Background

Summary of Council decision:

Five issues were investigated, all of which were Upheld.

Ad description

The website www.boots.com featured the product "Philips PR3092/00 BlueTouch Pain Relief Patch". The website stated "The Philips Blue Touch Patch offers a natural, drug-free way to treat back pain ... Blue Touch emits a specific wavelength of blue light that stimulates the body's natural healing process". Under the heading "Detailed product information" the ad stated "Treats the symptoms of musculoskeletal back pain ... Clinically proven technology ... Aids recovery and repair of damaged muscles". Further text stated "Hazards and Cautions ... Do not use Blue Touch without consulting your doctor if you suffer from ... Undiagnosed pain".

Issue

Two complainants challenged whether the following claims were misleading and could be substantiated:

1. "natural";

2. "Treats the symptoms of musculoskeletal back pain";

3. "stimulates the body's natural healing process";

4. "Aids recovery and repair of damaged muscles"; and

5. "Clinically proven technology".

Response

Philips Electronics UK Ltd responded on behalf of Boots UK Ltd.

1. Philips Electronics said that the product was designed to emit warmth and blue light, both of which occurred naturally. They said that warmth was a natural remedy and was used for many forms of pain relief. Furthermore, they said that blue light was also a naturally occurring phenomenon with two features: its wavelength was part of natural sunlight; and it also facilitated and promoted the natural processes in the body which aided healing and pain relief.

2. & 4. Philips Electronics said that blue light triggered the release of nitric oxide in the skin which was transported into deeper tissue layers, for example muscles. Nitric oxide then exerted biological effects such as increase in local blood flow which could be one of several contributory factors for the relief of pain and therefore recovery.

Philips Electronics provided references and study abstracts which they said supported their claims. This included in vitro and non-human studies on the action of nitric oxide on specific cells or skin samples together with online encyclopaedia references. Additional references and papers discussed the effect of nitric oxide, including inhaled and systemic effects on particular body organs and blood vessels which they said indicated the benefits of nitric oxide and the resulting healing and recovery.

Philips Electronics also submitted a study, conducted on volunteers with chronic mild to moderate musculoskeletal back pain. They said the study showed that the BlueTouch Pain Relief Patch was effective against mild to moderate musculoskeletal back pain.

3. Philips Electronics said that there were many potential causes for back pain and its pathophysiology was not always understood. They said that while there were many causes of back pain and therefore various remedies, the production of nitric oxide was crucial in many of these. They highlighted various roles of nitric oxide, for example: vasodilation through the relaxation of smooth muscle; as an antioxidant leading to protection against DNA damage; regeneration of muscle fibres; help to decrease the formation of scars; and the reduction of the inflammatory processes.

5. Philips Electronics said that they had arranged for an independent consortium to conduct a clinical trial which took place in three pain clinics and they reiterated their comments above regarding the study. They said that their study, which showed the BlueTouch Pain Relief Patch was effective against mild to moderate musculoskeletal back pain, supported the claim "clinically proven".

Assessment

1. Upheld

The ASA acknowledged Philips Electronics' assertion that because their product produced blue light, and because the spectrum of sunlight included blue light, their product could be described as natural. However, because the ad made reference to the natural properties of the device and the light emitted, we considered that to be called 'natural', consumers would expect a remedy to be based on a product or ingredient that had not been manufactured to produce an element that occurred in nature. We therefore considered that light produced from an artificial source was unlikely to be seen as akin to part of the spectrum of natural sunlight. Because the source of blue light was artificially produced and did not arise from a natural source, we concluded the claim was misleading and 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) 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 products and beauty products).

2. & 4. Upheld

We considered that consumers would interpret the claims for the BlueTouch Pain Relief Patch to mean that it was an effective treatment for back pain and its symptoms and in the context of references to blue light technology, that it was a treatment method that had additional benefits of muscle recovery and repair. We considered that the emphasis of the ad was on blue light technology and consumers would therefore expect the primary mode of action was blue light, rather than heat or warmth. Additionally, we considered consumers were likely to understand from the claims "Treats the symptoms of musculoskeletal back pain" and "Aids recovery and repair of damaged muscles" that use of the product was likely to ultimately resolve their back pain without the need for further treatment.

We noted the various studies, references and the study provided by Philips Electronics in relation to blue light and its influence on the production of nitric oxide and its action within the body. However, because a significant part of the substantiation submitted was in abstract form we were unable to fully assess its relevance to the claims and whether they were robust enough to support them. Furthermore, we did not consider that in vitro studies, animal or online encyclopaedia entries were suitable evidence to support the various claims made for the device, especially because evidence for such claims should usually be based on experimental human subjects.

We noted the study conducted on human volunteers and took expert advice. The study was a prospective, randomised, controlled, double-blind, multi-centre study which was sponsored by Philips Electronics. The study, while well designed, did not appear to be published and therefore was not peer reviewed. We considered that was likely to undermine the authority of the report.

We noted that the study showed that both the subjects in the device and control (placebo) groups showed an improvement in pain intensity during the study and the difference in the pain intensity scores between both groups was statistically significant. Nevertheless, on another score, pain relief, although average pain relief was higher in the device compared to the control group, that difference was not statistically significant. Furthermore, any improvements were not reflected in longer term follow-up.

From the study, it was also not clear whether the treatment effect was due to blue light or warmth emitted from the device. In addition, it did not discuss whether topical application of blue light influenced the production of nitric oxide which then penetrated further into tissue layers such as superficial or deep muscles. Because we had not seen evidence to support the claims in relation to the effects of blue light emitted by the product and the production of nitric oxide, we concluded they were misleading.

On these points, 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),  3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.  (Exaggeration) 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 products and beauty products).

3. Upheld

We considered that consumers would understand the claim related to the specific effect of the device to mean that it would influence the body's natural reaction to stress or injury. We understood that nitric oxide, in its various forms, could exert a physiological function, for example, the relaxation of smooth muscle. It was also understood that nitric oxide could be introduced into the body through a variety of methods, many of which were via drug delivery mechanisms where there was a clinical need. However, we considered that in healthy humans, certain circumstances would lead to the natural, endogenous production of nitric oxide. We noted Philips Electronics' assertion that blue light could initiate the production of nitric oxide. However, as with points 2 and 4 above, it was not clear from the evidence submitted whether the device initiated the production of nitric oxide over and above that which the human body could be expected to produce unaided. Because we had not seen evidence to support the claim that the product elicited an effect on the body's natural healing processes, we concluded the ad was misleading.

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.
 (Medicines, medical devices, health-related products and beauty products).

5. Upheld

We considered the word 'proven', in the overall context of the ad and its claims, was likely to convey to consumers that the product was superior to a placebo device for the treatment of musculoskeletal back pain and repair of damaged muscles. Notwithstanding the concerns set out in points 2 and 4 above, issues remained about the overall efficacy of the device. We acknowledged that the trial in which the device was used on human volunteers had been well designed and had shown an effect on pain intensity while the product was in use. However, we required a sound body of evidence to be presented to support the efficacy claims. Because the evidence had not adequately supported the various claims made for the product, we concluded the claim "clinically proven technology" was misleading and 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) 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 products and beauty products).

Action

The ad must not appear again in its current form. We told Boots UK Ltd to avoid calling an artificial light source natural and to ensure their efficacy claims were based on adequate evidence in future.

CAP Code (Edition 12)

12.1     3.1     3.11     3.7    


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