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

Dietary Supplements Manufacturing and Distribution is a unified reference source for the U.S. Food and Drug Administration’s regulations, guidance, and associated documents pertaining to the manufacture and distribution of dietary supplements. The dietary supplement industry includes a vast array of ingredients, product forms, suppliers, manufacturers, and distributors. With such diversity in the marketplace it is important to fully understand the rules governing the industry. It is the responsibility of the participants in all stages of the manufacturing and distribution process to protect dietary supplement consumers and to provide safe and consistent products. This reference book is a compilation of 21CFR (Code of Federal Regulations, Title 21) as it applies to dietary supplements, DSHEA (Dietary Supplements Health and Education Act of 1994), DSNDCPA (Dietary Supplement and Nonprescription Drug Consumer Protection Act), and related guidance documents. Also included are selected warning letters demonstrating communications from the FDA, a combined glossary of the legally defined terms, and a detailed index. Included Documents and Features: - FDA Overview and Orientation - Introduction to Dietary Supplements - Part 1: General Enforcement Regulations - Part 101: Food Labeling - Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements - Part 119: Dietary Supplements that Present a Significant or Unreasonable Risk - Part 190: Dietary Supplements - Dietary Supplement and Nonprescription Drug Consumer Protection Act - Dietary Supplement Health and Education Act of 1994 - Guidance Documents - Sample Warning Letters - Combined Glossary and Index