Ashwagandha’s Regulatory Patchwork: What USA & Europe Buyers Need to Track in 2026

Ashwagandha is one of the few Indian botanicals that crossed from Ayurvedic tradition into mainstream Western supplement shelves almost entirely on its own momentum — driven by consumer interest in stress and sleep support. That popularity is exactly why the ingredient now sits under more regulatory scrutiny than almost any other herb India exports. If you’re importing ashwagandha into the US or Europe, the commercial opportunity is real, but so is the need to know exactly what’s shifting under your feet.

The root is fine. The leaf is where things get complicated.

In the EU, ashwagandha root is generally treated as a non-novel food ingredient, since it was on the market before the cut-off date used to define “novel” foods — meaning it can currently be used in food supplements without needing separate novel food authorisation. Ashwagandha leaf is a different story: it does not have that same pre-existing market history in the EU, and leaf-derived ingredients are not authorised as a food in the EU under current novel food rules. India’s own regulators have moved in the same direction — as of April 2026, the Food Safety and Standards Authority of India restricted the use of ashwagandha leaf in food products, supplements, and Ayurvedic formulations, and limited manufacture and export to root-only ingredients, following safety concerns linked to withaferin A concentrations in the leaf. For buyers, the practical takeaway is straightforward: confirm you’re sourcing root-derived ashwagandha, not leaf, and ask your supplier for documentation confirming this.

Europe: authorised, but under active review

Root-derived ashwagandha remains usable in food supplements across most of the EU today, but the picture varies by country and is genuinely in motion. Denmark has banned ashwagandha in food supplements outright since 2023, following a national risk assessment that raised concerns about effects on thyroid and sex hormones. Sweden has issued similar advice, and other Nordic and Western European food safety agencies have flagged comparable concerns. At the EU level, food safety authorities recommended in 2024 that a formal Article 8 safety procedure be opened — a process that, if it proceeds, could eventually restrict or ban ashwagandha in food supplements across the whole bloc. None of this has happened yet, but it means the regulatory ground in Europe is not settled, and a compliance position that holds today may not hold in twelve months.

The United States: a more stable, but still bounded, framework

The US market has not seen the same wave of national bans. Ashwagandha is generally imported and sold as a dietary ingredient under the US dietary supplement framework, which is less prescriptive on a botanical-by-botanical basis than the EU’s system, but does require supplements to be manufactured under Good Manufacturing Practice and to avoid disease-treatment claims on labelling. For US buyers, the more immediate practical question tends to be less about legality and more about supply-chain documentation: standardisation level (withanolide content, commonly supplied at 1.5%, 2.5%, or 5%), extraction method, and root-only sourcing paperwork that downstream brands increasingly ask for as part of their own due diligence.

What this means for how we supply it

Ekagya Exports supplies ashwagandha as whole root, root powder, and standardised root extract, with documentation confirming root-only sourcing in line with current FSSAI requirements. We’d rather flag this regulatory movement upfront than have a buyer discover it after a shipment has already left port — if your target market’s rules are still shifting, it’s worth building that uncertainty into your supplier conversations now rather than later.

This is a general market and regulatory overview, not legal advice — rules vary by country and are actively changing, so confirm current requirements with your own regulatory counsel or national food safety authority before finalising an import.


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