Industries: Skin & Cosmetics

US Cosmetic Regulation - FDA CFR Title 21

Course Director: Wen Schroeder

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Today's consumer product companies face a tremendous task of bringing newer, better products into the market within a much shorter time frame. A successful market entry strategy often incorporates complex configuration of consumer trend analysis, scientific know-how, efficiency in product development and supply chain management. It is also essential to factor in regulatory feasibility analysis early in the game to avoid unexpected, last minute delay in product launch.

Cosmetic products marketed in the US are regulated under the authority of the Food & Drug Administration (FDA). The regulations pertinent to cosmetic products are published in Title 21, Code of Federal Regulations, in particular, parts 700 to 740. In addition, new legislation such as the Safe Cosmetics Act of 2011 is emerging and may lead to more stringent requirements in the foreseeable future.

This course provides an in-depth guide to the US cosmetic legislative framework. Key focus is placed on helping the participants to successfully navigate both existing cosmetic regulations and anticipated future legislation. A brief overview of international regulations will be given to help the participants develop global perspectives. Workshops with actual case studies will be conducted throughout the course to bring the participants closer to the reality of marketing cosmetic products in the US.

Who Should Attend

This three-day course is designed for professionals in the personal care, cosmetic and pharmaceutical industries engaged in all phases of cosmetic product development, including:

  • Research & Development
  • Technology, Formulation & Product Development
  • Marketing & Technical Sales
  • Regulatory Affairs
  • QA & QC Professionals
  • Business Decision Makers

Course Agenda

First Day

Introductions & Agenda Review — 9:00am – 9:30am

Global vs. US Cosmetic & Toiletry Market — 9:30am - 10:30am

  • The consumers
  • The market
  • Future trend & outlook

International Cosmetic Regulatory Overview — 11:00am – 12:00pm

  • Global legislative fundamentals
  • Product definition & classification
  • Major regulatory camps around the world

Lunch — 12:00pm – 1:00pm

US Cosmetic Regulation - Legislative Background — 1:00pm – 3:00pm

  • Historical legislative development
  • Legal definition & distinction
  • Drug vs. Cosmetic
  • The myth of "cosmeceuticals"
  • Product classification standards
  • What about combination products?

US Cosmetic Regulation – Manufacturing — 3:30pm – 4:30pm

  • Control of cosmetic ingredients
  • Safety & performance
  • Manufacturing requirements
  • Registration
  • GMPs

Workshop — 4:30pm - 5:30pm

Second Day

US Cosmetic Regulation - Labeling & Claims — 9:00am – 11:00am

  • Cosmetic labeling
  • Cosmetic advertising & promotion
  • Claims substantiation

Workshop - Claims Design & Analysis — 11:30am - 1:00pm

Lunch - 1:00pm – 2:00pm

US Cosmetic Regulation - In Market Control — 2:00pm – 3:30pm

  • Post sale cosmetic products control
  • Import requirements
  • Process
  • Inspection
  • Permit, certification & labeling

Workshop — 4:00pm - 5:30pm

  • Group exercise - launch a new product in the US
  • Group exercise - import a foreign-made product into the US
  • Review, recap, questions and answers

Third Day

US Color Cosmetics Regulation – Background — 9:00am – 10:30am

  • Historical perspectives
  • Regulatory background
  • Terminology & definition
  • Regulatory framework

US Color Cosmetics Regulation - Color Additives — 11:00am – 12:00pm

  • Exemption & certification
  • FDA nomenclature
  • Petition for new listing/use
  • Labeling

Lunch - 12:00pm – 01:00pm

US Cosmetics Regulation - Current Affairs — 1:00pm – 2:30pm

  • Workshop on colors - FDA warnings case studies
  • Legislation going green - concerning organic, natural & green
  • Legislation going small - concerning nanomaterial

Discussion, review, recap, questions and answers — 3:00pm – 4:00pm

Learning Objectives

Upon completion of this course, the participants will be able to:

  • Describe US and global and C&T market
  • Gain understanding of global regulatory framework regulating cosmetic products
  • Describe US cosmetic regulations and compliance requirements
  • Outline key differences between drugs and cosmetics based on appropriate product classification standards
  • Design product advertisement & promotion strategies
  • Design and plan business strategies for successful manufacturing and launching of cosmetic products in the US