Background
Summary of Council decision:
Two issues were investigated, both of which were Not upheld.
Ad description
A website for an antiseptic healing cream, www.sudocrem.co.uk/antiseptic-healing-cream/family-care, stated, "Although Sudocrem is the market leading nappy rash cream, you might not know it can also be used as a soothing, protective antiseptic cream for other skin conditions: … Minor burns … Bed sores …".
Issue
The complainant, who is employed as an emergency health care professional, challenged whether:
1. the claim that Sudocrem was suitable for the treatment of burns and bedsores was misleading and could be substantiated; and
2. the ad was potentially harmful, because they believed the application of Sudocrem could potentially make burns worse.
Response
1. Forest Laboratories said that Sudocrem Antiseptic Healing Cream (Sudocrem) was a licensed medicine and they believed it had been promoted in accordance with its marketing authorisation and its summary of product characteristics (SPC), which had been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). They explained that no secondary claims had been made and the wording of the claims in the ad was limited to what was contained in the MHRA approved SPC. Forest Laboratories said they believed the claims that Sudocrem was suitable for the treatment of burns and bedsores were justified and those ailments were part of a list of ailments for which Sudocrem was licensed to treat. Forest Laboratories stated that the claims were further justified as the SPC is integrated into Sudocrem's website and the wording "Always read the label" is found in all of the materials relating to the product.
2. Forest Laboratories pointed out that there had been no evidence to suggest Sudocrem had a harmful effect upon patients with burns. They asserted that there had been no documented reports to themselves or the competent authorities of Sudocrem having been harmful to the treatment of minor burns. Forest Laboratories asserted that there was no evidence that the claims in the ad were potentially harmful and the safety of Sudocrem was continually monitored and reported through Periodic Safety Update Reports, which were submitted to the MHRA.
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
12.1
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.
, claims for those products should conform to the SPC.
We noted that the SPC for Sudocrem stated "Therapeutic Indications In the treatment of: … Bedsores … Minor burns". We considered the claims that Sudocrem was suitable for the treatment of "minor burns" and "bedsores" were consistent with the approved claims in the SPC and, on that basis, concluded that those claims were not misleading.
On this point we investigated the claims under CAP Code (Edition 12) rules
1.3
1.3
Marketing communications must be prepared with a sense of responsibility to consumers and to society.
(Social responsibility),
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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration) 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), but did not find a breach.
2. Not upheld
We noted that the ad made it clear that Sudocrem was to be used for minor burns and the SPC confirmed this as one of its approved claims. Given that, consumers were only likely to use Sudocrem for minor burns and because we were not aware of any evidence that it could make minor burns worse, we concluded it was unlikely to cause harm.
On this point we investigated the ad under CAP Code (Edition 12) rules 4.5 4.5 Marketing communications, especially those addressed to or depicting a child, must not condone or encourage an unsafe practice (see Section 5: Children). (Harm and offence).
Action
No further action necessary.
