Ad description

A Facebook page, and the Ionic Balance website, viewed on 12 and 24 June 2011:

a. The Facebook page, headed "Ionic Balance - Benefits" stated "Utilising the unique healing properties of the gemstone tourmaline an Ionic Balance Band emits negative ions and far infrared rays, which can have the following benefits: - INCREASED ENERGY - INCREASED STAMINA - ENHANCED IMMUNE FUNCTION - QUICKER RESPONSE - REDUCED FATIGUE - IMPROVED FLEXIBILITY - DEEPER SLEEP - IMPROVED MOOD - FASTER HEALING - BOOSTED METABOLISM - IMPROVED BALANCE - GREATER WELLBEING - STABILISED BLOOD PRESSURE - SHARPER CONCENTRATION - REGULATED SERATONIN LEVELS - FASTER RECOVERY - AMPLIFIED STRENGTH - MORE FOCUS".

b. The Ionic Balance website was headed "Ionic Balance - Ultra Performance" and restated the claims from the Facebook page. Further pages discussed at length the efficacious effects of tourmaline, including the effects of negative ions, far infrared rays and alpha waves, which the ad claimed were generated by the mineral. The text referenced a number of studies and a range of medical conditions.

A page headed "Endorsements" listed the profiles of several sportspeople. The Inverness Caledonian Thistle player Ross Tokely was quoted as stating, "My Ionic Balance wristband definitely has increased my stamina, strength and endurance. My powers of concentration, my focus and my sleep patterns have improved dramatically. I have Ionic Balance to thank for this, and can recommend the wearing of an ionic-balance.com wristband, to anyone."

A paged headed "Disclaimer" stated "Ionic Balance nor its distributors, make any claim that any of its products are intended to prevent, cure, mitigate, treat or diagnose illness. If you believe you have a health problem, you should consult a doctor or health professiona.."

Issue

1. Two complainants challenged whether the efficacy claims in ads (a) and (b) were misleading and could be substantiated.

2. One complainant challenged whether the efficacy claims in the celebrity endorsements in ad (b) were misleading and could be substantiated.

3. One complainant challenged whether the disclaimer in ad (b) contradicted the efficacy claims throughout the website.

The ASA challenged whether the:

4. efficacy claims in ad (b) for negative ions, tourmaline, far infrared rays and alpha waves were misleading and could be substantiated;

5. efficacy claims in ad (b) for negative ions, tourmaline, far infrared rays and alpha waves misleadingly implied that the product would produce the same effects; and

6. references to serious medical conditions in ads (a) and (b) could discourage essential treatment for which medical supervision should be sought.

Response

1. Ionic Balance said the efficacy claims on the ‘Benefits’ page of their Facebook entry and on their website’s home page were keywords taken from well-known studies. They said the information supporting those claims was contained in the sections of their website relating to negative ions, far infrared rays and alpha waves. They provided 28 documents, including abstracts of studies, full studies, and surveys of literature on the subjects, which they said substantiated the efficacy claims.

2. Ionic Balance said they had added a disclaimer to their testimonials page to state that “This is some of the feedback we have received. This is for your reference and does not guarantee the efficacy/performance of the product. Please consult a doctor if you need medical treatment”.

3. Ionic Balance said their disclaimer was valid, because they did not sell a medical device and advised anyone with a medical condition to consult a doctor or healthcare professional.

4. Ionic Balance said they did not believe the claims were misleading because they quoted studies and well-known facts which were freely available on the internet. They said it might seem that there was almost too much information on their website, but they would rather have too much than too little. They referred to the documents they had provided to substantiate the efficacy claims.

5. Ionic Balance said the content in ad (b) did not in any way specifically promise consumers that they would experience the same effects. They said they tried to be as clear as possible, and had a no-quibble money-back guarantee.

6. Ionic Balance said they did not discourage people from seeking professional medical help, and if consumers asked them medical questions they told them to consult a doctor. They said that was proven in their responses to users on their Facebook page. They said that in some cases they had actively encouraged people to seek medical advice before buying the product.

Assessment

1. Upheld

The ASA considered that the efficacy claims in the ads would need to be supported by robust, controlled and blinded studies.

We noted that 13 of the 28 documents provided by Ionic Balance were abstracts. We noted we had not seen the full studies relating to the abstracts, and therefore considered that those abstracts alone were not sufficiently robust to substantiate the claims.

Out of the remaining 15 documents, ten made a range of claims in relation to the efficacy of far infrared rays and negative ions. Some of the documents referred to the results of studies and provided references for those, but others did not include any references or provide other evidence for their claims. None were detailed accounts of research studies. Most appeared on websites selling products which used far infrared rays and negative ions, and none appeared to have been published in peer-reviewed journals. We therefore considered that those documents did not constitute robust substantiation for the claims.

A further document was an article which had been published in a peer-reviewed journal in 1976, which primarily discussed research conducted by the authors and other scientists into the effects of positive and negative air ions on bacteria, mice and rats. The article referred briefly to research into the effects of positive air ions on humans and the results of a treatment using the inhalation of air which contained high numbers of negative ions. We noted the article had been peer-reviewed but considered that, without viewing the studies referenced in the article, that document in itself did not constitute robust substantiation for the claims.

A further three documents were research studies which examined the effects of negative ions in air on levels of stress, fatigue and reaction speeds, and on seasonal affective disorder (SAD). We noted those studies examined the effects of different levels of negative ions in the air rather than those generated by tourmaline. We also noted that those studies were conducted on 20, 24 and 25 subjects respectively, which we considered to be insufficient numbers for the studies to be robust substantiation for the strong efficacy claims made in the ad. It was also unclear as to whether the studies, which researched the effects of negative ions on levels of stress, fatigue and reaction speeds, had been published in peer-reviewed journals. We therefore considered that those studies did not constitute robust substantiation for the claims.

