What is hot in Claims Substantiation?
The Claims Support Seminar of the proDERM Academy – a Review
Following its debut success in 2014, this second proDERM Academy Seminar brought together a wider faculty of experts from diverse backgrounds covering all aspects of the claims development process. This years workshop, welcomed by proDERM Academy host Prof. Klaus Peter Wilhelm, opened with a practical session at the proDERM Clinical Research Centre. Demonstrations and practical knowledge were given on how to generate evidence for claims substantiation focusing on: ageing and facial parameters; sun-care and SPF measurements; antiperspirants and deodorants; and hair measurements.
Erik Schipper opened the second day with a very upbeat focus on the reality and enigma of the average consumer. The clear message was we need to be very aware of consumer insights when developing claims and the importance of how they fit together. We need to understand 3 key issues — what consumers say they do, what consumers actually do and why consumers do what they do.
This nicely followed into Theresa Callaghan's presentation on how a common sense approach to claims development will prevail. Theresa described the process from the common claims criteria of the legislation viewpoint with a focus on the developer, the disconnect between marketing and R&D, and the average consumer. Theresa also noted key basic rules to remember in understanding study data — what the product says it does, what the product actually does, and why the product does what it does — and why they are important in terms of relevance to the average consumer. The global impact of claims was also discussed. The “average consumer” was to be the running theme throughout all of the faculty workshop presentations.
Stephan Bielfeldt closed the first session with a concise overview of how information to develop a claim can be provided by clinical setting. Clinical studies are one of the best approaches to obtain credible and relevant information for claims and a wide variety of methods and tools are available. Studies need to be scientific and results must be based on sound statistical evaluation. For successful claims, good claim substantiation relies on effective cooperation between marketing, R&D, lawyers, regulatory affairs and the study investigator (CRO). It was important to note that claims can only be an interpretation of any data and, therefore, the claim risks are always the responsibility of the study sponsor and not the CRO.
Birgit Huber from Germany’s IKW and representing Cosmetics Europe, opened the second day with the EU Commission’s perspective of the legislation. She reiterated the importance of the claims development process revolving around the average consumer. Birgit also gave some insights into what may happen if compliance is not achieved by the 2016 timeline, indicating that the industry may or may not see lists of claims being legislated by the Commission. However, the whole process is a grey area with much to be resolved.
The second session was closed out with a lively presentation from Chris Gummer on how to prepare claims support evidence for advertising in the UK and the requirements of Clearcast. Chris outlined the tough and detailed requirements of UK advertising and predicted a similar process for the EU. In fact, Clearcast already gives guidance on the requirements for claim support and advertising in other EU countries.
The afternoon session set the stage for a practical claims workshop. Delegates were provided with a tranche of data covering consumer assessments, market share and technical study performance data for a new product from which they had to create a number of solid claims. Delegates, working in teams, were encouraged to interpret the data and compile strong and provocative claims. What followed was lively and vocal group session where claims were presented, challenged and defended.
Tadej Feregotto closed the final session of Day 2, providing the “reality” perspective of the role of the Responsible Person (RP). Whilst major brands and multinational companies have their own internal RP function(s), SME's (small & medium enterprises) contract this service to either independent companies or even their contract manufacturer. Tadej reiterated the warning, also given in a number of the presentations, that SME's have to comply with the legislation. This would be helped if the EU Commission better defined the role and responsibilities of independent RP's in terms of liability. Many brands do not provide correct or adequate claims information, a position easily challenged by an inspecting authority. Many SME's are still unwilling to comply with the legislation e.g. such as copy-paste raw material suppler data, and want to make claims that would be non-compliant. Legislation needs to be more specific, which may mean a positive-list of claims by 2016. The Commission must better define the qualifications of an independent RP when it comes to understanding all levels of claims evidence.
Day 3 of the seminar opened with an interesting and refreshing presentation by Judi Beerling on Organic and Natural claims and the opportunities as well as the challenges that invariably arise. Whilst there is market growth in this field creating authentic products with real consumer benefits is clearly required! Judi discussed the various organic and natural authorizing bodies and the efforts of COSMOS to qualify each ingredient in a central database. However there are central or specific regulations for natural or green claims even though there is “regulation” as regards to sourcing of natural/organic ingredients.
Gerd Mildau then covered the viewpoint of the claims inspecting authority. Claims are inspected based on the six common criteria and take into account language differences as regards skin definition and the relevance of claims based on degree of justification evidence. Furthermore, health-like claims and active ingredients are a key focus point for inspection, as are the way brands transfer raw material supplier data which is considered unacceptable depending on the claims being made.
This was followed by a presentation given by Ursula Loggen who discussed the role of official consumer testing bodies as represented in this case by the German Stiftung Warentest (StiWa). Ursula led the delegates through typical StiWa product reviews and assessments leading to the all important use of the StiWa logo.
Klaus-Peter Wilhelm followed on with a look at using seals and endorsements as part of the overall “claims” package, and provided a number of interesting examples on how these can work to improve sales and product credibility. Seals have a long tradition in many consumer areas including cosmetics. However, it is important to take into account that seals and endorsements must also comply within the regulations with responsibility falling to the manufacturer and seal provider, especially when challenged either legally or by a competitor. The strength and credibility of a seal will depend on the integrity and reputation of the seal provider.
Whilst the legislation in principle applies only to consumer products, it does impact enormously on the active ingredient supplier. The subject of scientific data was further elaborated by Harald van der Hoeven from the responsibility and innovation perspective of the active ingredients raw material supplier — active ingredients are commonly the basis of many cosmetic claims. Harald gave a good overview of the challenges of the market and demands of brands for strong claims. Whilst consumers do not exactly believe in product claims they are results driven. Harald spoke about the perils of extrapolation of ingredient properties into final product claims and again highlighted a previous theme on the issue that SME's and compliancy. Harald's parting comment was for cosmetic companies to be more distrustful of their raw material supplier and ask the right questions and demand the evidence.
The final session ended with a presentation from Arne Böhling discussing consumer cosmetic and medical devices, a growing category of products in the cosmetic industry. Arne explained the differences between cosmetic devices, medical devices and cosmetic products from the legislation viewpoint. The process of measuring claims for cosmetic devices was then discussed with a number of examples.
In all this event was yet another excellent success, and judging from the feedback (up to 90% top 2 box agreement!) the course delivered as part of proDERM Academy programmes, will become essential for anyone involved in claim substantiation or claims regulation in the cosmetics industry.
