ASA Adjudication on High Tech Health Ltd

Ad

A leaflet and a teleshopping ad made claims for a “circulation booster”.

a. The leaflet stated, “Immediate relief from aches, pains and swelling! Poor circulation? Swollen feet & ankles? Cold feet & aching tired legs? You need the all new Circulation Booster V3”. It went in to some detail about the action and effects of the product, claiming that it “applies mild electrical muscle simulation” to the feet, that it “can reduce foot and ankle swelling … With regular use of the Circulation Booster V3 you will experience a significant improvement in blood circulation and reduced swelling within four weeks", as well as that it “can increase blood flow throughout the lower limbs thereby reducing the risk of deep vein thrombosis” and “increase pain free walking associated with arthritis, neuropathy or circulation disorders”.

b. The TV ad showed a woman on a couch rubbing her legs in discomfort. On-screen text stated “Aches, pain or swelling?”. A voiceover stated “Do you suffer from aches and pains in your lower legs or swollen feet and ankles? You could benefit from the Circulation Booster V3 an effective device to help maintain healthy localised circulation in your lower legs and feet. Just one session a day could help to improve the flow of blood by causing the muscles in your lower legs to contract and release". On-screen text at stated “Consult your Doctor. If your symptoms are not due to any serious underlying disorder, Circulation Booster could help you … Not intended to treat serious or prolonged conditions”. The ad then included three testimonials. On-screen text stated "Unsuitable in the first trimester of pregnancy or with a pacemaker". Further on-screen text stated "VAT Exemption for long term illness and disability", “Reduces swollen ankles” and “Not intended to treat serious or prolonged conditions”. The voiceover continued "... If you suffer from a long-term illness or disability you may be able to claim back the VAT. Speak to one of our friendly operators on 0800 XXXX XXX now or go online to order our Circulation Booster V3. Our UK call centre is open 8am to 10pm seven days a week. Call now".

Issue

A reader challenged whether the following claims in the leaflet could be substantiated:

1. that the product "can ... reduc[e] the risk of deep vein thrombosis";

2. that the product "can ... [produce] a significant improvement in blood circulation and reduced swelling"; and

3. that the product "can... increase pain-free walking associated with arthritis, neuropathy or circulation disorders";

4. The ASA challenged whether the leaflet could discourage essential medical treatment.

5. A viewer objected that the TV ad was misleading in suggesting in the voice-over and on-screen text that the product was suitable for those suffering from a long-term illness or disability, whilst the on-screen text also stated that it was "not intended for serous or prolonged conditions".

6. The ASA also challenged whether the TV ad amounted to teleshopping for a medical treatment and was therefore unacceptable.

BCAP TV Code

Response

1. High Tech Health Ltd (High Tech) acknowledged that the claim in the leaflet that the product "can reduce the risk of deep vein thrombosis" was a medical claim which should not have been made. They agreed they did not hold evidence to support it and said they would remove it.

2. High Tech said they were confident the product could reduce swelling and poor circulation as advertised. They sent a summary of a clinical trial involving the product to support the claim along with expert comment on the trial.

3. High Tech acknowledged that the claim in the leaflet that the product "can increase pain-free walking associated with arthritis, neuropathy or circulation disorders" was a medical claim which should not have been made. They agreed they did not hold evidence to support it and said they would remove it.

4. High Tech said the removal of the claims challenged in points 1 and 3 would remove the possibility that their advertising could discourage essential medical treatment going forward.

5. High Tech said that the reference to long-term illness or disability was simply because, where a device which was originally designed solely for use by disabled people was purchased by chronically sick or disabled people for their domestic or personal use, such consumers could claim VAT exemption on the product. That did not mean that the broadcast suggested that the product could assist those viewers who suffered from long-term illnesses or disability. This was made clear by on-screen text which stated "If your symptoms are not due to any serious or prolonged disorder, Circulation Booster could help you ... Not intended to treat serious medical conditions". They stated that the reference to long-term illness and disability was only made in order to explain who could obtain a VAT exemption on the product and said they saw no reason why this information should be omitted. They did not believe the average viewer would interpret the broadcast as a statement that the product could be used to assist with serious and long-term conditions.

Clearcast said that on-screen text stating that the product was not intended to treat serious or prolonged conditions was added at the request of their consultant so as not to discourage anyone who may be suffering with an adverse condition from seeking the appropriate medical advice. They stated that the reference to viewers who suffered from a long-term illness for which the product may offer relief was considered necessary in order to distinguish between those who may qualify to claim back the VAT and those who may not. They acknowledged that the two claims were contradictory, but believed that in this particular context, the distinction between a serious condition and a long-term illness or disability would be understood by viewers with long-term illness or disability.

