Summary of Council decision:
Four issues were investigated, all of which were Upheld.
A product listing for incognito mosquito repellent spray, seen on the incognito website, www.lessmosquito.com in October 2016, stated “Tested to be 100% effective against mosquito bites…It is just as strong as any Deet based product yet incognito is certified 100% natural and can be used by all the family including young babies…There is nothing stronger than incognito mosquito repellent. It provides excellent protection against mosquitoes and biting insects. It protects you just as effectively as Deet, yet is 100% natural…incognito spray and roll-on are clinically proven to protect against malaria when used in conjunction with an impregnated mosquito net to sleep under”.
A product listing for incognito mosquito repellent roll-on on the same website stated “Tested to be 100% effective against mosquito bites…There is nothing stronger than incognito mosquito repellent. It provides excellent protection against mosquitoes and biting insects. It protects you just as effectively as Deet, yet is 100% natural…incognito spray and roll-on are clinically proven to protect against malaria when used in conjunction with an impregnated mosquito net to sleep under”.
Omega Pharma challenged whether the following claims were misleading and could be substantiated:
1. "Tested to be 100% effective against mosquito bites";
2. "It protects you just as effectively as Deet"; and
3. "incognito spray and roll-on are clinically proven to protect against malaria when used in conjunction with an impregnated mosquito net to sleep under".
4. The ASA challenged whether the claim “It protects you just as effectively as Deet” was verifiable.
1. Howad Ltd provided a copy of independent laboratory research that was carried out to test the effectiveness of the incognito roll-on against mosquito bites. They said the results found that their formulation had a Complete Protection Time (CPT) of four hours, which they believed supported the claim that the product was 100% effective following application. They also provided a copy of a second trial that evaluated the effectiveness of four different doses of the active ingredient used in incognito spray and roll-on against mosquito bites, and results of benchmark tests on a sunscreen product.
They said they were willing to revise the wording of the claim to make clear that the product provided 100% protection for four hours and with good protection up to eight hours. They said they would also make clear that only one species of mosquito had been used in the testing.
2. Howad said there were many factors to consider when judging the “effectiveness” of mosquito repellents and each of the products on the market had strengths and weaknesses. They believed the claim "protects you just as effectively as Deet" was likely to mean different things to different people and there were many factors consumers took into account when comparing repellents, including whether the application was oily, damaged clothes and plastic items, interfered with sunscreen efficacy or caused skin irritation, as well as concerns over the health effects of long-term use and damage to the environment. They provided copies of research, research abstracts and news articles to show the differences between mosquito repellent products containing DEET (diethyltoluamide) and those containing PMD (p-Menthane-3,8-diol), which was the active ingredient in incognito. They also provided an article referencing a research study comparing several different mosquito repellent products that stated DEET and PMD were the most effective and longest lasting mosquito repellents available.
Howad said taking all those factors into consideration and because they believed their product’s active ingredient was more effective than DEET on application and remained effective for a substantial length of time, the claim "protects you just as effectively as DEET" was robust.
3. Howad provided a published, peer-reviewed report on a clinical trial that evaluated the effectiveness of a plant-based insect repellent containing PMD in protecting against malaria when used in combination with an insecticide-treated bed net. They said that the PMD formulation used in the study was quite crude compared to the active ingredient used in their products. They believed that this was sufficient to substantiate the claim.
4. Howad did not respond on this point.
The ASA considered that consumers would understand that mosquito repellent needed to be re-applied at intervals in order to continue to provide protection, and that the timing would vary depending on the product. We therefore considered that consumers would understand the claim “Tested to be 100% effective against mosquito bites” to mean that the advertised products would prevent all mosquito bites in all users, if used as instructed. We noted that there was no guidance on duration of protection in the ad as it originally appeared. However, consumers would be aware that they should refer to the specific instructions that came with the product. We noted that the product labels stated “Clinically tested to be 100% effective for 4 hours and good protection for up to 8 hours…Reapply when necessary”. In light of that information, we considered that consumers would understand “Tested to be 100% effective against mosquito bites” to mean that the products would prevent all mosquito bites if re-applied every 4 hours.
We considered that consumers would understand that the product would provide this degree of protection from all types of mosquitoes, including those in tropical climates. We noted that mosquitoes carried a range of extremely serious, and potentially fatal, diseases. By the time an individual felt a mosquito bite and realised that it was time to renew protection, it could already be too late to prevent disease transmission. Taking this into account, consumers were entitled to expect an unequivocal claim that a product could protect them from bites when used as instructed to be supported by a very high standard of evidence.
