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Planning and Designing Claims Substantiation Tests for Cosmetic and Personal Care Products – Bite-Sized Learning

Published January 2025


Paul Cornwell, Director of Business Development, TRI Princeton, NJ, USA




Paul Cornwell, Director of Business Development, TRI Princeton, NJ, USA


Filipa de Castro, Intern, TRI Princeton, NJ, USA




Filipa de Castro, Intern, TRI Princeton, NJ, USA



Fact checked by:


“Advertising is legalized lying” – H G Wells


Introduction


Claims on cosmetic and personal care products are essential for describing their benefits to consumers and for influencing purchasing decisions.   However, mistrust of cosmetic claims has long been an issue for the industry.  As a result, in the last few decades, the regulations governing claim substantiation have become more stringent around the world.  Claim substantiation has, therefore, become an increasingly important responsibility for cosmetic scientists.   It is now vital that product developers understand the guidelines, to minimize the risks of adverse rulings from regulators or litigation from disgruntled consumers.  This short bite sized article will describe the regulations that apply to cosmetic claim support in the US, Europe and the UK, and provides a useful guide to how to get started with testing.  It also provides suggestions for further reading in the TRI Library and other literature sources.  This guide is designed for anyone new to claim substantiation, including students and those starting work in the cosmetics industry.  Finally, it should be noted that this short article intends to give a broad outline description of claims regulations.  It is not intended to be a replacement for professional legal or regulatory support.  It is advisable to get professional advice before attempting to launch products in the US, EU, UK, and elsewhere. 


Claims on cosmetic and personal care products are essential for describing their benefits to consumers and for influencing purchasing decisions.


Summary of the Key Points ⬇️



Three Step Process


Building a strategy for claims substantiation for cosmetic and personal care products can be broken down into three steps (Figure 1).  These are (i) understanding the rules, (ii) building a claims matrix, and (iii) designing the studies.


Figure 1.  How to do the right thing in claims substantiation

Figure 1.  How to do the right thing in claims substantiation



Step 1 - Understanding the Rules and Who Enforces Them


The first stage in understanding the rules is deciding which regulations apply to your product.  Is your product a cosmetic, a pharmaceutical, medical device, or a biocidal product, or even an ingestible product?   Each of these categories have different sets of regulations.  In this article we shall focus on cosmetic and medical product regulations, and only on the US, EU and UK.  More information about medical devices, biocides and foods regulations can be found in the following references [1,2,3].


The definitions of what is considered a cosmetic in the US and EU are described in the Federal Food and Drug and Cosmetic Act [4] and the Cosmetics Regulation (EC) No 1229/2009 [5], respectively.  For the U.K. the Cosmetic Products Enforcement Regulations 2013: Great Britain [6] provide guidance.  UK law is still closely aligned with EU regulations in many respects.


Regulators define cosmetics as products that are applied to the surface of the body, and which are linked with attractiveness, and personal care.  The definitions of what is considered a medicine in the US and EU can be found in the Federal Food and Drug and Cosmetic Act [4] and Medicinal Products Directive 2001/83/EC [7].  For the U.K., The Medicines and Healthcare Products Regulatory Agency (MHRA), provide the definition for medicines.  According to the EU regulations, medicines are defined as:

  • any substance or combination of substances presented as having properties of preventing or treating disease in human beings

  • any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis


In the US, some products can be covered by both cosmetic and pharmaceutical regulations.  These, so called, ‘OTC drug-cosmetics’ include items such as UV sunscreens, anti-acne treatments and anti-dandruff treatments.  In the EU and UK, products can only fall under one regulation.


Many products sit on the borderline between drugs and cosmetics.  Sometimes they are referred to as a ‘cosmeceutical’.  It should be stressed, however, that this term has no legal definition.  The US Food and Drug Administration (FDA), MHRA and EU all give detailed guidance on borderline products [8,9].


Legally speaking, a cosmetic claim can be defined as: ‘Any public information on the content, the nature, the effect, the properties, or the efficacy of the product’  [5].   Cosmetics regulations don’t just apply to the text on packaging, they apply to all types of communications to the public, including printed advertising, on-line advertising and TV advertising.


