ASA Adjudications
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Ad
A leaflet for a pain relief device was headlined "PainSolvTM". Further text stated "Cell Function Enhancement Using clinically proven technology ... 3 in 1 medical device Pain Relief Wound Relief Stress Relief". Inside the leaflet the headline text stated: "The clinically proven technology that PainSolvTM employs has successfully treated the following conditions as well as many others". The first section was headed "1 Pain Relief" and listed the following conditions: "Arthritis Carpal tunnel syndrome Frozen Shoulder Muscle Strains & Sprains Neuralgia Period Pain Backache Dental Pain Bursitis Chronic Back Pain Fibromyalgia Coccidynia Golfer's Elbow Gout Gouty Arthritis Heel Pain Housemaid's Knee Ligament Strains Lumbago Muscle Strains Osteoarthritis Painful Joints Rheumatoid Arthritis Sesamoiditis Synovitis Tendonitis Toothache".
The next section was headed "2 Wound Relief" and listed the following conditions "Burns Bone Fractures Cuts & Grazes Heel and Leg Ulcers Post-herpetic neuralgia Psoriasis & Eczema Scalds Shingles Sports Injuries Varicose Veins Acute soft tissue injury Dermatitis Slipped Disc Osteoporosis Post operative wounds Sore Veins Swollen Joints Tempromandibular Dysfunction Whiplish".
The final section was headed "3 Stress Relief" and listed the following conditions "Anxiety Blood Pressure Depression Exam Stress Insomnia Migraine Sleep Disorders Tension Work Stress Stress Deep vein thrombosis Menopause symptoms Muscle Spasm Post-natal depression Post-operative depression Post-traumatic Stress".
The next page was headed "So how does the PainSolvTM work?" The body copy stated "Application of the PainSolvTM therapy is based on more than 30 years of worldwide research carried out by renowned scientists ... clinical research carried out for NASA proved that millisecond duration pulsed electromagnetic fields have the greatest beneficial effect on living tissues over any other energy form. This is because the PainSolvTM pulsed waves pass through all types of body tissue including bone, without any reduction of wave strength ... "
The next page was headed "Is there just one setting for treating all the conditions mentioned?" and showed a picture of the PainSolvTM device and the price "£129.95 Plus postage, packaging and insurance". Text above the image stated "It is not clinically effective to have a single-setting for all types of treatment that may be required and Mediconcepts have ... developed different patented software algorithms for specific areas of therapy. Each of these programmed algorithms differs in duration, intensity and/or frequency".
The next page was headed "How will it benefit me?" The body copy stated "Exposure to PainSolvTM wave forms creates a ripple effect, which activates biological processes in the body which will work on your health problem for approximately 8-10 hours at a time ... ". The back page contained testimonials from customers and the text "DESIGNED & MANUFACTURED WITH PRIDE IN THE UNITED KINGDOM".
Issue
Pulse Medical Technology challenged whether:
1. the advertiser could substantiate their claim that the device treated the medical conditions listed;
2. the advertiser could substantiate their claim that the device used "clinically proven technology";
3. the claim "the PainSolvTM pulsed waves pass through all types of body tissue including bone, without any reduction of wave strength" could be substantiated;
4. the claim "Each of these programmed algorithms differs in duration, intensity and/or frequency" was misleading and could be substantiated;
5. the advertiser could substantiate the claim "Exposure to PainSolvTM wave forms creates a ripple effect, which activates biological processes in the body which will work on your health problem for approximately 8-10 hours at a time";
6. the advertisers could substantiate the claim that they had "patented software algorithms for specific areas of therapy"; and
7. whether the claim "DESIGNED AND MANUFACTURED WITH PRIDE IN THE UNITED KINGDOM" could be substantiated.
| The CAP Code: | 3.1;7.1;50.1 |
Response
1. MediConcepts Ltd (MediConcepts) said they had used incorrect terminology in the ad. They said the claim should have stated "Users say the technology that PainSolv employs has successfully reduced pain associated with many conditions". They said that was an oversight on their part and acknowledged that they should not have listed the conditions by name.
2. MediConcepts included a link to their database and said the information contained there showed the technology used in the PainSolv device was clinically proven. They said there was only one pulsed electromagnetic field modality and that all devices sold and tested used the same modality. Therefore the claim "clinically proven technology" was acceptable. They sent clinical trial data they said was based on a prototype for the PainSolv device. The notes to the trial data stated that it was collected over a period of ten months at a clinic in Germany and was to determine whether randomised controlled clinical trials would be feasible to assess the effectiveness and application of the PainSolv device. The data reported some "surprisingly effective results" based on follow-up telephone interviews after treatment, and stated that those results had not been measured "in any scientific way".
