Food Labeling Compliance Review

FOOD LABELING COMPLIANCE REVIEW......Page 5
Contents......Page 9
I. Introduction......Page 17
II. Overview of the History of Food Labeling......Page 19
III. Definitions......Page 25
2. Beverages that Contain Fruit or Vegetable Juice (21 CFR 101.30and 102.23)......Page 29
2. Nutrition Labeling Exemptions......Page 30
3. Nutrient Content Declarations......Page 31
5. Serving Sizes......Page 32
6. Daily Values - DRVs and RDIs......Page 33
G. Others: Noncertified Color Additives, Spices and Flavorings......Page 34
1. Identity Statement (21 CFR 101.3)......Page 35
4. Name and Address of the Place of Business (21 CFR 101.5)......Page 36
4. Seizure......Page 37
9. Detention (Import)......Page 38
1. Summary of the Requirements......Page 39
2. Questions and Responses......Page 40
3. Illustration VI.A.3 - Principal Display Pane! (21 CFR 101.1)......Page 43
4. Regulation VI.A.4 - Foods Named by Use of a Nutrient Content Claim and a Standardized Term (21 CFR 130.10)......Page 44
5. Chart VI.A.5 - Categories of Standardized Products (21 CFR Parts 131 through 169)......Page 46
6. Chart VI.A.6 - List of Standards of Identity for Foods (21 CFR Parts 131 through 169)......Page 47
7. Chart VI.A.7 - Common or Usual Names for Nonstandardized Foods (21 CFR Part 102)......Page 53
8. Regulation VI.A.8 - Identity Labeling of Food in Packaged Form (21 CFR 101.3)......Page 54
9. Chart Vl.A.9 - Requirements for Foods that Resemble and Substitute for Traditional Foods (21 CFR 101.3(6))......Page 56
10. Chart V1.A.10 - Flavor Labeling Regulations (21 CFR 101.22)......Page 57
1. Summary of the Requirements......Page 63
2. Questions and Responses......Page 64
3. Illustration VI.B.3-Information Panel (21 CFR 101.2)......Page 67
4. Regulation VI.B.4 - Other Common or Usual Names Specifically Prescribed by Regulations (21 CFR 101.4(b) (3) through 4(f))......Page 68
2. Questions and Responses......Page 71
1. Summary of the Requirements......Page 73
2. Questions and Responses......Page 74
1. Summary of the Requirements......Page 79
2. Questions and Responses......Page 81
3. Chart VI.E.3 - Format Styles for Nutrition Labeling......Page 86
(a) Full Vertical Format......Page 87
(b) Full Vertical Format with Footnote to the Side......Page 88
(c) Full Vertical Formats with Dual Declaration......Page 89
(d) Full Vertical Format with Bilingual Label Declaration......Page 90
(e) Full Vertical Format with Aggregate Declaration......Page 91
(f) Simplified Vertical Formats......Page 92
(g) Shortened Vertical Format......Page 93
(h) Full Tabular Format......Page 94
(i) Tabular Format for Small Packages......Page 95
(j) Simplified Tabular Format......Page 96
(k) Linear Formats......Page 97
(I) Format: Food Represented for Children Less than 2 Years of Age......Page 98
(m) Format: Food Represented for Children Less than 4 Years of Age......Page 99
5. Chart VI.E.5 - Reference Amounts for Infant and Toddler Foods (21 CFR 101.12, Table 1)......Page 100
6. Chart Vl.E.6 - Reference Amounts for the General Food Supply (21 CFR 101.12, Table 2)......Page 101
7. Regulation VI.E.7 - Nutrition Information for Separately Packaged Ingredients/Foods (21 CFR101.9(h))......Page 116
8. Chart VI.E.8 - Rounding Rule Table for Declaring Nutrients......Page 118
9. Chart VI.E.9-Rounding Rule Table for Serving Size......Page 121
10. Chart VI.E.10 - Nutrition Labeling Summary Sheet......Page 123
11. Guidelines VI.E.11 - Guidelines for Determining Metric Equivalents for Household Measures......Page 127
12. Chart VI.E.12-Daily Values for Nutrition Labeling......Page 131
13. Illustration VI.E.13-Illustration of Type and Point Sizes......Page 132
14. Chart VI.E.14 -Graphic Enhancements Used by FDA......Page 133
15. Regulation VI.E.15 - Exemptions and Special Labeling Provisions (21 CFR 101.90))......Page 134
16. Regulation Vi.E.16 - Nutrition Labeling for Restaurant Foods......Page 140
17. Regulation VLE.17 - Exemptions when it is Technologically Impractical to Nutrition Label (21 CFR 101.9(g)(9))......Page 141
18. Regulation VI.E.18 - Guidelines for Nutrition Labeling of Raw Fruits, Vegetables, and Fish (21 CFR 101.44 and 45)......Page 142
(b) Questions and Responses......Page 144
(c) Chart VI.F.1{c) - Definitions of Nutrient Content Claims (21 CFR 101)......Page 150
(d) Chart VI.F.1(d)-Disclosure Statement and Criteria (21 CFR 101.13(h))......Page 159
(e) Chart VI,F.1(e)- Conditions for Use of \"Healthy\"......Page 160
(b) Questions and Responses......Page 163
(c) Chart VI.F.2(c) - Examples of Approved Health Claims (21 CFR Part 101, Subpart E)......Page 166
