The Medical Messiahs:
A Social History of Health Quackery
in Twentieth-Century America

Chapter 8: The New Deal and the New Laws

James Harvey Young, PhD


"Every slimy serpent of a vile manufacturer of patent medicine is tight now working his wiggling way around this Capitol. I have heard heretofore about the effort dear old Dr. Wiley made to secure the passage of the original law 28 years ago. Historically I was familiar with it, but now from experience I am familiar with it. I know the devious ways of those who are seeking to defeat the effort of the Congress to give protection to the health and lives of our people."

—Royal S. Copeland in The Senate, 1935 [1]


A few days after the inauguration of Franklin D. Roosevelt, the Chief of the Food and Drug Administration, Walter Campbell, walked across the street to pay a call on a new Assistant Secretary of Agriculture, Rexford G. Tugwell. Tugwell had raised a point about a letter prepared for his signature in Campbell's office, and the Chief felt a personal explanation was in order. The matter settled, the two men went on to a general conversation about the way in which existing food and drug legislation failed to provide proper safeguards for the consumer [2].

That same afternoon Campbell was again summoned to Tugwell's office. "Mr. Campbell," the Assistant Secretary said, since I saw you this morning I have talked with the President. I repeated our conversation to him, and he has authorized a revision of the Food and Drugs Act." Thus began a five-year battle.

Inadequacies in Dr. Wiley's 1906 law had been recognized from the start. Wiley and his successors—despite what the "guinea pig" muckrakers said—had not been negligent in pointing out the scope which supplementary legislation should have [3]. From time to time bills had been presented to the Congress to rectify this or that omission. Only a few had passed [4]. No broad-gauge measure had been given serious consideration. Not since the Sherley Act of 1912 had Congress dealt with the drug provisions of the law. During the golden glow of prosperity particularly, the political climate had not been conducive to reform. Now there was a dramatic change.

The situation "goes so far beyond the boundaries of what we dreamed to be a possibility six months ago," wrote Charles W. Crawford, in charge of enforcement for the FDA, in August 1933, "that it does not seem possible. Perhaps I have not oriented myself to the tempo of the 'new deal.'" [5]

After the Campbell-Tugwell conversation, things moved fast, perhaps too fast. In order to get a bill to present to the emergency session of Congress, the drafting process had been hurried. FDA officials and Department of Agriculture lawyers, aided by young law school professors secured by Tugwell, had quickly concluded that their goals could not be satisfied by mere amendments to Dr. Wiley's law. Some of the 1906 language might be retained, but an entirely new bill was necessary. The draft was not yet in final form when preliminary conferences were held with representatives of the drug, food and publishing industries. Tugwell and his cohorts saw ar advantage in seeking ideas from the business community with out revealing a specific text upon which criticism could focus The businessmen, hoping to see such a text, were unnerved to discover that they were being asked to make suggestions about a new law without knowing exactly what government officials had in mind. The mystery of the unpresented bill struck them as ominous, especially since Rexford Tugwell was known to be its sponsor [6].

Of all that new breed of "brain trusters" whom Roosevelt had brought to Washington, none was more suspect to the ranks of business than the handsome young Tugwell. This Columbia University economics professor was frank to say that he believed in a planned economy. He had spent two months in Russia-in company with Stuart Chase. In a book published in May 1933, Tugwell had stated, "It is doubtful whether nine-tenths of our sales effort and expense serves any good social purpose." He was soon to assert that "Property rights and financial rights will be subordinated to human rights." These frightening phrases appeared in the middle of extended discussions of political economy also frightening because of the abstruse, academic, sophisticated nature of Tugwell's thought. In manner also Tugwell upset businessmen: his "gallant confidence" struck them as haughty and imperious. The reaction came quickly. This outspoken theorist was soon presented, in a nightmare dreamed by a business-oriented educator, as a key villain, playing the role of Stalin to Roosevelt's Kerensky [7].

When the proposed new food and drug law was at last revealed, its greatest handicap to acceptance in business circles and to some degree in Congress was not its particular provisions, worrisome as many of them were, but the name by which it was known, the "Tugwell bill." Indeed, opponents of particular provisions sought to gain allies by deliberately brandishing Tugwell's frightening name." This was in a measure unfair, for the Assistant Secretary had nothing to do with the exact terms of the draft bill. But such are the realities of politics. Wiley had been a bureaucratic wild man to opponents of legislation during the first decade of the century. During the thirties Tugwell was cast in a similar role.

There are other similarities between the two crusades. Both were protracted, requiring half a decade of intensive effort. Both ended with laws much modified from earlier drafts. So all-pervasive are foods, drugs, and cosmetics, and so complex the details of regulation, that there was both necessity and room for the politician's art of compromise. By 1938, as by 1906, there had come to be somewhat too much of compromise for the general welfare. Both Theodore and Franklin Roosevelt favored food and drug reform, but in a moderate rather than an energetic way, and neither was prompt to give the issue top priority. In both decades, industries to be regulated lobbied with greater effectiveness than did consumers. Women's organizations both times were the most important and steadfast of consumers' champions. To those who took part in both struggles, there was a feeling of familiarity about the second fight. They had been that way before. The opponents of reform used many of the same basic arguments, even the same angry adjectives [9]. In the end, the achievement of legislation depended on upsurges of public pressure felt in Congress, generated each case by a dramatic threat to the public health. Instead of the fear of impure meat, there was, in 1937, the "Elixir Sulfanilamide" disaster.

The events preceding 1906 and 1938 had also their differences. The 1933 bill presented more dramatically, with less of a gradual conditioning of industry to the general idea than was true at then of the century, and thus struck the business community with greater immediate shock. During the second campaign the public did not develop the degree of interest and concern that characterized the Wiley crusade. One reason is that the 1aw had done much good, especially respecting food. There was widespread popular feeling, indeed, mistaken but sincerely held, that the first law had solved almost all the problems, A supplementary crusade, perhaps, cannot elicit the fire and zeal of the initial one. Another reason for the lesser impact in the thirties of food and drug efforts upon public awareness was the total political and economic environment. The United States was struggling to lift herself from the worst economic disaster in her history by relief, recovery, and reform measures of unprecedented novelty. Competition for headlines and front-page space was keener than during the more prosperous days of the Square Deal.

Muckraking was different also. In Wiley's day, popular magazines had carried stark tales of food and nostrum evils into half the homes of the land. This did not happen in the thirties. The development of national advertising had made the slick, wide-circulation magazines more cautious. And since food, drug, cosmetic advertising was a field over which the proposed law sought to extend control, some of the same journals that fought hard for reform in 1906 were initially hostile in 1933 Partly for the same reason, perhaps, newspapers gave very little space to the continuing efforts in Congress to enact a law. Medicine proprietors sought to frighten publishers, as they had done at the turn of the century, about bow advertising revenue would tumble if the law should pass [10]. A St. Louis editor wrote Tugwell that opponents of the bill had generated the hottest "beat" he had felt in a quarter of a century." [11] It is hard to say how much of a club this proved to be in the thirties. Editors, like the broader public, were just more interested in other issues. Insofar as food and drug matters did concern them, they might favor some aspects of a new bill but be leary of bureaucratic control over advertising.

The "guinea pig" muckrakers of the thirties reached their public through books and slender-circulation magazines. Thus the number of people aroused was a smaller proportion of the public than that which had reacted to the expos6s of Mark Sullivan, Upton Sinclair, and Samuel Hopkins Adams. These old muckrakers had worked hand-in-glove with Wiley to secure the 1906 law. The new muckrakers stood in a different relationship to Walter Campbell and his aides, not collaborators but critics. Using the same harsh adjectives they employed for adulterators and quacks, the Consumers' Research spokesmen belabored Food and Drug officials for indifference to the public welfare. Kallet and Schlink thought the FDA draft of a bill not rigorous enough to be acceptable, whereas Campbell and Crawford considered Consumers' Research proposals too extreme to be practicable. The more the FDA yielded to political realities in the hope of getting some kind of a law, the more Consumers' Research rebuked the inconstancy of bureaucrats.

