A poster ad for Vicks First Defence nasal spray, seen in a London Underground train in October 2019, featured an illustration of a large handkerchief, on which the headline stated “EPITAPH FOR A COLD #2”. Text underneath stated “HERE LIES YOUR COLD, IT NEVER GREW OLD, BECAUSE IT WAS STOPPED, BEFORE IT TOOK HOLD”. The right-hand side featured an image of the nasal spray and its packaging, which featured the claims “HELPS STOP A COLD IN ITS TRACKS” and in smaller text “USE AT THE 1ST SIGNS”. Underneath the nasal spray and box were the claims “BLOCK THE VIRUS” and “HELP STOP THE COLD”. Smaller text underneath stated “TRAPS, NEUTRALISES AND REMOVES THE COLD VIRUS WHEN USED AT THE FIRST SIGNS OF A COLD”.
IssueThree complainants, who believed that the ad implied that the nasal spray could prevent or treat a cold, challenged whether it was misleading and could be substantiated.
Procter & Gamble (Health & Beauty Care) Ltd (P&G) said that Vicks First Defence nasal spray was certified as a class I medical device in 2007 in accordance with the EU Council Medical Device Directive (MDD) 93/42 EEC and provided CE documentation in support of this. They said that the claim “Help stop the cold” had a prominent place in the ad and “Helps stop a cold in its tracks” was in large lettering on the front of Vicks First Defence packaging. They considered these references to “help” were important because they implied that the product could assist in stopping the development of a full-blown cold but made no definite claims about its ability to do so. They said that they did not overstate the ability of their product or make any absolute claims on efficacy as this could not be supported by clinical data. They said that the claims “When used at the first signs of a cold” and “Helps stop a cold in its tracks” had been approved for use by the Proprietary Association of Great Britain (PAGB) in August 2017, following a review of the in-vitro and in-vivo data in support of Vicks First Defence nasal spray. They also provided a statement of opinion on consumer interpretation of the claims from an expert. They said that the product had been marketed for more than a decade in the UK. They said that the product could be used for the prevention of a common cold and to treat the symptoms of cold and flu-like symptoms and that this was supported by double-blind, placebo-controlled human studies, results of which they provided.
The evidence they provided contained analyses of five in-vivo human studies, two in-vitro studies and an in-vivo study using animals. They said that when used at the first signs of a cold, the product had three mechanisms which helped in its prevention and treatment. Firstly, they said that in-vitro experiments showed how the product reduced the adhesion of microorganisms to human cells and that their formula therefore trapped the virus. Secondly, they said that the low pH formula of the product neutralised or inactivated rhinoviruses and that this was demonstrated in a human cross-over study. Thirdly, they said that the product removed the virus by increasing the production of nasal fluid. They said that the product therefore had the ability to stop a cold from taking hold and could help to reduce symptoms when used at the first signs of a cold.
The ASA acknowledged that the product had been CE-marked as a class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims.
We noted P&G’s argument that the references to “help” mitigated the impression that the product could definitely stop a cold. However, we still considered consumers would understand that to mean that the product had the effect of stopping cold symptoms. We further noted the prominence of the more absolute claims “IT WAS STOPPED, BEFORE IT TOOK HOLD” and “BLOCK THE VIRUS”, which preceded the claim “Help stop the cold”, and the references to trapping, neutralising and removing the cold virus. We considered that the ad as a whole was therefore likely to be interpreted by consumers to mean that the nasal spray went beyond reducing symptoms and could eliminate cold symptoms completely if used as soon as they emerged. A statement of opinion, from an expert on the common cold, reflected P&G’s views on consumer interpretation of the claims in the ad. It did not make any comment on the evidence provided.
We considered the evidence submitted by P&G. That included a conference paper that referred to a number of studies, some of which were also provided in full, and the results of a consumer data survey. A double-blind and placebo-controlled trial, referenced in the summary document, but not provided in full, involved 70 healthy volunteers who had been inoculated with rhinovirus type 16 (RV-16) (a cold virus). In the Vicks First Defence Group, a smaller proportion of those infected with the virus developed a cold, while those who went onto develop cold symptoms experienced a greater reduction in symptoms on day three, when symptom severity was greatest, compared to the control group. We noted that the volunteers in the study had used the product 15 minutes after being inoculated with the virus.
