Food and Drug Enforcers in the : Restraining and Educating Business

James Harvey Young Emory University

"The hardest task for both industry and . . . [the Food and Drug Administration],"a law professorasserted a decadeago, "issimultaneously to be adversarialand cooperative"[16]. During the prosperitydecade of the 1920s,with businessat a lofty level in the structureand esteemof American society,cooperation between regulated and regulatorsmarkedly expanded, althoughcontinuing enforcement of the Food andDrugs Act of 1906sparked considerablecontroversy. In the first phaseof enforcingthe law, from 1907to 1912,under the redoubtableHarvey WashingtonWiley, controversyhad predominated. Securingthe law had been a long and complexprocess [5, 49]. Some branchesof businesshad supported the campaignwith the hopeof usingsuch a law as a weaponagainst competitors [44, 49]. Others desiringa law--a coalitionof state chemists,women's club members,muckraking journalists, physicians,and agrarian state legislators--weremotivated by consumerist objectives,to protect the public health and purse from abuses in the productionof foodsand drugs[49]. Wiley, chiefchemist of the Department of Agriculture,played the role of broker amongthe diversearray of pro-law factions.An astutecompromiser prior to victory,Wiley's basic convictions emergedas his Bureauof Chemistry,given authority to recommendactions under the law, beganits task. He has been calleda "hide-boundcrusader" who insistedon "chemicalfundamentalism" [1, 15]. His own"Poison Squad" experimentshad persuaded him that chemicalpreservatives in foods,indeed, almostall commercialtamperings with nature,were hazardousto healthand shouldbe taboo. He intendedto enforcethe law with utmostrigor [5, 49]. When an earlymember of Wiley'sstaff protested that a proposedaction was not authorizedby thelaw, the chiefchemist replied: "But we mustread it into the law!"[29] Suchimpetuousness disturbed Wiley's superiors, who came also to distrusthis science. Both Secretaryof AgricultureJames Wilson, who viewedhis own chiefmission as the protectionof agriculturalmarkets [23], and PresidentTheodore Roosevelt, who fearedpolitical repercussions from questionablepolicies, created machinery to curb Wiley's independent decision-making[5].

BUSINESS AND ECONOMIC HISTORY, SecondSeries, Volume Twenty-one, 1992. Copyright(c) 1992by the BusinessHistory Conference. ISSN 0849-6825.