Tugwell and Campbell had hoped that a food and drug law might be swept through Congress during the New Deal's first hundred days. This did not happen. Recovery was the prime national concern, and other measures held priority. The President did not label this particular reform a "must"; indeed, the bill's proponents did not make public the fact that Roosevelt had specifically authorized their effort.

Even had the President spoken out firmly, the bill might well have failed. Every state, every Congressional district, had manufacturers, wholesalers, and retailers concerned with foods and drugs. "The connections between businesses engaged in doubtful conduct and local politicians," as Tugwell later said, "turned out to be very direct in many places." There was even difficulty in securing a Congressional sponsor for the bill. The Food and Drug Administration was a unit in the Department of Agriculture, but the chairmen of the Committees on Agriculture in both the Senate and the House expressed their inability to consider the measure. Finally Royal S. Copeland came forward and volunteered for the assignment [12].

Copeland was not the ardent reformer's picture of a reforming Senator. A Tammany Democrat, his economic views were not noted for their liberalism. Copeland did not look like a crusader. A debonair man, he bore himself jauntily and was widely known for the fresh red carnation worn in his buttonhole each morning. Courteous in debate, be gave the impression of being much more anxious to compromise than to stand resolute. His physician's training had been homeopathic. He had written a health column for the Hearst papers, which soon would bitterly oppose his bill. All this made Copeland suspect among the more extreme crusaders. Yet there is no question that the dapper Senator was deeply devoted to the cause of food and drug reform. While serving as health commissioner of New York City, he had encountered evils which the 1906 law could not prevent. Coming to the Senate, he had introduced bills aimed at plugging some of these loopholes. Now he accepted the draft measure from Campbell and, as the emergency session of Congress drew to a close, introduced the bill. Copeland had not yet read it through [13].

When four months later Copeland did read the bill, he found that it would expand drastically the government's control over proprietary remedies. The 1906 law had provided a few "Thou shalt nots" regarding remedy labeling. The draft measure added to the prohibitions and included sweeping "Thou shalts." No longer would the government have to prove the fraudulent state of mind of a proprietor, as it had so expensively done in the B. & M. case: a drug was misbranded, according to the Tugwell bill, if its labeling made any therapeutic claim, even by ambiguity or inference, that was "contrary to the general agreement of medical opinion." The misbranding ban fell too on labels which gave the names of diseases for which the remedies were palliatives instead of cures, unless the labels clearly stated that the drugs were not cures. No longer would the names of only eleven drugs appear on labels; the draft bill required that all proprietary medicine labels list the common names and quantities of all medicinal ingredients. Medicines containing certain narcotic and hypnotic drugs must caution the consumer: "Warning-May be habit forming." And the list of dangerous drugs was longer than in the old law, for many new products—like the barbiturates—had developed or come into wider use since 1906. Germicides and antiseptics, if they would escape misbranding, must bear an accurate label statement telling under what precise conditions they would actually kill micro-organisms [14].

Whole categories of proprietary products which Dr. Wiley's law had not touched were covered in the Tugwell bill. Taboo were those remedies, like radium-containing liquids, which were desperately risky to take even though the labels, by avoiding therapeutic claims, told no untruth. A drug was adulterated, the draft bill stated, if it was dangerous to health when used according to directions on the label. Banished also were mechanical devices, like "electric" belts and Rube Goldberg machines with flashing lights, sold with claims to cure whatever ailed the customer. The definition of "drugs" was broad enough to encompass "devices intended for use in the cure, mitigation, treatment, or prevention of disease." Restricted too were remedies and gadgets that, strictly speaking, had nothing to do with illness, like weight-reducers, bust-expanders, and nose-straighteners, for the draft bill brought them under its control.

False advertising would also be illegal if the Tugwell bill should pass. The promotion of drugs, as well as of foods and the newly included cosmetics, must adhere, in general, to the same strict standards that were to apply to labeling. With respect to certain ailments, indeed, for which self-treatment was considered dangerous or futile, no remedies at all could be advertised to the' lay public. The fist was long, including appendicitis, blood poisoning, carbuncles, sexual impotence, sinus infections, and venereal disease. And the FDA could add to or subtract from it as the state of medical knowledge warranted.

Makers of proprietary drugs were also subject to general provisions of the bill. Their factories would be inspected by FDA agents. A permit system meant that their interstate shipments might be restrained; conflicts with the government could lead to widespread unfavorable publicity; and, should they be proved guilty of violating the law, proprietors would suffer penalties much stiffer than under Dr. Wiley's law. There was even a real threat of prison for the first offense.

Such, then, were the rigorous provisions of the Tugwell bill, no longer suspected items for fearful guessing, but now a matter of record for all to see. The target was in plain view, and firing began at once. It reached a peak at subcommittee hearings which Copeland held in December 1933 [15]. The proprietary manufacturers, asserted the New Republic in that month, became "the first group of industrialists openly to declare war on the Roosevelt administration." [16]

There was no need for a new law, they insisted. The old one served the purpose of controlling quackery well enough. What troubles there were resulted from "misdirected enforcement." To destroy the Wiley act would produce widespread confusion, wiping out a quarter of a century of legal precedents and disrupting the harmony between federal law and state laws enacted in imitation of it. Granted a few rascally charlatans still operated. The way to attack them was not to enact such a drastic new "un-American" bill. "To catch a rat in the garret," need Professor Tugwell "burn down the entire house?' "If a criminal is believed to be in a house with 9 other men who may be innocent of any wrongdoing,' do we "surround the house with police and shoot down every man in it to make sure that the criminal will not escape?" The Tugwell bill posed just such a grave threat. ". . . I have never in my life," asserted the general counsel of the Proprietary Association at the hearings, "read a bill or heard of a bill so grotesque in its terms, evil in its purpose, and vicious in its possible consequences." [17]

The enactment of this "professor's bill"—the phrase evoked a laugh in the crowded hearing room—meant nothing less than the end of the "constitutional right" of self-medication, which, along with freedom of religion and the press, had been "jealously guarded" since the foundation of the republic. And this tolled the death knell of proprietary remedies. Tugwell had assumed "the ambitious job of Volsteadizing and Carrie Nationizing" the industry. As a result of his measure, the "heavy, cold clammy hand of bureaucracy" would fall upon it. The FDA would turn into a "powerful, sinister machine." Each decision would be "a ukase of a satrap." Drugstores would be "sovietized." Drug advertising would be wiped out in five years.""

Much of this fear of dictatorship arose from discretionary powers given in the bill to the Secretary of Agriculture. Particularly worrisome was the clause which let the Secretary make regulations to interpret the bill which, as far as facts were concerned, would have the force of law. Walter Campbell might explain over and again that such a grant of regulation-making authority to an administrative agency had many precedents and that the reasonableness by which such decisions were reached could be tested in the courts. This did not still the oft-repeated cry of imminent czarism. The timing of the bill had something to do with this. There were under consideration other New Deal agencies which caused industry to look toward regulatory bodies with suspicion, and, anyhow, for those who did not or would not get the point, the shout of dictatorship was an effective weapon [19].

It was not only the regulation-making provisions that evoked this cry from the medicine men. Formula disclosure, now as four decades earlier, panicked them. This step, said one editor, was "Unreasonable, unnecessary, useless, unjust, and unwise." It would open the door to "piracy," charged another critic, letting every unscrupulous corner pharmacist reproduce and sell any product he desired, to the ruination of the manufacturer. Thus the bill would make "Uncle Sam a thief." [20]

The licensing of laboratories, testified Dr. James H. Beal, spokesman for a coalition of drug groups fighting the bill, would be "a very great menace." Penalties provided in the measure, wrote a spokesman for a proprietary group, were "severe enough to even satisfy a lust for blood." The term "general medical opinion" was much too vague and held dire threats for proprietors. So too did those elastic words which outlawed advertising if it was "in any particular . . . untrue, or by ambiguity or inference create[d] a misleading impression." It mattered not that the drafters had adapted the phrase from a Supreme Court ruling. "There is hardly one piece of [medicine] copy in five," wrote a worried agency man, "at which a zealous snooper could not point the trembling finger of indignant scorn crying. 'Ambiguous! Misleading by inference!" [21]

The "palliative" provision was also dynamite. The "negative advertising" it would require seemed grossly unfair. Proprietary makers should not have to make public confessions from which physicians were protected. "Why not," inquired the attorney for the United Medicine Manufacturers, "require that a sign be put over all doctors' doors saying, 'I do not Cure '? [22]

For all these reasons, there was scarcely a medicine proprietor throughout the land who did not join in the sentiment that Professor Tugwell's bill should be killed forthwith. Everything after the enactment clause, one witness told the Senate subcommittee, should be stricken out [23].

