Ad description
A TV ad and a video on demand (VOD) ad for BecoCleanse, a nasal cleansing product:
a. The TV ad, seen on 7 November 2021, featured a woman using the BecoCleanse product. A voice-over said, “Each day we breath in millions of viruses which can lead to cold symptoms. Clean your nose every day with new BecoCleanse. 100% Seawater. Rich in minerals. It cleanses away viruses and helps protect against winter symptoms. Help protect yourself with new BecoCleanse”.
b. The VOD ad, seen in December 2021, was the same as ad (a).
Issue
Four complainants, who believed the ads implied that the products could protect against viruses, challenged whether they were misleading and could be substantiated.
Response
Omega Pharma Ltd said BecoCleanse had successfully undergone a conformity assessment by a Notified Body, in accordance with Annex V and VII of Council Directive 93/42/EED concerning medical devices, and was a class IIa medical device.
The product was a daily saline nasal cleanse that used mechanical cleansing to help wash away mucus, pathogens (including viruses and bacteria), crusts, cell debris, air contaminants and allergens. The mechanical action of a saline nasal cleanse assisted in cleaning the nasal passage and therefore facilitated the expulsion of viruses from the nasal passage and subsequent prevention of microbial infections. They said the tissue lining of the nasal cavity played an important protective role. Mucus and pathogens were cleared from the nasal cavity by mucociliary clearance (small hair-like structures, known as cilia, which extended from the surface of cells and moved in co-ordination to move mucus), which helped to prevent microbial infections. Alterations in the ciliary beat frequency (the frequency of the cilia movement) impaired the mucociliary clearance. Using undiluted seawater as a nasal cleanse had shown superior effects on ciliary beat frequency compared to diluted sea water and normal saline, and was therefore the most suitable solution for nasal cleansing. In vitro results had been clinically confirmed and demonstrated that a mineral-rich solution such as BecoCleanse, close to seawater, provided a better nasal wash by increasing mucociliary clearance.
They said that there was no mention in the ad that the device protected against viruses, including COVID-19, nor would it be interpreted in that way. Instead, the wording used in the ad, including the claim “BecoCleanse cleanses away viruses and help protect against winter symptoms”, explained that the mechanical action of saline nasal douching assisted in cleaning the nasal passage to facilitate the expulsion of viruses from the nasal passage. That claim complied with the properties of the medical device.
Omega Pharma provided copies of four randomised clinical trials, four review papers, a scientific modelling study, an in vitro study, and a dossier summarising research that they said substantiated the claim in the ad.
They said that two of the randomised clinical trials had been performed in children, but that the results could be extrapolated to adults as the mechanisms of action relating to nasal mucociliary clearance were the same in all age groups, as were symptoms of the common cold. Both adults and children developed upper-respiratory tract infection (URTI) symptoms during winter, and they experienced the same symptoms, typically: runny nose, sneezing, congestion, nasal discharge, an altered sense of smell, postnasal drip (accumulated mucus that dropped from the nasal cavity to the back of the throat) with cough, and low-grade fever. Adults had two to five common colds a year, and children under ten years had three to eight. The risk factors for the development of URTIs were the same for children and adults: close contact with other people, for example, children who attended school and travellers with exposure to numerous individuals.
In relation to the first study performed in children, a product equivalent to BecoCleanse was assessed during a period of epidemic flu and acute respiratory virus infection (ARVI) such as the common cold. The product demonstrated high effectiveness in protecting children from the flu and ARVI and decreased the illness rate among children by 3.4 times. Omega Pharma believed that the study supported the preventative effect of BecoCleanse against winter symptoms.In the second study performed in children, the efficacy of using a saline nasal solution in 390 patients with cold and flu symptoms to relieve their symptoms was evaluated, as well as preventing the redevelopment of symptoms. The saline solution was administered six times per day during acute illness and three times per day during the prevention phase, for a total of 12 weeks. The study found that use of a saline nasal cleanse significantly improved nasal symptoms of the common cold and showed potential to prevent the recurrence of URTIs. Omega Pharma believed that the study supported the effect that BecoCleanse had in reducing the incidence of the common cold.
