Health Hippo: Food, Cosmetics and Tobacco
US CODE || CFR || CASES || FDA MODERNIZATION ACT || REPORTS || CONGRESSIONAL RECORD || BILLS || FEDERAL REGISTER
If we could give every person the right amount of nourishment and exercise, we would have found the safest way to health.
Title 21 of the US Code is divided into 27 Chapters covering all aspects of food, drug and
medical devices in the United States. In addition to chapters dealing with milk, tea, eggs, meats and
vegetables, 21 USC also regulates narcotic drugs, biological products, posions and establishes all
manner of drug and alcohol abuse prevention programs. Chapter 9 is “The Federal Food, Drug and Cosmetic Act”. This is the Chapter that houses the information most people are looking for related to food safety, drugs and
devices. It sets forth the basic legal authority for regulation of these things (as well as cosmetics
and tobacco), penalties and fines for violating the rules and the process for FDA review and approval. A major revision of these provisions was undertaken with the FDA Modernization Act of 1997. This Act
sought to streamline and simplify FDA procedures to make the agency more responsive to the needs of
Americans.
US Code
- Affordable Care Act: Food
- Sec. 4205. Nutrition labeling of standard menu items at chain restaurants.
- U.S. CODE: TITLE 7 AGRICULTURE
- CHAPTER 1 COMMODITY EXCHANGES (1–27f)
- CHAPTER 3 GRAIN STANDARDS (71–87k)
- CHAPTER 4 NAVAL STORES (91–99)
- CHAPTER 6 INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL (121-136y)
- Subchapter I Insecticides (Repealed)
- Subchapter II Environmental Pesticide Control
- CHAPTER 6A NATIONAL LABORATORY ACCREDITATION (138–138i)
- CHAPTER 9 PACKERS AND STOCKYARDS (181–231)
- CHAPTER 10 WAREHOUSES (241–256)
- CHAPTER 11 HONEYBEES (281–286)
- CHAPTER 12 ASSOCIATIONS OF AGRICULTURAL PRODUCTS PRODUCERS (291–292)
- CHAPTER 13 AGRICULTURAL AND MECHANICAL COLLEGES (301–349)
- CHAPTER 14 AGRICULTURAL EXPERIMENT STATIONS (361–390d)
- CHAPTER 15 BUREAU OF ANIMAL INDUSTRY (391–397)
- CHAPTER 16 BUREAU OF DAIRY INDUSTRY (401–404)
- CHAPTER 17 MISCELLANEOUS MATTERS (411–450l)
- CHAPTER 18 COOPERATIVE MARKETING (451–457)
- CHAPTER 20 DUMPING OR DESTRUCTION OF INTERSTATE PRODUCE (491–497)
- CHAPTER 20A PERISHABLE AGRICULTURAL COMMODITIES (499a–499t)
- Sec. 499a Short title and definitions
- Sec. 499b Unfair conduct
- Sec. 499b-1 Products produced in distinct geographic areas
- Sec. 499c Licenses
- Sec. 499d Issuance of license
- Sec. 499e Liability to persons injured
- Sec. 499f Complaints, written notifications, and investigations
- Sec. 499g Reparation order
- Sec. 499h Grounds for suspension or revocation of license
- Sec. 499i Accounts, records, and memoranda; duty of licensees to keep; contents; suspension of license for violation of duty
- Sec. 499j Orders; effective date; continuance in force; suspension, modification and setting aside; penalty
- Sec. 499k Injunctions; application of injunction laws governing orders of Interstate Commerce Commission
- Sec. 499l Violations; report to Attorney General; proceedings; costs
- Sec. 499m Complaints; procedure, penalties, etc.
- Sec. 499n Inspection of perishable agricultural commodities
- Sec. 499o Rules, regulations, and orders; appointment, removal, and compensation of officers and employees; expenditures; authorization of appropriations; abrogation of inconsistent statutes
- Sec. 499p Liability of licensees for acts and omissions of agents
- Sec. 499q Separability
- Sec. 499r Repealed.