We considered that under ordinary circumstances, people who had caught the cold virus would not exhibit symptoms until later, usually one to three days after exposure to the virus, and would not use the product until they had experienced at least some symptoms. We therefore considered that the study was not relevant to demonstrating the product’s capability to treat cold symptoms after they had emerged. A randomised, parallel, double-blind, and placebo-controlled study enrolled 400 healthy volunteers, who were asked to use the product four times a day for seven days, upon experiencing the first signs of a common cold and to score common cold symptoms daily. The symptoms assessed were sore throat, runny nose, blocked nose, cough and tired or run-down feeling.
We noted that the study showed some reduction in duration and severity in symptoms. The results, however, measured the average change in symptom severity across all symptoms over seven days, and we did not have information about the changes in relation to each individual symptom. Furthermore, the results did not demonstrate that the product could get rid of symptoms entirely, which was how consumers were likely to understand the ad. An in-vitro study used bacteria from human urinary tract infections and demonstrated that the bacteria were prevented from binding to human cells extracted from the mouth by HPMC, an ingredient in the product.
We considered that while it may have provided useful support for the concept underpinning the product, namely that the HPMC in the product gave it binding properties, because it was not a human trial and used bacteria instead of the cold virus, it did not measure the effect of the product on actual cold symptoms. A randomised, placebo-controlled, single-blind cross-over study with 21 healthy volunteers, referred to in the summary document, but was not provided in full, examined the production of nasal fluid following administration of the product. Three minutes after the product and control had been administered, results showed that the mean weight of nasal fluid expelled was 328.43 milligrams by those who used the product and 40.48 milligrams by those in the control group. However, while we noted that the results could be useful for underpinning the mode of action by which the product was intended to work, they did not measure its effect on a range of cold symptoms after they had emerged. A cross-over clinical trial comprising 12 healthy volunteers, referenced in the summary document, but not provided in full, looked at the pH of the nose following administration of the product.. The results suggested that the low pH formula of the product could create a low pH environment in the nose.
Another study used in-vitro solution tests by way of mixing the flu virus with animal cells and the product. The results showed that the flu virus was inactivated at a pH of 3.5. In an in vivo study conducted on ferrets, the product was applied five minutes after inoculation. Because these studies did not examine the product’s ability to treat cold symptoms in human subjects, we considered they were not, on their own, sufficient to substantiate the claims. A further study tested the effects of low-pH formulas on cold symptoms in humans. A total of 43 subjects completed the study, divided between those who used the product and those who were in the placebo group. The results showed that the spray did not reduce individual symptom scores or median daily symptom scores.
We understood that the objective of the consumer data survey was to measure consumers’ recall of the ad, whether they linked the unbranded version of the ad to Vicks First Defence and their familiarity with the brand generally. There were 500 participants in the survey, of which 330 of them were purchasers of cough and cold relief products. All participants were presented with the question “Which of the following statements best describes the product shown?” followed by four options: “Prevents cold from fully forming”, “Treats all symptoms of a cold”, “Treats blocked nose” and “Prefer not to answer”; 68% of the cough and cold buyers and 64% of all respondents selected “Prevents colds from fully forming” and 17% of the 500 respondents selected “Treats all symptoms of a cold”. We considered that “Prevents cold from fully forming” was somewhat ambiguous and could be understood in different ways, including to mean that the product prevented a person from catching a cold or that it prevented cold symptoms from fully manifesting. Those meanings went beyond a statement that the product could reduce the duration and severity of symptoms. The survey was primarily designed to understand consumers’ association of the product with the Vicks brand, not their understanding of how it worked, and participants had been limited to a choice of four options. We therefore considered that the survey did not support P&G’s view that consumers would understand from the ad that the nasal spray could reduce the duration and severity of symptoms if used at the first signs of a cold. Having considered the body of evidence provided, we considered that the overall impression that consumers were likely to take from the ad, that is, that Vicks First Defence Nasal spray could eliminate cold symptoms completely if used when they first emerged, had not been substantiated.
We concluded that the ad was misleading and therefore breached the Code. The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means. (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).
The ad must not appear again in its current form. We told Procter & Gamble (Health & Beauty Care) Ltd that any future claims in their advertising for Vicks First Defence Nasal spray should not state or imply that it could be used for the complete elimination of cold symptoms, unless they held sufficient evidence to support that claim.