Background
Summary of Council decision:
Four issues were investigated, all of which were Upheld.
Ad description
Claims on the website www.energydots.net promoted a range of devices produced by Phi Harmonics Ltd. Text on the home page stated "… powerful, revolutionary, scientifically tested products by phiharmonics - Man-made electromagnetic radiation is everywhere, for better or worse. An energyDOT is a small, ultra-thin disc, programmed to harmonise the effects of this radiation - to help keep your body balanced and healthy - all the time. The investment is modest, the results can be profound". Text in larger, bold print stated "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing*". Text towards the bottom of the page stated "*experienced by various energyDOT users".
Clicking on a tab labelled "electroDOT" took users to a page relating to that product. Text stated "The electroDOT is the core of the phi energyDOT range. It is programmed to harmonise electromagnetic frequencies (EMFs) from the electronic equipment you use regularly ... There are numerous reasons for tiredness, lack of concentration, headaches, dizziness, irritability and depression. If you suffer from any of these and have eliminated all obvious causes, it is possible that they relate to EMF exposure. Clinical studies around the world have linked EMFs to health problems. Many experts already consider the evidence to be overwhelming and advise strongly that precautions should be taken now". The words "clinical studies" and "precautions" contained a hyperlink to a page entitled "Discover", which contained links to various documents about EMF.
Issue
The complainant challenged whether the following claims were misleading and could be substantiated:
1. that the products were "scientifically tested" ;
2. "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing*";
3. "It is programmed to harmonise electromagnetic frequencies (EMFs) from the electronic equipment you use regularly ..."; and
4. "There are numerous reasons for tiredness, lack of concentration, headaches, dizziness, irritability and depression. If you suffer from any of these and have eliminated all obvious causes, it is possible that they relate to EMF exposure. Clinical studies around the world have linked EMFs to health problems ...".
Response
1. Phi Harmonics Ltd provided a copy of a study carried out on the electroDOT which they considered demonstrated its efficacy. They stated that that study had been carried out to internationally-accepted standards using double-blind, placebo-controlled methods, had concluded that the electroDOT was shown to be "profoundly effective in negating the adverse effects of mobile phone radiation on the human body" and had commented that prolonged exposure beyond the three-week trial period may produce greater benefits.
They said the electroDOT was the most popular of the products they offered and, because all of their energyDOTs were programmed according to the same principles and practices, the findings of the study were equally applicable to their other products and their objective had been to use the study as a paradigm to show the efficacy of the other energyDOTs as well.
Phi Harmonics stated that other trials had also been undertaken on the energyDOTs, and referred us to their website.
2. Phi Harmonics commented that the reported benefits were experienced very commonly by their customers and said they had made clear that the claim "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing" was based on user experience. They said they were aware that user testimony alone was unlikely to constitute sufficient evidence to support efficacy claims, and said they had therefore also made available on their website the documentary evidence they held in support of the claim. They said that evidence was the studies they had undertaken on their products, which could be read in conjunction with other scientific reports into the existence and effects of EMF.
3. Phi Harmonics said the claim "It is programmed to harmonise electromagnetic frequencies (EMFs) from the electronic equipment you use regularly ...", which referred to the electroDOT, expressed that the objective of the programming was for harmonisation to take place as a result of the positive vibrational frequency in the DOT entraining the physically antipathetic frequency from nearby electronic devices.
4. Phi Harmonics said the wording, "There are numerous reasons for tiredness, lack of concentration, headaches, dizziness, irritability and depression. If you suffer from any of these and have eliminated all obvious causes, it is possible that they relate to EMF exposure" had been carefully chosen to make reference to the sufferer having already "eliminated all obvious causes" and to include the conditional phrase "it is possible that ...". They said that reflected the fact that EMFs might not be the cause of the stated symptoms but that, as there were studies suggesting health problems resulting from EMF exposure, that was a factor worth considering. They said the claim did not suggest that, after elimination of all obvious causes, there was no possible source other than EMF exposure.
Phi Harmonics said the statement "Clinical studies around the world have linked EMFs to health problems ..." was intended to draw attention to the existence of multiple pieces of research conducted by various organisations around the world into the effects of microwave and radiofrequency radiation from mobile phones, phone masts, radar, microwave ovens and other electrical and electronic communication devices. They provided a link to a copy of the BioInitiative Report 2012, which they described as one of the most comprehensive sources of information regarding clinical studies and other research into the field. They highlighted the sections of that report that they considered relevant to the claim "There are numerous reasons for tiredness, lack of concentration, headaches, dizziness, irritability and depression. If you suffer from any of these and have eliminated all obvious causes, it is possible that they relate to EMF exposure. Clinical studies around the world have linked EMFs to health problems ...".
Phi Harmonics Ltd said the report contained a large amount of compelling evidence about the dangers of electromagnetic radiation. However, they also commented that the scientific background of EMF could be said to be inconclusive, but said they believed the precautionary principle should apply. They referred to a report by the Standing Committee on the Environment, Agriculture and Local and Regional Affairs that had been adopted by the Parliamentary Assembly of the Council of Europe in May 2011 and that strongly advised member states not to wait for conclusive evidence in this area before taking precautionary action. They said the UK Government also currently advised that those aged under-16 years should use mobile phones for essential purposes only and should keep calls short, which was an example of the precautionary principle in practice.
