ASA Adjudication on Aromatheutics Ltd

Ad

A national press ad for a pain relief device was headlined "NEW DRUG FREE ALTERNATIVE TO MEDICATION". The body copy stated "With the brand new PainSolv CE marked medical device, you now have truly portable health management! ... PainSolv encourages your body to enhance the efficiency of cell functions which in turn increases oxygen content in your blood as well as many other beneficial processes ... PainSolv can help relieve the pain associated with the following conditions and many more - Arthritis, Back Pain, Migraine, Whiplash, Joint Pain, Muscle Spasm, Stress, Leg Ulcers, Gout, Tendinitis ... Unlike TENS machines that simply block pain signals to the brain, PainSolv works directly on the cause rather than just the symptoms! ... Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions. The CE mark confirms that a product meets all essential European health, safety and environmental requirements."

Issue

1. Pulse Medical Technology challenged whether the claim "Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions" was misleading, because it implied the MDD certification specifically approved the device for treating the conditions listed in the ad.

One member of the public challenged whether the claims:

2. "PainSolv encourages your body to enhance the efficiency of cell functions which in turn increases oxygen content in your blood as well as many other beneficial processes"; and

3. "PainSolv works directly on the cause rather than just the symptoms" were misleading and could be substantiated.

CAP Code (Edition 11)

Response

1. Aromatheutics agreed to remove the claim "Painsolv is a CE marked MDD Class 11a medical device, approved for the treatment of pain, wound and stress conditions" from the ad. They sent a copy of the certificate of registration for the Medical Device and said that in future ads they would state that the CE mark confirmed the device met all essential health, safety and environmental requirements.

2. Aromatheutics said Pulsed Electromagnetic Field Therapy was scientifically proven to encourage the body's own immune system through a number of physiological reactions. They said the claim was not misleading because PainSolv worked on the same principal and sent a link to a database containing articles on the use of pulsed electromagnetic field therapy.

3. Aromatheutics said the claim "PainSolv works directly on the cause rather than just the symptoms" was supported by scientific experience. They sent three diagrams they said showed how pulsed electromagnetic field therapy worked at cellular level. They argued that it was logical to conclude that, because pulsed electromagnetic field therapy had been shown to reduce inflammation and neuralgic symptoms at site, it worked directly on the cause of the pain rather than just the symptoms.

Assessment

1. Upheld

The ASA welcomed Aromatheutics willingness to amend the ad and remove the claim. However, because the medical device certification did not approve the device for the treatment of pain, wound and stress conditions, as stated in the original ad, we concluded the claim was misleading.

On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).

2. Upheld

We noted Aromatheutics comments. However, because the articles contained in the database did not describe clinical trials on the PainSolv device itself, we considered they had not shown that the PainSolv device encouraged the efficiency of cell functions and increased oxygen content in the blood. We concluded the claim was misleading.

On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).

3. Upheld

We considered the evidence sent by Aromatheutics. We noted that the diagrams and accompanying text illustrated in general terms the theoretical basis behind the way in which pulsed electromagnetic field therapy worked at cellular level. However, we considered that the claim "PainSolv works directly on the cause rather than just the symptoms" should be supported by evidence from clinical trials using the PainSolv device, rather than general theory about pulsed electromagnetic field therapy. Because it was not, we concluded the claim was misleading.

On this point the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies).

Action

The ad must not appear again in its current form. We told Aromatheutics to ensure any future claims about the health benefits of the PainSolv device were supported by evidence relating directly to the testing of the different settings in the PainSolv device. We advised them to seek guidance from the CAP Copy Advice team before advertising again.

Adjudication of the ASA Council (Non-broadcast)