The opinion report, posted on the ANSES website earlier this month, advises against use of the herb in the following populations: pregnant or breastfeeding women, people under the age of 18, and those with endocrine disorders (particularly dysthyroidism and hyperandrogenism), liver or heart problems or undergoing treatment with a central nervous system depressant action.
Following a report of eight cases of adverse effects likely linked to the consumption of food supplements containing ashwagandha (Withania somnifera), the Directorate General for Competition Consumer Affairs and Fraud Prevention (DGCCRF) referred the matter to the French Food Safety Agency (ANSES) in April 2021.
ANSES relied on risk assessments already carried out in Germany, Denmark and more recently in the Netherlands.
It concluded that the listed populations should not consume the herb due to: lack of data demonstrating its safety, adverse effects observed in animals and humans, and its supposed traditional use to induce miscarriage.
The authority specified that a similar reflection should be carried out with regard to other foodstuffs containing Withania somnifera, in particular herbal teas.
Label warnings
Discussing this update on its LinkedIn page, PHINN, the scientific and regulatory database said it is highly likely that the French general directorate for food (DGAL) will take this new opinion into account and ask operators to affix new labeling warnings to food supplements containing the ingredient.
European law expert Luca Bucchini explained that unless stakeholders convince ANSES and DGAL that not all the warnings are required, they will have to go on label.
"The issue with ANSES is that since the competent authority in France was switched from the DGCCRF to the DGAL ANSES's opinions have changed status from merely advisory (the DGCCRF would asses the opinions, consider EU law, etc.) to basically the basis for regulatory action (DGAL does not do a legal assessment)," he said. "It is striking for example that consumption under 18 is advised against merely based on absence of data; that's a very pharmaceutical approach."
Claire Guignier, head of public affairs and communication at Synadiet, the French union for the food supplements and natural health products market, also highlighted that it was the lack of data that encouraged ANSES to advise against consumption of the plant by certain populations.
"The agency's caution is consistent with its previous positions," she told NutraIngredients. "It should be noted, however, that very few cases of nutrivigilance have been reported in France, and the severity of those reported is, fortunately, low.
"In case of doubt, consumers can turn to their pharmacist or other healthcare professional before purchasing an ashwaganda-based food supplement. They will be able to advise them on the best food supplement for their needs. In any case, manufacturers are always attentive to the advice of ANSES as part of their continuous improvement process, with the aim of ensuring consumer safety."
Industry response
The opinion comes in the wake of recent NutraIngredients reports that the UK FSA added the ingredient to its Risk Analysis Tracker and that a working group of 26 Member States had compiled a list of botanicals, including ashwagandha, which it deems eligible to be banned or heavily restricted.
Several botanical experts from across the industry have branded these health concerns as baseless with a lack of assessment of the peer-reviewed science available into this ingredient.
Shaheen Majeed, global managing director and CEO at Sabinsa, supplier of Shagandha ashwagandha, noted misinformation in the latest ANSES report, including its purported association with abortion. In fact, the ingredient has traditionally be used to support fertility.
"There is a lack of substantial scientific evidence supporting the claims of poisoning of liver damage when using properly standardized and high quality ashwagandha supplements," he said.
He pointed out the U.S. Pharmacopoeia-National Formulary (USP-NF) monograph provides a comprehensive framework for standardization, safety limits, quality control, evidence-based guidelines, transparency and monitoring. He argued that any supplier adopting these standards will automatically mitigate any and all of ANSES' concerns.
"The problems attributed to ashwagandha are often due to substandard products lacking proper standardization and quality control," he said. "A robust supply chain and strict adherence to quality standards are vital in providing consumers with effective and safe ashwagandha products.
"Instead of imposing restrictions on the use of this well-known and safe herb, we believe it would be more beneficial to increase vigilance in preventing substandard or contaminated products from entering the market. This can be achieved by involving key players from regulatory bodies and the industry to enhance education on the quality, standardization and supply chain management of this unique herb."
Kevin Burdin, scientific manager at the French natural medicine brand Anton & Willem, told NutraIngredients that he is concerned ashwagandha could become the next kava kava (Piper methysticum), which was banned in Europe in 2003 due to some supplements containing aerial parts of the plant, which led to toxicity issues that were not present when only the roots were used.
“The main issue is that while the roots of ashwagandha are traditionally used, some manufacturers are including aerial parts of the plant to increase yield and profitability. This practice could introduce hepatotoxicity to ashwagandha products,” he said. "All currently available data need to be carefully examined to truly establish the toxicity of this product, especially when adhering strictly to using only the roots of ashwagandha."
Rectifying misinformation
Majeed said experts in the industry are coming together to rectify misinformation spiralling around this ingredient.
"We are aware that neighboring countries have shown concerns based on the recent advisory from the National Institute for Public Health and the Environment (RIVM) in the Netherlands," he said. "The advisory mentions reports of poisoning and historical uses of ashwagandha, but it is crucial to note that these claims are not supported by substantial scientific research.
"The consensus among experts is that the concerns raised are unfounded and that efforts are underway to address and rectify the misinformation, and we at Sabinsa are willing to work with RIVM to ensure that accurate information is disseminated and to enhance the quality standards and safety of ashwagandha products in the European market."