Summary of Council decision:
Two issues were investigated, one was Upheld and the other was informally resolved after the advertiser agreed to amend or withdraw their advertising.
A regional press ad for Kijimea IBS, who sold capsules to those suffering from IBS (irritable bowel syndrome), seen in the Bromsgrove Standard on 1 September 2017, included text which stated, “Amazing study results The benefits of Kimjea IBS have actually been put to the test in a clinical study - with amazing results! IBS symptoms did not only significantly improve due to Kijimea IBS but also completely disappeared in some cases. On top of that, the bifidobacterium contained in Kijimea IBS is the only one worldwide that simultaneously showed an increase in the quality of life of IBS patients!”, “Finally available in the UK!” and “It is only available by order over the pharmacist counter at: … or online at www.chemistdirect.co.uk and www.amazon.co.uk!”.
Two complainants challenged whether the claims “IBS symptoms did not only significantly improve due to Kijimea IBS but also completely disappeared in some cases” and “…simultaneously showed an increase in the quality of life of IBS patients!” were misleading and could be substantiated.
Synformulas GmbH t/a Synformulas said the product was a CE-marked medical device for use by sufferers of Irritable Bowel Syndrome (IBS). They said the unique bacteria Bidiobacterium bifidum MIMBb75 was patented by Synformulas and contained in the product. They said they relied directly on the findings of a randomised, double-blind, placebo-controlled clinical trial which ensured there were no significant differences between the baseline characteristics of the study group and that the study group demographics were well balanced. They said the study produced statistically significant results, where patients who received the Bidiobacterium bifidum MIMBb75 treatment (the treatment) significantly improved their IBS symptoms pain/discomfort, distension and bloating, urgency and digestive order and the treatment also resulted in a significant gain in quality of life. They said the claim “IBS symptoms did not only significantly improve due to Kijimea IBS but also completely disappeared in some cases” was corroborated by the key study findings; completely relieved and considerably relieved patients were grouped as having received adequate relief and adequate relief was reported for 47% of the treatment group. They said the claim was rephrased to be easily understood by consumers. They said the claim “simultaneously showed an increase in the quality of life of IBS patients!” was a direct quotation from the conclusion pages of the study. They said they believed their direct referral to and extrapolation of the contents of the study complied with the Code.
The ASA considered that consumers would understand the claims “IBS symptoms did not only significantly improve due to Kijimea IBS but also completely disappeared in some cases” and “…the bifidobacterium contained in Kijimea IBS is the only one worldwide that simultaneously showed an increase in the quality of life of IBS patients!” to mean that the product was at least effective at improving all IBS symptoms but also effective at eliminating all IBS symptoms in some cases and would improve the quality of life of IBS patients generally. We noted the advertiser only referred to “IBS symptoms” and more specifically 'Bloating', 'Constipation', 'Diarrhoea' and 'Abdominal Pain'. We understood that the condition of IBS could manifest in different ways with different combinations of a wide range of symptoms. Nevertheless, we considered that consumers would expect an efficacy claim about the treatment of “IBS symptoms” to refer to all symptoms related to IBS.
We considered the evidence provided to us by Synformulas. We noted that the advertiser said the product held a CE certification from the relevant Notified Body showing that it conformed to Council Directive 93/42/EEC concerning medical devices and was classed as a medical device. While medical devices were regulated by designated Notified Bodies, marketing communications in the UK were assessed by the ASA against the Advertising Codes. We did not consider that certification alone was capable of substantiating the claims made in the ad.
We noted that the clinical trial provided was a randomised, double-blind, placebo-controlled, two-arm and peer-reviewed study. We noted the positive and statistically significant conclusions reported, that is, “Adequate relief (both ‘completely relieved’ and ‘considerably relieved’ were defined as ‘adequate relief’) was self-reported for 47% in the bifidobacteria and 11% of the patients in the placebo group; P < 0.0001”. We noted those observations were based on the subject’s perception of their own symptoms. We also noted the author’s conclusions on the limitations of the study; namely that the study population was not large enough for a subgroup analysis of IBS subtypes, the study population only had mild to moderate IBS symptoms as evidenced by the indicated SGA-baseline values and the duration of the study was short, at four weeks.
We considered that the advertising claims should accurately reflect the report’s conclusions, that is, not refer to specific IBS subtypes, not refer to chronic or all sufferers of IBS and not refer to long-term efficacy. We considered the claim “IBS symptoms did not only significantly improve due to Kijimea IBS but also completely disappeared in some cases” did not accurately reflect the findings of the study, as adequate relief was only observed for some and not all IBS symptoms. Further, we considered the claim implied all IBS sufferers’ symptoms would at least improve which we understood was not the case and that the term “completely disappeared” implied the efficacy was permanent.
We further considered that the claim “the bifidobacterium contained in Kijimea IBS is the only one worldwide that simultaneously showed an increase in the quality of life of IBS patients” implied that research demonstrated there were no other bifidobacteria that could have the same effect, whereas the study acknowledged this was the only bifidobacteria to the author’s knowledge that could achieve the results reported. We also had concerns about the quality of life measure at the baseline of the study (we understood part of the measure had been conducted at week three and four of the study rather than at its commencement), and considered the claim went beyond the reported conclusions of the study.
Because the evidence provided did not demonstrate the product was at least effective at improving all IBS symptoms for IBS sufferers, or effective at eliminating all IBS symptoms in some cases and did not demonstrate the product would improve the quality of life of IBS sufferers generally, we considered the ad breached the Code.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
(Misleading Advertising) and
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 the form complained of. We told Synformulas to ensure claims did not mislead by suggesting their product could improve all IBS symptoms for all IBS sufferers, was effective in some cases at eliminating all IBS symptoms and would improve the quality of life of IBS sufferers generally. We also told them to ensure they held adequate substantiation for claims made in their advertising.