An ad seen in What Doctors Don't Tell You magazine for Medical Thermal Imaging stated "100% Safe BREAST SCREENING ...Thermography can detect active breast abnormality before its [sic] possible with mammography ... Medically recognised". The ad included a flash which stated "BREAST CANCER AWARENESS MONTH".
The Nightingale Collaboration challenged whether the following claims were misleading and could be substantiated:
1. "Thermography can detect active breast abnormality before its possible with mammography" was misleading and could be substantiated;
2. "Medically recognised".
1. Medical Thermal Imaging Ltd (Medical Thermal Imaging) told us by phone that, unlike mammography that detected anatomical changes, thermography identified abnormalities early as it detected changes in physiology. They said abnormalities released nitrous oxide which was then converted to nitroglycerin and this was detected by thermography. They said because this process occurred early on in the process when an abnormality was developing, it would be undetectable with mammography.
2. Medical Thermal Imaging did not respond on this point.
1 & 2. Upheld
The ASA asked Medical Thermal Imaging to supply robust clinical evidence to support the claim that their product could detect abnormalities before mammography and that it was medically recognised. This information was not supplied.
Because the advertiser did not provide robust evidence to substantiate the claim that thermography could detect active breast abnormalities which also compared its efficacy with mammography or that it was medically recognised, we concluded the ad was misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
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).
The ad must not appear again in its current form. We told Medical Thermal Imaging Ltd to hold robust evidence before making efficacy claims.