Navigating ashwagandha: balancing safety, consumer demand and regulatory concerns

Ashwagandha (Withania somnifera) is one of the ancient Indian ayurvedic medicines, and its roots have a long history of use an as adaptogen. It is used for its neuroprotective and anti-inflammatory properties; some studies have been carried out to understand the modes of actions, investigating such effects. For instance, a randomised, double-blind, placebo-controlled study (2) conducted a few years ago concluded that an ashwagandha root aqueous extract was beneficial in reducing stress and anxiety.

This ayurvedic herb, along with others such as neem, brahmi and tulsi, are gaining traction with consumers as they are perceived as being a plant-based and ‘natural’ alternative to chemical and synthetic medicines. It is this universal consumer demand that food supplement companies are tapping into. But these companies need to watch the ashwagandha space in order to finetune their pathways for successful launches and promotions.

In April 2023, Denmark made a decision to ban ashwagandha in dietary supplements, and concluded that, based on available data, it was not able to establish a safe lower limit for intake. It also went far to say that “…ashwagandha has a possibly harmful effect on thyroid and sex hormones…” amongst other things (3). Sweden is reported to have ruled last year that the Danish risk assessment could also be applied in Sweden but left to the municipalities to decide (4), therefore generating a possibility that other EU Member States may follow this stance.

This decision has, quite expectedly, generated a lot of refutation, with the push-back from the World Ashwagandha Council and the ashwagandha industry claiming the Danish assessment to be “incorrect and misleading” (5). One comment stood out, which is that the differentiation between the leaves and the roots of ashwagandha was not taken into consideration. The Ministry of AYUSH, an Indian governmental body responsible for the education of research and propagation of traditional medicines, has advised “refrain from use of ashwagandha leaves (6)” and to use the roots.

Without a doubt, there is an increasing consumer demand for “natural” and plant-based botanicals that can support consumers’ health and well-being. Currently, within the EU, suppliers can use specific herbal botanicals in foods and food supplements, as long as the type is approved, and the levels used do not exceed the safe history of use (7). Furthermore, suppliers could elevate their products with botanical health claims (8). However, it should be noted that these claims are currently on-hold and pending the risk managers’ decision. The on-hold claims for ashwagandha include joint mobility/flexibility, cardiovascular system and adaptogenic benefits, and would require compliance with conditions of use, as well as significant substantiation of the relationship between the bioactives and the physiological benefit.

It is clear from watching the ashwagandha space, there needs to be an increased focus on provision of high-quality data, demonstrating without doubt the safety and efficacy of the bioactives. Ideally, data should be repeatable, reproducible and reflective of day-to-day consumption (i.e. format and eating patterns, etc.), and meeting the regulatory requirements. Only then, can supplement suppliers be more confident of their market entry plans.

Leatherhead Food Research can support companies in collation of evidence on safety & toxicity profiling, as well as on health benefits for specific botanicals. Follow the link to learn more about our global regulatory services.  

For help in assessing claims on botanicals do get in touch at [email protected].