [email protected]. Leatherhead’s team of experienced scientists and regulatory experts can support you every step of the way.

Leatherhead Food Research Members will be kept up to date with the latest ashwagandha regulatory news via our weekly Global Legal Highlights newsletter. To learn more about membership, get in touch with our membership team at [email protected] 

References:

1. Ashwagandha Market Size, Demand, Scope & Growth Drivers By 2030 (databridgemarketresearch.com)

2. Why did Denmark ban Ashwagandha? | Office for Science and Society - McGill University