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 Advertising Standards Authority.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the strain of coronavirus that causes coronavirus disease, the respiratory illness responsible for the COVID-19 pandemic. Colloquially known as simply “the coronavirus”, it was previously referred to by its provisional name, 2019 novel coronavirus and has also been called human coronavirus 2019.
In 2020, during the coronavirus health crisis, the ASA and CAP saw ads for a number of products and services presented with direct and indirect references to the coronavirus/COVID 19. Ads varied from those claiming to: provide a physical protection from virus transmission, provide protection from illness due to increased immunity, provide treatment for the symptoms of the virus and provide a diagnosis of virus antibodies.
Some products about which advertising claims are made will likely fall primarily under the scope of the Medicines and Healthcare products Regulatory Agency (MHRA) or the Health and Safety Executive (HSE). Marketers are advised to follow this MHRA guidance regarding the regulatory status of equipment being used to help prevent the spread of coronavirus before publishing ads.
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 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 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.
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.
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 it 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).
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).
Medicines presented in ads as treatments for the Coronavirus must be licensed for that purpose
Claims to prevent, treat or alleviate the symptoms of coronavirus (and long COVID) are medicinal and should not be made without being licenced by the MHRA for that purpose. CAP recommends consulting these MHRA documents for guidance on Advertising and Promoting Medicines alongside its general Guidance on Coronavirus.
The MHRA has reported that the vast majority of medicines offered for sale to treat or prevent coronavirus were in fact licensed, but for other indications.
In April 2020, the ASA considered a number of ads for IV nutrition drips during the coronavirus health crisis. One ad for an IV nutrition clinic, included products under the menu title “Coronavirus. Protecting you and your family from Coronavirus infection”. This was followed by claims such as “There is no vaccine available at present so maintaining and boosting your immune system is vital as this is your mechanism of protection against this virus and other pathogens” and “The Private Harley Street Clinic has assembled the best advice to boost your immune system and protect yourself from infection. Maintaining a strong immune system and fastidious hygiene is the best way to protect yourself from the Coronavirus infection”. The ASA ruled that the claims in the ad amounted to medicinal claims that the vitamin drips could protect against coronavirus, which were problematic without the necessary medicines licence from the MHRA which the marketer did not hold (The Harley Street Clinic, 22 April 2020). Similar claims were assessed in ASA rulings on other IV Vitamin drip products (Cosmetic Medical Advice UK Ltd, 22 April 2020, and REVIV UK Ltd, 22 April 2020).
Prescription only medicines (POMs) and prescription-only treatments should not be advertised to the public (Rule 12.12). During the coronavirus health crisis the ASA considered an ad for a Vitamin B12 injection which made claims that “in the fight against viruses” it would “boost immunity” and that it “supports your immune system, lung function and aids faster recovery from illness & viruses!”. It was established that the Vitamin B12 injection in question was a prescription-only medicine. Notwithstanding the fact the prescription-only medicine should not have been advertised to the public, the ruling also established that the medicine in question was not licensed for the treatment or prevention of viruses (including the Coronavirus) or the support of lung function (PCK Skin (Manchester) Ltd, 13 May 2020).
Claims that a food can prevent or treat Coronavirus or can “boost the immune system” should be avoided.
In 2020 the ASA considered various ads for foods and food supplements which made health claims were found not to accurately reflect the authorised claims under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (the EU Regulation). See CAP Advice on General health claims and Health claims.
The ASA considered social media ads for a drink product which included the claims “Vitamin C has been proven to boost immunity by many global studies….it is now being tested in the USA and China as a possible cure for COVID-19” and included the hashtags “#immunity #immunityboost #vitaminc … #staysafe” alongside the claim “After developing symptoms of a sore throat & headache I got paranoid. I ordered this concentration of Vit C and took one stick. In about half an hour I felt instantly revived and my headache disappeared and sore throat was greatly reduced”. The ASA considered these ads implied that the food product could be used to treat coronavirus and its symptoms, which was tantamount to a prohibited claim to cure human disease (15.6.2). It also assessed claims to “boost immunity” and ruled that it exaggerated the authorised claims for vitamins C and that the marketer had not provided evidence that any their products met the conditions of use associated with a relevant authorised claim on the Register (Revival Drinks, 27 May 2020).
Similar claims were assessed for a poster and website claims for these food products (Chuckling Goat, 13 May 2020).
Such claims may also result in products being classified as medicinal products and subject to the Human Medicines Regulations 2012.
Testing Kits - Coronavirus and antibodies
Marketers should ensure testing kits are appropriately authorised/registered and are being marketed for their intended purpose
Marketers should not advertise Coronavirus testing kits [as distinct to home swabs with lab testing]] to the public for home use, unless the kit holds the necessary certification from a Notified Body / Approved Body for use as a self-test kit.
Marketers should not imply that antibody tests can show immunity
Given this a complex and fast moving area, CAP recommends that marketers review MHRA Guidance on Covid 19 Tests and Testing Kits before considering the advertising of COVID-19 or antibody tests kits.
CAP understands that testing kits are medical devices and need to go through a specific type of authorisation/registration. This MHRA advice on In-vitro diagnostic devices explains the regime that applies to testing kits in more detail. Marketers of certified devices should not imply that that registered products are “MHRA approved” (or similar).
