Background
The CAP Code requires marketers to hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation before those claims are made (rule 3.7). Evidence which becomes available after that time cannot be used to demonstrate compliance with rule 3.7. However, it is possible that such evidence may lead the ASA to conclude that CAP Code rule 3.1, which prohibits marketing communications that materially mislead or are likely to do so, has not been breached.
The ASA has full discretion to consider evidence post-dating a claim if it is reasonable to do so. In assessing what is reasonable, we will look to a number of factors, which might include the nature of the claims, the extent to which the advertiser has had an opportunity to respond to points put to it by the complainant and/or the ASA, the time at which the evidence is obtained and submitted, and its potential significance.
As well as the information included with their initial response to the complaint (which was held before the claims were made), during the course of this investigation Vemedia Export BV t/a Vemedia Consumer Health submitted an additional piece of evidence to the ASA which they had not held at the time the claims were made. The ASA decided that it was proportionate and necessary to assess the evidence post-dating the claims.
Summary of Council decision:
Three issues were investigated, of which two were Not upheld and one was Upheld in part.
Ad description
A website for a nail fungus treatment, www.excilor.com, seen 23 October 2015, described how the treatment worked. Text on the home page included “Optimal penetration through(1) TransactiveTM Technology … 1 In-vitro results University of Antwerp”. A page headed “HOW IT WORKS?” included the claims “…Excilor…acts fast to block the progression of the fungal infection” and “The classic anti-mycotic molecules are so big, they cannot penetrate the nail without filing. Excilor’s molecule is so small it penetrates the nail without filing”. A page headed “PRODUCTS” included the claim “Complete penetration* through Transactive penetration technologyTM … *Excilor. Proven efficacy for the treatment of onychomicosis [sic] (tinea unguium)”. On a “FAQ” page text stated “My nail has a fungal infection. How long will it take to eliminate the fungus? … Excilor®…gets rid of the actual microorganisms (the dermatophytes, or fungi) which live under your fingernail or toenail. It can take several weeks to make all the microorganisms disappear”.
Issue
Bayer plc challenged whether the following claims were misleading and could be substantiated:
1. “Optimal penetration” and “Complete penetration”; and
2. “Acts fast to block the progression of the fungal infection”.
3. Bayer plc also challenged whether the claim referencing anti-mycotic molecules on the “HOW IT WORKS?” page and the claim “Excilor®…gets rid of the actual microorganisms (the dermatophytes, or fungi) which live under your fingernail or toenail” on the “FAQ” page misleadingly implied that the product had anti-fungal medicinal properties.
Response
Vemedia Consumer Health said that Excilor was a medical device that indirectly treated the fungal nail infection onychomycosis by regulating the microenvironment of the nail. It contained lactic acid and acetic acid, which they said penetrated the nail and acidified the affected area. This inhibited the ability of the fungus, which causes onychomycosis, to grow and reproduce, allowing the healthy nail to grow and replace the infected part of the nail as it grew out.
They said that other treatments worked on the same basis as Excilor, in that they acidified the affected area. However, those treatments generally required users to file the nail first to allow the treatment to penetrate into the nail. By contrast, the small molecular size of Excilor’s active ingredients, coupled with the TransActive technology, meant that the treatment completely penetrated through the nail without the need to either file or remove it.
1. Vemedia Consumer Health said the claim “Optimal penetration through …TransactiveTM Technology” appeared on a rotating banner, and was clarified by wording in the second section of the banner which stated “Effectively penetrating the hard nail surface is difficult. Many products require filing of the nail. Only Excilor is made with the unique TransActive penetration technology. Excilor is proven to penetrate deep into the nail without filing”. They believed that in that context consumers would interpret the claim “Optimal penetration” to mean that it was not necessary to file the nail before application in order for the product to penetrate it; the product was instead able to penetrate the complete nail. They believed the claim “Complete penetration” would be interpreted in the same way by consumers in the context in which it appeared.
