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Index

A

Adequacy of implementation of FDCA

charge to Committee, 2, 30

committee deliberations on, 73-80

compliance and, 5

consumer interest group views on, 72-73

criteria for determining, 4-7, 31, 80-82

definition of adequate, 4, 64, 69-70, 73, 80

enforcement and, 4, 5, 74, 77-78, 81, 142-144

evaluation process, 5-6, 30-33, 73-76

industry views on, 71-72

nonregulatory indicators of, 5, 76-78

regulations and, 4, 5, 74, 81

State and local views on, 69-71

State requirements as indicators, 78-80

Administrative Conference of the United States, 66

Administrative Procedure Act, 66, 67

Adulteration of foods

defined, 126, 128, 134

economic, 87, 88, 125, 134

honey, 119

poi, 125

pre-1900 concerns, 37

1900-1940, 41

noninjurious, 42

Advisory Committee on the Food and Drug Administration, 143-144

Advisory opinions

catfish, 21, 123

defined, 67

documents accorded status of, 76-77

implementation of FDCA with, 6-7, 66-67

procedure for obtaining, 76

significance given by Committee to, 6-7

wild rice, 126

Alabama requirements

discrepancies between Federal requirements and, 196

honey, 119 n.10

materials provided to Committee, 184

misleading containers, 93

prominence of required information, 100

Alaska requirements

artificial colors, flavors, and preservatives, 130 n.12

common or usual name, 121

discrepancies between Federal requirements and, 196

materials provided to Committee, 184

misleading containers, 93

Animal Drugs Amendments of 1968, 47

Apples, 196-201

Aquaculture products, 10, 121

Arizona Consumers Council, 113, 196

Arizona requirements

artificial colors, flavors, and preservatives, 130 n.12, 131

bottled water, 116 n.8

common or usual names, 110

discrepancies between Federal requirements and, 196



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Food Labeling: Toward National Uniformity Index A Adequacy of implementation of FDCA charge to Committee, 2, 30 committee deliberations on, 73-80 compliance and, 5 consumer interest group views on, 72-73 criteria for determining, 4-7, 31, 80-82 definition of adequate, 4, 64, 69-70, 73, 80 enforcement and, 4, 5, 74, 77-78, 81, 142-144 evaluation process, 5-6, 30-33, 73-76 industry views on, 71-72 nonregulatory indicators of, 5, 76-78 regulations and, 4, 5, 74, 81 State and local views on, 69-71 State requirements as indicators, 78-80 Administrative Conference of the United States, 66 Administrative Procedure Act, 66, 67 Adulteration of foods defined, 126, 128, 134 economic, 87, 88, 125, 134 honey, 119 poi, 125 pre-1900 concerns, 37 1900-1940, 41 noninjurious, 42 Advisory Committee on the Food and Drug Administration, 143-144 Advisory opinions catfish, 21, 123 defined, 67 documents accorded status of, 76-77 implementation of FDCA with, 6-7, 66-67 procedure for obtaining, 76 significance given by Committee to, 6-7 wild rice, 126 Alabama requirements discrepancies between Federal requirements and, 196 honey, 119 n.10 materials provided to Committee, 184 misleading containers, 93 prominence of required information, 100 Alaska requirements artificial colors, flavors, and preservatives, 130 n.12 common or usual name, 121 discrepancies between Federal requirements and, 196 materials provided to Committee, 184 misleading containers, 93 Animal Drugs Amendments of 1968, 47 Apples, 196-201 Aquaculture products, 10, 121 Arizona Consumers Council, 113, 196 Arizona requirements artificial colors, flavors, and preservatives, 130 n.12, 131 bottled water, 116 n.8 common or usual names, 110 discrepancies between Federal requirements and, 196

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Food Labeling: Toward National Uniformity materials provided to Committee, 185 placement of required information, 101 n.6 Arkansas requirements artificial colors, flavors, and preservatives, 130 n.12 common or usual names, 121 discrepancies between federal requirements and, 196 honey, 119 n.10 materials provided to Committee, 184 placement of required information, 99 n.1, 100 n.3 Armour meat products, 40 Artificial flavorings, colorings, or chemical preservatives, 29, 44 in bulk foods, 131 common or usual names, 127, 128, 131, 134-135 in dairy products, 130 discrepancies between Federal and State requirements, 129, 197, 200 enforcement activity, 128, 132-133 exemptions from declaration, 134-135 Federal requirements, 127-132 food innovations and, 59 industry opposition to legislation, 41 mixtures of preservatives, 131 prohibitions in specific foods, 130 prominence of required information, 101 quantity restrictions, 131 in restaurant/bakery foods, 132, 133 safety regulation, 47 in specific foods, 130 State requirements, 129-133, 134 sulfites, 128, 129, 132, 133, 196, 200, 201 Aseptic processing, 45, 48 Association of Food and Drug Officials (AFDO), 31, 32 membership, 55-56 Model Bottled Water Regulation, 18, 116-117, 217 purpose, 39-40 Uniform State Food, Drug, and Cosmetic Bill, 8, 55, 58 views on factors influencing adequacy of implementation, 69, 143 Association of Official Agricultural Chemists, 39 Association of Official Analytical Chemists, 39 Association of State and Territorial Health Officials, 32 B Beverages colors, flavors, and preservatives, 131, 197, 199, 200 fruit, 112 nonalcoholic, 101 powdered mixes, 93 water component in flavored products, 116 Blended foods, 44, 100-101, 123 Borden Foods, 153 Bottled water labeling AFDO Model Regulation, 18, 116-117, 216 carbonation, 117 case study, 209-217 Committee conclusions, 9, 18, 117, 217 common or usual name, 18, 110, 111-112, 115, 116, 209-210 Congressional scrutiny, 213-217 discrepancies between Federal and State requirements, 196-200 distilled water, 212 false and misleading claims, 18, 117 Federal requirements, 204, 209 Good Manufacturing Practice for, 116, 212-213 identifying terms, 115 industry perspective on, 106 mineral water, 116, 209 recalls, 209, 214 spring water, 89, 112, 212 standards of identity, 18 standards of quality, 104, 111, 115, 116, 209, 210-213 State requirements, 70, 89, 110, 111-112, 116, 204, 217 water component in flavored beverage products, 116 well water, 111, 212 Bulk foods, 43, 127, 196, 197, 199 Burditt, George, 145 Bureau of Enforcement Guideline, 128

