The law, the 2004 Traditional Herbal Medicinal Products Directive (THMPD), requires all herbal products across the EU’s 27-member state bloc that seek to make to health claims, be registered before a 2011 deadline.
The MHRA has previously proposed a simplified herbal products registration transfer system, to assist products with well-established science or traditional use pass through the system, and now has gone further.
“This Guidance interprets the legal requirements for advertising to the public and recommends best practice for advertisers to ensure safe and responsible advertising of these medicines,” MHRA said.
The Guidance notes that products can market themselves as having a specified benefit even if clinical data is not in place as long as the product wording along the lines of: “based upon long-standing use as a traditional remedy”.
Wording that implies clinically-backed treatments for particular conditions was unlikely to be accepted, the regulator said.
“In practice, given the nature of the traditional herbal scheme, it would be particularly difficult, in brief advertisements, to make reference to clinical trial data without misleading consumers.”
It added that clinical evidence could be presented partially, which was misleading, and this could land an advertiser in hot water.
It noted that testimonials were admissible, but must not “suggest that the product has proven efficacy.”
Long-standing use, under the THMPD, means those products that have been on the market for 30 years outside of the EU or 15 years within it.
The Guidance can be found here .
