Ad description
Claims on www.Ultralieve.com promoted an ultrasonic device. Text stated "Symptoms treated" and listed "Arthritic Inflammation, Arthritis & Joint Pain, Back Ache, Back Pain, Bursitis, Carpal Tunnel Syndrome, Chronic Pain, Foot & Ankle Pain ... Headache (Tension), Heel Spur, Hip or Shoulder Capsulitis, Ligament Strains ... Muscle Aches and Pains, Muscle Spasms, Muscle & Tissue Pain, Neck, Hip ... Pains, Neck Strain, Nerve Pain, Nerve Root Pain, Neuralgia, Plantar Fascitis, Post Exercise Recovery, Sciatica, Sports Injuries, Strains, Strains/Sprains, Tendonitis, Tennis Elbow, Trigger Point Pain".
Issue
The complainant challenged whether the claims that the device could treat the listed conditions and ailments were misleading and could be substantiated.
Response
Actegy Health Ltd (previously known as High Tech Health) said they had recently undertaken a review of the clinical evidence to support the indications for use of the Ultralieve PRO. In light of that evidence they said they were in the process of updating the indications for Ultralieve PRO to the promotion of healing soft tissue injuries and the provision of pain relief through thermal and non-thermal physiological reaction. They said the clinical evidence provided was therefore in support of the following indications: neck pain, strain, shoulder pain, joint pain (knee pain, hand pain, wrist pain), muscle spasms, muscle aches and pains and muscle and tissue pain. They stated that they did not seek to substantiate the other conditions listed in the ad, which they said were removed from the website on 6 February 2012, during the investigation.
They provided a clinical evaluation report, together with the literature search protocol, selection strategy, analysis and published articles. They said the report provided a documented systematic critical evaluation of the available evidence of the clinical performance and safety of the Ultralieve PRO ultrasound therapy device, for the purpose of demonstrating conformity with the clinical data requirements. They said the use of 1 MHz therapeutic ultrasound devices had been demonstrated to produce beneficial clinically relevant effects for pain relief and promotion of tissue healing with minimal complications. They said the published data from the studies had demonstrated the capability of 1 MHz therapeutic ultrasound devices to perform satisfactorily for their intended use.
Assessment
Upheld
The ASA noted that the advertisers had provided a number of studies and reviews to support their claims, but that the tests and trials had not looked at the effects of the product on some of the listed conditions and ailments. We noted that the website's claims had been amended, but still contained references to some of the conditions and ailments under investigation.
Because we had not seen evidence to support the claims that the device could treat the symptoms of "Arthritic Inflammation, Arthritis ... Back Ache, Back Pain, Bursitis, Carpal Tunnel Syndrome, Chronic Pain, Foot & Ankle Pain ... Headache (Tension), Heel Spur, Hip ... Capsulitis ... Hip ... Pains ... Nerve Pain, Nerve Root Pain, Neuralgia, Plantar Fascitis, Post Exercise Recovery, Sciatica, Sports Injuries, ... Tendonitis, Tennis Elbow, Trigger Point Pain", we considered that those claims were misleading.
We understood that the clinical evidence provided was intended to support claims about the following indications: neck pain, strain, shoulder pain, joint pain (knee pain, hand pain, wrist pain), muscle spasms, muscle aches and pains and muscle and tissue pain.
We sought expert advice. We noted that none of the six literature reviews showed clear or high level evidence in support of the claims. We also noted that the studies provided were not sufficient to support the efficacy of the device in treating the listed conditions and ailments.
Because we did not consider that we had seen sufficient evidence to support the claims that the ultrasonic device could treat the symptoms of the listed conditions and ailments, we concluded that the claims were misleading.
The claims 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),
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
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
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.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health-related products and beauty products).
Action
The claims must not appear again in their current form.