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Food Labeling: Toward National Uniformity C California requirements artificial colors and flavors, 130, 131 bottled water, 70, 110, 116 n.8 common or usual names, 110 container fill, 13, 92, 94, 95, 97 discrepancies between Federal requirements and, 196 honey, 119 n.10 materials provided to Committee, 185 olive and vegetable oils, 123 placement of required information, 99 n.1, 100 Candy, 88, 92 Caramel, 128 Case law Hobby Industry Association of America, Inc. v. Younger, 94 U.S. v. 30 Cases, 105 U.S. v. 46 Cases, 98 U.S. v. 62 Cases, 105 U.S. v. 70 Gross Bottles, 99 U.S. v. 88 Cases, 88 US. v. 95 Barrels, 88 U.S. v. 116 Boxes, 92 U.S. v. 174 Cases (Delson Thin Mints), 92 U.S. v. 274 Boxes, 99 U.S. v. Antonio Corrao Corp., 129 U.S. v. Caraldo, 92 U.S. v. Sullivan, 129 Catsup, 130 Center for Science in the Public Interest (CSPI), views on adequacy of FDCA implementation, 72, 96, 102, 133, 149 Cereals, 93 Cholesterol labeling terminology, 53 Cider, cider vinegar, and other vinegar products, 9, 18, 88, 100, 110, 112, 117-118, 130, 197, 198, 199, 208 Citrus products, 10, 18-19, 44, 111, 118-119, 131, 196 Code of Federal Regulations (CFR), Title 21, Parts and Sections (§) Part 1, 67 §1.20, 58 §1.21, 58 §1.24, 88 §10.85, 5, 67, 68, 76 §10.90, 68, 77 §70.3(f), 127 Part 74, 128 §101.1158, 98 §101.2, 58, 98 §101.3, 59, 98, 107, 112 §101.4, 58 §101.5, 58 §101.10, 129 §101.15, 58 §101.18, 58, 88, 95 §101.22, 58, 127-128, 131, 133, 135, 136 §101.35, 135 §101.100, 127, 128 §101.105, 58, 95 Part 102, 17, 58, 59, 66, 89, 107, 108, 112, 113-114, 120, 204 §103.14, 58, 104 §103.35, 106, 204 §105.62, 135 §105.65, 135 Part 129, 116, 204, 212-213, 217 Part 139, 124 Part 161, 206 §168.40, 206 §172.510, 127 §172.515, 127 §182.10, 127 §182.60, 127 §182.3739-.3862, 128 Part 184, 127 preambles to regulations, 6, 7, 66, 67, 76 Coffee and tea, 44, 48, 93 Color Additive Amendments, 47, 126 Colorado requirements artificial colors, flavors, and preservatives, 131 honey, 119 n.10 discrepancies between Federal requirements and, 196 materials provided to Committee, 185 placement of required information, 99 n.1 Common or usual names, 29, 59 blended oils, 123-124 CFR list, 108 delay in establishment of, 90 Federal requirements, 107-110 flavorings, 127 imitation, alternative, and substitute food products, 109-110 implementing regulations, 89, 107-108

