A Review by Theresa Callaghan and Chris Gummer
Following a break in 2017 from this ever popular seminar sponsored by the proDERM Academy, it was all go at the 2018 edition held here in Hamburg at the end of November. So much so that we were booked-up 2 months well in advance of the event – with bookings for the 2019 program filling up rapidly. In this 4th year, the proDERM Academy Claims Seminar brought together a wide faculty of experts from diverse backgrounds covering all aspects of the claims development process. This year’s workshop, welcomed by proDERM Academy host Klaus-Peter Wilhelm, opened on Day 1 with a practical session at the proDERM Clinical Research Centre. Demonstrations and practical knowledge were headed up by Stephan Bielfeldt and his team on how to generate evidence for claims substantiation focusing on: ageing and facial parameters; sun-care and SPF measurements; antiperspirants and deodorants; and clinical photography.
Clearly energized, the following 2 Days comprised lectures and discussions on bringing claims to fruition from regulation to effective implementation. Day 2 opened with a general keynote presentation from Theresa Callaghan (Callaghan Consulting International, Germany) setting the scene for following lectures. Theresa discussed the essentials of a claim, what they are and their basic anatomy, objectives that need to be addressed when creating claims, and of course where we find them. Theresa described a common sense approach when developing a claim in terms of concepts, product users, expectations of claims, what is to be measured and the weight of evidence required before a claim can be finalized. Examples of claims were given in all their media formats especially the use of images and photographs and the places where claims are found – literally everywhere. The presentation ended on a cautionary note highlighting the role and understanding of the consumer throughout the claims legislative process.
This led into a powerful presentation given by Erik Schipper (i3 Innovate, Sweden) who delved more deeply into the importance of the consumer when creating claims and gave practical examples of the consequences of getting it wrong. The message is clear – be very aware of consumer insights when developing claims and the importance of how they fit together. Listen to and understand the consumer. Overall, Erik’s presentation was a cautionary tale combined with real-life videos to drive home the message – focus, and clearly understand 3 key issues — what consumers say they do, what consumers actually do and why consumers do what they do, and importantly should never be biased toward a marketing whim!
From the consumer we ventured into the nitty gritty of legislation opened by Olivia Santoni from the UK’s CTPA, Chris Gummer at Cider Solutions & Clearcast Consultant, UK, and Jack Burgess of Delphic UK, providing real insights into the role of the Responsible Person. Olivia provided an update on the guidelines to be implemented in July 2019 with special reference to “hypoallergenic” claims and “free-from” claims. It was heartening to find that these issues have been clarified, yet we still have a long way to go. Of note was that finally the legislators made it clear that you cannot extrapolate raw material supplier data, and avoid claims that are not actually product relevant. ‘Free-from’ includes claims with a similar meaning, whether in text or other format. Not all are prohibited, but assessment will look at how the six Common Criteria apply to such claims. Some Member States may take particular interest in these claims and decisions will be taken nationally on a case-by-case basis (competent authority – national courts – ECJ).
Chris took us into evaluating how much data do you actually need when creating a claim i.e. how big does your body evidence have to be, and how this helps to pull together all 6 claims criteria when creating a claim. Chris clearly demonstrated that every claim has to evaluated on it own merits and generalization should be avoided. Key questions to bear in mind are: What are the advertising requirements? What do you want to claim? Where will you advertise? Why do you think you have enough data? Would others think the same? And, who will you be taking share from.
Jack Burgess then explained claims compliance from the perspective 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. Jack also reiterated the message of claims legislation compliance and the essentials of providing correct and adequate claims information, a position easily challenged by an inspecting authority. The responsible person has a tough task meeting obligations in relation to claims since legislation is not black and white; the role requires a level of practicality and flexibility;
and it is important to keep in mind overarching goals. The responsible person cannot please everyone but they can help to create a suitable balance, since it is as much about managing the parties involved as it is about meeting the requirements set out by law. In line with Olivia’s messages, Jack also took us through some of the scenarios regarding Brexit and how many independant RP’s will have to set up an office not only in the UK but also in the EU as well.
