Regulation

Cosmetic Claim Substantiation: Do’s & Don’ts

Cosmetic Claim Substantiation: Do’s & Don’ts
Language: English
Length: 90 min
Recorded on: 12 Mar 25

Package Includes

6 month access to Course Recording, Presentation Slides, Q&A Transcript

Course Description

Decode the complexity of cosmetic claims substantiation process to develop claims that hold up under scrutiny in a non-harmonized regulation environment.

Learn the do’s & don’ts from expert Karen Mann who will review the regulatory differences between various countries (incl. EU vs US) and guide you through all methods & tests (in-vitro, ex-vivo, in-silico, in-tubo…) that can be used to substantiate your claims.

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Karen LV Mann
Karen LV Mann
Cosmetic Chroma
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KarenLV MANN PhD is the Founder and Owner ofCosmetiChroma, a technical, scientific training and consulting company founded recently in July 2024, created for cosmetic industry professionals and businesses looking to master cosmetics development and global launches with confidence.

Karen has been in the cosmetic industry for 20 years, most recently as Global Head of Regulatory and Quality at Dolce&Gabbana in Milan.  Prior experience included 12 years at L’Oréal in Paris and Global Director of Regulatory at Intercos in Italy.  Other experience included Consumer Advisory, Public Relations, Supply Chain and within client Management, Quality, Scientific Affairs, and Regulatory Research & Development at the Senior Management level.  Equally, Karen has participated in lobbying at Cosmetic Trade Industry Association working groups such as Cosmetics Europe (EU) dealing with China, REACh at CTPA (UK), and the Middle East at FEBEA (France). So far, Karen has held webinars, written training courses on Regulatory and Scientific Affairs, and several articles on her company website.

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Participants of this course includes

Why should you view this course?

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 the 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.

Who should join this course?

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

  • Complete the course and (unlock your personalized certificate)– your badge of accomplishment awaits!

  • This course is suitable for intermediate level proficiency
    Intermediate
Questions you will be able to answer after this course:

  1. How do I ensure my cosmetic claims comply with FDA, FTC, and EU regulations?

  2. What testing methods (clinical, instrumental, consumer perception) are most effective for supporting specific claims?

  3. What are the latest regulatory updates impacting cosmetic claims, and how do I stay compliant?

Course Outline

What does "Cosmetic Claims" signify?

  • Recap of their history, legal situation
  • Scientific background in pharma and cosmetic applications

Types of claims

  • Categories (performance, ingredients, safety, technology, etc)
  • Interpretation examples

Claims evidence and substantiation:

  • Levels of evidence (widely acknowledged, needing evidence, scientific advances)
  • Types of evidence (in silico, in vitro, in vivo, ex vivo,...)
  • Types of protocols and tests
  • Consumer panels

Legislation on claims and advertising

  • EU commission regulation 655/2013
  • EU common criteria and borderlines
  • US regulations including Federal Trade Commission (FTC) and Federal Drug Administration (FDA)
  • US borderlines
  • Situation in ROW (rest of world)
  • Case studies

Claim substantiation dossier – do’s and don’ts:

  • Key elements to consider when considering claim substantiation
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Cosmetic Claim Substantiation: Do’s & Don’ts
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