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Food Labeling: Toward National Uniformity overlap with standards of quality and identity, 7, 80, 89, 110 petition process, 17, 90, 107, 108-109 preservatives, 128 purpose of, 88-89 rulemaking on, 66 for specific foods, 17-22, 89, 114-122 State requirements, 110-112 violations, 77 see also individual foods; FDCA Section 403(i)(1) Compliance Policy Guides, 7, 20, 76, 121, 122, 124 Connecticut requirements artificial colors, flavors, and preservatives, 130 n.12, 132, 133 bottled water, 110, 116 n.8 cider products, 118 n.9 common or usual names, 110 discrepancies between Federal requirements and, 196 honey, 119 n.10 materials provided to Committee, 185 misleading containers, 94 preservatives, 129 prominence of required information, 99 n.1, 100 nn.2, 4, 101 Constitutional Convention of 1789, 37-38 Consumer education, 28, 51, 54 Consumer interest groups views on adequacy of FDA implementation of FDCA, 71-72, 89, 96, 102 , 113, 133-134 see also individual groups Consumer Product Safety Commission, 150 Container fill, see Misleading containers; Slack fill; Standards of quality and fill Crawford, Bob, 142-143 Crepe labeling, 104, 106 D Dairy products, see Milk, milk products, and other dairy products Delaware requirements bottled water, 116 n.8 discrepancies between Federal requirements and, 196 prominence of required information, 99 n.1 Dietary recommendations, and food descriptors, 109 Dietary supplements, 52 Dingell, John D, 213-214 District of Columbia, food and drug legislation, 37 E Economic costs of nonuniformity, 23, 25 to consumers, 153 information requested on, 33 interstate commerce and, 43, 44, 47, 50 legal confrontations, 153, 156 monitoring of State legislative and regulatory activities, 153, 154 -155 practical value of uniform labeling, 157-159 product negotiations with individual States, 153, 155-156 product retrieval, relabeling, and scrapping, 154, 156-157 Eggs, 88, 92 Enforcement of Federal requirements and adequacy of FDCA implementation, 4, 5, 74, 77-78, 81 concerns about, 23-24, 90, 142-144 court actions, 65; see also Case law defined, 74 evaluation of, 5, 77-78 FDA priorities, 74 fiscal and resource constraints on, 23-24, 74, 78, 142, 144, 145, 148, 159, 215-216 formal remedies, 146 informal remedies, 44, 74-75, 146-147 under multiple sections of FDCA, 77, 86, 87 NLEA mandate, 28, 54 prior notification requirement, 29, 145, 146 process, 24, 144-147 sanctions, 44 State concerns about, 32 uniform code for, 148 Enzyme technology, 45 Europe, standardization of labeling, 158-159 Executive Order 12612, 68, 152 Extrusion of carbohydrate and protein foods, 45

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Food Labeling: Toward National Uniformity F Fair Packaging and Labeling Act of 1966 implementing regulations, 47 nonfunctional slack fill provision, 12, 14, 92, 97 preemption of State regulation, 47 statement of identity, 107 Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) advisory opinions and implementation of, 66-67 amendments, 47, 52, 65, 116, 126 automatic adoption by States, 55, 70-71 court enforcement actions, 65 enactment, 3, 27 enforcement by States, 29 food defined, 43-44 interstate commerce jurisdiction, 47 overlap in provisions of, 1, 86 provisions studied, 1-2, 28 purpose of misbranding provisions, 3, 46 rulemaking authority and activities, 65, 66 violations of labeling provisions, 46 see also Adequacy of implementation of FDCA FD&C Yellow Dye No. 5, 128 FDCA Section 201(f), 43-44 FDCA Section 401, 12, 15, 16, 19, 20, 91, 92, 103, 120, 210, 211 FDCA Section 402, 87, 88, 128, 136 FDCA Section 403(a)(1), 4, 77, 80 FDCA Section 403(b), 1, 11-12, 28, 87-90 adequacy of implementation, 9, 77 case law, 88 Committee conclusions and recommendations, 9, 12, 90 consumer perspective on, 11-12, 89 enforcement of, 89 exempted foods, 88 Federal and State requirements compared, 11-12, 87-89 industry perspective on, 11-12, 89 intent of, 11, 87-88 nomenclature issues, 59, 90 overlap with FDCA Section 403(i)(1), 11-12, 87 preemption date, 29, 63 see also Food sold under the name of another food; Section 403(i)(1) FDCA Section 403(c) preemption date, 29, 63 FDCA Section 403(d), 28 Committee conclusions and recommendations, 9, 13-14, 96-97 consumer perspective on, 13, 96 enforcement of, 95, 97 Federal and State requirements compared, 12-14, 72-73, 90-92 implementation of, 9, 91-92 industry perspective on, 13, 95 packaging innovations and potential violations, 59 preemption date, 29, 63 related statutory sections, 92 see also Misleading container, Slack fill FDCA Section 403(e), 4, 29, 77, 80 FDCA Section 403(f), 1, 14-15, 28, 97-103 case law, 98-99 Committee conclusions and recommendations, 9, 14-15, 102-103 consumer perspective on, 14, 102 Federal and State requirements compared, 14-15, 97-101 implementing regulations, 14, 98 industry perspective on, 14, 102 packaging innovations and potential violations, 59 preemption date, 29, 63 see also Prominence of required information FDCA Section 403(g), 29, 87 FDCA Section 403(h), 1, 15-16, 28, 103-106 case law, 104-105 Committee conclusions and recommendations, 9, 16, 106 consumer perspective on, 106 Federal and State requirements compared, 15-16, 72-73, 103-105 industry perspective on, 105-106 preemption date, 29, 63 related statutory provisions, 15, 92, 101 see also Standards of quality and fill FDCA Section 403(i)(1), 2 16-21, 28, 107-126, 209-210 adequacy of implementation, 9-11, 77 Committee conclusions and recommendations, 9-11, 17, 113-126 consumer perspective on, 17, 113

