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

Chapter 9: In Pursuit of the Diminishing Promise

James Harvey Young, PhD


"The purpose of the law is to protect the public, the vast multitude which includes the ignorant, the unthinking, and the credulous who, when making a purchase, do not stop to analyze."

—United States v. 62 Packages, More or Less,
 of Marmola Prescription Tablets, 1943 [1]


With their new law as weapon, Food and Drug officials launched a relentless campaign to make self-medication safe. It was a sort of cat and mouse game played at tortoise speed. Full-scale enforcement efforts could not begin at once, for only part of the law became effective immediately, and Congress had adjourned without appropriating funds to help an agency, already understaffed, in assuming its new tasks [2]. When all provisions of the law did go into effect, on the first day of 1940, less than two years remained before the nation was plunged into a massive war, a war which forced the Food and Drug Administration to assume emergency responsibilities and at the same time curtailed its staff and offered quacks new means of appeal to a disturbed public.

"The manufacturer who attempts to temporize or play hideand-seek with the law," wrote James F. Hoge, the Proprietary Association's counsel, "is going to pay dearly for his fun." Food and Drug officials themselves, through informal conferences with industry leaders, made it crystal clear that they were going to insist on the broadest and strictest interpretation of all sections of the law. Most major proprietors heeded such warnings and scrutinized their labeling. As a result, according to the estimate of a trade editor, 97 per cent of the labels used in the drug industry were modified. Some of these changes were much too modest to suit Walter Campbell and his aides, and they said so bluntly in a circular letter to the industry. Proprietary manufacturers, in their turn, termed FDA regulations issued to interpret provisions of the law too "drastic." Thus an old debate continued. But it was not the products of Mr. Hoge's clients that gave the Food and Drug Administration the most concern. The Proprietary Association continued policing the copy of its members, in 1944 tightening its code of advertising practices, and it sponsored research seeking more than an empirical basis for the botanical ingredients in traditional formulas. By 1947, Charles Crawford, in addressing the Association, could compliment the membership on "an impressive record of the number and extent of improvements you have made over the years." Such commendation did not mean that the FDA would sit idle if, in its opinion, a major proprietor should violate the law [3].

The FDA's most troublesome antagonists, in the battle to make self-medication safe, were made up of "a small fringe that cannot be catalogued as law-abiding." "In this group," as Crawford defined it, "are some who are clearly dishonest, some who are choice crackpots, and some who are grossly negligent in the conduct of their affairs." Year by year new faces appeared in this rogues' gallery. But some faces reappeared so often before the gaze of Food and Drug regulators as to be almost as familiar as the visages of their own associates. It was the "fringe operators," especially the perennials, who, in the words of a federal judge, "outline[d] the limits of action defined by a particular law, then proceed[ed] to operate to the full extent of those limits." Here the cat and mouse game was at its cagiest. The nostrum vendor sought a loophole. The regulator sought to close it by taking the vendor to court. So, case by case and through the years, the exact meaning of the law was spelled out. In the process, the freedom of quackery was vastly circumscribed but not eliminated—the techniques of quackery changed markedly [4].

With respect to one section of the law, 502(j), there was little that could be legally ambiguous: drugs were misbranded if "dangerous to health" when used as directed in the labeling. Within this danger zone were products against which the Food and Drug Administration had been impotent to act under the 1906 law. Now these hazards to health got top enforcement priority, "Our first search," Walter Campbell said, was for . . . [reducing remedies] containing dinitrophenol." But their manufacturers had heard the word. Although these deadly reducers had been abundant during the fight to secure the law, Campbell's inspectors could find none now. The agency turned to other obesity products containing dangerously potent drugs-including the dried thyroid nostrum named Marmola [5]

Also in the danger class were powerful pain-killers, proprietaries containing large amounts of cinchophen, aminopyrine, and mixtures of bromides and acetanilid. The FDA warned analgesic manufacturers to adopt labels giving sensible dosage instructions and cautioning against the hazards of overuse. Most heeded, but some did not, and the FDA undertook a widespread program of seizures. Caught in this particular net were major companies, like the Proprietary Association stalwart Bromo-Seltzer. Its maker protested the FDA's action as an arbitrary exercise of power" and vowed to fight up to the Supreme Court, but in the end did not. Instead the company consented to a decree of condemnation and changed its formula [6].

