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Cosmetics: How FDA Evaluates the Regulatory Status of Products (CHM561T)

Presented by: Will Woodlee
(*) Single User Price. For multiple users please call 1-844-384-4744
Pre Recorded Webinar
60 minutes
Event Description
See the sneak peek before you buy!

Learn How FDA Determines Regulatory Status

The focus of this webinar by expert speaker Will Woodlee will be on the U.S. Food and Drug Administration’s (FDA’s) rules for marketing personal care and beauty products like cosmetics and avoiding getting charged of unapproved drug promotion. Will would be explaining the differences in the drug and cosmetic categories, which includes the regulatory requirements which make marketing drugs a lot more costly and burdensome.

You will also get to know about how the regulatory status is determined by the FDA – cosmetic verses drugs – of personal care and beauty products under the “intended use” doctrine. After analysing crucial FDA positions as well as enforcement trends and precedents, you will be provided with practical tips for marketing these products as cosmetics consistent with current FDA policies.

Session Highlights:

  • What qualifies a personal care or a beauty product as a “drug” versus a “cosmetic,” and how does it matter?
  • How is the “intended use” of a personal care or beauty products determined by FDA for evaluating its regulatory status? Will putting “cosmetic” on the label do the trick?
  • What kinds of claims can make my beauty or personal care product a drug?
  • How might I revise my marketing materials to lower the risk of FDA objection?
  • Has FDA really taken enforcement action in this area?  What are the trends?
  • Can a product qualify as both a drug and a cosmetic?  How would that work?

Session Benefits:

You will gain a detailed understanding of:

  • How FDA evaluates the intended use of a beauty or personal care product to determine its regulatory status;
  • How the differences in regulatory requirements for drugs and cosmetics make the regulatory status question so important;
  • The differences in the “drug” and “cosmetic” regulatory categories;
  • Key FDA positions on drug versus cosmetic claims;
  • Trends in FDA assertion of drug status against beauty and personal care products; and
  • Tips for promoting beauty and personal care products as cosmetics and to avoid drug charges

Who Should Attend

  • Employees of 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
About Our Speaker(s)

Will Woodlee | Food and Drug Law SpeakerWill 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 l... More info

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    Event Title: Cosmetics: How FDA Evaluates the Regulatory Status of Products
    Presenter(s): Will Woodlee

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