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)
PL 97-414(Jan. 4,1983)
More information about orphan drugs
- Drug Price Competition and Patent Term Restoration Act of 1984(summary)
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 1988(summary)
PL 100-670(Nov. 16,1988)
- Nutrition Labeling and Education Act of 1990(summary)
PL 101-535(Nov. 8,1990)
- Safe Medical Devices Act of 1990(summary)
PL 101-629(Nov. 28,1990)
- Medical Device Amendments of 1992(summary)
PL 102-300(June 16,1992)
- Prescription Drug Amendments of 1992
PL 102-353(Aug. 26,1992)
- Prescription Drug User Fee Act (PDUFA)of 1992
PL 102-571(Oct. 29,1992)
More information about PDUFA
- Animal Medicinal Drug Use Clarification Act(AMDUCA)of 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 Act(FDAMA)of 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 Act(MDUFMA)of 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- Federal Food and Drugs Act of 1906 (repealed; for historical reference)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。