6. High Tech said that the TV broadcast was not teleshopping, and even if it was, it was not for medical treatment. On the teleshopping issue, they said that the prohibition in the BCAP Code reflected the prohibition on teleshopping for medical treatment in the Audiovisual Media Services Directive 2010/13 and its predecessor, and that the TV broadcast did not involve a "direct offer" required for teleshopping as defined in that Directive. In particular (i) the broadcast was in a 60-second advertising slot rather than a teleshopping slot; (ii) a consumer could not simply "accept" the offer but if they chose to purchase they could, having seen the broadcast, contact the company separately or by telephone or on their website or go to one of the many stores in the UK where the product was sold.

On the medical treatment issue, they again referred to Directive 2010/13. They said that the Circulation Booster V3 was a class 2A medical device, not a medical treatment. The term medical treatment was intended to refer to provision of a service by medical professionals. If the Directive had been intended to apply to medical devices, that could be used by the purchaser or by anyone else for the purpose of medical treatment, that would have been stated expressly. In support of that view, High Tech Health referred to the fact that medical devices were regulated by other EU directives and that, in their view, there were wide implications, in terms of restricting free movement of goods, of interpreting the prohibition on teleshopping for medical treatment to include medical devices. Also, the TV broadcast did not refer to adverse medical conditions (the reference to long-term illness or disability being explained solely by reference to the possible VAT saving) and was directed at healthy people who might wish to stimulate the lower limbs in order to feel more comfortable, for example if they were seated for extended periods working in the office or watching TV. The vast majority of those purchasing the Circulation Booster V3 were not chronically sick or disabled, as demonstrated by the fact that in the period from 1 July 2009 to 30 June 2010 only around a quarter of all orders claimed VAT exemption. They said, whilst the Circulation Booster could be used to help people suffering the symptoms of underlying disorders, the TV broadcast marketed the product to help healthy people with ordinary discomfort caused by temporary periods of inactivity, and as such was not a broadcast for a "medical treatment" and should not be prohibited under the Code.

Clearcast believed that the Circulation Booster could relieve the discomfort associated with certain medical conditions which made a "cash with order" ad for a medical device possible. They said the duration of the broadcast was 60 seconds and they had understood that its scheduling in conventional airtime rather than in teleshopping windows meant that the CAP (Broadcast) TV Advertising Standards Code prohibition on teleshopping ads for medical treatments was not a consideration. They said the reference to VAT exemption in the broadcast was intended as a reminder that some viewers might be eligible for VAT relief and should not be taken as evidence that the broadcast was promoting a medical treatment.

Assessment

1. Upheld

The ASA noted High Tech's response. We considered the leaflet should not have claimed that the product was capable of reducing "the risk of deep vein thrombosis", which was a serious medical condition, and in respect of which, moreover, the advertiser did not hold robust clinical trial evidence regarding the product's efficacy, and we concluded the leaflet breached the Code on those grounds.

On this point the leaflet breached CAP Code (Edition 11) clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 and 50.3 (Health and beauty products and therapies).

2. Upheld

We noted the leaflet claimed the product was conclusively capable of reducing swelling and poor circulation, stating "Simply sit back, relax and let the Circulation Booster V3 make you feel better today! Just 30 minutes a day ... Improve circulation, Reduce Swollen Feet and Ankles" and "What results can you expect? The use of muscle stimulation of the feet, as well as the calf, can: reduce foot and ankle swelling ... With regular use of the Circulation Booster V3 you will experience a significant improvement in blood circulation and reduced swelling within four weeks", and considered that the average consumer would infer from the leaflet that the product would improve circulation and reduce swelling whatever the cause. We noted the expert comment provided by the advertiser referred to a variety of studies on devices using a similar mechanism to the Circulation Booster and covered the use of the product by healthy individuals. We noted the meta-analysis suggested such devices had potential to increase blood flow after prolonged sitting and reduce swelling, blood pooling and discomfort in lower limbs, although not all studies produced evidence of efficacy. We also noted the trial had been conducted on people classified as "healthy" whereas we considered the leaflet also marketed the product to those with serious or prolonged medical conditions by making reference to "deep vein thrombosis", "arthritis, neuropathy or circulation disorders" and alluding to the possibility of VAT relief for the chronically sick and disabled. We also noted the trial did not follow the use of the product over four weeks and there was no evidence to suggest that users "would experience a significant improvement in blood circulation and reduced swelling within four weeks" as claimed in the ad. Whilst the trial indicated reported subjective improvements in swelling and discomfort we also noted those correlated weakly with measured swelling. We concluded that, the evidence seen by the ASA to date suggested that, whilst the product might help with swelling and poor circulation in some circumstances, the evidence did not justify the implication that it definitely would do so, or that results would improve after time.

On this point the leaflet breached CAP Code (Edition 11) clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and beauty products and therapies).