The barrage of criticism did not cause the Food and Drug Administration to forsake the field. At the subcommittee hearings, in articles, over the radio, Chief Campbell and his aides insisted on the compelling need for new legislation, explained the provisions of the bill, refuted criticism. Particularly irritating, was the proprietors' charge that home remedies would vanish because the bill would wipe out self-medication. If that had been the government's intent, Campbell told the Senators, it could have been achieved by "a single short section" explicitly saying so. What the bill did aim to do was "to make self-medication safe." [24]

To demonstrate that self-medication was not yet safe, Campbell showed the Senators a series of graphic posters, with bottles, labels, advertisements, death certificates attached. Each exhibit pointed up a hazard to life or limb which the FDA could prevent only with difficulty or not at all under existing law. One poster showed before-and-after photos of a comely Ohio woman whose eyeballs had been corroded to total blindness by an aniline eyelash dye. Another tied the horrible death of a Pittsburgh steel manufacturer directly to a proprietary radium water. Still others exposed quack devices, risky reducers, conflicts between controlled label and uncontrolled advertising claims. B. & M. was featured, with a stack of death notices testifying to the sad failure of a horse liniment to cure TB [25].

The "Chamber of Horrors" was what one reporter dubbed it, and it proved one of the most effective pressures for reform. Like the "Poison Squad" of Wiley's day, this dramatic exhibit caught public attention. Mrs. Roosevelt came to see it in the Food and Drug Administration offices and wrote about it in her column. A set of posters was sent to Chicago for display at the Century of Progress Exposition. Other sets circulated around the country. Time and again Copeland was to wave one of these grim posters on the Senate floor [26].

"Under present circumstances," Campbell testified before the Senate subcommittee, "a denizen of Central Africa, knowing nothing about administering to the sick, other than that imparted by the practices of a witch doctor, could land in this country, put up an article either of no more therapeutic value than a glass of water or as lethal as strychnine, sell it to the people of this country as a cure for every disease which man might have, and be within the terms of the law [27].

But neither the Chamber of Horrors nor Campbel's earnest urging could secure enactment of the Tugwell bill. Drug interests and their allies in certain segments of the press, organized into "one of the noisiest and most determined lobbies of modern times," made their great weight felt. Opposition came also from the most responsible elements of the industries to be regulated. Spokesmen for advertising, publishing, fruit growing, food processing, cosmetic making, and pharmaceutical manufacturing appeared before Copeland's subcommittee to condemn the bill. Like the proprietors, each group had particular complaints. Canners, publishers, and advertisers, for example, objected to provisions that would require quality standards for foods and establish grade labeling. Anathema to almost all the industries concerned were the broad discretionary powers given to the Secretary of Agriculture. Copeland himself, when he got around to reading the bill, shared this feeling. Even Walter Campbell was willing to retreat [28].

Copeland set to work at revising the bill in the light of what he had listened to in the hearings and what he kept learning in almost daily conferences with representatives of the affected industries. Never before, he told his Senate colleagues, had he suffered "so many worries and so much trouble." At last he produced a version be believed "sane, sensible, workable," and on it the entire Committee on Commerce held now hearings in late February and March 1934. The revised draft, in Walter Campbelrs judgment, was not as good as at first but nonetheless "desirable." His view and that of the makers of proprietaries were still far apart. Spokesmen for two of the three proprietary trade associations—the Proprietary Association and the United Medicine Manufacturers of America-had made their wishes frankly known at the hearings, as had several individual proprietors, The modifications in Copeland's draft, while embodying some of their suggestions, had not improved the bill at all, most of them felt. In some ways, indeed, the new version xas even more threatening to them than the original Tugwell draft. "The forbidden list of diseases has jumped from 34 to 42 in a few weeks," noted the UMMA's counsel, "making it possible for one to forecast the life expectancy of self-medication under this proposed law with almost mathematical certainty." Proprietors still favored the 1906 act, modestly revised, or, if some more thorough measure should pass in time, they felt it ought to be one of their own devising. Their version, as Campbell saw it, would provide the industry "extraordinarily solicitous consideration' and would provide the public "very much less protection than it now has." [29]

If the medicine proprietors were not satisfied with Copeland's new draft, neither were the representatives of Consumers' Research. Kallet had considered even the first version of only half-hearted help to consumers and, at the hearings, had rebuked Copeland for giving health talks on a radio program sponsored by a yeast firm which used suspect testimonials from foreign physicians. In view of these circumstances, Kallet said, the hearings should be "reconvened under a new committee and an unquestionably impartial chairman." The committee's "pro-commercial bias," Kallet charged at the second hearing, had "emasculated" the original version. "The subsequent career of the bill," he added scornfully, "should be recorded in political textbooks as a case history of how legislation supposed to protect the public against the depredations of business is made." Consumers' Research forces, therefore, favored the bil's defeat as ardently as did the medicine makers and, like them, had a bill introduced into Congress embodying their own extreme views [30].

Copeland brought a still further revised measure from the hearings to the Senate calendar. FDA men hoped that it would pass, and their moods alternated between optimism and gloom. "You have conducted a masterly retreat," wrote a law professor who had helped in the initial drafting process, "and have kept the principal vantage points." In mid-May, amid an atmosphere of tension, the bill got to the floor for an hour's debate. "Senators," Copeland warned his colleagues, "the wrath of thousands will come down upon the heads of those who willfully prevent the passage of the bill." But the measure was passed over and no more was beard of it before the session ended [31].

Before the next Congress opened, proprietary spokesmen leveled angry charges at the FDA. The agency was "sulking." Irked at the "severe trimming" which their pet bill had received, a trade journal asserted, officials, "in a blind fury . . . immediately started to swing the club at the heads of those who were mainly responsible for thwarting their plans." [32] Larger appropriations and a favorable political climate were permitting more rigorous enforcement than in the twenties, and proprietors were far from pleased.

At the beginning of the 74th Congress, in January 1935, Copeland reintroduced his bill. Now it bore marks of further change as a result of the Senator's continuing conferences with interested parties. The medicine makers had won some concessions on label claims—the bill gave "too big a present to the pain-killers," one FDA friend felt—but the changes were not sufficient to woo them from a bill of their own. Should the proprietary-sponsored measure pass, observed another FDA ally, "only a kind providence" could "protect the consumer." Such a contingency, however, seemed hardly likely, and, indeed, Copeland maneuvered so adroitly that his "hybrid mixture" that came back to the Senate in March after new subcommittee hearings still impressed an FDA spokesman as "a splendid bill." At this juncture Franklin Roosevelt sent his first words to Congress on the theme. They were by no means a command. The President expressed his "hope"' that legislation might be enacted to protect the "honest enterpriser" against "evaders and chiselers" and to "provide a bulwark of consumer confidence throughout the business world." [33]

The debate on Copeland's measure was extensive and acrimonious. While the makers of proprietary medicines flooded the Senate with telegrams and letters, vigorous efforts were made on the floor to amend the bill in those respects most desired by the proprietors. The "heart of the opposition;" as Copeland termed it, lay in two attempts, one, to substitute the Federal Trade Commission for the Food and Drug Administration as the agency that would supervise food, drug, and cosmetic advertising; the other, to reduce the multiple seizure authority of the FDA not only below the level of Copeland's bill, but even below that of the 1906 law [24].

For over 20 years, the FTC had maintained some control over false advertising, and Commissioner Ewin L. Davis had come before two of the committee hearings to state firmly that the Commission did not want to relinquish its monopoly. In Davis' desire, all proprietary groups staunchly concurred. Copeland was not persuaded. The deplorable condition of nostrum advertising, he told his Senate colleagues, was a sound argument for giving authority to the FDA. Since the FTC had performed inadequately, since the Raladam decision had limited its purview to cases involving injury to competitors, and since FTC procedures were slow and penalties weak, the FDA should take on the job. Food, drug, and cosmetic advertising was, after all, an inevitable extension of labeling, and the FDA, unlike the FTC, had the scientific staff to arrive at all the necessary decisions [35].

