The agency said the guidance document, which was published in draft in March, has been revised in the light of comments received from stakeholders and discussions with the Medicines Advertising Liaison Group (MALG).
While rules governing medicines advertising (Medicines (Advertising) Regulations 1994) also apply to traditional herbal medicinal products, advertising of herbals must also include ‘a specified form of wording to inform the consumer that the efficacy of the product for the stated indications is not scientifically supported but is based exclusively on evidence of long-standing use.’
The updated guidance now includes a section to cover the advertising of a range of products.
The agency notes that it may not be practical to include an individual statement for each product in a brief advertisement, and in this situation, it said it may be appropriate to use a single statement with the wording “based upon long-standing use as a traditional remedy” that covers all the products.
The final document also provides information on the new certification mark which the MHRA has registered. This allows companies, if they so wish, to include the logo in their advertising and/or on pack labelling to help the public to identify that the product holds a THM registration.
Last month, supplier Bio-Health announced that Salvian, its sage product designed to reduce excessive sweating in post-menopausal women,is the first herbal product to display the new Traditional Herbal Registration (THR) mark in the UK.
The MHRA, in its report Delivering High Standards in Medicines Advertising Regulation, said that it is working to ensure the effectiveness of self regulation in the herbal sector.
The agency reports that one of the cases of upheld complaints about the advertising of newly registered THM products highlights the key issue for advertisers getting to grips with the new scheme and it concerned an A.Vogel newsletter e-mailed to consumers.
“The newsletter did not indicate in any way that the products were ‘traditionally used’ to treat the conditions and suggested their clinical effects had been proven. The company was required to issue a corrective statement to recipients of the original newsletter,” stated the report.
It also noted that publicity for the launch of Duchy Herbals Echina-Relief and Hyperi-Lift Tinctures claimed incorrectly that the products had been assessed for efficacy by the MHRA.
“All traditional herbal medicinal products, registered under the Traditional Herbal Medicines Registration Scheme, are assessed for safety, quality and evidence of traditional use. Efficacy of the product based on scientific data is not assessed," affirmed the agency.
The Annual Report and the Guidance can be found here.