A website, www.hbhealth.com, promoting a health and beauty clinic included a home page which featured two treatment lists under the headings "HB TREATMENTS" and "External Care". Under the heading "External Care" the list included the text "Botox", which linked to another page which explained how Botox was commonly used as a beauty treatment.
1. The Independent Healthcare Advisory Service (IHAS) challenged whether the reference to 'Botox' on the website home page breached the Code by advertising a prescription-only medicine to the public.
2. The ASA challenged whether the references to 'Botox' on the website more generally breached the Code by advertising a prescription-only medicine to the public.
1. & 2 HB Health of Knightsbridge said they had removed the reference to 'Botox' from their home page and replaced it with "wrinkle softening treatment". They said that references to Botox were extremely common within the beauty industry and that many websites for clinics contained similar content.
1. & 2 Upheld
The ASA understood the advertising of prescription-only medicines (POMs) to the general public was prohibited by the Human Medicines Regulations 2012 (HMRs) and that was reflected in CAP Code (Edition 12) rule 12.12. However, we further understood that certain types of content that could be characterised as reference material or announcements of factual and informative nature were not covered under the scope of HMR’s definition of advertising and, as a result, could not be considered advertisements for the purposes of rule 12.12. We therefore assessed the claims on the website to establish whether they were of that nature and would be considered as advertising for the purposes of rule 12.12.
We noted the HB Health of Knightsbridge website was for a clinic that focused primarily on health screening and non-invasive beauty procedures. We also noted it offered Botox treatments and understood that Botox was a POM. We also understood that Botox was sold under the trading names (Dysport, Vistabel, Azzalure, Xeomin, Bocouture) and that these were therefore also POMs.
We noted HB Health of Knightsbridge had made changes to the website to remove references to “botox”. However, we considered that the removal of the word itself from the home page alone did not itself resolve the issue because visitors who clicked on the replacement text hyperlink (wrinkle softening treatment) were then connected directly to content about Botox.
We considered that in order to comply with the rule 12.12 of the CAP Code and to avoid the direct promotion of a POM to the general public, marketers needed to ensure that references to Botox were only presented in the context of a potential outcome of a consultation with the clinic. We therefore considered that it was the consultation itself that needed to be the subject of the website ad, and not Botox. We further considered that any description of Botox (as the outcome of that consultation) needed to be both factual and balanced and that such factual references needed to reflect the content of the Summary of Product Characteristics (SPC).
We noted the HB Health of Knightsbridge website made a reference to the potential side effects which would be discussed by the individual administering the Botox treatment. However, we noted no reference was made to the fact that a consultation was required to be carried out before any decisions were made about the type of treatment that would be given. We therefore considered that the presentation of the website pre-empted the outcome of any potential consultation offered through the service and that the references to Botox constituted a direct promotion of a POM to the general public.
Because Botox references needed to be presented within the context of a consultation, we considered that website ads should not provide separate information on Botox which could be navigated to directly, without consumer’s also viewing information about the consultation process.
We understood that POMs were only licensed for use of the ‘therapeutic indications’ detailed in the SPC and noted the only aesthetic use for which Botox was licensed was the ‘glabellar’ lines, which are the vertical lines on the forehead, between the eyes. We therefore understood that Botox was not licensed for use on any other lines or wrinkles or for any other aesthetic treatment. We noted the web page referred to “forehead wrinkles”, “crows feet lines”, “bunny lines on the nose”, “neck wrinkles”, “smiles between the mouth and nose”, “smokers lines around the lips” and “creases and dimples in the chin”. We noted references to these areas were made throughout the page including “… Botox is the leading treatment for frown lines, temple lines and crow feet/lines around the eyes”. Although we understood it was common in clinical practice for Botox to be used in areas not specified in the SPC, we considered such references on the website constituted an ad for a POM because they went beyond factual information that was representative of the SPC.
We noted the claims on the page which described how Botox worked referred to a specifically named POM and its effectiveness, much of which we considered to be advertising and therefore under the scope of rule 12.12. We noted the page included the phrases “Botox dramatically softens facial lines and wrinkles leaving you looking younger”, “If your dynamic wrinkles make you look older than you are, there is now a way to erase these lines without surgery, scars and recovery time” and “even one treatment of botox will relax facial lines leaving you looking younger and more refreshed”. We considered that those descriptions went beyond balanced and factual references to Botox and therefore fell under the scope of rule 12.12.
We noted the web page also included claims such as “Botox is the brand name for a form of Botulinum type A, which is produced by the bacteria clostridium Botulinum. Botox is an injection of minute doses into certain facial muscles …”, “Botox is injected using a disposable syringe with a very fine needle. A very small amount of the botox powder is diluted with saline …”, “The pain associated with the injections is minimal. Many patients describe it is a bug bite or a sting for only a couple seconds [sic] No local anaesthetic is needed and you can resume normal activities immediately”, “Botox is a widely known and highly used procedure … Botox has been used around the world for over a period of ten years: it was first used to treat perspiration problems in individuals” and “Once you have been treated it usually takes two to five days before wrinkle softening treatment actually takes effect and sometimes even a little longer to notice the full effect”. We considered that these types of claim were factual, as opposed to promotional, and that they sufficiently reflected the SPC. We therefore considered that they were likely to be acceptable because they did not constitute the advertising of a POM under 12.12.
Because some of the direct and implied references to Botox within the website constituted a promotion of a POM to the general public, we therefore concluded that the Code had been breached.
On these points the ad breached CAP Code (Edition 12) rule 12.12 (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told HB Health of Knightsbridge to take special care when referencing Botox in the future.