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Thesehigh-level battles dominated the headlines as well asWiley's time and concern. He paid scantattention to workadayadministration [5]. The chief"was somewhat distant to us,"recalled one of the earlyinspectors; "he wasan imagemore than a man"[30]. The inspectors,hired to collectsamples of foodsand drugs entering interstate commerce, were given minimal training, and no structuredplan of actionwas initially devised [18, 1907report, p. 5; 1921 report, p. 457]. "When we first started,"remembered Walter G. Campbell,whom Wiley appointedchief inspector, "it wasa sort of gum shoe method,because we couldbring down game no matterwhere we aimed"[11]. Experienceand emergenciesrevealed where the greatestproblems lay [48]. Foodsmentioned most frequently in the Bureau'searly annual reports were milk, eggs,vinegar, oysters, tomato products, stock feed, olive and saladoils, andcanned vegetables. As to drugs,outrageous patent medicines received the main emphasis. Even in these early days,Bureau of Chemistryofficials began to educateindustry as they policed it. The chemicalreagents they depended on for theiranalyses, Bureau scientists discovered, showed deficiencies, and these were pointedout to theirmanufacturers who were then cooperative in making "marked improvements"[18, 1904 report, p. 99; 1910 report, p. 158; 1911 report, p. 223]. Hearingswith producersof syntheticdrugs revealed that shortcomingsseldom resulted from "willfulintent" but rather from "lax or faultycontrol" systems; manufacturers took the lessons to heartand sought to enhancetheir procedures[18, 1912report, pp. 273-74].The law did not give theBureau direct authority over santitation in processingplants, but inspectors like W. R. M. Wharton realizedhow poor sanitationcould lead to illegal products,and he madethat lesson clear to manufacturers[19, 32 (May 1948), pp. 107-108]. To educateindustry in better methodsof cold-storageand transportationof eggs,poultry, and fish,Wiley setup in Philadelphiaa Food ResearchLaboratory directed by Mary E. Pennington[38]. Bacteriologyas applied to foodprocessing and pharmacology as related to drugproduction were still in their earlydays when the 1906law beganto be enforced. Until the 1930s,Louis Lasagnahas said, the American drug industrywas "a pygmy"; even at the endof the '30s,Macy's department store in City had an annualsales volume larger than that of any American ethical drug manufacturer[26]. Pharmaceuticalresearch was minimal,and industryscientists were scornedby academicians[35]. Food processingwas more firmly established at the startof the century,accounting for a fifth of the nation'stotal manufacturing,but the real heydayof canning wasstill two decadesaway [37]. In 1905,per capitaproduction of canned fruitsand vegetableswas 9.7 cans;in 1925it reached24.9 cans[13]. Exceptfor theProprietary Association, established by the major makers of so-calledpatent medicines in 1881,the major trade associations in the food anddrug field followed in the wakeof the law'senactment: the American PharmaceuticalManufacturers' Association in 1906, the American Drug ManufacturersAssociation in 1907, and the National CannersAssociation, formedby fusionof tworegional groups, in 1907[7, 14]. At the turnof the century,the canopener was deemed an evilsymbol, but by theend of the '20s publicprejudice against canned goods had been so conqueredthat the can 121 openerwas called "Boss of the Kitchen"[12; 3 (February1929, pp. 59-60)]. The American diet during these decadesbecame restructured [28]. Two historians, indeed, have linked canned food to a broader revolution in Americanlife: for Daniel Boorstin"foods . . . preservedout of season" constitutedone of thejolts to the traditionalsense of comfortablereality that hadcharacterized the earlierrural nation, and for JacksonLears canned goods were a symbolfor the "prepackagedartificiality" of life that broughttrauma to middleclass Americans at the dawnof the new century[8, 27]. In 1912,Harvey Wiley, weary from his bureaucratic battles and desiring greaterincome to supporthis wife andbaby son, resigned from government to takea positionwriting on foodand drug matters for GoodHousekeeping [5; 3 (November15, 1912),p. 9]. PresidentWilliam HowardTaft replacedhim with Carl Alsberg,a pharmacologistfrom the Departmentof Agriculture's Bureauof PlantIndustry [20]. Alsberghad a lesscombative personality than Wiley's. While believingin firm enforcementof the law, the new chiefwas morewilling to accommodateindustry if he thoughtit couldbe donewithout jeopardizingthe publicinterest. "Educationmust go hand in hand with federal and state regulation,"Alsberg told the AmericanPublic Health Association,"in the futuredevelopment of food control. As in our public schools,the old systemof usingthe rod freelyhas longsince given way to better methodsof teaching,so will the use of drasticlegal actiongradually becomeless necessary as an enlightenedfood industry utilizes better methods for manufacturing,handling and preparing foods. But just asthe best results are obtainedin schoolswhere someform of disciplinesupplements the best methodsof teaching,so the highestresults in the productionof purefood in those cases where educational methods alone are not effective will be obtained when there is availablesufficient legal powerand adequatemachinery to administercorrective discipline" [1]. Alsbergtook this stance,for example,with respectto artificialcolors for butterand oleomargarine[22], and the newchief gave more authority to Walter Campbellwho replaced the Bureau'ssomewhat haphazard method of samplecollection with a projectsystem [19 (November1921), pp. 1-2]. This planset priorities of effortfor eachyear based on carefullydetermined needs and specifiedwhat work should be doneby eachstation and district.In 1927, theBureau of Chemistry'sbasic research and its regulatory role were split, the latter given to a new Food, Drug, and InsecticideAdministration with Campbellas director[18, 1927report, pp. 645-48;1928 report, p. 679]. In his first annualreport, Campbellexplained the viewshe had held throughouthis service [18, 1928report, pp. 679-80]. He regardedthe lawshe had to enforce as "correctiverather than punitive." The Agriculture Department,he stated,"has adopted an advisory-before-the-actattitude by offeringconstructive suggestions which should enable manufacturers to keep their productsin compliancewith the law. It hasnot hesitated,however, to initiateproceedings under the law in thoseinstances where the protectionof the consumeror negligenceor willfulnesson the part of the shipperindicated suchaction to be proper." "Cooperationrather than conflictwith industry," Campbellasserted, "... is the key-noteof law-enforcementwork today" [10]. He cited as examplesthe sardinecanning industry in Maine and tomato 122

