ASA Adjudication on Derann Productions

Ad

A magazine ad, for the BioEnergiser D-tox Spa, was headlined "Energy boost Want to detox without dieting. We show you how". Further text continued "… The BioEnergiser D-tox Spa is a spa treatment for your feet or hands. This nifty little device looks like a foot spa but it actually helps start the process of re-balancing your body's bio energy. Your body's energy flow is essential to maintaining good health and keeping your body in balance. When everything is working properly and harmoniously, you have improved physical energy, better concentration and good circulation. The BioEnergiser D-tox Spa is a relaxing 30 minute treatment, which involves placing your feet into a spa bowl filled with warm salted water. An energising cartridge creates a flow of electrons and a bioenergetic field that provides a relaxing and enjoyable treatment. The BioEnergiser rebalances and harmonises by sending signals up through the lymph glands to stimulate the detox process …". Boxed text stated "Anyone can use it to help get their body back in balance, however on going [sic] clinical trials conducted by medically qualified clinicians have seen significant results achieved during the treatment of a variety of conditions: Psoriasis 80% positive treatment response Eczema 70% positive treatment response Leg oedema 95% positive treatment response Lymph oedema 95% positive treatment response Hyper hydrosis [sic] 90% positive treatment response Lymphatic gland detox 95% positive treatment".

Issue

1. Aqua Detox International (CI) Ltd challenged whether the product's claims to treat the listed medical conditions could be substantiated.

2. The ASA challenged whether the product could re-balance and detoxify the body.

CAP Code

Response

Derann Productions (Derann) argued that use of the BioEnergiser D-tox Spa (BioEnergiser) resulted in improved cell hydration and renewed energy levels as well as increased blood circulation. They said it exclusively used SIGMA Q technology, which was expected to advance the development of stimulation therapies. They asserted that the flow of the body's vital life force or energy was essential to maintaining its good health and balance and claimed that the BioEnergiser re-balanced and harmonised the body by sending gentle pulse signals through the lymph glands to stimulate detoxification. They said ongoing clinical trials had seen significant results in the treatment of eczema, psoriasis, leg oedema, hyperhidrosis, lymph oedema, lymphatic gland detox and increased blood circulation. They added that clients had reported increased feelings of well-being. They said the results of the clinical trials were held by the British Standards Institute (BSI), which had certified the product; they sent a copy of the certificate. They said the product met the requirements of the European Medical Devices Directive and complied with all necessary safety standards; they pointed out that the product carried a Medical Device CE mark. They submitted clinical trial review papers for each ailment listed in the ad.

Derann sent testimonials from customers who had reported softer feet and improvements in energy levels, cystitis, sleeping patterns, skin conditions, menstruation problems, joint mobility, constipation and migraine as a result of using the BioEnergiser. Derann claimed that their medical advisor had personally noted regular use of the product improved energy levels and removed leg oedema caused by prolonged sitting, flying or driving.

Assessment

1. Upheld

The ASA noted the ad's claims that the product had a "positive treatment response" to the listed medical conditions were based on the results of clinical trials. We noted, however, the results of those trials reported the effect of using the BioEnergiser, for set periods of time in a clinically supportive environment, on participants' perceived quality of life and sense of well-being, for example, improvements in their interpersonal relationships and their ability to carry out daily activities, such as housework and gardening. While we acknowledged the responses seemed positive, we considered that most readers would interpret the product's "positive treatment response" claims and the claim ...clinical trials conducted by medically qualified clinicians have seen significant results achieved during the treatment of a variety of conditions" to refer to medically proven, objective improvements in the physical aspects of each disorder, which we noted was not the case. We considered, therefore, that the survey responses of the trial participants were not sufficient to substantiate claims that the product could effectively treat the medical conditions listed.

We noted the product had been certified by the BSI but understood that the level of certification, category A, meant merely that the product was manufactured to pre-defined specifications; it did not affirm that the product had been certified to be clinically effective. We noted the product met the requirements of the European Medical Devices Directive but understood that the Directive was not in harmony with the EU regime in respect of misleading advertising, which was subject to a separate EU Directive. We considered that testimonials did not constitute sufficient substantiation. We were concerned that the listed ailments included serious medical conditions and considered that, by claiming BioEnergiser had a "positive treatment response" to certain medical conditions, sufferers of those conditions could be discouraged from seeking essential treatment from a suitably qualified health professional. We concluded that the claims were misleading.

2. Upheld

We noted we had not seen any evidence to substantiate the product's claims to re-balance and detoxify the body over and above Derann's own background information on how the product worked. We considered that that was not independent and was insufficient to warrant the claims.

On points 1 and 2, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 and 50.3 (Health & beauty products and therapies - General).

Action

We told Derann to remove references to re-balancing, detoxifying and the treatment of medical conditions from future ads and advised them to seek guidance from the CAP Copy Advice team before advertising the BioEnergiser again.

Adjudication of the ASA Council (Non-broadcast)