ASA Adjudication on J D Williams & Company Ltd

Ad

An ad in a catalogue from House of Bath for a device called PowerBreathe stated "Exercise and Strengthen Your Lungs Against Breathlessness". It showed a woman holding the device to her mouth with a clip on her nose. The ad continued "If you get breathless or wheezy just climbing the stairs, PowerBreathe can help you reclaim your essential lung capacity ... PowerBreathe can be helpful for asthma, emphysema and chronic obstructive pulmonary disease, helping to improve your strength and endurance."

Issue

1. The complainant challenged whether the ad was irresponsible, because she believed people with respiratory problems, and in particular those conditions listed, could exacerbate their conditions by using the device.

The ASA challenged whether:

2. the efficacy claims for the product were misleading and could be substantiated and

3. the ad could discourage readers with serious medical conditions from seeking essential treatment.

CAP Code (Edition 11)

Response

1. JD Williams & Company Ltd t/a House of Bath (House of Bath) said they had been in touch with their suppliers who said that supporting information was provided in the brochures on the PowerBreathe website and included in users' manuals to clarify that if a person suffered from certain conditions they should ask for advice from their medical practitioner prior to using the product.

2. House of Bath said the supplier's website provided information about how the device could help asthma, emphysema and chronic obstructive pulmonary disease and other conditions, and that the website also included health related research. They said the supplier had additionally provided their registration documents for the device with the Medicines and Healthcare products Regulatory Agency (MHRA). They sent copies of those to show that.

3. House of Bath said that the ad did not make claims that by using the product a person could or should stop taking any medication or could or should avoid seeking appropriate medical advice. House of Bath said the supplier had explained that their literature clearly stated that use of the device did not mean a person should stop taking any medication or doing what their medical practitioner had recommended.

Assessment

1. Upheld

The ASA understood that PowerBreathe was designed to train the muscles concerned with inhalation of air to the lungs. We noted the PowerBreathe website stated that inspiratory muscle training was not recommended for patients with a history of spontaneous pneumothorax (air in the lung lining cavity) and only for those with a history of that after complete recovery. We noted the website also said such training was not suitable for asthma patients with low symptom perception and those who suffered from frequent severe episodes, or for those who had recently experienced a perforated ear drum, and that it should only be used by those under 16 years of age with the supervision of an adult. We noted the ad did not contain information about these contraindications and concluded it was irresponsible on those grounds.

On this point the ad breached CAP Code clause 2.2 (Social responsibility).

2. & 3. Upheld

We noted PowerBreathe was appropriately registered with the MHRA as a Class 1 medical device, for the intended use of strength training for the respiratory muscles. However, we also noted such registration was concerned with standards of manufacture and safety and did not alone provide proof of efficacy.

We noted a number of clinical studies on the manufacturer's website, in particular a 2002 meta-analysis of studies into the effect of inspiratory muscle training on patients with Chronic Obstructive Pulmonary Disease (COPD) published in the European Respiratory Journal, which concluded that inspiratory muscle training was a meaningful addition to pulmonary rehabilitation programmes for COPD patients with inspiratory muscle weakness. We also noted an article published in CHEST (the Cardiopulmonary and Critical Care Journal) which reported on a clinical trial that showed inspiratory muscle strength training for six months could improve asthma symptoms, and another article (not peer reviewed) which stressed the importance of training the inspiratory muscles using the correct load factor and recommended weekly monitoring of patients using the device. It also explained that, like all muscle training, maintenance was required. We understood that emphysema was a form of COPD but did not find any published clinical studies relating to patients specifically with emphysema on the PowerBreathe website to which the advertiser had directed us.

Whilst we acknowledged that inspiratory muscle training with a registered medical device such as PowerBreathe might be helpful for patients with COPD and mild to moderate asthma who had inspiratory muscle weakness, we also noted use of the device was contraindicated for patients with some forms of asthma and we had not seen evidence to show the device being tested on patients specifically with emphysema.

We reminded House of Bath that advertisers should not discourage essential treatment, including offering diagnosis or treatment for serious or prolonged conditions, unless it was conducted under the supervision of a doctor or other suitably qualified health professional. We concluded that the references to "asthma, emphysema and chronic obstructive pulmonary disease" could discourage readers from seeking essential treatment and concluded the ad breached the Code on those grounds.

On these points the ad breached CAP Code clauses 3.1 (Substantiation) and 7.1 (Truthfulness) and 50.1 and 50.3 (Health and beauty products and therapies).

Action

The ad must not appear again in its current form.

Adjudication of the ASA Council (Non-broadcast)