Before you start planning a new ashwagandha product line, pause for a moment. What is happening now at the international level could completely reshape the rules of the game. Here is a concrete analysis of the situation – without the marketing noise.
What the new alliance is and who is behind it
The newly established alliance is a coalition of extract manufacturers, supplement companies and research institutions with a single objective: to develop international quality standards for ashwagandha (Withania somnifera). The initiative is built on two pillars – raw material standardisation and the development of a scientific evidence base acceptable to regulators.
Why does this matter? Ashwagandha comes in dozens of variants – different plant parts, different extraction methods, different withanolide concentrations. The absence of uniform standards means that clinical studies conducted on one extract do not automatically apply to another. Regulators, including EFSA, have repeatedly identified this as an obstacle to assessment.
- Standardisation of withanolide content (the principal active compounds)
- Protocols for purity and contaminant testing
- Guidelines for clinical studies acceptable to EFSA
- Industry education on correct documentation practices
Expert Tip: In practice, manufacturers frequently source extracts from different suppliers without verifying whether the specifications are comparable. The result? Inconsistent product performance and problems when documentation is scrutinised during an inspection. The alliance aims to prevent this through certification.
Legal status of ashwagandha in the EU – the facts
Ashwagandha exists in a regulatory limbo. It is not prohibited, but it also has no authorised health claims within the meaning of Regulation 1924/2006. All applications for health claims have been placed on hold – EFSA has not issued a positive scientific opinion due to insufficient data.
What does this mean in practice? You cannot place on a label or in advertising any health claim such as "supports stress resilience" or "helps reduce cortisol levels". Any such statement violates Article 10 of Regulation 1924/2006 and may result in a GIS decision requiring product withdrawal.
- No authorised health claims (Articles 13 and 14 of Regulation 1924/2006)
- "On hold" status in the European Commission register
- Permitted for sale as a food supplement – but without health claims
- Risk of challenge by the Polish Chief Sanitary Inspectorate (GIS) where aggressive marketing is used
Expert Tip: Some manufacturers attempt to circumvent the prohibition by using formulations such as "traditionally used in Ayurveda for...". This is a risky strategy. The Polish Chief Sanitary Inspectorate (GIS) is increasingly treating such references as veiled health claims.
How the new standards could unlock health claims
EFSA has repeatedly identified specific deficiencies in the ashwagandha documentation. The principal criticisms are: inadequate product characterisation, heterogeneity of studies (different extracts, doses and populations), and a lack of data on the mechanism of action. The alliance is targeting precisely these gaps.
The plan involves creating a "master file" – comprehensive documentation that could serve as the basis for a fresh application for health claim authorisation. If the industry provides consistent data for a standardised extract, the prospects for a positive EFSA scientific opinion improve significantly.
- Harmonisation of extract specifications (e.g. minimum 5% withanolides by HPLC)
- Coordination of clinical studies according to EFSA-accepted protocols
- A central toxicological and safety database
- Joint funding of the authorisation process (costs in the order of hundreds of thousands of euros)
Expert Tip: The health claim authorisation process is a marathon, not a sprint. Even with perfect documentation, a minimum of 2–3 years elapses between submission of an application and a European Commission decision. Manufacturers should plan for the long term.
The most common mistakes made by supplement manufacturers with ashwagandha
Analysis of GIS decisions and RASFF notifications reveals recurring patterns of non-compliance. Most arise not from bad faith, but from a misunderstanding of the specific regulations governing ingredients without authorised health claims.
- Using health claims "quietly" – hiding them in website product descriptions rather than on the label does not protect against liability
- Citing scientific studies in marketing materials – this also constitutes an unauthorised health claim (Article 10(1) of Regulation 1924/2006)
- Absence of supplier specifications or incomplete specifications – during an inspection you must be able to demonstrate exactly what the product contains
- Declaring withanolide content without a certificate of analysis – this constitutes misleading the consumer
- Importing extracts from third countries without verifying novel food status – certain forms of ashwagandha may require authorisation
Expert Tip: Picture this scenario: a GIS inspection, and the inspector requests documentation confirming the product's composition. If your supplier sent only an invoice and a COA from two years ago – you have a problem. The certificate of analysis must relate to the specific batch of raw material used in the product.
What you can communicate right now – a compliant approach
The absence of authorised health claims does not mean you must sell your product in complete silence. There are lawful ways to inform consumers that do not infringe Regulation 1924/2006.
- The ingredient name and quantity – mandatory under Regulation 1169/2011
- Standardisation information (e.g. "extract standardised to 5% withanolides") – this is compositional information, not a health claim
- Plant part and extraction method – purely technical information
- Recommended daily intake – required for food supplements
- Warnings (pregnancy, lactation, interactions) – required and advisable
What to avoid absolutely? Anything that implies an effect on health: "supports", "helps with", "contributes to", "for people under stress", "for a good night's sleep". Even apparently neutral terms such as "adaptogen" are risky – they imply an effect on the body.
Expert Tip: The industry often asks: "What about influencers – can they say whatever they like?" No. Under Regulation 1924/2006, the prohibition applies to all commercial communications – including those commissioned from influencers. Liability rests with the business operator placing the product on the market.
How to prepare for the new standards – a manufacturer's checklist
Regardless of when the alliance finalises its guidelines, it is worth putting your documentation in order now. Manufacturers who do so early will have a competitive advantage when health claim authorisation eventually comes.
- Verify your supplier – do they hold GMP or ISO 22000 certification, and can they provide full supply chain documentation?
- Request detailed specifications – withanolide content (HPLC method), contaminant profile (heavy metals, pesticides, aflatoxins)
- Retain certificates of analysis for every batch – for a minimum of 5 years after the product's expiry date
- Monitor novel food status – check the European Commission's novel food catalogue regularly
- Document the doses used and their justification – this will be useful during an inspection or a future authorisation application
Expert Tip: There is a tendency in the industry to treat documentation as a formality. Yet when a dispute with an enforcement authority arises, it is precisely the documentation that determines the outcome. It is better to invest an hour a week in keeping records in order than to spend weeks appealing against enforcement decisions.
The timeline – when to expect change
Even under an optimistic scenario, authorisation of health claims for ashwagandha is at least 3–5 years away from the point at which a complete application is submitted to EFSA. The scientific assessment process takes 12–18 months, and a European Commission decision takes a further 6–12 months. Details of the industry's standardisation work can be followed on the IADSA (International Alliance of Dietary/Food Supplement Associations) website and in the EFSA claims register.
What should you do in the meantime? Build your market position on the basis of product quality, not aggressive marketing. Companies that risk penalties for unlawful health claims now may not survive long enough to benefit from authorisation.
Expert Tip: Experience shows that the food supplement market is cyclical. Ingredients come in and out of fashion. Ashwagandha, however, has solid scientific foundations – it is not a passing trend. Investing in regulatory compliance now will pay dividends when health claims are eventually authorised.