Cosmetic Claim Substantiation: Do’s & Don’ts

Despite no standardized regulation, consumers and governments are paying much more attention to cosmetic claims and are demanding substantial “proof” for these claims. As a formulator, lab manager or marketer, you certainly don’t want to go ahead with products that have unproven claims. It could taint the reputation of your whole company and can cost you your time & efforts.

Then, how to proceed? Join this course and our expert will help you in decoding the complexity of claims substantiation process. You will be able to:

1. Best align your cosmetic claims attractiveness vs. regulation by understanding regulatory differences between various countries.


2. Define solid protocols to liaise more easily with independent labs by reviewing different classes of testing (in-vitro, ex-vivo, in-silico, in-tubo, bibliography...).


3. Understand the do’s & don’ts to strengthen your substantiation dossiers by reviewing practical examples of success.

Formulators, R&D and lab managers, marketers at ingredient suppliers or cosmetics manufacturers with a need to better master claim substantiation / evidence-based claims.

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The following sections will be covered during this session:

1. What does "Cosmetic Claims" signify?
• Recap of their history, legal situation
• Scientific background in pharma and cosmetic applications


2. Types of claims
• Categories (benefits, ingredients, safety, technology)
• Interpretation examples


3. Current regulation standards:
• EU regulation 655/2013
• Situation in US, Canada, Europe
• Federal Trade Commission (FTC) rules
• FDA


4. How to evaluate claims supplied for various ingredients?
• In-vivo/In-vitro tests
• Gene Array analysis


5. Claim substantiation dossier - do’s and don’ts :
       • Based on literature
       • Based on in vitro data
       • Based on vehicle controlled clinical studies
       • Ingredient based or finished formula


6. Examples of success, challenges and failure


7. What claims are acceptable before becoming a drug claim?


8. 30 mins Q&A - Interact live/ ask questions directly from the expert!

Have a query? Email us for any help!