Claims Support Seminar

A review by Theresa Callaghan and Chris Gummer

Cosmetics claims legislation that came into effect in July 2013 is having a profound if not confusing effect on the industry. Many brand owners affected are still unaware of their obligations and what is required to be fully compliant. Although claims substantiation is an international legal requirement, translating new research findings into language the consumer understands and trusts, and without losing scientific integrity is an opportunity being missed by both brands and raw material suppliers. Failure to capture market opportunities is often driven by an unwillingness to spend, the choice and lack of understanding of evidential studies, concern over the return on investment, and the requirements of regulatory and advertising standards authorities.

Whilst there have been a number of international events covering the EU claims legislation, they have only focused on certain aspects rather than give a good provision from concept to consumer. Thus this proDERM Academy Workshop brought together a wider faculty of experts from diverse backgrounds covering all aspects of the claims development process.

Participants were welcomed to the workshop by proDERM Academy host Klaus Peter Wilhelm.
Imogen Matthews opened the presentations with a very constructive, if somewhat sobering overview of what the consumer actually thinks and their belief of cosmetic claims. The message was clear, most consumers do not believe in, nor trust, product claims preferring instead a friend’s recommendation. Imogen summarised clearly that whilst beauty consumers do not believe claims, they do want realistic advertising, truthful image presentation (no photoshop), believable claims that are backed by science, and claims that are endorsed by professional bodies.

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 pointed the key basic rules to remember in understanding study data, and why they are important in terms of relevance to the average consumer, providing proof of claims, as well as the importance of ensuring good data correlation. The global impact of claims was also discussed. The “average consumer” was to be the running theme throughout all of the faculty workshop presentations.

Harald Büttner representing Cosmetics Europe closed the first session with the EU Commission perspective of the legislation. He reiterated the importance of the claims development process revolving around the average consumer. Harald 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 a positive list of claims being legislated by the Commission.

The second session was opened up 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 give guidance on the requirements for claim support and advertising in other EU countries.

Health-like claims from the French perspective was covered by Laurence Mulon, and from the German perspective, Ina Gerstberger discussed with examples of how claims are judged in a court of law. As with all presentations the message was clear – stick with the truth and avoid exaggerated, imprecise wording of claims and provide clear justification for those claims. Claims that exceed the substantiation are non-compliant and are deemed misleading to the consumer.

Stephan Bielfeldt opened Day 2 and provided 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 in the claims development process, and a wide variety of methods and tools are available. Studies need to be scientific and results must have to be based on sound statistical evaluation. For successful claims, good claim support 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.

Whilst Gerd Mildau was unable to attend in person, his presentation 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.

This session was closed out with a very interesting presentation by Laure Normand on oral beauty supplements which have been a growing trend in the industry for a number of years. Whilst such supplements are regulated by the food legislation, beauty claims are also judged by the cosmetic claims legislation. However, unlike topical cosmetics there is no consensus amongst the EU countries as regards interpretation of the legislation and claims. This will continue to create problems for marketeers in terms of lack of provision of master-pack copy and possible consumer confusion in countries selling the same product yet with different claims to comply with individual national interpretations.

Tadej Feregotto opened the final session of the workshop 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 Callaghan’s presentation, 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 as many brands do not provide correct or adequate claims information which could be easily challenged by an inspecting authority. Many SME’s are 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-complaint, e.g. some “free-from” claims etc. 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 – in vitro, ex-vivo, clinical and peer-review scientific publications.

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. Whilst the legislation in principle applies only to consumer products, it does impact enormously on the active ingredient supplier. Harald gave a good overview of the consumer, and the challenges of the market, supporting the information provided at the start of the workshop by Imogen Matthews. 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 comment on the issue that SME’s have i.e. budget constraints, the troublesome relations between marketing and R&D, marketing departments not knowing what they want except “give me something new”, lack of scientific knowledge at the SME’s and contract manufacturers, and not enough legal guidance. The role of the raw material supplier tends to be that of a consultant, especially for SME’s, but they can get carried away with presentations rather than fact. 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 session ended with a presentation from Arne Böhling discussing consumer medical devices, another 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.

The workshop then moved to the proDERM Clinical Research Centre for practical demonstrations on how to substantiate cosmetic claims focusing on wrinkle measurements and facial parameters; how to evaluate “attractiveness”; anti-aging – structural, optical and functional parameters, and finally, evaluating and quantifying dandruff.

In all, the consumer, and particularly the “average consumer” remains an enigma, and the marketing rule book and NPD processes may require re-writing!