3. Upheld

We noted High Tech's response. We considered the leaflet should not have claimed that the product was capable of increasing "pain-free walking associated with arthritis, neuropathy or circulation disorders", which were serious or prolonged medical conditions and in respect of which, moreover, the advertiser did not hold robust evidence regarding the product's efficacy, and we concluded the leaflet breached the Code on those grounds.

On this point the leaflet breached CAP Code (Edition 11) clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 and 50.3 (Health and beauty products and therapies).

4. Upheld

We were concerned that the leaflet made reference to serious or prolonged medical conditions, as discussed at points 1 and 3 above, and concluded that, in doing so, the leaflet could discourage readers from seeking essential medical treatment, which was prohibited under the Code.

On this point the leaflet breached CAP Code (Edition 11) clause 50.3 (Health and beauty products and therapies).

5. Upheld

We noted the broadcast stated that the product was not intended to treat serious or prolonged conditions and was not suitable for serious underlying disorders. However, we also noted the broadcast stated "If you suffer from a long term illness or disability you may be able to claim back the VAT" and understood from Her Majestys Revenue and Customs guidance on VAT reliefs that this exemption was available only on products for personal and domestic use which had been designated solely for the relief of a severe abnormality or a severe injury. We considered that viewers who were classed as VAT exempt were likely to consider themselves to have a serious or prolonged condition and, as such, were likely to understand from the broadcast that the product was suitable for treating such conditions. We considered that those viewers were likely to find the disclaimers and implied suitability claims to be contradictory and unclear as to whether the product was suitable for their condition or not. We therefore concluded that the broadcast was misleading.

On this point the TV ad breached CAP (Broadcast) TV Advertising Standards Code rule 5.1.3 (Misleading Advertising).

6. Upheld

We noted that Directive 2010/13 defined television advertising as being "any form of announcement broadcast ... in order to promote the supply of goods and services ... in return for payment"; and defined teleshopping as "direct offers broadcast to the public with a view to the supply of goods or services ... in return for payment". We disagreed with High Techs contention that teleshopping must involve a contractual offer by the trader. Because the broadcast contained both a (free phone) telephone order number and a website address that directed viewers to a website which took orders for the product and because the script was explicitly seeking a direct response from customers, stating, "Speak to one of our friendly operators on 0800 XXXX XXX now or go online to order your Circulation Booster V3. Our UK call centre is open 8am to 10pm seven days a week. Call now", we considered it went beyond mere promotion and was making a direct offer, with a view to supply. We noted the product was also available to purchase in shops but this was not referred to in the broadcast, which exhorted customers to order now directly online or by telephone

We also disagreed that because the broadcast was scheduled in conventional airtime in a 60-second slot rather than teleshopping windows, rule 8.2.1 did not apply. We noted that the AVMS Directive provided for teleshopping to take place in slots as well as windows, and that Ofcoms "Code on the Scheduling of Television Advertisements" did not suggest that teleshopping spots were not subject to rule 8.2.1 if scheduled in conventional airtime rather than in teleshopping windows.

We also noted High Tech's view that the Circulation Booster V3 was a medical device and was not advertised as and did not constitute a "medical treatment". We noted the Medical Devices Directive 93/42/EEC defined a medical device as "intended by the manufacturer to be used for human beings for the purpose of i) diagnosis, prevention, monitoring, treatment or alleviation of disease, ii) diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap".

In our view the device was presented for purchase for the purpose of treating medical conditions. The broadcast referred to relieving aches, pains and swelling by improving blood circulation. Whilst it stated that the product was "not intended to treat serious or prolonged conditions" it also informed viewers that "If you suffer from a long term illness or disability you may be able to claim back the VAT". We further noted that the website to which the broadcast directed viewers stated "What the Circulation Booster treats" and then listed ""blood circulation, bad circulation, arthritis, back pain/sciatica, cold feet and cold hands, deep veined thrombosis, diabetes, foot and leg ulcers, joint pain/leg pain, lymphodema/swelling, mobility and inactivity, muscular atrophy, muscular injuries/pain, peripheral neuropathy, numbness, peripheral vascular disease, poor circulation/circulatory disease, Raynaud Syndrome, restless leg syndrome, stress and tension, swelling/fluid retention/gout". We noted the consumer protection rationale in the AVMS Directive for the prohibition on teleshopping (as opposed to advertising) for medical treatment. We considered the broadcast constituted teleshopping for a medical treatment and that it breached the Code on those grounds.

On this point, the broadcast breached CAP (Broadcast) TV Advertising Standards Code rule 8.2.1.

Action

The leaflet must not appear again in its current form. The teleshopping ad must not appear again.

Adjudication of the ASA Council (Broadcast)

Adjudication of the ASA Council (Non-broadcast)