Food 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 which 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 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 the focal point for handling 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 the History of Food Labeling III. Definitions IV. Changes in Food Labeling Regulations A. Ingredient Labeling B. Certified Color Additives C. Common or Usual Names for Nonstandardized Foods D. Standardized Foods E. Nutrition Labeling F. Descriptive Claims: Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh G. Other Noncertified Color Additives, and Spices and Flavorings H. Food and Drug Administration Modernization Act (FDAMA) of 1997 V. Outline for Compliance Review A. Establish Jurisdiction B. Determine the Completeness and Accuracy of the Required Label Information C. Determine the Degree of Compliance with Applicable Regulations D. Advise Responsible Firm of Label(s) Needing Corrections VI. Compliance Label Review Program A. Identity Statement B. Designation of Ingredients C. Name and Place of Business D. Net Quantity of Contents Statements E. Nutrition Labeling F. Nutrient Content Claims G. Health Claims H. Statements Made Concerning the Effect of Product on the Structure or Function of the Body I. Authoritative Statements (FDAMA) J. Labeling of Foods in Special Categories VII. Administrative Rules, Decisions and Special Labeling Requirements A. Salt and Iodized Salt B. Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh C. Natural D. Organic VIII. Exemptions from FDA Requirements for Foods A. Procedures for Requesting Variations and Exemptions from Required Label Statements B. Exemptions from Required Label Statements C. Petitions Requesting Exemption from Preemption for State or Local Requirements D. Exemptions When it is Technologically Impractical to Nutrition Label E. Nutrition Labeling of Food: Exemptions/Special Labeling Provisions F. Food: Exemption from Labeling G. Temporary Exemption for Purposes of Conducting Authorizing Food Labeling Experiments H. Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity IX. Compliance Provisions A. Failure to Reveal Material Facts B. Misleading Containers C. Food with a Label Declaration of Nutrients D. Food Subject to Nutrition Labeling E. Food: Prominence of Required Statements F. Misbranding of Food G. Substantial Compliance of Food Retailers with the Guidelines for the Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish X. Special Food Issues A. Food Allergy B. Food Bioengineering C. Botanical and Other Novel Ingredients in Conventional Foods XI. Charts, Illustrations, Statements, Regulations XII. Index to the January 6, 1993 Federal Register Preamble and Final NLEA Regulations XIII. Index to the August 18, 1993 Federal Register Preamble: Nutrition Labeling Technical Amendments XIV. Table of Contents for Chapter 5 - Foods, Colors, and Cosmetics for the Compliance Policy Guide, DHHS, PHS, FDA, ORA, OF, DCP XV. Table of Contents for Food Labeling Questions and Answers for Guidance to Facilitate the Process of Developing or Revising Labels for Foods Other than Dietary Supplements, U.S. DHHS, PHS, FDA, August 1993 XVI. Table of Contents for Food Labeling Questions and Answers, Volume II, A Guide for Restaurants and Other Retail Establishments, U.S. DHHS, PHS, FDA, August 1995 Index