With the war came a shocking revival of an ancient danger, abortifacient pastes. As with dinitrophenol, these corrosive wares were just too hazardous for any use at all: no adequate directions could be written that would make them safe. Cases of death and serious injury mounted. The FDA turned all three of its weapons—seizures, injunctions, and criminal actions—on Leunbach's Paste, Dependon Intra Uterin Paste, Interferin, and others of that ilk [7].

Other dangerous drugs were seized, like laxatives which did not admit their nature on their labels and purported cures for the drinking habit containing emetine. And section 502(j) gave the FDA power to act for the first time against another threat to the public health, hazardous devices. A preliminary survey on the West Coast turned up such gadgets in fantastic profusion: "pessaries, dilators, nipple shields, breast pumps, syringes of all descriptions, electric insoles, pile pipes, respirators, ear droppers, trusses, catheters, massagers, bust developers, Sea Tangle Tents." The FDA moved to take the worst examples off the market [6].

The new law required drug labeling to bear "adequate directions for use," and these directions had to include proper warnings to the would-be self-doser. If the drug might be unsafe for children, or hazardous in too large or too long-continued doses, or risky if the user was suffering from a given ailment, the labeling had to say so. For violation of this provision, the FDA had acted against some of the bromide-acetanilid proprietaries. Scores of other traditional formulas on the market, in the view of Food and Drug officials, must be used with similar restraint if self-medication was to be safe. To guide manufacturers, the FDA prepared a long list of warning statements appropriate for laxatives, nose drops, douches, vermifuges, cough remedies, liniments, pain-killers, tonics, and other popular proprietary products. The omission or dilution of such warnings could lead to legal trouble [9].

The "adequate directions" injunction, the law said, might be excused if deemed by the FDA unnecessary to protect the public health, and the agency did issue regulations permitting some exceptions. Some home remedies-like tincture of iodine -were so well known that directions would be superfluous. At the other extreme, some drugs, while extremely useful, were so powerful-like the new sulfa compounds-that they should not be taken except under the direction of a physician. Therefore, the regulation stated, such potent drugs could not be marketed with directions for self-medication, but only with a label warning against their use except upon the prescription of a doctor. To guide industry, the FDA announced a list specifying some of these potent drugs, but the agency made it clear that others might be included, to be determined in each case by the cautious manufacturer. In between the mild home remedies and the potent prescription items lay a border zone that caused much trouble. For many drugs perhaps safe for self-medication were also weapons in the physician's armamentarium, and manufacturers began to market these drugs in both forms. This led to confusion among pharmacists. If a certain drug was labeled with directions for self-dosage, why could not the same drug, though bearing the prescription legend, also be safely sold over the counter? Many pharmacists, FDA surveys revealed, were doing just that. And how could the pharmacist distinguish, amid the increasing array of drugs available, which items marked with the prescription legend might safely—if not legally—be sold direct to customers and which might not? The task was difficult. "In the course of our surveys to uncover dangerous drugs," wrote the chief of FDA's Western District, "it was . . . learned that practically all retail druggists will sell anything a customer asks for and has the money to buy." This problem would vex the Food and Drug Administration for many years to come [10].

The existence of this border zone did not go unnoticed by the fringe. The prescription legend, some of them decided, might be a shield of safety for them in their promotions. Since the legend was so often honored in the breach, and since they could not label their true intentions without risk, they disguised their nostrums as prescription items and sought to reach the attention of potential customers in other ways. Makers of supposed sex rejuvenators, for example, adopted this ruse. When the FDA announced that there was no specific evidence that dried and ground-up glands had any physiological effect when taken by mouth, promoters adopted the prescription legend and sought to entice buyers in ways less direct. In time the FDA began to plug this loophole, seizing two drugs purporting to be Orchic Substance and Spleen Liquid [11].

