June 6, 2012
European Academics Are Speaking Out On Ignoring, Suppressing Tradition-of-Use Data
The Chinese have successfully used acupuncture for 2500 years for many different ailments. For untold millenia African tribes have employed hallucinogens pharmacologically to stimulate the central nervous system and treat hundreds of disorders. South Americans have wisely learned how specific medicinal herbs counter disease for centuries. Yet, all tradition-of-use data obtained from our ancestors is discarded and trashed by modern science. European academics are now speaking out on the likely devastation to the botanicals sector if Europe ignores tradition-of-use (TOU) data in favour of randomized clinical trials when assessing herbal food supplement health claims.
Plants had been used for medicinal purposes long before recorded history. Ancient Chinese and Egyptian papyrus writings describe medicinal uses for plants as early as 3,000 BC. Indigenous cultures (such as African and Native American) used herbs in their healing rituals, while others developed traditional medical systems (such as Ayurveda and Traditional Chinese Medicine) in which herbal therapies were used. Researchers found that people in different parts of the world tended to use the same or similar plants for the same purposes.
A significant number of medicinal products despite their long tradition of use do not fulfill the requirements of a well-established medicinal use, with recognised efficacy and acceptable levels of safety and therefore cannot fulfil the requirements of EU regulatory bodies for nutrition and health.
St John's wort: Relieving mild-to-medium depression through the ages? Not according to nutrition and health claims regulation (NHCR).
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 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..."
The criteria the NHCR used is supposedly designed to provide an appropriate legal framework for placing traditional herbal medicinal products on the market within the European Union.
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.
As the U of M Medical Center states, "herbalism has a long tradition of use outside of conventional medicine. It is becoming more mainstream as improvements in analysis and quality control along with advances in clinical research show the value of herbal medicine in the treating and preventing disease." We must honour and respect tradition and the teachings of our ancestors.
"The consideration 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 assessment leading 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."
Marco Torres is a research specialist, writer and consumer advocate for healthy lifestyles. He holds degrees in Public Health and Environmental Science and is a professional speaker on topics such as disease prevention, environmental toxins and health policy.