There is growing interest and use of ashwagandha (Withania somnifera) around the world, but some European countries have expressed concerns about the Ayurvedic herb, despite a long history of safe use.
As reported previously by NutraIngredients, the UK Food Safety Agency (FSA) launched a consultation into the herb on July 8, welcoming data from food business operators (FBOs) who manufacture, process, distribute, use, sell or import food supplements containing ashwagandha, as well as any other experts or researchers within the field.
The purpose of the call for evidence is to build an evidence package on ashwagandha which will be assessed through the FSA’s risk analysis process and inform any future risk management advice and actions.
AHPA submission highlights ashwagandha's Botanical Safety Handbook entry, research and history of traditional use. The comments were signed by Holly Johnson, PhD, AHPA’s chief science officer, and Jane Wilson, its director of program development.
Details
Focusing on FSA's request for “any available information/data on the safety assessment of food supplements containing ashwagandha, including toxicological testing and relevant toxicological data” as specified in the call for evidence, AHPA's submission includes comments on:
• Botanical safety: In the most recently updated entry for ashwagandha in the online edition of AHPA's Botanical Safety Handbook, 2nd Ed., AHPA classifies ashwagandha as a Class 1 herb (safe for consumption when used appropriately) with Class A interactions (no expected clinically relevant interactions).
• Hepatotoxicity concerns: AHPA reviewed 14 cases linking ashwagandha to liver toxicity. However, insufficient botanical identification, dosage information, and inconsistent assessment methods across the case reports make it difficult to confirm a causal link.
• Abortifacient claims: Concerns over ashwagandha as an abortifacient are traced to an incomplete interpretation of historical and ethnobotanical reports. Traditional use of ashwagandha, as well as recent research, do not substantiate these claims.
• Global usage: Ashwagandha's global market presence has surged, potentially leading to more reported cases of adverse effects, though AHPA suggests these could be idiosyncratic.
• Scientific research: New studies, including 90-day toxicity assessments, may contradict earlier reports in which toxicity concerns were raised. Further, ashwagandha is one of the most researched botanicals with a long history of use in traditional Ayurvedic medicine as well as in contemporary food supplement products.
In an update from the association, AHPA said it “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.”
A long history of safe use
Ashwagandha has a history of use in ayurvedic medicine that dates back as much as 4,000 years to the teaching of renowned scholar Punarvasu Atreya and in subsequent works that make up the ayurvedic tradition, according to a monograph from the American Herbal Pharmacopoeia (AHP). The name of the herb derives from Sanskrit, and means “smells like a horse”, which refers to the strong smell of the root which is said to be redolent of horse sweat or urine.
Ashwagandha root is a well-known adaptogen—a substance believed to increase the body’s ability to adapt to different forms of stress.
Call for papers for Phytotherapy Research
An independent initiative is also underway to collect scientific papers about ashwagandha for a special issue of Phytotherapy Research.
Dr. Thomas Brendler from the University of Illinois and Prof. Jo Barnes from the University of Auckland in New Zealand are the guest editors for the special issue that is seeking reports of primary investigations and robust reviews that address the various concerns around ashwagandha.
To watch our interview with Dr. Brendler, please click HERE.