Elizabeth J. (Betty) Campbell & James L. Summers 
Food Labeling Compliance Review 

Consultant and long-time Food and Drug Administration (FDA) food
labeling expert James Summers answers the many questions
surrounding FDA food labeling regulations and compliance in Food
Labeling Compliance Review. Now in its third edition, the manual is
a comprehensive food labeling compliance handbook designed to aid
in understanding the requirements of the FDA. This reference is a
must-have for regulatory officials, industry personnel, and others
responsible for assuring that the label and labeling of domestic
and imported food products in interstate commerce comply with the
requirements of the Federal Food, Drug and Cosmetic Act, as
amended.

The manual is available in book or searchable CD-ROM formats (or
both together if you order the first choice on the right). The text
is composed of three essential parts:

1.) Introduction and how-to information, including the outline
of a compliance review.

2.) Compliance step-by-step review procedure (in the form of
questions and answers) for the food label reviewer to establish the
degree to which a product’s label complies with applicable
laws and regulations. These sections also provide a basis for
developing a label for prospective food products, as well as a
foundation for responding to label deviations observed during the
review.

3.) Guidance and information for decision making such as ready
references, charts, illustrations, regulations, Federal Register
indexes and tables of content for related publications.

Clearly illustrated with dozens of charts, sample label panels
and ‘Nutrition Facts’ boxes, Food Labeling Compliance
Review is the practical, no-nonsense tool needed by both the
experienced and inexperienced food label reviewer.

About the Author: 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.

Contributor: Elizabeth J. (Betty) Campbell joined AAC
after a 35-year career with the FDA where she served as Director of
Programs and Enforcement Policy in the Office of Food Labeling in
the Center for Food Safety and Applied Nutrition, and as Acting
Director of the Office of Food Labeling. Ms. Campbell played a key
role in writing the Nutrition Labeling and Education Act (NLEA)
regulations in the early 1990s, and then had major responsibility
for implementing those regulations.

Table of Content

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

About the author

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