Vemedia Consumer Health said the treatment’s penetration into the nail was influenced by various factors including the physical and chemical properties of the molecules (size, shape, charge and hydrophobicity), the characteristics of the formulation (vehicle, pH and concentration), as well as the presence of any penetration enhancers. The lactic acid and acetic acid in Excilor were ideal for nail penetration as they were polar molecules, therefore having a small molecular size, and the fact that a hydrated nail behaved like a hydrogel, which made it more permissible to polar molecules. They provided copies of three published studies, and a published literature review of studies, relating to fungal nail treatments, as substantiation for the general processes by which they said the product worked. They also provided three reports on in vitro experiments conducted on the product; a copy of a document given to healthcare professionals to provide information about the product, which included descriptions of the in vitro experiments and two trials of the product on humans; and a report of a clinical study conducted over a period of 168 days.
2. Vemedia Consumer Health said the overall treatment period when using Excilor was made clear to consumers in many statements on their website, and that the full context of the claim was “Excilor…acts fast to block the progression of the fungal infection. Results directly visible when the nail grows back healthy”. The web page on which the claim appeared also included additional statements which made clear that the effects were achieved as the nail grew back. Additional information, including the statement “It can take several weeks to make all the microorganisms disappear” appeared on the FAQ page. They considered the advertising made clear that the period of time in which the product started to take effect (i.e. stopping the growth/progression of the fungi) was fast, but that the overall treatment period (the period of time it took for the fungi to be removed) was longer. They referenced one of the in vitro experiments, which was undertaken on human nails, in support of the claim, and the clinical study report. They highlighted that this study reported a clinical improvement in nails after 14 days of treatment with Excilor, which continued throughout the study period, and that a significant minority of subjects reported improvements after 14 days (a proportion which also increased throughout the study period).
3. Vemedia Consumer Health understood that Bayer considered the claims suggested that the product’s principal intended mode of action was achieved by pharmacological, immunological or metabolic means (‘medicinal’ modes of action). Such claims were not allowed for products which were not licensed as a medicine. Vemedia Consumer Health said that Excilor was licensed as a Class IIa medical device rather than as a medicine, because it treated onychomycosis via the modification of the anatomy or a physiological process rather than via a medicinal mode of action. They provided a copy of the products’ medical device certification.
Vemedia Consumer Health said that the claim “Excilor®…gets rid of the actual microorganisms (the dermatophytes, or fungi) which live under your fingernail or toenail” stated the end result of using the product rather than implying any particular mode of action, whether via medicinal or other means. They also highlighted that the claim appeared below a paragraph which included the statement “Excilor physically impedes the growth of infectious fungi, by reducing the pH value of the nail (making it more acidic). This is not a pharmacological effect”, and that a further claim on that FAQ page stated “Excilor is a Class IIa medical device, not a medicinal product. It does not have a pharmacological effect on the mycosis. Its effect is based on a physical principle …”.
They further considered that the mechanism of the product was clearly explained on the “HOW IT WORKS” page, where the claim “The classic anti-mycotic molecules are so big, they cannot penetrate the nail without filing. Excilor’s molecule is so small it penetrates the nail without filing” appeared. They highlighted that further text on that page stated “Excilor Fungal Nail Infection is able to penetrate the nail and modify its microenvironment, making it hostile to fungal growth”.
Assessment
1. Not upheld
The ASA considered consumers would interpret the claim “Optimal penetration” to mean that the product had been developed to use a particularly effective method of penetrating the nail. We considered that the text displayed on the second section of the banner’s rotation provided further clarification that the claim related to the ability of the product to penetrate the nail without the need for filing. We considered consumers would understand the claim “Complete penetration” to mean that the product penetrated through the entirety of the nail. We considered consumers would understand the claims to relate specifically to the product’s ability to penetrate the nail rather than as wider efficacy claims for the product.
We acknowledged that the published studies and literature review supported the general principles that a hydrated nail behaved like a hydrogel, therefore making it more permissible to polar molecules such as the lactic acid and acetic acid in the product. However, we considered that to support the claims about Excilor we would need to see evidence which specifically related to the product’s ability to penetrate nails. We therefore reviewed the in vitro experiments and trials which tested the product.
