Food and Drug Administration Chapter 6 Graded A+
History of FDA - Answers butter v. oleo
moving from local to mass-produced
Spanish-American War and The Jungle publicized need for change
Pure Food and Drug Act (1906) - Answers aka Wiley Act
forbids commerce of misbranded food and drugs
must a...
Spanish-American War and The Jungle publicized need for change
Pure Food and Drug Act (1906) - Answers aka Wiley Act
forbids commerce of misbranded food and drugs
must abide by standards
variations must be disclosed on label
Food and Drug Administration - Answers created by FDA
started as Bureau of Chemistry
Food, Drug, and Cosmetic Act of 1938 - Answers Manufactures must prove that drug is safe before it can
be used; requires FDA approval; distinguishes prescription drugs from over-the-couter
Extended power of FDA to cosmetics and therapeutic devices
Exempt: Meat (under dep. of Ag.)
Kefauver-Harris Amendments - Answers FDA had to approve drugs based on effectiveness
gave greater powers to FDA (including advertising)
Food Regulation - Answers Originally over just canned food (quality, quantity in can)
Delaney Clause (1958) - Answers FDA assumed control over food additives;
Banned carcinogenics (causes cancer)
Structure of FDA - Answers Under Dep. of Health and Human Serivces
Enforcement by the FDA - Answers Recalls; Injuctions; Seizure of the subject product; Fines; Consent
decree; Criminal investigation
Food Additives - Answers Delaney Clause: no additives execpt for GRAS; manfacturer has burden of
proof (ex: Red Dye No 2 and M&Ms)
Food Quality Protection Act: food additives must have reasonable certainty of no harm - expands FDA to
include pesticides
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