Dietary Supplement Labeling Compliance Review

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.

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.