Latent in the "adequate directions for use" section were other and more dramatic judicial adventures. The legislative record was vague as to how elastically Congress had intended to define the clause. Some early commentators held that it applied merely to dosage instructions. But the Food and Drug Administration saw a chance to make of the clause a club to wield against fringe operators. Few who shared in enacting the 1938 law, asserted attorney Hoge less than a decade later, "could have envisaged the faraway destination" section 502(f) would reach [12].

One of the reasons directions for use might be inadequate, FDA's interpretative regulations asserted, would be the omission of such directions for use "in all conditions for which" the drug-or device-was "prescribed, recommended, or suggested in its labeling, or in its advertising." [13] Recalling their long and frustrating experience with tame labels and venturesome advertising, Food and Drug officials seemed to be seeking by their regulation-making authority to gain a little of the control over advertising they had sought and Congress had denied during the long efforts to expand the law.

The first court test of the regulation involved the regulators with an opponent already well known to them. Chester Walker Colgrove, a Californian who had been in trouble in the courts because of his oil stock and insurance schemes, had turned his attention to petroleum in another way. Owning a well that produced so little oil no company would operate it, Colgrove set up a family corporation to market his petroleum medicinally. A two-ounce bottle of Colusa Natural Oil sold for three dollars with a label recommending its use for treating a variety of skin ailments, including psoriasis, eczema, leg ulcers, and athlete's foot. Colgrove's oil was also put up in capsule form labeled with the same claims. Believing Colgrove's statements and before-and-after pictures to be false and misleading, the FDA moved against him with seizure actions, which he did not contest, and a criminal case. A jury found Colgrove guilty of misbranding and fined him $1,500. An appeal court dismissed this verdict on the grounds that the trial judge had not permitted one of Colgrove's experts to testify about the experimental use of Colusa oil on dogs with mange, and remanded the case for a new trial. But Colgrove pleaded nolo contendere and paid the original fine. He did not, however, stop marketing petroleum. Having moved his therapeutic claims from labels to circulars packed with packages of his nostrum, Colgrove now took a new tack. He withdrew entirely any glowing promises from his labeling and contented himself with suggesting that Colusa Natural Oil was "for use in treatment" of psoriasis, eczema, leg ulcers, and athlete's foot [14].

The government responded by wielding its multiple seizure weapon, and Colgrove fought. Pitted against each other in the trial were a whole host of medical and chemical experts for the government and, for Colgrove, satisfied users, depositions from various doctors, and one live physician from Houston, age 83. Again the government won. Harking back to the McAnnulty rule, Colgrove had argued the existence of a conflict in medical opinion, but the judge could find "no credible or adequate scientific or medical foundation for any claim" that Colgrove's oil would cure the four diseases or would give relief' or "assist in the treatment of them." Nor did his new-found labeling modesty help him. The phrase "for use in treatment," the judge ruled, in conjunction with the disease names, "would be understood by a person of average intelligence who was suffering from one of the diseases . . . and who was seeking a remedy" as a promise to "cure or alleviate."

Colgrove's next maneuver brought 502(f) squarely into play. He had new labels printed containing directions but no diseases. "Apply to affected parts," the label read, "and rub it in thoroughly morning and night. For open sores saturate cotton pad with oil and bind on by gauze." But there was no mention of what might produce the open sores—no reference to psoriasis, eczema, leg ulcers, or athlete's foot. Colgrove had not forsaken these ailments, however; he had merely moved them to the advertising pages of the nation's press. Indeed, he supplied newspapers with matrices of what he wanted printed and ordered extra copies of the ads to be delivered to dealers who vended Colusa Natural Oil.

Again the government struck, asking a court for an injunction to stop Colgrove from distributing his misbranded petroleum. Directions for use were not adequate, the district attorney argued, citing the Food and Drug Administration's regulations, unless they explained fully how a drug should be taken for ailments specified in advertising. The judge agreed, and Colgrove was enjoined. But he read the injunction decision with the utmost care. In this perusal he found grounds for his next gambit.

