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History of Food History of Food Regulation Regulation and the FDAand the FDA

Food LawFood LawFSC-421FSC-421

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Ancient Food RegulationAncient Food Regulation

370-285 BC “370-285 BC “Enquiry Into PlantsEnquiry Into Plants” – ” – Theophrastus Theophrastus Treatise on plants as sources of food and Treatise on plants as sources of food and

medicinemedicine Noted that balsum gum was mixed with Noted that balsum gum was mixed with

adulterants for economic reasons adulterants for economic reasons 234-149 BC 234-149 BC “Treatise On Agriculture” “Treatise On Agriculture”

– Cato– Cato Noted use of boiled down musk, salt, marble Noted use of boiled down musk, salt, marble

dusk and resin in winesdusk and resin in wines Method to determine if wine watered downMethod to determine if wine watered down

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Ancient Food RegulationAncient Food Regulation 23-79 AD 23-79 AD “Natural History” Pliny “Natural History” Pliny

the Elderthe Elder Adulteration of breads with chalk and Adulteration of breads with chalk and

peppers with juniper berriespeppers with juniper berries ““so many poisons are used to force wine so many poisons are used to force wine

to suit our taste – and we are surprised to suit our taste – and we are surprised that it is not wholesome”that it is not wholesome”

““Greatest aid to health is moderation in Greatest aid to health is moderation in food”food”

Urged use of kitchen gardensUrged use of kitchen gardens

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Ancient Food RegulationAncient Food Regulation 131-201 AD 131-201 AD “Galen”“Galen” Roman Roman

physician physician Warned against adulteration of pepperWarned against adulteration of pepper

StellionatusStellionatus ““where anyone has substituted some where anyone has substituted some

articles for another; or has put aside articles for another; or has put aside goods which he was obligated to deliver, goods which he was obligated to deliver, or has spoiled them, he is liable for this or has spoiled them, he is liable for this offenseoffense””

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Middle AgesMiddle Ages

EnglandEngland - government decided price of food - government decided price of food should be determined by its qualityshould be determined by its quality

1266 1266 - - Sale of any corrupted wine, meat, Sale of any corrupted wine, meat, fish, bread or water that is not wholesome for fish, bread or water that is not wholesome for man’s body prohibitedman’s body prohibited

1844 - 1844 - Trade GuildsTrade Guilds were major regulatory were major regulatory bodybody Searched and seized unwholesome productsSearched and seized unwholesome products

1820 - 1820 - “Treatise of Adulteration of Food “Treatise of Adulteration of Food and Culinary Poisons –Frederick Accumand Culinary Poisons –Frederick Accum

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Early Food Regulation in the USEarly Food Regulation in the US

Simple and local food production and Simple and local food production and distribution systemsdistribution systems

Consumer could exert substantial Consumer could exert substantial influence over purity or influence over purity or wholesomenesswholesomeness

Most foods grown by users, Most foods grown by users, neighbors or from local neighbors or from local marketplace where handling and marketplace where handling and production of produce could be production of produce could be observedobserved

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EarlyEarly Food Regulation in the US Food Regulation in the US

English experience worked at firstEnglish experience worked at first Population increasedPopulation increased Growing urban communitiesGrowing urban communities Reliance upon “food retailers” for Reliance upon “food retailers” for

surveillance of handling and surveillance of handling and productionproduction

Now retailer exerted the influence Now retailer exerted the influence over suppliersover suppliers

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Colonial Food LawsColonial Food Laws

Food Law in US is 300 years oldFood Law in US is 300 years old 1646 1646 Massachusetts Bread LawMassachusetts Bread Law

set price for a “loaf of bread” at one set price for a “loaf of bread” at one penny and decree penny and decree how much it how much it should weighshould weigh

Official inspectorsOfficial inspectors could enter could enter homes and seize “light” breadhomes and seize “light” bread

Baking of bread was first commercial Baking of bread was first commercial food activity in new worldfood activity in new world

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Colonial Food LawsColonial Food Laws

Profits increased if short Profits increased if short “short “short weights”weights” and used cheap ingredients and used cheap ingredients like chalk and ground beanslike chalk and ground beans

Mass, and NY enacted laws to inspect Mass, and NY enacted laws to inspect flour for wormsflour for worms

1641 inspection of exported fish, 1641 inspection of exported fish, and meat to improve trade and meat to improve trade relationshipsrelationships

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General Food LawGeneral Food Law

FirstFirst StateState law applying to foods law applying to foods generally instead of a specific productgenerally instead of a specific product

1785 Act Against Selling 1785 Act Against Selling Unwholesome ProvisionsUnwholesome Provisions

““where some evilly disposed persons where some evilly disposed persons from motives of avarice and filthy lucre, from motives of avarice and filthy lucre, have been induced to sell diseased, have been induced to sell diseased, corrupted, contagious or unwholesome corrupted, contagious or unwholesome provisions to the great nuisance of provisions to the great nuisance of public health and peace…..public health and peace…..