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Food Labeling: Toward National Uniformity distinction from FDCA Section 403(b), 87 enforcement of, 17 Federal and State requirements compared, 16-17, 107-112 industry perspective on, 17, 112-113 nomenclature issues, 59 overlap with other statutory provisions, 11-12, 110 petition process, 17, 108-109 preemption date, 29, 63, 80 see also Common or usual name FDCA Section 403(i)(2), 4, 28, 77, 80 FDCA Section 403(k), 2, 22-23, 28, 59, 126-136 case law, 129 Committee conclusions and recommendations, 11, 22-23, 134-136 consumer perspective on, 22, 133-134 exemptions from, 127 Federal and State requirements compared, 16-17, 22-23, 126-133 implementing regulations, 127-128 industry perspective on, 22, 133 preemption date, 29, 63 related statutory provisions, 16, 101 see also Artificial flavorings, colorings, or chemical preservatives FDCA Section 403(q), 29 FDCA Section 403(r), 29 FDCA Section 410, 116 FDCA Section 701(a), 65 FDCA Section 706(a), 65 Federal Register notices, use of, 76 Federal Trade Commission, 3, 52 Fish List, The 10, 21, 67, 120, 122 Fish catfish, 10, 121, 123, 198 common or usual names, 120-121 discrepancies between Federal and State requirements, 196, 204 halibut, 121, 199, 201, 204 misleading containers, 93 nonstandardized products, 59, 89 red snapper, 121 substitutes, 10, 121-122 Florida requirements artificial colors, flavors, and preservatives, 130 n.12 bottled water, 111, 116 n.8 citrus code, 18-19, 69, 111 common or usual names, 19, 111, 116 n.8 discrepancies between Federal requirements and, 196 enforcement concerns, 142-143 honey, 119 n.10 materials provided to Committee, 185 misleading containers, 93 prominence of required information, 100 n.3 standards of fill of container, 105 Foam-mat drying, 44-45 Food, statutory definition, 43 Food additives guidance on safety studies, 67 legislation, 126-127 see also Artificial flavorings, colorings, or chemical preservatives Food Additives Amendment of 1958, 47, 126 Food and Drug Administration, 3 authority under NLEA, 54 cooperative relationship with States, 23, 24, 142, 147-149 expenditures on food activities, 56, 57 Fish List, The 67 food program categories, 56 joint initiatives with States, 56-57 National, Regional, and State Telecommunications Network (NRSTEN), 31, 32 preemption policy, 69-69, 151-153 Red Book, The 67 regulatory authority, 27, 28 review and reform of food labeling, 52, 53 Food descriptors, 28, 52, 54, 102, 106, 109 Food industry concerns about nonuniformity of regulations, 27-28 protectionist requirements, 69 support of legislation by, 42, 54 views on adequacy of FDA implementation of FDCA, 71-72, 89, 95, 102 , 105-106, 112-113, 133 Food labeling Federal and State requirements compared, 7-23, 85-136 value of uniformity in, 39

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Food Labeling: Toward National Uniformity Food labels criticisms of, 4, 52 Food labels format, 14, 52, 53, 54, 102, 104 prior approval, 43 Food production and marketing before 1900, 36 1900-1940, 40 1940-1970, 44-46 1970-1990, 48-50 diverting network, 49-50 innovations in, 44-45 Food products, evolution of, 3, 36, 40, 49 Food safety common or usual names and, 21, 113, 122, 128, 135-136 guidance on studies, 67 regulation of, 41, 44, 47 warning statements on labels, 22, 134, 136 Food sold under the name of another food, 29, 77, 87-90 see also FDCA Section 403(b) Fortification/enrichment of foods, 46, 52 Freshly prepared and catered products, 49 Fruit juices, 19, 110, 111, 118, 200 Frozen desserts, 100, 112, 199, 200, 201 Frozen foods, 40, 44, 199 G Gelatin desserts, 40, 91-92 Georgia requirements artificial colors, flavors, and preservatives, 130 n.12 common or usual names, 111, 125 discrepancies between Federal requirements and, 196 honey, 119 n.10 materials provided to Committee, 185 misleading containers, 95 Vidalia onions, 10, 21, 125, 196 Good Manufacturing Practice, 116, 212-213 Grading systems, 19, 118, 119, 123, 196, 197 Grain mixtures, 198 Great Atlantic and Pacific Tea Company (A&P), 36, 40 Grits, 198 Grocery Manufacturers of America (GMA), views on FDCA implementation , 72, 89, 105, 106-107, 113, 145, 153 Grocery stores chains, 36, 40 self-serve, 40 H Harden, Betty, 143 Hawaii requirements bottled water, 112, 116 n.8 common or usual names, 112 discrepancies between Federal requirements and, 197 materials provided to Committee, 185 oriental noodle products, 124 poi, 20, 125, 152, 197 standards of identity, 124, 125 Health and organic foods, 45 Health and nutrition claims, 4, 28, 29 petition mechanism under NLEA 54 regulation of, 51, 52-54 Health Research and Health Services Act, Proxmire Amendment, 52 Honey, 10, 19, 100, 119-120, 196-201, 205-206 House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, 116, 209, 213 Hutt, Peter Barton, 64 Hypoallergenic foods, 135 I Idaho requirements discrepancies between Federal requirements and, 197 materials provided to Committee, 186 prominence of required information, 99 n.1, 100 nn.2, 3 Identity labeling of food, 98 Illinois requirements discrepancies between Federal requirements and, 197 materials provided to Committee, 186 Imitation foods, 29, 52, 63 defined, 109 Federal labeling requirements, 109-110, 121-122, 197 flavors, 199 seafood, 121-122 Implementation of FDCA advisory opinions as means of, 6-7, 66-67, 74

