Summary of Council decision:
Three issues were investigated, one of which was Upheld.
A TV ad for Urostemol, seen in August 2015, featured an older male actor getting out of bed, while on-screen text stated "Frequent urge to urinate?" and "Often getting up at night?". During this scene a voice-over stated, "Frequent urge to urinate? Often having to get up at night?" and continued "If your bladder constantly feels under pressure, try new Urostemol Men. Its unique combination of naturally-sourced active ingredients is traditionally used to relieve the frequent urge to urinate. For a good night, undisturbed by frequent urges, try new Urostemol Men. Used by over 10 million to relieve urgency and frequency." A graphic showing a balloon compressed by a weight labelled "URINARY URGE" was featured, followed by a shot of Urostemol Men packaging and graphics showing the claims "NEW" and "USED BY 10 MILLION". During the ad, on-screen text stated "Traditional herbal remedy for the relief of lower urinary tract symptoms related to an overactive bladder, based on long-standing use" and, during the last part of the ad, "In Germany, 1964-2015 sales data" then "Always read the leaflet".
The ASA received 15 complaints:
1. thirteen complainants (including a GP), who understood that frequent nocturnal urination was a symptom of health conditions for which medical advice should be sought, challenged whether the ad was irresponsible and potentially harmful because it could discourage viewers from doing so;
2. two complainants challenged whether the claim "Used by over 10 million" was misleading and could be substantiated; and
3. one complainant challenged whether, in light of the claim that the product had been used by over 10 million consumers, the claim "New" was misleading.
1. Omega Pharma Ltd said that Urostemol Men contained active herbal ingredients and was licensed by the MHRA as a Traditional Herbal Remedy (THR). The Summary of Product Characteristics (SPC) for Urostemol Men stated that it was a traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men related to an overactive bladder or bladder weakness, such as urgency to urinate, urinary incontinence, and frequent urination day and night, based on traditional use only. Omega Pharma said that in accordance with MHRA guidance, they were permitted to make claims about the product that were consistent with the SPC and approved licence information. They said there were no statements in either, requiring ads for the product to include specific warnings about diseases in which lower urinary tract symptoms presented.
Omega Pharma said that night-time frequency could be caused by other factors and with this in mind there were explicit instructions in the product information to ensure consumers were monitoring their symptoms and were clear on the appropriate use of the product, as well as when (if necessary) to seek the advice of a healthcare professional. The Patient Information Leaflet (PIL) for the product stated that users should seek medical advice if they presented with fever, bladder spasms, blood in urine, pain when urinating, loin, stomach or back pain during use of the product. The PIL also stated that medical advice should be sought if symptoms worsened after 7 days or persisted for more than 4 weeks. The product packaging also stated clearly that the product was intended for the relief of symptoms relating to overactive bladder. Omega Pharma said they took care to ensure the ad was clear in this regard and that the message was further enforced through the on-screen text that was present for half the ad. They said the advertising of the product therefore did not discourage seeking medical attention but encouraged it where symptoms persisted.
Omega Pharma said that over-the-counter (OTC) treatments were for short-term symptomatic relief for everyday health problems - from relieving headaches or joint pain to treatment for coughs. In line with the advertising of other OTC products, they believed consumers would understand Urostemol to be a self-treatment OTC option for urinary frequency, including frequency at night, relating to an overactive bladder. Omega Pharma said that other OTC products, such as those relating to coughs, would be well understood by consumers as for self-treatment for common coughs relating to colds and flu, rather than to serious conditions such as emphysema or asthma. The indication of product use was visible on screen for longer than the minimum required and emphasised by a following statement instructing consumers to read the PIL. This PIL was available on the internet, so consumers could read it before purchasing. Omega Pharma said the combination of the on-screen indication and the instruction to read the PIL, whether in pack or online, were measures that safe-guarded consumers and encouraged them to seek medical advice where necessary and appropriate.
Clearcast stated that the script and product were seen by a doctor before the ad was approved. They said that they and their consultant doctor did not believe that the ad discouraged viewers from seeking medical advice for serious conditions. They noted that the medicine was licensed by the MHRA and that the warnings relating to worsening and persistent symptoms required by the licence were indicated in the leaflet, which the product packaging directed users to read, and in on-screen text during the ad. Clearcast said that the ad was in line with those for other OTC products and the MHRA SPC for the product. The said their consultant physician was firmly of the view that the ad was not irresponsible because it complied with long-held conventions around advertising of OTC medicines.
2. Omega Pharma said that Urostemol was approved as a THR based on long-standing use within Europe (more than 15 years) of the active ingredients for the proposed indication. They stated that Urostemol product combinations had been marketed for over 50 years in Germany and had been used by over 10 million people. It was marketed in Austria and Germany under the brand name 'Granufink', where it was first produced in the 1960s. Omega Pharma provided German IMS sales data from 1996 and 1997 showing total Granufink sales (of all varieties) and stated that between 1996 and 2014 over 21 million units had been sold, with nearly 800,000 sold in six months of 2015. They said that sales data was not available prior to 1996, so for the period 1964-1995 they had used factory production volumes of 6 million units. They provided data from a consumer panel showing that, on average, consumers purchased two packets of the product. As such, they calculated that over 13 million people in Germany had used the product over the last 50 years.