We took expert advice. The most relevant evidence for this claim was the laboratory test on the incognito roll-on, which included six participants. The test recorded how long it took for each volunteer to get their first mosquito bite after applying the repellent – this was defined as their CPT. The results were analysed to assess the average time in which a group of people would get their first bite, giving a median CPT of 04:00 hours with a 95% confidence range of 03:24 to 04:35 hours. This meant that half of the volunteers were bitten before 4 hours and the other half of the volunteers were bitten after 4 hours, with an expectation that 95% of the volunteers would be bitten between 03:24 and 04:35 hours. The sample size of six was very small and may not include a range of susceptible users – we noted that individuals varied widely in their attractiveness to mosquitoes, and this was acknowledged in the report. We understood that although the average CPT of 4 hours would probably not vary greatly, increasing the number of participants in this type of test would likely narrow the range of the 95% confidence interval and increase the accuracy of the average CPT. Furthermore, we considered that while insect repellents could reduce the risk of mosquito bites, they could never provide 100% protection, for a variety of reasons, including insects biting through clothing where repellent had not been applied, and the dilution of repellent through sweating.
The laboratory tests on the products’ active ingredient did not test the incognito products themselves, and had similar issues with sample size. The benchmark tests on a sunscreen were based on only three volunteers, which we understood would result in weak statistical analysis of the results. The varying outcomes in these tests indicated that different formulations containing the same amount of PMD (15%) could provide differing average durations of protection, which further suggested that claims about particular products needed to be based on tests carried out on those specific products.
In addition, we noted that the roll-on test only used one species of mosquito – Aedes aegypti. We understood that the degree of protection from the bites of medically-important mosquito species varied considerably between species and, in some cases, between insects of the same species found in different geographic regions within the tropics. We also noted the World Health Organisation Guidance for Efficacy Testing of Mosquito Repellents for Human Skin stated that three or more species of mosquito should be used in laboratory tests, encompassing vectors of all the most dangerous mosquito-borne diseases. Given that consumers would understand that the products provided full protection from all types of mosquito, including those that carried potentially deadly diseases, we considered that it was insufficient to test against a single species of mosquito. We acknowledged Howad’s willingness to add qualification stating that only one species had been used in the tests, but we considered that this would be insufficient to counteract the overall impression given to consumers, particularly in light of the very serious consequences of being bitten in some regions.
We understood that an average CPT of 4 hours was not adequate to demonstrate that the products would prevent all mosquito bites in all users if used as instructed –i.e., re-applied every 4 hours as per the product instructions. We concluded that the claim “Tested to be 100% effective against mosquito bites”, as it would be understood by consumers, had not been substantiated and was therefore misleading.
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), 3.9 (Qualification) and 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration).
We acknowledged that consumers were likely to take a number of factors into consideration when deciding which type of insect repellent to purchase. However, we considered they would understand the claim "It protects you just as effectively as Deet" to refer to the efficacy of the product in preventing insect bites, rather than secondary considerations such as whether the product stained clothing or caused skin irritation. While we acknowledged that consumers were also likely to take into account the possible health effects of the ingredients in their mosquito repellent, we did not consider that was relevant to their likely understanding of “effective” protection.
The claim referred generically to DEET. We considered that consumers would be aware that this was a reference to an active ingredient, rather than to a specific repellent, and we noted that there were a range of different DEET-based products on the market, which consumers would be capable of identifying. DEET was recommended by many different public health bodies as the most reliable protection against being bitten by mosquitoes, and we considered it was widely known that the strongest available dose of DEET would provide the longest-lasting available protection from mosquitoes. Taking that claim in isolation, we considered that consumers would understand the claim “it protects you just as effectively as Deet” to mean that incognito spray and roll-on would significantly reduce their risk of mosquito bites when used as instructed, as a DEET-based repellent would, and we considered that the standard of evidence required to support it should be very high, demonstrating as close to 100% protection as possible.
However, we noted that both product listings also featured the claim “There is nothing stronger than incognito mosquito repellent”, and the spray listing additionally stated “It is just as strong as any Deet based product”. These claims implied that the incognito products provided the same duration of protection as any DEET-based product, including the strongest available. In the UK, the strongest legal dose was 50% DEET. In light of these accompanying claims, we considered that consumers would interpret “It protects you just as effectively as Deet” to mean that the products would provide the same duration and level of protection as all DEET-based products. In order to substantiate such a claim, we expected to see a robust, adequately-controlled clinical trial comparing the duration of protection provided by the incognito spray and roll-on products, and a DEET-based product representative of the strongest dose available on the market.
A large proportion of the material provided by Howad related to the safety and toxicity of products containing DEET and PMD, as well as concerns over mosquitos becoming resistant to DEET. We considered that, because they did not relate to the efficacy of products containing PMD to protect against mosquito bites, those documents were not relevant substantiation to the challenged claim.
Howad also referenced articles on NHS and Public Health England websites. We noted that one of the NHS articles stated that PMD gave the same protection as 15% DEET, but for a shorter period, although the source for that claim was not quoted, while another NHS article said DEET was the most effective protection against mosquito bites. One of the Public Health England articles Howad provided recommended DEET as protection from the mosquito borne infection chikungunya, while another recommended PMD as a mosquito repellent, but stated that 50% DEET was the most effective.