Two of the in vitro experiments were designed to test Excilor’s ability to penetrate nails. In the first experiment, Excilor, a competitor product and water were applied to slices from a horse hoof, which were placed on agar plates containing a pH indicator. Photographs were taken of the plates after 96 hours which showed that the agar under the hoof loaded with water remained the same blue colour (alkali), and the agar under the hooves loaded with Excilor and the competitor product showed yellow (acid) circles surrounded by green-blue (neutral-alkali). The yellow circle around the hoof loaded with Excilor was larger than that around the hoof loaded with the competitor product. Side-view photographs, taken after five and a half hours, showed that a small amount of liquid remained in the tube above the Excilor-loaded hoof compared to a much larger amount above the competitor product-loaded hoof. The second in vitro experiment, conducted on human nails, involved loading the nail with either Excilor or the competitor product and monitoring the pH level under the nail using a pH electrode. At baseline the pH below both nails was between pH6 and pH7. The pH under the Excilor-treated nail decreased to pH5 (the pH of the surface of a human nail) after eight minutes, and to pH4 within 20 minutes. The pH under the competitor product-treated nail rose slightly over the same period.
The two trials conducted on humans, as described in the document for healthcare professionals, and the report of the 168-day clinical study, tested the safety and efficacy of the product. However, we noted they did not include any specific measurements which addressed whether the product penetrated the nail in its entirety.
While we understood that the use of horse or bovine hooves was common in testing anti-fungal treatments, we considered that the results of tests of the product only on hooves would not have been sufficient to support the claim. However, we noted that the results of the first experiment were supported by the results of the test on the human nail. In the context of claims which we considered would be understood as relating specifically to the product’s ability to penetrate the nail (rather than as wider efficacy claims), we considered that in vitro test results constituted adequate substantiation. Because the in vitro test results showed that the product penetrated through the nail, we concluded the claims had been substantiated and were not misleading.
On this point, we investigated the ad under 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), but did not find it in breach.
2. Upheld in part
The full paragraph in which the claim appeared stated “Only Excilor is made with TransActive technology - it dries within seconds without filing and acts fast to block the progression of the fungal infection. Results visible when the nails grows[sic] back healthy”. In that context, we considered consumers would understand the claim to be an efficacy claim for the product; that it acted quickly to prevent fungal infections from progressing, and that when the nail grew out the infection would be gone.
We noted that the in vitro experiments conducted on human nails (referenced above) found that the product penetrated the nail and reduced the pH level underneath it within 20 minutes. However, to substantiate the efficacy claim in the ad we expected to see evidence consisting of in vivo trials of the product which demonstrated that the product had a clinically significant effect on fungal infections. We therefore reviewed the information about the two human trials as described in the document for healthcare professionals and the 168-day clinical study.
This document reported that the first trial, which involved 33 subjects using the product for 42 days, found that in 26 (81%) subjects the clinical appearance of the affected nail was improved. It further reported that the spreading of the infection was stopped and healthy nail replaced the infected part, although visible dermatophytes were still present. We noted that the primary aim of the study was to evaluate its safety rather than efficacy, and that the trial was not randomised, blinded or controlled. The document reported that one subject failed to complete the trial satisfactorily, but it did not provide further details. We noted that the percentage calculation of how many subjects saw an improvement did not take into account the subject who dropped out. The reporting of the results also lacked detail and did not describe what was considered to be a clinical improvement. We considered the report was not adequate to support claims of efficacy in the advertising for the product.
