The safety of botanicals is coming under increasing scrutiny in Europe.
Misinformation and, in some cases, myths are prompting misplaced concerns regarding ancient botanicals that have been used safely for hundreds of years.
To cut through the noise and understand where the weight of the scientific evidence lies, the Kerry Health and Nutrition Institute (KHNI) has launched a new podcast, KHNI Talks. The series brings the voice of science to some of the most challenging questions facing the food and beverage industry, with scientific experts putting ashwagandha under the microscope in episode one.
KHNI Talks host, Brian Short, was joined by Dr Thomas Brendler, founder of the consultancy Plantifile and Guest Editor of a special series of papers on ashwagandha in the journal Phytotherapy Research and Dr Mukesh Summan, former FDA toxicologist and current Global Director of Toxicology at Kerry to discuss the latest scientific data on ashwagandha.
Starting at the beginning: What is ashwagandha and what are its benefits?
Dr Thomas Brendler: Ashwagandha is a botanical with a 3,000 year history in traditional Indian medicine. As an adaptogen, it helps the human body to respond and become more resilient to stress. It regulates your physiological and mental states to keep you balanced.
Dr Mukesh Summan: Numerous gold-standard clinical trials have been conducted on the safety and effectiveness of ashwagandha root and leaf, which demonstrate that it is completely safe. In addition, the health benefits are incredible. Studies have shown that ashwagandha enhances sleep quality, reduces stress and anxiety, improves cognitive function and also boosts women’s health. At Kerry, we use a root and leaf extract of ashwagandha and it was shown to relieve menopausal symptoms such as hot flashes, reduce night sweats and sweating by more than 20%, making it particularly beneficial for women.
So given all its health benefits, what has started this sudden regulatory scrutiny of ashwagandha in Europe?
Dr Thomas Brendler: Ashwagandha was first assessed as far back as 2013 by the German Institute for Risk Mitigation. At that time, there was limited clinical trial data surrounding the ancient botanical and nothing much came of it. But this has somehow triggered a slow but steady wave of regulatory assessments by national authorities. Most of these new assessments don’t take into account the extensive pre-clinical and clinical research conducted over the last decade. So we looked at the list of concerns the different countries were having and brought together a team of academic and industry experts to establish a well-curated data set that would enable regulators to make informed decisions about the future of ashwagandha.
What were the main concerns of European competent national authorities?
Dr Thomas Brendler: The primary concern of competent authorities has been that they didn’t really know what the safe dose of ashwagandha was. There was no information on the safe duration of consumption, making it difficult to identify if there could be safety issues. Additionally, there were also some concerns raised about the different components, such as the root and leaf. So this is exactly what the special journal series tried to address.
Dr Mukesh Summan: There have also been some concerns about some adverse event reports linking ashwagandha to liver injury. Our clinical trials at Kerry studied the effect of ashwagandha on liver function and liver enzymes and we saw no impact at all. Other researchers have also conducted meta-analyses of clinical trials and concluded there was no evidence of liver injury. In addition, health authorities in Australia and the Netherlands have weighed in on Ashwagandha extracts, concluding that liver injury is a rare event.
What were the results of your research?
Dr Thomas Brendler: We established a good baseline dataset demonstrating the safety of ashwagandha, including the safe daily dose and duration of consumption. Clinical trials showed that ashwagandha is safe to take at doses of up to three, four or five grams per day over longer periods of time such as 90 days or longer. We also didn’t find any evidence that ashwagandha leaf is unsafe. We reviewed evidence from more than 100 clinical trials published over the last 40 years, of which approximately 25% looked at the efficacy and safety of leaf or leaf and root products. Both root and leaf were studied for similar, if not the same effects, and what we found is that there are no obvious differences in either efficacy or safety of root products or leaf products, or combinations of root and leaf.
Another issue commonly discussed within the industry is linking ashwagandha to abortive effects. Could you please comment on that?
Dr Thomas Brendler: This is an interesting one and actually a rather sad case where modern myths are created as a result of mis-citation. The idea that ashwagandha is linked to abortion is based on some hearsay from the 19th century, and this has been carried throughout the scientific literature without anything backing it up. Let me be clear. There is absolutely no evidence for ashwagandha acting as an abortifacient or abortive. To the contrary, there is good scientific evidence that it doesn’t. All that said, it becomes extremely difficult to remove something like this from the scientific canon once it’s gotten a foothold, and we’ll probably be dealing with this false information popping up for a long time until it’s properly eradicated.
So, there is no reason to restrict the use of ashwagandha?
Dr Thomas Brendler: Indeed, we have a good baseline data set that demonstrates the safety of use for ashwagandha, including what a safe daily dose and duration of consumption can be. Further, the efficacies that we’re seeing in the clinical trials remain within clinical range. The data provides a very good basis for ashwagandha not to be banned.
Dr Mukesh Summan: I absolutely agree with Dr. Brendler. There is a whole body of evidence, numerous clinical trials including clinical trials with root and leaf, which have shown us that ashwagandha products and supplements are safe to take. So I think it’s absolutely critical that the regulatory health authorities review that data and draw their conclusions and give evidence to the wider public to let them know that ashwagandha products are safe.
To listen to the full interview with Dr Thomas Brendler and Dr Mukesh Summan, tune into KHNI Talks on YouTube, Spotify or Apple Podcasts.