Clearcast said the product’s patient information leaflet confirmed that BecoCleanse was a daily nasal cleanse intended to help eliminate nasal viruses, bacteria and allergens and for preventative treatment of hayfever in adults and children from the age of six years.
They said the advertiser provided evidence to support the claims “Each day we breath in millions of viruses which can lead to cold symptoms” and “It cleanses away viruses and helps protect against winter symptoms. Help protect yourself with new BecoCleanse”, which was reviewed by one of Clearcasts’ medical consultants. They said the evidence confirmed that concentrations of virus-like particles measured in different indoor and outdoor air samples ranged from approximately 300,000 to 1.2 million per square metre. The consultant accepted that the mechanical action of saline nasal douching assisted in cleansing the nasal passage and facilitated the expulsion of viruses. Daily use of nasal saline, either in healthy individuals or continued use during recovery from a common cold, helped reduce nasal symptoms of a cold. Clearcast was satisfied that the claim, “BecoCleanse helps protect against winter symptoms”, was supported.
They believed the claims did not provide a guarantee of protection from all viruses and that it was clear that the ad was relating specifically to symptoms of the common cold.
Assessment
Upheld
The ASA acknowledged that the product had been CE-marked as a class IIa medical device. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held adequate evidence for such claims.
The ads featured the claim “Each day we breath in millions of viruses which can lead to cold symptoms. Clean your nose every day with new BecoCleanse […] It cleanses away viruses and helps protect against winter symptoms”. We considered that consumers would understand the claim to mean that, by using the advertised product on a daily basis, it would protect against viruses to help prevent cold symptoms. Therefore, we expected to see evidence, in the form of randomised clinical trials, to demonstrate that using BecoCleanse would result in fewer cold symptoms that were caused by viruses.
Some of the complainants had raised concerns that the ad implied the product could protect against COVID-19. We noted that there were no references to COVID-19 in the ad. Although the word “virus” was used, it was in the conjunction with “cold symptoms” and “winter symptoms”. Additionally, the on-screen visuals showed a woman acting out a blocked, itchy and runny nose. We understood that these were not symptoms of COVID-19 listed by the NHS at the time the ad was broadcast. We therefore considered that in the context of the ad, the references to “viruses” would not be interpreted by viewers as referring to COVID-19. We therefore did not expect to see evidence that the product could prevent COVID-19.
Ten papers were provided in full; four randomised trials, four review papers, a scientific modelling study, and an in vitro study.
We considered that three of the review studies established the number of colds that adults and children experienced, on average, each year and the symptoms that they typically presented with. We also considered that the scientific modelling study showed that, in a device identical to BecoCleanse, nasal irrigation using small-volume continuous spraying covered all areas of the nasal cavity with solution, but with less volume and more slowly than large-volume irrigation devices. We further considered that two of the randomised trials, the in vitro study and fourth review study indicated that undiluted seawater, or a mineral-rich solution similar to seawater, was more effective than diluted seawater or normal saline on ciliary beat frequency or mucociliary clearance. We therefore considered that these studies provided useful support for the concept underpinning the product, namely that mucociliary clearance moved mucus and pathogens from the nasal cavity.
However, we noted that the two trials, although had been carried out on humans, were conducted on participants who had undergone nasal surgery. We considered that those participants were not reflective of the target audience of the ad; adults that were likely to be otherwise generally healthy. Also, we noted that one of the reviews discussed research on nasal irrigation as a treatment during nasal congestion in infants and children. However, none of the studies discussed in the review had used BecoCleanse. Therefore, because the studies did not measure the incidence of cold symptoms in generally healthy participants using the advertised nasal cleanse compared to participants who were not using it, they were not relevant to the claims in the ad.
