Background
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ad description
The website for Ionic Balance Bands www.ionic-balance.com included various pages which made claims for their products:
a. A product page for a "BLUE IONIC CORE BAND" included text which stated "Scientifically Proven" and "The Ionic Balance Band is SCIENTIFICALLY PROVEN to improve: Flexibility Strength Balance Endurance".
b. A product page for a "BLUE IONIC BALANCE WATCH" included text which stated "Our patent formula is unique to Ionic Balance and is the only Ionic Wristband formula to be scientifically tested by a proper Double Blind Placebo Crossover Human Clinical Study. Accept no imitations".
c. A page linked to via the "TECHNOLOGY" tab was headed "The POWER Within - Our 9th Generation Formula" and text included "BENEFITS Increased Far Infrared emission Decreases joint stiffness Increases blood flow Enhances the delivery of oxygen and nutrients in the blood cell to the body's soft tissue areas Leads to pain relief Affects soft tissue injury Assists in reduction of inflammation Promotes regeneration and recovery", "Increased Alpha Wave resonance Deep Relaxation of Body and Mind Improved Mood and Stability of Emotions Regulated levels of Serotonin" and "Negative Ion Therapy Negative Ions increase your sense of well-being and mental clarity by removing the debilitating effects of excessive positive ions in your environment Negative Ions have a relaxing effect and have been reported to normalize your breathing rate, decrease blood pressure and relieve tension Studies show high levels of Negative Ions can be as effective at treating Seasonal Affective Disorder (SAD) Elevated mental concentration and performance Better sleep".
Issue
The complainant challenged whether the following claims were misleading and could be substantiated:
1. "Scientifically Proven" and "The Ionic Balance Band is SCIENTIFICALLY PROVEN to improve: Flexibility Strength Balance Endurance" in ad (a);
2. "… scientifically tested by a proper Double Blind Placebo Crossover Human Clinical Study" in ad (b); and
3. the efficacy claims listed under "BENEFITS" in ad (c).
Response
1, 2 & 3. Ionic Balance said they would amend the ads to remove the claims complained about. They said they did not see any issue with the claims highlighted in ad (b).
Assessment
1. Upheld
We considered that consumers would understand from the claims "Scientifically Proven" and "The Ionic Balance Band is SCIENTIFICALLY PROVEN to improve: Flexibility Strength Balance Endurance" that robust evidence had shown that the product would improve flexibility, strength, balance and endurance. The website included a page linked to via "Technology" and "Scientific testing" which featured a report of a 2012 study of the product, which we understood was the study also referred to in ad (b). We therefore considered whether that study supported the claims in ad (a). Ad (a) related to the "BLUE IONIC CORE BAND", but we understood that the claim related to all the Ionic Balance bands. The study stated that the premise of the product was to emit negative ions, far infrared rays and alpha waves. We had not previously seen robust evidence to support claims for the product, or similar products, and we considered that as breakthrough claims they needed to be supported by a robust body of evidence.
The 2012 study was carried out by an integrative health research institute which specialised in obtaining clinical trials to support marketing claims, but it had not been published or peer reviewed. It was described as an exploratory pilot study, was carried out on 16 subjects and was double-blinded, placebo controlled and used a crossover design. The subjects ranged in age from 20 to 57 and 11 were male and 5 female, with the gender ratio based on customer demographics for Ionic Balance. The subjects were in general good health and did not have a high level of fitness. Although the subjects appeared to be from the appropriate population, we noted the study did not detail how they were recruited or give a further breakdown of the subjects' demographic data. The crossover design meant that one group wore the active band for one week and one group the placebo band – the results were then measured and compared to baseline and the bands swapped and the process repeated. The study referred to randomisation, but did not explain how the groups were randomised. It also did not give details of the placebo band and how they ensured it was identical. The study measured 16 objective outcomes relating to flexibility, strength, balance and endurance and was therefore relevant to the claims in the ad. Average (mean) outcomes and standard deviations were reported, but it did not confirm whether or not all subjects completed the study. The study reported that statistically significant differences were seen between the active band and placebo band outcomes when compared to baseline results for all measures, apart from one (right-hand strength). It concluded that the results demonstrated that the product significantly improved flexibility, balance, strength and endurance. Although we acknowledged the study's results and conclusions, we noted that it was an exploratory pilot study of only 16 subjects, which had not been published or peer reviewed. We also considered that although it appeared to be carried out in accordance with generally accepted standards, it had been carried out by a company that had the stated purpose to produce trials to support marketing claims, which introduced the possibility of bias. We did not consider that the trial was sufficient to substantiate the claims in ad (a) and therefore concluded that they were misleading.
On this point ad (a) 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. Upheld
Ad (b) referred to the "BLUE IONIC BALANCE WATCH" and stated Ionic Balance's products had been "scientifically tested by a proper Double Blind Placebo Crossover Human Clinical Study", which we understood was a reference to the 2012 study. We considered that, in this context, the claim implied that the Ionic Balance products had been tested in a double-blind placebo crossover human clinical study and found to be effective. Because we did not consider that the study was sufficient to support claims for the product, we concluded that the claim in ad (b) was misleading.
On this point ad (b) 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).
3. Upheld
Ad (c) listed various benefits for the Ionic Balance products, including decreased joint stiffness, increased blood flow, improved mood and normalising breathing rate. We had not seen any evidence relevant to any of the claims in ad (c) and therefore concluded they had not been substantiated and were misleading.
On this point ad (c) 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 ads must not appear again in the form complained about. We told Ionic Balance not to: state or imply that their products could improve flexibility, strength, balance and endurance; imply that scientific testing had demonstrated efficacy; or to repeat any of the claims in ad (c). We told them not to make efficacy claims for their products unless they were supported by new and robust evidence.
