Background
Summary of Council decision:
Two issues were investigated of which one was Upheld and one was Not upheld.
Ad description
Claims on www.infacol.co.uk, promoting Infacol Simeticone, stated "Britain's No. 1 infant colic remedy ... Infacol the trusted help for infant colic is right here ... Although it is not a serious medical condition it is possible to alleviate the distress and discomfort. Find out how infacol can help". Text below stated "Treating colic with infacol", which linked to further information about colic. Another link to "About Infacol' stated "Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic".
Issue
The complainant challenged whether the claims:
1. "infant colic remedy", "infacol the trusted help for infant colic", "alleviate the distress and discomfort" and "Treating colic with infacol"; and
2. "Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic"
were misleading and could be substantiated, because she understood that in clinical trials Simeticone had been demonstrated to have no effect beyond placebo on its effectiveness for treating colic.
Response
1. Forest Laboratories said Infacol was a medicine (as understood by the legislation enshrined with the Medicines Act) and it held a marketing authorisation in the UK with the indications of 'an antiflatulent for the relief of griping pain, colic or wind due to swallowed air'. They said the use was specified on the UK Summary of Product Characteristics (SPC) for infants and that Infacol was licensed for the treatment of infant colic. They said the license was granted in the UK in 1986 on the basis of submitted evidence of efficacy, safety and quality and they also obtained the licence by submitting data showing the reduction in frequency and severity of crying attacks. They said the claims were consistent with the clinical evidence available and provided a clinical study which they said concluded that Infacol statistically significantly reduced the frequency and severity of crying attacks in infant colic.
2. They acknowledged that other published studies had questioned the efficacy of simeticone in the management of infant colic, but stated that none of those studies used Infacol, or used the same dose and frequency of dosing of simeticone, and most used under-doses. They said the balance of benefit to risk of Infacol had been regularly evaluated as part of the advertisers' on-going commitment to pharmacovigilance, and they said it was consistently shown that the balance remains satisfactory.
Assessment
1. Not upheld
The ASA noted that the CAP Code required medicines to have a licence from the MHRA before they were marketed and that, under CAP Code rule
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.
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.
claims for those products should conform with the SPC.
We noted that the SPC for Infacol stated "Therapeutic Indications: An antiflatulent for the relief of griping pain, colic or wind due to swallowed air" and "Posology and Method of Administration For infants ... Treatment with Infacol may provide a progressive improvement in symptoms over several days". We considered that the claims "infant colic remedy", "infacol the trusted help for infant colic", "alleviate the distress and discomfort" and "Treating colic with infacol" were consistent with the approved claims in the SPC and, on that basis, concluded that those claims were not misleading.
On that point, we investigated the claims under CAP Code (Edition 12) rule
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.
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), but did not find them in breach.
2. Upheld
We noted that the SPC stated "Treatment with Infacol may provide a progressive improvement in symptoms over several days", but did not provide further detail or make express or direct reference to "crying attacks" or to providing a significant reduction in the frequency and severity of that symptom. We therefore considered that that claim was related to the wording permitted by the SPC, but went beyond the specific wording listed in the SPC.
We therefore sought our own legal advice and consulted the MHRA in order to clarify how CAP Code rule
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.
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.
which was derived from UK medicines regulations, should be applied to claims.
The MHRA noted that the SPC provided information about the relief of colic and therefore considered that a claim concerning the reduction in severity or frequency of crying associated with colic was a supplementary clarification of the information in the SPC. They therefore considered that because the claim "Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic" was not in conflict with the SPC, it could be said to comply with it. However, the MHRA also considered that the marketers should be able to provide substantiation to support such a supplementary claim. We therefore understood that it was necessary to assess the substantiation provided by the advertisers in support of the supplementary claim as it went beyond the specific wording of the SPC.
We consulted an independent expert. We understood that the evidence provided in support of the claim was a brief, single study with major limitations; for example, it did not include a sample size calculation and there was no statistical justification for the number of patients planned, it did not specify the entry criteria, the dose was variable and the treatment blinding was not tested. In light of those limitations we considered that the study was not sufficient to support the claim "Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic".
Although we noted that the claim "Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic" was a supplementary clarification of the SPC and was not in conflict with the claims permitted in the SPC, we considered that the advertisers had not satisfied the requirement that they provide evidence to support the claim and therefore concluded that it was misleading.
On that point, the claim breached CAP Code (Edition 12) rules
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.
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).
Action
The claims must not appear again in their current form. We told the advertisers not to make claims supplementing the information in the SPC if they did not hold supporting evidence for those supplementary claims.
