依据的法律法规

时间: 2021-12-30


    美国有关食品安全的法律法规非常繁多,这些法律法规覆盖了所有食品,为食品安全制定了非常具体的标准以及监管程序,对进口食品的认证、包装、标识及检测、检验方法作了详细的规定,构成了一张非常严密的食品安全保护法规网。其中,《联邦食品、药品和化妆品法》是美国食品安全的主要法规。此外,还有一系列的相关的法律法规,它们共同构成了美国食品安全监管的法律依据。

1.《联邦食品、药品和化妆品法》
    《联邦食品、药品和化妆品法》是美国关于食品和药品的基本法。自1938年颁布以来,历经数次修改,已成为世界同类法中最全面的一部法律。

2 与《联邦食品、药品和化妆品法案》相关的法案

    有许多法律是对这部法案的重要补充,还有许多法律是与食相关的。
   (1) 对《联邦食品、药品和化妆品法》重要补充的法案:
  • Infant Formula Act of 1980 summary

        Public Law(PL)96-359(Oct. 26,1980)

  • Orphan Drug Act

        PL 97-414(Jan. 4,1983)

        More information about orphan drugs

  • Drug Price Competition and Patent Term Restoration Act of 1984summary
        PL 98-417(Sept. 24,1984)
  • Prescription Drug Marketing Act of 1987
        PL 100-293(Aug. 18,1988)
  • Generic Animal Drug and Patent Term Restoration Act of 1988summary
        PL 100-670(Nov. 16,1988)
  • Nutrition Labeling and Education Act of 1990summary
        PL 101-535(Nov. 8,1990)
  • Safe Medical Devices Act of 1990summary
        PL 101-629(Nov. 28,1990)
  • Medical Device Amendments of 1992summary
        PL 102-300(June 16,1992)
  • Prescription Drug Amendments of 1992
        PL 102-353(Aug. 26,1992)
  • Prescription Drug User Fee Act PDUFAof 1992
        PL 102-571(Oct. 29,1992)

        More information about PDUFA

  • Animal Medicinal Drug Use Clarification ActAMDUCAof 1994
        PL 103-396(Oct. 22,1994)

        More information about AMDUCA

  • Dietary Supplement Health and Education Act of 1994
        PL 103-417(Oct. 25,1994)
  • Food Quality Protection Act of 1996
        PL 104-170(Aug. 3,1996)
  • Animal Drug Availability Act of 1996
        PL 104-250(Oct. 9,1996)
  • Food and Drug Administration Modernization ActFDAMAof 1997
        PL 105-115(Nov. 21,1997)

        More information about FDAMA

  • Best Pharmaceuticals for Children Act
        PL 107-109(Jan. 4,2002)
  • Medical Device User Fee and Modernization ActMDUFMAof 2002
    PL 107-250(Oct.26,2002)

        More information about MDUFMA

  • Animal Drug User Fee Act of 2003 PDF(51 KB)
        PL 108-130(Feb. 20, 2003)

        More information about ADUFA

  • Pediatric Research Equity Act of 2003
        PL 108-155(Dec. 3,2003)
  • Minor Use and Minor Species Animal Health Act of 2004
  • Food Allergen Labeling and Consumer Protection Act of 2004
        PL 108-282 (Aug. 2, 2004)
    (2) 对FDA有重要影响的法案有:
  • Federal Food and Drugs Act of 1906 (repealed; for historical reference)
  • Federal Meat Inspection Act (March 4,1907)
  • Federal Trade Commission Act (Sept. 26,1914)
  • Filled Milk Act (March 4,1923)
  • Import Milk Act (Feb. 15,1927)
  • Public Health Service Act (July 1, 1944)
  • Trademark Act of 1946 (July 5, 1946)
  • Reorganization Plan 1 of 1953 (March 12,1953)
  • Poultry Products Inspection Act (Aug. 28,1957)
  • Fair Packaging and Labeling Act (Nov. 3,1966)
  • The National Environmental Policy Act of 1969 (Jan. 1,1970)
  • Controlled Substances Act (Oct. 27, 1970)
  • Current regulations listing schedules of controlled substances
  • Controlled Substances Import and Export Act (Oct. 27,1970)
  • Egg Products Inspection Act (Dec. 29,1970)
  • Lead-Based Paint Poisoning Prevention Act (Jan. 13,1971)
  • Federal Advisory Committee Act(Oct. 6,1972)
  • Government in the Sunshine Act (Sept. 13,1976)
  • Government Patent Policy Act of 1980 (Dec. 12,1980)
  • Federal Anti-Tampering Act (Oct. 13,1983)
  • Sanitary Food Transportation Act (Nov. 3,1990)
  • Mammography Quality Standards Act (MQSA)(Oct. 27,1992)
  • Bioterrorism Act of 2002 (June 12,2002)
  •         More information about the Bioterrorism Act
  • Project BioShield Act of 2004 (July 21,2004)
    所有这些法律也同时收录在21USC中。
 
3. 食品法规
    美国所有与食品有关的法规都汇编与21CFR中。