Food Labeling Compliance Review,9780813800165

Food Labeling Compliance Review

by
Edition: 3rd
ISBN13: 9780813800165
ISBN10: 0813800161
Format: Hardcover
Pub. Date: 2003-06-30
Publisher(s): Blackwell Pub
List Price: $191.80

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Summary

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. Available in book or searchable CD-ROM formats, 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 productrs"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 Contents

Introduction
1(2)
Overview of the History of Food Labeling
3(6)
Definitions
9(2)
Changes in Food Labeling Regulations
11(8)
Ingredient Labeling
11(1)
Certified Color Additives
11(1)
Common or Usual Names for Nonstandarized Foods
11(1)
Protein Hydrolysates (21 CFR 102.22)
11(1)
Beverages that Contain Fruit or Vegetable Juice (21 CFR 101.30 and 102.23)
12(1)
Standardized Foods
12(1)
General Provisions (21 CFR Part 130)
12(1)
Special Varieties of Foods (21 CFR Parts 131 through 169)
12(1)
Nutrition Labeling
12(4)
Mandatory Labeling
12(1)
Nutrition Labeling Exemptions
13(1)
Nutrient Content Declaration
13(1)
Nutrition Label Format
14(1)
Serving Sizes
15(1)
Daily Values -- DRVs and RDIs
15(1)
Nutrient Content Descriptors
16(1)
Health Claims
16(1)
Descriptive Claims: Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh (21 CFR 101.95)
16(1)
Others; Noncertified Color Additives, and Spices and Flavorings
16(1)
Food and Drug Administration Modernization Act (FDAMA) of 1997(Pub.L. 105-115)
17(2)
Outline for Compliance Review
19(4)
Establish Jurisdiction
19(1)
Food Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act, as Amended (FD&CA)
19(1)
On Requests for Information on a Label Review and Certificate of Free Sale
19(1)
Determine the Completeness and Accuracy of the Required Label Information (21 CFR Part 101)
19(2)
Identity Statement (21 CFR 101.3)
19(1)
Net Quantity of Contents Statement (21 CFR 101.105)
20(1)
Ingredient Statement (21 CFR 101.4)
20(1)
Name and Address of the Place of Business (21 CFR 101.5)
20(1)
Nutrition Labeling (21 CFR 101.9)
21(1)
Determine the Degree of Compliance with Applicable Regulations
21(1)
Advise Responsible Firm of Label(s) Needing Corrections
21(2)
Untitled Letter
21(1)
Product Recall
21(1)
Warning Letter
21(1)
Seizure
21(1)
Citation
22(1)
Prosecution
22(1)
Injunction
22(1)
Release With Comment Notices (Import)
22(1)
Detention (Import)
22(1)
Compliance Label Review Program
23(150)
Identity Statement (21 CFR 101.3)
23(23)
Summary of the Requirements
23(1)
Questions and Responses
24(2)
Illustration VI.A.3 -- Principal Display Panel
26(1)
Regulation VI.A.4 -- Foods Named by Use of a Nutrient Content Claim and a Standardized Term (21 CFR 130.10)
27(2)
Chart VI.A.5 - Categories of Standardized Products (21 CFR Parts 131 through 169)
29(1)
Chart VI.A.6 - List of Standards of Identity for Foods (21 CFR Parts 131 through 169)
30(6)
Chart VI.A.7 - Common or Usual Names for Nonstandardized Foods (21 CFR Part 102)
36(1)
Regulation VI.A.8 - Identity Labeling of Food in Packaged Form (21 CFR 101.3)
37(2)
Chart VI.A.9 - Requirements for Foods that Resemble and Substitute for Traditional Foods (21 CFR 101.3(e))
39(1)
Chart VI.A.10 - Flavor Labeling Regulations (21 CFR 101.22)
40(6)