Clearcast noted that at the end of the ad, where the claim "Used by 10 million" appeared on-screen, further text clarified that this was based on German sales data from 1964 to 2015.
3. Omega Pharma stated their understanding that a product could be considered new to the market if it had not previously been available for sale, and that such a claim would be valid for 12 months following the introduction to the UK market. They said that Urostemol was a new product range in the UK and had not been on the market prior to July 2015, hence the claim "New" appearing on the ad. They said that the product had not previously been marketed under the name Urostemol in any other market.
Clearcast stated that the product had launched in the UK in July 2015 and that the on-screen text made clear that the "Used by 10 million" claim referred to the German market.
THIS RULING REPLACES THAT PUBLISHED ON 11 MAY 2016. THE DECISION ON POINT ONE HAS REVERSED, MAKING THE COMPLAINT ‘NOT UPHELD’ ON THAT POINT.
1. Not upheld
The ASA understood that frequent urination by men, particularly at night, could be a symptom of conditions such as prostate cancer, diabetes and urinary tract infections. These were conditions for which suitably qualified medical supervision should be sought. We acknowledged that frequent urination could also be the result of less serious conditions such as overactive bladder (a condition with symptoms including frequent urination and nocturnal urination, which was more common in older people), for which the product was intended and licensed to be used as a treatment.
We understood from the MHRA that the product was considered suitable for general sale without the intervention of a healthcare professional and that it could be advertised as traditionally used for treatment of lower urinary tract symptoms (within the terms of the licensed condition) without a requirement to seek prior diagnosis from a healthcare professional. We understood that the product labelling and leaflet provided safeguards to promote safe use; in this case, warnings to seek advice from a healthcare professional should symptoms worsen after 7 days of use or persist after 4 weeks of use or if ‘red flag’ symptoms that may suggest a more serious condition were present.
We noted that the presentation of the character's symptoms did not state or imply how long he had had them, how severe or recurrent they were, or what the condition causing them was, but considered that it implied the symptom was present on an ongoing basis. We therefore considered that consumers were likely to understand that Urostemol Men was a product intended to treat the symptom of frequent urination in general, regardless of its cause, and that those suffering from the symptoms shown in the ad would understand that the product could generally be taken to treat those symptoms.
However, we did not consider the ad implied that the product was suitable to treat any medical condition by which the symptom was caused, other than the one referred to in onscreen text. Therefore, we considered that it did not discourage essential treatment for conditions for which medical supervision should be sought by offering treatment for a symptom of such conditions, and concluded that the ad did not breach the Code.
On this point, we investigated the ad under BCAP Code rules 1.2 1.2 Advertisements must be prepared with a sense of responsibility to the audience and to society. (Social responsibility), 4.4 4.4 Advertisements must not include material that is likely to condone or encourage behaviour that prejudices health or safety. (Harm and offence) and 11.3 11.3 Advertisements must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional (see rule 11.9). That does not prevent advertising for spectacles, contact lenses or hearing aids. (Medicines, medical devices, treatments and health) but did not find it in breach.
The "used by 10 million" claim appeared on screen during a pack shot of Urostemol Men, and disappeared when other packages in the range were shown. The voice-over also referred to the claim immediately after making a statement about Urostemol Men and while only the Urostemol Men packaging was shown. The ASA therefore considered that consumers would understand the claim as relating to Urostemol Men specifically, and not as relating to other Urostemol products. We noted the Omega Pharma’s statement that over 21 million packets of Granufink had been sold in Germany, and considered that if this was the previous market in which the product had been sold then it was reasonable to base the claim on data from this country.
However, we understood that this data related to the whole range of Granufink products, not just to the equivalent of Urostemol Men, and that it therefore did not match the likely interpretation of the use claim. We also noted that, although Omega Pharma had stated the total German sales figures for 1996-2015, they had only provided data relating to 1996 and 1997. Furthermore, we understood that sales figures from 1964 to 1996 were estimated on the basis of factory production figures. We did not consider, however, that this was an appropriate way to estimate sales because there was no indication that all the units produced had been sold. Finally, we noted that the consumer panel data showed that respondents bought two packets on average. However, information about the mean number of packets purchased was insufficient to demonstrate the number of consumers actually purchasing the product because detail about this distribution would necessarily be lost during the calculation of an average. As such, we did not consider that the methodology used to calculate the number of consumers who had purchased Urostemol Men was sufficiently robust to substantiate the claim "used by over 10 million". We therefore concluded that the ad was misleading and breached the Code.
On this point, the ad breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation).
3. Not upheld
The ASA understood that the complainant was concerned that the product could not be 'new' if it had already been used by over 10 million people. We understood that the prior use information related to product sales in a different country and that the product had only been sold in the UK since July 2015. We considered that, although the product had existed prior to its introduction onto the UK market, as it had not been available in the UK it was reasonable for the product to be described as 'new' in UK advertising. We noted that the product had only been available for about two months when the ad was seen, and considered that this was well within the timeframe under which a newly introduced product could reasonably still be considered 'new'. We therefore concluded that the claim "new" was not likely to mislead consumers about the degree to which the product had been available.
On this point, we investigated the ad under BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising) and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation), but did not find it in breach.
The ad must not appear again in the form complained about. We told Omega Pharma Ltd to ensure that future ads did not repeat the claim "used by 10 million" or any similar statement unless they held documentary evidence to substantiate it.