A test on the FTC issue did not arise at once. Senator Bennett Champ Clark, who came from the state in which Listerine was made, talked of offering an amendment, but did not do so. Regarding multiple seizures the problem was immediate. Senator Josiah W. Bailey presented, and the Senate accepted, amendments that left proprietary drugs virtually immune to the most effective weapon FDA had possessed for clearing the market quickly of threatening nostrums. A critic had once called the seizure action of no value, like the arrest of a murderer's revolver after it had killed its victim. On the contrary, the FDA held, seizure was comparable to arresting the murderer's bullet in flight before it reached its intended victim [36].

Throughout the twenties, the Proprietary Association had offered unceasing objections, and to eliminate or circumscribe multiple seizures had been one of its main goals. To accomplish this aim had been an expressed purpose of all proprietary groups at hearings on the various versions of the Copeland bill [37]. Now during debate concerted pressure was brought. Copeland was convinced that a plot existed to destroy or emasculate his bill.

"There is, in effect," the Senator said, "a conspiracy on the part of these patent-medicine men—and some of them are sitting in the gallery right now as I speak—seeking to defeat the bill. Then there are certain newspaper interests who are so afraid that they will not be permitted any more to run the vile advertising which I have exhibited, who are so afraid that their dividends will be affected by this attack upon their revenues that they are here in force, and possibly, though I pray not, they may have influence enough to beat the bill." [38]

Copeland poured out his bitterness and scorn on "the patent-medicine advertiser and manufacturer, the vilest man on the face of the earth," as be sought in vain to prevent the weakening of the multiple seizure authority. And when be failed—the vote on the Bailey amendment was 44 to 29—Copeland said that, as far as he was concerned, the bill was dead. But Copeland rallied from his despair, conferred with Bailey and Clark, got the best compromise he could, and on May 28 saw his much-patcbed measure pass the Senate [39].

The pure food and drug bill was by now so transformed from the draft that first had borne his name that Tugwell, now Under Secretary of Agriculture, could scarcely recognize it. Consumers' groups were angry at Copeland's yielding. "Ironically," a Consumers' Research spokesman said, the Senate bill was "a more adulterated and misbranded product than anything marketed" by the industries which were supposed to be controlled. By passing the bill, charged Kallet, the Senate had "made itself, knowingly or not, an accessory to thievery and murder." Representatives of the women's organizations which had banded together to press for an adequate law did not use such strong language, but they were disappointed. Opponents of the original bill, said the spokesman for the American Association of University Women, had "drawn the teeth they feared," and she summed up the details of the weakening process: [40]

"The list of incurable diseases for which so-called 'cures' can not be sold has been cut from forty-two to nine.
"The restriction against advertising a mere palliative as a cure has been removed.
"Standards of strength for germicides and antiseptics have been eliminated. . . .
"There are no minimum fines; fines have been reduced.
"Protection against cumulative poisons, stimulant-depressants and sedatives has been removed. . . .
"Weakening administrative changes have been made.
"There is the shocking restriction of multiple seizures to those products only that are 'imminently dangerous to health.'"

Trade circles were saying the Senate bill was not unlike the draft which had been sponsored by the Proprietary Association. Indeed, the key weakening amendments had been transferred into Copeland's document from that draft. So it was not surprising that the Proprietary Association's general counsel should term Copeland's measure "fair and reasonable" and urge its prompt passage by the House [41].

Within the Food and Drug Administration it was hard to get "enthusiastic" about the bill. Nonetheless, Campbell and his aides would not protest the erosion process too strenuously—if only the House could somehow soften the impact of the Bailey amendment circumscribing multiple seizures. Gross deception, Campbell suggested, as well as imminent danger, should be actionable [42].

During the summer a House subcommittee held lengthy hearings. Virgil E. Chapman, a Kentuckian, was chairman, and he set about the task with the President's wishes for good speed. The same old ground as in the Senate hearings was retrod, but with a different step. Copeland had debated points with witnesses from industry, but not sharply, nor had he sought to inquire into their backgrounds. Chapman equipped himself ahead of time with information on those who came to testify and on the products they represented. Suavely and cleverly, he used these facts as the basis for penetrating probing [43].

Lydia Pinkham's daughter and granddaughter were in the hearing room while Chapman posed for the company's attorney embarrassing questions the latter seemed not prepared to answer. Reading a purported formula for the Vegetable Compound, the Congressman asked the lawyer if it was a "fair analysis." [44]

"I do not know, sir. I cannot answer your question."

"Does the alcohol in it have any effect?"

"Well, I think so, of course, Mr. Chairman. I think alcohol—I believe in the use of small doses of alcohol."

What, Chapman queried, was the medicine good for?

"It is a beneficent product, sir, for women and women's trouble. Beyond that, I do not know. I never took it."

Chapman inserted into the record a pink slip signed by the Pinkham Company suggesting that the Compound might be very hard to buy if a new food and drug bill was passed, and urging that a letter be mailed immediately to the reader's Congressman opposing the measure. "We are trying," the pink slip read, "to stop this bill from becoming law." Was the Pinkham Company, Chapman asked, "responsible for that propaganda?"

"Mr. Chairman," the attorney replied, "it is the first time I have ever seen or heard of the pink slip."

Chapman read also two versions of multigraphed letters which the pink slip would aim toward Washington. "The women of America will show you," one of them stated, "that you cannot deprive them of Lydia E. Pinkham's Vegetable Compound without hearing from us at election time." The letter also disparaged competing remedies made by other members of the Proprietary Association.

Chapman also brought out in questioning one of Senator Bailey's constituents, Smith Richardson, head of the company that made Vick's Vaporub, that Richardson had modified his labeling under Food and Drug Administration pressure rather than risk multiple seizures for implying, during an epidemic, that his ointment might prevent pneumonia and the flu. Richardson had just told the House subcommittee that his company had sent a letter to 2,100 newspapers favoring the Copeland bill "providing there be no tampering with the Bailey amendment." [45]

An evasive but most revealing witness, under the Kentucky Congressman's dogged questioning, was William P. Jacobs, who, it turned out, wore at least five proprietary hats. He made a medicine. He ran an advertising agency. He operated Jacobs' Religious List, responsible for placing advertising in a long string of church papers published throughout the South. He served as publicity chairman for the United Medicine Manufacturers of America. And he was executive vice-president of the Institute of Medicine Manufacturers [46].

Jacobs was slow to admit that there was personal advantage in these multiple connections, although he did agree, under Chapman's prodding, that he had solicited UMMA members for advertising placed in the religious press. Likewise, Jacobs denied threatening the press with loss of advertising should a new food and drug bill pass, although be did confess to writing letters to newspapers and radio stations describing the kind of law he favored.

"You held out to them," said Chapman, "that there was a 'Sword of Damocles' hanging over their heads in the form of this bill pending in Congress, and if this bill became a law the 'Fasteeth' and 'Lydia E. Pinkham's Vegetable Compound' with 18 percent alcohol would not advertise with them any more. Is that correct?"

"I was not quite that fluent, Mr. Chairman," Jacobs replied.

Nor would Jacobs admit to knowing that medicines advertised in his religious papers had been in serious trouble with the Food and Drug Administration for claiming efficacy in treating such things as snakebite, ulcers, and cancer.

"Don't you think," Chapman asked, "that before you insert advertisements in these religious journals, along in the same columns or parallel columns with hymns and prayers, and lessons from the Bible for the children, you ought to know what is in these products . . . ?"

"If that rule, Mr. Chairman, were applied to all newspapers and advertising," Jacobs answered, "there would be no advertising."

Such unawareness seemed difficult for Chapman to grasp.

"You know," he stated, "that many a person, when he picks up that church paper, believes it is second only to the Bible, and believes everything in it even down to the advertisements of Calotabs and 666."

But Jacobs would not confront this paradox.

"You are a good salesman . . . " he told Chapman in reply, "I wish we had one as good as you are."