It was the case of the substituted conjunction. FDA regulations required labeling to contain adequate directions for use in all conditions for which the drug was "prescribed, recommended, or suggested" in collateral advertising. The injunction, in referring to this clause, had changed the or to and. So Colgrove went on with his lavish and flamboyant advertising. At the same time he tried to meet the law's labeling requirements by restoring the names of his four key diseases, along with what he obviously hoped might be adequate directions for applying Colusa oil in their treatment. But Food and Drug officials were not persuaded. They sought a judgment holding Colgrove in criminal contempt for violating the injunction. Colgrove was still transgressing section 502(f), they argued, because other ailments than the labeled four were mentioned in the advertising, acne and poison oak, for example. But Colgrove demurred. His advertising may have recommended and suggested his product for acne and poison oak, but being no doctor, he certainly could not have prescribed. And to violate the injunction, the and having replaced the or, he must be guilty of all three.

Such a feeble and far-fetched defense the court did not accept. Neither "logic nor fairness" required such a narrow definition of "prescribe," the judges said. "Plainly" Colgrove "had intended to be understood as adopting as his own the statements of the doctors and professional dispensers" which he quoted glowingly in his ads. And, in referring to the and-or matter, the court commented: "Colgrove was quick to seize upon the discrepancy, and he steered his course so as to sail as closely into the wind as he thought he safely could." Such sailing was typical of Colgrove's whole course—for his involvement with the Food and Drug Administration was not yet done—a course very characteristic of the pseudo-medical fringe.

Colgrove was by no means the only medicine man to test the outer limits of section 502(f). FDA's chief counsel, William Goodrich, once paid a sort of grudging tribute to a woman, Ada Alberty, another "perennial litigant," saying she had served a useful purpose in that her many cases had explored and stretched the "adequate directions for use" clause [15]. Mrs. Alberty's ingenious efforts to market her nutritional wares also helped secure judicial definition of another important section of the 1938 act.

Section 201(m) defined labeling to mean "all labels and other written, printed, or graphic matter" either "upon any article or any of its containers or wrappers" or "accompanying such article." Promoters had grown accustomed to being wary of what they said on circulars packed with their bottles, for the old Sherley Act had covered them. Some proprietors had found a new and safe way to circumvent the Sherley labeling taboo. In packages separate from their medicines, they shipped placards and pamphlets replete with extravagant claims. Dealers displayed the posters, handed out the pamphlets, and sold the medicines. How free was this marketing method to continue under the new law? What did "accompanying" really mean?

At first various courts spoke with differing voices, as Food and Drug officials initiated various cases against Mrs. Alberty and other proprietors. "Accompanying" must be narrowly construed, decided a federal district judge in Wisconsin, in a case concerned with the vitamin products of Royal Lee, another of the FDA's through-the-years antagonists. Words in a criminal statute should not be defined more broadly by courts than Congress intended. Since Congress had seen fit to give advertising to the FTC, labeling under FDA authority should not be defined so as to transgress upon the advertising sphere. Promotional literature shipped separately from Lee's vitamins, the court ruled, even though it was "placed on shelves, display counters, or in window displays" by dealers who sold Lee's wares, did not "accompany" and was therefore not labeling, but advertising [16].

A federal district judge in nearby Minnesota viewed things differently. Concerned with jugs of a sick-chicken remedy, the judge ruled that Congress had intended through the 1938 law to expand consumer protection, thus the law, including the word "accompanying," must be construed elastically. Dr. Salsbury's printed matter and his poultry "cure" were interlocking units of a single distribution scheme. It mattered not that pamphlets and drugs were shipped on different occasions, over different routes, arriving at different times [17].

The conflict in judicial interpretation occurred not only in district courts, but in circuit courts as well. Finally, the Supreme Court was called upon to resolve the issue. Judges in the Seventh Circuit, like the Minnesota judge, had given a broad construction to the law. Health lecturer Lelord Kordel was guilty of misbranding. His separately shipped books and circulars had been displayed on a rack near the counter where his products were sold. It mattered not that some of the books bore a price tag, or that some of them had been sent 561 days later than the drugs. The test of "accompanying" under the law was one of commercial connection—"not of physical contiguity but of textual relationship." On the other hand, judges in the Fifth Circuit sounded like the Wisconsin district judge. A Florida naturopath, Fred Urbeteit, who ran a College of Sinuothermic Institute in Tampa, had shipped 16 Sinuothermic machines—some sold, some rented—to an Ohio chiropractor. Sent separately from Florida to Ohio were copies of a simulated newspaper, "The Road to Health," citing testimonials praising the success of Dr. Urbeteit's methods in treating arthritis and other ills. The machine was mentioned, though not described, pictured, or explained. This literature ended up in the chiropractor's waiting room. The judges could not see that it accompanied the machines. "Accompany means to go along with. In a criminal and forfeiture statute the meaning cannot be stretched." [18]