- Sec. 499s Depositing appropriations in fund
- Sec. 499t Omitted
- CHAPTER 21 TOBACCO STATISTICS (501–509)
- CHAPTER 21A TOBACCO INSPECTION (511–511s)
- CHAPTER 21C TOBACCO REFORM (518–519a)
- Subchapter I Transitional Payments to Tobacco Quota Holders and Producers of Tobacco (518–518f)
- Subchapter II Implementation and Transition (519–519a)
- CHAPTER 25 EXPORT STANDARDS FOR APPLES (581–590)
- CHAPTER 25A EXPORT STANDARDS FOR GRAPES AND PLUMS (591–599)
- CHAPTER 26 AGRICULTURAL ADJUSTMENT (601–641-659)
- CHAPTER 26A AGRICULTURAL MARKETING AGREEMENTS (671–674)
- CHAPTER 30 ANTI-HOG-CHOLERA SERUM AND HOG-CHOLERA VIRUS (851–855)
- CHAPTER 32 PEANUT STATISTICS (951–958)
- CHAPTER 33 FARM TENANCY (1000–1040)
- CHAPTER 34 SUGAR PRODUCTION AND CONTROL (1100–1172-1183)
- CHAPTER 35 AGRICULTURAL ADJUSTMENT ACT OF 1938 (1281–1401-1407)
- CHAPTER 35A PRICE SUPPORT OF AGRICULTURAL COMMODITIES (1421–1472)
- CHAPTER 36 CROP INSURANCE (1501–1531)
- CHAPTER 37 SEEDS (1551–1611)
- CHAPTER 38 DISTRIBUTION AND MARKETING OF AGRICULTURAL PRODUCTS (1621–1638d)
- CHAPTER 39 STABILIZATION OF INTERNATIONAL WHEAT MARKET (1641–1642)
- CHAPTER 41 FOOD FOR PEACE (1691–1738r)
- CHAPTER 42 AGRICULTURAL COMMODITY SET-ASIDE (1741–1749)
- CHAPTER 43 FOREIGN MARKET DEVELOPMENT (1761–1769)
- CHAPTER 46 SURPLUS DISPOSAL OF AGRICULTURAL COMMODITIES (1851,_1852–1860)
- CHAPTER 48 HUMANE METHODS OF LIVESTOCK SLAUGHTER (1901–1907)
- CHAPTER 49 CONSULTATION ON AGRICULTURAL PROGRAMS (1911–1913)
- CHAPTER 50 AGRICULTURAL CREDIT (1921–2009ee-2009ee3)
- CHAPTER 51 SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (2011–2036a)
- Sec. 2011 Congressional declaration of policy
- Sec. 2012 Definitions
- Sec. 2012a Publicly operated community health centers
- Sec. 2013 Establishment of supplemental nutrition assistance program
- Sec. 2014 Eligible households
- Sec. 2015 Eligibility disqualifications
- Sec. 2016 Issuance and use of program benefits
- Sec. 2017 Value of allotment
- Sec. 2018 Approval of retail food stores and wholesale food concerns
- Sec. 2019 Redemption of program benefits
- Sec. 2020 Administration
- Sec. 2021 Civil penalties and disqualification of retail food stores and wholesale food concerns
- Sec. 2022 Disposition of claims
- Sec. 2023 Administrative and judicial review; restoration of rights
- Sec. 2024 Violations and enforcement
- Sec. 2025 Administrative cost-sharing and quality control
- Sec. 2026 Research, demonstration, and evaluations
- Sec. 2027 Appropriations and allotments
- Sec. 2028 Consolidated block grants for Puerto Rico and American Samoa
- Sec. 2029 Workfare
- Sec. 2030 Repealed.
- Sec. 2031 Minnesota Family Investment Project
- Sec. 2032 Automated data processing and information retrieval systems
- Sec. 2033 Repealed.
- Sec. 2034 Assistance for community food projects
- Sec. 2035 Simplified supplemental nutrition assistance program
- Sec. 2036 Availability of commodities for emergency food assistance program
- Sec. 2036a Nutrition education and obesity prevention grant program
- CHAPTER 54 TRANSPORTATION, SALE, AND HANDLING OF CERTAIN ANIMALS (2131–2159)
- CHAPTER 55 DEPARTMENT OF AGRICULTURE (2201–2279h)
- CHAPTER 55A DEPARTMENT OF AGRICULTURE ADVISORY COMMITTEES (2281–2287-2289)
- CHAPTER 56 UNFAIR TRADE PRACTICES AFFECTING PRODUCERS OF AGRICULTURAL PRODUCTS (2301–2306)
- CHAPTER 57 PLANT VARIETY PROTECTION (2321–2583)
- CHAPTER 58 POTATO RESEARCH AND PROMOTION (2611–2627)
- CHAPTER 59 RURAL FIRE PROTECTION, DEVELOPMENT, AND SMALL FARM RESEARCH AND EDUCATION (2651-2654–2670)
- CHAPTER 60 EGG RESEARCH AND CONSUMER INFORMATION (2701–2718)
- CHAPTER 61 NOXIOUS WEEDS (2801-2813–2814)
- CHAPTER 62 BEEF RESEARCH AND INFORMATION (2901–2912-2918)
- CHAPTER 63 FARMER-TO-CONSUMER DIRECT MARKETING (3001–3007)
- CHAPTER 64 AGRICULTURAL RESEARCH, EXTENSION, AND TEACHING (3101–3363)
- CHAPTER 65 WHEAT AND WHEAT FOODS RESEARCH AND NUTRITION EDUCATION (3401–3417)
- CHAPTER 66 AGRICULTURAL FOREIGN INVESTMENT DISCLOSURE (3501–3508)
- CHAPTER 67 IMPLEMENTATION OF INTERNATIONAL SUGAR AGREEMENT, 1977 (3601–3606)
- CHAPTER 68 AGRICULTURAL SUBTERMINAL FACILITIES (3701–3703)
- CHAPTER 69 SWINE HEALTH PROTECTION (3801–3813)
- CHAPTER 70 ANIMAL CANCER RESEARCH (3901–3904)
- CHAPTER 71 AGRICULTURAL TRADE SUSPENSION ADJUSTMENT (4001–4005)
- CHAPTER 73 FARMLAND PROTECTION POLICY (4201–4209)
- CHAPTER 74 FLORAL RESEARCH AND CONSUMER INFORMATION (4301–4319)
- CHAPTER 75 INTERNATIONAL CARRIAGE OF PERISHABLE FOODSTUFFS (4401–4406)
- CHAPTER 76 DAIRY RESEARCH AND PROMOTION (4501–4538)
- CHAPTER 77 HONEY RESEARCH, PROMOTION, AND CONSUMER INFORMATION (4601–4613)