Punished by fine, imprisonment, Punished by fine, imprisonment, standing in pillory…”standing in pillory…”

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Early Food LawsEarly Food Laws

Iowa 1838 “Iowa 1838 “Act to punish Vendors Act to punish Vendors of Unwholesome Liquors and of Unwholesome Liquors and ProvisionsProvisions

Oregon Territory 1848 adopted Iowa Oregon Territory 1848 adopted Iowa ActAct

California 1850 regulated sale of California 1850 regulated sale of unwholesome provision under unwholesome provision under Offenses Offenses Against Public Morality, Health and Against Public Morality, Health and PolicePolice Law Law (exercise of police power?)(exercise of police power?)

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State vs. Federal LawsState vs. Federal Laws

Complications when foods crossed Complications when foods crossed state boundariesstate boundaries

Conflicts of LawsConflicts of Laws Imported product more suspicious Imported product more suspicious

than locality produced products than locality produced products (Turf) b/c of lack of ability of (Turf) b/c of lack of ability of scrutinize handlingscrutinize handling

States needed to cooperate to tradeStates needed to cooperate to trade

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Early Federal Regulation Early Federal Regulation

1789 1789 Act for Laying a Duty on Goods, Act for Laying a Duty on Goods, Wares and Merchandize Imported into Wares and Merchandize Imported into the USthe US

Place duty of specific food items (booze, Place duty of specific food items (booze, molasses, sugar, coffee, cheese) to control molasses, sugar, coffee, cheese) to control quantities coming into US (Imported)quantities coming into US (Imported)

1883 1883 Impure Tea ActImpure Tea Act prevented prevented importation of adulterated teasimportation of adulterated teas

Provided for inspections for purity and Provided for inspections for purity and fitnessfitness

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ProhibitionProhibition

Booze only “food product” which has been Booze only “food product” which has been the subject of a Constitution Amendmentthe subject of a Constitution Amendment

1818thth Amendment prohibited Amendment prohibited “manufacture, sale or transportation, “manufacture, sale or transportation, importation or exportation of importation or exportation of intoxicating liquorsintoxicating liquors

Repealed December 18Repealed December 18thth 1933 1933 Followed by Followed by Alcohol Administration ActAlcohol Administration Act

Protection from Protection from adulterated or misbrandedadulterated or misbranded articlesarticles

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OleomargarineOleomargarine

Subject of early food legislation b/c of Subject of early food legislation b/c of competition between manufacturers competition between manufacturers and dairy farmersand dairy farmers

1879 “Act for Protection of 1879 “Act for Protection of Dairymen and to prevent Dairymen and to prevent deception in sales of butter and deception in sales of butter and cheese in District of Columbiacheese in District of Columbia

Margarine must be stamped Margarine must be stamped “Margarine“Margarine

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Inflence of EconomicsInflence of Economics

Congress believed food supply was local Congress believed food supply was local matter and should be left to Statesmatter and should be left to States

1880’s American Dress beef, and 1880’s American Dress beef, and bacon strong in export market to bacon strong in export market to EuropeEurope

Europe started to reject American beef Europe started to reject American beef b/c of encounters with diseased beefb/c of encounters with diseased beef

Congress acted to save US beef export Congress acted to save US beef export marketmarket

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Influence of EconomicsInfluence of Economics

1889 Secretary of Agriculture called 1889 Secretary of Agriculture called for national inspection of cattle and for national inspection of cattle and condemnation of unfit carcassescondemnation of unfit carcasses

Prohibited importation of diseased Prohibited importation of diseased cattlecattle

Congress took positive action to Congress took positive action to improve the quality of the food improve the quality of the food supplysupply

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The “Jungle”The “Jungle”

Published February 1906Published February 1906 Set in Chicago stockyardsSet in Chicago stockyards Upton SinclairUpton Sinclair, novelist concerned with , novelist concerned with

unsanitary conditions in meat packing unsanitary conditions in meat packing plantsplants

