Summary of Council decision:
1 issue investigated and Upheld
A website for alternative therapy provider Carolyn Stevens, www.carolynstevens.co.uk, seen on 24 February 2018. A web page headed ‘Asyra Bio-Energetic Screening’ included text that stated, “Asyra Pro system is the most advanced, flexible and user-friendly bio-energetic screening and therapy device available today. The Asyra can be used for screening for a multitude of issues and imbalances in your system, including food sensitivities, nutritional, hormonal and toxic loads”. The page also stated, “Bio-energetic screening can be used to determine sensitivities to foods or allergens and much more. The tests can check the energetic status of 40 major organs as well as specifics on the following …” and listed: “Food Sensitivities and Intolerances”, “Allergy Profile (good for hay fever and allergies of unknown origins)”, “Environmental Sensitivities”, “Digestive Issues”, “Nutritional Assessment”, “Dental Profile”, “Hormonal Profile”, “Parasites and Infections”, “Toxicity”, “Menstrual & Menopausal Problems”, “Emotional Stressors”, “Neurotransmitter Disturbance”, “Vitamins and Minerals”, “Heavy Metals”, “NAET”, “Addiction Protocols for Alcohol and Nicotine”.
The complainant challenged whether the claims that Asyra Bio-Energetic device was effective in screening the health conditions referenced were misleading and could be substantiated.
Carolyn Stevens did not respond to the ASA’s enquiries.
The ASA was concerned by Carolyn Stevens’ lack of response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rules 1.7 1.7 Any unreasonable delay in responding to the ASA's enquiries will normally be considered a breach of the Code. (Unreasonable delay). We reminded them of their responsibility to provide a substantive response to our enquiries and told them to do so in future.
The ASA noted that the ad included a number of claims, such as “The Asyra can be used for screening for a multitude of issues and imbalances in your system” and “The Asyra will identify issues and help with the start of a balancing, desensitisation or detoxification protocol”, and listed a number of health conditions, including allergies, nutrition levels, infections, alcohol addiction and others. We considered those claims were medical claims for the Asyra Pro device used by Carolyn Stevens that it was effective in screening and diagnosing the various health conditions listed in the ad.
The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical advice. We had not seen any documentary evidence to demonstrate that the Asyra Pro Bio-Energetic device used by Carolyn Stevens was a CE-marked medical device and because of that, no medical claims could be made for the product. In addition, we had not been provided with any documentary evidence to substantiate the claims that the device could be used to diagnose the conditions listed in the ad.
Because the ad made medical claims for a product which was not a CE-marked medical device, and because we had not seen evidence to support the efficacy claims made for the device, we concluded that the ad was misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
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. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told Carolyn Stevens to ensure that they did not make medical claims for a product, unless it was a CE-marked medical device and they held evidence to demonstrate that it was effective in screening and diagnosing the various conditions listed in the ad. We referred this matter to the CAP Compliance team.