- CHAPTER 79 PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION (4801–4819)
- CHAPTER 80 WATERMELON RESEARCH AND PROMOTION (4901–4916)
- CHAPTER 82 STATE AGRICULTURAL LOAN MEDIATION PROGRAMS (5101–5106)
- CHAPTER 83 AGRICULTURAL COMPETITIVENESS AND TRADE (5201–5235)
- CHAPTER 84 NATIONAL NUTRITION MONITORING AND RELATED RESEARCH (5301–5342)
- Sec. 5301 Congressional statement of purposes
- Sec. 5302 Definitions
- Subchapter I Nutrition Monitoring And Related Research (5311–5316)
- Subchapter II National Nutrition Monitoring Advisory Council (5331–5332)
- Subchapter III Dietary Guidance (5341–5342)
- CHAPTER 85 ADMINISTRATION OF ENVIRONMENTAL PROGRAMS (5401–5405)
- CHAPTER 86 WATER QUALITY RESEARCH, EDUCATION, AND COORDINATION (5501-5505–5506)
- CHAPTER 87 EXPORT PROMOTION (5601–5723)
- CHAPTER 88 RESEARCH (5801–5938)
- CHAPTER 89 PECAN PROMOTION AND RESEARCH (6001–6013)
- CHAPTER 90 MUSHROOM PROMOTION, RESEARCH, AND CONSUMER INFORMATION (6101–6112)
- CHAPTER 91 LIME PROMOTION, RESEARCH, AND CONSUMER INFORMATION (6201–6212)
- CHAPTER 92 SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION (6301–6311)
- CHAPTER 93 PROCESSOR-FUNDED MILK PROMOTION PROGRAM (6401–6417)
- CHAPTER 94 ORGANIC CERTIFICATION (6501–6523)
- Sec. 6501 Purposes
- Sec. 6502 Definitions
- Sec. 6503 National organic production program
- Sec. 6504 National standards for organic production
- Sec. 6505 Compliance requirements
- Sec. 6506 General requirements
- Sec. 6507 State organic certification program
- Sec. 6508 Prohibited crop production practices and materials
- Sec. 6509 Animal production practices and materials
- Sec. 6510 Handling
- Sec. 6511 Additional guidelines
- Sec. 6512 Other production and handling practices
- Sec. 6513 Organic plan
- Sec. 6514 Accreditation program
- Sec. 6515 Requirements of certifying agents
- Sec. 6516 Peer review of certifying agents
- Sec. 6517 National List
- Sec. 6518 National Organic Standards Board
- Sec. 6519 Violations of chapter
- Sec. 6520 Administrative appeal
- Sec. 6521 Administration
- Sec. 6522 Authorization of appropriations
- Sec. 6523 National organic certification cost-share program
- CHAPTER 95 RURAL REVITALIZATION THROUGH FORESTRY (6601–6617)
- CHAPTER 96 GLOBAL CLIMATE CHANGE (6701–6711)
- CHAPTER 97 FRESH CUT FLOWERS AND FRESH CUT GREENS PROMOTION AND INFORMATION (6801–6814)
- CHAPTER 98 DEPARTMENT OF AGRICULTURE REORGANIZATION (6901–7035)
- Sec. 6901 Purpose
- Sec. 6902 Definitions
- SUBCHAPTER I GENERAL REORGANIZATION AUTHORITIES (6911–6920)
- SUBCHAPTER II FARM AND FOREIGN AGRICULTURAL SERVICES (6931–6934)
- SUBCHAPTER III RURAL ECONOMIC AND COMMUNITY DEVELOPMENT (6941–6945)
- SUBCHAPTER IV FOOD, NUTRITION, AND CONSUMER SERVICES (6951)
- SUBCHAPTER V NATURAL RESOURCES AND ENVIRONMENT (6961–6963)
- SUBCHAPTER VI RESEARCH, EDUCATION, AND ECONOMICS (6971–6972)
- SUBCHAPTER VII FOOD SAFETY (6981–6982)
- SUBCHAPTER VIII NATIONAL APPEALS DIVISION (6991–7002)
- SUBCHAPTER VIII-A MARKETING AND REGULATORY PROGRAMS (7005)
- SUBCHAPTER IX MISCELLANEOUS REORGANIZATION PROVISIONS (7011–7014)
- SUBCHAPTER X FREEDOM TO E-FILE (7031–7035)
- CHAPTER 99 SHEEP PROMOTION, RESEARCH, AND INFORMATION (7101–7111)
- CHAPTER 100 AGRICULTURAL MARKET TRANSITION (7201–7334)
- CHAPTER 101 AGRICULTURAL PROMOTION (7401–7491)
- CHAPTER 102 EMERGENCY FOOD ASSISTANCE (7501–7517)
- Sec. 7501 Definitions
- Sec. 7502 Availability of CCC commodities
- Sec. 7503 State plan
- Sec. 7504 Initial processing costs
- Sec. 7505 Federal and State responsibilities
- Sec. 7506 Assurances; anticipated use
- Sec. 7507 State and local supplementation of commodities
- Sec. 7508 Authorization and appropriations
- Sec. 7509 Relationship to other programs
- Sec. 7510 Commodities not income
- Sec. 7511 Prohibition against certain State charges
- Sec. 7511a Emergency food program infrastructure grants
- Sec. 7512 Regulations
- Sec. 7513 Finality of determinations
- Sec. 7514 Incorporation of additional commodities
- Sec. 7515 Allotment and delivery of commodities
- Sec. 7516 Settlement and adjustment of claims
- Sec. 7517 Hunger-free communities
- CHAPTER 103 AGRICULTURAL RESEARCH, EXTENSION, AND EDUCATION REFORM (7601–7672)
- CHAPTER 104 PLANT PROTECTION (7701–7786)
- CHAPTER 105 HASS AVOCADO PROMOTION, RESEARCH, AND INFORMATION (7801–7813)
- CHAPTER 106 COMMODITY PROGRAMS (7901–8002)
- CHAPTER 107 RENEWABLE ENERGY RESEARCH AND DEVELOPMENT (8101–8114)
- CHAPTER 109 ANIMAL HEALTH PROTECTION (8301–8322)
- CHAPTER 110 ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS (8401–8411)
