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Food and Drug Legislation in the New Deal
By Charles O. Jackson PRINCETON UNIVERSITY PRESS
Copyright © 1970 Princeton University Press
All rights reserved.
ISBN: 978-0-691-04598-6
CHAPTER 1
THROUGH THE LOOKING GLASS
Probably the proximity of the Sylvanian Theater to the Department of Agriculture where they played Alice in Wonderland brought the thought for the preparation and introduction of this bill.
— H. B. THOMPSON, COUNSEL FOR THE PROPRIETARY ASSOCIATION, DECEMBER 1933
WALTER CAMPBELL, Chief of the Food and Drug Administration, was irritated. It was a winter day in 1933, and he was on his way across the street to see the new Assistant Secretary of Agriculture, Rexford Tugwell. Tugwell had returned to the FDA office a routine letter, prepared there for his signature, on tolerance levels of fruit spray residue. Attached was a curt penciled comment to the effect that if lead arsenate was a poison why didn't FDA prohibit its use altogether. Campbell's assistant Paul Dunbar was in the office when his chief read Tugwell's notation. The terse comment, Dunbar later recalled, was like "a kick in the teeth" after so many long years of fighting a lone battle against spray residues. So now Campbell was irritated, and he was on his way to tell the Assistant Secretary "a thing or two."
Certainly Campbell would prohibit lead arsenate residue, if he could. No one seemed to understand. There were many things he would do, if only the law allowed, but it did not. His bureau operated under the provisions of a legal statute now twenty-seven years old with very little having been done to update it. Granted that the 1906 Pure Food and Drugs Act had been a good law. Perhaps that was half the problem. Too many people thought it was too good. Even Harvey Wiley who had fought the battle for the first statute came to insist that it was little short of perfect. Wiley, as principal enforcement officer for five years, had waged constant warfare with Presidents Roosevelt and Taft. He had ultimately resigned in 1912, having never converted his superiors to his own militant views on administration of the law. But Wiley argued that the problems in law enforcement were administrative tangles. As late as 1928 he could still say that "there is absolutely no need of any further legislation in addition to what is now on the statute books."
Walter Campbell certainly knew better. There were now serious shortcomings in the old statute. For one thing it did not cover cosmetics, which was a booming business, legitimate and otherwise. A bill before Congress in 1897 had included cosmetics within the definition of drugs, but this language had been dropped in 1900 as partial payment for support of industry groups in a National Pure Food and Drug Congress, organized to develop pressure for enacting a law. It did not seem much of a loss at the time; the great growth of the cosmetic industry was to come after 1906.
Nor did the old law provide adequate control over patent medicines. The Wiley statute was far outdated in its definition of dangerous drugs, for many new products, such as barbiturates, had since been developed or come into wider use. In 1912 Congress sought to correct an adverse court decision on the statute by passing the Sherley Amendment, the language of which proved especially unfortunate. Misbranded items were defined as those bearing statements regarding curative or therapeutic effects which were "false and fraudulent." Thereafter the government was saddled with the exceedingly difficult task of proving fraudulent intent in every misbranding case.
The old statute was vague and ambiguous in its language regarding adulteration of food. What the government really needed, and did not have, was authority to set for food products quality and identity standards that would carry the force of law. The 1897 bill had set up machinery for establishing such standards. The final law omitted these provisions, however, and even previously held powers to "suggest" standards were lost in 1907 when the standards clause was dropped from a fiscal act for that year. It was true that the McNary-Mapes Amendment of 1930 allowed the Secretary of Agriculture to set minimum standards of quality and fill for canned goods, but minimum standards were inadequate.
Perhaps the single most significant weakness of the 1906 law was that it did not provide for control over false advertising. Not only had Congress failed to invest this power in the FDA, but by 1933 the consumer was virtually without any protection in this area. The Federal Trade Commission, originally charged with responsibility over false and misleading advertising, was itself greatly hamstrung after 1931. In the Raladam Case of that year the Supreme Court ruled that FTC could act only where false advertising was clearly injurious to competitors. It was not enough that the consumer be deceived. For the food and drug market this meant that false therapeutic claims, open to legal action under the Sherley Amendment when printed on labels, could be made with considerable safety in all forms of nonlabel advertising.
The 1906 law was inadequate, and flagrant abuses in the market were growing. A large number of the proprietary panaceas bought by the American consumer each day were useless and in certain conditions dangerous. One such nostrum widely advertised and used was Crazy Crystals, represented as a cure for stomach troubles, colitis, diabetes, and other diseases. "Crazy Crystals Pulled Me Out of the Grave" heralded a testimonial circular. In truth the nostrum was essentially nothing more than Glauber's salt, a cathartic which could be purchased at any drugstore for forty cents a pound. Continued use of the crystals, even by the healthy, could be harmful. "Crazy Crystals are wonderfully effective," an Iowa physician pointed out, "in rupturing the appendix. I had one where the solution ran out of the abdomen after drainage and recrystalized on the sheets."
