In 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this guidance regarding the regulatory status of equipment being used to help prevent coronavirus (COVID-19).
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 stated 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.
Claims to prevent or treat COVID-19 using a topical products like hand sanitiser may also be considered medicinal and marketers wishing to make claims in advertising for unlicensed products should check with the MHRA before doing so.
Surgical masks and facial masks
Marketers should be aware that depending on the nature of the face-mask, such products are likely either to be regulated as Class 1 Medical Devices or Personal Protective Equipment (PPE). Marketers should ensure products meet product specifications under the relevant regulations (including any relevant certification and marketing authorisations) before making 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 COVID-19 health crisis.
In early 2020, when COVID-19 virus/Coronavirus was starting to spread in the UK, the ASA ruled against two online consumer ads for surgical facemasks.
In these cases, the ASA considered recent Public Health England (PHE) advice – which did not recommend the use of face masks as a means of personal protection against the virus – as well as the lack of evidence to support claims about the face masks’ efficacy in protecting against infection from coronavirus, and ruled that the ads broke the rules.
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.
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