- CHAPTER 113 AGRICULTURAL COMMODITY SUPPORT PROGRAMS (8701–8793)
- CHAPTER 114 AGRICULTURAL SECURITY (8901–8922)
- U.S. CODE: TITLE 21 – FOOD AND DRUGS
- CHAPTER 1 ADULTERATED OR MISBRANDED FOODS OR DRUGS (includes the repealed or transferred Food and Drug Act of 1906 and miscellaneous provisions relating to dairy products, apples and imitation butter and cheese)
- CHAPTER 2 TEAS (Repealed)
- CHAPTER 3 FILLED MILK (61–64)(The term “filled milk” means any milk, cream, or skimmed milk to which has been added, blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream, or skimmed milk)
- CHAPTER 4 ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS (71 to 92)
- SUBCHAPTER I EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS (Repealed, transferred or omitted)
- SUBCHAPTER II IMPORTATION OF CATTLE AND QUARANTINE (mostly repealed or transferred)
- Sec. 101 Suspension of importation of all animals
- SUBCHAPTER III PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION (mostly repealed or omitted)
- Sec. 113a Establishment of research laboratories for foot-and-mouth disease and other animal diseases; research contracts; employment of technicians and scientists; appropriations
- Sec. 114i Pseudorabies eradication
- Sec. 136 Additional inspection services
- Sec. 136a Collection of fees for inspection services
- SUBCHAPTER IV IMPORTATION OF MILK AND CREAM (Prohibitions, inspections, penalties, 141–149)
- CHAPTER 5 VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS (related to the treatment of domestic animals, 151–159)
- CHAPTER 9 FEDERAL FOOD,
DRUG, AND COSMETIC ACT- Subchapter I Short Title
- Subchapter II Definitions (includes the definition of butter, package, milk, catfish and ginseng)
- Subchapter III Prohibited Acts And
Penalties- Sec. 331 Prohibited acts
- Sec. 332 Injunction proceedings
- Sec. 333 Penalties
- Sec. 334 Seizure
- Sec. 335 Hearing before report of criminal violation
- Sec. 335a Debarment, temporary denial of approval, and suspension
- Sec. 335b Civil penalties
- Sec. 335c Authority to withdraw approval of abbreviated drug applications
- Sec. 336 Report of minor violations
- Sec. 337 Proceedings in name of United States; provision as to subpoenas
- Sec. 337a Extraterritorial jurisdiction
- Subchapter IV Food
- Sec. 341 Definitions and standards for food
- Sec. 342 Adulterated food
- Sec. 343 Misbranded food
- Sec. 343-1 National uniform nutrition labeling
- Sec. 343-2 Dietary supplement labeling exemptions
- Sec. 343-3 Disclosure
- Sec. 343a Repealed
- Sec. 344 Emergency permit control
- Sec. 345 Regulations making exemptions
- Sec. 346 Tolerances for poisonous or deleterious substances in food; regulations
- Sec. 346a Tolerances and exemptions for pesticide chemical residues
- Sec. 346b Authorization of appropriations
- Sec. 347 Intrastate sales of colored oleomargarine
- Sec. 347a Congressional declaration of policy regarding oleomargarine sales
- Sec. 347b Contravention of State laws
- Sec. 348 Food additives
- Sec. 349 Bottled drinking water standards; publication in Federal Register
- Sec. 350 Vitamins and minerals
- Sec. 350a Infant formulas
- Sec. 350b New dietary ingredients
- Sec. 350c Maintenance and inspection of records
- Sec. 350d Registration of food facilities
- Sec. 350e Sanitary transportation practices
- Sec. 350f Reportable food registry
- Sec. 350g Hazard analysis and risk-based preventive controls
- Sec. 350h Standards for produce safety
- Sec. 350i Protection against intentional adulteration
- Sec. 350j Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- Sec. 350k Laboratory accreditation for analyses of foods
- Sec. 350l Mandatory recall authority
- Sec. 350l-1 Annual report to Congress
- Subchapter V Drugs And Devices
- Subchapter VI Cosmetics
- Subchapter VII General Authority
- Part A General Administrative Provisions (371–379d5)
- Part B Colors (§ 379e)
- Part C Fees (379f–379j62)
- Part D Information and Education (379k–379l)
- Part E Environmental Impact Review (§ 379o)
- Part F National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics (379r–379s)
- Part G Safety Reports (§ 379v)
- Part H Serious Adverse Event Reports (379aa–379aa1)
- Part I Reagan-Udall Foundation for the Food and Drug Administration (379dd–379dd2)
- Subchapter VIII Imports And Exports
- Subchapter IX Tobacco Products
- Sec. 387 Definitions
- Sec. 387a FDA authority over tobacco products
- Sec. 387a-1 Final rule
- Sec. 387b Adulterated tobacco products
- Sec. 387c Misbranded tobacco products
- Sec. 387d Submission of health information to the Secretary
- Sec. 387e Annual registration
