Vitamin-herb brain claims are ok, finds UK authority

24-Jan-2011 - Last updated on 24-Jan-2011 at 12:44 GMT

Brain claims are OK, says ASA

The UK branch of German pharma player Boehringer Ingelheim has had brain health adverts for a vitamin-based medicine backed by local watchdog, the Advertising Standards Authority (ASA).

Responding to a complaint about a radio ad promoting Pharmaton as a herb, vitamin and mineral blend that could enhance mental capacity, the ASA found no problem with the ad, because the product had received a medicinal product authorisation for the product with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

“Because we understood that the MHRA licence for Pharmaton stated that it could increase mental capacity we considered that the claim that Pharmaton could enhance mental capacity had been substantiated and was not misleading,” the ASA wrote in its ruling on the matter.

Pharmaton Vitality Capsules contain a bland of vitamins and minerals as well as ginseng. Increasing mental and physical capacity as well as relieving states of exhaustion had been provided to the MHRA bu Boehringer in the Summary of Product Characteristics (SmPC) required in medicinal product applications.

Scientific data backing the claims including the specific wording, "pronounced increase in the physical and mental capacity", had been examined and approved by MHRA staff, due to the presence of the ginseng extract. Boehringer had provided several human studies supporting the claims.

In Boehringer’s case, the UK radio copy clearing service said it had checked the MHRA authorisation, including the SmPC, and agreed that the claims were not misleading.

“We noted the MHRA licence for Pharmaton and the accompanying SmPC,” the ASA said.

“We noted that the SmPC stated that the ginseng extract in the product raised the general level of cellular activity which was expressed by a pronounced increase in physical and mental capacity.”

THMPD, NHCR

The fact that claims can be approved in this way, as with the EU Traditional Herbal Medicinal Products Directive (THMPD), is drawing increasing interest from the herbal sector which is struggling to have its science and claims approved under the nutrition and health claims regulation.

Indeed, the European Commission recently removed botanicals from that process to reconsider how science in the sector should be treated. That issue issue is unlikely to be revisited until the end of 2012, while the deadline for THMPD registrations is April 30 – little more than three months away.

As of December 31, 2010, there had been 187 registrations for individual products under the THMPD. Eighty four products have been approved and none rejected.

Approvals have been granted for about 30 herbs including valerian, sage, black cohosh, St John’s Wort and Echinacea.

THMPD registrations state: “There is no requirement under the Traditional Herbal registration Scheme to prove scientifically that the product works.”