Dietary Supplements: Current Good Manufacturing Practice, Labeling and Premarket Notification Concise Reference

This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Dietary Supplements regulations, guidance, and associated documents.

Dietary Supplements Regulations and Guidance:
* FDA Overview and Orientation
* Introduction to Dietary Supplements
* Part I: Regulations
- Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Part 101: Food Labeling
- Part 190: Diettary Supplements
* Part II: Legislative Acts and Significant Amendments
- Dietary Supplement and Nonprescription Drug Consumer Protection Act
- Dietary Supplement Health and Education Act of 1994
* Part III: Guidance and Associated Documents
- Dietary Supplements Final Rule
- Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts
- Dietary Supplement Labeling Guide
- Structure/Function Claims, Small Entity Compliance Guide
- Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
- Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
- Responses to Questions about Codex and Dietary Supplements

Reference Tools
* Part IV: Combined Glossary and Index