- Sec. 387f General provisions respecting control of tobacco products
- Sec. 387f-1 Enforcement action plan for advertising and promotion restrictions
- Sec. 387g Tobacco product standards
- Sec. 387h Notification and other remedies
- Sec. 387i Records and reports on tobacco products
- Sec. 387j Application for review of certain tobacco products
- Sec. 387k Modified risk tobacco products
- Sec. 387l Judicial review
- Sec. 387m Equal treatment of retail outlets
- Sec. 387n Jurisdiction of and coordination with the Federal Trade Commission
- Sec. 387o Regulation requirement
- Sec. 387p Preservation of State and local authority
- Sec. 387q Tobacco Products Scientific Advisory Committee
- Sec. 387r Drug products used to treat tobacco dependence
- Sec. 387s User fees
- Sec. 387t Labeling, recordkeeping, records inspection
- Sec. 387u Studies of progress and effectiveness
- Subchapter X Miscellaneous
- CHAPTER 10 POULTRY AND POULTRY PRODUCTS INSPECTION (prohibited acts, penalties, seizure, 451–472)
- CHAPTER 12 MEAT INSPECTION (601–695)
- Subchapter I Inspection Requirements; Adulteration and Misbranding (601–625)
- Subchapter II Meat Processors and Related Industries (641–645)
- Subchapter III Federal and State Cooperation (661)
- Subchapter IV Auxiliary Provisions (671–680)
- Subchapter IV-A Inspections by Federal and State Agencies (683)
- Subchapter V Miscellaneous Provisions (691–695)
- CHAPTER 15 EGG PRODUCTS INSPECTION (labeling, prohibitions, recordkeeping, seizure, 1031–1056)
- CHAPTER 19 PESTICIDE MONITORING IMPROVEMENTS (1401–1403)
- CHAPTER 26 FOOD SAFETY (2101–2110)
- Sec. 2101 Findings
- Sec. 2102 Ensuring the safety of pet food
- Sec. 2103 Ensuring efficient and effective communications during a recall
- Sec. 2104 State and Federal cooperation
- Sec. 2105 Enhanced aquaculture and seafood inspection
- Sec. 2106 Consultation regarding genetically engineered seafood products
- Sec. 2107 Sense of Congress
- Sec. 2108 Annual report to Congress
- Sec. 2109 Publication of annual reports
- Sec. 2110 Rule of construction
- CHAPTER 27 FOOD SAFETY MODERNIZATION (2201–2252)
- SUBCHAPTER I Improving Capacity to Prevent Food Safety Problems (2201–2206)
- SUBCHAPTER II Improving Capacity To Detect And Respond To Food Safety Problems (2221–2225)
- SUBCHAPTER III Improving the Safety of Imported Food (2241–2243)
- SUBCHAPTER IV Miscellaneous Provisions (2251–2252)
Code of Federal
Regulations
- 7 CFR SUBTITLE A OFFICE OF THE SECRETARY OF AGRICULTURE
- Part 1 Administrative Regulations (1.1 – 1.674)
- Part 2 Delegations of Authority by the Secretary of Agriculture and General Officers of the Department (2.1 – 2.501)
- Part 5 Determination of Parity Prices (5.1 – 5.6)
- Part 6 Import Quotas and Fees (6.2 – 6.44)
- Part 7 Selection and Functions of Farm Service Agency State and County Committees (7.1 – 7.34)
- Part 8 4-H Club Name and Emblem (8.1 – 8.9)
- Part 11 National Appeals Division (11.1 – 11.33)
- Part 17 Sales of Agricultural Commodities Made Available Under Title I of the Agricultural Trade Development and Assistance Act of 1954, as Amended (17.1 – 17.11)
- Part 20 Export Sales Reporting Requirements (20.1 – 20.12)
- 7 CFR SUBTITLE B REGULATIONS OF THE DEPARTMENT OF AGRICULTURE
- Chapter I Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture (Parts 27 To 206)
- Chapter II Food and Nutrition Service (Parts 210 To 296)
- Chapter III Animal and Plant Health Inspection Service (Parts 300 To 381)
- Chapter IV Federal Crop Insurance Corporation (Parts 400 To 458)
- Chapter V Agricultural Research Service (Parts 500 To 550)
- Chapter VII Farm Service Agency (Parts 700 To 799)
- Chapter VIII Federal Grain Inspection Service (Parts 800 To 868)
- Chapter IX Agricultural Marketing Service: Fruits, Vegetables, Nuts (Parts 900 To 999)
- Chapter X Agricultural Marketing Service: Milk (Parts 1000 To 1171)
- Chapter XI Agricultural Marketing Service: Miscellaneous Commodities (Parts 1200 To 1291)
- Chapter XIV Commodity Credit Corporation (Parts 1400 To 1499)
- Chapter XV Foreign Agricultural Service (Parts 1520 To 1599)
- Chapter XXV Office of Advocacy and Outreach (Parts 2500 To 2502)
- Chapter XXVI Office of Inspector General (Parts 2610 To 2620)
- Chapter XXXIV National Institute of Food and Agriculture (Parts 3400 To 3434)
- Chapter XXXVI National Agricultural Statistics Service (Parts 3600 To 3601)
- 21 CFR CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER A GENERAL (Parts 1 to 99)
- SUBCHAPTER B FOOD FOR HUMAN CONSUMPTION (Parts 100 to 191)
- Part 100 General (100.1 – 100.155)
