Dietary Supplement Labeling Compliance Review

Consultant and long-time FDA food and dietary supplement labeling expert James Summers offers a comprehensive guide to understanding and complying with the dietary supplement labeling requirements of the Food and Drug Administration (FDA) in Dietary Supplement Labeling Compliance Review, Third Edition.

Available in book or searchable CD-ROM (view CD-ROM version) formats, this updated review is composed of three essential parts:

• 
  
• Sections I through V consist of the introduction and how-to information.
  
• Sections VI through IX consist of the compliance step-by-step review procedure (in the form of questions and responses,) and other labeling requirements.
  
• Sections X through XV consist of guidance and information for decision making.

Clearly illustrated with dozens of charts, sample label panels, and supplement facts boxes, this manual is the straightforward, no-nonsense tool both inexperienced and experienced dietary supplement label reviewers need to assure labeling compliance

Introduction

Overview of Dietary Supplements Labeling

Definitions

Need for Specific Regulations Governing Dietary Supplements

Outline for Compliance Review of Dietary Supplement Labels

Compliance Label Review Program

Exemptions from FDA Requirements for Foods

Compliance Provisions

Dietary Supplement Labeling Issues

Listing of Charts, Graphics, Guidelines, Illustrations and Regulations

Office of Dietary Supplements

Conforming Amendments

Notices and Proposed, Interim Final, and Final Regulations Concerning Dietary Supplements

Index to the September 23, 1997, Federal Register Preambles and Final DSHEA Regulations

Index to the June 22, 1998, Federal Register Preambles to the Interim Health Claims Final Rules

James L. Summers is a senior consultant at AAC Consulting Group, Inc. (Rockville, MD), a firm providing consulting services in food, dietary supplement, cosmetics and other areas that fall under the jurisdiction of FDA. He has been offering expert labeling and compliance advice to AAC clients since he ended his 32-year tenure at the FDA. He has held positions as aquatic sampling specialist, supervisory microbiologist, public health sanitarian, general biologist, FDA inspector, regional shellfish specialist, and consumer safety officer (in the Division of Regulatory Guidance). In his last position at FDA, he served as supervisory consumer safety officer, branch chief in the Office of Food Labeling. There he was at the center of solving the most controversial, complex, and precedent-setting problems involving regulatory compliance issues dealing with food labeling. He participated in the development of policies and regulatory strategies regarding the enforcement of NLEA and other food labeling regulations Consultant and long-time FDA food and dietary supplement labeling expert James Summers offers a comprehensive guide to understanding and complying with the dietary supplement labeling requirements of the Food and Drug Administration (FDA) in Dietary Supplement Labeling Compliance Review, Third Edition.

Available in book (view book version) or searchable CD-ROM formats, this updated review is composed of three essential parts:

• 
  
• Sections I through V consist of the introduction and how-to information.
  
• Sections VI through IX consist of the compliance step-by-step review procedure (in the form of questions and responses,) and other labeling requirements.
  
• Sections X through XV consist of guidance and information for decision making.

Clearly illustrated with dozens of charts, sample label panels, and supplement facts boxes, this manual is the straightforward, no-nonsense tool both inexperienced and experienced dietary supplement label reviewers need to assure labeling compliancetions.