President Theodore RooseveltPresident Theodore Roosevelt read read book and called for investigationbook and called for investigation

4 months later, 4 months later, Meat Inspection Meat Inspection AmendmentAmendment was passed as small part was passed as small part of appropriations bill, of appropriations bill, not a separate not a separate act of Congressact of Congress

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Harvey WileyHarvey Wiley

First “Chief Chemist” of Bureau of First “Chief Chemist” of Bureau of Chemistry of USDAChemistry of USDA

Examined foods for evidence of Examined foods for evidence of adulterationadulteration

Formed “Poison Squad”Formed “Poison Squad” President of AOAC for 25 yearsPresident of AOAC for 25 years Helped to develop sugar industry in Helped to develop sugar industry in

USUS

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““Pure Foods”Pure Foods” (1906) (1906)

1906 Senate Committee on 1906 Senate Committee on Manufacturers recommended a Manufacturers recommended a “Pure Food Law”“Pure Food Law”

Dr. Wiley played big role lobbyingDr. Wiley played big role lobbying Standards established for many Standards established for many

imported foodsimported foods Six new branch laboratories of Six new branch laboratories of

Division of Chemistry establishedDivision of Chemistry established

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CocaineCocaine

Coca - aine ("Fruit of the Coca plant")Coca - aine ("Fruit of the Coca plant") Toot, snow, white powder, young girl, blowToot, snow, white powder, young girl, blow No laws prohibiting drug sales or useNo laws prohibiting drug sales or use Cocaine used as “Pep pills” and Cocaine used as “Pep pills” and

prescribed to women for “medicinal prescribed to women for “medicinal purposes”purposes”

Cocaine treatment centers treated Cocaine treatment centers treated “addicts” and Cocaine freely prescribed “addicts” and Cocaine freely prescribed by doctorsby doctors

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CocaineCocaine

OpiumOpium use prohibited in the west in use prohibited in the west in the early 1900s due to perception the early 1900s due to perception that it caused Asians to become that it caused Asians to become violentviolent

CocaineCocaine use prohibited in south use prohibited in south due to perception that it caused due to perception that it caused “cocaine crazed negroes” that could “cocaine crazed negroes” that could not be stopped by regular bulletsnot be stopped by regular bullets

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CocaineCocaine

Prior to 1906, cocaine freely used in Prior to 1906, cocaine freely used in food products, (coca cola), medicines food products, (coca cola), medicines

Given freely to migrant and dock Given freely to migrant and dock worker because increased their worker because increased their “productivity”“productivity”

Southern fears of violence from drug Southern fears of violence from drug crazed minorities prompted call for crazed minorities prompted call for some type of regulation of some type of regulation of cocainecocaine and and opiumopium

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Cocaine RegulationCocaine Regulation

Result was congressional action to Result was congressional action to introduce control legislationintroduce control legislation

Pure Food and Drug Act of 1906Pure Food and Drug Act of 1906 was was first attempt to regulate drugs and foodsfirst attempt to regulate drugs and foods

Doctors no longer prescribed cocaine Doctors no longer prescribed cocaine and all Treatment centers were closedand all Treatment centers were closed

Patients became addicts / Doctors Patients became addicts / Doctors became pushers / became pushers / Black market Black market developeddeveloped

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““Pure Food and Drug Act” 1906Pure Food and Drug Act” 1906

Passed June 22, 1906 Passed June 22, 1906 ““an act for preventing the an act for preventing the

manufacture, sale, or manufacture, sale, or transportation of adulterated transportation of adulterated or misbranded or poisonous or or misbranded or poisonous or deleterious food, drugs, deleterious food, drugs, medicines and liquors….medicines and liquors….

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Institutional HistoryInstitutional History The FDAThe FDA

1862-18901862-1890 Chemical DivisionChemical Division USDAUSDA

1890-19011890-1901 Division of ChemistryDivision of Chemistry USDAUSDA

1901-19271901-1927 Bureau of ChemistryBureau of Chemistry USDAUSDA

1927-19301927-1930 Food, Drug and Food, Drug and Insecticide Insecticide

AdministrationAdministration

USDAUSDA

1930-19401930-1940 FDAFDA USDAUSDA

1940-1953 1940-1953 FDAFDA Federal Security Federal Security AgencyAgency

1953-19791953-1979 FDAFDA Dept. Health Dept. Health Education and Education and

WelfareWelfare

1979 - Date1979 - Date FDAFDA Dept. of Health Dept. of Health and Human and Human

ServicesServices