Ashwagandha science, regulation and transparency

Ashwagandha is one of the most extensively researched botanicals used in the supplement industry.

Traditionally used in Ayurvedic medicine, it is now being studied in relation to sleep, stress, cognition and more. At the same time, ashwagandha is coming under increasing regulatory scrutiny, raising questions around standardisation and compliance.

The global ashwagandha supplements market was valued at US$721.5m in 2024 and is projected to reach US$1.53bn by 2033.¹ This growth is being driven by increasing consumer demand for natural solutions that support stress management, sleep and overall wellbeing.

As demand grows, so does scrutiny, with increasing attention paid to extract standardisation, product quality and supply chain transparency.

In a recent Spotlight On in partnership with Ixoreal Biomed, ‘Ashwagandha: Science, regulation and transparency’ experts including Dr Tieraona Low Dog, MD, ABOIM and founding member of American Board of Integrative Medicine; Mari Lyyra, regulatory affairs manager, Medfiles Ltd; Tom Johnsson, founder of Swedish brand Medicine Garden; Jordan Rubin, formulator and founder of Garden of Life and Beyond Organic and Ancient Nutrition; and Ewa Hudson director of insights, Lumina Intelligence, examined the science behind the herb, the consumer need and regulatory considerations shaping the category’s future.

Linking traditional use cases and modern science

Dr Tieraona Low Dog looked closely at the growing body of clinical evidence surrounding ashwagandha root extract KSM-66 and noted that modern research is increasingly exploring and helping to validate some of the uses that have long been associated with traditional herbal medicine. According to Ixoreal Biomed, KSM-66 has undergone more than 90 clinical studies, making it one of the most extensively studied ashwagandha ingredients for both safety and efficacy.

“We saw modern science literally supporting traditional use here,” Low Dog said when discussing research based on KSM-66 root extract, investigating stress and cortisol management.

This includes a 12-month safety study, a 12-week high-dose study at 2,000 mg/day^, and a large global study involving more than 1,000 participants.^2-4 Together, these studies demonstrate that KSM-66 has been evaluated across longer durations, higher doses and a large participant population, making it one of the most comprehensively studied ashwagandha root extracts from a safety perspective.

“What is particularly important is that the research has examined not only efficacy, but also safety across longer durations, higher doses and large participant populations,” said Low Dog. “That breadth of evidence gives formulators and consumers a more complete understanding of the specific extract.”

Low Dog examined evidence across multiple areas, including stress management, sleep quality, cognitive function, sports performance, healthy ageing, men’s health and women’s wellbeing. She also emphasised the importance of understanding exactly which extract is used in clinical research.

“Not all root extracts or ashwagandha extracts are equivalent,” said Low Dog. “We want to know if we’re looking at the clinical research, what was the clinical research done on? Is the extract reproducible and is the research reproducible?” KSM-66 is a root-only extract with 5% total withanolides, produced by a green chemistry extraction process. It also has a fully integrated vertical supply chain.

Discussing the relevance of adaptogens for consumers in today’s increasingly busy and demanding world, Low Dog described how certain botanicals may help support the body’s ability to cope with everyday stressors.

“There are plants that help the body increase its capacity, widen the margin for resilience, and over time allow people to manage their stress more effectively… Ashwagandha is the most calming of the adaptogens,” she continued.

Consumer demand for stress and sleep support

As consumer interest in ashwagandha increases, the opportunity for evidence-backed ingredients that have been researched in relation to benefits for improving sleep and stress grows.

Jordan Rubin, natural health expert, formulator and founder of Garden of Life, Ancient Nutrition and Beyond Organic, believes ashwagandha is a vital ingredient in the formulator’s toolbox. He explores the category, and looks at KSM-66’s performance specifically, in a SPINS data in the video below.

Ewa Hudson, Lumina Intelligence, presented new data that highlighted sleep as the leading health concern across genders and age groups with stress ranking second among health concerns. And according to the research, consumers experiencing higher levels of stress are increasingly turning to adaptogens, including ashwagandha, as part of their wellbeing routines.⁵

“The older we become, the more we look at our diet and supplementation, and it actually over indexes here as we’re hitting 30,” Ewa explained. “By recognising how wellness routines change with age and showing up as a consistent, supportive partner alongside these daily activities, brands can actually become truly trusted partners.”

This growing interest in adaptogens is something Jordan Rubin has observed during more than 25 years in the supplement industry as a formulator. Drawing on SPINS market data, Rubin highlighted the growth of products containing KSM-66 across both in bricks-and-mortar retail stores and ecommerce channels.

“Eight out of the 10 fastest growing brands of ashwagandha [are] utilising KSM-66 as their premier ingredient… on Amazon out of the best-selling ashwagandha products, the only branded ingredient that is used is KSM-66 Ashwagandha,” said Rubin. “And most importantly, [it’s] backed by dozens of randomised controlled trials and truly represents an ingredient for this generation.”

Regulatory considerations

Alongside the growing consumer interest in ashwagandha, regulatory developments are becoming increasingly important for the sector.

Mari Lyyra, regulatory affairs manager at Medfiles, a consultancy that works with companies across the food and supplement sectors to navigate regulatory frameworks, provided an overview of the current European landscape, explaining that while ashwagandha is not considered a novel food ingredient in the EU, questions continue to be raised around safety assessments, extract characterisation and differences between plant parts.

Lyyra set out the different phytochemical profiles of different plant parts. “It’s clear that root and other plant parts need to be separated and more characterisation, and safety data on different ashwagandha parts and products and extracts is needed,” she said.

Lyyra also discussed ongoing regulatory reviews taking place across Europe and noted that any future EU-wide assessment process could take considerable time to complete.

For manufacturers and formulators, this underlines the importance of ingredient labelling, supply-chain transparency and robust safety data as the category continues to mature. There have been reports of ashwagandha adulteration globally, highlighting the importance of robust quality controls, accurate labelling and supply-chain transparency. KSM-66 positions its vertically integrated supply chain as a means of supporting traceability and consistency.⁶

Formulator’s viewpoint

As regulatory scrutiny increases, transparency around sourcing, standardisation and ingredient selection is becoming increasingly important for brands operating in the category.

In this Spotlight On, Tom Johnsson explored the ingredient from a formulator’s standpoint. As founder of the Medicine Garden brand, he talked about the benefits of using KSM-66 Ashwagandha:

“We have been working actually 40 years in the health industry and we’ve always been focusing on adaptogens… But we have never, ever worked with a supplement that gives so much positive feedback from the consumer,” said Johnsson.

“The main reason why we [use] it is of course what it can do for the consumer, but it’s also that the very even grade of extraction makes it very easy to flow in the capsule. There are no additives into the capsules. So we can use clean label, and that is also very important for us.”

To discover more about KSM-66’s scientific studies and why transparency is so important in the face of category regulation, watch Ashwagandha: Science, regulation and transparency on demand now.

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