Monday 5:30 PM 2nd FDA Registration Seminar
FDA Registration Seminar
Speaker: Joel Choi
Time: 5:00 PM
Location: CM Holdings USA Conference Room
If you would like to attend, please let us know in advance.
Attendees: 10 or fewer




Summary of contents

FDA Supplement Registration Presentation

Slide 1: Title Slide

Title: "FDA Supplement Registration Process"

Subtitle: "Guidelines and Compliance for Dietary Supplements"

Company Logo & Date

Slide 2: Introduction

Overview of FDA’s role in supplement regulation

Importance of compliance for market entry

Slide 3: Definition of Dietary Supplements

What qualifies as a dietary supplement?

FDA classification and key regulations

Slide 4: Regulatory Framework

Dietary Supplement Health and Education Act (DSHEA)

FDA requirements for supplements

Distinction between drugs and supplements

Slide 5: Notification Requirements

New Dietary Ingredient (NDI) Notification

Generally Recognized As Safe (GRAS) requirements

Pre-market notification procedures

Slide 6: Labeling and Claims Compliance

FDA rules for supplement labeling

Structure/Function claims vs. Disease claims

Required disclaimers

Slide 7: Good Manufacturing Practices (GMPs)

FDA’s 21 CFR Part 111 compliance

Key GMP requirements for manufacturers

Quality control and record-keeping obligations

Slide 8: Registration Process

Facility registration with FDA (FDA Food Facility Registration – FFR)

Submitting necessary documentation

Timeline and approval process

Slide 9: Post-Market Responsibilities

Adverse event reporting (Serious Adverse Event Reporting - SAER)

FDA inspections and enforcement actions

Recalls and corrective measures

Slide 10: Conclusion & Best Practices

Ensuring regulatory compliance

Avoiding common pitfalls

Resources for additional guidance

Slide 11: Q&A

Open floor for questions

Contact information for further inquiries