Food Labeling Compliance Review (eBook)

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 1995Index

"Designed to aid in understanding the FDA food labelling
regulations."

International Food Information Service