Two online ads for Pranamat ECO acupressure mats seen on 25 October 2015:
a. The Pranamat ECO website, www.pranamat.com, featured text that stated “PRANAMAT ECO - THE ULTIMATE IN THERAPEUTIC MASSAGE MATS … It also works to reduce muscle or joint inflammation … RELIEVE LOWER BACK PAIN Effective and totally natural treatment for lower back pain SCIATICA Fastest and most natural solution for sciatica-related pain … Certified and clinically tested to meet your needs … BANISH YOUR HEADACHES Relieve your headache pain without painkillers …”.
b. A product page on amazon.co.uk for a “Pranamat Eco Acupressure Mat” sold by Pranamat, featured text that stated “Pranamat Eco can release endorphins that help to … relieve stress, reduce headache and back pain and improve circulation”.
Osteo SIA challenged whether:
1. the ads breached the Code because they made medical claims for a device which they did not believe was CE-marked; and
2. the claim “Certified” in ad (a) misleadingly implied that the product was a CE-marked medical device.
1. & 2.
PranaLine Ltd t/a Pranamat ECO stated that they did not promote their website in the UK, having withdrawn all their marketing activities. They stated that their product had been certified by the Certification Centre of the Latvian Academy of Sciences and provided a copy of the certificate, which stated that the product could be used for relaxation, reduction of stress and exhaustion and ease of muscular pain.
Pranamat ECO stated that they had made changes to ad (b) following our enquiries, so that it was more compliant with the CAP Code.
1. & 2. Upheld
The ASA noted that the website www.pranamat.com was accessible for UK consumers and that they could purchase the product in British pounds sterling. Furthermore, contrary to what Pranamat ECO stated in their response, we noted that the claim “Pranamat Eco can release endorphins that help to … relieve stress, reduce headache and back pain and improve circulation” remained in ad (b).
We considered that the claims “It also works to reduce muscle or joint inflammation”, “RELIEVE LOWER BACK PAIN Effective and totally natural treatment for lower back pain”, “SCIATICA Fastest and most natural solution for sciatica-related pain” and “BANISH YOUR HEADACHES Relieve your headache pain without painkillers” in ad (a) were medicinal claims.
We also considered that the claim “Pranamat Eco can release endorphins that help to … relieve stress, reduce headache and back pain and improve circulation” in ad (b) was a medicinal claim.
We understood that medicinal claims could only be made for a product that was licensed by the MHRA, or under the auspices of the European Medicines Agency (EMA), or for a CE-marked medical device.
We understood that the product had been certified by the Certification Centre of the Latvian Academy of Sciences as conforming to Latvian “Technical Regulations”, although Pranamat Eco had not explained what those regulations were. However, we were concerned that they had not provided evidence showing that the product was either a CE-marked medical device or licensed as a medical device by an appropriate authority.
Referring to ad (a), we considered that because the claim “Certified” was made along with the medicinal claims, suggested that the product was a CE-marked medical device.
Therefore, we concluded that the medicinal claims in both ads breached the Code and that the claim “Certified” in ad (a) misleadingly implied that the product was a CE-marked medical device.
The ads 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 Pranamat ECO that their advertising must not make medicinal claims for the product and imply that it was a medical device, unless that was the case.