Cosmetic Claim Substantiation:Do’s & Don’ts
Early in the launch of CosmetiChroma, I wrote an article about Cosmetic Claims. This article builds on this and shows how you can find out more in our first ever LIVE Training session …
Introduction: What is a Cosmetic Claim?
Cosmetics Europe defines cosmetic claims as statements that describe the characteristics and functions of a cosmetic product. They are used primarily for marketing purposes – on the content, type, effect, properties or efficacy of cosmetic products.
Article 20 of the EU Regulations 1223/2009 states: «….labelling… advertising … text, names, trademarks, pictures or other signs shall not be used to imply …products have characteristics or functions which they do not have …»
Types of a Cosmetic Claim
The two main categories for cosmetic claims are:
- Functional Claims: These refer to the specific benefits a product provides, such as “moisturises skin” or “strengthens hair”.
- Sensory Claims: These focus on the sensory experience of using the product, like “leaves skin feeling silky smooth” or “has a refreshing scent”.
Under these categories can be found 8 sub-categories of cosmetic claim:
- Performance – linked to the product’s efficacy
- Ingredients – cited in the cosmetic product adding a particular benefit
- Formulation – type of formulation, i.e, vegan, organic,…
- Sensory & Aesthetic – evoking the senses, e.g., perfumes or appearance, e.g., stick vs gloss format
- Comparative – comparisons to other products on the market
- Environmental – sustainability practices contributing to the environment
- Perception – how a claim is perceived to the consumer
- Puffery – clear exaggeration e.g., “RedBull gives you wings“
Cosmetic Claim Evidence & Substantiation
There are Levels and Types of cosmetic claim substantiation.
- Levels of substantiation are those which are: a) widely acknowledged; b) need evidence; and c) have evidence from significant advances in science.
- Types of substantiation consist of: a) publications, b) in silico, c) in vitro, d) ex vivo, e) in vivo
- in silico consists of “computer modelling”
- in vitro are living components of an organism
- ex vivo are organ cultures, e.g., human hair tresses
- in vivo are tests conducted on live people which is the gold standard 💫
Protocols and Test Reports for Cosmetic Claim Testing
Protocols used for testing for cosmetic claims and their resulting test reports must be:
- Repeatable • Predictable • Reliable • Robust
- Step-by-Step: Test method & relevance to study objective • results • results interpretation • discussion • conclusions
- Follow Good Document Practices: Person conducting the test • signatures • dates • validity • sample numbers & references
- Credibility: Relevant panels • results representative of all studies
- Product Information File (PIF): Regulatory EU file • must contain any proof needed for the claimed effect
- Claims Advertising: for all claims made a full claims dossier demonstrating “proof of effect”
Consumer Panel in Claims Studies
Biological
Essential to cosmetic claim substantiation is making sure the “panel” consists of the right consumers for the claim being made. In other words, if your claim is related to “sensitive skin“, you targeted claims testing panel MUST have sensitive skin otherwise the “sensitive skin” claim is null and void.
Other biological factors must also be considered such as: ethnicity, gender, skin type, age and circadian rhythms.
Dermographics
Also, what about dermographics? Things like the location, consumer panel lifestyle and habits are equally important when doing claims testing.
Legislation on Claims and Advertising
EU
“Proof of effect” is needed for compliance to the EU Cosmetic Regulations 1223/2009 via the product information file (PIF – as above) which means proof of the effect claimed is required i.e., substantiation.
Furthermore, the EU Cosmetic Claim Criteria (Commission Regulation (EU) No 655/2013) introduced us to 6 key principles relating to claims in the EU notably:
- Legal compliance: can not claim something which is already not permitted
- Truthfulness: whatever claim must be true
- Evidential support: claims must be substantiated
- Honesty: target group is included in the test panels
- Fairness: can not denigrate your competition
- Informed decision-making: the averagely informed consumer must be able to make a decision
USA
There are 2 primary agencies in the US that regulate cosmetic claims and they do so from different angles:
- The Federal Trade Commission (FTC) regulates advertising claims for cosmetics to ensure they are truthful, not misleading, and adequately substantiated.
- The Food and Drug Administration (FDA) oversees labelling of claims, e.g, packaging and they state that “…under the law, information on cosmetic labeling, including claims, must be truthful and not misleading. In addition, if a product is marketed with claims for purposes such as treating or preventing disease, or affecting the structure or function of the body—including the skin—it’s a drug according to the law, and it must meet the requirements for drugs..”
Also, 21CFR Chapter 9 – Subchapter VI of the United States Code states that «…Cosmetic products are deemed misbranded if their labelling is false or misleading…»
Note that, a cosmetic is classed as a drug when:
- it claims that it can look after, reduce, treat or prevent an illness
- it claims that it can change the structure, or the functioning of the human body
- it contains an ingredient destined for medical use
Conclusion: Do’s and Don’ts for Cosmetic Claims
Do’s:
- Be Truthful: Ensure all claims about your cosmetic products are accurate and truthful.
- Substantiate Claims: Back up your claims with reliable evidence, such as scientific studies or consumer perception data.
- Disclose Important Information: Provide all necessary information that could influence a consumer’s decision.
- Use Clear Language: Make sure your claims are easy to understand and not misleading.
- Stay Consistent: Ensure your advertising claims are consistent with your product labelling and other promotional materials.
Don’ts:
- Avoid Exaggeration: Do not make exaggerated claims that cannot be substantiated.
- Mislead Consumers: Avoid making claims that could mislead consumers about the benefits or effects of your product.
- Ignore Regulations: Do not overlook the regulatory requirements in the market.
- Use False Endorsements: Do not use fake endorsements or testimonials to promote your products.
- Hide Information: Do not withhold important information that could affect a consumer’s purchase decision.
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