We reviewed the evidence that assessed the effectiveness of PMD in preventing mosquito bites. The relevant body of evidence included six full, published studies on other formulations containing PMD. The doses of PMD evaluated in each study varied, and in some they were not clearly defined. In some cases, PMD products were compared with other mosquito repellents, including various concentrations of DEET.
We noted that the wider literature indicated that PMD had been shown to be quite effective in repelling a range of insects, and in some cases, but not all, it was comparable with DEET. However, to support the claim, Howad needed to provide adequate evidence relating to the products themselves. As discussed above, we did not consider that laboratory tests on the roll-on product were sufficient to demonstrate that the product would prevent all mosquito bites if used as instructed (i.e., re-applied every 4 hours). Given the very high standard created by the product’s intended function to protect from mosquitoes carrying potentially deadly diseases, neither did we consider that the study was sufficient to support the likely consumer interpretation of “It protects you just as effectively as Deet”, seen in isolation with reference to the information on the label – i.e., that it would significantly reduce mosquito bites if re-applied every four hours.
That notwithstanding, in both ads the claim “It protects you just as effectively as Deet” was presented alongside additional claims which were likely to cause consumers to understand that it provided an equal duration of protection as the strongest available DEET-based product on the market. We noted that we had not seen any studies directly comparing the efficacy and duration of protection of the incognito products with a DEET-based product of any strength.
We concluded that the claim "protects you just as effectively as Deet", as consumers were likely to understand it in the context of the ads, had not been substantiated and was therefore misleading.
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), 3.9 (Qualification), 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration) and 3.33 3.33 Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product. (Comparisons with identifiable competitors).
We considered that consumers would understand the claim "incognito spray and roll-on are clinically proven to protect against malaria when used in conjunction with an impregnated mosquito net to sleep under" to mean that the products had been proven in a clinical trial to significantly reduce their risk of contracting all types of malaria, when used as instructed with a treated mosquito net. We therefore expected to see a robust clinical study comparing the incidence of malaria in a group using the incognito product with that of a group using an appropriate control product.
In support of the claim, Howad provided a study which involved over 4,000 individuals in the Bolivian Amazon in a double-blind, randomised, controlled clinical trial. One group was instructed to apply a plant-based insect repellent containing 20% PMD (30% active mixture containing 65% PMD) in the evening and was also supplied with insecticide-impregnated bed nets. The control group was given a placebo repellent to be used alongside the bed nets.
We noted that the study did not assess the effect of the specific incognito spray or roll-on formulations, and contained a slightly higher dose of PMD than that found in the advertised products.
The study was limited to one species of malarial mosquito – Anopheles darlingi – which was only present in Latin America. We understood that there were many other carriers of malaria worldwide, including Anopheles gambiae, which was responsible for the majority of malaria morbidity and mortality around the world and therefore widely used in efficacy assays. Furthermore, while the study found that the tested repellent contributed to a significant level of protection from one type of malaria parasite – Plasmodium vivax – the results for the more dangerous strain, Plasmodium falciparum, were not significant.
We also noted that the population assessed consisted of indigenous people in the Amazon rainforest, who could be expected to have some level of resistance to malaria parasites due to having lived in the area all their lives. Therefore, we did not consider that the results of this study could be applied to the general public in the UK, who were the likely market for incognito’s products, and who were unlikely to have developed similar resistance to tropical diseases.
For those reasons, we considered that we had not seen sufficient evidence to substantiate the claim "incognito spray and roll-on are clinically proven to protect against malaria when used in conjunction with an impregnated mosquito net to sleep under" and concluded that it was misleading.
On this point, the ad breached CAP Code rules
Marketing communications must not materially mislead or be likely to do so.
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.
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
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).
We considered that consumers would be able to identify other brands of mosquito repellent that contained DEET on the market. Therefore we considered that “It protects you just as effectively as Deet” was a comparison with identifiable competitors. The CAP Code required comparisons with identifiable competitors to be verifiable. That meant that an ad which featured a comparison with an identifiable competitor or competitors needed to include, or direct a consumer to, sufficient information to allow them to understand the comparison, and be able to check the claims were accurate.
The ad did not signpost or make available further information that would enable consumers to check the comparison was accurate for themselves. We therefore concluded that the claim was not verifiable and breached the Code.
On this point, the ad breached CAP Code (Edition 12) rule 3.35 (Verifiability).
The ad must not appear again in the form complained about. We told Howad Ltd not to state or imply that the incognito spray and roll-on could prevent all (or a significant proportion of) mosquito bites; or that the products could provide an equal duration of protection as any DEET-based product. We told Howad Ltd to ensure they held sufficient substantiation to support objective claims made in their advertising. We also told them to ensure that comparisons with identifiable competitors were verifiable.