The European Federation of Associations of Health Product Manufacturers (EHPM) said only a major revision could prevent, “an unfair competitive situation between the pharmaceutical and food supplement sectors, which cannot be logically justified.”
The treatment of such science is being debated at the moment by the European Commission and member states, after more than 1500 botanical claims were two years ago withdrawn from the EU nutrition and health claims regulation (NHCR) process by the EC to consider whether the prevailing approach was suitable for herbals.
A recent EC discussion document has proposed two options: Sticking with the existing system that favours human intervention studies which many botanicals don’t possess; or adopting a system that gives more weight to tradition-of-use data.
Such traditional use backing is given more credence under the EU Traditional Herbal Medicinal Products Directive (THMPD) – which some see as nonsensical in that the scientific criteria is more stringent under food law than medicines law.
“The current EFSA approach does not consider traditional information alone as sufficient evidence for the substantiation of a claim,” said EHPM Chairman Keith Legge.
“With no changes to the approach towards traditional use, most of the health claims on botanicals will no longer be authorised, while medicinal claims will continue to be allowed based only on ‘traditional use’.”
Member states are set to debate the discussion document in mid-September.
EHPM director of European policy, Cynthia Rousselot, said it was difficult to see how the issue would unfold with a great variance in the stances of, “member states toward herbal law harmonisation”.
“But we are pleased that option 2 exists – it is a first success that it is there.”
Legge added: “The problem of claims cannot be separated from other aspects that concern botanical food supplements, such as safety, quality and borderline issues. We therefore encourage the Commission and the member states to reflect on a future harmonised legal framework that would offer a coherent approach to, and tailored solutions for, botanicals on these issues.”