Ad description
A sponsored social media post, for Nanovibronix, stated "Stop Trigeminal Neuralgia [website address]".
Issue
The complainant challenged whether the claim "Stop Trigeminal Neuralgia" could be substantiated.
Investigated under CAP Code Rules 3.1 (Misleading advertising), 3.7 (Substantiation), 12.1 and 12.6 (Medicines, Medical Devices, Health-related products and beauty products).
Response
NanoVibronix Inc said that ultrasound therapy had been widely used in the clinical setting for many years and that its effectiveness for treating pain and to induce the healing of injured tissue had been studied and was supported with a broad body of evidence, published in the medical literature. They said that their product, PainShield, was a device that had been found to be effective for a variety of pain, soft tissue injury and neurologic treatments. They provided several documents which they said supported the claim made for PainShield. They also provided their device CE mark certificate and approval from the US Food and Drug Administration (FDA).
Assessment
Upheld
The ASA noted that the ad stated "Stop Trigeminal Neuralgia" which we considered would be understood by consumers to be an absolute claim that their PainShield product would result in complete cessation of the symptoms of trigeminal neuralgia, or that it would cure the condition.
We acknowledged the various documents provided by Nanovibronix. We understood that PainShield was registered as Class I medical device and that classification related to the potential safety risk associated with the device, sold on a self-declaration basis without having been assessed by any notified body. We also noted Nanovibronix's FDA approval letter which gave the indications for the use of PainShield, which stated that it was for prescription rather than over-the-counter use. However, the FDA was a regulatory agency based in the USA and we did not consider that their approval of a product, or their stated indications for use, was sufficient to support the claims.
The CAP Code required that objective claims, including medical claims for a CE-marked medical device to be backed by evidence, if relevant, consisting of trials conducted on people. We noted the documents provided by Nanovibronix, some of which were not related to the use of ultrasound for the relief of trigeminal neuralgia. We therefore did not consider that they were adequate to support the claim made. Additional material included a study overview, a trial abstract and several testimonials. Nanovibronix did not provide full studies, which we required in order to assess whether the claim could be substantiated. We noted the testimonials provided, however, in the absence of robust evidence, we did not consider that they constituted substantiation for the claim.
Because we had not seen adequate evidence that PainShield could stop trigeminal neuralgia, we concluded the ad was misleading and the claim "Stop Trigeminal Neuralgia" had not been substantiated.
The ad breached CAP Code 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),
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.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, Medical Devices, Health-related products and beauty products).
Action
The ad must not appear again in its current form. We told NanoVibronix Inc not to make direct or indirect claims that their product, in the absence of adequate substantiation, could stop trigeminal neuralgia.
