Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website for BioLife Solutions, www.airnergy-oxygen-therapy.co.uk, seen in March 2017, promoted an oxygen therapy device, and included text which stated “Benefits to COPD sufferers may include: Breathe easier, cough less … Exercise capacity increased (walk further / climb stairs) … Improvement in sleep…Improvement in peak flow…Normalisation of blood pressure … Boosting of immune system (faster recuperation from colds & flu)” and “Dr. R. Simmons (NHS) – ‘As a long term sufferer of COPD, and after a winter of several chest infections / bronchopneumonia, my wife was getting fed up with me using her asthma inhalers. Therefore I researched and discovered AIRNERGY … Within days of starting my breathing has improved enormously’ … Extensive research and studies have been carried out to prove the effectiveness of Airnergy - see the related downloads at the bottom of this page to read two of our COPD studies and articles and the latest COPD Compendium from the Academy of Health, Sports & Prevention in Germany”.
Issue
1. The complainant challenged whether the claims that the product could benefit health and medical conditions could be substantiated.
2. The ASA challenged whether the ad discouraged essential treatment for conditions for which medical supervision should be sought.
Response
1. & 2. BioLife Solutions Ltd t/a Biolife said international research and studies as well as academic literature confirmed the positive benefits of energised oxygen. They said the science behind the product and the theory of enriched oxygen had been developing since the 1980s and the research and studies available were now extensive. They said the theory behind the technology was widely accepted by practitioners, doctors, professors and scientists worldwide and the product had received a number of accolades. They suggested the product provided an alternative therapy to classical treatment. However, they acknowledged that most of the evidence in support did not fit within the boundaries set by the ASA and CAP. They provided a number of documents in support of their position as well as correspondence from the German product supplier (Airnergy).
They said it was never their intention to deflect consumers from seeking or taking suitably qualified medical advice in relation to any medical conditions they may be suffering from. They said the ad gave no general or specific warranty that the product was a substitute for proper medical treatment and/or advice from a qualified medical practitioner in respect of any medical condition. They said, for example, there was no claim in the ad that the product was an alternative to seeking medical advice or continuing with a course of previously prescribed medical treatment. They noted the term used in the ad was “therapy device” rather than “treatment” and considered the two were clearly distinguishable in meaning.
They said the ad listed a number of benefits that could possibly be gained from using the device, but it clearly stated that “benefits may include”, rather than “will” include.
They said that at the bottom of the ad text clearly stated “Note: Readers should consult appropriate health professionals on any matter relating to their health and well-being”, and that a medical disclaimer also appeared on a web page marked “Legal Notices”.
They also said they received a letter from the manufacturer dated 6 February 2015 that stated the certificate CE 574617 would be renewed and they had no reason to believe this would not happen.
Finally, they said the ad and all medical-related claims, reviews and references had been removed from their website.
Assessment
1. & 2. Upheld
The ad made various references to chronic obstructive pulmonary disease (COPD). The ASA considered that consumers would interpret the various claims on the website to mean that the device could assist those with COPD with breathing, coughing, increased capacity for exercise such as walking further and climbing stairs, improved sleep, improved peak flow, normalised blood pressure and boosted immunity for faster recuperation from colds & flu. We noted the use of a disclaimer, but considered this did not undermine the overall impression of the ad or absolve the advertiser of their responsibility to hold current certification.
We considered that these claims were medical claims. The CAP Code stated that medical claims may be made for CE-marked medical devices. We noted that the product had previously been certified as a Class IIa medical device. However, the CE certificate had not been renewed upon expiration. We therefore concluded that, as the product did not have the requisite certification, medical claims could not be made about the product.
We also considered that COPD was a condition for which medical supervision should be sought. The CAP Code stated that 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 was conducted under the supervision of a suitably qualified health professional.
We considered that by marketing the product as a treatment for COPD, the ad discouraged essential treatment for COPD. Further, because the treatment offered by the product did not take place under the supervision of a suitably qualified health professional, we concluded that the claims breached the Code.
The ad breached CAP Code (Edition 12) rules
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 ad must not appear again in its current form. We told BioLife not to state or imply that use of the device could treat medical conditions, unless they held current CE certification. We also told them not to state or imply that the device could treat conditions that required medical supervision unless that treatment would take place under the supervision of a suitably qualified health professional.
