UK firm Rutland Biodynamics Ltd has had four of its valerian liquid oil products approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA), based on traditional use.
The THMPD – which has a March 31, 2011 deadline for EU-wide registration – is recognised as a valid means of product and claim substantiation.
The four products are identical in constitution and become the 69th the MHRA has approved. The agency, which has by far been the most active in the European Union, is yet to reject a single registration application.
Rutland’s approval means the products – English Herbal Medicines Valerian Relaxisleep, Herbs hands Healing ValRelax, Brook Green Valerian Elixir and Swiss Herbal Remedies Valerian Elixir – can continue to be sold without prescription in chemists and other retail outlets.
The MHRA said of Rutland’s dossier: “Valerian Oil Liquid is used for the temporary relief of symptoms of mild anxiety and to aid sleep, based on traditional use only. The active ingredient of this product comes from the roots of the Valerian plant, which is also known as Valeriana officinalis L.”
“This registration is based exclusively upon evidence of traditional use of Valerian as a herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration scheme to prove scientifically that the product works.”
“No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Traditional Herbal Registration Certificate could be granted.”
The initial license for the products was granted in 1972 to Potters Ltd under the old UK herbal registration scheme.
Fellow UK company, BioHealth also won a THMPD approval for an anti-anxiety herbal valerian product in July, 2008. The company said it spent about €60,000 on its dossier.
Of the 69 MHRA approvals, 27 herbs have featured from valerian to sage, black cohosh, St John’s Wort and Echinacea. Thirty one applications have been lodged so far in 2010 out of a total of 151. A list of the latest registrations can be found here.
But the UK Herbal Forum is concerned about the relatively low rate of application for registration and is concerned apathetic companies may be about to face the wrath of the THMPD come April next year when non-registered products may come under the scrutiny of the local agencies.
“There are some member states that are ahead of the rest but a great majority of member states have not registered a single product,” chairman Penny Viner told NutraIngredients. “In general the uptake has been pretty poor.”
Despite the positive pass rate in the UK, the Alliance for Natural Health has sought legal advice and says it will launch a legal challenge to the regulation it believes discriminates against certain herbs such as Ayurvedic and Traditional Chinese Medicines.