Traditional knowledge of herbs and botanicals are just as valuable as scientific knowledge when assessing health claims and could remove or reduce the need for clinical trials, according to the European Botanical Forum (EBF).
In reference to the European Union's Nutrition and Health Claims Regulation, the Belgium-based EBF said the European Food Safety Authority (EFSA), which is charged with assessing nutrition and health claims in Europe, should take local and historical knowledge into account.
The regulation applies to both botanical products and foodstuffs containing botanicals such as fortified foods, herbal teas and food supplements, but does not make clear how both scientific and traditional knowledge will inform the claims granting process.
"According to the regulation, claims should be based on generally accepted scientific evidence," said Manfred Ruthsatz, chairman of the European Botanical Forum. "But there is no indication what this exactly means, how much evidence and what type of evidence will be needed for a claim to be acceptable. It states that the substantiation should take into account all of the available scientific data and weigh up the evidence. That, therefore, is implicit acceptance that other aspects can also be considered, and in the field of botanicals, a substantial part of supporting evidence relates to practice and practical experience which has accumulated over the years."
The Nutrition and Health Claims Regulation states that claims made about herbal products must include information about the herb's effect and intended usage. Since many products do not have a large dossier of scientific backing due to their traditional usage, claims made for them must gain EFSA approval to be added to the Regulation's positive list. The deadline for such submissions is 2011.
"Especially in the field of traditional herbal medicinal products, the value of observational evidence and experience is given substantial weight when assessing efficacy of medicinal effects under medicinal law — in such way that it is accepted that proof of traditional use may eliminate the need for clinical efficacy trials," said EBF secretary, Patrick Coppens. "It would be quite disproportionate if requirements for proving efficacy of a health effect would need to be more demanding than for a medicinal therapeutic effect."
The EBF is set to discuss these matters with EFSA, the European Commission and Member States in the near future.
EBF was established in 2004 by the European Responsible Nutrition Alliance (ERNA) and the European Federation of Associations of Health Product Manufacturers (EHPM) as a discussion platform for scientific and regulatory issues related to the use of herbs in food supplements.