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