Cosmetics Claims Substantiation: What You Need to Know
The claims you put on your cosmetic product’s packaging must be substantiated. Even where cosmetics claims substantiation isn’t required by law, it’s a responsible business practice to put your cosmetic products through appropriate testing before they hit the market.
Let’s take a look at what cosmetics claims are, how they are substantiated, and what options you have for cosmetics claims substantiation as a brand or manufacturer.
What Are Cosmetic Claims?
Simply put, a cosmetic claim is any result that your cosmetic or skin product promises to deliver–whether that promise is on its packaging, on your brand’s website, or in an advert.
Examples of cosmetic claims are:
- moisturizer
- cleanser
- reduces the appearance of wrinkles
- balances skin oils
- prevents hair loss, etc.
Depending on your target market, cosmetics claims substantiation may be mandatory or voluntary. For instance, in the EU, regulations require that claims for cosmetic products must be supported by “adequate and verifiable evidence.”
Meanwhile, in the U.S., the Food and Drug Administration (FDA) does not approve cosmetic label claims, but it does monitor products already on the market. In the past, the FDA issued warning letters to firms that made unapproved claims on their cosmetic products.
How Is Cosmetics Claims Substantiation Done?
Even if cosmetics claims substantiation is not mandatory in your target market, backing up your products’ claims with proper evidence is the responsible thing to do. Not only does it help your consumers make informed choices, but it strengthens your brand’s reputation and gives you an opportunity to prove your products are innovative and effective.
There are different methods to support your cosmetics claims, the main three of which are:
- gathering evidence via consumer perception tests and questionnaires
- using information from scientific publications and market data
- experimental studies (in silico, in vitro, ex vivo, in vitro, etc.)
Let’s look at some of the options available for experimental studies:
Evaluation on Human Volunteers (In Vivo)
To gather evidence about a cosmetic product’s effectiveness, volunteers may be asked to use a product as instructed for a certain period of time, or have it applied to their skin under controlled laboratory conditions. Specialized equipment is then used to accurately measure the relevant parameters, such as the degree of hydration, skin elasticity, sun protection, and so on.
Ex Vivo / In Vitro Tests
Both ex vivo and in vitro tests are performed outside of living organisms. The main difference between the two is: ex vivo uses harvested tissue, such as cut human hair or human skin explants–while in vitro uses artificial models and cell lines (e.g., reconstructed human epidermis). Depending on the exact product and claims, researchers choose the most appropriate methods and models for cosmetics claims substantiation.
In Silico: Virtual and Simulated Testing
An innovative approach to testing, in silico experiments are performed on a computer or via computer simulation. What makes in silico testing especially interesting is that it needs no physical samples. Instead, this method can use existing data on chemical compounds to create models and simulations. More complex in silico models can even predict the potential effects of new compounds using extrapolation, linear regression and cutting-edge artificial intelligence technologies.
Best Practices for Experimental Studies in Cosmetics Claims Substantiation
Whichever method (in silico, in vitro, ex vivo, in vivo) you use for experimental studies in cosmetics claims substantiation, certain best practices must be followed:
- studies should use standardized conditions and protocols with validated methods
- test facilities must maintain a quality assurance system and standard operating procedures
- a monitoring system should be set up for each study to ensure that the protocol and procedures are followed
- appropriate statistical analysis of the data should be performed
- persons conducting the study must have appropriate qualifications, training, experience, as well as high ethical standards and professional integrity
The list above is far from exhaustive. You can find detailed information about best practices for cosmetics claims substantiation in certain documents applicable to your market, such as European Regulation 655/2013 and the Technical Document on Cosmetic Claims.
Find a Cosmetics Testing Program to Suit Your Needs
At Bioalternatives, we are committed to developing effective in silico, in vitro and ex vivo alternative options to animal experimentation methods, by offering a full range of solutions for the development of active ingredients and cosmetic formulations.
We offer customized technical solutions to guide your product research and support the claims of your cosmetic products. Our selection of in vitro and ex vivo testing solutions can be used to characterize your cosmetic products’ active ingredients, demonstrate the efficacy of your formulations, substantiate your label claims, and test the safety of your cosmetic products at an early stage (for R&D purposes only).
With extensive experience in cosmetic product testing and state-of-the-art facilities, we are pleased to offer you dedicated project management support and consulting for your R&D process.
Ready to discuss a testing and research program that will suit your business’s needs?
