UK safety body to conduct risk assessment on ashwagandha

The UK’s FSA said of its call for further data, which took place between July and September,: “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.”

The open call for evidence from the country’s Committee on Toxicity comes after similar assessments were made by Danish (DTU) and Dutch regulators, questioning its quality and safety.

More recently, European scrutiny of ashwagandha (Withania somnifera) was the focus of Germany’s Federal Institute for Risk Assessment (BfR), which issued a warning last month of possible health risks to children, pregnant women, and people with liver complications.

UK does not have a safe limit for ashwagandha in food supplements

The UK agency said it was especially interested in receiving information on specialised formulations intended to modify the absorption or metabolism of the supplement as well as manufacturing processes.

The call also extended to information describing the types of products on the market and which were the most prevalent, as well as consumer information that helps better understand the audience.

Currently, the UK does not have a specific legally mandated safe limit for ashwagandha in food supplements. However, guidance is provided by regulatory bodies and industry standards.

The same applies to Germany with manufacturers ensuring the safety of their products through proper risk assessment. Some German health authorities recommend not exceeding 300-500 mg of ashwagandha root extract per day based on safety evaluations and traditional use.

Across Europe, Denmark tends to follow European Food Safety Authority (EFSA) recommendations with ashwagandha dosages varying between 200-600mg of the root extract per day, depending on the concentration of active compounds.

A ‘flawed’ DTU report resulted in RASSF notification

Commenting on the FSA’s plans Mark J. Tallon, chief executive officer at Legal Products Group said: “In the UK for the past 24 months, we have been defending the safe use of ashwagandha in food supplements.

“The issues in the UK started after a flawed DTU report that resulted in RASSF  [Rapid Alert System for Food and Feed] notification by Denmark in Feb 2022. Despite evidence to the contrary, the UK are now requesting evidence to demonstrate safety that will go forwards to a risk assessment.

“I can say so far there has been no assistance to clients that faced enforcement action when carrying generic or branded forms of ashwagandha.

“Now is the time for these firms to invest in a coherent defence or look to lose access of their products for lawful sale in the UK.”

Questions over the methodology of DTU’s report centre on claims that the herb could induce abortions and disrupt functions of sex hormones and the thyroid.

The research has since raised questions from researchers with a number of factors in the report highlighted that cast doubt over the conclusions drawn about ashwagandha.

AHPA reacts to FSA call for data

Commenting on its submission to the FSA, the American Herbal Products Association (AHPA), said: “AHPA remains committed to providing science-based guidance and supporting regulatory frameworks that ensure consumer safety while preserving access to widely used herbs such as ashwagandha.

“As global interest in this botanical continues to grow, AHPA encourages regulators to consider the full scope of scientific evidence and the herb's long-standing history of safe use.

“The association looks forward to ongoing collaboration with the FSA and other regulatory bodies to ensure transparent, evidence-based decisions that reflect the best available research on ashwagandha.”