Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website, www.taymount.com, that promoted the Taymount Clinic, featured text that stated "Taymount Clinic: Specialists in Faecal Microbiota Transplant Treatment Practice and research in Faecal Microbiota Transplant, Clostridium difficile treatment, IBS & IBD treatment ... We are currently applying Faecal Microbiota Transplant (FMT) to the following conditions at this clinic: Ulcerative Colitis Crohn's Disease Clostridium difficile Infection (RCDI) IBS (Irritable Bowel Syndrome) Post-Infectious Dysbiosis (IBS) Post-Antibiotic Dysbiosis (IBS) CFS (Chronic Fatigue Syndrome) & ME (Myalgic Encephalopathy) MS (Multiple Sclerosis) ... ". Further text stated "The Taymount Clinic specialises in health conditions influenced by the functions of Gut Microflora. Researching the modification of intenstinal Bacteria since 2006, the Taymount Clinic are leaders in applying Faecal Microbiota Transplant (FMT) techniques in a broad range of gut conditions".
Issue
1. The complainant, who believed the ad made efficacy claims in respect of FMT, challenged whether those claims were misleading and could be substantiated.
2. The ASA challenged whether the ad discouraged essential treatment for conditions for which medical supervision should be sought.
Response
1. The Taymount Clinic said the statement that 'We are currently applying Faecal Microbiota Transplant (FMT) to the following conditions at this clinic' was factually accurate. They pointed out that they had amended the ad to include a statement that they could not claim with any established scientific evidence that FMT was a cure for the conditions listed in the ad, except for clostridium difficila, which was documented scientifically and academically. They also pointed out that the ad had been amended to include a link to a page labelled "References & Sources" that included journal articles that related to FMT. They believed the website did not make any efficacy claims and said that if it did, the claims were qualified clearly.
2. The Taymount Clinic pointed out that the ad stated "FMT is not a replacement for medical treatment; please consult your medical professional in the first instance". In that context, they believed the ad did not discourage essential treatment for conditions for which medical supervision should be sought.
Assessment
1. Upheld
The ASA noted that the Taymount Clinic had amended the ad to include a statement that they could not claim with any established scientific evidence that FMT was a cure for the conditions listed in the ad, except for clostridium difficila, which was documented scientifically and academically. The ad had also been amended to include a link to a page labelled "References & Sources" that included journal articles that related to FMT. We also noted their view that the ad made a factual statement that they were currently applying FMT to the conditions listed.
However, the ad featured text that stated ”Taymount Clinic: Specialists in Faecal Microbiota Transplant Treatment Practice and research in Faecal Microbiota Transplant, Clostridium difficile treatment, IBS & IBD treatment” and ”The Taymount Clinic specialises in health conditions influenced by the functions of Gut Microflora. Researching the modification of intenstinal Bacteria since 2006, the Taymount Clinic are leaders in applying Faecal Microbiota Transplant (FMT) techniques in a broad range of gut conditions”.
In the overall context of the original ad, we considered consumers would understand it made efficacy claims that FMT was effective against the conditions listed in the ad. We concluded that the efficacy claims in respect of FMT were misleading because they had not been substantiated.
We noted the amendments made to the ad. However, we considered the changes did not remove the implication that people used the service because it was effective against the conditions listed in the ad. Furthermore, we considered the additional text relating to a lack of established scientific evidence that FMT was a cure for the conditions listed in the ad, except for clostridium difficila, contradicted the impression created by the ad; that FMT was effective against the conditions listed. We concluded that, despite the amendments made, the presentation of the ad was likely to mislead.
On this point, the ad 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), 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).
2. Upheld
Crohn's disease and multiple sclerosis were conditions for which medical supervision should be sought. Marketers therefore 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. The ad stated "FMT is not a replacement for medical treatment; please consult your medical professional in the first instance". However, in the overall context of an ad for FMT, we considered consumers would understand the ad made claims that the advertised service was effective against Crohn's disease and multiple sclerosis. We had not seen evidence to demonstrate that the advertised service was carried out under the supervision of a suitably qualified medical professional. We therefore considered the ad should not make efficacy claims in relation to Crohn's disease and multiple sclerosis. Because the ad made such claims, we concluded that it discouraged essential treatment for conditions for which medical supervision should be sought.
On this point, the ad 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
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 and beauty products).
Action
The ad must not appear again in its current form. We told the Taymount Clinic to ensure they held robust substantiation to support efficacy claims in respect of FMT in future. We also told them to ensure their future advertising did not discourage essential treatment for conditions for which medical supervision should be sought.