FDA once seized consignments of the crystals under the Sherley Amendment, but the company simply shifted its claims from the labels to other advertising forms and profitably continued to defraud the public. The advertising-control void was of course an open invitation to abuse. Even the venerable old proprietary Lydia E. Pinkham's Vegetable Compound was widely sold under a label which read simply, "Recommended as a vegetable tonic in conditions for which this preparation is adapted." Its advertising matter, however, asserted the balm's value for sundry female disorders and nervous troubles.
The obesity cures also provided a fertile field for abuse. One was Marmola, which contained a thyroid preparation. Introduced into the system indiscriminately, thyroid was apt to produce radical changes in the condition of the human body and thyroid intoxication. The Federal Trade Commission sought to take legal action against the product on the basis of its advertising claims. The result, however, was the earlier mentioned Raladam decision in 1931 which virtually emasculated the consumer protection efforts of FTC.
More vicious than Crazy Crystals or Marmola were such cure-alls as Radithor and B & M External Remedy. Radithor was a radium water advertised for the treatment of 160 diseases. Its ingredients could be highly dangerous, even fatal. In at least one documented case, that of a wealthy Pittsburgh businessman, its radioactive components had caused death by bringing about the disintegration of bones in the head. B & M was originally a horse liniment, composed mainly of ammonia, turpentine, water, and egg. It came to be offered to the public as a treatment for human tuberculosis, pneumonia, and other diseases. The Food and Drug Administration collected records of sixty-four fatalities laid to the direct or indirect effects of B & M, as part of a legal case against its producers. Even at this, it took FDA ten years and a cost of $75,000 to prosecute the case successfully.
The abuses within the cosmetic and food trades might be less spectacular, as a rule, but they were just as real. Koremlu, the "safe" depilatory cream, included as one active ingredient thallium acetate, a well-known rat poison. Koremlu, Inc. boasted that its advertising was carried in the "best" magazines. This was basically true. It had also made the pages of the Journal of the American Medical Association, which reported nearly twenty cases of thallium poisoning in two years from the use of the depilatory. In July 1932, the Koremlu company, with $2,500,000 in damage suits against it, went into bankruptcy. The depilatory was gone, but no thanks to the Food and Drug Administration. Cosmetics were beyond the legal scope of that agency.
Then there were the food preservatives. As the founders of Consumers' Research put it, with perhaps a bit too much melodrama, "the hamburger habit is just about as safe as walking in an orchard while the arsenic spray is being applied." The meat preservative sodium sulphite was a case in point. The sulphite was a hazard to the kidneys and the digestive process. FDA understood these problems. Quantities of chopped meat preserved with sodium sulphite, which restored a fresh red color, were constantly being seized by food inspectors, federal and state. But so easy and profitable was the fraud and so slight was the punishment for violation that the practice remained common.
These facts were general knowledge to Walter Campbell. Perhaps that was the real reason for his irritation as he walked toward Secretary Tugwell's office. He had long wanted to strengthen the law but had gained little Congressional support. The only significant amendments to the 1906 statute since its passage were the earlier mentioned Sherley Amendment of 1912 and the McNary-Mapes Amendment of 1930, along with the Net Weight Act of 1913. The latter required a declaration of quantity on packaged foods. What had been more typical, during the 1920s at least, was a series of so-called ripper bills aimed at reducing FDA's authority, especially its power to make an unlimited number of seizures in the marketplace of products adjudged in violation of the 1906 law. FDA was always on the defensive. Dr. Wiley, with his respected reputation, did not help much either. He had been very critical of the operation of FDA during the decade before his death in 1930, and this attitude was apparent in his writings.
The tide of popular opinion was apathetic if not hostile to FDA's regulatory activities in the twenties. That was bad enough. Even worse, it had proved far too easy for some opportunist to generate criticism and doubt regarding the operations of the agency. Certainly Campbell would never forget the name Howard K. Ambruster. If by chance the name did slip his mind the drug chief need only glance over the constantly growing FDA correspondence file on Ambruster. The whole painful memory would quickly return. As Campbell later wrote, "he [Ambruster] has regarded it as his special mission in life to attack the Food and Drug Administration."
The beginning of that story went back to the fall of 1927. Ambruster was known in the chemical industry as an expert on pesticides and insect control. In 1927 he also became a dealer in crude ergot, a drug used in extract form to combat postpartum hemorrhage. He had telephoned the editors of Drug Markets to make this fact known, as well as his asking price, which was slightly more than twice the current market price. The editors were surprised. How, they queried, did he expect to get so much for his crude material? Was the available market supply low? 'Tou had better check," he replied, "I don't think there is any around." So they did. The result of their inquiry was published in the September issue of Drug Markets under the title, "A Corner in Ergot."