- Part 101 Food Labeling (101.1 – 101.108)
- Part 102 Common Or Usual Name for Nonstandardized Foods (102.5 – 102.57)
- Part 104 Nutritional Quality Guidelines for Foods (104.5 – 104.47)
- Part 105 Foods for Special Dietary Use (105.3 – 105.66)
- Part 106 Infant Formula Quality Control Procedures (106.1 – 106.120)
- Part 107 Infant Formula (107.3 – 107.280)
- Part 108 Emergency Permit Control (108.3 – 108.35)
- Part 109 Unavoidable Contaminants In Food for Human Consumption and Food-Packaging Material (109.3 – 109.30)
- Part 110 Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food (110.3 – 110.110)
- Part 111 Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations for Dietary Supplements (111.1 – 111.610)
- Part 113 Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers (113.3 – 113.100)
- Part 114 Acidified Foods (114.3 – 114.100)
- Part 115 Shell Eggs (115.50 – 115.50)
- Part 118 Production, Storage, and Transportation of Shell Eggs (118.1 – 118.12)
- Part 119 Dietary Supplements That Present A Significant Or Unreasonable Risk (119.1 – 119.1)
- Part 120 Hazard Analysis and Critical Control Point (Haccp) Systems (120.1 – 120.25)
- Part 123 Fish and Fishery Products (123.3 – 123.28)
- Part 129 Processing and Bottling of Bottled Drinking Water (129.1 – 129.80)
- Part 130 Food Standards: General (130.3 – 130.20)
- Part 131 Milk and Cream (131.3 – 131.206)
- Part 133 Cheeses and Related Cheese Products (133.3 – 133.196)
- Part 135 Frozen Desserts (135.3 – 135.160)
- Part 136 Bakery Products (136.3 – 136.180)
- Part 137 Cereal Flours and Related Products (137.105 – 137.350)
- Part 139 Macaroni and Noodle Products (139.110 – 139.180)
- Part 145 Canned Fruits (145.3 – 145.190)
- Part 146 Canned Fruit Juices (146.3 – 146.187)
- Part 150 Fruit Butters, Jellies, Preserves, and Related Products (150.110 – 150.161)
- Part 152 Fruit Pies (152.126 – 152.126)
- Part 155 Canned Vegetables (155.3 – 155.201)
- Part 156 Vegetable Juices (156.3 – 156.145)
- Part 158 Frozen Vegetables (158.3 – 158.170)
- Part 160 Eggs and Egg Products (160.100 – 160.190)
- Part 161 Fish and Shellfish (161.30 – 161.190)
- Part 163 Cacao Products (163.5 – 163.155)
- Part 164 Tree Nut and Peanut Products (164.110 – 164.150)
- Part 165 Beverages (165.3 – 165.110)
- Part 166 Margarine (166.40 – 166.110)
- Part 168 Sweeteners and Table Sirups (168.110 – 168.180)
- Part 169 Food Dressings and Flavorings (169.3 – 169.182)
- Part 170 Food Additives (170.3 – 170.106)
- Part 171 Food Additive Petitions (171.1 – 171.130)
- Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption (172.5 – 172.898)
- Part 173 Secondary Direct Food Additives Permitted In Food for Human Consumption (173.5 – 173.405)
- Part 174 Indirect Food Additives: General (174.5 – 174.6)
- Part 175 Indirect Food Additives: Adhesives and Components of Coatings (175.105 – 175.390)
- Part 176 Indirect Food Additives: Paper and Paperboard Components (176.110 – 176.350)
- Part 177 Indirect Food Additives: Polymers (177.1010 – 177.2910)
- Part 178 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers (178.1005 – 178.3950)
- Part 179 Irradiation In The Production, Processing and Handling of Food (179.21 – 179.45)
- Part 180 Food Additives Permitted In Food Or In Contact With Food On An Interim Basis Pending Additional Study (180.1 – 180.37)
- Part 181 Prior-Sanctioned Food Ingredients (181.1 – 181.34)
- Part 182 Substances Generally Recognized As Safe (182.1 – 182.8997)
- Part 184 Direct Food Substances Affirmed As Generally Recognized As Safe (184.1 – 184.1985)
- Part 186 Indirect Food Substances Affirmed As Generally Recognized As Safe (186.1 – 186.1839)
- Part 189 Substances Prohibited From Use in Human Food (189.1 – 189.301)
- Part 190 Dietary Supplements (190.6 – 190.6)
- SUBCHAPTER G COSMETICS (Parts 700 to 741)
- Part 700 General (700.3 – 700.35)
- Part 701 Cosmetic Labeling (701.1 – 701.30)
- Part 710 Voluntary Registration of Cosmetic Product Establishments (710.1 – 710.9)
- Part 720 Voluntary Filing of Cosmetic Product Ingredient Composition Statements (720.1 – 720.9)
- Part 740 Cosmetic Product Warning Statements (740.1 – 740.19)
- SUBCHAPTER K TOBACCO PRODUCTS (Parts 1107 to 1141)
- SUBCHAPTER L REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION (Parts 1210 to 1272)
Cases
- Prude v. Clarke (7th Cir. 2012)(it is possible that jail officials were aware that nutriloaf was sickening the prisoner yet decided to do nothing, showing deliberate indifference to a serious health problem in violation of the Eighth Amendment)
