Regulatory update: Spotlight on international authorities’ response to ashwagandha safety concerns

23 Aug 2024 --- There is increased scrutiny over ashwagandha (Withania somnifera) among national food safety agencies in the EU and UK due to safety concerns associated with the botanical used for several thousand years in traditional remedies. The botanical is banned in food supplements in Denmark, while Dutch and French authorities have advised against its consumption in specific population groups. 

In this three-part series, Nutrition Insight explores the regulatory status of ashwagandha and the food authorities’ safety concerns with botanical experts, food safety agencies and industry players. Today’s special highlights the latest regulatory developments in Europe. 

In upcoming articles, we will examine available scientific safety data on ashwagandha and how to address agencies’ concerns and market responses. As an adaptogen, the botanical is increasingly popular in supplements to relieve stress and anxiety, boost focus and promote sleep.

Thomas Brendler, Ph.D., an expert in medicinal plant use and regulation, tells us that the regulatory considerations in the UK may be involving as the country’s Food Standards Agency (FSA) recently opened a call for evidence to support its request for a risk assessment on ashwagandha from the country’s Committee on Toxicity. The call is open until September 2. 

Meanwhile, Brendler highlights that in the EU, “we could see more bans on a national level because the member states have the purview to do that for their own country.” 

National authorities have come to different conclusions on ashwagandha, he continues. “Some say ‘add a warning,’ some say ‘ban it,’ some say, ‘maybe not for pregnant women.’ All of which, except for the ban, could make sense.” 

“I’m not challenging the regulators in the position they’re taking — their job is to protect the public, and based on what is at their disposal, they must be guided by the precautionary principle. The only way of resolving it is to present better data,” he details. 

Initial safety concerns

European safety concerns on ashwagandha go back to 2013 when the German BfR (Federal Institute for Risk Assessment) published a level A risk assessment on several botanicals used in food and supplements, including ashwagandha. 

The report concludes that “essential information is missing” on the botanical, referring to limited toxicological studies, safety and historical exposure data and information on dosages or use as a food in Europe. 

Ashwagandha is increasingly popular in supplements to relieve stress and anxiety, boost focus and promote sleep.“In addition, as there are indications of safety concerns, it is recommended that the root of W. somnifera be included in List C of Annex III to Regulation (EC) No, 1925/2006,” reads the report. The safety concerns the organization refers to include ashwagandha’s traditional use as an abortifacient and indications of an influence on thyroid function. 

This regulation covers the addition of vitamins, minerals and certain other substances to foods. List C in Annex III covers “substances under (European) Community scrutiny,” adding new substances to this overview is specified in Article 8 of the legislation. However, the substance was not added to this list. 

Impending Article 8 procedure

Brendler tells us that “the 2013 report remained without consequence.” He adds that since this report was published, “all the concerns are still pretty much the same.” 

“We’ve wasted ten years looking away, and now it’s a race against time because the FSA wants data by September 2,” he underscores. 

Based on earlier botanicals that underwent Article 8 procedures, he estimates that this process might take several years. However, he cautions: “Once the wheels are in motion, I would suspect that this machinery is difficult to stop or reverse.” 

Ban in Denmark

In recent years, the same concerns have resurfaced. On behalf of the Danish Food and Drug Administration, the country’s DTU National Food Institute published a report in 2020 concluding that based on the available data, “no limit can be set for the intake of the root or extracts of the root, below which the intake will be without risk of harmful effects.” 

The organization referred to potential toxicological effects, effects on sex hormones and reproduction and effects on metabolism, the immune system and the central nervous system. 

Safety concerns concerning ashwagandha include a use as an abortifacient, impact on thyroid function and liver toxicity.Based on this assessment, Denmark banned using ashwagandha in food and supplements in 2023. 

“I think the strongest concerns came from the Danish study, but also from the German study that was done early on,” details Brendler. He explains that a working group of the EU Heads of Food Safety Agencies took up these outcomes. 

In June 2024, this working group recommended prioritizing ashwagandha for an Article 8 procedure “due to (potential) effects on reproduction, thyroid hormones, acetylcholinesterase, the immune system and due to liver toxicity. The toxicity data are limited and insufficient to derive a safe dose level or health-based guidance value.” 

Advice against ashwagandha consumption

Meanwhile, the Dutch National Institute for Public Health and the Environment (RIVM) and the French National Agency for Food, Environmental and Occupational Health and Safety (ANSES) have published risk assessments on ashwagandha. 

RIVM advises consumers not to use ashwagandha-containing supplements or tea, especially pregnant women since the “effects can be serious and may occur even when people use the product as instructed on the packaging.” 

The organization notes that little scientific research has been conducted into the botanical’s harmful effects, such as potential effects on the liver and purported abortifacient properties. However, it states that physicians have seen intoxications in individuals who took the food supplements and reported harmful effects on the liver and thyroid hormones and cortisol levels. 

ANSES shares the findings of the previous reports submitted by Germany, Denmark and the Netherlands, “in particular on the impossibility of defining a risk-free level of consumption due to the insufficient quality of the available data.” 

The organization advises people with thyroid, liver or heart conditions, hyperandrogenism, pregnant women and people on sedatives to avoid ashwagandha supplements due to potential adverse effects. 

ANSES and RIVM advise pregnant women and other vulnerable populations not to use ashwagandha products.EU health claim review

When considering an EU-wide response, a European Food Safety Authority (EFSA) spokesperson tells us that the organization has “not received any mandate to perform a safety assessment of W. somnifera.”

“Under the current regulatory framework [Regulation (EC) No 1924/2006], we were asked to look at the W. somnifera in an opinion that addresses the scientific substantiation of health claims (‘beneficial effects’) in relation to various food(s)/food constituent(s) and protection of cells from premature aging, antioxidant activity, antioxidant content and antioxidant properties, protection of DNA, proteins and lipids from oxidative damage.” 

“The evaluation focuses on the beneficial effects — a safety assessment is not foreseen.” 

Additionally, EFSA concludes that “no evidence has been provided” for ashwagandha’s antioxidant properties and that a “cause and effect relationship has not been established” between consumption of the botanical and the protection of DNA. 

“No safe levels established”

Nathan Barnhouse, FSA director of Wales, highlights that the UK organization’s call for evidence on ashwagandha will help support an assessment of the botanical and ensure that decisions made on its safety are based on science and evidence. 

“This will ensure that consumers are presented with the best available information to help inform their decisions when it comes to food,” Barnhouse affirms.

Food authorities note there is limited available data on safe ashwagandha use and dosage levels.“Currently, in the UK, there are no safe levels established for ashwagandha in food supplements or set limits for its use, and we are aware of several incidents relating to potential adverse effects on the thyroid and liver.” 

“For this reason, we want to learn more about ashwagandha when it is used in food supplements, and we have decided to ask for advice from the Committee on Toxicity — one of our independent scientific advisory committees. This will help us identify and assess any potential risks the product may have and whether there should be set limits for its use.” 

Barnhouse details that ashwagandha products will still be available on the market throughout this process. 

“We are not currently considering a ban on them,” he stresses. “However, any further emerging evidence of risks to public health will necessitate appropriate action to protect public health.”

In addition to ashwagandha’s potential liver toxicity and adverse impact on thyroid hormones, he adds that consumption has also been linked to nausea and gastritis — an irritation or inflammation of the stomach — and affecting blood sugar levels.

Although there are limited studies on ashwagandha in humans, he warns: “Based on the available lines of evidence, a risk to health from exposure to ashwagandha cannot be excluded, particularly for exposures over long periods and the Committee on Toxicity will consider this further.”

By Jolanda van Hal