Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
An ad for Easylife masks seen in The Sun on 9 May 2020 was headed “Disposable & Reusable Protective Face Masks from easylife”. Further text stated “Protection against bacteria and viruses! ‘Coughs and sneezes spread diseases’, so get peace of mind for yourself and those around you with a month’s supply of these UK Standard CE approved Face Masks”.
Three products were featured on the page, with accompanying photographs. The first was “3x Protective Layer Face Masks (Pack of 30 or 50)”. It had the appearance of a paper surgical mask. Text stated “Designed with 3 protective layers that work in conjunction to filter 95% of airborne particles…Perfect whilst out and about or at home. CE EN149”. The second product was labelled “3x Protective Layers Reusable Washable Face Mask (Pack of 3)”. There was an image of a solid-coloured fabric mask with a cross-section showing the different layers. Text stated “Your first line of defence against coughs and sneezes in current times. A face mask makes very good sense and this reusable mask is one of the best available. Ergonomically designed to fit the shape of the face, it’s made in 3-layers [sic] from clinical-quality polyester with a pure cotton lining…they’re a sensible way to stay safe and stay protected”. The third product was labelled “5x Protective Layers KN95 Face Mask (Pack of 3)”.
An image showed a man in a white half-mask with a pointed cup shape. Text stated “With high filtration efficiency these masks are thicker than a normal mask, designed with 5 protective layers that work in conjunction to filter 95% of airborne particles, including ones too tiny to be blocked by regular masks. With good two-way protection they filter both inflow and outflow of air….A typical respiratory face mask will last up to one week. Wear when you are near other people, for example, when travelling on public transport”. A box at the top right-hand corner of the page stated “SUPPORT THE NHS. All products featured are sourced separately to NHS requirements and do not impact on NHS supplies”.
Issue
1. The ASA challenged whether the stated and implied claims that the masks would protect the wearer from infection with the COVID-19 virus, were misleading; and
2. The ASA also challenged whether the claim “SUPPORT THE NHS. All products featured are sourced separately to NHS requirements and do not impact on NHS supplies” was misleading and could be substantiated.
Response
Easylife Group Ltd stated that Public Health England and Government advice was advice only, without legal basis or grounding, and open to interpretation. They said that the products offered in the ad were “barrier masks” that provided a function beyond that of a simple “face covering” such as the “DIY” type referred to in Government advice, but did not meet the criteria for personal protective equipment (PPE). They stated that no mask could be said to protect the wearer from infection in a wholesale way, as they should be used in conjunction with a range of other behaviours.
Even PPE meeting the prescribed requirements would need to be professionally fitted before it was even a useful article. They believed that any reasonably-informed person would understand that there were a variety of ways to contract COVID-19 and inhaling droplets was only one of those. They said they had made claims about helping to stem the flow of droplets and airborne particulates in good faith, as supported by testing and the available applicable evidence.
Easylife stated that the “3x Protective Layer Face Mask” was based on a surgical mask design, but they made no claim that it was a surgical mask. The product was tested against two different standards (EN149 and GB-T-32610-2016), intended to demonstrate that it was safe and provided some kind of protective barrier. They said that “CE” had been used in this case to draw attention to the fact that EN149 was a Harmonised Standard in Europe and was used to allow for the application of CE mark if certain other circumstances were in place and requirements were met. In relation to the “3x Protective Layers Reusable Washable Face Mask”, Easylife stated that the use of the word “protection” or reference to “protective qualities” did not in itself mean that this must be legally supported. They referred to an Office for Product Safety & Standards (OPSS) document entitled “COVID-19 – Face Masks and Coverings: An Enforcement Guide for Trading Standards Services in Great Britain and Environmental Health Services in Northern Ireland”, which stated “a product, that has not been designed or manufactured to comply with essential requirements of the PPE or Medical Devices legislation, does not become PPE or a medical device if a business in the supply chain (that was not involved in the design or manufacture of the product) states, suggests or implies the product provides protection”.
