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Expandly Blog

Ashwagandha Leaf Ban: EU Supplement Brand Compliance Guide 2026

New EU customs rules from July 2025 will increase landed costs on orders under €150 — here’s what it means for your brand.

In This Article

01The FSSAI advisory and what it restricts
02Markets with active bans or proposals
03The withaferin-A safety concern
04Industry response and EFSA signals
05What US brands need to do now
06How Expandly supports EU market entry

Key Takeaways

►EU sports nutrition grows to $9.64bn by 2031 at 8.35% CAGR
►US brand credibility in this category is an established advantage
►Regulatory compliance window is open now — before harmonisation tightens
►Novel Food and labelling checks must happen before products move to EU warehouse

India's food regulator issued an advisory on April 16, 2026 restricting ashwagandha leaf in any form in food products — permitting only root-derived material. The decision by India's Food Safety and Standards Authority (FSSAI) adds the world's largest ashwagandha-producing country to a growing list of jurisdictions acting against leaf-derived formulations. Denmark has an existing ban. The Netherlands has a formal proposal on the table. EFSA has a safety assessment running since 2024. The regulatory direction is now consistent across multiple markets.

3 markets now have active bans or formal proposals restricting ashwagandha leaf — Denmark, the Netherlands, and India — with EU-wide and UK assessments ongoing. Source: FSSAI / NutraIngredients Europe, April 2026.

The safety concern centres on withaferin-A, a compound found in higher concentrations in ashwagandha leaf than in root material. Denmark's ban and the Netherlands' proposal both cite liver toxicity risk — particularly for children, pregnant women, and people with existing liver conditions. Germany's BfR has issued targeted warnings for these same groups. India's FSSAI advisory specifically cites higher withaferin-A concentrations in leaf material as the basis for restriction.

Industry response has been mixed. Kerry Group published research the day before the India ban, claiming their Sensoril root and leaf extract was safe at 19 times the standard supplemental dose. This is significant, but it must be read in context: the study is industry-funded, and the EU's operative signal will come from EFSA's formal assessment — not from individual safety studies. For brands selling into EU or UK markets, the prudent default is root-only formulation. Relying on counter-research during a regulatory review carries real market entry risk.

For US supplement and sports nutrition brands planning European market entry, this is a formulation review moment. Ashwagandha appears across recovery, endurance, stress-response, testosterone-support, and general wellness formulations. Identifying leaf-derived material now — before a brand invests in EU setup — avoids a much more costly reformulation problem after the fact.

  • Root-only ashwagandha is the safe standard for any EU or UK market entry. Leaf-derived material carries active regulatory risk in Denmark (banned), the Netherlands (formal proposal), and India (banned April 16, 2026).
  • EFSA's formal safety assessment has been running since 2024. Its conclusion will be the operative EU-level signal and may precede new maximum levels for specific withaferin-A concentrations.
  • The UK FSA is conducting an ongoing review. Brands treating the UK as a simpler alternative to EU entry should include ashwagandha leaf in their UK compliance checklist.
  • Industry-funded safety data does not override national regulatory actions. Kerry Group's counter-research is useful context, not a compliance green light for leaf-derived formulations.
  • Conduct a formulation audit before EU or UK market setup begins. Reformulating after market entry is significantly more disruptive than catching it in the onboarding phase.

Expandly works with supplement and wellness brands on EU product compliance from day one, including formulation guidance and label reviews as part of the onboarding process.

Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled. We’ve supported 2,000+ brands make the move.

Find out more
  • VAT registration handled across UK, Germany, Netherlands and all EU markets
  • EPR compliance managed from day one — packaging, WEEE, batteries and beyond
  • EU fulfilment from our Netherlands warehouse — fast access to the whole continent
  • IOSS registration and management for DTC shipments under €150

The bigger picture

What Europe's sports nutrition growth signals for US active lifestyle brands.

The $6.61 billion figure is the current market — not the opportunity. The opportunity is that European consumers already recognise and seek out US sports nutrition brands, the category is growing faster than regulatory frameworks, and the infrastructure to enter the EU market properly is more accessible than most US brands realise. The compliance setup — Novel Food checks, maximum levels review, EU-format labelling — is a one-time project that unlocks a multi-year market position.

  • Novel Food status checks and maximum levels review are part of Expandly's compliance onboarding for sports nutrition brands entering the EU.
  • EU-format labelling — nutrition facts panel, permitted health claims, ingredient INCI names — is a deliverable before products go live, not an ongoing brand task.
  • Netherlands and Germany are the primary entry markets for sports nutrition brands — both show strong consumer demand data that supports the market investment case.

EU Sports Nutrition Market

Europe's fitness market revenue grew 9.1% in 2025 to €39.1bn — with 64% of Europeans regularly participating in fitness activities. Sports nutrition is the fastest-growing spend category within that base.

€39.1bn

EU fitness market revenue, 2025 — up 9.1% year-on-year

EU Supplement Compliance

Sports nutrition products sold in the EU must comply with the Food Supplements Directive and Novel Food Regulation. Ingredients not on the EU authorised lists require Novel Food authorisation before sale.

27

EU member states covered under a single EU compliance review at onboarding

Compliance-First Onboarding

For sports nutrition brands, Expandly begins with ingredient-level EU compliance — Novel Food checks, maximum levels, label format — before stock moves to the Netherlands warehouse. Brands launch knowing their products are cleared.

2,500+

brands expanded with Expandly

If this sounds like your world,
let's talk.

Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled.

Self-Serve

  • £1,150/month
  • Platform-led with email support
  • Best for: $1M–$5M brands

Guided

  • £3,000/month
  • Dedicated Account Manager
  • Best for: $5M–$20M brands

VIP

  • £5,000/month
  • Dedicated VIP Consultant
  • Best for: $20M–$50M+ brands
See full pricing and what's included