The Supreme Court, in five-to-four decisions, concurred in the Kordel case logic and reversed the Urbeteit decision. "A criminal law is not to be read expansively to include what is not plainly embraced within the language of the statute . . . ,"Justice Douglas wrote. But "strained and technical constructions" should not defeat the law's purpose "by creating . . . loopholes in it." The purpose of the 1938 law was to protect the public health. No easy ruse, such as the "sale" of advertising matter (like Kordel's books), should be permitted to circumvent the law. What is required in "accompanying" is to have two transactions "integrate" by "functional standards." The time of shipment of literature and drug or device, relative to each other, is not germane [19].

So the Supreme Court, in this as, in other ways, gave a broad construction to the law. The Food and Drug Administration could thus persevere in fighting fringe operators who continued to devise new ways of keeping their drugs or devices separate from their promises. The literature for an elaborate therapeutic gadget called Color-Therm was typed by a salesman in Oklahoma from an instruction sheet given him in Missouri by the machine's maker. In another instance, an Illinois man bought an intricate device in California and took it home himself by plane to treat his wife. With the machine he got an instruction pamphlet, and more advice came later in printed and letter form from the machine's vendor. The governnent won both cases. The labeling, courts held, had accompanied the devices [20].

In a similar spirit, courts aided the Food and Drug Administration by generously construing many other parts of the law so as to rein in the pseudo-medical promoter. Labeling might mean a roadside sign beside an interstate highway. Misleading might mean quoting only favorable parts from medical textbooks while omitting unfavorable words. It might mean deceptive layout: the size of type and the arrangement of text and pictures on the printed page. Or it might signify cautious—indeed true—wording that, hurriedly read, sounded like the promise of a cure. A slight change of labeling since the previous legal encounter, judges said, did not force the government to begin all over again: a summary judgment could be rendered. Nor did a slight change in the name of a product bring about a new case, nor the addition of a new ingredient that made no material therapeutic difference [21]. In ways too numerous to recount, judges adhered to justice Frankfurter's judgment given in the second case under the law to reach the highest court.

"By the Act of 1938," he said, "Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience. The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words." [22]

The nostrum provisions of the law, then, as seen by the courts, turned out to be more rigorous than even the most ardent-and disappointed-advocates of a strong bill could have anticipated on the day of its passage. Summarizing the situation at the end of a decade of enforcement, one scholar wrote, "The law leaves no apparent loopholes through which the nostrum maker can make unfounded claims." [23] In one sense this assertion was true, but in another sense misleading.

There had indeed been a wholesale flight of false claims from the labeling. It had once been, wrote a district director of the FDA, that a simple survey of packaged remedies in wholesale houses revealed many with suspicious therapeutic promises. This situation was no longer true; such surveys proved futile, To be sure, nothing ever really dies in quackery, and every now and then a new promotion would appear labeled with a grim uninhibited gusto reminiscent of the 19th century. Such, for example, were the Tree of Life General Tonic, the Asthma Aid, the Hair Growing Aid, and other herbal mixtures of Samuel Shokunbi, a West African who had studied at Oxford and Heidelberg, although the only license he held was that of Swedish masseur. Shokunbi's formulas, which made him thousands of dollars a month in the mid-South, came from a popular medical book written by an English doctor who had died in 1640. Such outrageous nostrums earned Shokunbi in 1950, the most severe first conviction sentence that had ever been handed down under the law-a nine-year prison term [24].