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Food Labeling: Toward National Uniformity court enforcement actions, 65 historical approach of FDA, 65-69 informal communications and, 6, 67-68 preemption policy of FDA, 68-69 rulemaking used for, 66 see also Adequacy of implementation of FDCA; Code of Federal Regulations Indiana requirements discrepancies between Federal requirements and, 197 materials provided to Committee, 186 placement of required information, 99-100 Industry, see Food industry Infant foods, 135 Infant Formula Act, 52 Information panel, 98 Ingredient statement, 28, 29, 52 artificial colors, flavors, and preservatives in, 134, 135 blended oils, 123-124 importance to consumers, 59 reforms, 53, 54 trade secrets and, 134 violation, 77 International Bottled Water Association (IBWA), 213 Interstate commerce, 43, 44, 47, 49-50, 58-59, 146, 150, 154 Intrastate commerce, 145, 146 Iowa requirements cider products, 118 n.9 discrepancies between Federal requirements and, 197 honey, 119 n.10 materials provided to Committee, 186 prominence of required information, 99 n.1, 100 n.5, 101 n.7 Irradiation of foods, 48, 201 K Kansas requirements artificial colors, flavors, and preservatives, 130 n.12 discrepancies between Federal requirements and, 197 honey, 119 n.10 materials provided to Committee, 186 prominence of required information, 99 n.1 Kellogg Company, 153 Kentucky requirements artificial colors, flavors, and preservatives, 130 n.12 discrepancies between Federal requirements and, 197 materials provided to Committee, 187 Kessler, David, 110, 143 Kraft General Foods, Inc., 71, 113 L Land O'Lakes, 153 Legislation, see specific statutes Life expectancy, 41 Louisiana requirements artificial colors, flavors, and preservatives, 130 n.12 bottled water, 116 n.8 discrepancies between Federal requirements and, 197 honey, 119 n.10 materials provided to Committee, 187 M Macaroni, 130, 199 Madison, James, 38 Maine requirements artificial colors, flavors, and preservatives, 130, 132 bottled water, 116 n.8 cider products, 112, 118 common or usual names, 112, 118, 122 discrepancies between Federal requirements and, 197 materials provided to Committee, 187 seafood, 122 Manufacturer's name and address, 29, 77 Maple products, 10, 19, 100-101, 112, 123, 197, 198, 199, 201, 206 Maryland requirements artificial colors, flavors, and preservatives, 132 bottled water, 116 n.8 common or usual names, 122 discrepancies between Federal requirements and, 197 enforcement concerns, 142-143 materials provided to Committee, 187 seafood, 122, 132 standards of fill of container, 105

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Food Labeling: Toward National Uniformity Massachusetts requirements artificial colors, flavors, and preservatives, 130 n.12 cider products, 118 n.9 common or usual names, 121 discrepancies between Federal requirements and, 197 materials provided to Committee, 188 prominence of required information, 99 n.1, 100, 101 n.7 Meat and poultry products common or usual name, 110 inspection programs, 54-55 nutrition labeling, 51-52 regulation of, 43, 47-48 Meat Inspection Act of 1907, 43 Membrane Processing systems, 45 Michigan requirements artificial colors, flavors, and preservatives, 130 n.12, 133 cider products, 112, 118 common or usual names, 112, 118 discrepancies between Federal requirements and, 197 materials provided to Committee, 188 misleading containers, 93 prominence of required information, 99 n.1 Microbiological standards, 19, 119 Microwave cooking, 48 Milk, milk products, and other dairy products artificial colors, flavors, and preservatives, 129, 130, 135 Committee conclusions, 10, 19-20, 120 discrepancies between Federal and State requirements, 19-20, 129, 196-201 instant and dried milk powders 44, 45 monitoring of legislative activities, 154 packaging innovations, 36 pasteurization, 36 product negotiations, 155 prominence of label information, 14, 99-100 standards of identity, 20, 112, 120 substitutes, 14, 99-100, 154, 201 Minnesota requirements artificial colors, flavors, and preservatives, 130 n.12 131, 133 discrepancies between Federal requirements and, 197 honey, 119 n.10 materials provided to Committee, 188 misleading containers, 94 prominence of required information, 99 n.1, 100, 101 standards of quality and fill, 101, 105 wild rice, 125 Misleading containers, 29, 37, 59 downsizing or package shorting, 70, 93, 96, 198 case law on, 91-92, 96 deceptive packaging, 90, 198 evaluation criteria, 92 Federal requirements, 90-92 slack fill, nonfunctional, 47, 90, 92, 94, 95, 196 State regulation of, 12-14, 70, 72-73, 91, 93-95, 96, 97 see also FDCA Section 403(d) Mississippi requirements bottled water, 116 n.8 common or usual names, 121 discrepancies between Federal requirements and, 198 honey, 119 n.10 materials provided to Committee, 188 prominence of required information, 99 n.1, 100 Missouri requirements discrepancies between Federal requirements and, 198 materials provided to Committee, 188 prominence of required information, 100 n.2 Monosodium glutamate, 127, 132, 133-134, 135-136, 197 Montana requirements bottled water, 116 n.8 discrepancies between Federal requirements and, 198 materials provided to Committee, 188 prominence of required information, 100 n.4 N National Association of Attorneys General, 32 National Association of Consumer Affairs Administrators, 31