3. MediConcepts said that the claim should have stated "the PainSolvTM pulsed waves pass through all types of body tissue including bone, without any refraction of wave strength" and not "reduction of wave strength". They said that was a type setting error. They said it was a scientific fact that magnetic waves could pass through all materials without refraction at any level.
4. MediConcepts said the claim "Each of these programmed algorithms differs in duration, intensity and/or frequency" had been independently tested and scientifically proven. They sent a report from the Academy of Sport, Physical Activity and Wellbeing at South Bank University that measured the frequency and intensity of the algorithms for the three different settings of the PainSolv device and stated the different duration of the algorithms. The report concluded that the peak field intensity ranged from 12 kHz to 75 kHz but was likely to be below those figures depending on the distance of the device from the tissue.
5. MediConcepts said it was scientifically proven that pulsed electromagnetic fields that permeate body tissue set in motion the effect described in the claim. They emphasised that it was not a product specific claim, and included a link to their database of articles on pulsed electromagnetic field therapy. They acknowledged that the amount of time stated in the claim could very, and said they would remove the reference to "approximately 8 -10 hours" from the ad.
6. MediConcepts said they were currently considering which parts of their technology to patent, and acknowledged that they should not have included the term "patented software algorithms ... ". They said they would amend the claim to "software algorithms for which we are in the process of applying for patents".
7. MediConcepts said the product was designed and manufactured in the UK. They sent signed testimonials from the companies involved in the design, manufacture and assembly of the product, including the circuit boards and the moulded parts that enclosed the device. They sent a sample of invoices from the component manufacturers they used who were based in the UK.
Assessment
1. Upheld
The ASA acknowledged MediConcepts willingness to amend the ad. However, we considered that the impression created by the ad, particularly the claim "The clinically proven technology that PainSolvTM employs has successfully treated the following conditions ... " combined with the extensive list of conditions strongly implied PainSolv could treat those conditions. Because the advertiser did not send evidence to substantiate that claim, we concluded it was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
2. Upheld
The ASA noted that the information contained in the database showed articles had been published on the use of pulsed electromagnetic field therapy in a range of clinical trials on both people and animals. However, we also noted that those articles did not show that the technology used in those trials was the same as the technology used in the PainSolv device. We noted that the results in the German trial relating to a prototype device had not been measured in a scientific way, and the trials themselves had been carried out to determine whether it would be feasible to carry out a randomised controlled clinical trial using the device. Because we had not seen evidence that the effectiveness of the technology used in the PainSolv device had been proven in clinical trials we concluded that the claim "clinically proven technology" was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
3. Upheld
We acknowledged that the word "reduction" was a type-setting error and welcomed MediConcepts decision to remove it from the ad, particularly because we understood that the intensity of pulsed electromagnetic waves decreased with distance from the source. We noted their assertion that the PainSolv pulsed waves could pass through all types of body tissue including bone, because it was a scientific fact that all magnetic waves passed through all materials. Because we understood that only magnetic field pulses of low frequencies (below around 50 kHz) could pass through all types of tissue, but the settings of the device ranged from 12 kHz to 75 kHz, we considered the claim should be supported by evidence related to the testing of the three different settings of the device. Because it was not, we concluded the claim had not been substantiated and was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
4. Not upheld
We considered the evidence sent by MediConcepts. We noted that the report from the Academy of Sport, Physical Activity and Wellbeing concluded that the PainSolv device had three settings, and the frequency and intensity of each of those settings was different. We noted that the report stated that the duration of the programmed algorithms was different for each setting. Although we noted the report concluded that the peak field intensity was likely to be below the recorded figures of 12 kHz, 50 kHz and 75 kHz depending on the distance of the device from the tissue, we concluded the testing substantiated the claim "Each of these programmed algorithms differs in duration, intensity and/or frequency".
On this point we investigated the ad under CAP Code clauses 3.1 (Substantiation) and 7.1 (Truthfulness) but did not find it in breach.
5. Upheld
We noted MediConcept's assertion that the claim was not product specific, and referred to pulsed electromagnetic fields in general. However, because the claim "Exposure to PainSolvTM wave forms creates a ripple effect, which activates biological processes in the body which will work on your health problem for approximately 8-10 hours at a time" referred specifically to the ability of the PainSolv wave forms to work on health problems for a set amount of time, we considered it should be supported by evidence that showed how the PainSolv wave forms worked on health problems for 8-10 hours. Because it was not, we concluded the claim was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
6. Upheld
We were concerned to note that MediConcepts had included the claim "patented software algorithms ... " before they had decided which algorithms to patent. However, we welcomed their decision to amend the claim so that it stated they were in the process of applying for patents.
