Want the Truth: Claims Development is More Than Just Evidence.*

*A portion of this paper was presented as the “Claims Workshop” held at in-cosmetics Barcelona in April 2015.

Consumers have needs. Without those needs, the cosmetics industry would not enjoy the success it continues to generate. Yet, these needs often are not given enough consideration. In fact, some marketers acknowledge they create those needs.

Today’s consumers, though, are not easily influenced by promises, e.g., of eternal youth. Even if they’re not highly educated, more often than not they’ve generated knowledge through outlets such as social media, which obviously has played a large role in recent years. And as illustrated by press and social media, today’s consumers do not read claims evidence in isolation—they bring their past brand experiences and associations with them.

This means both marketing and R&D have major responsibilities in the claims development process. But that’s not all—regulations, risk, vulnerabilities, communication, study design, costs and more also are at play. These and other influences in the claims development process are discussed in the present article.

Marketing vs. R&D and Missed Opportunities

Active ingredients and final formulae require claims substantiation, and neither R&D nor marketing can drop this responsibility solely onto the other. Moreover, the inability for both to understand and translate new research findings into a language the consumer understands—without losing scientific integrity—is an opportunity being missed by many brands. The same can be said for raw material suppliers communicating with brands.

This is compounded by the eternal “battle of wills” between marketing and R&D. R&D complains that marketing develops (late) launch plans rather than coming up with new products; is obsessive about certain features and benefits of the products; and doesn’t listen. On the other hand, marketing complains that R&D fails to include them up front in the development process; does not understand them; and takes all the credit for a product succeeding while denying any culpability if a product fails. It’s no wonder the development and execution of product claims seems lost in space and/or translation.

The failure to capture market opportunities is often driven by: cost; clinical study choices—and a lack of understanding them; a focus on the return on investment (ROI); and concerns over regulatory and advertising standards authorities. However, whether the industry likes it or not, ingredients or finished formulas require claims substantiation, and neither suppliers nor customers can pass this responsibility on to one another. Disappointingly, some in the industry actually encourage this practice, i.e., running “cheap and cheerful” studies to avoid costs and then passing the buck. Unfortunately, all they get back is cheap data and often not-so-cheerful results.

Further, reviewing the claims and clinical projects executed for clients clearly highlights a common underlying theme—a disconnect between marketing’s understanding of the consumer need, the scientific data generated, claims promoted by raw material suppliers, R&D’s interpretation of the data, legislation, the formulation chemist, the clinical testing company or department, and both knowledge and common sense.

Stability in Truth

The EU claims legislation enacted in July 2013 is still having profound yet confusing effects on the industry. Many brand owners, especially outside the EU, remain unaware of what’s required to comply but the reality remains: cosmetic claims legislation is here to stay. Why did this legislation come about? In addition to complaints by consumers, advertising authorities, the industry and even politicians was the commercially driven displacement by marketing/commercial teams of what you might call the “pyramid of common sense” for product development (see Figure 1a-b).

This pyramid, in its stable form, places the broader body of scientific knowledge underlying product claims at the bottom (i.e., why a product does what it does). On top of this is a smaller layer of effects or results (i.e., what a product actually does). Topping it off, the peak of the pyramid includes claims that relate to the results but are written to appeal to consumer needs (i.e., what marketing says a product does). When commercial teams displaced this pyramid, they turned it upside-down, placing a broad portfolio of marketing claims atop a small body of scientific knowledge, rendering the pyramid unstable.

Thus, commercial demands on speed to market, “sexing up” the consumer and misunderstanding resources to maximize profit came at the expense of the consumer—and the integrity of the industry itself. Until recently, advertising has been littered with irrelevant and incomprehensible images and statements that have no bearing on the product itself in the eyes of the average consumer. So in a nutshell, the legislation states that product labeling and advertising, including text, names, trademarks, pictures and figurative or other signs, shall not be used to imply that products have characteristics or functions they do not have. This applies to any claim, irrespective of the medium or type of marketing tool used; the product functions claimed; and the target audience. Essentially, it means don’t lie.

Furthermore, the criteria for this legislation^1, 2 cannot be viewed or taken in isolation—they are inextricably linked and without one another, the process forward cannot operate or function. For example, claims cannot be considered “legal” unless they are “truthful”; and truthfulness requires “evidence.” Evidence is also linked to being “honest” which requires “fairness” to provide for “informed decision making,” and ultimately a satisfied consumer.

