Industry, scientists, and regulatory experts met in Brussels on Tuesday (July. 14) as European regulators consider whether ashwagandha should be subject to an “Article 8” review—an EFSA process which could lead to restrictions, label requirements, or prohibition if the evidence were to indicate a safety risk.
The meeting was organized by Kerry Group to mark the formal launch of Safeguard Ashwagandha, an initiative to ensure the extensive body of peer-reviewed safety data on the herb informs regulatory decisions.
Hosted by MEP Sean Kelly, meeting delegates heard presentations from Dr. Thomas Brendler, adjunct assistant professor of pharmaceutical sciences, University of Illinois Chicago, and Dr. Mukesh Summan, global director of toxicology, Kerry Group, outlining the body of clinical evidence backing the benefits and safety of the herb.
On hearing their evidence, MEP Kelly assured delegates he felt any EFSA assessment of ashwagandha would be completed relatively quickly, thanks to the strong dataset that has been pulled together by industry.
“I think there will be positives from this in due course,” he said, noting the ideal timing of the meeting. “If there is a vacuum of factual information then emotions can be whipped up through campaigns in the media and social media, and there could be a movement very quickly to ban ashwagandha. Having a discussion like this is vitally important.”
He said that with the drive for regulatory harmonization in Europe, its important that decisions be taken at European level, not with fragmented opinions across Member States, as has been the case thus far with a ban in Denmark and several others now considering prohibition.
He further noted that an opinion at European level could set a precedent across the globe.
“If something is done at European level, it tends to become the global standard,” he said.
“Europe has the highest standards in the world when it comes to safety and we need to guard that rigorously,” he said, addressing the room of stakeholders and scientists. “With your evidence and clinical trials, you have plenty of examples of safety of the product.”
He argued that bans are usually based on emotion, but the industry’s body of evidence will ensure EFSA can reach a rational opinion.
“You have sought to influence opinion before the discussion is on the table so the commission will have all the information they need to make an assessment properly,” he told the room.
“We stand a good chance”
Dr. Brendler’s review covering 131 clinical trial reports and toxicological assessments found safety concerns listed by authorities were not backed by evidence.
“I think we are actually in a good spot as far as ashwagandha is concerned,” he informed delegates.
“I think the data we have at our fingertips is sound and should be sufficient for regulators to come to an informed decision on consumer safety and benefits.”
He added: “Our job is to get this data to the regulators and, if we achieve that, I think we stand a good chance.”
Benefits of European assessment
Discussing the risks to industry if an Article 8 procedure is initiated, Monica Gispert Sararols, President of the Spanish Association of Food Supplements (Afepadi), warned that just the initiation of a review could have a significant impact on the industry.
“These products have a long shelf life, of around three years, so companies have to start trying to predict what is going to happen,” she warned.
“For companies, it extremely disruptive so we have to be careful even with the initiation of these assessments because consumers start to question and companies start making decisions.”
Marianna Domolki, Kerry’s regulatory principal scientist, pointed out that the introduction of bans in some Member States is already causing confusion and questions in the minds of consumers.
“They don’t know why one member state would find it risky and another would not,” she noted, suggesting that an Article 8 procedure could be the best outcome.
r“As much as the industry might look at Article 8 as a risky tool because it could result in prohibition, in some respects its our chance to provide the information for EFSA to come up with what is a safe dose,” she said, adding that any Member State that had a ban in place may have to lift it, if EFSA concludud the herb was safe.
Best outcome for consumer safety
Stefano Colicchia, director of regulatory and quality pharma & nutraceuticals, EMEA, at Barentz, argued that a ban on ashwagandha could threaten consumer safety.
“I believe a ban on ashwagandha will not solve the problem because the consumer will move toward other adaptogens.”
He argued that many alternatives are less controlled and backed by less evidence.
“If consumers aren’t able to find ashwagandha in brick and mortar stores, they will go online to find replacements, which will undermine trust and safety,” he added.