Assessment
1. & 2. Upheld
The ASA considered that consumers would be likely to understand the claim "scientifically tested", which appeared on the website home page, to mean that all of the energyDOTs had been proven efficacious through robust scientific testing. Because it appeared near to the prominent claim "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing*", we further considered that consumers would be likely to understand that the products had been scientifically demonstrated to have those effects.
We acknowledged that the claim "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing*" was linked by an asterisk to smaller print further down the page that stated "*experienced by various energyDOT users". However, we considered that consumers would expect reports of user experience to reflect evidenced effects of using the products and that the reference to user testimonials should be supported by robust substantiation as to the efficacy of the energyDOTs in producing the listed outcomes.
We considered the study supplied by Phi Harmonics Ltd. We noted that it had been intended to measure the effects on the body and the "biofield" of the electroDOT product only, during mobile phone use, and therefore considered that it could not be used in support of wider claims relating to other products or other usage situations. The study had been conducted on a relatively small sample size of 60 participants. Participants had been assigned to a test or control group and given an electroDOT or a placebo, with instructions to place it on their mobile phone for the duration of the study. They were monitored at the beginning of the 21-day trial and every seven days thereafter. The monitoring comprised of the use of "Electro Photonic Imaging" ("EPI"), which was designed to record and enable analysis of photon emissions from subjects' fingertips, and "Medical Thermal Imaging" ("MTI"), which measured heat distribution across the body. At the end of the trial, participants were also asked to complete a questionnaire recording the effect the trial had had on symptoms such as headaches and anxiety.
The study reported that the electroDOT had been found to be "profoundly effective in negating the adverse effects of mobile phone radiation on the human body". We were concerned, however, that the testing methodology was not comprehensively described; for example, no information was given as to what steps had been taken to ensure that participants were exposed to the same levels of radiation from the mobile phones, and although differences in body temperature had been recorded through the MTI scans, it was not clear whether those scans had been performed in a controlled environment. We understood that analysis of the "biofield", which was described in the study as another name for the "aura", was not a generally accepted, scientifically robust method of determining exposure to radiation. Whilst the study noted that use of a mobile phone was known to generate heat, particularly on the surface of the head, it did not explain how heat measurements demonstrated the presence or absence of electromagnetic radiation. We further noted that neither the EPI nor the MTI scans were intended to measure the effect of the electroDOT on energy, concentration or stress levels, sleep patterns, frequency of headaches or the participants' sense of wellbeing. Although some of those outcomes were included in the questionnaire completed at the end of the trial, few participants had recorded having experienced such problems before the start of the trial and so the sample size for the questionnaire was further reduced. We considered in any case that a self-reporting study would not constitute sufficiently robust evidence for objective efficacy claims.
For the reasons outlined above, we considered that the study supplied by Phi Harmonics was not sufficient to constitute robust substantiation for the claims that their products were "scientifically tested" and resulted in "More energy - Greater concentration - Better sleep - Fewer headaches - Less stress - All-round wellbeing*".
Further documentation available from Phi Harmonics’s website included an analysis of the effects of electroDOT-use on live blood cells and a single-blinded study into the effects of the electroDOT on 100 participants (ten of whom were in a control group) on electromagnetic radiation from mobile phones, which used as its testing mechanisms Polycontrast Interference Photography, Gas Discharge Visualisation (which appeared to be similar to EPI) and Resonant Field Imaging. We noted that neither study related to or showed the effects of the product on energy, concentration or stress levels, sleep patterns, frequency of headaches or sense of wellbeing, and that the only product tested was the electroDOT, and we were concerned that the studies were again not sufficiently robust to produce scientifically valid results.
Because we considered that consumers would understand the claims to mean that the use of all of Phi Harmonics’s products had been shown through robust scientific testing to result in increased energy and concentration, less disturbed sleep, fewer headaches, less stress and better all-round wellbeing, and that those claims had not been adequately substantiated, we concluded that they were misleading and in breach of the Code.
On those points, the claims 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),
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.
(Medicines, medical devices, health-related products and beauty products).
3. & 4. Upheld
We noted that the website contained a direct response mechanism which allowed consumers to purchase energyDOTs from Phi Harmonics. We considered that the main focus of the website was to market the energyDOT products, including the electroDOT, and to promote them as having a beneficial effect on users. We acknowledged the information supplied by Phi Harmonics in relation to the effects of electromagnetic radiation as well as the aspirational element of the wording "It is programmed to ...". However, we considered that, in the context of a page on a retail website promoting and selling the electroDOT, consumers would understand the claims "It is programmed to harmonise electromagnetic frequencies (EMFs) from the electronic equipment you use regularly ..." and "There are numerous reasons for tiredness, lack of concentration, headaches, dizziness, irritability and depression. If you suffer from any of these and have eliminated all obvious causes, it is possible that they relate to EMF exposure. Clinical studies around the world have linked EMFs to health problems ..." to be statements as to the efficacy of the electroDOT, and would therefore infer that use of that product would result in a harmonisation of electromagnetic frequencies and the treatment or prevention of the listed conditions and ailments. Because, as described at points (1) and (2) above, we had not received robust documentary evidence demonstrating the efficacy of the electroDOT, we concluded that the claims were misleading and in breach of the Code.
On those points, the claims 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).
Action
The claims must not appear again in their current form. We told Phi Harmonics Ltd to ensure that they held adequate substantiation for objective claims before they were made.