The legal restrictions that apply to cosmetic claims have been designed to protect the public from misleading advertising.  The Federal Food and Drug and Cosmetic Act [4] states that ‘A cosmetic shall be deemed to be misbranded- (a) If its labeling is false or misleading in any particular’, and the EU Cosmetics Regulation [5], states that claims must ‘not be used to imply that these products have characteristics or functions which they do not have’.  Similar restrictions are found in fair trading regulations that cover a wide range of products and services [10,11].  It is useful to note at this stage that the legal definition of a misleading statement, is usually based on the assumption that the person reading the claim is ‘an averagely informed consumer’.   An averagely informed consumer can be legally defined as a person who is ‘reasonably well informed, and reasonably observant and circumspect’ [12].  


In addition to legal restrictions on cosmetic claims, regulations are also emerging on green claims, to prevent so-called ‘greenwashing’ and the use of misleading information.  This falls outside the scope of this short article, but more information can be found in these references [13,14].


Recently, the EU has provided further, more detailed, guidance on the standards expected for cosmetics claims substantiation in what are called the ‘Common Claims Criteria’ [15].  The six Common Criteria for claims are (1) legal compliance, (2) truthfulness, (3) evidential support, (3) honesty, (4) fairness, and (5) informed decision making.  Perhaps the most important is evidential support, which requires companies to support claims with ‘sufficient and verifiable evidence, including expert assessments where necessary’.  Whilst the Common Criteria do not apply to the US and the rest of the world, they are widely regarded as a good description of best practice.  


When a cosmetic product is placed on the market in the EU or UK, it must have a Responsible Person (RP) assigned to it [5,6]. The RP has many legal responsibilities, one of which is the collection of claim substantiation data in the Product Information File (PIF).   


But who enforces all the rules?  In the US, the Federal Trade Commission enforces the Federal Trade Commission Act, and the Food and Drug Administration enforces the Federal Food, Drug and Cosmetic Act.   Enforcement of the EU Cosmetic Regulation and the EU fairtrade regulations is performed by national bodies.  For example, in the UK, cosmetic and fairtrade regulations are enforced by UK National Trading Standards.  Government bodies in both the US and the EU have the power to demand withdrawal of misleading claims, sometimes leading to the removal of the product from the market.


In addition to governmental controls, there is also industry self-regulation of advertising claims.  In the US, the Better Business Bureau (BBB) regulates advertising through their National Advertising Division (NAD), National Advertising Review Board (NARB) and Electronic Retailing Self-Regulation Program (ERSP).  In EU, all the nation states have their own systems of self-regulation.  In the UK, for example, the Advertising Standards Association (ASA) creates advertising guidelines (Committee of Advertising Practice, CAP, Code), and adjudicates on consumer complaints about misleading advertising.  The ASA can ask companies to withdraw advertising if they are seen to have breached its guidelines.  


In most cases no pre-registration is required for cosmetic claims.  However, in the UK, pre-clearance is required for free-to-air TV advertising and radio advertising, through Clearcast and RACC, respectively.  Furthermore, some TV shopping channels (e.g. QVC, HSN, etc) are now also asking for pre-clearance of advertising, before making products available on their shopping sites.  It is advisable to check all your media and supply-chain channels, before launch, to check whether any pre-clearances are needed. 


In addition to imposed regulations, some companies also choose to hold themselves to higher standards through various accreditations, for example, organic, vegan, not tested on animals, and halal.  If this of interest to your brand, it is best to open discussions with accreditation bodies very early-on in the innovation process, to ensure that ingredient choices and formulation choices will comply with their guidelines.  Many accreditations will require pre-registration of the products before launch.


2.  Build Your Claims Matrix


The next stage is to build your claims matrix.  This is simply a table with 4-5 columns (Figure 2).  

Figure 2.  Claims matrix template

Figure 2.  Claims matrix template


The first column lists all the claims you are aiming to make.  The second lists the nature, or classification of the claim.  The third lists the level of supporting data that is required to support the claim.  The fourth lists the tests that need to be performed, or the evidence that needs to be gathered.  The claims matrix provides a clear, rational plan for your claim support studies.  In addition, if you add a costs column to your matrix, it can also help with budgeting and deciding on which claims are affordable, and which are not. 


