Background

Ad description

A TV ad for paingone plus, seen during December 2016, featured a presenter in what appeared to be a pharmacy setting. Two banners behind the presenter each stated “Pain Control” and on-screen text stated “exclusively at Lloyds Pharmacy” in the style of that business’ branding. The presenter stated, “Have you heard about paingone plus? It’s the new automatic TENS pen for effective relief of minor aches and pains. Paingone plus is an affordable therapy that you can use alongside your current pain relief medication. The device delivers a series of controlled therapeutic pulses that’s known as TENS”. The ad also included consumer testimonials one of which was accompanied with on-screen text that stated, “No leads, pads or gels”. The ad then featured an image of paingone plus which showed yellow and orange circles that radiated out from the end of the product.

Text at the foot of the ad stated “Paingone is a trade mark. The name doesn’t imply complete pain relief. For temporary relief of pain as part of current medication”.

Issue

Fifteen complainants, a number of whom found the small on-screen text difficult to read but believed it included material information, challenged whether the ad misleadingly implied that paingone plus could relieve pain.

Response

Medi-Direct International Ltd t/a PainGone said they were a certified manufacturer of transcutaneous electrical nerve stimulation (TENS) devices and that paingone plus was a class IIa medical device manufactured in compliance with the International Electrotechnical Commission (IEC) Standard, which included the requirements for the essential performance of electrical nerve and muscle stimulators. They provided a CE certificate to that effect which they said demonstrated the product’s classification as a TENS device and they believed they had followed the CAP guidelines for the advertising of such devices.

They said when producing the ad they wanted to ensure that it was clear that paingone plus was for the temporary relief of pain as part of a current medication programme and that there was no guarantee of pain relief. They said they also took the step to ensure that the trademark name paingone was not misleading and therefore added the additional disclaimer to their ad stating that the name did not imply complete pain relief.

They said the size of the on-screen text conformed to the relevant BCAP guidance and as the TV script had also stated that the product was for the temporary relief of pain as part of a consumer’s medication programme, they felt that the consumer understood completely the available benefits from the product.

Clearcast understood that the established published evidence available supported the likelihood that TENS was effective for the temporary relief of pain in general. They said they had seen evidence that the device was registered as a medical device for the use of TENS and they believed the ad made clear that the device was only intended for the relief of minor aches and pains and as an adjunctive treatment along with current medication. They also believed that the super, “Paingone is a trademark. The name doesn’t imply complete pain relief. For temporary relief of pain as part of current medication”, made sufficiently clear that the name was a trademark, and was not a performance claim in its own right.

Clearcast also referred to the BCAP guidance based on previous rulings.

Assessment

Upheld

The ASA considered consumers would understand claims spoken by the presenter such as “Have you heard about paingone plus? It’s the new automatic TENS pen for effective relief of minor aches and pains. Paingone plus is an affordable therapy that you can use alongside your current pain relief medication” to mean the product, when used as directed, would provide effective relief from pain and would also be suitable for use alongside pain relief medication.

We had previously accepted claims that standard TENS devices could lead to the temporary relief of minor aches and pains, but only when used alongside pain medication and not when used alone. The CE certification demonstrated that the device was classified as TENS and we understood that the notified body that issued the certificate had assessed evidence for the product and approved claims for the product packaging, including “fast, simple, drug free pain relief” and “paingone is a registered trademark. The name does not imply efficacy/performance. It is intended for the temporary relief only, as part of your regular pain relief treatment plan”.

We took advice from an expert about the nature of the advertised device. We considered, despite there being some differences (particularly the short duration of the stimulation), the device was similar enough to standard TENS to be considered in the same group of devices and therefore similarly effective. As we had previously accepted claims that standard TENS could temporarily relieve minor aches and pains only when used alongside pain medication, we concluded that such claims made about the paingone plus were unlikely to mislead.

