EU regulatory experts debate herbs (don’t panic) and health claims (shout louder)

The European Union Traditional Herbal Medicinal Products Directive (THMPD) is ultimately a force for good, although some “small guys” may disagree, says leading consultancy and contract research organisation, analyze&realize. The nutrition and health claims regulation (NHCR)? Well, that’s another matter.

THMPD: Uniformity is good

“We are a believer in European harmonisation – we think it is a good thing…that one product can go to all the member states and be distributed with the same labels and the same claims,” said owner and president Joerg Gruenwald, PhD.

“[But] every legislation change is good for some people and bad for other people... There will be products coming off the shelves – it’s hard for some companies definitely – but I would say the majority of products will stay on the markets and there will be more uniformity of the products all over Europe.”

Gruenwald said building files to gain THMPD botanical registrations typically cost at least €100,000, which inevitably meant, “small guys suffer the most”.

NHCR: Listening is good

“I think some aspects of batch four are interesting because it shows there are chances to get positive opinions like polyphenols, sugar replacers and other starches,” commented senior consultant Christiane Alexander, PhD.

“There is a chance to really convince EFSA in a scientific way of the effects that products can have. But there were many opinions that were again disappointing.”

She observed the joint health area was particularly disappointing because the “inflammation aspects cannot be dealt with”.

“There was guidance on joint health but it is not useful because it is just a summary … of the published opinions which we know. We expected something new… that they give us good directions about how we should design the trials and also show a willingness of making this whole thing of the health regulation useful for the industry and for the customers.”

Alexander said she hoped a recently announced restructuring at EFSA would improve the chances of dialogue with the agency, including ongoing stakeholder meetings.