They also referred to World Health Organisation (WHO) “Advice on the use of masks in the context of COVID-19”, which included information on the filtration efficiency of different common materials and recommendations for the construction of “non-medical” masks. In relation to the “5x Protective Layers KN95 Face Mask”, Easylife stated that they did not accept that the product was presented as PPE. They stated that the claims for protection were substantiated by testing to the EN149 standard. They said it was clear the ad was intended for general consumers and did not suggest or imply that its usage was endorsed by the authorities or was suitable (in all aspects) for use in specific high risk environments.
Any possible misunderstanding would be heavily caveated by warnings on the packaging and instructions when the goods were received. They felt that given the different types of masks available in the marketplace, it was difficult for the average person to differentiate between what was used by front-line workers in the NHS and what was not. By including the statement “SUPPORT THE NHS. All products featured are sourced separately to NHS requirements and do not impact on NHS supplies”, they sought to make clear the products were not the same as those used by the NHS and allow consumers to purchase with a clear conscience. They said that use of face masks appeared to be being encouraged and referred to discussion in the WHO document about overcoming cultural stigma attached to mask-wearing. They said they had sourced and supplied their products with this in mind.
Assessment
1. & 2. Upheld
At the time of the publication of this ruling, the various Governments of the UK had, in response to the COVID-19 pandemic, introduced laws making the wearing of face coverings mandatory on public transport and in shops.
We understood that requirement was based on scientific evidence that suggested that a face covering could help reduce transmission of infected airborne droplets from the person wearing it to those around them, thus helping to reduce the transmission of the virus in the community. However, we also understood that the evidence did not currently show that such coverings conferred a protective benefit on the wearer. For example, advice from Public Health England stated “The evidence suggests that wearing face covering does not protect you, but may protect others if you are infected but have not developed symptoms”.
While we therefore considered that the widespread availability and responsible advertising of face coverings was desirable in general terms, we also considered that it was important that marketers of face coverings and masks should not mislead consumers about the capabilities of their products, for example by giving the impression they would protect the wearer when there was little evidence that was the case. We considered that, where marketers wished to make claims that their product would provide the wearer with protection from COVID-19, they would need to be able to demonstrate that the product was more than just a face covering as recommended for the general public and had, for example, met the higher regulatory standards for Personal Protective Equipment (PPE) that would enable them to make such claims. We assessed the ad in that context.
The ad was headlined “Protective Face Masks”, with further text stating “Protection against bacteria and viruses”, “‘Coughs and sneezes spread diseases’, so get peace of mind for yourself and those around you with a month’s supply of these UK Standard CE approved Face Masks”, “your first line of defence against coughs and sneezes in current times”, “high filtration efficiency”, “filter 95% of airborne particles” and “with good two-way protection, they filter both inflow and outflow of air”. There were multiple other references to the “protective” qualities of the three masks.
The ASA considered that consumers were likely to understand that all three products had the ability to protect the individual wearer from infection with COVID-19. We appreciated that no mask would provide total protection, and considered that most consumers would recognise that a range of Government recommended safety behaviours were important to help minimise their risk of contracting the virus. However, they were likely to understand from the overall presentation and claims made that the purpose of the masks in the ad was to provide a barrier against airborne particles, which would help prevent the wearer from becoming infected. We did not consider that the claims would be understood to relate to the potential collective protective benefit afforded by the widespread use of masks.
We noted that the text “SUPPORT THE NHS. All products featured are sourced separately to NHS requirements and do not impact on NHS supplies” had been included with the intention of indicating that the products in the ad were not the same as those used by health and care professionals, and which had been subject to shortages widely reported in the media.
As Easylife acknowledged, there was a relatively low level of understanding among the general public about the differences between the various face masks products available on the market, the visibility and variety of which had greatly increased since the beginning of the COVID-19 pandemic. We noted that one of the masks looked similar to a surgical mask, and another looked similar to a respirator mask used as PPE. The ad also referenced standards EN149 and KN95, which consumers may have seen used in relation to PPE. In that context, we considered that the meaning of the statement about NHS supplies implied the products were of a standard that could be used by the NHS, but had been sourced separately. It further contributed to the overall impression that the products could protect the wearer.
