Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website, www.nicobloc.co.uk, featured text that stated "IF YOU'RE READY TO STOP YOU'RE READY FOR NICOBLOC. NicoBloc is the next generation aid to stop smoking. Made from totally safe food grade ingredients, NicoBloc reduces the amount of nicotine and tar you inhale from your own brand of cigarettes. Used over a short period, it will gradually reduce your body's dependence on nicotine, whilst helping to protect you from withdrawal symptoms. NicoBloc is a coloured liquid that works by adding drops to the filter of the cigarette over a three to six week period. You start by adding one drop to the filter of your cigarette which blocks 33% of the nicotine and tar. In week two, you add two drops to the filter of your cigarette and this blocks 66% of the nicotine and tar and in week three you add three drops thus blocking up to 99% of the nicotine and 99% of the harmful tar. NicoBLOC helps you with your addiction to Nicotine. To go ‘cold turkey’ can be an extremely difficult way of quitting smoking. Using patches and gum or even e-cigarettes are all helpful but all of them are based on giving you a dose of Nicotine in an alternative way and do not address the fundamental addiction problem. Why not stop the way you got hooked ... one cigarette at a time?.. ’gradually’. NicoBloc uses the gradual reduction method that allows you to quit smoking one cigarette at a time while reducing your intake of Nicotine and Tar. NicoBloc is simple to use and contains natural ingredients that can trap up to 99% of tar and Nicotine in the cigarette while you smoke. You apply NicoBloc to the cigarette and not to your body so you do not ingest anything. As a consequence its [sic] free from Nicotine and free from the controversy surrounding e-cigarettes at the moment. Even though NicoBloc is not classed as a medicine (you do not ingest any of the contents of the bottle) or medical device, it is available on prescription via your GP."
Issue
1. The complainant, who believed the ad made medical claims for a product that was neither a medicine nor a medical device, challenged whether the smoking cessation claims were misleading and could be substantiated.
2. The complainant also challenged whether the claims regarding the capability of the product to block 33%, 66% and 99% of nicotine and tar were misleading and could be substantiated.
Response
1. Health & Beauty Innovations Ltd t/a NicoBloc said the ad did not claim that the advertised product was a smoking cessation device; rather they said it referred to the product as a helpful aid and stated its effect on nicotine and tar. They referred to three studies, which they said demonstrated the advertised product reduced exposure to nicotine and tar. They believed it followed that a reduction of nicotine would be helpful to smokers wanting to stop smoking.
NicoBloc provided a number of testimonials from organisations that had implemented the Rosen Stop Smoking Programme (Rosen Programme), which entailed smokers being given the advertised product, shown a motivational film, having lung carbon monoxide readings taken, keeping daily smoking records and being set weekly targets. They said an average of 58% of participants quit smoking through the Rosen Programme. They provided a further study in which the advertised product had been used in conjunction with participants meeting with a therapist each week throughout the duration of the six-week trial. They believed that study demonstrated the effectiveness of NicoBloc when used as part of a smoking cessation programme.
2. NicoBloc pointed out that the ad did not state an exact number; rather it made clear that the product could reduce "up to [%]" of nicotine and tar. They said different cigarettes contained different amounts of nicotine and tar and included different filter constructions, which would affect the NicoBloc's effect. They provided three studies, which they believed supported the claims.
Assessment
The ASA understood that the advertiser would no longer sell NicoBloc in the UK.
1. Upheld
The ad stated "Used over a short period, it will gradually reduce your body's dependence on nicotine, whilst helping to protect you from withdrawal symptoms", "NicoBLOC helps you with your addiction to Nicotine", "Using patches and gum or even e-cigarettes are all helpful but all of them are based on giving you a dose of Nicotine in an alternative way and do not address the fundamental addiction problem", and "Give up Nicotine before giving up cigarettes". In the overall context of the ad, we considered these were claims to treat nicotine addiction. Because we understood that the product had not been licensed by the MHRA or CE marked as a medical device for that purpose, we concluded that the ad breached the Code.
NicoBloc was designed to reduce levels of nicotine and tar. However, in order to enable smokers to stop smoking, determination on the part of the participant was required. We considered the claims "IF YOU'RE READY TO STOP YOU'RE READY FOR NICOBLOC", "To go ‘cold turkey’ can be an extremely difficult way of quitting smoking", "Why not stop the way you got hooked ... one cigarette at a time?", and "NicoBloc is the next generation aid to stop smoking" did not make sufficiently clear that determination on part of the user was required in order to stop smoking. Rather, the claims implied that using the product would enable individuals to stop smoking. We understood that smoking cessation claims were permitted for NicoBloc provided they were capable of robust substantiation.