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Food Labeling: Toward National Uniformity National Association of State Departments of Agriculture, 31 National Association of State Directors of Agriculture, 32 National Conference of Weights and Measures, 31 National Food Processors Association (NFPA), 150, 153 National Frozen Pizza Institute (NFPI), 95, 102 National Primary Drinking Water Standards, 116 National, Regional, and State Telecomunications Network (NRSTEN), 31, 32 Nebraska requirements discrepancies between Federal requirements and, 198 materials provided to Committee, 188 Net weight statement, 29, 47, 91, 94, 95 Nevada requirements common or usual names, 112 discrepancies between Federal requirements and, 198 honey, 119 n.10 materials provided to Committee, 188 prominence of required information, 99 n.1 New Hampshire requirements artificial colors, flavors, and preservatives, 130 n.12 cider products, 118 n.9 discrepancies between Federal requirements and, 198 honey, 119 n.10 materials provided to Committee, 188 prominence of required information, 100 n.2, 3, 101 n.7 New Jersey requirements bottled water, 116 n.8 discrepancies between Federal requirements and, 198 honey, 119 n.10 materials provided to Committee, 188 misleading containers, 94 prominence of required information, 101 n.7 New Mexico requirements artificial colors, flavors, and preservatives, 130 n.12 discrepancies between Federal requirements and, 198 honey, 119 n.10 materials provided to Committee, 189 pine nuts, 20, 124 New York requirements bottled water, 70 cider products, 118 n.9 discrepancies between Federal requirements and, 199 honey, 119 n.10 maple syrup, 123 materials provided to Committee, 189 misleading containers, 72-73, 93 olive and vegetable oils, 123-124 prominence of required information, 99 n.1, 100, 101 n.7 standards of fill of container, 105 Niles, Ray, 89, 111 Nonorganic solvent techniques, 48 North Carolina requirements discrepancies between Federal requirements and, 199 materials provided to Committee, 189 North Dakota requirements artificial colors, flavors, and preservatives, 130 n.12 bottled water, 116 n.8 discrepancies between Federal requirements and, 199 materials provided to Committee, 189 prominence of required information, 100 n.3 Nutrient claims, see Health and nutrition claims Nutrient content information, 28, 29, 53, 54 rulemaking on, 66 Nutrition deficiency diseases, 41 and health, 46, 50-51 Nutrition labeling amendment of FDCA and provisions for, 52 appropriateness review of, 3-4, 52 dietary recommendations and, 51 mandatory, 28, 51, 53, 54 reform efforts, 52-54 preemption schedule, 29 prevalence and adequacy of, 51-52 voluntary, 28, 51, 54