What Congressman Chapman found out by his keen questioning made him an enthusiastic convert to the cause of a strong law. When he became aware that the major proprietors were all for speeding the Senate bill through the House, Chapman withstood the pressure. Rumor had it that an effort was made but failed to get enough Congressional signatures to discharge the committee and bring the bill to the floor. Chapman opposed haste. More education was needed, he believed, both among House members and among the broader public. Peeved that the press had paid so little attention to his lively hearings, the Kentucky Congressman looked into the possibility of using motion pictures and the radio [47].

The FDA, hopeful that a more rigorous bill than Copeland's might emerge because of Chapman's enthusiasm, itself sought to quicken public interest. Ruth deForest Lamb who handled public relations for the agency, published a book. Dedicated to the women's organizations which had provided the FDA unflagging support, American Chamber of Horrors summed up the case for a strong new law. It described once more, with poignant case histories, the evils which could not be touched and sorrowfully narrated the way in which a good bill had been pummeled into an indifferent one by the relentless blows of its enemies. Miss Lamb's conclusion was not defeatist: there were both optimism and exhortation in the title of her concluding chapter, "There's Going to Be a Law!" Proprietors who had reached the point of espousing almost the same bill as the FDA were shocked at Miss Lamb's lion-like attack. "All of which clearly indicates," asserted a trade paper, "that the Administration does not give a damn for the industry or its cooperation." If the FDA was renewing its efforts for a measure stronger than the bill that had passed the Senate, elements of the drug and cosmetic industry were drumming up new antagonism to a measure even as restrictive as that [48].

Chapman's campaign of education among his fellow Congressmen was only partially successful. Nine months after the hearings a substitute food and drug bill was brought into the House. It contained some restoration of the multiple seizure powers which had been weakened by the Bailey amendment in the Senate bill. But it gave sole control of food, drug, and cosmetic advertising to the Federal Trade Commission. Such a disposition was in accord with the desires of proprietary groups, but this was not the compelling reason for the change. Several members on the House committee in charge of the bill were antagonistic to the Food and Drug Administration for actions it had taken against powerful fruit-growing interests in their districts. Tugwell especially was blamed for what apple growers considered an arbitrary and needless order sharply reducing the amount of spray residue permissible on apples going to market. Even more important, FTC chairman Ewin Davis was a former member of the House and made the most of this old school tie in his very effective testimony before the House subcommittee. Chapman had fought the move to deprive the FDA of advertising control in committee and argued against it in "Additional Remarks" appended to the House Report. His effort, however, was in vain. The committee majority went all the way with the FTC [49].

President Roosevelt notified the Speaker that he wanted action before the waning session ended. The rules were suspended and, after only 40 minutes of debate, the bill was passed. To ensure this result, House leaders had pledged themselves not to yield on the FTC issue in conference with the Senate. And, though other issues were reconciled between the two conflicting versions, the House conferees stood firm on this, even when Copeland said he would rather see the bill die than agree to this change. Finally Copeland phoned the White House. One of the President's secretaries reported that Roosevelt preferred to have the FDA in charge of advertising, but he would not veto the bill solely because control was given to the FTC. A last-minute compromise was tried: the FDA would be given jurisdiction over advertising relating to health, the FTC over advertising relating to economic cheats. This effort failed when two House conferees objected. Senator Copeland and Representative Sam Rayburn agreed that the conference report of disagreement should stand, but Copeland should present the bill to the Senate including the health economics proviso. This he did, and the Senate accepted it and sent the amended version to the House [50].

As the last minutes of the session ticked away, the food and drug issue was stated from two opposing views. As Chapman saw it, the question was: "Will we stubbornly resist this reasonable compromise and thereby deny the consuming millions of American people the protection to which they are entitled?" But Representative Carroll Reece, who, like Commissioner Davis, came from Tennessee, phrased the matter differently: "If you want to place the advertising under Dr. Tugwell and give him a whip lash not only over business, but over the press of this country, vote for the motion made, but if you want to give it to the Federal Trade Commission, a quasi-judicial body, vote against it." "The printed Record," an observer wrote, can give you no idea of the boos and catcalls that greeted the mention of Dr. Tugwell's name or the cheers for Ewin Davis." [51]

Rayburn fought the trend. "There might be a little lobbying around here by some people," he told the House, "but there is nobody who has lobbied around this Capitol on any bill in the 23 years I have been in Congress more than the members of the Federal Trade Commission have lobbied on this bill. . . ." When the vote was taken, the score stood: Tugwell and the FDA, 70; Davis and the FTC, 190. So the bill died [52].

"Peculiarly enough," wrote Charles Crawford, "the worst enemies of the legislation originally, the patent medicine group, are in no wise responsible for the defeat of the measure." The bill had reached a form which the large proprietors were willing to accept. Also, as prior to 1906, the protracted agitation over a national bill had spurred states to action. New laws much more rigorous than old ones were passing state legislatures, and from state to state their terms were different. Proprietors were becoming almost eager to assume greater obligations under a new national law, since it would tend to bring harmony among state practices [53].

Some advocates of reform were rather more pleased than grieved that this particular version of the battered food and drug bill had gone down to defeat. Copeland's "willing hand," asserted a consumer's periodical, had been guided by the lobbies to create a "legislative monstrosity." This very same word expressed the view of the American Medical Association. The AMA had played a less active role in working for a new law than prior to 1906. Almost as critical as industry of the Secretary of Agriculture's potential "dictatorship" under the Tugwell bill, the AMA appreciated later modifications of the administrative provisions at the same time that they deplored the simultaneous weakening of controls over drugs. The AMA's legislative counsel, Dr. William C. Woodward, had appeared at every hearing to present the doctors' point of view. Both in his corporate and in his personal capacity, he was a firm foe of quackery: as health commissioner of Boston he had once launched an attack on B. & M. By the time of the House hearings, Woodward objected to the way in which drug controls had been "whittled away and- undermined." This same note was sounded in a journal editorial in May 1936. "The first bill introduced," the editorialist wrote, "has been subjected to a sort of plastic surgery in the legislative operating rooms which has resulted in a specimen not even resembling the original model and utterly deficient in many particulars. Altogether the result is an asthenic, chinless and impotent monstrosity." [54]

Not until 1938 did the House of Representatives again bring to vote a comprehensive food and drug bill. In the meantime, however, they settled the imbroglio over advertising. The House vote had made clear the sentiments of that body, and a bill was prepared bolstering the scope of Federal Trade Commission control over food, drug, and cosmetic advertising. Chapman and Copeland, in their respective Houses, fought the bill but, realizing that it had the votes to pass, sought to equip it with stronger sanctions to deter wouldbe violators. As the bill stood, only advertisers who could be proved guilty of fraud or who vended commodities inherently dangerous need fear more than an order telling them to cease and desist their false advertising. But the attempt to add fines failed, largely because the FTC did not want them. The amendment to put more teeth into the bill, said Representative Lea, after talking with an FTC representative, "would, in effect, convert the Federal. Trade Act . . . into a criminal statute primarily as to advertisements . . . . This is not the practical way to deal with business men." [55]

Thus the FTC won its jurisdictional contest with the FDA, securing in the Wheeler-Lea Act the kind of advertising control measure its members desired. The Secretary of Agriculture urged the President to veto the bill, but he did not [56].

With the controversial advertising issue settled, one major deterrent to revision of the 1906 law was gone. A second obstacle, the presence of Tugwell in the Department of Agriculture, disappeared when the Under Secretary quit the government to become vice-president of a molasses company." A third handicap was also reduced. Public interest, despite the Chamber of Horrors and the activities of women's groups, had remained tepid. Now it came to a quick boil.

Headlines the country over broke the news of a mounting death toll from "Elixir Sulfanilamide." The report was especially disturbing since sulfanilamide had been widely heralded in the press as a miracle medicine, a chemotherapeutical breakthrough. In this case, nothing was wrong with the sulfa, but in another respect a terrible mistake had been made. The chief chemist at a small pharmaceutical plant in Bristol, Tennessee, seeking for a liquid dosage form, had hit upon the solvent diethylene glycol. Unaware of reports describing the compound's toxicity, the chemist had tested his new concoction for appearance, fragrance, and flavor—but not for safety. Production began both in Bristol and in the firm's Kansas City plant. Nearly 2,000 pints of the viscous pink liquid were made, and on not one label was the solvent named [58].

