Regulation

US Cosmetic Claims: How to be Attractive yet Non-misleading?

US Cosmetic Claims: How to be Attractive yet Non-misleading?
Language: English
Length: 90 min
Recorded on: 20 Oct 16

Package Includes

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

Course Description

Craft attractive cosmetic claims for the US market without falling into drug claims.
(i.e. Avoid getting into trouble: seizure of illegal products, criminal sanctions…)

Norman Estrin (> 35 years of experience handling OTC drug and cosmetic industries FDA regulatory issues …) will help you sharpen your judgement skills by helping you:
  • Clarify the cosmetic / drug fine line
  • Practice on avoiding drug claims with an interactive real claims quiz (anti-aging, anti-wrinkle, slimming…)

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Norman F Estrin
Norman F Estrin
Estrin Consulting Group LLC
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Dr. Norman F. Estrin, Ph.D., has over 35 years of experience handling scientific, technical, and FDA regulatory issues in the medical device, OTC drug, and cosmetic industries.

ECG’s services for the cosmetic and OTC drug industries include labeling reviews, where Dr. Estrin assesses regulatory risks of proposed claims and suggests lower-risk alternative claims. He also assists companies in addressing U.S. Customs issues.

Dr. Estrin holds a doctorate in physical-organic chemistry from Florida State University. He is Regulatory Affairs Certified by the Regulatory Affairs Professional Society. He has created and edited books on cosmetic, drug, and medical device regulation, as well as the International Cosmetic Ingredient Dictionary. He currently serves on the board of Maven Biotech and was co-founder of Discovery Pharmaceuticals, Inc. and Réma, LLC, a cosmetic company.

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Why should you view this course?

In recent times ,FDA issued more warning letters than in the past for cosmetic companies making" drug-like" claims. Is the scrutiny increasing? Join this course &avoid crossing the fine line:

  1. Avoid issues with FDA, FTC... by understanding rules set by FD&C Act / FPLA for cosmetic labeling

  2. Get fresh ideas to phrase your cosmetic claims by benefiting from expert's advice and suggestions

  3. Sharpen your judgment skills by practicing on real claims (anti-aging, anti-wrinkle, slimming...)

Who should join this course?

  • Marketing, R&D, Regulatory & Corporate Management dealing with cosmetic claims for the US market and interested in minimizing regulatory risks.

  • This course is suitable for intermediate level proficiency
    Intermediate
Course Outline

Norman Estrin, who helps companies develop lower-risk claims for the US market as part of his consulting practice, will cover:

Overview of the U.S. Regulatory Authority for Labeling

How to distinguish between claims for cosmetics and OTC drugs

  • Importance of Intended Use: Clarifying the Cosmetics / Drug Fine Line
  • What is “Misbranding”?
  • What does “False & Misleading” mean?

Real Life Case Studies from Latest FDA Warning Letters

Mini Quiz: Distinguish between Cosmetics & Drug Claims

Promoting your Cosmetic Product on your website

Drafting Good Cosmetic Claims for the US Market

Regulatory/Business Risks

How to Best Manage Product Liability

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US Cosmetic Claims: How to be Attractive yet Non-misleading?
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