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Food Labeling: Toward National Uniformity Nutrition Labeling and Education Act of 1990 (NLEA) ambiguities in, 16, 106 enactment, 1, 28, 54 enforcement authority under, 29, 40, 74, 141, 144-147 exemption policies, 68, 142 FDA authority under, 28 overlap with FDCA, 1 purpose of, 63, 141 reforms addressed by, 4 requirements of, 28, 54 Section 4, 144-146 Section 6, 28, 63, 64-65, 74, 85, 136 Section 7, 136 Section 403A(b), 150, 151 study mandate to IOM, 29-30, 64, 85, 165-166 see also Preemption of State and local regulations Nuts, 11, 20, 124, 196, 198, 199, 207 O Ohio requirements artificial colors, flavors, and preservatives, 130 n.12, 131 bottled water, 116 n.8 cider products, 118 n.9 discrepancies between Federal requirements and, 199 honey, 119 n.10 materials provided to Committee, 189-190 Oklahoma requirements artificial colors, flavors, and preservatives, 130 n.12 bottled water, 116 n.8 discrepancies between Federal requirements and, 199 honey, 119 n.10 materials provided to Committee, 191 Oleomargarine/margarine, 99-100, 131, 199, 200 Olive and vegetable oils, 44 adulteration, 129, 130 Committee findings and conclusions on, 10, 20, 123-124 discrepancies between Federal and State requirements, 123-124, 196 , 199, 200, 207 prominence regulations, 100 Onion rings, 59 Onions, 21, 199, see also Vidalia onions Open dating, 52 Oranges, 131 Orange juice, 69, 88, 89 Oregon requirements common or usual names, 121 discrepancies between Federal requirements and, 199 materials provided to Committee, 191 prominence of required information, 100 n.3 Oriental noodles, 10, 20, 112, 124, 197 Oysters, canned, 75, 105, 196, 197 P Packaging branded, 40 innovations, 36, 44, 45-46, 59 and marketability, 3 materials, 40, 45 microbiological growth control, 49 misleading containers, 59, 90-91 plastics, 45-46, 48-49 retort pouch, 45 Uneeda Biscuit, 36 see also Misleading containers Peanut spreads, 89 Pecans, 196, 198, 207 Pellagra, 41 Pennsylvania requirements artificial colors, flavors, and preservatives, 130, 131 cider products, 118 n.9, 130 discrepancies between Federal requirements and, 200 materials provided to Committee, 191 prominence of required information, 99 n.1, 100, 101 Pepsico-Frito Lay, 153 Pesticides Amendment of 1954, 47 Petition process, 23, 25, 68-69, 142, 144-147, 149-153 Piggly-Wiggly, 40 Pine nuts, 11, 20, 124, 198 Poi, 11, 20, 112, 125, 152, 197 Potato chips 59, 89 Poultry inspection program, 43, 47 Poultry Product Inspection Act of 1957, 47 Preemption of State and local regulations conditions for, 29, 63 exemption policy, 24, 68, 150

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Food Labeling: Toward National Uniformity under Fair Packaging and Labeling Act of 1966, 47 FDA policy, 68-69, 151-153 impact evaluation, 31 implementation problems, 38 industry support of, 42, 54 on meat and poultry inspections, 47-48 origin of doctrine of, 37-38 petition process for exemptions, 23-25, 32, 142, 144, 149-153 schedule for, 1, 28, 54, 63-64 strictness of requirements as a consideration, 4, 75, 81, 133 uniformity without, 39-40 Principal display panel, 98 flavors on, 127 identity labeling, 98 Prior label approval, 47 Processed foods, 47 Processed Products Inspection Improvement Act of 1986, 47 Procter & Gamble Company, 153 Produce, nutrition labeling of, 28, 54, 196-199, 201 Prominence of required information, 29, 47, 54, 59 blended products, 100-101 colors flavors, and preservatives, 101 dairy product substitutes, 99-100 Federal requirements, 98-99 State requirements, 99-101 see also FDCA Section 403(f) Public health before 1900, 37 1900-1940, 41-42 1940-1970, 46 1970-1990, 50-51 Public Voice for Food and Health Policy, 149 Puerto Rico requirements materials provided to Committee, 191 Pure Food and Drugs Art of 1906, 3, 27, 41, 42-43, 86, 87, 88, 126 Q Quaker Oats Company, 95, 153 R Recycling, 45 Red Book, The, 67 Reference values, 53 Refrigerated prepared foods, 48 Regulation of misbranded food before 1900, 37-40 1900-1940, 42-44 1940-1970, 47-48 1970-1990, 51-54 current Federal and State roles, 54-58 exemptions to protect local interests, 58 historical context for, 3-4, 35-54 increasing use of rulemaking, 66 interstate commerce and, 43, 44, 47, 50, 58-59 see also Code of Federal Regulations; Preemption of State and local regulations Regulatory Amendments of 1948, 47 Restaurant/bakery foods, 132, 133 Rhode Island requirements artificial colors, flavors, and preservatives, 130, 132 cider products, 118 n.9, 130 discrepancies between Federal requirements and, 200 materials provided to Committee, 192 olive and vegetable oils, 123 Rice, 200; see also Wild rice RJR Nabisco, 153 Roosevelt, Theodore, 147-148 S Safe Drinking Water Act, 116, 212 Safe Medical Devices Act of 1990, 65 Salad bars, 132, 133 Salt/sodium, 127 Sanitation, 37, 39, 41 Schreiber Foods, Inc., 95 Schultz, William, 64 Seafood, 20-21, 120-123 artificial colors, flavors, and preservatives, 132, 200 Committee findings and conclusions, 10, 20-21, 120-123 common or usual names, 20-21, 110, 113, 120-122 Federal requirements, 197 finfish and shellfish, 113, 120-121 misleading container, 93 nutrition labeling, 28, 54 State requirements, 93, 197 surimi-based imitations and substitutes, 10, 21, 121-122, 207 see also Fish