Despite such an occasional sport from an earlier era, the trend in exaggerated claims was away from the immediate labeling to methods less direct. Collateral advertising, be it pamphlet, newspaper spread, placard, or roadside sign provided one broad avenue, as we have seen, with the Food and Drug Administration traveling in hot pursuit. Another technique, increasingly popular along the fringe, was oral speech. Sometimes the spokesman went out among the people as a spieler or, as the big operators preferred to bill themselves, a "lecturer," talking to those assembled in a crowd. Such pitchmen, the FDA's George Larrick reported in 1948, had increasingly engaged the agency's attention. Long ago, he said, there had been the "Konjola Man," who moved from one drugstore to another talking to little informal groups. More recently, spielers had been vending their wares through variety stores, booming their pitches over public address systems. The big timers rented an auditorium for a week or two, advertising in advance their course of lectures—the first one usually free, the rest for a fee—in the press or by direct mail. All kinds of showmanship—including scantily clad girls—sought to increase the lure. Lecturers, under FDA pressure, had abandoned labeling claims, had even ceased sending circulars to health food stores selling their wares. Now the vogue, Larrick said, was to recommend the products from the lecture platform. Some lecturers managed to take in $25,000 a week in fees and sales [25].

Equally popular was the door-to-door approach. Teams of salesmen were recruited to ring door bells, bringing their pulverized alfalfa and complex vitamin and mineral mixtures into the parlors of America. Under Food and Drug Administration pressure, the immediate labeling approached rectitude. No claims were printed on the bottles. But what the salesman said, after assessing the health worries of those he chatted with, might reach the outer limits of exaggeration. His product might cure cancer, relieve arthritis, mend a broken leg. Or it might merely prevent the common cold. "You eat food to make blood," one salesman told a would-be customer. "You send down junk, your body will be junk. Your body will wind up in the junk pile. You send down vital elements that are needed, you're okay. Whenever you get your body normalized, you won't have no condition. You can't even take a cold. I don't care how you're exposed to freezing temperature, wet feet and cold feet, you'll never take it if you get your blood stream up to par." [26]

Food and Drug inspectors knew what was going on, for they posed as customers and caught the fleeting words of doorbell ringers with tape recorders. Such tapes helped them win cases in court, for judges agreed that oral promises were "advertising" and therefore adequate directions for use must be printed in the labeling [27]. It was hard for a promoter to devise labeling that could demonstrate how alfalfa taken daily for several months could cure a serious disease. But bow could a small staff of inspectors police the impromptu utterances of thousands of salesmen blanketing the country? In any case, in the nutrition field, some assertions could be made, very persuasive to ill-informed listeners, which might be dubious but did not contravene the law.

For with the change in techniques of reaching the public, promoters of drugs and devices for self-treatment also modified the kinds of therapeutic promises they made. They moved into the gray areas where medical science had not yet won major victories—arthritis and the common cold, for example or where scientific opinion had not yet fully crystallized as to the certain path a person should follow to retain or regain his health. The greenest pasture in this respect was nutrition, the relation of diet to health.

Of great advantage to promoters in this field was a list of 31 allowable claims listed in a sort of legal truce negotiated in 1951 between the FDA and one of the major distributors of food supplements, after a protracted and bitter battle in the courts. Vended by some 15,000 door-to-door salesmen, Nutrilite contained vitamins, minerals, alfalfa, watercress, and parsley. Its early promotion centered on a pamphlet written by the president of the company, a Stanford University Ph.D., offering it as a cure for most non-infectious ailments, including asthma, ulcers, eczema, arthritis, and mental depression. In successive editions, claims were toned down. But the FDA considered Nutrilite a major imposition on the public, especially the doctrine that the average American diet lacked essential protective ingredients, and sought by seizures, injunction, and criminal indictment to drive the product off the market. Nutrilite fought back and gained a significant weapon while taking a deposition from Oscar R. Ewing, administrator of the Federal Security Agency. (The FDA had been moved into the Agency from the Department of Agriculture in 1940.) Part of the FDAs evidence regarding the state of the national diet had come from Ewing's" 1948 report to the President on The Nation's Health. In questioning Ewing, the Nutrilite attorney cited from this report the opinions of some experts that dietary deficiencies still existed in America. Did Ewing agree? He answered that he did. The Food and Drug attorney got into the record the fact that Ewing was no physician and could not speak in this field with authority. But a delicate contretemps had arisen. Should the case come up in court, the Nutrilite lawyers could demonstrate a conflict between the FDA's position and that of their chief. This development, perhaps, played some part in the FDA's desire to compromise rather than risk losing the suit. More fundamental was the desire to draw as quickly as possible some kind of line between promotional claims that were permissible and those that were not, in a very complicated field. A long trial and inevitable appeals, even if victory should be forthcoming, would mean delay. And nutritional nonsense was expanding in the market [28].

