Ad description
The website www.paingenie.net advertised a product called The Pain Genie Scenar. Text included "The Pain Genie is the most technically advanced pain relief device in existence and represents a breakthrough in stimulating the body's natural self healing abilities" and "It is highly effective in all forms of pain relief".
Issue
The complainant challenged whether the claims in relation to the products efficacy for pain relief could be substantiated.
Response
PainGenie Ltd (PainGenie) said PainGenie was the brand name for the RitMedic home scenar device which was sold by the manufacturer and that their package included a 28-day money back guarantee, so if anyone bought the device and was not satisfied, they could claim a full refund. They provided a clinical data evaluation document on 'Scenar' devices which included references to multiple clinical trials (of various types and sizes). They also provided a published trial on a device called "ENAR", which examined its effectiveness on chronic neck pain. They said the ENAR device was a derivative of the scenar technology found in the PainGenie product and provided a link to the product website. They said much of the data in relation to the ENAR device was in Russian and therefore was problematic to supply. They also supplied the results of a US clinical trial that examined 14 individuals' self-assessment, which reported a reduction in pain following the use of the device. They stated that more trials were in progress.
Assessment
Upheld
The ASA considered that the evidence for the claim "It is highly effective in all forms of pain relief" would need to demonstrate that the scenar device had been shown to be efficacious in treating all types of pain, regardless of the cause. The clinical evaluation document linked types of pain and/or medical conditions to annexes which themselves listed 'reports', 'records', 'theses' and 'monographs'. The referenced reports were not supplied and PainGenie did not provide evidence to demonstrate that the device(s) tested in those documents were of the same type, pulse rate or frequency as the PainGenie scenar device.
Although we understood PainGenie believed the ENAR device tested in the clinical trial examining neck pain was relevant to the claims for the advertised device, we noted evidence had not been supplied to demonstrate that the devices were sufficiently similar for the results of that trial to be extrapolated. The US trial on the scenar device was based on the self-assessment of pain relief of 14 individuals who reported various types and locations of pain. The trial included a statement that the device "stimulated the nervous system" and "is able to teach the body to heal itself" but did not include further examination of these points. The trial was not supplied in full and it was therefore not possible to establish whether it was published in a peer-reviewed journal or that it had been placebo controlled, blinded (or double blinded) or carried out in such a way that demonstrated the self-reported results were statistically significant. Evidence was also not supplied to demonstrate that the tested device was the same as the device sold by PainGenie.
We considered that the claim "the most technically advanced pain relief device in existence" would be understood by consumers to mean that the PainGenie device was more effective at treating pain than other comparative products and noted no comparative evidence was supplied.
We considered the claims "The Pain Genie is the most technically advanced pain relief device in existence and represents a breakthrough in stimulating the body's natural self healing abilities" and "It is highly effective in all forms of pain relief" had not been substantiated and therefore concluded that the ad was misleading.
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 should not appear again in its current form. We told PainGenie to ensure it held robust evidence before making any efficacy claims.
