St John's wort health claim puts Bioforce in good mood
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. In addition to the claims potential of a product registration, the THMPD dictates that all herbal products not classified as food supplements (like many 'spice rack' herbs such as garlic and sage) or those considered medicines, must gain THMPD registration by April 2011 to legally remain on market. Registration requirements Bioforce quality assurance manager, David Belshaw, told NutraIngredients.com product manufacturing (GMP standard), scientific and administration costs were difficult to define but estimated the cost of registering Hyperiforce was upwards of €100,000. "It then costs more to manufacture the products when you consider some of the Good Manufacturing Practice requirements," he said. "Guaranteed agricultural practices are required such as not threatening any endangered species. It's a complex process which might explain why it took 18 months for the MHRA to process our application." The claim's wording had been carefully negotiated with MHRA, which made it clear reference to the term 'depression' would not be permitted. "We worked closely with MHRA to get it right," Belshaw said. "Obviously we would have liked to be making claims about depression, which there is strong evidence for, but we are very pleased to be able to make a claim about this product after waiting so long. Being able to make claims like this is a powerful marketing tool and it empowers consumers because they know that the claims being made are backed by strong science." The claim language on Hyperiforce matches that of another recently registered St John's wort-based product, HyperiCalm, manufactured by UK competitor, MedicHerb, which is owned the German pharma group Schwabe. "MHRA has been consistent in that sense which we can't argue with," Belshaw said. Since the registration process opened for business in 2005, MedicHerb has been the most active, gaining about half of the 14 registrations. 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.