We understand that Lateral Flow Tests are permitted to be sold commercially, provided they are sold in line with their intended use and that the intended use is made clear. Commercially available Lateral Flow Tests, which are intended to be used by healthcare professionals only, should not be advertised for the purposes of home or self-testing. Marketers who are unsure should consult with the MHRA.
CAP understands that claims to detect anti-bodies or T-Cells from venous samples would only be acceptable if made in line with the necessary medical device authorisation.
Even if an antibody test has been certified for the use of detecting coronavirus anti-bodies, care would need to be taken when presenting claims about those tests, including claims about the accuracy of tests and the impact of antibody-positive results on patients.
On 13 July 2020, Guidance was published by the Department of Health and Social Care which stated that as yet, there was no strong evidence to suggest that those who had been proven to have had the virus and to have produced antibodies were immune. Further, it stated that receiving a positive antibody result did not mean that a person was immune, or that they could not pass the virus on to others. As such, claims which state or imply that the tests can give any indication of immunity or can provide “peace of mind” (and the like) are likely to be considered by the ASA and CAP to be misleading and irresponsible.
In October 2020, the ASA ruled on ads by three clinics providing antibody tests, where the blood samples were taken at the clinic by trained medical professionals. The ASA considered that all of the ads contained content which either implied that the presence of antibodies would mean that patients could get back to ‘normal’, or which referenced the existence of an “immune response”, without additional clarification that this immune response would not necessarily result in future immunity. The ASA subsequently ruled that the ads misleadingly implied that the tests could show a level of immunity to future infection. The ASA also ruled that a claim that one of the tests provided “100% accurate results” was misleading because the evidence was not adequate to substantiate that the antibody test would detect, without fail and in all circumstances, whether or not a patient had contracted COVID-19. Finally, a claim that one of the tests was “Public Health England and Government approved” was ruled misleading because although, as with many tests of this type, the test had been evaluated by Public Health England, the test was neither endorsed nor accredited by them or the Government (360 Health Ltd, 14 October 2020, Solihull Health Check Clinic, 14 October 2020, X-Medical Ltd, 14 October 2020).
Marketers of air or surface purifiers should not make claims to prevent COVID-19 infection or claim that Coronavirus can be removed or destroyed, unless they hold robust documentary evidence.
Marketers using biocides intended to destroy viruses (as opposed to mechanically or physically removing them) may also need to demonstrate that the substance they are using is an approved active substance. Marketers should seek advice from the Health and Safety Executive (HSE).
Marketers should also review the government SAGE guidance on the “Potential application of Air Cleaning devices and personal decontamination to manage transmission of COVID-19”,
In 2021, the ASA ruled on an ad for an air and surface purifier which included the claim “Proven to destroy Coronavirus cells”, which was considered to be claim that the device would remove the virus and prevent COVID-19 infection.
The ASA understood that the product included an approved active substance that could kill the virus and that in principle, the UV light which also formed part of the device could also be effective in removing viruses. It was noted that the efficacy of the device itself was reliant a large number of factors and that as such, evidence would need to demonstrate that the product would be effective in the specific conditions in which the product was likely to be used.
Because the submitted tests were not carried out in such a way that they could demonstrate the results would be replicated the real life conditions in which the device would be used, the ASA ruled that the submitted evidence did not support the efficacy claims for the product that appeared in the ad (Go-Vi Ltd, 23 June 2021).
Marketers should not cause unjustifiable fear or use fear to take advantage of vulnerable consumers
Marketers should not encourage irresponsible behaviour
In early 2020, the ASA issued a Regulatory Forbearance indicating that during the national crisis, the ASA was likely to take a pragmatic approach to investigations that at other times may be treated differently. However, it also made clear that both the ASA and CAP remained committed to act quickly and robustly against ads that exploit people’s health-related anxieties and the difficult financial or employment circumstances that many people are now facing.
Living through a pandemic is of course a frightening experience for a large number of people and the ASA and CAP acknowledge that references in ads to the risks of the virus and its health and economic consequences could cause anxiety in consumers. Whilst the immediate threat of the virus itself may have reduced in severity due to different strains and the vaccine roll out, care would still need to be taken to avoid causing unjustifiable fear and distress (Rule 4.2).
For example, care would still need to be taken not to exaggerate current risks or to focus on the risks in such way that consumers are likely to be made disproportionately fearful or distressed. Care would also need to be taken to avoid taking advantage of consumers’ health or economic fears. The ASA and CAP are likely to take a dim view of using the crisis to market some types of product to those who could be considered vulnerable. Particular care would need to be taken in promoting high interest, short term loans or high risk financial investments to those who may be suffering financially or fearful of future financial difficulties.
In September 2020, the ASA issued a statement on its likely approach where concerns were raised about ads which did not depict the then current government and scientific rules and guidelines on measures designed to limit the spread of Covid-19 through the population
Whilst Government rules and guidelines have largely been removed, marketers should still be mindful that regulations may change at relatively short notice and care would still need to be taken in the context of ads that make specific refences to the pandemic. Marketers who are unsure should seek advice from the CAP Copy Advice team.