Background
Summary of Council decision:
Six issues were investigated, all were Upheld.
Ad description
Three ads for a pain relief product called O24™, a blend of essential oils applied topically to the skin:
a. A banner ad on Facebook was headlined "Relief From Chronic Pain! Allnaturalpainmanage ...". Underneath was an X-ray image of someone sat down, bending over and text stated "Eliminates pain from arthritis, fibromyalgia, joint & muscle pain, back pain, headaches ...".
b. Cover shots of Golfer, GQ and Men's Health magazines appeared on www.menshealthweeklyonline.com/UK/ on 1 June 2012 and were accompanied by the claim "Article originally featured in". The web page included content about O24™ which stated "SPECIAL REPORT: Revolutionary finding by U.K. researchers leads to fastest selling chronic pain solution in the world". Underneath, it stated "Are you living in pain? Is chronic pain causing you to be left behind? Do your shoulders, elbows, hips, knees and hands cry for help?". The web page continued "Most doctors will say that pain is a symptom of an underlying health problem. If you treat the problem, the pain should go away. But, for a staggering number of Britons that pain never goes away. The National Academy of Science Institute of Medicine estimates that over 30 Million Britons suffer from some form of debilitating and chronic pain. What is even scarier is that without treatment, simple pain in muscles and joints can quickly develop into chronic and lifelong pain such as Arthritis and Fibromyalgia ...".
Text continued under the heading "Traditional Pain Medication Can Kill You", and stated "It's obvious traditional pain medication both over-the-counter variety and prescription are not the answer. Over the counter medication of NSAIDS (non-steroidal-anti-inflammatory drugs) like Aspirin and Ibuprofen may not be strong enough and can actually kill you. A study published by the National Academy of Science Institute of Medicine shows that there are over 100,000 hospitalizations and over 16,000 deaths each year in the UK alone. The causes are ulcers and severe stomach bleeding caused directly by these over-the-counter pain pills. Prescription medication has even greater side effects such as addiction and the potential for abuse (Oxycontin for example). They simply do more harm than good.
So what is the solution? The only solution is to go directly to the source of chronic pain, using an all-natural solution that doesn't produce these nasty side effects. A shocking discovery by UK researchers may have just produced the perfect solution. Revolutionary all natural and patented O24TM Pain Management System is scientifically formulated and clinically proven to provide incredible pain relief and long term healing without any side effects".
Under the heading "What is the O24TM Pain Management System?", text stated "O24 is an all-natural and patented topical painkiller that is clinically proven to provide incredible pain relief with absolutely no side effects. It is a proprietary blend of 7 essential oils (their website lists the following ingredients: peppermint, eucalyptus, orange, camphor, aloe vera, lemon and rosemary) ...".
(c) Claims on www.allnaturalpainmanagement.com stated "The Only All Natural FDA Approved Pain Management Solution That Guarantees Results! O24 STOP Letting Everyday Pain Hold You Back. Eliminate Chronic Pain Caused by ... Arthritis, Osteoarthritis, Fibromyalgia, Carpal Tunnel, Diabetic Neuropathy, Weight Gain, Muscle Aches, Sports Injuries. Because You Deserve to Always Feel At Your Best, Eliminate Pain with FDA Approved, US Patented O24™ Pain Management System". Underneath text stated "THE ONLY ALL NATURAL, PATENTED AND FDA APPROVED PAIN MANAGEMENT SOLUTION THAT GUARANTEES RESULTS WITH ABSOLUTELY NO SIDE EFFECTS". The page explained what the product could be used for, it provided a list of the ingredients and included a number of customer testimonials. It also included a response panel whereby consumers could apply for a special offer.
Issue
The complainant challenged whether:
1. the efficacy claims made in ad (a) were misleading and could be substantiated;
2. ad (b) resembled editorial content and failed to make clear it was a marketing communication; and
3. the claim that the content of ad (b) had appeared in Golfer, GQ and Men's Health magazines was misleading and could be substantiated.
The ASA challenged whether:
4. ads (a) and (c) discouraged essential treatment for a condition, arthritis, for which medical supervision was required;
5. ads (a), (b) and (c) made medicinal claims for an unlicensed product; and
6. the claims in ads (b) and (c) that the product was guaranteed to work, without side effects, and the implication that it was safe because it was natural were misleading and could be substantiated.
