Dietary Supplement Labeling Compliance Review

Summers, James L.

3. Edition June 2004
246 Pages, Softcover
Wiley & Sons Ltd

ISBN: 978-0-8138-0426-2

John Wiley & Sons

Wiley Online Library

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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

I. Introduction.

II. Overview of Dietary Supplements Labeling.

III. Definitions.

IV. Need for Specific Regulations Governing Dietary
Supplements.

V. Outline for Compliance Review of Dietary Supplement
Labels.

VI. Compliance Label Review.

VII. Exemptions from FDA Requirements.

VIII. Compliance Provisions.

IX. Dietary Supplement labeling Issues.

X. Listing of Charts, Graphics, Guidelines, Illustrations, and
Regulations.

XI. The Office of Dietary Supplements.

XII. Conforming Amendments.

XIII. Notices and Proposed, Interim Final, and Final Rules
Related to Dietary Supplements.

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

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

Index.

Bibliography.

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.

J. L. Summers, EAS Consulting Group, LLC