In 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this guidance regarding the regulatory status of equipment being used to help prevent the spread of coronavirus (COVID-19).
Hand sanitisers and hand washes
- Hand washes and sanitisers presented in ads as a way prevent the spread of Coronavirus should be licensed as medicines for that purpose
At the end of 2006, the Advertising Standards Authority (ASA) upheld a complaint about an ad, for a handwash gel, that stated “KILLS 99.8% OF GERMS. NO GERMS. INSTANT HAND SANITISER.” The ad featured two quotes from the Daily Mail that stated “£2.99 HANDWASH KILLS MRSA and BIRD FLU” and “On average, people touch their faces every five minutes.” A further quote by Dr Charles Gerba of the University of Arizona stated “80% of disease-causing illness is spread by Hand.” The ASA ruled against the claim “Kills MRSA and Bird Flu”: because it suggested that the product could be used to treat or prevent infections caused by MRSA or Bird Flu pathogens (which the advertiser could not evidence) and also was considered an unauthorised medicinal claim.
In reaching its decision, the ASA took advice from the Borderline Section at the Medicines and Healthcare products Regulatory Agency (MHRA). Guidance from the MHRA indicated that any direct claim or implication that a product can be used to treat or prevent an infection associated with specifically named pathogens would be considered medicinal. This particularly applies to micro-organisms, such as MRSA, E-coli and Salmonella, that are frequently brought to the attention of the general public by the media. Claims such as “Kills MRSA” or “Effective against MRSA” are likely to be considered medicinal claims to prevent or treat infections that are caused by the MRSA micro-organism and are therefore unacceptable under law and the Committee of Advertising Practice (CAP) Code for unlicensed products.
CAP understands that claims to prevent or treat COVID-19 using topical products like hand sanitiser are also likely to be considered medicinal and marketers should not make these claims in relation to unlicensed products.
General antibacterial or antimicrobial claims (those that do not include references to a named pathogen) may be acceptable subject to the Biocidal Products Regulation administered by the Health and Safety Executive (HSE). Marketers who intend to make general antibacterial or antimicrobial claims are advised to review the HSE guidance on this point.
Surgical masks, medical facemasks and respirators
- Medical face-masks and PPE should be appropriately certified/authorised in line with the relevant legislation(s)
- Marketers should not claim that medical devices (like surgical masks) intended to protect patients (or other people) from the wearer can protect the wearer against infection
- Marketers should check with HSE and Trading Standards before promoting PPE to the public for domestic use.
Marketers should be aware that depending on the nature of the face-mask, such products may be regulated as either Class 1 Medical Devices or Personal Protective Equipment (PPE). Marketers should ensure that products meet product specifications under the relevant regulations (including any relevant certifications) before making any advertising claims about the nature of protection provided by the product. Marketers who are unsure which regulatory regime their product falls under should view this guidance – which was issued by the MHRA during the coronavirus health crisis.
CAP understands that surgical (medical) masks, which are intended to protect the patient (or other people) from the clinician (wearer) are regulated as Medical Devices. Marketers would therefore need to demonstrate the product has been suitably certified. This MHRA guidance explains in more detail the responsibility of Class 1 Medical Device manufacturers. Marketers should not claim that surgical style masks or medical devices designed to protect the patient, can protect the wearer.
We also understand that equipment which is intended to protect the wearer, is regulated as Personal Protective Equipment (PPE), typically classed as category 3 PPE. This means that the product needs to be “type approved” and the production control system needs to be reviewed by a notified body, either through audit or sample testing. Marketers should seek additional advice from the Health and Safety Executive (HSE) and also their local Trading Standards office if planning to market certified PPE products to the public (for domestic use) as a means of self-protection.
Fabric masks and home-made face coverings.
- Marketers promoting non-medical, Non-PPE face-coverings should not suggest they protect the wearer against infection.
CAP understands that general purpose face coverings which are manufactured and offered for sale are not Medical Devices or PPE.
Face coverings being sold to the public must however meet the existing requirements of the General Product Safety Regulations 2005 (GPSR), which sets out the responsibilities of the producers and distributors of these products.
As face coverings are not medical devices or PPE it should be noted that the MHRA/HSE do not regulate these products. The Office for Product Safety and Standards (OPSS) has issued this guidance to manufacturers of non-medical face-coverings. Marketers are also advised to seek advice from Trading Standards.
During the Coronavirus pandemic, Public Health England (PHE) updated its position several times on the use on fabric masks and home-made face coverings. This position was later updated alongside the introduction of the mandatory wearing of face-coverings in England and, separately the devolved nations, on public transport, hospitals/health clinics and, later, enclosed public spaces.
CAP is aware that there have been multiple statements from various sources on the efficacy of general face-coverings with regard to protection from coronavirus (protection against spread vs personal protection) and that the evidence is evolving. However, the ASA and CAP are, in the first instance, likely to follow the published government guidance on the efficacy of general face-coverings unless there is overwhelming scientific consensus to the contrary.
During the pandemic, Public Health England (PHE) and the World Health Organisation (WHO) indicated that fabric masks and home-made face coverings had some effectiveness in preventing an infectious but asymptomatic wearer from spreading the disease, in some circumstances, when used alongside other more established measures (social distancing, hand washing etc.) but that there was no evidence that these types of face-covering could protect the individual wearer against infection. Marketers are therefore advised to avoid implications that general face coverings are likely to protect the wearer from airborne infections, including COVID-19, unless they hold sufficient evidence to support such claims and be in a position to demonstrate that their products had been tested to, and meet, PPE standards.
CAP considers that, if it is otherwise clear that the product is not PPE or a medical device and no “protection” type claims are stated or implied, it may be feasible for ads for general face-coverings to directly replicate or mirror current government guidance on general face-coverings. However, this has not yet been tested through an ASA ruling.
In August 2020, the ASA considered ads for face mask products which made various claims to protect the wearer including “Protective Face Masks”, with further text stating “Protection against bacteria and viruses”, “Coughs and sneezes spread diseases” and “so get peace of mind for yourself and those around you with a month’s supply of these UK Standard CE approved Face Masks”. The ASA considered the ad suggested that the products could protect the wearer against infection despite not having been through the appropriate authorisation regimes for PPE. Because the products had not been classed as PPE and were not medical devices, it was considered that they would likely be classed as general face coverings and as such, in the absence of evidence and the absence of the product being certified as PPE, the ASA deferred to the position from WHO and PHE on the extent of protection offered by such products during the pandemic. Because the marketer had not been able to demonstrate that the products could protect the wearer from infection (and been tested to and met PPE standards) the ASA ruled the claims were misleading (Easylife Group Ltd 12 August 2020).
CAP recommends caution with using claims which state or imply that the purchase of the advertised face-mask/face-covering products will not have an impact on the NHS supply chain. Whilst we understand the intention of such claims may be to reassure consumers that the products are not the same as those used by the NHS and would therefore not prevent the NHS from receiving vital equipment, depending on presentation, such claims could be seen to imply that the products were of a type that were certified suitable for NHS use but had been sourced separately, which is potentially misleading if this were not the case (Easylife Group Ltd, 12 August 2020).
Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the ASA. CAP’s AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.
How can we help!
At LS Consultancy, we provide a cost-effective and timely pre-publication advice to make sure all your advertising and campaigns are compliant, clear and suitable for their purpose.