Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
The website www.electroflex.co.uk, which made efficacy claims about the Electroflex circulation massager, included, under the heading "CLINICALLY PROVEN", a quotation labelled "Dr Sinatra". It stated “The better your circulation, the better every part of your body will work". The quotation appeared next to an image of a man wearing a white coat and a stethoscope.
Issue
The complainant challenged whether the ad misleadingly implied:
1. Dr Sinatra was a registered medical practitioner; and
2. a registered medical practitioner had found the claimed benefits of the product to be "CLINICALLY PROVEN".
Response
1. Tower Health provided a link to Dr Sinatra's website, which included his CV, and said he had well-documented experience in the field as well as a medical certificate.
2. Tower Health said the product manufacturer had a class IIa medical device certificate, which required the submission and approval of a report that evaluated clinical evidence in order to demonstrate efficacy. They believed that because the device certification required clinical evidence, which had been reviewed by a qualified doctor, the product had been "CLINICALLY PROVEN" to be effective.
They said a doctor, who was a former scientific advisor to the government, had provided a testimonial that stated "In my opinion, I have seen consistent and positive results. The calf muscles in the lower limbs contracted and released which in turn forces blood back towards the heart. This use of passive electrical muscle stimulation will give patients temporary relief from swelling and pain. I saw patients improve their range of mobility. I was very impressed by the device". They submitted further text, which stated that the doctor was happy to be quoted as saying that, in his opinion, the device had been clinically proven to be effective and increased blood circulation in the lower leg. They said that quotation was from a technical file; although Tower Health were not the manufacturer of the product and could not therefore hold the technical file, they were able to market information based on it. They said that was a medical opinion, rather than the opinion of Tower Health. They submitted a document, which was written by the doctor. It gave details of his academic and professional positions as well as comments on a previous ASA adjudication.
Assessment
1. Upheld
The ASA considered the ad was likely to be interpreted as suggesting that Dr Sinatra was a registered medical practitioner, because it referred to him as "Dr Sinatra" and included an image of him wearing a white coat and a stethoscope. We noted Dr Sinatra's CV, which gave details of, for example, his education, training, certificates, affiliations and professional activities. We considered, however, that was not sufficient to demonstrate that he was a registered medical practitioner. In the absence of, for example, confirmation of Dr Sinatra's medical registration or copies of relevant qualifications, we concluded that the ad breached the Code.
On this 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) and 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).
2. Upheld
We noted the claim "CLINICALLY PROVEN" was not intended to relate to the quotation attributed to Dr Sinatra in the ad, but to the opinion of another doctor. We noted the quotation provided from that doctor. However, we noted it was not, for example, signed and dated. Nevertheless, we considered a brief testimonial, even if it was signed and dated, was not sufficient to demonstrate that a registered medical practitioner had found, or had reason to be of the opinion that, the product was clinically proven to be effective. We considered, however, because the quotation from Dr Sinatra appeared under the heading "CLINICALLY PROVEN", the ad was likely to be interpreted as suggesting at least that the efficacy of the product had been clinically proven and that Dr Sinatra (who was likely to be interpreted as being a registered medical practitioner for the reasons outlined above) endorsed that position, even if he had not personally found that to be the case. We noted Tower Health's comments about the device certification but noted we had also not seen any evidence related to its efficacy. Nevertheless, we understood that a product's device classification related to the potential safety risk associated with the device rather than to its efficacy. Because we had not seen evidence to demonstrate that the efficacy of the product was clinically proven and that Dr Sinatra accepted that was the case, we concluded that the ad was misleading.
On this 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) and 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).
Action
The ad must not appear again in its current form. We told Tower Health to ensure that in the absence of adequate evidence, they did not state or imply that people referred to in their future advertising held a general medical qualification. We also told them to ensure they did not imply registered medical practitioners had found, or were of the opinion that, a product was proven to be effective, in the absence of adequate substantiation.
