Botox, the trade name for Botulinum toxin, acts by blocking acetylcholine, the chemical which transmits electrical impulses that cause muscle contractions. It is injected directly into muscles that cause lines and wrinkles using a small needle, which then results in a temporary muscle paralysis. In addition to its cosmetic indications, it is also widely used to treat medical conditions ranging from Hyperhidrosis, neuromuscular disorders and migraines.
Given the popularity of Botox for cosmetic use, it is understandable that advertisers may not be completely clear about how this product should be referred to in marketing material. Rule 12.22 of the CAP Code makes it clear that “Prescription-only medicines or prescription-only medical treatments may not be advertised to the public”. Therefore any reference to Botox, or other trade names for Botulinum toxin, whether direct, implied, or abbreviated is likely to be problematic.
An exception to this rule is where ads are directed at healthcare professionals, for example doctors or dentists. Healthcare professionals are “persons qualified to prescribe or supply” medicines as defined by the Human Medicines Regulations 2012.
There are also some limited exceptions for references to Botox on marketers' websites. A marketer may offer a consultation for the treatment of lines and wrinkles, for example by simply including the claim “a consultation for the treatment of lines and wrinkles”, so long as they offer other facial treatments besides Botox. This should be presented in the context of an ad which may include various treatment options, and it should be clear that a discussion of these treatments will take place. What can marketers say about Botox specifically? The ASA considers that the information has to be balanced and factual. So, any reference or information which goes beyond the wording found on the patient information leaflets (PIL’s), information found in the Summary of Product Characteristics (SPC’s) or other non-promotional reference information about the product, puts marketers at risk of advertising a prescription-only medicine.
In one ruling the ASA noted that the marketer was advertising a prescription-only medicine because the Homepage of the website included logos and testimonials which referred to Botox, and further pages on the website included the claims, “Tiny injections are placed in specific areas of the skin which relax the muscle, that causes the lines/wrinkles... Botox is proven to be a useful treatment for the relief of severe primary axillary hyperhidrosis in patients unable to obtain relief using antiperspirants...” The ASA considered that it would be acceptable for a website to make very limited references to Botox, but the claims in this case went beyond information which was balanced and factual. (Skinboost) As did, describing the benefits of Botox offered in a so called “Botox party” (where groups of friends receive cosmetic treatments at home) by another marketer. (Beauty a la Maison)
Other than referring to a consultation for lines and wrinkles, marketers should take care not to refer to Botox at all on the Home page of their website. Links, hover text, and any small print at the bottom of a Home page should not refer to Botox or link consumers to a page where it is referred to. And, price lists included on a website should not include product claims or encourage viewers to choose Botox based on the price. Ultimately, the casually browsing consumer should not be able to come across information relating to Botox with ease.
The ASA ruled on another website which included claims such as “facial rejuvenation... renewed confidence that people gain from the results”, referring to the potential benefits of Botox. Again, the claims were found to go beyond balanced and factual references to Botox as a potential treatment option. Moreover, the advertiser used a qualified dental surgeon to endorse the product, “Dr. Natalia (Natty) Burgess” who was quoted in the ad as saying “Facial injection rejuvenation treatment is not about 'stopping facial expression' or 'freezing the face' … The goal is to gently slow down and/or reverse much of the visual impact of wrinkles appearing on the face over a number of years... patients will enjoy a greatly rejuvenated confidence both privately, and in their public appearance”. While only suitably qualified health professionals should administer Botox, using health professionals to endorse the product breaches rule 12.8 of the CAP Code (“Marketers must not use health professionals or celebrities to endorse a POM”). (Anesis Spa)
Further information about the advertising and promotion of medicines and, prescription only medicines specifically can be found in the Blue Guide, also available on the MHRA website.
The CAP Code stipulates that marketers should hold documentary evidence that the before and after photographs used in their communications are genuine, and hold signed and dated proof to this effect. However, before and after photos illustrating the claimed benefits of Botox or the inclusion of patient testimonials will, in all likelihood be seen as promoting a prescription-only medicine.
How will a topical cream stack up to its injectable counterpart? As far as the ASA and CAP are currently concerned, it won’t. Until we see adequate evidence which shows that a lotion, oil serum or cream can produce the same effect as Botox, promoting a topical product as consolation for the needle-phobic, is highly likely to be considered problematic by the ASA. Marketers should steer clear from making comparative claims of this nature, which might also be considered medicinal.
A complaint against a website promoting anti-aging products which stated “Better than Botox! Injection free solution for younger skin” was upheld in 2012. The ASA had not received any evidence which showed that the product could achieve the same or better results than undergoing Botox treatments, and considered that the claim was also a medicinal one, which raised an additional issue given that the product did not hold a marketing authorization from the MHRA. (Rejuvenex Direct UK Ltd)
On another note, currently dermal fillers do not have to be prescribed and can be administered by anyone in a high street beauty salon. Sir Bruce Keogh's Review of the Regulation of Cosmetic Interventions, including the use of injectable cosmetic products such as fillers, could change the way these products are regulated, administered and marketed. As a result, we are now considering the possible implications of the review for our future guidance. You can read the review here.
You can read more about Botox and Treatments using fillers in our guidance. If you require bespoke advice on your promotions, contact the CAP Copy Advice team on 0207 492 2100 or submit your enquiry via our website.