canningacross the country. The latter had begunin Wiley's day when the Bureau'sB. J. Howard had developedhis mold countmethod of estimating the amount of decomposedtomato in catsup and tomato sauce, and manufacturerswere educatedin the use of the techniquesso as to improve their packingprocesses [5]. Federaland stateofficials were still in the '20s holdingclasses for canneryworkers [18, 1928report, pp. 679-80]. Working together to solve problemsbrought an ententecordiale betweenregulators and major segments of the regulatedindustries. Industry's "suspicionand positive enmity in the earlydays," observed the agency'shouse organ,Food and Drug Review,had changedto an "attitudeof appreciation, cordialcooperation and enthusiasticassistance. The food and druginspector todayis not lookedupon in mostquarters as a detectiveor policeman,but as a technicianwho will assista manufacturerby timelysuggestions to produce a legaland therefore a moreprofitable product" [19 (February1927), pp. 4-5]. From this atmosphereof harmonythe consumerbenefited. Although some "dishonestproducers" of foodproducts, using ever more deviousmethods of deceit,persisted, and although general factory sanitation needed sprucing up, "thereis no other articleof commerce,"proclaimed a food and drug official in 1922, "more free from adulterationand misbrandingthan food" [19 (November1922), p. 1]. Two examples,one from the food field, the other aboutdrugs, supply substanceto supportthe regulators'generalizations. One eveningin January 1920,an Italian housewdein the Bronxbecame suddenly ill with disturbing symptoms,and the next morningshe died, the doctorascribing death to "uremia,chronic nephritis" [9, 41, 46]. Three dayslater, the bereaved family preparedsupper in the kitchen,the husband,two sons,a daughter,and two of the husband'sbrothers. They sharedthe meal of macaroniand a salad madeof anchovies,pickled peppers, ripe olives,olive oil, andvinegar. Within three daysall the maleshad died;only the girl of nine survived.Hospital doctorssuspected food poisoningand rememberedrecent news reports of similar tragediesin Ohio and . Epidemiologicalsurveys and laboratorytests placed the blame on botulism. The jar of ripe oliveshad been taintedwith the deadlytoxin. Bureauof Chemistryinvestigation established that the midwestern incidentshad been caused by olivespacked on the sameday in the samebatch at the sameCalifornia plant [9]. The processorrefused to acceptthe blame: he chargedthat an enemyagent during the late war musthave poisoned the rubber ringsused for sealingthe jars. The New York olives,the Bureau discovered,had been packed by oneof the mostreputable of Californiafood processors,a member of the statelegislature. Bureau officials warned the public,removed ripe olivesfrom the marketplace,and sought explanations for the disaster. Alreadythe Bureau had done some research on botulism, and now this wasintensified in collaborationwith industry.In 1913the NationalCanners Associationhad createda researchcommittee, hiring to manageit Wiley's secondin command,Willard D. Bigelow,long head of the Bureau'sfood division[33]. Duringthe 1920s,to lookahead, a numberof Bureauscientists and inspectorswere lured to higherpaying jobs in trade associationsand 123