Response
Revive BioScience UK did not respond to the ASA's enquiries.
Assessment
The ASA was concerned by Revive BioScience UK's lack of response and apparent disregard for the Code, which was a breach of the CAP Code (Edition 12) rule 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 respond promptly to our enquiries and told them to do so in future.
1. & 5. Upheld
We considered the claims "Relief From Chronic Pain!" and "Eliminates pain from arthritis, fibromyalgia, joint & muscle pain, back pain, headaches ...", "... chronic pain solution", "... scientifically formulated and clinically proven to provide incredible pain relief and long term healing without any side effects ...", "Eliminate Chronic Pain Caused by ... Arthritis, Osteoarthritis, Fibromyalgia, Carpal Tunnel, Diabetic Neuropathy, Weight Gain, Muscle Aches, Sports Injuries ..." implied that the product, O24™ could relieve pain caused by those conditions. The complainant challenged whether those claims could be substantiated. However, we considered such claims were medicinal and, therefore, we understood Revive BioScience was required to hold a marketing authorisation from the Medicines and Healthcare products Regulatory Agency before marketing the product to UK consumers. Because they did not hold the relevant authorisation, we considered they were making medicinal claims for an unlicensed product. The Code prohibited Revive BioScience from making such claims and, therefore, we did not investigate those points further. We reminded them of their obligation to check their claims were legal under medicines law (CAP Code
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach 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.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
.
The ads breached 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),
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.
(Medicines, medical devices, health related products and beauty products) and
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach 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.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
(Medicines).
2. Upheld
Ad (b) was written in the style of editorial content; however, we were unable to find details of a publication called "Men's Health Weekly". We noted that the popular magazine, Men's Health, was a monthly edition and its website had a different URL address. We understood from Men's Health that ad (b) was not connected or associated with them in any way.
ReviveBioScience had not shown us evidence that the website was one for a publication and in the absence of such evidence, we considered that it was not editorial content but rather advertising for O24™. The Code required advertising to be obviously identifiable as such and we considered that was not the case here. Because of that, we concluded the ad breached the Code.
The ad breached CAP Code (Edition 12) rule 2.1 2.1 Marketing communications must be obviously identifiable as such. (Recognition of marketing communications).
3. Upheld
We had not seen evidence that ad (b) had originally appeared as editorial content in Golfer, GQ or Men's Health magazines and because of that, we considered the claim was misleading.
The claim breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 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).
4. Upheld
We considered arthritis was a condition for which medical supervision should be sought and as such, we were concerned that ReviveBioScience made claims that O24™ could treat such a condition. Notwithstanding our concerns set out above in point 1 that they should not be making medicinal claims, we considered consumers, seeing the efficacy claims, could start to use the product without seeking medical advice to check whether it was appropriate to include it as part of their treatment regime. For those reasons, the ad discouraged essential treatment for a condition for which medical supervision should be sought and therefore we concluded the ad breached the Code.
On this point, the ads breached CAP Code (Edition 12) 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).
6. Upheld
We had not seen evidence which supported ReviveBioScience's claims that the product was guaranteed to work or that it did not have any side effects. Because of that, we concluded those claims were misleading and breached the Code. We considered ad (b), in particular, implied that because O24™ was natural, it was therefore safe; claims which were prohibited by the Code. For that reason, we concluded the ads breached the Code.
On this point, the ads breached CAP Code (Edition 12) 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.
12.9
12.9
Marketers must not encourage consumers to use a product to excess and must hold proof before suggesting their product or therapy is guaranteed to work, absolutely safe or without side-effects (subject to 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.
).
and
12.10
12.10
Marketing communications must not suggest that any product is safe or effective merely because it is "natural" or that it is generally safer because it omits an ingredient in common use.
(Medicines, medical devices, health-related products and beauty products).
Action
The ads must no longer appear. We told Revive BioScience not to make medicinal claims for an unlicensed product and not to discourage essential treatment for a condition for which medical supervision should be sought. We told them to hold substantiation for the claim that the content had appeared in Golfer, GQ and Men's Health magazines and to ensure their advertising was identifiable as such. We referred the matter to the CAP Compliance team.
CAP Code (Edition 12)
1.7 12.1 12.10 12.11 12.2 12.9 2.1 3.1 3.7