On this point the ad breached CAP Code clauses 3.1 (Substantiation) and 7.1 (Truthfulness).
7. Not upheld
We accepted that the evidence sent showed the product had been designed, manufactured and assembled in the UK. We concluded they had substantiated the claim "DESIGNED AND MANUFACTURED WITH PRIDE IN THE UNITED KINGDOM".
On this we investigated the ad under CAP Code clauses 3.1 (Substantiation) and 7.1 (Truthfulness) but did not find it in breach.
Action
The ad must not appear again in its current form. We told MediConcepts to ensure any future claims about the health benefits of PainSolvTM pulsed waves were supported by evidence relating directly to the testing of the different settings in the PainSolv device. We advised them to seek guidance from the CAP Copy Advice team before advertising again.
Adjudication of the ASA Council (Non-broadcast)
ASA Adjudications
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Ad
A national press ad for a pain relief device was headlined "NEW DRUG FREE ALTERNATIVE TO MEDICATION". The body copy stated "With the brand new PainSolv CE marked medical device, you now have truly portable health management! ... PainSolv encourages your body to enhance the efficiency of cell functions which in turn increases oxygen content in your blood as well as many other beneficial processes ... PainSolv can help relieve the pain associated with the following conditions and many more - Arthritis, Back Pain, Migraine, Whiplash, Joint Pain, Muscle Spasm, Stress, Leg Ulcers, Gout, Tendinitis ... Unlike TENS machines that simply block pain signals to the brain, PainSolv works directly on the cause rather than just the symptoms! ... Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions. The CE mark confirms that a product meets all essential European health, safety and environmental requirements."
Issue
1. Pulse Medical Technology challenged whether the claim "Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions" was misleading, because it implied the MDD certification specifically approved the device for treating the conditions listed in the ad.
One member of the public challenged whether the claims:
2. "PainSolv encourages your body to enhance the efficiency of cell functions which in turn increases oxygen content in your blood as well as many other beneficial processes"; and
3. "PainSolv works directly on the cause rather than just the symptoms" were misleading and could be substantiated.
| The CAP Code: | 3.1;7.1 |
Response
1. Aromatheutics agreed to remove the claim "Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions" from the ad. They sent a copy of the certificate of registration for the Medical Device and said that in future ads they would state that the CE mark confirmed the device met all essential health, safety and environmental requirements.
2. Aromatheutics said Pulsed Electromagnetic Field Therapy was scientifically proven to encourage the body's own immune system through a number of physiological reactions. They said the claim was not misleading because PainSolv worked on the same principal and sent a link to a database containing articles on the use of pulsed electromagnetic field therapy.
3. Aromatheutics said the claim "PainSolv works directly on the cause rather than just the symptoms" was supported by scientific experience. They sent three diagrams they said showed how pulsed electromagnetic field therapy worked at cellular level. They argued that it was logical to conclude that, because pulsed electromagnetic field therapy had been shown to reduce inflammation and neuralgic symptoms at site, it worked directly on the cause of the pain rather than just the symptoms.
Assessment
1. Upheld
The ASA welcomed Aromatheutics willingness to amend the ad and remove the claim. However, because the medical device certification did not approve the device for the treatment of pain, wound and stress conditions, as stated in the original ad, we concluded the claim was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
2. Upheld
We noted Aromatheutics comments. However, because the articles contained in the database did not describe clinical trials on the PainSolv device itself, we considered they had not shown that the PainSolv device encouraged the efficiency of cell functions and increased oxygen content in the blood. We concluded the claim was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
3. Upheld
We considered the evidence sent by Aromatheutics. We noted that the diagrams and accompanying text illustrated in general terms the theoretical basis behind the way in which pulsed electromagnetic field therapy worked at cellular level. However, we considered that the claim "PainSolv works directly on the cause rather than just the symptoms" should be supported by evidence from clinical trials using the PainSolv device, rather than general theory about pulsed electromagnetic field therapy. Because it was not, we concluded the claim was misleading.
On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).
Action
The ad must not appear again in its current form. We told Aromatheutics to ensure any future claims about the health benefits of the PainSolv device were supported by evidence relating directly to the testing of the different settings in the PainSolv device. We advised them to seek guidance from the CAP Copy Advice team before advertising again.
Adjudication of the ASA Council (Non-broadcast)
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