industry, this aspect of the revolving door fostering agency-industry cooperation. Also, Secretaryof CommerceHerbert Hoover urged trade association-governmentbureau collaboration [4, 40]. In 1916the cannershad begunto fmancea broad studyof food poisoningby a Harvard professor, supervisedby a committeeof the NationalResearch Council [3 (April 1917), pp. 183-84]. When the ripe olivecrisis came, Bigelow hurried to California. Advisedby Bureauof Chemistryofficials, members of the CaldorniaOlive Association,the CaliforniaState Board of Health, andprofessors from several universities,he createda three-memberBotulism Commission of distinguished scientiststo savethe olive industryand reviveflagging consumer confidence in all processedfoods [9, 32]. From the targetedresearch efforts much new knowledge resulted: that Clostridiumbotulinum is telluric,its naturalhabitat the surfacelayers of virgin soil all overthe world;that a minutetrace of the bacillusor its sporesgetting onto fruit or vegetablesor meat as a resultof contactwith susceptiblesoil, andthen being processed in sucha wayas to providean anaerobiccore, then heatedinadequately, then later eatenwithout boiling, can quickly kill [31]. A Bureauof Chemistrybacteriologist found the bacillusand its toxinin an old olive dump at the rear of the Californiaplant that had processedthe fatal New York olives, and a member of the Botulism Commissionfound the bacillusin the grove in which those olives were grown [9, 37]. The Commissionset processingstandards sufficient to kill the spores. In 1921, Carl Alsberg urged the Public Health Serviceand the National Canners Associationto join the Bureauof Chemistryin a majornational campaign to educateall thosewho came in contactwith food, whether in store or at home, "asto their responsibilitiesfor the destructionof spoiledfood" [37]. The Bureau raised its threshold of alertness as to the risk of botulism in the foods it inspected. A major field of cooperationbetween regulators and industryin the '20s concernedmedicinal drugs intended for prescriptionto sick patients, especiallypills and tablets[47]. The law set two officialstandards for such pharmaceuticalpreparations, the United StatesPharmacopoeia and the NationalFormulary, and for drugsnot includedin thesevolumes required that they meet the standardsstated on their labels. In 1912 the Bureau of Chemistryhad studiedsuch tablets and pills and found a wide variation between the quantity of active ingredientclaimed, be it nitroglycerin, morphine,or nuxvomica, and the amountthat analysisrevealed to be present [18, 1912report, p. 279]. Court actionsfollowed, and leadingmanufacturers did not escape. In 1923 a marked expansionof Bureau drug controlwork occurred, directedby GeorgeHoover, a physicianand chemistwho had come to the Bureaubefore the 1906law was passed[19 (January1923), p. 4]. Hoover confessedthat hithertodrug policieshad beenrandom and the Bureauhad "notkept up with the growingtendency of the times"[19 (June1923), pp. A-B]. Americandrug manufacturing had takena spurtsince war had broken Germandrug dominance.Now, with new vigor,Bureau scientists checked anestheticsfor their purity, performedbioassays of crude drugs and of galenicalsmade with them,and of glandularproducts. Pharmaceutical tablets 124