Claim trends were then addressed with Olivia returning to present on vegan claims from a legislative perspective. However since there is no legislative definition of such claims, any claim will always be judged against the six common claims criteria. Furthermore, although there is an ISO guideline tool for quantifying the amounts of organic/natural components within a given formulation, a key contention raised by Theresa Callaghan is that the document is more of a hindrance since not only has the ISO standard itself has been globally criticized for its contradictions and lack of clarity, but that this lack of clarity is driving confusion. Thus, it could be considered legitimized greenwashing, since it is a malleable document rather than a good solid basis which could have led finally to a standard worthy of inclusion into the Cosmetics Directive. There are too many hidden “what-if’s” and no provision for a definition of an organic product. Consumers are more conscious of product origins from food to cosmetics and the ISO standard excludes this. It also allows the use of petrochemicals.
To complete the session Shane Hanson (Panasonic, UK) took us through a very interesting example-led presentation on a rapidly growing sector of the industry, cosmetic device claims. Shane demonstrated through her product examples how Panasonic turned their claims around by virtue of generating a body evidence resulting in product success. The key steps involved in cosmetic claims for cosmetic devices require the following steps: identification of consumer insight, identification of the device USP, claim strategy, claim substantiation, claims communication. By using different Panasonic products for each step, Shane demonstrated the importance of each for marketing devices.
The mid-afternoon session set the stage for the ever-popular practical claims workshop. Delegates were provided with a selection 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. For many this is a new and challenging task. Delegates, working in teams, were encouraged to interpret the data and compile strong and provocative claims. What followed was lively group session where claims were presented, robustly challenged and in some cases very-well defended! The take-home message here was clearly “does the consumer understand what you are getting claiming, and is it actually relevant to them”.
Day 3 opened with an energizing buzz and straight into how and where to obtain data to support your claims. Firstly, Stephan Bielfeldt (proDERM, Germany) opened the session with a concise overview of how information to develop a claim can be provided by clinical setting. Clinical studies can really help bolster and help create strong claims for cosmetics and 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.
Obtaining data was further expanded into the important involvement of the raw material supplier – basically this is one of the key starting points for most claim concepts. Harald van der Hoeven (CLR Berlin, Germany) provided an outstanding presentation on the importance of the raw material supplier in the claims development process and used the development of actives for the microbiome as an on-trend example. If we do not understand the microbiome how can we make claims? Harald pointed out that understanding the ‘healthy’ situation of the skin microflora is the key starting point; Offering a relevant solution implies understanding the problem so you will need to “research” well; efficacy claims on the skin microflora can only be secondary and need rigorous substantiation; the term ’Help’ is safer, but weakens the claim; communication of ‘expertise’ and knowledge possibly allows for a stronger ‘claim’
Completing this data gathering session, consumer trials for claims development were then presented by Shazia Ginai (Good Hair Day, UK). Shazia showed that the world really is awash with cosmetic claims and as such the bombardment of them by advertising companies gives rise to many consumer perceptions which are miss-read by developers if they are not careful. Consumer research is very powerful as it showcases the realistic perspectives and they go hand-in-hand with the technical support provided by laboratory and CRO testing. Consumer language and avoidance of bias and “forcing” in questioning are paramount in consumer studies.
The final session of the seminar looked at expert endorsements for claims and TV advertising. Klaus-Peter Wilhelm (proDERM Germany) took us through 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. On this note Klaus-Peter provided a very good example of what happens when challenged in advertising such endorsements and claims. The strength and credibility of a seal will always depend on the integrity and reputation of the seal provider!
Chris Gummer then brought us full circle and the event was closed out with a lively presentation 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 Clearcast already gives guidance on the requirements for claim support and advertising in other EU countries.
In all this popular evolving event was yet another excellent success, and judging from the feedback the course delivered as part of proDERM Academy programs, will become essential for anyone (especially marketing, R&D and legal) involved in claim substantiation or claims regulation in the cosmetics industry. We look forward to welcoming you all to the next annual Claims seminar to be held again in Hamburg, November 2019.