An appealing product story and strong claims can boost sales of products. It is the job of marketing to stretch the boundaries and maximise the strength of the product message. Enthusiasm and imagination can, however, result in exaggerated or over-claiming, culminating in illegal or misleading advertising, which is counterproductive in the long term. Advertising controls are there to initially protect the consumer, but ultimately also protect the brand.
The Commission Regulation (EU) No 655/2013 of 10 July 2013 ‘laying down common criteria for the justification of claims used in relation to cosmetic products’ listed six headings whereby product claims should be considered against: 1. Legal compliance 2. Truthfulness 3. Evidential support 4. Honesty 5. Fairness and 6. Informed decision-making. These criteria are now within the new EC Cosmetics Regulation and it is the responsibility of the national competent authorities to monitor and control claims made for products. The common criteria are reasonably broad in scope and do not specifically deal with advertising.
Advertising controls in Europe are essentially self-regulated (easa-alliance.org). The official regulatory body in the UK is the Advertising Standards Authority (ASA, asa.org.uk), which oversees all forms of advertising including print (magazines, leaflet and billboards), broadcast (TV and radio), cinema and websites. The ASA investigates product claims used in advertising in response to consumer complaints (only one complaint is needed) or as a result of an investigation by its monitoring team. Results of ASA investigations are published on its website monthly and usually further reported in the daily press. The Committee of Advertising Practice (CAP, cap.org.uk) creates the code of practice which the ASA uses to check legal compliance of adverts.
Find out more on regulatory updates and claims at the 2016 Cosmetics Business Regulatory Summit.
Separate and in addition to the regulatory activity of the ASA, broadcasting companies in the UK must have a system to pre-clear advertisements prior to broadcasting in order to fulfil their licence responsibilities. RACC (radiocentre.org/clearance) is the organisation that pre-clears for radio and most commercial television channels use Clearcast (clearcast.co.uk) to clear TV adverts. These organisations utilise experts to assist in the assessment of claims support data. Clearcast, for example, has more than 20 experts from different fields of interest whom it calls upon to give guidance to decide whether an advert has sound data to support the claims and complies with the CAP code of advertising practice. Previous ASA adjudications on similar products and claims are also considered.
BEAUTY ON TV
I have been a consultant to Clearcast on cosmetic and topical products since 2001; I evaluate scientific evidence in support of claims, and advise on the strength and limitations of the data and the suitability in supporting the claims that the advertiser wishes to make. The aim is to achieve a robust advertisement that is not misleading and could be defended in the event of a challenge from the ASA. Clearcast and its consultants work with the advertiser to create the safest and best advert given the data available. I would evaluate on average three advertising scripts per week, of which around 50% would need to be rephrased or claim(s) are considered insufficiently supported.
During the process of advert and claims development, Meet the Consultant (MTC) sessions have proven to be very useful to advertisers. This is a pre-booked session with a consultant and a Clearcast executive to discuss new claims, and scientific tests and data are required to support the intended claims. These meetings usually take place early in the process to improve the chances of achieving a successful and safe advert.
When submitting an advertising script to Clearcast, the advertiser completes a pro forma document called a Claims Support Model (CSM), which, when completed satisfactorily, should contain all the necessary information to support the claims. The main reasons why a submission can be unsuccessful are: insufficient or no data (40%), over-claiming and exaggeration of effect (24%), inappropriate trial design (10%), rephrasing of claims wording required (6%), misleading or exaggerated effect with images (4%) and poorly completed or written CSM (7%).
There are many product claims and test methodologies that are generally accepted by Clearcast and the ASA, and will require only product-specific information for claims support. In the event that a new or breakthrough claim is being considered, then there is a more complex process involving ‘proof of principle’ in addition to high level clinical studies to prove product effect. In 2006, the ASA was given the responsibility of regulating all advertising in the UK. It was quickly realised that there were “some areas of disagreement between Clearcast experts and those of the ASA, which resulted in some adverts being considered to be misleading by the ASA when they had been assessed and accepted by the clearance bodies and their own experts”, according to the ASA website. It was agreed by the ASA, Clearcast and RACC to establish a panel of experts in the field of dermatology to:
- Reduce disagreement between experts over acceptable standards of evidence
- Increase certainty for advertisers
- Increase consumer confidence in advertising claims in the beauty sector
- Provide consistency between experts through establishing protocols on how scientific evidence for advertising should be assessed.
There are five members (including myself) on the expert panel that meet or communicate on an ad hoc basis as required by Clearcast or the ASA. More information can be found at asa.org.uk/Industry-advertisers/Our-experts/Dermatology-experts.aspx. The panel usually meets to discuss the acceptance or otherwise of new ‘breakthrough’ claims. The most recent of the claims that the panel discussed and agreed by majority vote to allow was a cumulative anti-wrinkle claim for a topical cosmetic product. The process of establishing a breakthrough claim is complex, time consuming and very involved. Development of support for breakthrough claims can be facilitated by early and regular meetings with the consultant and Clearcast executive who will clarify the best approach to testing and the wording of the claim, and advise on the support documentation. This is particularly useful in finalising clinical trial design.
Most, if not all, clinical studies should have a control site or group. Too many submissions to Clearcast have clinical studies that compare zero time measurements with measurements made days or weeks later. These studies would be rejected at the outset and are in effect a waste of money and time. A trial control does not automatically mean a ‘placebo’ control. Unless there is a very strong claim made about a specific ingredient or complex of ingredients, then placebo controls are not needed. Placebo controls are more useful in a pharmaceutical trial where there is a specific pharmacological activity for the active. Cosmetic products, in general, may have actives but also rely on the overall effect of the whole product. Controls for cosmetic studies therefore utilise no treatment sites or previous formula or a bland cream as control. The use of one of these controls allows the trial design to be double blind and/or half-face, or with paired groups.
When all the data is available the final submission to Clearcast should take the form of a body of evidence as follows:
- Background of the biology of the skin characteristics and parameters and effect of ageing
- Explanation of the technology and formulation and why the product would improve the skin in relation to these parameters
- Detail the claims and rationale of why the product would show benefit Summarise and represent the laboratory and clinical data in a format that will directly support the effects investigated
- Appendices with complete study reports with original data for each individual subject.
Advertisers are much more in control of the outcome of whether a product claim is acceptable or not to Clearcast and the ASA than is generally considered. They need to ensure that the correct and full information is collated and submitted by a scientist who is experienced in the subject matter, and that the claim can be clearly supported by the data. Too many scripts fail due to the inadequacy of the submission.
Dr Jack Ferguson, Skinnovation Ltd