Nearly two months later, the FDA heard a rumor that deaths were occurring in Oklahoma from some sulfa compound. Investigation quickly revealed the terrible truth. Only a technicality made the drug misbranded and let the FDA take action: all elixirs, according to the Pharmacopeia, must contain alcohol, and this "Elixir" did not. The agency threw its entire staff into the task of tracking down and seizing the poisonous medicine. Most of the 93 pints which had reached patients had been prescribed by doctors. Some, however, had been sold over the counter by druggists to customers whom they did not know, largely because of publicity praising sulfanilamide's effectiveness in treating gonorrhea. Displaying great patience and ingenuity, Food and Drug inspectors, aided by state and local authorities, managed to account for 99.2 per cent of all "Elixir Sulfanilamide" produced. In South Carolina, one bottle, not yet empty, was found on the very grave of an "Elixir" victim, tossed there by the bereaved in accordance with an ancient local rite.

Death from diethylene glycol is protracted and it is painful. The "Elixir," according to FDA calculations, brought death to at least 107 persons, many of them children. One of the most poignant documents in the whole record of food and drug legislation is a letter written to Franklin Roosevelt by the mother of one of the victims. She told how her child, a little girl of six, had died in agony, and begged the President to get a law so that other families would not have to suffer as hers had done. With the letter she sent a picture of her daughter's smiling face.

The chemist who concocted the "Elixir" took his own life, The doctor who owned the company—during the unfolding tragedy he had told the press, "I do not feel that there was any responsibility on our part"—paid a fine of $26,100, the highest ever levied under the 1906 law. The public, shocked into a new awareness that the law had loopholes, urged Congress to remedy the fault.

But there still were problems. A rift had developed between Copeland and the President. Differing with Roosevelt on many policies, Copeland had refused to attend the 1936 Democratic convention and had spent much of the campaign touring the Holy Land. Later he fought FDR!s plans for expanding the Supreme Court. The President came to hope that someone other than Copeland might lead the Congressional effort in behalf of food and drug reform. Responding to one of Dr. Harvey Cushing's several letters urging Roosevelt's support for a vigorous law, the President replied in December 1936: "My difficulty is a political one. I hope to have someone other than your medical colleague, Dr. Copeland, handle it at the comig session. Enough said!" [59]. Tugwell, in first broaching the subject of a new law to Franklin Roosevelt, had reminded the President that the first law had been enacted during Theodore Roosevelt's administration, and the second Roosevelt had not been indifferent to the continuing attempt to secure revision. Except for his one message to Congress, however, his own efforts to help the cause occurred behind the scenes. Initial opposition from many industrial groups and powerful segments of the press was so heated that the President, for political reasons, let Tugwell shield him and bear the brunt of the bitter attack. Within the government, too, the marked differences in judgment about how far the new law should go forced upon the President the role of reconciler. At one point fairly early in the game, Roosevelt's private secretary noted in a memorandum, "President suggests having Rex Tugwell and Copeland together to fight it out. The President will sit in and hold the sponge." Later, when the FDA-FTC dispute over control of advertising became a troublesome problem, Roosevelt called in Tugwell and Davis for a joint—and futile—conference. From time to time, the President brought pressure to speed Congressional action or to influence its direction. When, in a personal letter or phone call, he expressed a personal opinion, his weight was thrown toward strengthening rather than weakening the draft being considered at the time. He urged Senator Bailey, for example, not to destroy the FDA's multiple seizure authority, the President's letter, indeed, being a verbatim copy of a draft prepared for him by Tugwell. But the food and drug bill never received from Roosevelt the staunch support he gave to other measures. His difficulties with Copeland obviously made it harder for the President to make effective what interest be had. Things reached the point where reporters joked Roosevelt about his ignorance concerning the legislative status of the Senator's bill [60].

Another obstacle had developed by 1937. A new provision had appeared in the House committee draft which came close to reducing food and drug controls to an absurdity. It was the work mainly of the apple growers, still fearful that the FDA would be too stringent in policing insecticide spray residues. The clause would set up such an endless chain in the appealing of FDA regulations to the district courts that the agency would be reduced to impotence. The Secretary of Agriculture informed the House of "the departments considered judgment that it would be better to continue the old law in effect than to enact [the new bill] with this provision." The Attorney General concurred, and a minority of the House committee felt the same. But in June 1938 the House of Representatives passed the measure with the offending clause remaining [61].

Once again, as two years before, Senate and House conferees met to try to reconcile their differences. "Frankly," wrote Charles Crawford, "I do not feel very optimistic because it looks like the worse rather than the better provisions of the two bills are to be combined in the Conference Committee." But the debacle of 1936 was not repeated, and Crawford's gloomy presentiments were not fulfilled. To the committee Copeland took his associate and former food and drug aide, Ole Salthe, who had sought advice from FDA officials as to which of the differing provisions might be best calculated to serve the consuming public. Regarding some matters, Salthe was provided with written compromise provisions that would make the measure, as Campbell and Crawford saw it, a better bill. In the committee it soon became apparent that the conferees were willing in general to accept Copeland!s judgment as to which provisions to adopt. When disputes arose, the Senator called upon Salthe to present and explain the way he would resolve the matter. As a result, the list of suggestions Salthe took with him was accepted almost without exception. The judicial review provision was modified to make it much less objectionable. The multiple seizure authority was somewhat restored. "Had the Committee adopted the alternatives to the provisions Salthe proposed , ' Crawford later wrote, "the resulting bill would have been worthy only of veto." [62]

As it was, the Senate quickly approved the conference report, and the House, after bearing another round of objections from the apple growers, also voted for the bill. On June 25, 1938, President Roosevelt added his signature. At long, weary last, the fight was over. The Food, Drug, and Cosmetic Act was one of the last major domestic measures enacted during the New Deal [63].

Tugwell the terrifying was gone from government. He viewed the final bill as "a subverted thing," the result of "a cause . . . betrayed." Copeland the compromiser was also gone. Driving himself too hard, he had collapsed on the Senate floor and died on the last night of the session, never knowing whether or not the President with whom he had squabbled would sign the measure that had been his main preoccupation during his last five years. Walter Campbell, Chief of the Food and Drug Administration, was still around. He had done his best, initially and through all succeeding stages, to secure as strong a measure as practical politics would permit. Two months before the bill was passed, writing to a man who had fought hard for legislation before 1906, Campbell said, "I believe that if Doctor Wiley and you, prior to the passage of the present (19061 act, had taken the position that only a perfect bill would be accepted, we might not even now have as good a law as we do have." Now he was not jubilant, but neither was he so despairing as his former ally and superior. "Five years of legislative consideration," he wrote in his 1938 report, "have produced a measure that will unquestionably afford greatly increased public protection even if it does not contain all of the provisions its advocates have urged." [64]

Misbranding provisions relating to proprietary medicines were markedly stronger than in Dr. Wiley's now superseded law. Many Tugwell bill clauses, indeed, had survived in the 1938 law with only moderate change. Any false and misleading statement in the labeling of a remedy was now banned; no longer need the government prove fraudulent intent with respect to therapeutic claims. False labeling included not only erroneous positive statements but also the failure to reveal germane facts, especially the omission of warnings in circumstances when medication might be hazardous. Drugs dangerous to health when used according to directions were outlawed. A significant step was taken in the direction of formula disclosure for non-official drugs. The common names of all active ingredients were required upon the label. In addition, for a list of potent drugs and habit-forming narcotic and hypnotic substances, quantity and proportion had to be given. Antiseptics must be germicidal, And new drugs—like Elixir Sulfanilamide—must not be marketed until their manufacturers had persuaded Food and Drug officials that the drugs were safe [65].

The law took account of medical devices. It covered articles aimed at affecting the body's structure or function. It also sought to secure honest labeling on medicines shipped by "doctors" who diagnosed by mail.

The FDA got one new weapon, the injunction, to add to its seizures and criminal actions. Penalties were also stiffened and were made heavier for second offenses and for fraud. Even a first offense might now bring up to a year in prison.

