Accessible to consumers, industry players, academics, regulators, and anyone with an interest in ashwagandha’s safety, the new website provides scientific studies, analysis of the available data, an update on regulations across the globe, and addresses concerns around root and leaf safety.
Other suppliers are invited to share their studies for inclusion on the platform, as the firm aims to safeguard the ingredient for the entire industry.
“The launch of Safeguard Ashwagandha comes at a critical time for the botanical,” said Dr. Mukesh Summan, global director of toxicology at Kerry, and Diplomate of the American Board of Toxicology since 2007. “While the weight of the scientific evidence stands in our favor, we face a serious situation in which myths and misinformation risk shaping policy outcomes. It’s vital that regulatory discussions focus on the science and evidence-based risk management processes.”
Speaking to NutraIngredients at the launch of the platform during Vitafoods Europe (May 5-7), Dr. Summan said Kerry would like to engage with the other players within the marketplace.
“This site has been set up as a central hub for individuals and groups to support the campaign.”
He added: “If we don’t counteract misinformation with science then all people will hear is the misinformation.”
Kerry will communicate with authorities any and all safety data available and encourage the use of incremental limitations if necessary, said Dr. Summan, such as cautions on-pack.
“There are many steps you can take before saying something needs to be banned and that is a more credible approach, in my mind.”
Discussing the industry’s response to bans in other countries, Dr. Summan said Kerry’s clients have been more concerned about their ability to continue sourcing the ingredient, as opposed to having any safety concerns.
Tradition to controversy
Ashwagandha has a history of use spanning thousands of years. Yet, a growing number of European regulators are showing signs of concern over the ingredient related to potential abortifacient, endocrinological and immunological effects and hepatotoxicity.
The safety concerns have been dismissed by many as being the result of poor quality studies or adulterated products as well as a lack of relevant expertise within the assessing food safety agencies.
Most concerns have come as a result of countries considering risk assessments by the Technical University of Denmark, criticized by many in the industry as ‘hearsay and misinformation’.
“I’m aware of 12-20 cases of liver injury in the literature, although I’ve heard people citing up to 70 cases, I’m yet to see where they’ve got that number from,” he said. “In any case, it’s not a high number considering its use worldwide throughout history.
“And we have to put it into context. Look at how many cases of liver injury there has been as a result of taking paracetamol, for example, and so should we be banning drugs like that? We don’t ban them, we put a warning on them.”
Some have blamed any issues of toxicity on the inclusion of leaf extract in supplements, as this wasn’t the traditionally used plant part and has a smaller portfolio of scientific evidence backing its safety.
In fact, on April. 16, India — the world’s primary producer and exporter of ashwagandha — issued an advisory restricting the use of ashwagandha leaves in food products. The government cited “possible safety concerns for ashwagandha leaves due to higher concentrations of reactive withanolides, particularly withaferin A” as its reasoning.
The Netherlands and the UK are expected to finalize their safety assessments of the botanical soon.
The research landscape into ashwagandha’s safety has rapidly evolved as a result of raised concerns; Kerry’s own recently published study in mice, provides evidence to suggest its root and leaf blend is safe at 19 times the standard dose.
Thomas Brendler, PhD, founder of consultancy Plantaphile, and Professor Jo Barnes, of the University of Auckland, NZ, initiated a call for papers for a special edition of Phytotherapy Research in which they reviewed all the safety concerns. The review is due to publish imminently.
Dr. Summan said: “Gold-standard clinical trials, OECD-compliant pre-clinical studies, meta-analyses and systematic reviews have been published in peer-reviewed journals on the topic with the overwhelming consensus being that ashwagandha is safe when dosed responsibly.”