We therefore considered that in order not to mislead, the ad should make clear that the product was for temporary relief only and only effective when used alongside pain relief medication. However, as noted above, the voice-over did not make clear that the relief was temporary and also gave the impression that the product would be effective when used on its own.

We noted that the text at the bottom of the screen stated “Paingone is a trademark. The name does not imply complete pain relief. For temporary relief of pain as part of current medication”. However, while that text complied with the relevant size, height and duration requirements of the BCAP guidance, we considered that the similarity of the light colour of the text set against the light colour of the background imagery made the text at the bottom of the screen difficult to read and would therefore be unlikely to effectively communicate material information about the product’s efficacy.

Because the ad implied that the product was effective for pain relief when used alone and did not make clear that it only offered temporary relief even when used alongside pain medication, we concluded that the ad was misleading.

The ad breached BCAP Code rules  3.1 3.1 The standards objectives, insofar as they relate to advertising, include:

a) that persons under the age of 18 are protected;

b) that material likely to encourage or incite the commission of crime or lead to disorder is not included in television and radio services;

c) that the proper degree of responsibility is exercised with respect to the content of programmes which are religious programmes;

d) that generally accepted standards are applied to the contents of television and radio services so as to provide adequate protection for members of the public from inclusion in such services of offensive and harmful material;

e) that the inclusion of advertising which may be misleading, harmful or offensive in television and radio services is prevented;

f) that the international obligations of the United Kingdom with respect to advertising included in television and radio services are complied with [in particular in respect of television those obligations set out in Articles 3b, 3e,10, 14, 15, 19, 20 and 22 of Directive 89/552/EEC (the Audi Visual Media Services Directive)];

g) that there is no use of techniques which exploit the possibility of conveying a message to viewers or listeners, or of otherwise influencing their minds, without their being aware, or fully aware, of what has occurred"

Section  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.  2).  and  3.2 3.2 Advertisements must not mislead consumers by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that consumers need in context to make informed decisions about whether or how to buy a product or service. Whether the omission or presentation of material information is likely to mislead consumers depends on the context, the medium and, if the medium of the advertisement is constrained by time or space, the measures that the advertiser takes to make that information available to consumers by other means.  (Misleading advertising) and  3.11 3.11 Qualifications must be presented clearly.
BCAP has published Guidance on Superimposed Text to help television broadcasters ensure compliance with rule  3.1 3.1 The standards objectives, insofar as they relate to advertising, include:

a) that persons under the age of 18 are protected;

b) that material likely to encourage or incite the commission of crime or lead to disorder is not included in television and radio services;

c) that the proper degree of responsibility is exercised with respect to the content of programmes which are religious programmes;

d) that generally accepted standards are applied to the contents of television and radio services so as to provide adequate protection for members of the public from inclusion in such services of offensive and harmful material;

e) that the inclusion of advertising which may be misleading, harmful or offensive in television and radio services is prevented;

f) that the international obligations of the United Kingdom with respect to advertising included in television and radio services are complied with [in particular in respect of television those obligations set out in Articles 3b, 3e,10, 14, 15, 19, 20 and 22 of Directive 89/552/EEC (the Audi Visual Media Services Directive)];

g) that there is no use of techniques which exploit the possibility of conveying a message to viewers or listeners, or of otherwise influencing their minds, without their being aware, or fully aware, of what has occurred"

Section  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.  2).  . The guidance is available at:
http://www.cap.org.uk/~/media/Files/CAP/Help%20notes%20new/BCAP_Advertising_Guidance_Notes_1.ashx  (Qualification).

We investigated the ad under BCAP Code rules  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) and  11.4 11.4 Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, the 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, treatments and health), but did not find it in breach.

Action

The ad must not be broadcast again in its current form. We told Medi-Direct International Ltd to ensure that their ads made clear that the product was only effective when used alongside pain medication and only offered temporary relief.

BCAP Code

11.4     3.1     3.11     3.2     3.9    

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