In its ruling the IAP (Istituto dell'Autodisciplina Pubblicitaria) said the company Specchiasol had gone too far in marketing of the NOCIST food supplement. It said the company itself only had proof the product could limit the likelihood of relapse in recurrent cystitis, not eliminate the risk completely.
The IAP said the marketing material as well as the brand name NOCIST itself was highly misleading to consumers.
There are no approved claims for cranberry’s ability to prevent or treat UTI under the EU’s NHCR. Agencies like the UK's Advertising Standards Authority (ASA) typically reference the NHCR as reasoning for a rejection, not what evidence a company could proffer.
Dr Luca Bucchini, managing director of Hylobates Consulting, said this was indicative of the Italian national authorities’ maverick shift away from the NHCR as a legal reference point.
The IAP ruling followed an Italian court defense of botanical company Named S.p.a’s right to make AIDS and Alzheimer’s disease claims, overturning a fine of €250,000 imposed by the Italian national competition authority.
At the time Bucchini said the “absurd” decision could potentially void the EU health claims regulation in Italy in that it suggested courts should rely on the proof put forwards by a company not scientific opinions from the European Food Safety Authority (EFSA).
While there had been no further news on this specific case, the latest NOCIST ruling showed a continuation of this stance that unauthorised health claims were not in themselves automatically misleading.
“The NOCIST decision is notable in that, once more, IAP does not take the NHCR into account in examining advertising with health claims. This is unlike the UK's ASA or Spain's Autocontrol.”
He added: “The company did have evidence to back up the claim, so it is a wording issue. What is interesting is that IAP did not even consider whether the wording is compatible with food law, whether the claim is pending under the NHCR or not, or its standing with Italian guidelines, or even EFSA opinions on cranberry. They don't even use EFSA's standards to assess the studies.”
Bucchini said this, coupled with a separate ruling on misleading ‘reduced fat’ claims from crisp maker Tar Lazio, set a dangerous precedent that meant Italy would have no legal provisions to enforce rules on health claims.
“If you read this in combination with Tar Lazio's rulings, you conclude that the NHCR is not considered relevant for advertising, either by courts or self-regulation bodies, most evidently with botanicals, in Italy. This may anticipate the outcome of the roadmap that the EC has recently announced - it also means that there is no single market for botanicals.”
He warned this could lead to a diversion of company investment from research to marketing.
“It also seems that the ultimate aims of the NHCR - building consumer trust in the benefits of food and food supplements, through a rigorous authorisation process, and protecting investment in research - are lost in the process.”
Cystitis - an inflammation of the bladder usually caused by a bladder infection – is a common type of urinary tract infection (UTI), particularly in women.
According to the UK’s National Health Service (NHS), half of all women in the UK will have a UTI at least once in their life while one in 2,000 healthy men develop a UTI each year.
Cranberry & medical device recap
There are no approved claims for cranberry’s ability to prevent or treat UTI under the EU’s NHCR. This has seen many companies reroute to gain medical device status, which means the products sit alongside bandages and life-support equipment.
Under Council Directive 93/42/EEC, medical device are defined as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination…intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease…” or other uses.
To gain medical device status, as opposed to medicine status, under the European Commission Directive 2001/83/EC, Directive 93/42/EEC states that a product must “not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.
In essence this means a medical device must have a primarily physical mechanism of action.
This has been hailed as a legal loophole by some and a legal market opportunity by others.
NOCIST however is a food supplement product.