were reexaminedwith specialemphasis on those intended for use in hypodermicinjections. Variationsranged disturbingly far from official or professedstandards. Nitroglycerintablets, for example,deviated from a deficiencyof 93 per centto an excessof 600per cent[47]. At eitherextreme, patientsmight suffer severely. Regulatory actions were launchedagainst the worstabuses. Bureau officials realized they did not knowwhat tolerances the stateof manufacturingtechnology would warrant. In 1924Hoover spoke at the annualmeetings of both the AmericanDrug ManufacturersAssociation and the American Pharmaceutical Manufacturers' Association. He asked themto gatherinformation on thisproblem and to takesteps to remedythe situation. Each organizationselected a contactcommittee to make studies jointly and to conferwith the Bureau[14, 19 (August1924), pp. 37-39]. The Combined Contact Committee developedmonographs on individualtablets, proposing methods of analysisand suggestingfeasible tolerances[19 (January 1928), p. 26]. Sometimesthe Bureau urged modifications. The f'mal results were published in a notebook, "PharmaceuticalStandards Including Tolerances and Methods of Assay"[25]. The processwas extended to a studyof ampuls. Both manufacturersand regulatorsexpressed satisfaction at the waycollaboration worked to improve the pharmaceuticalmarketplace and enhance patient care [18, 1926 report, p. 638; 1927report, p. 667; 1928report, p. 682]. A tradeassociation resolution termedthe process"epoch-making" [19 (),p. 229]. The contact committeesystem continued beyond the decade'send [14, 3 (January1928), p. 26]. Using the new standardsagreed upon, the new Food, Drug, and InsecticideAdministration wielded its regulatorypower to forcelaggards to conform[18, 1928 report,p. 696]. Dr. Hoovergot help from established manufacturersin reportingviolations they had discoveredand in testifying aboutthe highertrade standardswhen casescame to court. Another importantresult of cooperationwas the abandonmentby pharmaceuticalmanufacturers of misleading drug names [47, 19 (), p. 5]. Many therapeuticproducts had entered the prescriptionmarket called "liver stimulant,""heart remedy," and "indigestiontablets." Under agency urging,drug companies modified their labels and catalogs to designatethese medicinesby compositionrather than by body organor diseasecondition. These revisions,the FDIA asserted,had "been of great assistancein connectionwith the considerationof proprietarypreparations of similar compositions,by removingthe excusethat similarunwarranted titles . . . [were]being used by pharmaceuticalmanufacturers." Relationsbetween regulators and the makers of proprietarymedicines duringthe 1920sunderwent a slightwarming trend but remainedfrosty. No cooperativeprojects developed between bureaucrats and proprietarycontact committees.Prior to the 1906law's enactment, the patentmedicine business had been subjectedto savagemuckraking, and proprietorshad been among the mostvigorous opponents of a law [49]. With defeat,however, came also opportunity,as the majorfirms in the ProprietaryAssociation reassessed the situation[45, 50]. The tradeassociation had some 250 members, whereas the nationcontained three thousand nostrum-making firms [42 (January 1915), pp. 5-6;42 (April 1920),pp. 13-14]. Theymust reform sufficiently to meetthe 125