The third randomised trial, which included school children aged seven to ten years, assessed the effectiveness of a saline nasal cleanse on illness rates from flu and ARVI. A product identical to BecoCleanse was used by 100 children once a day (treatment group), and a further 160 children received no treatment during the study (control group). We had concerns about the methodology used in the study. Although the study had a control group, participants in that group did not receive a placebo treatment. Therefore, study participants were not blinded as to whether or not they were receiving a treatment. We also understood that those involved in running the study were not blinded as to which participants were receiving the treatment. Additionally, while a smaller proportion of subjects in the treatment group got sick compared to those in the control group, no statistical analysis had been carried out on the results, and it was not clear how “sickness” was measured in the study. Furthermore, although the study was described as “randomised”, it was not clear from the methodology used in the study how participants had been randomly assigned to their respective groups. We noted that it was not peer-reviewed and not published in a mainstream scientific journal. For those reasons we considered that the trial did not provide adequate evidence to support the advertising claim.
The fourth randomised trial, which included children aged six to ten years who had a cold or flu, assessed the effectiveness of a saline nasal cleanse on nasal symptom relief during illness, and on preventing the recurrence of a cold or flu. This trial consisted of 390 children who had visited one of eight outpatient clinics. They were randomised to receive either standard treatment (the control group - 101 participants) or standard treatment plus a saline nasal cleanse (the treatment group - 270 participants). We understood that the saline solution was identical to BecoCleanse. The treatment group was split into three sub-groups, each of which received a saline solution, but with different cleansing applications: a fine spray, a medium jet, or a dual formula wash for eyes and nose with a fine spray. We understood that the efficacy of the nasal saline cleanse was similar between the three sub-groups.
Because consumers would understand the ads to mean that the product could help prevent cold symptoms from occurring, rather than eliminating them once they already had a cold, we assessed the part of the trial related to the effectiveness of a saline nasal cleanse on preventing the recurrence of a cold or flu only. During that part of the trial, participants in the treatment group were asked to use the saline nasal cleanse three times a day. However, we understood that, for the prevention of nasal infections, consumers were recommended to use BecoCleanse one to two times a day. We therefore considered that the test conditions did not reflect how consumers would likely use the product.
We noted that, at the end of the study, statistically significant improvements were found in those who had used a nasal cleanse compared to the control group, with regards to nasal secretion, nasal breathing, medication use, reported illness and reported school absence. However, as noted by the authors, the study did not account for whether the improvements in symptoms were clinically meaningful.
Additionally, we had concerns about the methodology used in the study. With regards to randomising participants to the ‘treatment’ or ‘control’ groups, this was done by the physician and was based on the sequence the participants appeared at the clinic. We considered that whilst there was some effort to randomly allocate the participants, it was not completely random. Also, we considered that because the physician assessed the participants at each visit during the study and they were aware whether the participant was assigned to a nasal wash group or not, they were not blinded to the treatment. Participants were also not blinded to their treatment.
Further, it was not clear from the methodology how the results were recorded and we considered that the outcomes that were assessed were based on subjective measures. Especially given that both the participant and their parent were involved in the reporting, and they were both aware whether or not the participant had used a nasal cleanse, we considered that these factors could influence the results.
Therefore, because the study did not reflect how often consumers would use the product, and because there were limitations to the study design, we considered it was not sufficient to support the advertising claim.
Because we had not seen sufficient evidence that BecoCleanse could protect against viruses to help prevent the occurrence of cold and “winter” symptoms, we concluded that the claims in ads (a) and (b) that the product did so had not been substantiated and were therefore misleading.
Ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising), 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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 11.2 11.2 If they are necessary for the assessment of claims, broadcasters must, before the advertisement is broadcast, obtain generally accepted scientific evidence and independent expert advice. (Medicines, medical devices, health-related products and beauty products).
Ad (b) breached CAP Code (Edition 12) rules
3.1
3.1
Advertisements must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Advertisements must not falsely imply that the advertiser is acting as a consumer or for purposes outside its trade, business, craft or profession. Advertisements must make clear their commercial intent, if that is not obvious from the context.
(Substantiation) and
12.1
12.1
Radio Central Copy Clearance – Radio broadcasters must ensure advertisements subject to this Section are centrally cleared.
(Medicines, medical devices, health-related products and beauty products).
Action
The ads must not appear again in the forms complained of. We told Omega Pharma Ltd not to claim that BecoCleanse could cleanse away viruses and help protect against cold or ‘winter’ symptoms unless they held sufficient evidence to support the claims.
