Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
The crowd funding website www.indiegogo.com, promoted "Wireless Armour: Men's Underwear Protecting Your Health". Text stated "... By carrying our devices on our bodies 24/7 we are subjecting ourselves to huge amounts of Electromagnetic radiation. There is a long list of health affects that have been attributed to Electromagnetic radiation but one of the most studied is the link between electromagnetic radiation and infertility in men. There has [sic] been many studies showing that using and carrying wireless devices, especially mobile phones, lowers the sperm count and motility (a measure of how well sperm moves and in what direction) in men ... After a few months of research I found the answer, a range of men's underwear that blocks the electromagnetic radiation emitted by wireless devices". Further text under the heading "How it works" stated "Wireless Armour's products have a mesh of pure Silver woven into the fabric of each item. This encases the user in a cage of metal. This is a special type of cage called a Faraday Cage ... The reason this cage is special is because any electromagnetic radiation that hits it is distributed around the cage, therefore not allowing it to enter the cage and affect what ever [sic] is stored within ...".
Issue
One complainant challenged whether the following claims were misleading and could be substantiated:
1. regarding the link between electromagnetic radiation (EM) and infertility in men; and
2. that the product could protect a user from EM.
.
Response
1. Wireless Armour Ltd provided brief summaries of eight studies and three full papers, which they believed demonstrated that mobile phone radiation had a negative impact on male fertility.
2. Wireless Armour provided a test report from a third party, showing the results achieved when the fabric utilised by the product was tested for electromagnetic shielding. They said the report showed the fabric was able to shield a high degree of EM. Wireless Armour also explained that although the product had openings to allow a consumer to wear it, it was only when worn that the product approximated a Faraday cage, as the holes were filled with a wearer's body. As human flesh was not a good conductor of EM, it would dissipate the energy.
Assessment
1. Upheld
The ASA reviewed only those papers supplied in full, as we considered the summaries of the other studies did not provide sufficient detail regarding the subjects and methodology used, to ascertain whether they had been conducted robustly. We noted that the first paper studied the impact of EM from a mobile phone only when it was emitting a blue-tooth signal, for an hour, on in vitro human sperm. We understood that the study involved samples collected from 32 males, which were exposed to EM from a phone positioned 2.5 cm away, to mimic the close proximity of the testes to a cell phone in a trouser pocket. We noted that the paper concluded that mobile phone radiation led to a decrease in the motility and viability of the sperm, but that because male productive organs were separated by multiple tissue layers, it was not possible to extrapolate the effects seen under in vitro conditions to real-life conditions without further research.
The second study focused on the impact of EM from mobile phone on male rat sperm in vivo. The authors concluded that the EM resulted in low sperm motility. We considered, however, that a paper focused on the impact of mobile phone radiation on rats did not provide adequate evidence that the same impact would be experienced by humans. In particular, we noted that another of the papers provided stated that it was "impractical to compare a rat model to humans because of its small testicular size, nonpendulous scrotum, and the fact that its testis can migrate between the abdomen and scrotum in the inguinal canal".
The third paper explored the correlation, if any, between infertility and mobile phone usage. The study involved 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. men who were undergoing infertility evaluation, and who were divided into four groups according to their active mobile phone usage. Samples of the men's sperm were collected and analysed, and the results collected appeared to show an inverse correlation between mobile phone use and sperm count, motility, viability and normal morphology. We noted, however, the authors acknowledged that the study was limited as it had not taken into account relevant confounding factors such as the occupational history of the subjects, and their EM exposure from other sources such as radio towers, PDAs, Bluetooth devices, computers and so forth. The study also relied on the subjects' self-perceived history, as their mobile phone usage was not validated, and did not consider the effects of mobile phones when in the standby position. We also noted that the paper was unable to conclude whether the perceived negative impact was the result of EM emitted from the phone or of the temperature of the testes increasing, or both. We therefore considered that none of the papers that had been provided demonstrated that mobile phone radiation had a proven negative impact on human male fertility, and concluded that the claims asserting a link between the two were misleading.
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
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
Notwithstanding our assessment of point 1 above, we reviewed the test report provided to see whether the product was able to shield wearers from EM. We noted, however, that the report referred to a sample of the fabric that was used to construct the product and not to the product when assembled into pants, and worn by consumers. We therefore considered that the evidence provided was not sufficient to show that the product, when utilised by consumers, was able to prevent EM from reaching the genitals. In the absence of any such evidence, we concluded that the claims were misleading.
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
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 must not appear again in its current form. We told Wireless Armour Ltd to ensure they held adequate evidence to substantiate the efficacy claims in their marketing in future.