Hammered out after long negotiations, the Nutrilite consent decree would have been hard for the average door-to-door salesman of nutritional supplements to comprehend, let alone follow. The average customer, in attempting to read it, might have been at an even greater loss to catch its fine distinctions. A paragraph on vitamin C illustrates the problem: "If it is claimed that a deficiency of vitamin C leads to dental caries, anemia, defective teeth and gums, sponginess of the gums, pyorrhea, some gum infections, loss of appetite, and local hemorrhages of the mucous membranes of the nose, mouth, gums and about the face, it shall be explained (1) that these symptoms could occur only when the daily intake of vitamin C is less than the minimum daily requirement over a prolonged period, (2) that these conditions, while they may be concomitant signs of a vitamin C deficiency, do not of themselves prove a vitamin C deficiency, and (3) that these symptoms are nonspecific and may be caused by any of a great number of conditions or may have functional causes!" [29]

Whatever the complex nature of nutritional science, this was not the sort of language, these not the caveats, that door-to-door salesmen were accustomed to using. Nor did they all adopt them. Even deeper trouble with nutritional nonsense lay ahead.

Another trend along the fringe, in the migration from claims on labeling, brought the development of "clinics." Shrewd operators sought to avoid battles with the Food and Drug Administration by withdrawing from interstate commerce, setting up treatment centers, and enticing the sick and frightened to come to them. A new wave of state food and drug laws had been enacted in imitation of the 1938 act, but many had loopholes and most were ill enforced. In any case, the clinic operator sought to evade their terms—and federal law as well—by pretending to the legitimate practice of one of the licensed health professions. Unscrupulous physicians, osteopaths, naturopaths, and chiropractors either ran the clinics or were hired by lay operators to diagnose and treat. Some of these schemes relied on impressive electrical devices, like Urbeteit's Sinuothermic machine. Others dispensed drugs and pseudo-drug products: dried vegetables, glandular extracts, vitamins, and minerals, sometimes labeled "food" in an effort to impart to them an ethical aroma. The prescribing even of the horns and hoofs of animals was not unknown [30].

In seeking to combat this kind of quackery, the Food and Drug Administration occasionally uncovered an interstate angle that gave it jurisdiction. But cases were extremely difficult and costly to develop. And victories that were won caused later opponents to fight the FDA with even greater determination. In the late 1940's, the agency discovered that a greater proportion of its cases was being contested, in part because of the heavier penalties provided in the 1938 law, compared with 1906, in part because already convicted promoters knew that convictions for second or third offenses meant larger fines and longer prison terms [31].

If penalties were severe enough to force fringe operators to fight when challenged, penalties were nonetheless too weak to frighten disreputable promoters into abandoning their lucrative schemes. Prison sentences, given in only a small proportion of convictions, were short, and more often than not suspended if the violator abstained from resuming his illegal operation for a probationary period. Fines were too small to be a true deterrent. In 1950 the average fine for all food and drug cases terminated was $565 [32].