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Food Labeling: Toward National Uniformity Serving size, 53 Shank, Fred, 215-216 Silverglade, Bruce, 149 Slack fill, nonfunctional, 47, 90, 92, 94, 95 Sodium content and descriptors, 52 Soup mixes, 93 South Carolina requirements discrepancies between Federal requirements and, 200 materials provided to Committee, 192 South Dakota requirements artificial colors, flavors, and preservatives, 131 common or usual names, 112 discrepancies between Federal requirements and, 200 materials provided to Committee, 192 prominence of required information, 100 n.5, 101 n.6 Soybean cheese, 89, 111 Spaghetti sauce, 93 Specialty stores, 36, 49 Spices, 127, 134-135, 197, 198 Squalene, 129 Squibb, E.R., 39 Standards of identity, 3, 52, 104 citrus products, 118-119 defined, 107 maple syrup, 123 overlap with common or usual names, 7, 80, 89, 110 preemption date, 28, 29, 80 reforms, 53, 66 relationship to standards of quality, 105-106, 110 Standards of quality and fill, 29, 54 canned oysters, 75 Federal requirements, 103-105, 197 relationship to standards of identity, 105-106, 110 overlap with common or usual names, 110 State requirements, 16, 94, 105, 197 see also FDCA Section 403(d); Deceptive packaging; Misleading containers; Slack fill Statements of Policy and Interpretation, 67 States authority under Pure Food and Drugs Act, 43 automatic adoption of Federal statutes and regulations, 8, 55, 7071 categorization of requirements, 6 cooperative relationship between FDA and, 23, 24, 142, 147-149 concerns of, 80 enforcement authority, 28, 29, 31, 38-39, 40, 54, 141, 144-147 funding for enforcement programs, 48, 55 joint initiatives with FDA, 56-57 laws and regulations, 32, 37 meat and poultry inspection programs, 54-55 monitoring of legislative and regulatory activities, 154-155 obsolete provisions, 58 overlap with Federal activities, 7, 58, 72 product negotiations between industry and, 155-156 reasons for regulation by, 7, 8, 55-56, 78-79 regulations as indicators of FDCA implementation, 78-80, 81 respondents to request for information, 31, 173, 175-181 review of requirements of, 5, 79-80, 81 role in regulation, 70, 72-73 sovereignty, 37-38 views on adequacy of FDA implementation of FDCA, 69-71 see also individual statues Strawberries, 197 Substitute foods, 44, 52, 59 Federal requirements, 109-110, 121-122 prominence of label information, 99-100 seafood, 121-122 Sulfites, 128, 129, 132, 133, 196, 200, 201 Supercritical carbon dioxide, 48 Supermarkets, 36, 44, 49, 158 Surimi products, 10, 21, 112, 121-122, 123, 197, 207 T Tennessee requirements artificial colors, flavors, and preservatives, 132

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Food Labeling: Toward National Uniformity discrepancies between Federal requirements and, 200 materials provided to Committee, 192 Texas requirements artificial colors flavors, and preservatives, 131, 132 bottled water, 116 n.8 discrepancies between Federal requirements and, 200 materials provided to Committee, 192-193 prominence of required information, 100 n.4, 101 n.7 seafood, 122 Texturized vegetable protein, 45, 59, 135 Thompson, Merrill, 71-72, 146 Tomato sauce, 130 Trade correspondence, 7, 67, 76, 91, 128 Tuna fish, canned, 93 U U.S. Department of Agriculture, 3, 44, 53 authority to preempt State regulation, 48 Bureau of Chemistry, 39, 43 Food Safety and Quality Service, 52 grade standards, 119 meat and poultry inspection budget, 55 U.S. Department of Health and Human Services, 53 Utah requirements common or usual names, 112 discrepancies between Federal requirements and, 200 materials provided to Committee, 193 prominence of required information, 100 n.2 V Vanilla, 130 Vanillin, 128, 130 Vegetable oils, see Olive and vegetable oils Vending machines, 44 Vermont requirements artificial colors, flavors, and preservatives, 130 n.12 common or usual names, 112 discrepancies between Federal requirements and, 201 maple syrup, 123 materials provided to Committee, 193 prominence of required information, 99 n.1, 100 nn.3, 5, Vidalia onions, 11, 21, 125, 196 Vinegar, see Cider, cider vinegar, and other vinegar products Virginia requirements discrepancies between Federal requirements and, 201 materials provided to Committee, 193 W Warning Letters, 75, 146 Warning statements on labels, 22 134, 136 Washington requirements artificial colors, 130 common or usual names, 121 discrepancies between Federal requirements and, 201 honey, 119 n.10 materials provided to Committee, 193 misleading containers, 94 prominence of required information, 100 n.4, 101 n.7 Waxman, Henry A., 64 West Virginia requirements artificial colors, flavors, and preservatives, 130, 132 cider products, 118 n.9, 130 discrepancies between Federal requirements and, 201 honey, 119 n.10 materials provided to Committee, 193 prominence of required information, 100 n.5 White House Conference on Food, Nutrition, and Health, 3, 51, 66, 109 Wholesome Meat Act, 48 Wholesome Poultry Products Act, 48 Wild rice, 11, 14, 21, 125-126, 197, 201, 208 Wiley, Harvey, 39, 41 Wilms, Heinz, 148 Wisconsin requirements artificial colors, flavors, and preservatives, 130 n.12 discrepancies between Federal requirements and, 201 materials provided to Committee, 194 prominence of required information, 99 n.1, 101 n.7

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Food Labeling: Toward National Uniformity wild rice, 125 Wyoming requirements discrepancies between Federal requirements and, 201 honey, 119 n.10 materials provided to Committee, 194 Y Young, Frank E., 147

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