ABCs of Developing Claims

When gathering evidence, remember substantiation testing is required when the claim refers to the effectiveness of a product, or the benefits or improvements in skin, hair and/or nail attributes that result from using the product. To develop a claim, the developer must:

• Know the product(s) intimately
• Understand the science of the product(s)
• Use the right “experts”
• Understand the claim(s) being made—what do they really say?
• Question how the competition, consumer and inspecting authority will react to the proposed claim(s)

By Assuming nothing, Believing skeptically and Checking the facts (i.e., the ABCs), the developer can compile a coherent set of claims. However, remember the data you generate does not give you the claims, only the information from which you develop the claim. Claims typically are: unique, superior, comparative, efficacious or factual, and they tend to be divided into three main categories:

1. Cautious, e.g., “contains vitamins known for their antioxidant properties.” Even if you only include a few molecules.
2. Extreme, i.e., any unsubstantiated claim including uncorrelated data, incorrect substantiation, incorrect conclusions, animal vs. human efficacy data, in vitro data, etc.
3. Ambiguous, for example, “cosmeceutical soother,” which legally means nothing.

These categories can be further subdivided as follows.

Empty, including phrases such as “approved by dermatologists.” Does this mean the product was, in fact, assessed by a team or board of credible dermatologists?
Unfinished, i.e., “…lip gloss does it with more shine.” Does what with more shine?
Different/unique, “There’s no other mascara like it.” Was the clinical study conducted vs. every other mascara on the planet?
Vague, i.e., “Your skin blossoms over night.” 
Endorsements from celebrities, superstars, etc.
Scientific/statistical, e.g., “78% of users liked it.” Liked what?
Complimentary, “Because you’re worth it.”
Questioning, “Could your skin use a miracle?” (Author’s note: the skin is a miracle.)

Disconnect Leads to Vulnerability

Clearly there is a disconnect between knowledge and understanding when it comes to claims development and claims substantiation. Yet, understanding studies is not rocket science. A good, quality study should address a relevant and important cosmetic question; have the ability to make an actual difference to consumers; use the best available clinical techniques; generate significant yet consumer relevant data; be scientifically and ethically sound; and recognize and ensure good clinical practices (GCP) with both the contract research organization (CRO) and the customer.

If this is not the case, the validity as well as quality of the study can be regarded as vulnerable. Vulnerability often comes from misunderstanding the goals. This is driven by company culture issues, which are difficult to change. Classic examples are retailers and private label companies that rely on external input during the product development process. Technologists and project managers may be well-versed in formulation and manufacturing but can equally be missing in crucial basic skin science and clinical expertise. Further, being pressured by development deadlines and not knowing how to choose external expertise drives this vulnerability, in addition to the lack of information from customers about purpose of the product concept, including why certain ingredients were chosen.

Further areas of claims substantiation vulnerability are:

Failure to identify priorities: Marketing is often too focused on their “desires” rather than the requirements of the project objectives, particularly if they do not understand the objectives of the study and/or were not informed of the objectives. R&D, in turn, makes satisfying marketing their priority and the real objective becomes the victim.

Poor study design: This involves a diminishing focus on the actual objectives of the study, as well as reductions in financial and expert resources to achieve the quality necessary for transparent objectives. Again, such a “one size fits all” mentality is often related to not understanding the requirements and objectives of the study. Studies should be designed to generate claims, not the reverse, “We have the claim, design us a study to fit,” approach. Pulling a study off the shelf to fit a claim is poor quality and ignorance on the part of both the CRO and its customer.

Development deadlines: Few development deadlines actually are achieved on time. Therefore, making changes and bringing marketing on board early to understand the objectives and requirements of a clinical study will ease pressure in the normal panic. Charging the CRO to, “Just do the study and give me the data,” will only have one (negative) outcome.

Division of roles in project management: The project manager, technologist and formulator are not the experts in clinical studies, pre-clinical studies or claims substantiation. When they play these roles, they can end up being a “Jack of all trades and master of none,” losing focus of the objectives and even being exploited by others.

Globalizing studies: With the world becoming a smaller place, the global market has increased exponentially, and with global brands comes the need for global studies. Although some CROs have their own international activities, at times they lack an understanding of the local culture and study requirements. Oftentimes, EU or U.S. Food and Drug Administration (FDA) requirements are imposed without even giving a thought to national requirements that may also need to be incorporated.

Risk aversion: The fear that a study will fail and give a poor return on investment (ROI) can drive the demand for “guaranteed results” from the CRO. However, offering and demanding guaranteed results is illegal and obviously corrupt. Risk aversion also is driven by a lack of knowledge and not understanding the study objectives.

Repressing innovation: Repressing innovation, e.g., through preconceived ideas and assumptions, occurs in both clinical research and product development. Furthermore, resistance to or paltry implementation of new clinical approaches or technologies diminishes badly needed advances in clinical study design. While innovation in in vitro and ex vivo pre-clinical studies proceeds at lightning speed, the same cannot be said for clinical studies. Again, this is often due to a lack of understanding, which then generates false assumptions and ideas.

