September 18, 2024 AHPA's submission highlights ashwagandha's Botanical Safety Handbook entry, research, and history of traditional use Amid growing interest and use of ashwagandha (Withania somnifera) around the world, the American Herbal Products Association (AHPA) has submitted comments to the United Kingdom Food Standards Agency's (FSA) call for evidence for ashwagandha issued this year. FSA – the government agency responsible for protecting public health in relation to food in England, Wales and Northern Ireland – issued the call for evidence to “gather information on ashwagandha food supplements in order to build an evidence package which will be assessed through the FSA's risk analysis process.” 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. 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.
Advocacy
AHPA advocates the U.S. Congress; state governments; FDA; FTC; USDA; FWS; NIH; NCCIH; U.S. Pharmacopeia and others for effective laws and regulations that promote the responsible commerce of herbal products.
News
AHPA informs members and the industry about news and issues through daily email alerts and a monthly newsletter. AHPA also promotes the benefits of herbs to mainstream and industry media as well as scientific journals.
Events
AHPA regularly produces in-person and online educational events featuring industry-leading experts discussing regulatory and technical issues that impact the herbal product industry.
Resource Library
AHPA provides Guidance Documents, Policies, Trade Requirement, and Reference Materials to help members comply with the herbal industry laws and regulations.
Events
-
8Oct
AHPA Workshop - Microbiology Essentials for Botanicals and Dietary Supplements
10/8/2024 to 10/9/2024 EDT
-
28Oct
SupplySide West 2024
10/28/2024 to 10/31/2024 PDT
-
29Oct
AHPA Member Reception
5:30 PM to 7:30 PM PDT
AHPA Annual Fund Sponsors
AHPA has no responsibility for any transaction entered into with any of these companies.