Ambruster failed to make the quick profit he expected from his presumed monopoly of crude ergot. This fact was the crux of the problems which FDA faced for the next three years. Ambruster had misjudged the current market need as well as the ability of the large drug manufacturers to hold off buying his high-priced Spanish material until the arrival of cheaper Russian ergot around the first of the year. He insisted Russian ergot was inferior to that imported from Spain, but whether this was true or not, he could clearly see his profit collapsing with the new imports. He knew also that he could not long hold his own material in its existing form, for crude ergot had a rapid deterioration rate. He might, of course, drop his own price, but that would be to admit that he had sought originally to make an excessive profit.
The alternative was to turn his crude material into extract form, which was more durable, and then to compete directly with the manufacturers who had rejected his goods. If he could also persuade the public that his extract was superior to other extracts on the market, he might even force those manufacturers to buy from him or else risk losing their own retail outlets. The logical means to this end was to reinforce his original claim that Russian ergot was inferior by asserting that substandard, even impotent cargoes, mainly of Russian origin, were actually being processed into extract for the American market. One could only be sure, then, by buying Ambruster extract.
The obvious corollary of all this was that Walter Campbell's Food and Drug Administration had been woefully negligent. It was that agency which presumably had allowed adulterated material to enter the country in disregard of the 1906 law. Ambruster launched these charges with zeal about the beginning of 1928.21 Working through the Confidential Trade Information Bureau, run by Manuel DeCastro, he sought to insert his allegations against FDA in various state medical journals as paid advertisements. This attempt failed primarily because the publishing bureau of the American Medical Association advised against their acceptance. Through personal speeches, and an elaborate distribution of circulars, however, Ambruster did get the charges before a wide audience. By April 1929, his circular campaign against FDA had progressed to the degree that he was propagandizing such diverse groups as the National Better Business Bureau, the Daughters of the American Revolution, and the Federal Council of the Churches of Christ in America. The scope of the charges was also widened by his assertion that FDA had also permitted faulty ether, digitalis, and other drugs on the marketplace.
The plausibility of the charges was materially enhanced by the vigorous support of Dr. Henry Hurd Rusby, Dean of Columbia University College of Pharmacy and a prominent figure in national drug circles. Why such a renowned pharmacologist and a one-time consultant to Harvey Wiley's old Bureau of Chemistry should have become involved in the ergot intrigues is difficult to say. He denied any financial arrangement with Ambruster and attempted, though unsuccessfully, to sue Time magazine when it advanced such a thesis. It was true, however, that in recent years Rusby had lent his name to several surprising causes, including the famous patent medicine Wine of Cardui. It is also worth noting perhaps that Rusby's association with the Bureau of Chemistry had not always been a happy one. Charges had once been made that Rusby was illegally overpaid for services rendered to the Bureau. The doctor was exonerated by a special investigating committee but the committee did recommend Rusby's dismissal. The AMA made it clear that they had lost all confidence in Rusby's medical opinions. Whatever the reason, Rusby's name provided unwarranted dignity for the attack on FDA and provided it an entree into circles which might otherwise have been closed. Thus Rusby was given the occasion to introduce the Ambruster thesis into the 1929 convention of the American Pharmaceutical Association, although Ambruster was refused permission to speak to that body.
The surprising thing was that the charges did not enlist more support than they did. With very few exceptions, they received little backing among organized medical and pharmacological bodies. The AMA Journal was openly hostile to both Ambruster and Rusby. Reaction in the lay press was brief, sporadic, and of the news variety. Yet, if the extent of concern with the allegations was limited, the support obtained was not without influence. It was certainly sufficient to cast a cloud over the integrity of the Food and Drug Administration at a time, as Walter Campbell pointed out, when popular support for "our work" was never more requisite.
The support for the Ambruster case included no less a body than an official investigation committee of the American Association of Obstetricians, Gynecologists, and Abdominal Surgeons headed by Dr. Edward 111 of New Jersey. Equally important, the cause was taken up by Dr. Harvey Wiley, ex-chief of the Bureau of Chemistry and architect of the 1906 food and drug law. These sources could hardly be dismissed as commercially interested and were undoubtedly highly influential in gaining the support of others within drug circles. Both Ambruster and Rusby insisted by 1930 that they had received many letters of concern from physicians, chemists, and pharmacologists over the country. While the number was likely exaggerated there is every reason to believe that the expressions of concern were quite real.
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Excerpted from Food and Drug Legislation in the New Deal by Charles O. Jackson. Copyright © 1970 Princeton University Press. Excerpted by permission of PRINCETON UNIVERSITY PRESS.
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