Regulatory Requirements: Who Knows?

The number of marketing individuals who do not know, let alone understand, the regulatory requirements for launching product(s) they develop is surprising. Even more surprising is the number of R&D individuals who don’t understand the requirements. So, neither is in a position to objectively discuss these issues with their regulatory team or legislators, when required to do so.

Furthermore, the legislation has not taken into account issues surrounding the role of the independent responsible person. For major multinationals, they take role of the Responsible Person (RP) on themselves since they usually have all areas of expertise required within their company organization. However, when it comes to private label and retailers, this can be an issue since more often than not, they must outsource this role.

In addition to the RP putting together the product information file (PIF), ensuring safety evidence, manufacturing, etc., he or she must determine the appropriate and sufficient methodology to be used for claims substantiation—with its appropriateness and relevance potentially being evaluated by authorities as part of their market surveillance activities. The RP must also determine and hold the appropriate supporting evidence to substantiate the claim being made, whether explicit or implied, with appropriate support; they may consult an expert to provide the appropriate support. Furthermore, the RP must ensure the evidential support is still applicable when the formulation of the product changes.

Many questions have been raised criticizing Cosmetic Europe as to the appropriateness of this requirement on an individual RP. Many do not possess the expertise or experience in developing active ingredients to understand pre-clinical test methods; have not worked with human study designs to determine the appropriateness of available methods, let alone understand them; and are unable to read across in vitro/ex vivo data with human study designs to ensure correlation of the data. Then they are expected to figure out if the user-trial/consumer study design fits? On top of this, there is also scientific literature to contend with.

While the independent RP or RP company can bring expertise on board to fill this knowledge gap, budget constraints, the lack of motivation and fear are prohibitory factors. The onus still remains with the owner of the product but few realize this responsibility until they are challenged or inspected. It will be interesting to see the EU inspecting authorities’ feedback when the industry hears from Cosmetics Europe in 2016.

Top 9 RP Complaints

There are a number of good independent RPs across the EU, and all express similar complaints about their customers. Key issues faced are as follows.

1. Clients make and push for prohibited claims.
2. Proof of evidence for claims is either absent or insufficient, as customers do not want to share information.
3. Clients incorrectly interpret their data.
4. Most clients do not want to substantiate data, i.e., are non-compliant.
5. Clients avoid spending money at all costs.
6. Clients are too reliant on raw material data and extrapolate information.
7. Clients prefer questionnaires, homemade studies, etc.; again, they are non-compliant.
8. Clients prefer to provide an attestation that claims are true.
9. Contract manufacturers and private labelers are the worst culprits.

Key Principles of Clinical Studies

Companies often place inflexible limitations on the resources available to run clinical studies, without giving any thought or consideration to the objectives and outcomes of studies and what benefits they bring. Three key principles must clearly be understood or the data generated for claims development also becomes vulnerable. These are:

1. Exactly defining the objectives
2. Making the objectives and data transparent
3. Ensuring the relevance of test methods

Ask yourself: Have the studies been appropriately specified? Do they measure the product/ingredient that is the subject of the claim? Have the studies appropriately specified and measured the problem that is the subject of the claim? Are the conclusions about the product/problem relationship based on the totality of available scientific evidence?

Unfortunately, cosmetic clinical trials are more often than not constructed on poor quality and/or non-relevant pre-clinical research data. The consequent lack in correlating the data is an industry-wide problem that affects the major multinationals as well as small companies.

Also keep in mind: What are you/they selling/claiming? What is the mechanism of action? How was it tested? What concentrations of the ingredient were used? Were proper controls in place? Are/were the methods clearly described? Is the data valid and relevant? Is all of the data being presented? Is relevant statistical significance demonstrated? Does the generated data support the suppliers’ conclusions? How will this ingredient work in the final formulation and what pre-formulation work and proof of principle testing has been conducted? How does/will this impact on final formulation clinical testing?

Oftentimes, these questions are either not considered or are overlooked, resulting in serious claims errors versus, for example, in vitro generated data. Many cosmetic claims bear absolutely no resemblance to what the raw material suppliers are communicating—and this is exacerbated by the inability of the project manager or formulator to understand and read across data provided by the raw material supplier. Ask yourself: Is their evidence correct? Does it make sense, and is it relevant?

Keep Communication Simple

Albert Einstein once said, “If you can’t explain it simply, then you don’t understand it well enough.” Communication is the process of meaningful interaction to transmit information, ideas and attitudes; to persuade; to ensure understanding; to get action; and to change behavior—e.g., buy my product not my competitor’s.

Effective communication involves actively listening to the consumer. This reflects accountability of the marketer as well as consumer. Effective communication utilizes feedback, is clear and achieves one or more of the goals you are trying to communicate and achieve; i.e., what the product says it does, what the product actually does, and why the product does what it does.