MEP Kelly agreed prohibition could lead to a black market and ultimately be a greater risk to consumer safety than more considered approaches, such as dose limits or labeling requirements.
List of concerns have not evolved with science
Dr. Brendler agreed that “a ban wouldn’t help anybody”.
He pointed out that the first ‘red flag’ over this botanical came from the German Federal Institute of Risk assessment in 2013 and subsequent assessments have simply repeated the same concerns.
“What baffled me was this laundry list of concerns never changed, It was carried all the way until the most recent recommendation for an Article 8 procedure,” he said.
But the level of scientific data available today is far superior to 2013, he argued, suggesting regulators have not been looking at new data.
Discussing his own review of individual case reports of toxicity, he said it was difficult to decipher causality in any case because the damage reported is “all over the place” with no clear signal of ashwagandha as the cause.
“What we are likely looking at is idiosyncratic cases that could occur with any ingredient, be it botanical or otherwise,” he said. “Additionally, co-morbidities and co-pharmacies are not being considered, which could put the culprit quite in a different place, not with ashwagandha as the cause.”
Criteria for quality
Dr. Summan noted that the focus should be on ensuring quality across the market as “not all extracts are created equal”, but there is no current criteria for good quality ashwagandha extracts.
He argued the criteria should include: clinical scientific backing to prove efficacy and safety; quality control through testing for heavy metals, contaminants and allergens; and full chemical characterization to identify bioactive compounds, authenticate ingredients and ensure batch-to-bath consistency; and safety data from OECD-compliant studies, genotoxicity assessments, and sub-chronic toxicity tests.
He added that Kerry had conducted a safety study indicating safety of its Sensoril root and leaf extract at 19 times the standard daily dose and that sort of study can ensure quality and safety for consumers.
“At Kerry, we are supportive of an Article 8 review as we believe that EFSA will conduct a science-led evidence based review based on the body of data, and ignore misinformation,” he said.
Global safeguarding initiatives
Blake Ebersole, co-founding member of the Ashwagandha Standards Alliance, a North American based coalition with a similar principal to Safeguard Ashwagandha, joined the meeting by video and stated that some have raised questions over whether plant part—root, leaf or stem—could be the source of safety concerns.
“While it’s true that some ashwagandha products are mislabeled as to plant part in order to reach a number on the label, regulations already require accurate plant part and potency labels,” he said.
“What we are dealing with is not a question of safety, but a question of quality, standards and proper labeling.”
He said the Ashwagandha Standards Alliance will lobby governments to ensure they do not “confuse the need for consistent standards, with alarmist irrational responses which conflict with evidence and approvals in other nations.”
Evidence for a safe dose
Dr. Brendler further noted that regulators want to see evidence to define a safe dose for the herb and a safe duration of consumption.
He said in order to do this “we need to find a common denominator” between the preparations on the marketplace. Thankfully, industry has been open to revealing the composition of their extracts, he said.
“I started asking members of industry for information on their formulations and most of them were open to disclosing what’s in their product.
“This is important information to elucidate what the consumer is ingesting and with that data at hand from the majority of the industry we could derive that dosing recommendations pretty much aligned with what the Ayurvedic Pharmacopoeia establishes.”
His review concluded this was the case even after applying a commonly utilized safety factor of 100 (FDA, 2007).
Health cost analysis a missing piece
Finn Murray, owner of Health stores Ireland, questioned why there has been little discussion or focus on the risk-benefit cost ratio and the human health costs associated with banning this herb.
“There’s a missing piece in advocating for the clear benefits of this herb,” he said. “EFSA has started to look at risk-benefit analyses…so this notion of assessing risk without looking at the positive human health element—reduction of disease and reduce public health costs—I’d like to see that part of the discussion opened up.”
Delegates agreed and Dr. Brendler noted his review outlined 12 scientifically backed health benefits of the herb, with sleep benefits having the greatest scientific backing.
