2. 1 History of Food Regulation and the FDA Food Law FSC-421

3. 2 Ancient Food Regulation 370-285 BC “Enquiry Into Plants” – Theophrastus 370-285 BC “Enquiry Into Plants” – Theophrastus Treatise on plants as sources of food and medicine Treatise on plants as sources of food and medicine Noted that balsum gum was mixed with adulterants for economic reasons Noted that balsum gum was mixed with adulterants for economic reasons 234-149 BC “Treatise On Agriculture” – Cato 234-149 BC “Treatise On Agriculture” – Cato Noted use of boiled down musk, salt, marble dusk and resin in wines Noted use of boiled down musk, salt, marble dusk and resin in wines Method to determine if wine watered down Method to determine if wine watered down

4. 3 Ancient Food Regulation 23-79 AD “Natural History” Pliny the Elder 23-79 AD “Natural History” Pliny the Elder Adulteration of breads with chalk and peppers with juniper berries Adulteration of breads with chalk and peppers with juniper berries “so many poisons are used to force wine to suit our taste – and we are surprised that it is not wholesome” “so many poisons are used to force wine to suit our taste – and we are surprised that it is not wholesome” “Greatest aid to health is moderation in food” “Greatest aid to health is moderation in food” Urged use of kitchen gardens Urged use of kitchen gardens

5. 4 Ancient Food Regulation 131-201 AD “Galen” Roman physician 131-201 AD “Galen” Roman physician Warned against adulteration of pepper Warned against adulteration of pepper Stellionatus Stellionatus “where anyone has substituted some articles for another; or has put aside goods which he was obligated to deliver, or has spoiled them, he is liable for this offense” “where anyone has substituted some articles for another; or has put aside goods which he was obligated to deliver, or has spoiled them, he is liable for this offense”

6. 5 Middle Ages England - government decided price of food should be determined by its quality England - government decided price of food should be determined by its quality 1266 - Sale of any corrupted wine, meat, fish, bread or water that is not wholesome for man’s body prohibited 1266 - Sale of any corrupted wine, meat, fish, bread or water that is not wholesome for man’s body prohibited 1844 - Trade Guilds were major regulatory body 1844 - Trade Guilds were major regulatory body Searched and seized unwholesome products Searched and seized unwholesome products 1820 - “Treatise of Adulteration of Food and Culinary Poisons –Frederick Accum 1820 - “Treatise of Adulteration of Food and Culinary Poisons –Frederick Accum

7. 6 Early Food Regulation in the US Simple and local food production and distribution systems Simple and local food production and distribution systems Consumer could exert substantial influence over purity or wholesomeness Consumer could exert substantial influence over purity or wholesomeness Most foods grown by users, neighbors or from local marketplace where handling and production of produce could be observed Most foods grown by users, neighbors or from local marketplace where handling and production of produce could be observed

8. 7 Early Food Regulation in the US English experience worked at first English experience worked at first Population increased Population increased Growing urban communities Growing urban communities Reliance upon “food retailers” for surveillance of handling and production Reliance upon “food retailers” for surveillance of handling and production Now retailer exerted the influence over suppliers Now retailer exerted the influence over suppliers

9. 8 Colonial Food Laws Food Law in US is 300 years old Food Law in US is 300 years old 1646 Massachusetts Bread Law set price for a “loaf of bread” at one penny and decree how much it should weigh 1646 Massachusetts Bread Law set price for a “loaf of bread” at one penny and decree how much it should weigh Official inspectors could enter homes and seize “light” bread Official inspectors could enter homes and seize “light” bread Baking of bread was first commercial food activity in new world Baking of bread was first commercial food activity in new world

10. 9 Colonial Food Laws Profits increased if short “short weights” and used cheap ingredients like chalk and ground beans Profits increased if short “short weights” and used cheap ingredients like chalk and ground beans Mass, and NY enacted laws to inspect flour for worms Mass, and NY enacted laws to inspect flour for worms 1641 inspection of exported fish, and meat to improve trade relationships 1641 inspection of exported fish, and meat to improve trade relationships