Starting with the classification of claims, the guidelines created by the UK CTPA and ASA helpfully classify claims into five classes [16]: performance claims, ingredient claims, sensory/aesthetic claims, combination claims and comparison claims.  Performance claims, for example, relate to the actions of the product (e.g. increases hair smoothness, reduces fine lines).  Ingredient claims relate to the product’s ingredients and, sometimes, what benefits they are known to have (e.g. contains retinol, known to reduce wrinkles, or contains elderberry extract).  Sensory and aesthetic claims refer to the subjects’ perceptions or sensorial attributes of the product (e.g. skin cooling cream).  Combination claims are, as the name suggests, claims that contain mixtures of the first three types of claims, and comparison claims compare performance with benchmark products.


The level of evidence for claims can be split into three levels [16]: (i) established and widely available evidence, (ii) requires specific evidence, and (iii) significant advance in science and technology.   The first level of evidence applies to claims that can be supported through published data, or through ingredient information.  For example, ‘cleansing shampoo’, ‘new formulation’, and ‘contains elderberry extract’.  Very little effort (or cost) is required to support this level of claim.  The second level of evidence is required when claims are made about a specific product action, for example ‘reduces hair breakage’, ‘24 hour skin moisturization’.  These claims usually need experimental evidence to be supported. Performance claims must also be supported by relevant statistical data.  The third level of evidence is reserved for breakthrough or revolutionary claims, where the product action claimed is a significant advance in science and technology.  Good examples might include, ‘restores protein bonds in the hair and makes hair stronger’, or ‘restores skin barrier function and reduces dry skin’.  These claims often need multiple, in-depth, scientific tests to provide the evidence needed.  A body of data showing the scientific advancement and importantly, the relevance to the consumer experience, will be expected to be presented.


So far, we have assumed that the technical tests required to support each claim are straightforward and obvious.  However, this is not always the case.  Often consumer terms do relate exactly to testing methods.  For example, hair moisturization claims do not usually relate to increasing hair water content.  Reducing scalp skin dryness might not relate to applying more oil to the scalp.  The cosmetic scientist often must learn the art of translating claims language into more accurate scientific language The art of translation is the subject a separate article in this series. 


Of course, there are a wide range of possible test methods to choose from when building your claims matrix.  Further articles in this series will help with the selection of test methods for skin care, and hair care products.


3.  Design Your Studies


To execute a testing plan, the next step is to design each claims substantiation study.  A good overall plan for designing any claim support study is described in the IFSCC Monograph, Principles of Product Evaluation: Objective Sensory Methods [17].  The monograph suggests 6 steps: (1) objective, (2) outline considerations, (3) detailed protocol, (4) operation, (5) validity, and (6) conclusions.  The objective (step 1) is key to the whole process.  As in any field of science, claims testing should seek to answer a clear scientific question.  The objective should define the products being tested, the parameters being measured, and the conditions under which the test should be performed (e.g. investigation of the effects of a hair mask on hair shine after a single application on virgin Chinese hair’).  Outline considerations (step 2) relate to the many guidelines and accepted protocols that should be followed when designing a study.  These will be covered in a separate article in this series.  Detailed protocol (step 3) is the step-by-step set of instructions for a study.  In many cases this might be covered by an over-arching test protocol, and several instrumental Standard Operation Procedures (SOPs).  It is important to mention here that instruments need to be properly serviced and calibrated.  Operation (step 4) relates to having all the staffing, panelists, facilities and consumables required to deliver the studies to the standards described in the protocol.  Validity (step 5) relates to the statistical analysis of the data.  Best practice is to select the appropriate statistical tests ahead of running the study, and to use statistical power calculations to ensure that sample sizes are adequate.  Conclusions (step 6) relates to the reporting of the data in a final report.  Valid conclusions need to be made that draw back to the stated objectives.   


A final tip.  Having a high quality test report does not guarantee that the authorities will agree with the claims you are trying to support, so ensuring you understand the testing being performed is essential to determine whether it will meet your requirements for claims support.  Supporting the claim remains the responsibility of the brand alone.