When it comes to consumer communication, in terms of empowering individuals to make an informed decision, their knowledge and understanding are paramount. Knowing what the product does is fine but understanding what it does is the pivotal point for informed decision-making on the part of the average consumer—supporting the decision to buy or not, which is the sole purpose of any cosmetic claim.

Whereas knowledge is readily available information, the consumer can’t just know the facts. They must be able to interpret them; e.g., raw material supplier data vs. clinical data, discussed previously. On the other hand, understanding is the ability to think and act flexibly with what you know. It is key for marketing in particular to understand this, otherwise consumers will continue to misunderstanding products and ingredients—the likes of which have led to many unwarranted issues surrounding certain harmless cosmetic ingredients, for example. Moving from knowledge to understanding requires real-world insight into consumers. Put yourselves directly into your consumers’ shoes.

Costs of Non-compliance Run Deep

Some readers may have already experienced the cost of non-compliance, which can be rougher in some EU countries than others. However, the courts and legislation are not there to stop your product—after all, the economy needs them—but to make your product honest. In addition, companies must realize their impact of non-compliance on: industry credibility, consumers, employers/companies and loss of revenue, integrity, etc. Many small companies still do not believe the law applies to them since they assume they are “under the radar.” They justify their actions with statements such as, “If they are saying it... why can’t we?” They do not understand what it takes to put a product on the market.

Examples of non-compliance (EU 655/2013) reported from experts and inspecting authorities include:

• Claiming the presence of an ingredient when it is not present (truthfulness);
• Over-stating the product’s proven efficacy with big, bold claims (honesty);
• Claiming product-specific or unique benefits if they aren’t unique (honesty);
• Claiming the product has been approved by a competent authority within the EU (legal compliance) or claiming it contains EU-approved ingredients;
• Claims of not being tested on animals and including cruelty-free statements when it has been tested on animals (honesty);
• Claiming or implying the finished product has the same properties as its raw materials without proven evidence (truthfulness);
• Using opinions from experts or spokespersons as evidence, which can’t be shown as verified claims unless they can be verified with other evidence (truthfulness);
• Using claims extrapolating ingredient properties to the finished product without adequate and verifiable evidence (evidential support);
• Using claims denigrating the competitors or ingredients legally used (fairness); e.g., silicone-free, preservative-free, etc.;
• Making claims that create confusion with a competitor’s product (fairness);
• Using unclear, not understandable or irrelevant claims (informed decision-making);
• Making claims related to treating or preventing skin diseases or wounds; and
• Making claims on the basis of poor quality consumer tests.

Conclusion

With innovation and demands for high-ROI products, development paths are becoming increasingly challenging, inefficient and a waste of resources. The ROI for cosmetic clinical studies is not just about cost versus benefit—and putting a financial value on an industry that thrives on emotion and vanity is laden with subtleties, value judgement and error. Simultaneously, the rate of legislative development work has not kept up with the rapid advances in so-called cosmetic science, resulting in a technological disconnect between scientific developments and the product development process.

Cosmetic technology performance is actually measured in terms of product safety and effectiveness, and the applied sciences required for product development struggle to keep pace with lightning advances in the basic sciences. New scientific discoveries are not being used to guide the technology development process in the same way as they are in accelerating the technology development process.

Furthermore, there has been and still is insufficient applied scientific work to create new clinical tools and methods to fundamentally answer how the effectiveness of new products can be demonstrated faster, with more certainty and more cost effectively. Thus, the path to market is viewed as inefficient, due in part to reliance on the cheapest option driven by a lack of strong practical expertise across all functions. Expectations always run higher than reality, and pressure is often put on the clinical testing companies to guarantee results, which is ignorant, corrupt, immoral, unethical and actually illegal.

The victim in all this is, of course, common sense. Both R&D and marketing need to understand each others’ value in this process and how they each complement one another. Obviously marketing needs to know they are a major stakeholder in the outcomes of cosmetic clinical studies since they are, in essence, a “dress rehearsal” for the product’s performance in the hands of the consumer.

If R&D and marketing shared the cost of running clinical studies, it would help both to understand that neither of them can dominate the development process and the value of discussing the testing needs together. Joint monitoring and discussions with the testing company/department helps all parties involved, not least the testing company/department, since they are not always in a position to clearly understand formulations or basic skin research discoveries. Furthermore, the development of a common language together will help them remain consumer focused rather than egocentric.

References

1. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF (Accessed Apr 4, 2016)
2. file:///C:/Users/rgrabenhofer/Contacts/Downloads/guidance_doc_cosm-medicinal_en.pdf (Accessed Apr 4, 2016)