11. 10 General Food Law First State law applying to foods generally instead of a specific product First State law applying to foods generally instead of a specific product 1785 Act Against Selling Unwholesome Provisions 1785 Act Against Selling Unwholesome Provisions “where some evilly disposed persons from motives of avarice and filthy lucre, have been induced to sell diseased, corrupted, contagious or unwholesome provisions to the great nuisance of public health and peace….. “where some evilly disposed persons from motives of avarice and filthy lucre, have been induced to sell diseased, corrupted, contagious or unwholesome provisions to the great nuisance of public health and peace….. Punished by fine, imprisonment, standing in pillory…” Punished by fine, imprisonment, standing in pillory…”

12. 11 Early Food Laws Iowa 1838 “Act to punish Vendors of Unwholesome Liquors and Provisions Iowa 1838 “Act to punish Vendors of Unwholesome Liquors and Provisions Oregon Territory 1848 adopted Iowa Act Oregon Territory 1848 adopted Iowa Act California 1850 regulated sale of unwholesome provision under Offenses Against Public Morality, Health and Police Law (exercise of police power?) California 1850 regulated sale of unwholesome provision under Offenses Against Public Morality, Health and Police Law (exercise of police power?)

13. 12 State vs. Federal Laws Complications when foods crossed state boundaries Complications when foods crossed state boundaries Conflicts of Laws Conflicts of Laws Imported product more suspicious than locality produced products (Turf) b/c of lack of ability of scrutinize handling Imported product more suspicious than locality produced products (Turf) b/c of lack of ability of scrutinize handling States needed to cooperate to trade States needed to cooperate to trade

14. 13 Early Federal Regulation 1789 Act for Laying a Duty on Goods, Wares and Merchandize Imported into the US 1789 Act for Laying a Duty on Goods, Wares and Merchandize Imported into the US Place duty of specific food items (booze, molasses, sugar, coffee, cheese) to control quantities coming into US (Imported) Place duty of specific food items (booze, molasses, sugar, coffee, cheese) to control quantities coming into US (Imported) 1883 Impure Tea Act prevented importation of adulterated teas 1883 Impure Tea Act prevented importation of adulterated teas Provided for inspections for purity and fitness Provided for inspections for purity and fitness

15. 14 Prohibition Booze only “food product” which has been the subject of a Constitution Amendment Booze only “food product” which has been the subject of a Constitution Amendment 18 th Amendment prohibited “manufacture, sale or transportation, importation or exportation of intoxicating liquors 18 th Amendment prohibited “manufacture, sale or transportation, importation or exportation of intoxicating liquors Repealed December 18 th 1933 Repealed December 18 th 1933 Followed by Alcohol Administration Act Followed by Alcohol Administration Act Protection from adulterated or misbranded articles Protection from adulterated or misbranded articles

16. 15 Oleomargarine Subject of early food legislation b/c of competition between manufacturers and dairy farmers Subject of early food legislation b/c of competition between manufacturers and dairy farmers 1879 “Act for Protection of Dairymen and to prevent deception in sales of butter and cheese in District of Columbia 1879 “Act for Protection of Dairymen and to prevent deception in sales of butter and cheese in District of Columbia Margarine must be stamped “Margarine Margarine must be stamped “Margarine

17. 16 Inflence of Economics Congress believed food supply was local matter and should be left to States Congress believed food supply was local matter and should be left to States 1880’s American Dress beef, and bacon strong in export market to Europe 1880’s American Dress beef, and bacon strong in export market to Europe Europe started to reject American beef b/c of encounters with diseased beef Europe started to reject American beef b/c of encounters with diseased beef Congress acted to save US beef export market Congress acted to save US beef export market

18. 17 Influence of Economics 1889 Secretary of Agriculture called for national inspection of cattle and condemnation of unfit carcasses 1889 Secretary of Agriculture called for national inspection of cattle and condemnation of unfit carcasses Prohibited importation of diseased cattle Prohibited importation of diseased cattle Congress took positive action to improve the quality of the food supply Congress took positive action to improve the quality of the food supply

