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St John's wort health claim puts Bioforce UK in good mood
By Shane Starling

11-Jun-2008 - Botanicals manufacturer Bioforce UK will be able to make mood-lifting and anxiety-combating claims for a St John's wort product that will be re-launched later in the year, after winning a Traditional Herbal Medicinal Products Directive (THMPD) registration.

The UK manufacturer first sought to make a mood-based claim for a St John's Wort product in 1995, but was rebuffed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for failing to meet the body's "standards of evidence".

Thirteen years later the company has been granted the right to make a claim about a herb that has been shown in many studies to have benefits for those suffering from mild to moderate depression.

But the claim cannot claim to treat depression, only "low mood" and "mild anxiety".

Bioforce, which has a turnover of about €7m, lodged its registration 18 months ago and it is its fifth since the THMPD registration process began in the UK in 2005.

The others are two pain-relief products, a prostate product and a relaxant.

Hyperiforce becomes the 14th product to be registered by MHRA. The government agency has another 21 submissions in process and as yet has rejected no applications.

In all, 10 companies have lodged applications with MHRA.

The UK and Germany have been the most active in product registrations among the European Union's 27 member states to date.

There is expected to be something of a product registration flood as the 2011 deadline looms prompting the UK Health Food Manufacturers' Association (HFMA) to warn companies not to leave it to the last moment.

"The registration takes a minimum of 215 days and there is often some to-and-fro between the applying firm and the governing body, so companies would be advised to lodge their applications sooner rather than later," said HFMA director David Adams.



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