Will Ashwagandha Face a UK Ban?
Ashwagandha, known scientifically as Withania somnifera, is an adaptogenic herb traditionally used in Ayurvedic medicine where it is used to treat conditions including rheumatism, digestive issues, insomnia, and joint inflammation.
Adaptogens are plants which help the body respond to stress, anxiety, fatigue, and overall well being. Ashwagandha has become popular for its claimed benefits, including increased energy, and improved concentration. Despite its popularity, there are no established safe levels for its use in food supplements in the UK.
As a result, the Food Standards Agency has been looking for stakeholder views to build, what they call, an evidence package. This evidence package on ashwagandha food supplements, will be assessed through the FSA’s risk analysis process. Information received during the consultation will be reviewed and form part of the Committee on Toxicity’s wider consideration of food supplements containing Ashwagandha. The FSA’s statement concludes; “Outputs will include a risk assessment and evidence base which will inform any future risk management advice including possible risk management options to be presented to Ministers.” Several concerns have triggered this regulatory scrutiny:
Thyroid Imbalance: Ashwagandha may affect thyroid hormone levels, leading to potential thyroid toxicity. This is a significant concern as it can disrupt the body's endocrine system and cause various health problems.
Liver Impact: There have been reports of potential liver toxicity associated with Ashwagandha use, although rare cases of severe liver failure have also been documented.
Blood Sugar Fluctuations: Some research indicates that ashwagandha might lower blood sugar levels, which could be problematic for people with diabetes or hypoglycemia.
Drug Interactions: Ashwagandha's potential interactions with certain medications, such as immunosuppressants and sedatives, have also raised red flags.
Lack of Standardised Dosages: The current lack of standardised dosages for ashwagandha supplements adds to the complexity, making it difficult for consumers to gauge safe consumption levels.
Presently, the UK lacks specific safety limits for ashwagandha use in food supplements. The FSA's call for evidence aims to rectify this gap and inform future risk management strategies.
What are other countries doing about Ashwaghanda?
In 2020, the Technical University of Denmark (DTU) carried out several risk assessments 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. 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”. The Swedish Food Agency ruled last year that the Danish risk assessment could also be applied in Sweden.
The implications of the UK based review are far-reaching
Setting Safe Limits: The FSA might establish maximum permissible levels of ashwagandha in supplements to safeguard consumers.
Targeted Restrictions: Vulnerable populations, such as pregnant or breastfeeding women, individuals with pre-existing medical conditions, or those on specific medications, might face restrictions or warnings regarding ashwagandha use.
A Potential Ban: In an extreme scenario, if significant evidence of serious health risks emerges, ashwagandha could face a complete ban in the UK, following the footsteps of Denmark.
The Industry's Stance on Ashwagandha
The supplement industry has responded to these developments, emphasising ashwagandha's long history of traditional use and underscoring the need for sound scientific evidence to underpin regulatory decisions. Many stakeholders are actively participating in the FSA's call for evidence, aiming to demonstrate the herb's safety when used responsibly.
Awaiting the Verdict
The FSA’s consultation closed on September 2, 2024. The FSA's review will play a crucial role in the future use and sale of this popular adaptogen in the UK. Based on previous studies of other supplements an outright ban appears unlikely at this point, however there is the real possibility of stricter regulations and restrictions.
Until a definitive decision is reached, the FSA statement advises consumers to exercise caution and seek guidance from healthcare professionals before using Ashwagandha, particularly if they have any pre-existing health conditions or are taking medications. This proactive approach will help ensure their safety and well-being considering the ongoing regulatory scrutiny.
The current situation also highlights the broader need for a balanced approach to herbal supplements, prioritising consumer safety while also preserving access to natural remedies supported by robust scientific evidence. At Taylored Consultancy, we specialise in providing expert regulatory affairs consulting services to the food supplements industry across the UK and EU. We’d love to hear from you with any questions you have regarding Ashwagandha.