(d) Chart VI.F.2(d) - Health Claims Criteria and Disqualifying Nutrient Levels......Page 173
(e) Chart VI.F.2(e) - Listing of Health Claims that Meet Significant Scientific Agreement (SSA)......Page 174
(a) Summary Comments......Page 176
(b) Regulation VI.F.3(b) - Notifications of Health Claims Based on \"Authoritative Statements\" (Proposed 21 CFR 101.90)......Page 177
(c) Chart VI.F.3(c) - Interim Final Rules Prohibiting Health Claims Based on \"Authoritative Statements\"......Page 178
(d) Statement VI.F.3(d) - Allowable Authoritative Statements by Action of the Statue......Page 188
(e) Chart V!.F.3(e) - General Criteria and Disqualifying Nutrient Levels......Page 189
(f) Chart VI.F.3(f) - Listing of Specific FDAMA Claims......Page 190
(a) Summary Comments......Page 191
(b) Guidance VI.F.4(b) - Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Dietary Supplements......Page 192
(c) Guidance VI.F.4(c) - Interim Evidence-based Ranking System for Scientific Data......Page 194
(d) VI.F.4(d) - Example of Decision Letter......Page 196
(e) Chart VI.F.4(e)- Examples of Permitted Qualified Health Claims......Page 197
(a) Summary Comments......Page 205
(b) Regulation - VI.F.5(b) Notification Procedures for Certain Types of Statements on Dietary Supplements (21 CFR 101.93(a) through (e))......Page 206
(c) Regulation - VI.F.5(c) Certain Types of Statements on Dietary Supplements (21 CFR 101.93(f) through (g))......Page 207
(d) Regulation VI.F.5(d) 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)......Page 208
(e) Chart VI.F.5(e) - Examples of Disease Claims and Structure/Function Claims for Dietary Supplements (21 CFR 101.93(g))......Page 209
(b) Compliance Policy Guide......Page 214
(c) Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108282)......Page 217
(d) Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling......Page 221
(b) Guidance for Industry and FDA: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006......Page 222
(c) Guidance for Industry: Food Labeling, Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims {Small Entity Compliance Guide)......Page 223
2. Questions and Responses......Page 225
1. Summary Comments......Page 229
1. Summary Comments......Page 230
D. Dietary Supplements (Subject is covered in a separate manuai)......Page 231
B. Exemptions from Required Label Statements (21 CFR 1.24)......Page 233
C. Petitions Requesting Exemption from Preemption for State or Local Requirements (21 CFR 100.1)......Page 237
D. Food: Exemptions from Labeling (21 CFR 101.100)......Page 240
E. Temporary Exemption for Purposes of Conducting Authorized Food Labeling Experiments (21 CFR 101.108)......Page 244
F. Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity (21 CFR 130.17)......Page 246
B. Misleading Containers (21 CFR 100.100)......Page 249
C. Food with a Label Declaration of Nutrients (21 CFR 101.9(g))......Page 250
E. Food: Prominence of Required Statements (21 CFR 101.15)......Page 251
F. Misbranding of Food (21 CFR 101.18)......Page 252
G. Substantial Compliance of Food Retailers with the Guidelines for the Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish (21 CFR 101.43)......Page 253
A. FDA Letter on Labeling Food Products Presented or Available on the Internet......Page 255
B. FDA/FTC Labeling Responsibility......Page 257
C. Dietary Supplement/Drug Combination Product......Page 258
D. Food Bioengineering......Page 259
E. Botanical and Other Novel Ingredients in Conventional Foods......Page 263
F. Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy under Section 403(w) of the Federal Food, Drug, and Cosmetic Act......Page 265
G. Guidance for Industry: Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution {Small Entity Compliance Guide)......Page 266
H. Guidance on Labeling of Foods That Need Refrigeration by Consumers......Page 269
I. Food Labeling; Gluten-Free Labeling of Foods; Public Meeting......Page 270
J. Guidance for Industry and FDA Staff: Whole Grain Label Statements; Draft Guidance......Page 273
XI. Charts/lllustrations/Statements/Regulations......Page 277
XII. Index to the January 6, 1993 Federal Register Preamble and the Final NLEA Regulations......Page 281
XII! Index for Food Labeling Technical Amendments; August 18, 1993......Page 311
XIV. Table of Contents: Chapter 5—Foods, Colors, and Cosmetics for the Compliance Policy Guide......Page 317
XV. Table of Contents for \"Food Labeling Questions and Answers,\" August 1993......Page 327
XVI. Table of Contents for \"Food Labeling Questions and Answers,\" Volume II, August 1995......Page 329
Index......Page 331
Bibliography......Page 335