With over 3000 years of traditional use, Ashwagandha (Withania somnifera) has evolved into one of the most commercially significant adaptogens on the market.
The plant’s roots and leaves contain bioactive compounds known as withanolides, which have been studied for their potential role in areas including stress reduction, sleep support, cognitive health, and sports performance. As a result, it is now used widely across supplements, functional foods, and beauty products.
Market analysts expect consumer interest in supplements containing the adaptogenic herb to continue to grow, with projections suggesting the category will reach $2.01bn globally by 2035, up from $837.5m in 2025, a CAGR of 9.17%.1
Much of the scientific research surrounding ashwagandha has focused on both the safety of the ingredient, and from a mechanistic perspective, its interaction with the hypothalamic-pituitary-adrenal (HPA) axis, the body’s central stress‑response system. Research has explored the botanical’s support for stress management, sleep, and cognitive health, although differences in extract composition and standardization approaches remain an ongoing topic of discussion within the category.
Regulatory questions
Alongside its commercial success, ashwagandha is facing intensifying scrutiny from authorities. Concerns have been raised by regulators around long-term safety, potential thyroid and reproductive effects, and uncertainty over safe intake levels. The US National Center for Complementary and Integrative Health has also noted rare cases of liver injury.2
Denmark introduced restrictions on ashwagandha in 2023 following concerns around establishing safe intake thresholds. In 2024, national food safety authorities across Europe urged the European Commission to initiate an Article 8 assessment – a move that may confirm ashwagandha’s safety and reassure national regulators, or potentially lead to EU-wide guidelines or restrictions.
The TGA in Australia concluded that there was a very rare risk of liver injury with ashwagandha and advises consumers to be aware of potential gastrointestinal adverse effects and the possible risk of liver injury in very rare cases.3
Industry stakeholders point to variability in extracts with plant part, extraction method, characterization and product specific substantiation all adding to this, creating challenges when comparing products and interpreting resesearch findings.4 These differences sit at the heart of ongoing discussions around standardization, product quality, and how evidence should be interpreted across the category.
For manufacturers, this creates questions around formulation strategy, market access, and future investment decisions. The result is a fragmented landscape where brands must navigate differing national interpretations, evolving safety assessments and extract-specific considerations.
Industry response: Clarity, quality, and communication
With regulatory uncertainty mounting, industry stakeholders are stepping forward to address gaps in scientific communication and quality assurance. In May 2026 an industry led initiative, Safeguard Ashwagandha, was launched with support from leading manufacturer Kerry, this platform is designed to centralize peer-reviewed research, ensure public access to safety data, provide updates on regulatory developments and a live regulatory tracker outlining permitted uses across global markets.
The initiative reflects a broader industry push toward standardization – particularly around withanolide content, extraction methods, analytical testing, and traceability. As the category expands, many stakeholders argue that greater alignment around these will play an important role in supporting consumer trust and regulatory compliance. Indeed, the future of the category may depend on whether industry can build greater alignment.
Join our event
In partnership with Kerry, NutraIngredients is hosting a Spotlight On ‘Ashwagandha: Understanding the Science, Scrutiny and Standards’. The broadcast will examine whether greater alignment around science, standards, and quality can help the industry navigate regulatory scrutiny to support the category’s growth.
During the Spotlight broadcast you will:
- Explore the clinical science behind ashwagandha with botanical quality and standardization expert Dr Thomas Brendler.
- Gain clarity on the regulatory pressures surrounding the ingredient from food lawyer Dr Mark Tallon.
- Learn how standardization and analytical testing can support greater consistency across botanical products from Petra Erlandson, VP of Sales at Alkemist Labs.
- See how brands are merging traditional knowledge with modern clinical validation with Dr Laura Collins, RDA Director of Cognitive Health at Kerry.
- Learn how brands are approaching ingredient selection, quality assurance and consumer demand in an increasingly scrutinized category with Jason Watkin, CEO of Canadian wellness brand Purica.
References
- Pandey, D. Ashwagandha Market Size, Share and Trends 2026 to 2035, Precedence Research.
- National Center for Complementary and Integrative Health, Health Info, Ashwagandha.
- Australian Government, Department of Disability, Health and Ageing, Herbal preparations containing Withania somnifera (Withania, Ashwagandha).
- Domián, B. M.; et al. The ashwagandha paradox: a mixed-methods analysis of regulatory gaps, deceptive vendors and safety risks in the European online market. Applied Food Research, Volume 6, Issue 2, December 2026, 102444.