Keep It Cosmetic: Update on Regulatory and Enforcement Issues

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Oct 31, 2017
60 Minutes
Product Description

How Changes to the FDA Regulations for Cosmetics Might Impact Your Business


This session by expert speaker Will Woodlee serves as an update on the U.S. Food and Drug Administration’s (FDA’s) rules for marketing beauty and personal care products as cosmetics. In this session, Will will review the differences in the cosmetic and drug categories as well as provide practical tips for marketing these products as cosmetics and how to avoid charges of unapproved drug promotion. He will also provide updated information on key FDA positions, enforcement trends, and federal legislative proposals affecting the segment. 

Session Highlights

  • Just what qualifies a beauty or personal care product as a “drug” versus a “cosmetic,” and why does it matter?
  • How does the FDA determine a beauty or personal care product’s “intended use” for evaluating its regulatory status? Will putting “cosmetic” on the label do the trick?
  • What kinds of claims and products does FDA target for drug enforcement? What are the trends?
  • How should you revise your marketing materials to lower the risk of FDA objection?
  • Changes to FDA’s regulation of cosmetics seems to be under consideration. How would they impact your business?

Key takeaways

You will gain a detailed understanding of:

  • The differences in the “drug” and “cosmetic” regulatory categories
  • How the differences in regulatory requirements for drugs and cosmetics make the regulatory status question so important
  • How FDA evaluates the intended use of a beauty or personal care product to determine its regulatory status
  • Key FDA positions on drug versus cosmetic claims
  • The latest trends in FDA enforcement against products marketed for appearance enhancement
  • Tips for promoting beauty and personal care products as cosmetics and to avoid drug charges
  • The current state of proposals to reform FDA’s regulatory authorities over cosmetics

Who Should Attend

  • Manufacturers, distributors, and retailers of cosmetics
  • Attorneys
  • Regulatory affairs specialists, and marketing professionals serving the industry
  • Investors
  • Entrepreneurs
  • Scientists and government employees interested in learning more about regulation of the category and advertising issues

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Will Woodlee

Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan, and Becker, LLP, in Washington, DC. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco product, and consumer product companies on regulatory and advertising law matters. In 2015, Super Lawyers named Mr. Woodlee a "Rising Star" of the Washington, DC, metro area's “Food & Drugs” bar....   More Info
More Events By The Speaker

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