19. 18 The “Jungle” Published February 1906 Published February 1906 Set in Chicago stockyards Set in Chicago stockyards Upton Sinclair, novelist concerned with unsanitary conditions in meat packing plants Upton Sinclair, novelist concerned with unsanitary conditions in meat packing plants President Theodore Roosevelt read book and called for investigation President Theodore Roosevelt read book and called for investigation 4 months later, Meat Inspection Amendment was passed as small part of appropriations bill, not a separate act of Congress 4 months later, Meat Inspection Amendment was passed as small part of appropriations bill, not a separate act of Congress

20. 19 Harvey Wiley First “Chief Chemist” of Bureau of Chemistry of USDA First “Chief Chemist” of Bureau of Chemistry of USDA Examined foods for evidence of adulteration Examined foods for evidence of adulteration Formed “Poison Squad” Formed “Poison Squad” President of AOAC for 25 years President of AOAC for 25 years Helped to develop sugar industry in US Helped to develop sugar industry in US

21. 20 “Pure Foods” (1906) 1906 Senate Committee on Manufacturers recommended a “Pure Food Law” 1906 Senate Committee on Manufacturers recommended a “Pure Food Law” Dr. Wiley played big role lobbying Dr. Wiley played big role lobbying Standards established for many imported foods Standards established for many imported foods Six new branch laboratories of Division of Chemistry established Six new branch laboratories of Division of Chemistry established

22. 21 Cocaine Coca - aine ("Fruit of the Coca plant") Coca - aine ("Fruit of the Coca plant") Toot, snow, white powder, young girl, blow Toot, snow, white powder, young girl, blow No laws prohibiting drug sales or use No laws prohibiting drug sales or use Cocaine used as “Pep pills” and prescribed to women for “medicinal purposes” Cocaine used as “Pep pills” and prescribed to women for “medicinal purposes” Cocaine treatment centers treated “addicts” and Cocaine freely prescribed by doctors Cocaine treatment centers treated “addicts” and Cocaine freely prescribed by doctors

23. 22 Cocaine Opium use prohibited in the west in the early 1900s due to perception that it caused Asians to become violent Opium use prohibited in the west in the early 1900s due to perception that it caused Asians to become violent Cocaine use prohibited in south due to perception that it caused “cocaine crazed negroes” that could not be stopped by regular bullets Cocaine use prohibited in south due to perception that it caused “cocaine crazed negroes” that could not be stopped by regular bullets

24. 23 Cocaine Prior to 1906, cocaine freely used in food products, (coca cola), medicines Prior to 1906, cocaine freely used in food products, (coca cola), medicines Given freely to migrant and dock worker because increased their “productivity” Given freely to migrant and dock worker because increased their “productivity” Southern fears of violence from drug crazed minorities prompted call for some type of regulation of cocaine and opium Southern fears of violence from drug crazed minorities prompted call for some type of regulation of cocaine and opium

25. 24 Cocaine Regulation Result was congressional action to introduce control legislation Result was congressional action to introduce control legislation Pure Food and Drug Act of 1906 was first attempt to regulate drugs and foods Pure Food and Drug Act of 1906 was first attempt to regulate drugs and foods Doctors no longer prescribed cocaine and all Treatment centers were closed Doctors no longer prescribed cocaine and all Treatment centers were closed Patients became addicts / Doctors became pushers / Black market developed Patients became addicts / Doctors became pushers / Black market developed

26. 25 “Pure Food and Drug Act” 1906 Passed June 22, 1906 Passed June 22, 1906 “ an act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious food, drugs, medicines and liquors…. “ an act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious food, drugs, medicines and liquors….

27. 26 Institutional History The FDA 1862-1890 Chemical Division USDA 1890-1901 Division of Chemistry USDA 1901-1927 Bureau of Chemistry USDA 1927-1930 Food, Drug and Insecticide Administration USDA 1930-1940FDAUSDA 1940-1953FDA Federal Security Agency 1953-1979FDA Dept. Health Education and Welfare 1979 - Date FDA Dept. of Health and Human Services