The testimonials provided by the advertiser related to feedback on the Rosen Programme, rather than the advertised product alone. In one study, participants used NicoBloc in conjunction with meeting with a therapist who used a motivational enhancement approach to suggest subjects decreased the number of cigarettes per day they used and to encourage participants to declare their own plan for smoking cessation. We therefore considered the testimonials and study were not sufficient to demonstrate the efficacy of NicoBloc when used in isolation.
We noted NicoBloc's belief that because NicoBloc reduced nicotine and tar levels, it followed that using NicoBloc would be helpful to smokers wanting to stop smoking. However, we had not seen evidence to demonstrate that NicoBloc enabled smokers to stop smoking. Indeed, one of the studies made clear that although the advertised product reduced exposure to components of tobacco smoke, further studies were required to determine the benefit of that approach as an aid to smoking cessation.
Because the ad made claims to treat nicotine addiction, but the product had not been licensed by the MHRA or CE marked as a medical device for that purpose, we concluded that those claims breached the Code. Because the claims relating to smoking cessation had not been substantiated, we concluded that they were misleading and breached the Code.
On this point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising)
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are 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) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health related and beauty products).
2. Upheld
The ad stated "NicoBloc reduces the amount of nicotine and tar you inhale from your own brand of cigarettes" and made claims that one drop of NicoBloc to the filter of a cigarette blocked 33% of nicotine and tar; two drops blocked 66% of nicotine and tar; and three drops blocked up to 99% of nicotine and 99% of tar. In that context, we considered consumers would understand that NicoBloc would block up to 99% of nicotine in a representative sample of cigarettes used by consumers in the UK. We considered consumers would understand the distinction between the "up to" claim made in respect of three drops of NicoBloc blocking 99% of nicotine and the additional performance claims which did not include the "up to" claim. We considered consumers would understand the performance claims that did not include the claim 'up to' were absolute claims that the product would reduce nicotine and tar content to the extent stated in the ad in the cigarettes used by consumers in the UK.
The first test report showed that one drop of NicoBloc reduced nicotine content by more than 33%, two drops reduced nicotine content by more than 66% and three drops reduced nicotine by less than 99%. The report was conducted in accordance with a number of ISO standards, including ISO 10315:2013, which we understood to be a machine test for the determination of nicotine in cigarette smoke condensates obtained by non-standard smoking.
The second test report showed that one drop of NicoBloc reduced nicotine and tar content by more than 33%, two drops reduced nicotine and tar content by more than 66% and three drops reduced nicotine and tar content by less than 99%. The report had been conducted in accordance with ISO 4387:2000, which we understood to be a machine test method that allowed cigarettes to be smoked using a strictly controlled set of parameters and enabled the nicotine-free dry particulate matter ("tar") and nicotine from cigarettes to be compared. However, we understood that the standard did not account for modifications to the cigarettes, such as the addition of NicoBloc. We were therefore concerned that the test report was not sufficient to substantiate the performance claims.
The third test report concluded that three drops of NicoBloc reduced nicotine and tar content by close to 99%. The report related to a single test on one type of cigarette from two different brands. We understood that it was not conducted in accordance with the current ISO standards. We considered that, in and of itself, the report was not sufficient to support the performance claims.
We considered the first test report, conducted in accordance with ISO 10315:2013, produced robust results as to the nicotine content in cigarette smoke condensates when using NicoBloc. However, we considered the ad presented the performance claims as being representative of the performance level that would be achieved in cigarettes used by consumers in the UK. We were concerned that we had not seen sufficient evidence to demonstrate that and therefore concluded that the performance claims had not been substantiated.
On this point, the ad breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are 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).
Action
The ad must not appear again in its current form. We told NicoBloc to ensure future ads did not claim to treat nicotine addiction if the product had not been licensed by the MHRA or CE marked as a medical device for that purpose and to ensure they held robust documentary evidence to support smoking cessation claims in future. We also told them to ensure that future ads did not imply that performance claims were representative of the performance level that would be achieved in cigarettes used by consumers in the UK, unless they held robust documentary evidence to substantiate that claim.
