Ch. 6 - Food and Drug Administration (FDA)
Consumer Product Safety Commission (CPSC)
1972; applies to consumer goods; goal is to prevent injuries and a loss of money;
Food Additives
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
CPSC Activities and Powers
Develops product safety performance standards and labeling standards; CPSC can ban or recall a product
Food, Drug, and Cosmetic Act of 1938
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.)
Food Regulation
Originally over just canned food (quality, quantity in can)
Delaney Clause (1958)
FDA assumed control over food additives; Banned carcinogenics (causes cancer)
Kefauver-Harris Amendments
FDA had to approve drugs based on effectiveness gave greater powers to FDA (including advertising)
FDA and tobacco
FDA regulates tobacco products and advertising; has outlawed flavored cigarettes
Medical Devices Amendment Act (1976)
Gives FDA jurisdiction over medical devices Example: silicon breast implants
Enforcement by the FDA
Recalls; Injuctions; Seizure of the subject product; Fines; Consent decree; Criminal investigation
Consumer Product Safety
Regulated by States prior to 1967
Consumer Product Safety Improvement Act of 2008
Regulates virtually ALL children's products; requires General Certificate of Conformity (GCC) based on test of each product
Structure of FDA
Under Dep. of Health and Human Serivces
Pure Food and Drug Act (1906)
aka Wiley Act forbids commerce of misbranded food and drugs must abide by standards variations must be disclosed on label
Fair Packaging and Labeling Act 1966
before labeling was only for diet products; says labeling must be honest and informative; does not consider serving size
History of FDA
butter v. oleo moving from local to mass-produced Spanish-American War and The Jungle publicized need for change
CPSC Structure
independent regulatory agency; 5 members appointed by president for 7 year terms
Federal Anti-Tampering Act
influenced by Tylenon/cyanide incident in 1983
Flammable Fabrics Act
pajama materials cannot be flammable
Nutrition Labeling and Education Act of 1990
Standardizes food labeling and makes it more consumer friendly; considers serving size
Food and Drug Administration
created by FDA started as Bureau of Chemistry
Hatch-Waxman Act
deals with generic drugs
