Pure Foods and Drugs Act of 1906 Food Law FSC-421 “Lawdoc” Pure Food and Drug Act “for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.” Pure Foods and Drugs Act of 1906 • Did not apply to intrastate commerce • Jurisdiction was based on adulterated or misbranded articles in interstate commerce • Dealt with interstate and foreign commerce in adulterated or misbranded foods… • Exempted items intended for export that were prepared according to foreign manufacturers specifications Food • Pure Foods and Drugs Act of 1906 defined food as: – “all articles used for food, drink, confectionery or condiment by man or other animal, whether simple, mixed or compound Food Adulterated if: • Any substance mixed with so as to lower or injuriously affect its quality • Any substituted substance wholly or in part • Any valuable component extracted • Treated so as to conceal damage or inferiority • Contains any added ingredient which may render it injurious to health • Any putrid, diseased substance or unfit for food Misbranded if: • Imitation offered for sale under name of another article • Falsely labeled so as to confuse or mislead purchaser • Contents in terms of “weights and measures” not plainly or correctly stated on outside of package • Label contains false or misleading statements or design concerning the ingredients of the food Remedies • Seizure – Under direction of court • Disposal – Of adulterated of misbranded articles • Imprisonment and/or $500 fine – Violation considered a misdemeanor criminal offense – Stiffer penalties for repeat offenses “Safe Harbor” • Dealer protected from prosecution under the 1906 Act if had “guarantee” signed by supplier/vendor /jobber/wholesaler attesting that articles not misbranded or adulterated when purchased Problems with the First Act: • Food industry resisted passage of the 1906 Act – Not accustomed to regulation • Failed to provide clear-cut definitions and standards – Could not determine imitation if no std for the original • Appropriations bills to fund enforcement and to establish food standards were not passed • Expert opinions successfully challenged as “arbitrary b/c no “legal stds” Problems with the First Act: • “no set of authorities can equitably execute a food law without a set of standards of purity for their guide” Harvey Wiley • Requirement of Intent: – First Act required not only proof of adulteration or misbranding, but also Gov had to prove offender “intended” to adulterate or misbrand • Gov never won a case / defendant plead ignorance Problems with the First Act: • Harvey Wiley “hell-raising” – Poison squad determined preservatives as a group were bad. (Reported in Bulletin 13, Foods and Food Adulterants) • Responsibilities of Secretary of Agriculture not clearly stated – Defenders could argue Secretary “exceeding authority” • Attention diverted from first Act by WWI Amendments to the First Act: • Sherley Amendment (1912) • Gould Amendment (1913) – “net weights” • Kenyon Amendment (1920) – “wrapped meat in paper = in packaged form” • Butter Amendment – Defined butter (oleomargarine) • McNary-Mapes Amendment (1930) – Standards of quality for canned foods (Birdseye) • Sea Food Inspection Amendments (1934) Other factors: • Consumers demonstrating for stricter laws • “Guinea Pigs” Kallet & Schlink 1933 – Exposed dangers in everyday foods, and drugs – Similar to Upton Sinclair book – Same year Roosevelt became President • Draft of a new bill introduced as the “Copeland Bill” on Jan 4, 1934 • Passed by 75th Congress 1937 and • Signed by President Roosevelt on June 25, 1938 Food, Drug and Cosmetics Act 1938 “Next Time”