FDA Regulations for Marketing Dietary Supplements in the U.S

Event Information
Product Format
Prerecorded Event
60 Minutes
Product Description

Dietary Supplement Regulations and Trends

In order to successfully market dietary supplements in the United States, it’s essential to understand FDA’s dietary supplement regulations and trends. This audio conference will offer an excellent overview of FDA requirements for marketing, labeling, and promotion of dietary supplements in the U.S.  Our expert speaker Norma Skolnik will cover how dietary supplements can be effectively marketed in compliance with FDA requirements as well as structure/function claims, and their importance to supplement compliance in general. Understanding how to make Structure/Function claims will enable those who market them to make optimal product claims while remaining in compliance with FDA rules.

In this 60-minute session, Norma will review the Dietary Supplement GMP requirements and Adverse Event Reporting rules for Dietary Supplements. Get insights on how to overcome challenges of marketing dietary supplement in the U.S; handy tips on how to avoid regulatory problems and Dietary Supplement Warning letters, and more!

In addition, references to all relevant FDA regulations, guidance documents, and FDA websites for dietary supplements will be provided along with regulatory insights and tips.

Session Highlights:

  • Background & History of  Dietary Supplement Health & Education Act (DSHEA)
  • How dietary supplements can be marketed in the U.S. in compliance with FDA regulations
  • Overview of Structure/ Function Claim regulations
  • Insights on dietary supplement labeling requirements
  • Summary of dietary supplement GMP requirements
  • FDA rules for adverse event reporting of dietary supplements
  • Why do dietary supplement firms get warning letters & how to avoid them
  • And more!!

Points to be covered:

  • Dietary Supplement Health & Education Act (DSHEA)
  • DSHEA: How it Changed FDA’s Role in Supplement Claims & Labeling
  • U.S. Dietary Supplements
  • Dietary Supplement Controversies
  • FDA Dietary Supplement Regulatory Enforcement Priorities
  • Food Safety & Modernization Act/ Dietary Supplement Registration Requirements
  • Bioterrorism Act Requirements
  • Dietary Supplement claims / Health Claims
  • FDA Disclaimer Required for Structure/Function Claims
  • Dietary Supplement Labeling
  • Why so much controversy?
  • Conventional Food vs. Dietary Supplement
  • 2014 Final Guidance Documents on Beverages and Dietary Supplements
  • Requirements for Dietary Supplements vs. Foods
  • Points to Consider if Marketing a Dietary Supplement in the USA
  • Dietary Supplement Good Manufacturing Practices (GMPs)
  • Is it a dietary supplement? What’s Your Opinion?
  • What to expect in the near future

Who should attend: Regulatory affairs managers, Directors & associates, Compliance specialists, Marketing managers and Anyone planning to market, label or promote dietary supplements in the U.S.


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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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