FDA Regulation of Cosmetics & New Legislation

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

Marketing Cosmetics and Personal Care Products in Compliance with New FDA Regulations

Cosmetic regulations are changing and FDA is looking at cosmetics more closely than ever. A new legislation for cosmetics, that is, the Personal Care Products Safety Act, was proposed in 2015. Once it is passed into law, it will increase and strengthen the regulatory requirements for cosmetics and personal care products.

Join this webinar by expert speaker Norma Skolnik, where you will learn about the current FDA requirements and regulations for marketing and labeling cosmetics. You will get insights on the new requirements to be implemented once the Personal Care Products Safety Act of 2015 is passed.

Session Highlights

  • Laws and regulations applicable to Cosmetics in the U.S.
  • FDA’s Cosmetic Labeling Requirements
  • Cosmetic claims and compliance issues
  • What are “Cosmeceuticals” and how they can be legally marketed?
  • The 2015 proposed cosmetics legislation, the Personal Care Products Safety Act
  • Adverse event labeling and reporting requirements for Cosmetics and how they will change under the Personal Care Products Safety Act
  • Citations to all relevant FDA regulations
  • Relevant FDA website references
  • Know-how tips on marketing Cosmetics and Personal Care Products in compliance with FDA regulations

Session Agenda

  • What is a cosmetic?
  • Cosmetic vs. drug
  • Implications of cosmetic
  • Cosmeceuticals
  • Cosmetic labeling requirements
  • Name and place of business of manufacturer, packer, or distributor (21 CFR 701.12)
  • Establishment of warning statements 740.1
    • Warning statements
  • Cosmetic ingredient nomenclature
    • International nomenclature of cosmetic ingredients (INCI)
  • Cosmetic claims
  • FDA warnings re: cosmetics
    • FDA warning letter April 2016
  • Cosmetic GMPs & quality assurance
  • Cosmetic compliance
  • Cosmetic adverse event (AE) reporting
  • Personal Care Products Safety Act (S. 1014)
  • What is a serious adverse event?
    • Cosmetic adverse event reporting
    • Serious adverse event reporting requirements
  • On-line reporting of Medwatch forms
    • AE reporting
  • FDA Medwatch forms (Form 3500A) for SAE reporting
  • Summary

Who Should Attend

  • Regulatory Affairs Managers and Associates
  • QA Managers
  • Cosmetic and Personal Care Marketing Managers
  • Cosmetic Company Product Managers

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...   More Info
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