Designation of Ingredients (21 CFR 101.4)
46(7)
Summary of the Requirements
46(1)
Questions and Responses
47(2)
Illustrations VI.B.3 - Information Panel
49(1)
Regulation VI.B.4 - Other Common or Usual Names Specifically Prescribed by Regulations (21 CFR 101.4(b)(3) through (f))
50(3)
Name and Place of Business (21 CFR 101.5)
53(2)
Summary of the Requirements
53(1)
Questions and Responses
53(2)
Net Quantity of Contents (21 CFR 101.105)
55(5)
Summary of the Requirements
55(1)
Questions and Responses
56(4)
Nutrition Labeling (21 CFR 101.9)
60(55)
Summary of the Requirements
60(2)
Questions and Responses
62(5)
Chart VI.E.3 - Format Style Chart for Nutrition Labeling
67(1)
Illustrations VI.E.4(i) through (xiii) - Nutrition Facts Box Formats
Full Vertical Format
68(1)
Full Vertical with Footnote to the Side
69(1)
Full Vertical Dual Declaration
70(1)
Full Vertical Bilingual Label Declaration
71(1)
Full Vertical Aggregate Declaration
72(1)
Simplified Vertical Format
73(1)
Shortened Vertical Format
74(1)
Full Tabular Format
75(1)
Tabular Format for Small Packages
76(1)
Simplified Tabular Format
77(1)
Linear Formats
78(1)
Format: Food Represented for Children Less Than 2 Years of Age
79(1)
Format: Food Represented for Children Less Than 4 Years of Age
80(1)
Chart VI.E.5 - Reference Amounts for Infant and Toddler Foods (21 CFR 101.12, Table 1)
81(1)
Chart VI.E.6 - Reference Amounts for the General Food Supply (21 CFR 101.12, Table 2)
82(15)
Regulation VI.E.7 - Nutrition Information for Separately Packaged Ingredients/Foods (21 CFR 101.9(h))
97(2)
Chart VI.E.8 - Rounding Rule Table for Declaring Nutrients
99(3)
Chart VI.E.9 - Rounding Rule Table for Serving Size
102(2)
Chart VI.E.10 - Nutrition Labeling Summary Sheet
104(4)
Guidelines VI.E.11 - Guidelines for Determining Metric Equivalence
108(4)
Chart VI.E.12 - Daily Values for Nutrition Labeling
112(1)
Illustration VI.E.13(i) - Illustration of Type and Point Sizes
113(1)
Chart VI.E.13(ii) - Graphic Enhancements Used by FDA
114(1)
Nutrient Content Claims (21 CFR 101.13)
115(17)
Summary Comments
115(1)
Questions and Responses
115(6)
Chart VI.F.3 - Definition of Nutrient Content Claims (21 CFR 101)
121(9)
Chart VI.F.4 - Disclosure Statement and Criteria (21 CFR 101.13 (h))
130(1)
Chart VI.F.5 - Conditions for Use of ``Healthy''
131(1)
Health Claims (21 CFR 101.14 and Part 101, Subpart E)
132(10)
Summary Comments
132(1)
Questions and Responses
132(2)
Chart VI.G.3 - Health Claims (21 CFR Part 101, Subpart E)
134(6)
Chart VI.G.4 - Health Claims Criteria (21 CFR 101.14)
140(2)
Statements Made Concerning the Effect of Product on the Structure or Function of the Body
142(9)
Summary Comments
142(1)
Regulation VI.H.2 - Notification Procedures for Certain Types of Statements on Dietary Supplements (21 CFR 101.93(a) through(e))
143(1)
Regulation VI.H.3 - Certain Types of Statements for Dietary Supplements (21 CFR 101.93(f) and (g))
144(1)
Regulation VI.H.4 - Other Evidence that the Intended Use of a Product is for the Diagnosis, Cure, Mitigation, Treatment, or Prevention of a Disease (21 CFR 201.128)
145(1)
Chart VI.H.5 - Examples of Disease Claims and Allowable Structure/Function Claims for Dietary Supplements (21 CFR 101.93 (g))
146(5)
Authoritative Statements (FDAMA)
151(14)
Summary Comments
151(1)
