Ashwagandha

Withania somnifera, Indian winter cherry

Sold freely in United States and restricted in European Union. Same substance, same evidence, different decisions.

An Ayurvedic adaptogenic root sold for stress and sleep.

Ashwagandha shows how the same revered herb can be a food in one country, a traditional medicine in another, and a fresh safety concern in a third. Central to Ayurveda for centuries, it is a mainstream supplement in the US, an AYUSH medicine in India, and the subject of liver-safety warnings in some European countries, with its own home regulator recently tightening the rules on which part of the plant may be used.

Where it stands, jurisdiction by jurisdiction

United States
Open, sold freely
Decided on: Contested
A mainstream over-the-counter dietary supplement for stress and sleep. Under DSHEA, the FDA does not approve supplements before they are marketed; ingredients sold before October 15, 1994 are grandfathered, and newer botanical preparations follow the New Dietary Ingredient notification path. Ashwagandha faces no federal restriction, though the FDA can act against unsafe or misbranded products after they reach the market.
- FDA, Dietary Supplements
- FDA, New Dietary Ingredients in Dietary Supplements, Background for Industry
India
Open, sold freely
Decided on: Custom and history, Contested
A classical Ayurvedic medicine regulated by the Ministry of AYUSH under the Drugs and Cosmetics framework, where claims can rest on traditional texts, while also sold as a food supplement under FSSAI. In April 2026 the Ministry of AYUSH (15 April) and a following FSSAI advisory (16 April) directed that only ashwagandha roots and their extracts may be used, prohibiting leaves in crude, extract, or any other form over higher withanolide content such as Withaferin A and limited traditional oral-use history, a call industry has contested.
- FSSAI, Advisory on non-use of ashwagandha leaves in food products (April 2026)
- FSSAI, Advisories (official listing)
European Union
Restricted, restricted
Decided on: Precaution, Contested
There is no single EU-wide ruling; treatment varies by member state. Denmark holds that it is unlawful to sell food products containing ashwagandha, citing a 2020 risk assessment by the DTU Food Institute for the Danish Veterinary and Food Administration that could not set a safe intake for the root over concerns for sex hormones, reproduction, the nervous system, and metabolism. France's ANSES issued a 2024 opinion that stops short of a ban but advises against use by pregnant or breastfeeding women, minors, and people with thyroid, liver, or heart conditions. It sells more freely in other member states.
- Fødevarestyrelsen (Danish Food Authority), Ashwagandha i kosttilskud og drikkevarer
- ANSES, Avis relatif aux risques liés à l'utilisation des préparations de Withania somnifera (Saisine 2021-SA-0077)

Regulatory positions change, sometimes quickly. Check the date on a source before relying on it.