- Int’l Dairy Foods Ass’n v. Boggs (6th Cir. 2010) (there is a “compositional difference” between milk from rBGH-treated cows and milk from untreated cows)
- FDA v. Brown & Williamson Tobacco Corp. 529 U.S. 120 (2000)(reading the FDCA as a whole, as well as in conjunction with Congress’ subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA the authority to regulate tobacco products as customarily marketed).
- In re: Burnette Foods (2014)(tart cherries that are promptly canned with no processing are exempt from restriction requirements)
- In re: Rosberg Farm (2014)(respondent’s applications for organic certification did not meet the requirements of the regulations)
- In re: Finch (2013)(affirming violations of the Perishable Agricultural Commodities Act, enacted to suppress unfair and fraudulent practices in the marketing of perishable agricultural commodities in interstate or foreign commerce)
- National Advisory Committee Reports on Meat Inspections and Microbiological Criteria From the Food Safety Inspection Service of USDA.
- Animal & Plant Imports and Exports From the Animal and Plant Health Inspection Service of USDA.
- Tobacco Product Regulation: Most FDA Spending Funded Public Education, Regulatory Science, and Compliance and Enforcement Activities (GAO 2014) In 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) granted FDA authority to regulate tobacco products, including marketing and distribution to youth. The act established CTP, which implements the act by educating the public on the dangers of tobacco use; developing the science needed for tobacco regulation; and developing and enforcing regulations on the manufacture, marketing, and distribution of tobacco products.
- Pesticide Safety: Improvements Needed in EPA’s Good Laboratory Practices Inspection Program (GAO 2014) EPA and FDA have independent but similar sets of GLP regulations. Officials from both agencies said it would be useful to know which laboratories the other agency was planning to inspect and to have those inspection results, since each agency can only inspect a certain number of laboratories each year. Absent collaboration and information sharing with FDA on planned and completed GLP inspections, EPA will have difficulty efficiently using its limited resources to increase the number of inspections it conducts.
- Limited Data Available on USDA Attorney Fee Claims and Payments (GAO 2014) GAO found that the Department of Agriculture (USDA) did not report any aggregated data on attorney fee claims and payments made under the Equal Access to Justice Act (EAJA) and other fee-shifting statutes for fiscal years 2000 through 2010, but USDA and other key departments involved—the Departments of the Treasury and Justice—maintained certain data on individual cases or payments in several internal agency databases.
- More Disclosure and Data Needed to Clarify Impact of Changes to Poultry and Hog Inspections (GAO 2013) USDA inspectors provide continuous inspection of each meat and poultry carcass and its parts that enter interstate commerce. In 1998, USDA began three pilot projects at slaughter plants for healthy young chickens, young turkeys, and young hogs, with a purpose to deploy inspection resources more effectively in accordance with food safety and other consumer protection requirements.
- FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources (GAO 2012) We identified five major actions the Food and Drug Administration (FDA) is to complete under the FDA Food Safety Modernization Act (FSMA) to establish a reliable system that uses third-party audits conducted by foreign governments or other third parties to help ensure food safety.
- FDA’s Food Advisory and Recall Process Needs Strengthening (GAO 2012) Several government entities, including federal agencies such as the Food and Drug Administration (FDA) and the Consumer Product Safety Commission, and some states such as Texas, have the authority to order product recalls.
- Responsibility for Inspecting Catfish Should Not Be Assigned to USDA (GAO 2012) With FDA’s new authority under FSMA, the federal government has an opportunity to enhance the safety of all imported seafood—including catfish—and avoid the duplication of effort and cost that would result from FSIS’s implementation of its proposed program.
- Improvements Needed in FDA Oversight of Fresh Produce (GAO 2008) While FDA has considered fresh produce safety a priority for many years, resource constraints and other work–including counterterrorism efforts and unplanned events such as foodborne illness outbreaks–have caused FDA to delay key produce safety activities.
