Ignore herbal tradition-of-use data and destroy “important heritage”: Researchers

By Shane Starling

- Last updated on GMT

Related tags European union

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European academics have warned of the likely devastation to the botanicals sector if Europe ignores tradition-of-use (TOU) data in favour of randomised clinical trials when assessing herbal food supplement health claims.

The researchers noted TOU data was acceptable under the 2004 EU Traditional Herbal Medicinal Products Directive (THMPD), but it did not appear it would be accepted under the nutrition and health claims regulation (NHCR).

“…the effects observed must be proven under the new health claims rules,” ​wrote the researchers in the European Food and Feed Law Review​, led by Robert Anton from the Faculty of Pharmacy at the University of Strasbourg.

The substantiation required relies mainly on the availability of randomised controlled trials. Evidence from traditional use is not considered. This is bound to lead to the loss of an important heritage.

In fact no clear indication about how TOU data will be treated under the NHCR has as yet been given as around 1500 botanical-health claim propositions have been put on hold by the European Commission, as it said the clinical trial-weighted NHCR criteria may not be appropriate for those substances.

“…valid scientific discipline…”

But under which criteria they are to be dealt with by the European Food Safety Authority (EFSA) and other EU institutions has not as yet become apparent.

Theconsideration of traditional evidence from various sources is a valid scientific discipline,” ​they wrote before providing an outline of how to verify and validate herbal TOU data, “as a basis for the assessmentleading to the acceptance of health effects for botanicals.”

Examples like ginseng, tea, St John’s wort and chamomile are given where TOU data has sometimes been validated by clinical data at a later juncture.

“Old books often also carry accounts of beneficial effects of plants..."

They recommended that if a claim is fundamentally backed by TOU data, then the claim should reflect that reading something like, “Plant X is traditionally used to contribute to [the physiological function concerned]”.

“This approach adequately informs the consumer about why the specific food(supplement) in question is being recommended in relation to the labeled health effect.”

“The consumer may either accept the traditional basis and use the product or not and abstain from buying/using the product.”

They added: Many of the traditionally observed health effects are transmitted orally, but many countries, civilizations and cultures have written accounts, including pharmacopeia (China, India, …).”

“However, such sources may not always be easily accessible (language barriers, etc), but there is more and more research into these ethnobotanic sources of knowledge making their information more readily available.”

“Old books often also carry accounts of beneficial effects of plants, used locally in ancient times (Hippocrates, Galen, Paracelsus, …). The traditional uses described in these ancient sources of information are now increasingly being confirmed by fundamental and applied research.”


European Food and Feed Law Review

Volume 7, Number 2

‘Traditional Knowledge for the Assessment of Health Effects for Botanicals – A Framework for Data Collection’

Authors: Robert Anton, Mauro Serafini and Luc Delmulle

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