We understood that face masks generally fell into one of three different regulatory categories. Face masks that were intended to protect the wearer were subject to the requirements of PPE regulation, administered by the Health & Safety Executive (HSE). All PPE for the specific use to protect against the risk of COVID-19, including respiratory face masks, was category 3 PPE. That meant that products must be “type approved” and that the production control system must be reviewed by a notified body, either through audit or sample testing. Surgical face masks, intended to protect the patient from the clinician, were subject to requirements set out in the Medical Devices legislation, regulated by the Medicines and Healthcare Regulatory Authority (MHRA). Finally, general purpose face coverings that were manufactured and offered for sale, and did not fall within those categories, were subject to the General Product Safety Regulations.
We noted Easylife’s assertion that the products in the ad fell into the category of “general face coverings”. They said that the products offered were more sophisticated than what they assumed to be homemade “DIY” coverings referred to in Government advice. Easylife believed the products in the ad were not PPE and therefore not required to meet the relevant standards. However, they believed they should be able to make claims that the products could offer some protection to the wearer on the basis of testing carried out by the manufacturer, and WHO advice on the use of “non-medical” masks.
We considered that if the products were not PPE or medical devices, then they were likely to be general face coverings, regardless of differences in their construction. We therefore considered that Government advice on such face coverings was relevant. Government advice stated that there was little evidence that face coverings that were not PPE or medical devices would protect the wearer. The WHO advice cited by Easylife provided recommendations for the construction of “non-medical” masks, stating that they should consist of three layers. It also listed the filtration efficiency of a number of everyday materials, ranging from 5% to 26%. However, it gave no indication that those measurements were relevant to protecting the wearer. In addition, it specifically stated that “non-medical” masks should only be recommended to the public for “source control” – that is, the protection of others if the wearer was positive for COVID-19 but displayed no symptoms. We considered the information on testing provided by Easylife. They stated that the “3x Protective Layer Face Mask” (the surgical-style disposable mask) was tested to EN149 and GB-T-32610-2016 by the manufacturer. EN149 was European Standard specifying the minimum requirements for filtering half masks used as respiratory protective devices. It allowed for the classification of masks into three different categories based on their level of filtration.
Easylife had neither specified the level to which the mask had been tested under this standard, nor provided the test results. The standard was used to certify products under the PPE regulations, which would require it to be tested by an authorised, independent notified body under the auspices of the HSE. We understood from Easylife’s comments that the product was not PPE, and therefore it had not undergone this process. GB-T-32610-2016 was a Chinese standard for “Technical specification of daily protective mask”. Classification was divided into different levels of protective effect and filtration efficiency. Easylife did not provide details of the classification or test results.
Easylife stated that the “5x Protective Layers KN95 Face Mask” (respirator-style mask) was tested to KN95 standard. That was a Chinese standard relating to filtration of masks intended for respiratory protection. We had not been provided with test results. We noted that the HSE had issued a warning against the purchase and use of KN95 masks as PPE, as they relied on self-declaration of compliance by the manufacturer, and there was no independent certification or assurance of their quality. While Easylife did not consider the mask to be PPE, we considered that information was relevant to our consideration of whether the mask had been substantiated to protect the wearer. We had not been provided with information that the third product, the “3x Protective Layers Reusable Washable Face Mask”, had been tested to any standard for respiratory protection of the wearer. Taking into account Government and WHO advice on face masks and the information provided by Easylife, we considered that they had not provided adequate evidence to substantiate the impression given by the ad, that the masks shown were able and likely to help protect the wearer from infection with COVID-19.
We therefore concluded that the ad was misleading. The ad breached CAP Code rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
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),
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).
Action
The ad must not appear again in the form complained about. We told Easylife Group Ltd not to state or imply that the face mask products presented in the ad were likely to protect the wearer from airborne infections, including COVID-19, unless they held sufficient evidence to show that they had been tested to, and met, PPE standards.