Conclusions


This article describes how building a good plan for claims substantiation involves three steps: (i) understanding the rules, (ii) building a claims matrix, and (iii) designing the studies.  It is the responsibility of the cosmetic scientist to brief their business colleagues on the benefits of good quality claim support and to enable properly informed decision making.  Doing this properly will minimize the risks of adverse rulings from regulators or litigation from disgruntled consumers.


More information in the TRI Library





Test Your Knowledge with Our Multiple Choice Quiz ⬇️




 

References


  1. Malinowski, M. (2021) Advertising of Medical Devices and Principles of Claim Substantiation in European Union. American Journal of Biomedical Science & Research, 12(4), 389-391. http://dx.doi.org/10.34297/AJBSR.2021.12.001777 


  2. Knight, D.J., & Cooke, M. (Eds.) (2002). The Biocides Business: Regulation, Safety and Applications.  Wiley.  https://doi.org/10.1002/352760197X


  1. González-Díaz, C., Gil-González, D. and Álvarez-Dardet, C. (2018). Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA. Journal of Food Science, 83: 2710-2717. https://doi.org/10.1111/1750-3841.14359 

  2. U.S. Food & Drug Administration. (2024). Federal food, drug, and cosmetic act. Retrieved September 29, 2024, from https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act 

  3. European Union (2024) Regulation (EC) No. 1223/2009 Cosmetic products.  Retrieved September 29, 2024, from  https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223 

  4. U.K. Office for Product safety and Standards (2023) Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain.  Retrieved January 2025, from https://www.gov.uk/government/publications/cosmetic-products-enforcement-regulations-2013/regulation-20091223-and-the-cosmetic-products-enforcement-regulations-2013-great-britain

  5. European Union (2021) Directive 2001/83/EC Medicinal Products for Human Use.  Retrieved January 3rd, 2025, from https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0083:EN:HTML 

  6. European Commission (2018) Manual of the Working Group on Cosmetic Products (Sub-group on Borderline Products) on the scope of application of the Cosmetics Regulation (EC) NO 1223/2009 (ART. 2(1)(A)) Version 3.1.  Retrieved January 3rd, 2025, from https://ec.europa.eu/docsroom/documents/29002

  7. U.S. Food & Drug Administration. (2024). Is it a cosmetic, a drug, or both? (Or is it a soap?).  Retrieved January 3rd, 2025, from https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap  ​

  8. European Union. (2024). Directive 2005/29/EC Unfair business-to-consumer commercial practices in the internal market. Retrieved September 29, 2024, from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32005L0029 

  9. Federal Trade Commission. (2024). Federal trade commission act. Retrieved September 29, 2024, from https://www.ftc.gov/legal-library/browse/statutes/federal-trade-commission-act

  10. Boulieri, M. (2022) The average consumer: Is there truly an “average’ when it comes to human behavior and how can it be defined? Retrieved January 3rd, 2025, from https://www.linkedin.com/pulse/average-consumer-truly-when-comes-human-behavior-how-can-boulieri/ 

  11. European Commission. (2024). Green claims: New criteria to stop companies from making misleading claims about environmental merits of their products and services. Retrieved September 29, 2024, from https://environment.ec.europa.eu/topics/circular-economy/green-claims_en

  12. Federal Trade Commission. (2024). Green guides. Retrieved September 29, 2024, from https://www.ftc.gov/news-events/topics/truth-advertising/green-guides

  13. European Commission. (2017). Technical document on cosmetic claims.  Retrieved January 3rd, 2025, from https://ec.europa.eu/docsroom/documents/24847 

  14. Cosmetic Toiletry and Perfumery Association CTPA (2018) CTPA Guide to Cosmetic Advertising Claims, 2nd Edition. Retrieved January 3rd, from https://www.ctpa.org.uk/news/new-ctpa-guide-to-advertising-claims-4080 

  15. International Federation of Societies of Cosmetic Chemists. (1987). Principles of product evaluation: Objective sensory methods. (I.F.S.C.C. Monograph Number 1) https://ifscc.org/monographs/monograph-no-1-principles-of-product-evaluation-objective-sensory-methods/

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