Campbell and his associates set right to work at regulation-making and at enforcing those parts of the law that became immediately effective. To eliminate one of the grimmest exhibits in the Chamber of Horrors, the FDA made its first seizure under the new law. The product was an aniline eyelash "beautifier" of the type that had corroded the eyeballs of the woman from Ohio [66].

References

  1. Cong. Record, 74 Cong., I ses., 5138 (1935). Charles Wesley Dunn, in Federal Food, Drug, and Cosmetic Act: A Statement of Its Legislative Record (N.Y., 1938), has reprinted all the pertinent portions of the Congressional Record relating to the efforts from 1933 into 1938 to secure the law. The work also contains other material, especially the portions of Congressional hearings citing testimony of FDA and FTC spokesmen. For leads on material used in this chapter, the author wishes to express appreciation to graduate students who prepared course papers on various aspects of the law's background: David L. Coker, Norman B. Ferris, William J. Harkins, Shirley Hinton, Charles O. Jackson, Robert L. Keele, Jr., Bartlett C. Jones, Anne Lide, Choice McCoin, R. L. McConnell, Joseph C. Ray, Jr., Jane Stubbs, and Edwin H. Trainer.
  2. Ruth deForest Lamb, American Chamber of Horrors, 278-79.
  3. Wiley expressed his views in testifying before a House Committee in 1912. The Pure Food and Drugs Act: Hearings before the Committee on Interstate and Foreign Commerce, House of Representatives (62 Cong., 2 ses.). Carl Alsberg, Chief of the Bureau of Chemistry, described "serious limitations" of the law in his 1917 Report of Bureau of Chemistry.
  4. The several amendments that had been passed since 1906 are summarized in 1931 Report of Food and Drug Administration.
  5. Crawford to David F. Cavers, Aug. 8, 1933, "Correspondence on Legislation " Office of the Commissioner, Records of the Food and Drug Administration, RG 88, NA.
  6. David F. Cavers, "The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions," Law and Contemporary Problems, 6 (Winter 1939), 7-8; the FDA prepared summary statements concerning the conferences with industry which are reproduced in Dunn, 1033-47; Bernard Sternsher, Rexford Tugwell and the New Deal (New Brunswick, N.J., 1964), 248; N.Y. Journal of Commerce, Apr. 11 and 28, 1933, "Clippings on Food and Drug Legislation," Scrapbook, FDA Records, RG 88, NA.
  7. Rexford G. Tugwell, The Industrial Discipline (N.Y., 1933), 180; Elliott Roosevelt, ed., F.D.R.: His Personal Letters (N.Y., 1950), 1, 37273; Sternsher, 228-30; Current Biography 1941 (N.Y., 1941), 874-76; Cavers, 6. The late John J. McCann of FDA told the author that, at a small informal meeting held by Tugwell and FDA officials to discuss what form the new law should take, Stuart Chase was present.
  8. Sternsher, 244.
  9. Charles H. LaWall, "Fads and Frauds in Foods and Drugs," Amer. Jnl. of Pharmacy, 109 (1937), 115-23; Dr. A. T. McCormack, Foods, Drugs, and Cosmetics: Hearings before a Subcommittee of the Committee on Interstate and Foreign Commerce, House of Representatives ... on H.R. 6906 ... and S.5 (74 Cong., I ses., 1935), 103-104.
  10. An example is reproduced in Lamb, 307.
  11. Sternsher, 234.
  12. Ibid., 230; Tugwell, The Democratic Roosevelt (Garden City, N.Y., 1957), 464-66; Cavers, 4, 8. Lamb, 287, says there was no expectation that the bill would pass during the emergency session.
  13. Wash. Post, June 18, 1938, FDA Scrapbook; Cavers, 10; Tugwell, The Democratic Roosevelt, 466; Sternsher, 249; Campbell to Cavers, June 14, 1933, "Correspondence on Legislation"; Copeland in Senate, May 16, 1934, Cong. Record, 73 Cong., 2 ses., 8957.
  14. Ibid.; Dunn cites the text of S. 1944, the "Tugwell bill," 37-50.
  15. Food, Drugs, and Cosmetics: Hearings before a Subcommittee of the Committee on Commerce, United States Senate, . on S. 1944 (73 Cong., 2 ses., 1933).
  16. 77 (1933), 119.
  17. Standard Remedies, 20 (July 1933), 2; Oil, Paint and Drug Reporter, Oct. 9, 1933, FDA Scrapbook; United Medicine Manufacturers of America resolution, cited in Drug Trade News, Sep. 18, 1933, FDA Scrapbook; Standard Remedies, 20 (Nov. 1933), 5-6, 14; Advertising & Selling, 22 (Nov. 9, 1933), 13; H. B. Thompson of the Proprietary Association, Senate Subcommittee Hearings on S. 1944, 172.
  18. The "professor's bill" phrase was that of Dr. James H. Beal, speaking for the National Drug Trade Conference, ibid., 98. Drug Trade News, Sep. 18, 1933, Jan. 22, 1934, FDA Scrapbook; PI, 164 (Aug. 3, 1933), 37; 165 (Nov. 2, 1933), 6; 166 (Mar. 15, 1934), 78; Standard Remedies, 20 (Nov. 1933), 5-6; New Republic, 76 (Nov. 8, 1933), 353-55; Advertising & Selling, 22 (Nov. 9, 1933), 48.
  19. Senate Subcommittee Hearings on S. 1944, 20-21; Lamb, 291-92.
  20. Advertising & Selling, 22 (Nov. 9, 1933), 48; Senate Subcommittee Hearings on S. 1944, 101, 132.
  21. Ibid., 104, 405, 184-94; Advertising & Selling, 22 (Nov. 9, 1933), 52.
  22. New Republic, 76 (Nov. 8, 1933), 354; Advertising & Selling, 22 (Dec. 21, 1933), 32.
  23. Senate Subcommittee Hearings on S. 1944, 172.
  24. Campbell's testimony, ibid., 43-60. John J. McCann of FDA had a private file of mimeographed texts of radio speeches given by FDA officials; Campbell explained the drug provisions in, among other places, Oil, Paint and Drug Reporter, Nov. 27, 1933, FDA Scrapbook, and Tugwell wrote not only for trade periodicals but for the American Scholar, 3 (Winter 1934), 85-95.
  25. Lamb reproduces a number of the posters.
  26. Lamb, 116, 296, 298; Copeland in Senate, for example, on May 16, 1934, Cong. Record, 73 Cong., 2 ses., 8958,
  27. Senate Subcommittee Hearings on S. 1944, 44.
  28. Sternsher, 231; the Senate Subcommittee Hearings were a primary sounding board for this opposition. Copeland's opinion in Cong. Record, 73 Cong., 2 ses., 8957; Campbell' s in Foods, Drugs, and Cosmetics: Hearings before a Subcommittee of ;he Committee on Commerce, United States Senate, . . . on S. 5 (74 Cong., I ses., 1935), 358-59.
  29. Copeland in Senate, Cong. Record, 73 Cong., 2 ses., 1934, 2728-29; Foods, Drugs, and Cosmetics: Hearings before the Committee on Commerce, United States Senate, . . . on S. 2800 (73 Cong., 2 ses., 1934), 58-62, 131-43, 199-208, 390-401, 468, 606. Campbell is cited at 606 and Clinton Robb, UMMA counsel, at 132. The proprietary interests favored the bill drafted by Dr. J. H. Beal and introduced by Representative Black of N.Y,, Cavers, 10; N.Y. Herald-Tribune, Aug. 17, 1934; Standard Remedies, 21 (June 1934), 12-13.
  30. Senate Subcommittee Hearings on S. 1944, 355-56; Senate Committee Hearings on S. 2800, 276-314.
  31. Cong. Record (73 Cong., 2 ses.), 4567-73, 8955-67, quotation at 8967; Cavers to Crawford, Mar. 24, 1934, "Legislation, 1927-40 Bills," FDA Records, RG 88, NA; Crawford to Cavers, May 18, 1934, "Correspondence on Legislation."
  32. Drug and Cosmetic Industry, Sep. 1934, FDA Scrapbook.