Regulation VI.I.2 - Notifications for Health Claims Based on ``Authoritative Statements'' (Proposed 21 CFR 101.90)
152(1)
Chart VI.I.3 - Interim Final Rules Prohibiting Health Claims Based on ``Authoritative Statements''
153(10)
Statements VI.I.4 - Allowable Authoritative Statements by Action of the Status
163(2)
Labeling of Foods in Special Categories (21 CFR 105)
165(8)
Foods for Special Dietary Uses (21 CFR Part 105)
165(1)
Questions and Responses
165(4)
Medical Foods (21 U.S.C. 360EE(B)(3) - Orphan Drug Act)
169(1)
Infant Formula (Infant Formula Act)
170(1)
Restaurant Foods (21 CFR 101.10)
170(1)
Dietary Supplements (Not Included)
171(1)
Nutrition Labeling of Raw Fruit, Vegetables, and Fish (21 CFR 101.42)
171(2)
Administrative Rules, Decisions, and Special Labeling Requirements
173(4)
Salt and Iodized Salt (21 CFR 100.155)
173(1)
Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh (21 CFR 101.95)
174(1)
Natural (FR., Vol. 58, 1/6/93, p. 2407)
174(1)
Organic (FR., Vol. 58, 1/6/93, p. 2408)
175(2)
Exemptions from FDA Requirements for Foods
177(22)
Procedures for Requesting Variations and Exemptions from Required Label Statements (21 CFR 1.23)
177(1)
Exemptions from Required Label Statements (21 CFR 1.24)
177(4)
Petitions Requesting Exemption from Preemption for State or Local Requirements (21 CFR 100.1)
181(3)
Exemptions when it is Technologically Impracticable to Nutrition Label (21 CFR 101.9 (g)(9))
184(1)
Nutrition Labeling of Food: Exemptions/Special Labeling Provisions (21 CFR 101.9(j))
184(6)
Food: Exemptions from Labeling (21 CFR 101.100)
190(4)
Temporary Exemption for Purposes of Conducting Authorized Food Labeling Experiments (21 CFR 101.108)
194(3)
Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity (21 CFR 130.17)
197(2)
Compliance Provisions
199(6)
Failure to Reveal Material Facts (21 CFR 1.21)
199(1)
Misleading Containers (21 CFR 100.100)
199(1)
Food with a Label Declaration of Nutrients (21 CFR 101.9(g))
200(1)
Food Subject to Nutrition Labeling (21 CFR 101.9(k))
201(1)
Food: Prominence of Required Statements (21 CFR 101.15)
201(1)
Misbranding of Food (21 CFR 101.18)
202(1)
Substantial Compliance of Food Retailers with the Guidelines for the Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish (21 CFR 101.43)
203(2)
Special Food Labeling Issues
205(14)
Food Allergy
205(4)
Summary Comments
205(1)
Compliance Policy Guide
206(3)
Food Bioengineering
209(6)
Summary Comments
209(1)
Guidance for Industry
209(6)
Botanical and Other Novel Ingredients in Conventional Foods
215(4)
Summary Comments
215(1)
Letter to Manufacturers
216(3)
Charts/Illustrations/Statements/Regulations
219(2)
Index to the January 6, 1993 Federal Register Preamble and the Final NLEA Regulations (FR., Vol. 58, 1/6/93)
221(30)
Index for Food Labeling Technical Amendments; August 18, 1993 (FR., Vol. 58, 8/18/93, 44020-44096)
251(6)
Table of Contents for Chapter 5 - Foods, Colors, and Cosmetics for the Compliance Policy Guide
257(10)
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, August 1993
267(2)
Table of Contents for ``Food Labeling Questions and Answers'', Volume II, A Guide for Restaurants and Other Retail Establishments, August 1995
269(2)
Index 271(6)
Bibliography 277

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