Background
Summary of Council decision:
Two issues were investigated, of which one was Upheld and one was Not upheld.
Ad description
A national press ad promoting an Instalife acupressure pad, seen on 13 December 2015, included claims such as “HELPS STOP PAIN in its tracks!”, “Independently tested & certified by physiotherapists”, “Now you can carry on with working, walking, jogging, running, playing golf, tennis, Pilates, yoga … in fact just any activity you do, you can do wearing Insta life …” and “Helps to RELIEVE lower back PAIN After just one use!”. Text next to an image of a woman, who appeared to be in pain, stated “Insta Life Acupressure Pad helps relieve both short term and chronic sciatic back pain”. The bottom of the ad featured a testimonial which stated “The relief after applying Insta Life is wonderful and I can now carry on with my life again!”.
Issue
The complainant challenged whether:
1. the pain relief claims were misleading and could be substantiated; and
2. the testimonial was genuine.
Response
1. Chums Ltd provided a clinical trial to support the pain relief claims made in the ad along with a physiotherapy report and evidence related to the Instalife Acupressure Pad’s class 1 medical device status. They said in light of the evidence provided, they were satisfied that the claims had been adequately substantiated and that view was further reinforced by the positive comments they had received from customers.
Chums said they were willing to make amendments to their advertising to remove reference to the word “chronic”, the claim “after just one use” and to ensure that pain relief claims were only made in relation to lower back pain and sciatica.
2. They also provided a copy of the letter sent by a customer, whose words had been used in the testimonial. Chums believed the letter demonstrated that the testimonial in the ad was genuine. They also provided an alternative testimonial in email format which contained similar feedback.
Assessment
1. Upheld
The ASA acknowledged Chums’ willingness to make some amendments to their advertising. However, we considered that consumers reading the ad would be likely to understand that the Insta Life Acupressure Pad was proven to be effective in providing immediate pain relief for lower back, hip and leg pain, and both short-term and chronic sciatic pain, including during differing levels and intensity of physical activity.
We noted that the physiotherapy report and two documents relating to the same clinical trial did not make clear the basis on which the participants of the trials were selected and whether pain had been professionally or self-diagnosed. Both documents also referred to trials that lacked a control group, had no blinding and also no proper comparison of pain before and after treatment, because the trial was purely dependent on the participants self-reporting of pain improvement without reference to any measure.
We considered that a clinical trial lasting four weeks, with no control or placebo device, dependent of the self-reporting of pain was not sufficient to substantiate the various pain relief claims in the ad, including “The relief after applying Insta Life is wonderful”, in the testimonial. In particular, it was not adequate to substantiate the claims that pain relief with the product was immediate, because pain was not assessed immediately after using the product. The trial also did not last long enough to examine whether relief could be provided with regular use of the product and we also noted that it was not clear whether the tests involved physical activities of the type referred to in the ad (such as jogging, yoga, Pilates and playing golf) and, importantly, the physiotherapy report showed that certain types of pain actually increased during that trial. We considered that the evidence was not able substantiate the pain relief claims for the Insta life Acupressure Pad.
In addition, because the ad offered treatment for “chronic” sciatic pain, which was not carried out under the supervision of a suitably qualified medical professional, we considered it discouraged essential treatment for a condition for which medical supervision should be sought.
In light of the above, we concluded that the claims had not been adequately substantiated, or should not have been made because they discouraged essential treatment, and that they therefore breached the Code.
On that 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
3.47
3.47
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and testimonials) 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.
and
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health related products and beauty products).
2. Not upheld
Notwithstanding our concerns regarding the pain relief claims that featured in the testimonial, as set out above, we noted that the evidence provided by Chums contained the address and signature of the customer and showed they had made the statement reflected in the ad. We therefore considered it demonstrated that the testimonial in the ad was genuine and did not breach the Code.
On that point, we investigated the ad under CAP Code (Edition 12) rule 3.45 3.45 Marketers must hold documentary evidence that a testimonial or endorsement used in a marketing communication is genuine, unless it is obviously fictitious, and hold contact details for the person who, or organisation that, gives it. (Endorsements and testimonials), but did not find it in breach.
Action
The ad must not appear again in its current form. We told Chums Ltd not to make pain relief claims if they did not hold adequate documentary evidence to substantiate such claims.
