EU herbal product registrations “pretty poor”, says UK group

By Shane Starling

- Last updated on GMT

Related tags: European union

The chairman of the UK Herbal Forum has warned that the European Union may find its pharmacy store shelves filled with illegal herbal products if companies don’t register their products under the Traditional Herbal Products Medicinal Directive (THMPD).

“There are some member states that are ahead of the rest but a great majority of member states have not registered a single product,” ​PennyViner told NutraIngredients this morning. “In general the uptake has been pretty poor.”

The Directive become law in 2004, giving herbal products making medicinal claims across the EU bloc seven years to register their products by submitting a supporting dossier.

With that deadline of April 30, 2011 less than a year away, concern is growing that a swathe of products that may be perfectly legal under national laws will find themselves on the wrong side of the THMPD.

“What happens when April arrives will depend on the attitude of the enforcement authorities in each member state,” ​Viner added.

The UK has been the most active member state by far in terms of product registrations, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) approving 69 products so far out of 152 applications received. None have as yet been rejected.

The 69 approvals have featured 27 different herbs from valerian to sage, black cohosh, St John’s Wort and Echinacea. Thirty one applications have been lodged so far in 2010. A list of the latest registrations can be found here.

Registrations are known to have occurred in Germany, the Netherlands and Slovenia but at low numbers.

Supplements or medicines?

Despite the apparent apathy so far, the THMPD is gaining increasing attention from herbal suppliers who are finding their claim applications rejected by the European Food Safety Authority (EFSA) under the 2006 nutrition and health claims regulation (NHCR).

This is driven by the fact THMPD registrations state: “There is no requirement under the Traditional Herbal registration Scheme to prove scientifically that the product works.”

Viner said the UK Herbal Forum which focuses on the THMPD, and the European Herbal Forum which is more concerned with the NHCR, advises its members to keep all regulatory options open.

UK Herbal Forum members include the British Herbal Medicine Association, the UK Council for Responsible Nutrition, the European Herbal Practitioners Association, the UK Health Food Manufacturers Association and the Proprietary Association of Great Britain.

Related topics: Botanicals, Regulation & Policy, Suppliers

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1 comment

THMPD too restrictive

Posted by Dr. Mathias Schmidt,

We have been preaching for years that this situation will come. However, the reason why the acceptance of the THMP by the industry is so poor is regularly the same:
- The restrictions of the Directive on herbs only
- The burden to demonstrate 30 years of (substantial!) use
- The tremendous costs for the analytical development and stability testing
- The impossibility to expect a return of investments for analytical testing of combination preparations (quantification of every single constituent!)
- The duration of the developmental process: It takes at lest 3 years to get a product which can be marketed. There is the otion to submit with 6 months of stability, but such a product cannot be sold on the market as no pharmacy will accept it on the shelves.

Even if a company goes through all this effort, they will still face the situation that they have to invest for three years before they earn a single cent.

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