The second trial was placebo-controlled, randomised and double-blinded with intra-individual comparison in subjects. It involved 19 subjects and its primary aim was to evaluate the product’s efficacy, with the evaluation of its microbiological efficacy as one of the trial’s secondary aims, after 100 days of use. The document reported that 18 subjects completed the trial (nine in each group) and that the overall appearance of the nail in most of the subjects improved. Digital analysis showed that in the active group, the decrease in the total infected area was significantly higher than in the placebo group. It further reported that the tests for microbiological efficacy found that the number of positive subjects decreased from 100% to 38% in the active group, compared to a decrease from 100% to 78% in the placebo group. While we noted that the trial was blinded, controlled and randomised, the document did not provide further details and it was not clear whether the results were based on all the subjects who started the trial or the 18 who completed it. The reporting of the results lacked details and no statistical analysis was carried out. While the methodology of the trial appeared to be more robust than that of the first trial, we considered we had not seen adequate evidence that its methodology and results were sufficiently robust to support the advertising claim that the product “acts fast to block the progression of the fungal infection”.
The 168-day clinical trial report post-dated the complaint and therefore had not been available when the claim was published. On that basis, we concluded that Vemedia Consumer Health had not held substantiation for the claim at the time of publication and that it therefore breached CAP Code rule 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.
We noted that the 168-day study involved over 100 subjects, was open label, investigator-blinded, randomised and placebo-controlled, comparing the efficacy of Excilor with that of a topical anti-fungal medicinal treatment. The primary outcome measure was an evaluation of the effect of Excilor compared to the comparator product on the percentage of healthy surface of toenail. Secondary outcome measures included comparisons between the efficacy of Excilor and the comparator product based on a clinical evaluation and microbiological data. The report concluded that over the study period, in the Excilor-treated group, the proportion of healthy nail to infected nail significantly increased, clinical indicators of fungal infection reduced, and, for both the Excilor and comparator groups, there were significant reductions in the number of positive fungal cultures.
We noted the study report provided in-depth detail of the study methodology and results. We did not have any significant concerns about the study methodology or reporting, and we considered the study demonstrated that Excilor was an effective treatment for fungal nail infections. We therefore concluded the report constituted robust evidence of the efficacy of Excilor. We noted that the greatest improvements were to be seen at the end of the trial, but that the trial observed improvements in subjects after 14 days. We considered that because the study showed improvements in the infected nails after 14 days, and with continuing improvement over the rest of the study period, we had seen sufficient evidence that Excilor acted quickly to prevent fungal nail infections, and that when the nail grew out the infection would be gone.
We therefore concluded that, although the claim “Acts fast to block the progression of the fungal infection” had not been adequately substantiated with evidence held at the time it was published, it was supported by evidence which had become available at a later date and on that basis would not mislead consumers.
On this point, the ad breached CAP Code (Edition 12) rule 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).
We also investigated the claim under CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising) and
12.1
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 it in breach.
3. Not upheld
We considered that in isolation, the claim “Excilor®…gets rid of the actual microorganisms (the dermatophytes, or fungi) which live under your fingernail or toenail” might be understood by consumers as a claim that the product worked via a medicinal mode of action. However, the claim appeared on the FAQ web page which began with a clear explanation of the mode of action of the product, described how the affected nail would grow out to be replaced by healthy nail, and which specifically stated that the product was a medical device which did not have a pharmacological effect on the fungus. We therefore considered that in the context in which it appeared, consumers would be unlikely to understand the claim as implying that the product worked by medicinal means. We concluded that the claim was not misleading.
With regard to the claim “The classic anti-mycotic molecules are so big, they cannot penetrate the nail without filing. Excilor’s molecule is so small it penetrates the nail without filing”, we considered the claim would be understood by consumers as a description of an element of the mode of action of the product, and that there was no implication that that mode of action was medicinal. We further noted that the “HOW IT WORKS” web page on which the claim appeared included further descriptions of the mode of action of the product. We therefore considered that consumers would be unlikely to understand the claim as implying that the product worked by medicinal means. We concluded that that claim also was not misleading.
On this point, we investigated the ad under CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising) and
12.1
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 it in breach.
Action
No further action required. We reminded Vemedia Export BV t/a Vemedia Consumer Health to ensure they held adequate evidence to substantiate advertising claims before they were published.