A final study researched the biological effects on human skin of a cream containing powdered tourmaline, when applied to the faces of ten adults. However, we considered that to support the “Benefits” claims in the ads, we would need to see robust evidence relating to the product. We also considered that a study on only ten subjects was not sufficiently robust to support the claims in the ad. We concluded the study did not constitute robust substantiation for the claims.

Because the advertiser had not provided robust substantiation for the efficacy claims in the ads, we concluded the claims were misleading.

On this point, ads (a) and (b) breached CAP Code rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 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.  (Substantiation),  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.
   12.6 12.6 Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.  and  12.7 12.7 References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as "cure" and "rejuvenation" are not generally acceptable, especially for cosmetic products.  (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We noted Ionic Balance had not provided any evidence that the celebrities had made the statements on the testimonials page, nor that they had experienced the effects described in the testimonials. Because we had not seen evidence to support the efficacy claims in the celebrity endorsements, we concluded they were misleading.

On this point, ad (b) breached CAP Code rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 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.  (Substantiation),  3.45 3.45 Marketers must hold documentary evidence that a testimonial or endorsement used in a marketing communication is genuine, unless it is obviously fictitious, and hold contact details for the person who, or organisation that, gives it.  and  3.47 3.47 Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.  (Endorsements and Testimonials) and  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.
 (Medicines, medical devices, health-related products and beauty products).

3. Upheld

We noted that Ionic Balance did not consider their product to be a medical device, but noted the ad made a number of efficacy claims, including “BOOSTED METABOLISM”, “STABILISED BLOOD PRESSURE”, “IMPROVED BLOOD CIRCULATION”, “FASTER HEALING”, and “ENHANCED IMMUNE FUNCTION”, which suggested that the product could restore, correct or modify a physiological function or metabolic action and was, therefore, medicinal. We considered that efficacy claims throughout the website both directly stated and implied that the Ionic Balance Band could prevent, mitigate or cure a range of medical conditions. We therefore considered the disclaimer contradicted, rather than clarified, the claims it was intended to qualify. We concluded the ad breached the Code.

On this point, ad (b) breached CAP Code rule  3.9 3.9 Marketing communications must state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify.  (Qualification).

4. Upheld

For the reasons noted above, we considered we had not seen robust evidence to substantiate the efficacy claims for negative ions, tourmaline, far infrared rays and alpha waves. We therefore concluded the efficacy claims were misleading.

On this point, ad (b) breached CAP Code rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 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.  (Substantiation),  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.
   12.6 12.6 Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.  and  12.7 12.7 References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as "cure" and "rejuvenation" are not generally acceptable, especially for cosmetic products.  (Medicines, medical devices, health-related products and beauty products).

5. Upheld

We acknowledged that, in its descriptions of the effects of negative ions, tourmaline, far infrared rays and alpha waves, the ad did not specifically state that wearers of the Ionic Balance Band would experience the same effects. However, we considered that, because the ad highlighted that tourmaline, the ‘active ingredient’ of the product, produced negative ions, far infrared rays and alpha waves, and went on to make efficacy claims in relation to them, the ad implied that the Ionic Balance Band would also have those effects on wearers. Because we had not seen any evidence that the product could have the effects claimed for tourmaline, negative ions, far infrared rays and alpha waves, we concluded the ad was misleading.

On this point, ad (b) breached CAP Code rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 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.  (Substantiation),  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.
   12.6 12.6 Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.  and  12.7 12.7 References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as "cure" and "rejuvenation" are not generally acceptable, especially for cosmetic products.  (Medicines, medical devices, health-related products and beauty products).

6. Upheld in relation to ad (b) only

We noted Ionic Balance’s view that they did not discourage people from seeking essential medical advice because, when potential customers contacted them and asked whether the product could help a specific medical condition, they told them they should contact a doctor. However, we considered that many people would purchase the product without contacting Ionic Balance, and furthermore, that the advertiser’s actions after being contacted by potential customers was not relevant to whether the ads themselves could discourage people from seeking essential medical advice.

We noted ad (a), the Facebook page titled ‘Benefits’, did not specifically refer to any serious medical conditions. We concluded that it did not discourage essential treatment for which medical supervision should be sought.

We noted ad (b) referred to a range of health problems, including serious medical conditions such as asthma, arthritis, stroke, high blood pressure, gout, bronchitis and kidney problems. We considered that those conditions were conditions for which medical supervision should be sought, and that the claims could discourage patients from seeking essential treatment for those conditions. We therefore concluded that the claims breached the Code.

On this point, we investigated ad (a) under CAP Code rule  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), but did not find it in breach.

On this point, ad (b) breached CAP Code rule  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

Ads (a) and (b) must not appear again in their current form. We told Ionic Balance they should not make efficacy claims for the Ionic Balance Band, including in testimonials and endorsements, unless they held robust substantiation that the product could have those effects. We also told them they should not make efficacy claims for tourmaline, negative ions, far infrared rays or alpha waves unless they held robust substantiation that they could have those effects. We told them they should not refer to medical conditions for which medical supervision should be sought. We also told them that they should ensure any disclaimers did not contradict the information it was intended to qualify.

CAP Code (Edition 12)

12.1     12.2     12.6     12.7     3.1     3.45     3.47     3.7     3.9    


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