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

• IntroductionOverview of Dietary Supplements LabelingDefinitionsNeed for Specific Regulations Governing Dietary SupplementsOutline for Compliance Review of Dietary Supplement LabelsCompliance Label Review ProgramExemptions from FDA Requirements for FoodsCompliance ProvisionsDietary Supplement Labeling IssuesListing of Charts, Graphics, Guidelines, Illustrations and RegulationsOffice of Dietary SupplementsConforming AmendmentsNotices and Proposed, Interim Final, and Final Regulations Concerning Dietary SupplementsIndex to the September 23, 1997, Federal Register Preambles and Final DSHEA RegulationsIndex to the June 22, 1998, Federal Register Preambles to the Interim Health Claims Final Rules