  33. Text of bill, S. 5, a number it was to bear until its final passage in 1938, in Cong. Record (74 Cong., 1 ses.), at 100; Cavers to Crawford, Jan. 8, 1935, Milton Handler to Crawford, Feb. 25, 1935, and Crawford to Cavers, Mar. 16, 1935, "Correspondence on Legislation"; Christian Science Monitor, Mar. 5, 1935, FDA Scrapbook; FDR's mesFage, Cong. Record, 4262. From this point on, Copeland had the coDftnt help of his technical adviser, Ole Salthe, who had served as director of food and drug work while Copeland was health commissioner of New York City.
  34. The Senate debate continued for a week in early April and then again in late May. Cong. Record (74 Cong., I ses.), 4734-38, 4748-50, 4840-51, 4858-69, 4900, 4905-20, 4982, 4989, 5018-25, 5093, 5099, 5137-40, 5215-34, 7963, 8162-63, 8341, 8350-56. Copeland refers to "the beart of the opposition" at 5022. Wash. Daily News, Apr. 2, 1935, FDA Scrapbook.
  35. Senate Committee Hearings on S. 2800, 231-40; Senate Subcommittee Hearings on S. 5, 109-15, for Davis' appearances. One expression of Copeland's view of this is in Cong. Record (74 Cong., I ses.), 5023.
  36. 1935 Report of the Food and Drug Administration, 16.
  37. Standard Remedies, 10 (June 1924), 12; 12 (June 1926), 21; 14 (May 1927), 22; Cavers, 13-15; Senate Committee Hearings on S. 2800, 206, 390, 468.
  38. Cong. Record (74 Cong., I ses.), 5025.
  39. Ibid., 5023, 5231, 8350-56; N.Y. Jnl. of Commerce, Apr. 10, 1935, FDA Scrapbook.
  40. Christian Science Monitor, May 29, 1935, FDA Scrapbook; House Subcommittee Hearings on S. 5, 505, 523, 386.
  41. PI, 171 (June 13, 1935), 71; Ruth Lamb to Mrs. Helen Woodward, Jan. 31, 1938, FDA Decimal file .062, F&D Act Gen May-June 20, 1938, Federal Records Center, Alexandria; N.Y. Jnl. of Commerce, June 7, 1935, FDA Scrapbook. The Institute of Medicine Manufacturers, another proprietary trade association, was still not happy.
  42. Crawford to Cavers, May 29, 1935, and Crawford to William Cantrell, Aug. 26, 1935, "Correspondence on Legislation"; Campbell before House Subcommittee Hearings on S. 5, 86, 98.
  43. Ibid., passim.
  44. Lamb, 298; House Subcommittee Hearings on S. 5, 240-50. The Pinkham attorney was Hugh H. Obear. Ibid., 341-56.
  45. Ibid., 189-92, 660-94.
  46. One of Jacobs' five hats, his UMMA publicity chairmanship, was not mentioned at the hearings. Lamb, 304.
  47. Cavers, 16-17; Crawford to Cavers, Aug. 30, 1935, "Correspondence on Legislation."
  48. Drug and Cosmetic Industry, Mar. 1936, FDA Scrapbook; Lamb, 323.
  49. Text of the House bill and accompanying majority and minority reports (No. 2755), Cong. Record (74 Cong., 2 ses.), 10,237-40, 10,23536, 10,242. Davis' testimony, House Subcommittee Hearings on S. 5, 631-49; suspicion of Tugwell because of his lead-residue-tolerance decision reflected in Cong. Record (75 Cong., 3 ses.), 10,240, 10,243-44.
  50. Crawford to Cavers, June 25, 1936, "Correspondence on Legislation." Earlier in the session Roosevelt had sought to get the House to act. Roosevelt to Sam Rayburn, undated memorandum in the President's hand, Official File 375, Franklin D. Roosevelt Library, states, "Food & Drug Bill. Why not report it out & get it passed." Typed on this memo is a note, Feb. 7 , 1936, indicating that Marvin McIntyre, the President's secretary, had learned by phone from Rayburn that he had already begun on the task and would get the bill acted on as soon as possible. The House debate is reported, Cong. Record (74 Cong., 2 ses.), 10,235-37, 10,240-44; the Senate action, ibid., 10,514-20.
  51. Ibid., 10,677; Ruth Lamb to Mrs. Helen Woodward, Jan. 31, 1938, FDA Decimal file .062, F&D Act Gen May-June 20, 1938, Federal Records Center, Alexandria,
  52. Cong. Record (74 Cong., 2 ses.), 10,679-80.
  53. Crawford to Cavers, June 25, 1936, "Correspondence on Legislation'; Drug and Cosmetic . industry, July 1936, Drug Trade News, Mar.1, 1937, and Ntl. League of Women Voters News Letter, July 23, 1937, FDA Scrapbook.
  54. Consumers Union Reports, June 19, 1936, FDA Scrapbook. Dr. Woodward's testimony appears in Senate Subcommittee Hearings on S. 1944, 46-67 (a written statement); Senate Committee Hearings on S. 2800, 349-89; Senate Subcommittee Hearings on S. 5, 153-69; House Subcommittee Hearings on S. 5, 298-321. JAMA, 106 (1936), 1902; 109 (1937), 74B.
  55. Cavers, 18-19; Charles Wesley Dunn, in Wheeler-Lea Act. A Statement of Its Legislative Record (N.Y., 1938), reprinted all pertinent material from the Cong at Record. Congressman Lea's statement appears in House Report No. 1744 (75 Cong., 3 ses.), 406.
  56. Henry A. Wallace to D. W. Bell, Acting Director, Bureau of the Budget, Mar. 17 and Mar. 19, 1938 (carbons), FDA Decimal file .062, F&D Act Gen May-June 20, 1938, Federal Record Center, Alexandria. A draft of a proposed veto message was enclosed which, it appears, was prepared b Crawford.
  57. Sternsher, 322.
  58. Report of the Secretary of Agriculture on Deaths Due to Elixir Sulfanilamide-Massengill (Sen. Document No. 124, 75 Cong., 2 ses.); 1938 Report of the Food and Drug Administration, 13; 1939 Report, 23-24; FDA Notices of judgment 28324, 29751, 29752, and 30776; James Harvey Young, "The 'Elixir Sulfanilamide' Disaster, " Emory University Qtly., 14 (1958), 230-37; the chemist's suicide is reported in Kenneth G. Crawford, The Pressure Boys (N.Y., 1939), 73.
  59. Wash. Daily News, Jan. 4, 1937, and Wash. Star [Feb. 24, 19371, FDA Scrapbooks; N.Y. Times, Feb. 24, 1937; Roosevelt to Cushing, Dec. 28, 1936, Presidents Personal File, Roosevelt Library.
  60. Sternsher, 225, 230; M. A. LeHand to Marvin McIntyre, Feb. 28, 1934, O.F. 375, Roosevelt Library; Roosevelt to McIntyre, Feb. 9, 1935,ibid.—Roosevelt's appointment book shows that the Tugwell-Davis conference took place on Feb. 14; Tugwell to Roosevelt [Apr. 1935], ibid.; Roosevelt to Bailey, Apr. 26, 1935, ibid.; Press conference, March 10,1936, Press Conferences, vol. 7, p. 185, Roosevelt Library.
  61. The majority and minority views are given in Food, Drug, and Cosmetic Act, House Report No. 2139 (75 Cong., 3 ses.), the minority report citing the Secretary of Agriculture. The Attorney General is cited, Cong. Record (75 Cong., 3 ses.), 7892. Debate and passage are given, ibid., 7773-99, 7889-7903.
  62. Crawford to Milton Handler [June 19381, FDA Decimal file .062, F&D Act Gen June-July, Federal Records Center, Alexandria; Crawford on Salthe, F&D Rev., 36 (Oct. 1952), 201.
  63. Cong. Record (75 Cong., 3 ses.), 8731-38, 9087-9101, 9616.
  64. Tugwell, The Democratic Roosevelt, 466; Wash. Post, June 18, 1938, FDA Scrapbook; Campbell to Robert M. Allen, Apr. 30, 1938, FDA Decimal file .062, F&D Act A (May-Dec,) 1938, Federal Records Center, Alexandria; 1938 Report of Food and Drug Administration, 1.
  65. 52 Stat. 1040, Dunn reprints the law, 1-22.
  66. Detroit Free Press, July 23, 1938, FDA Scrapbook.

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