- Youth Use of Cigars: Federal, State Regulation and Enforcement (OIG 1999) Describes the regulatory environment of cigars at the national and State levels, as well as Federal and State tobacco control and enforcement activities regarding minors’ access to and use of cigars.
- Youth Use of Cigars: Patterns of Use and Perceptions of Risk (OIG 1999) To describe patterns of cigar use among teens in our focus groups and their peers, specifically exploring the initiation, frequency, and variations of use, as well as the motivations and influences to use. In addition, to ascertain their access to cigars and awareness of health risks associated with cigar use.
- Issues Surrounding a National Tobacco Settlement (GAO 1998) Focusing on: (1) tobacco-related industries and existing studies that assess the national and regional economic impacts of the tobacco industry; (2) smoking trends for United States and Canadian youths; (3) the potential effect of a settlement on state revenues from cigarette excise taxes; and (4) the extent to which interstate and international cigarette smuggling affects the United States.
- Lawsuits Facing the Cigarette Industry in the United States (GAO 1998) Focusing on the: (1) recent trend in the number of tobacco-related lawsuits pending against the five largest cigarette companies in the United States; and (2) number of these lawsuits that, to date, have been decided or settled and that have resulted, or will result, in some form of payment to the plaintiffs and the amount of these payments.
- Compliance by Dietary Supplement and Conventional Food Establishments (GAO 1994) The Food and Drug Administration (FDA) regulates dietary supplements, which include vitamins, proteins, herbs, and fish oils, on a case-by-case basis, generally responding to complaints or other information on health risks.
- Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry (GAO 1994) Because of outdated statutory requirements for visual inspection of meat and poultry, the federal Food Safety and Inspection Service is unable to target scarce resources to detect microbial contamination, a primary cause of foodborne disease.
- A Unified, Risk-Based Food Safety System Needed (GAO 1994) The nation’s food safety system hampers efforts to address public health concerns and is slow to respond to changing health risks.
- Fundamental Changes Needed to Improve Monitoring of Unsafe Chemicals in Food (GAO 1994) GAO identified five basic weaknesses in the overall federal structure and systems for monitoring chemicals in food.
- Meat and Poultry Inspection: Impact of USDA’s Food Safety Proposal on State Agencies and Small Plants (GAO 1995) Pursuant to a congressional request, GAO reviewed state meat and poultry inspection programs, focusing on the possible effects of new food safety regulations on: (1) current state inspection programs; and (2) small meat processing plants.
- Fruit Juice Adulteration: Detection Is Difficult, and Enhanced Efforts Would Be Costly (GAO 1995) Pursuant to a legislative requirement, GAO reviewed the sale of adulterated fruit juice to school meal programs.
- Reducing the Threat of Foodborne Illnesses (GAO 1996) Pursuant to a congressional request, GAO discussed foodborne pathogens and their impact on public health.
- Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry (GAO 1994) The federal inspection system falls short in protecting the public from the most serious health risks caused by microbial contamination.
- Changes Needed to Minimize Unsafe Chemicals in Food (GAO 1994) GAO identified five basic weaknesses in the overall federal structure and systems for monitoring chemicals in food. First, fragmentation of responsibility among multiple agencies results in inefficiencies and gaps in federal monitoring activities.
- Salvaged Food: Lessons Learned from the Americold Fire (GAO 1995) Pursuant to a congressional request, GAO provided information on the events surrounding a fire at a food storage warehouse in Kansas, focusing on the: (1) disposition of food salvaged from the facility; and (2) lessons learned from the incident that could be used to improve regulation of the food salvaging industry.
- FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable (GAO 1996) Pursuant to a congressional request, GAO reviewed the Food and Drug Administration’s (FDA) plan to consolidate its Office of Regulatory Affairs’ (ORA) 18 field laboratories for product testing.
- FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable (GAO 1996). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration’s (FDA) plan to consolidate its Office of Regulatory Affairs’ (ORA) 18 field laboratories for product testing.
- Spit Tobacco and Youth: Additional Analysis (OIG 1993) To describe the potential impact of raising the Federal excise tax on spit tobacco in discouraging use of these dangerous products by youth and in raising substantial Federal revenues for health care.
- Spit Tobacco and Youth (OIG 1992) This study describes the present status of youth use of spit tobacco in six areas: prevalence and patterns of use, health effects, environmental influences on use, product promotion and sales, regulation and enforcement, and educational efforts.
- Youth Access to Tobacco (OIG 1992) In 1990, the Office of Inspector General (OIG)inspection, “Youth Access to Cigarettes” found that 45 States had laws prohibiting the sale of cigarettes to minors. However, States were not enforcing their laws.
- Youth Access to Cigarettes (OIG 1990)
Research has documented that millions of youth smoke, despite the existence of laws in 44 States and the District of Columbia prohibiting the sale of cigarettes to minors. Yet, a Journal of the American Medical Association article estimates that more than 3 million American children under age 18 consume 947 million packs of cigarettes yearly. - Youth Use of Smokeless Tobacco: More Than a Pinch of Trouble (OIG 1986) Youth start dipping and chewing at very young ages. The average age of first use is only 10 years, in fifth grade, and regular or daily use begins at only 12 years.
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