law's demands,the leadingproprietors decided, while letting regulators restraintheir smallercompetitors. So the ProprietaryAssociation adopted a code[42 (May 1916),pp. 11-12,17-19; (November 1916), pp. 20-23,37-39; (August1917), pp. 7-10;(January 1918), pp. 14-21;(April 1919),pp. 30-31]. No member should market narcotic medicines for children or vend abortifacientsor male weaknessremedies. Dangerous ingredients should be omittedor keptto a strictminimum. Label claims "must be neitherobviously unreasonableor demonstrablyfalse." Even advertising--notcontrolled by the law--shouldavoid making curative claims for incurablediseases. In the '20s, indeed,the namesof dread diseasesdisappeared from advertisingin the popularmagazines, replaced by the hazardsof acid indigestion,body odor, halitosis,intestinal fatigue, sneaker smell, and underarmoffence [36]. The ProprietaryAssociation'splan succeeded. Few caseswere brought againstits members by theBureau of Chemistry[42 (January1918), pp. 8-10]. Smallercompetitors were curbed considerably, even though a SupremeCourt decisionhampered enforcement. The 1906 law, the Court ruled, was not meantto banfalse and misleading therapeutic claims on nostrumlabeling [43]. The SherleyAct of 1912,in seekingto plug the loophole,placed upon the Bureauthe difficulttask of provingcurative claims both falseand fraudulent [50]. Surveysat the startof the '30sshowed that half the moneyspent by the Americanpublic for medicationswent for secretself-dosage preparations, and 80 per centof thisvolume was produced by ProprietaryAssociation members [34, 39]. The United Stateswas the largestexporter of packagedmedicines in the world, the makersaided in their marketingby the Departmentof Commerce[6, 42 (April 1920),pp. 13-14]. ProprietaryAssociation officials baskedin the successof their industryand its enhancedprestige. They grantedthe law's contribution to a greaterpublic confidence in theirproducts [42 (January1919), pp. 8-10]. Bureaucratswelcomed proprietors to their offices to talk over problems,and proprietors invited bureaucrats to their conventionsto address the stateof the industry[42 (January1928). p. 11]. In the mid-'20s,Bureau of Chemistry officials commentedon a "changedattitude" among manufacturers,a greater willingness to makechanges in labelingin response to criticism[19 (June1925), pp. 8-9]. Industry"suspicion" had diminished, and in turn regulatorssought to maintain"a policyof helpfulfriendliness" [42 (),pp. 46, 48]. ProprietaryAssociation leaders, finding officials too "fussy"early in thedecade and "not perfect" later on, nonetheless believed that their "bureaucontacts" provided one of the tradeassociation's greatest assets to its members[42 (September1920), pp. 13-14,23; (),p. 12]. Bureau officialsbecame more willing to discussformulas and to evaluate labelsbefore proprietorswent into the marketplace[19 (July 1929), pp. 232-33]. The agencyalso began to make advanceannouncements of campaignsagainst specific labeling abuses, giving prudent proprietors time to makechanges. Such evidences of "growingcooperation," an officialtold the ProprietaryAssociation in 1928,greatly gratified him [19 (June1928), p. 29]. Despite diplomaticwords and mutually admired deeds,relations betweenregulatory officials and proprietors remained tense. Severalactions undertakenby regulatorsto curbabuses upset proprietors especially. They 126

considered"monstrous" the useof multipleseizures by whicha manufacturer's entire operationcould be shutdown before his guilt wasproved in court [42 (November1926), p. 13; (May 1927),p. 22]. Ripperbills to ban the practice appearedin Congressbut did not pass[19 (1931), pp. 342-33]. Proprietors alsoprotested the Bureau'suse of claimsmade in collateraladvertising to interpretlabel claims too vagueor ambiguousto taketo court[42 (September 1922),pp. 20, 22, 24]. And, as the decadeended and an influenzaepidemic raged, proprietorsbecame angry at the Food, Drug, and Insecticide Administrationfor launchingan attackon a wide varietyof products,some made by major companies,promoted as effectiveagainst the flu [18, 1929 report, pp. 696-99]. As the Great Depressionbegan, ethical restraintsin advertising tumbled. Regulatorsseeking to stemthe tide increasedthe ire of proprietors [50]. "The drug industryis long suffering,"an editorialistcomplained. "It apparentlyis afflictedwith some sort of inferiority complex. It has been law-riddenfor ages,and it seeminglyknows not how to get rid of its 'old Man of the Sea.' . . . When will the drug trade . . . shake off its fear of over-zealousofficials . . . and fight as it couldfight for its rights"[17]. A fightlay ahead, indeed, but notone in whichthe proprietary industry soughtto regainfreedom lost, rather a fight to preventthe Food and Drug Administrationfrom securinggreater regulatoryauthority over food and drugs,including drugs intended for self-dosage.In the 1920s,as Pendleton Herring explainedin a 1935article, the balanceof socialforces had shifted awayfrom the weightof consumerinterest peaking in 1906 so needfulin securingthe law [21]. Businessascendancy in the '?.Oshad given it the advantage.Enforcers could find plentyto do "withoutinsisting upon a rigid interpretationof the act." Facing"potentially hostile forces and poorly armed with legal power,"officials placed great emphasison conciliation. The depression,however, and the New Deal were to bring a new changein the balanceof socialforces. In thisnew climate,after a five-yeartussle, a new lawwould emerge, a law containingmore rigorous restraints on business,the Food,Drug, and CosmeticAct of 1938[24].

References

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