Other handicaps hampered the Food and Drug Administration in fighting quackery. Its resources were not sufficient for the magnitude of its task. During the first 18 years under the 1938 law, the agency handled a fifth more cases of all types than it had handled during the 32-year span of the 1906 law. But this was not enough. The staff of the FDA grew only modestly as the years went by—and sometimes diminished, as certain members of the appropriation committee in the House regarded some FDA enforcement actions with disfavor. At the same time the industries to be surveyed and regulated kept expanding. When Walter Campbell resigned in 1944, to be succeeded by Paul B. Dunbar, a trade periodical noted Campbell's greatest achievement as commissioner: how much he could get done on such a small appropriation. The paucity of funds continued, At the 1953 inspection rate, Commissioner Larrick stated, it would take the agency ten years to give just one inspection to every food, drug, and cosmetic establishment—not counting retail stores—doing a substantial business in interstate commerce [33]. Medical quackery was a part of this total complex of business, and it got a high priority in the enforcement plans. But there were not enough inspectors to do the exhaustive job required. As with other crime, the amount of quackery varied inversely with the amount of enforcement time devoted to it [34]. The Food and Drug Administration performed yeoman's service, but pseudo-medicine continued.

Something of the massive effort required of the FDA in preparing a major case is illustrated by its contest with Marmola. During the Congressional hearings, this thyroid-extract reducing remedy had been mentioned as an egregious example of the dangerous drugs which the old law could not keep off the market. Other regulatory agencies had had their try, but obesity was not a disease within the purview of the FDA's labeling control. With the new law, Marmola was one of the first proprietaries against which the FDA began to develop evidence, and in several ways the case turned out to be significant [35].

Marmola promotion, in the wake of its 1931 Supreme Court victory over the Federal Trade Commission, had become especially cocky, its pamphlets referring disparagingly to "silly gossip about harmful ingredients." [36], The Commission's defeat in this case, indeed, became a key argument for giving control of drug advertising to the FDA. Seeking to reverse this major loss, the FTC issued in 1935 a new complaint against Marmola, this time making sure that injury to competitors as well as to consumers was amply demonstrated. In the hearing Edward Hayes once again defended the proprietary that had supported him so well for more than three decades, his testimony bolstered by that of a Detroit physician telling the tale of a lazy beagle. After chasing rabbits for half an hour, the doctor said, the hound fell to the ground exhausted. But on a diet of the thyroid glands of sheep, the beagle revived, two months later winning a blue ribbon in the Canadian trials. This and more human testimony did not save Hayes from a cease and desist order, issued in 1937. But Marmola appealed, and in the same month in 1941 that the Food and Drug Administration action went to trial, won another victory over the FTC, when a circuit court adjudged the cease and desist order void [37]. Hayes could not know this cheering news, or appear as witness in the FDA trial. He had died in 1939 [38].

Marmola labeling had been somewhat toned down with the passage of the 1938 law, recommending its four tablets a day "only as a treatment for adult fat persons whose excess fatness is caused by bypothyroidism . . . but who are otherwise normal and healthy." But its main gospel was the same. Science had dispelled the old notion that "laziness or gluttony" were the sole reasons for excess weight. The "basic cause" was a "deficiency" in the body, which Marmola's half grain of desiccated thyroid would counteract. From person to person the speed of weight loss would vary, but "a moderate rate of reduction" was best. There might be side effects, for all drugs could produce in some susceptible persons "unpleasant or harmful symptoms. If this occurred, the circular advised, stop taking Marmola until the symptoms disappeared, then resume with half the former dose. The labeling disavowed explicitly that it was diagnosing; only physicians could do that [39].

Believing Marmola dangerous and even its more cautious claims false and misleading, the FDA seized 62 packages that had been shipped from Detroit to LaCrosse, Wisconsin. To make its case in court, the FDA employed the opinions of expert scientists, a mail inquiry of physicians, evidence from clinical trials, and sad instances of women whose use of Marmola had brought disaster.

At the trial in Madison before a judge, 19 notable scientists—drawn from private practice and such institutions as the Mayo Clinic and the universities of Wisconsin, Michigan, and Chicago—challenged Marmola's basic theories, Obesity did not result, they said, from an underactive thyroid gland. Undue weight was gained simply by taking into the body more calories through food and drink than the body expended through work or the output of heat. Nor did the thyroid hormone, necessary to normal life, exert any direct effect upon the fat deposits of obesity, Indeed, some people with hypothyroidism—too small an output of the hormone—were very thin, and some with hyperthyroidism—too great an output were too fat. For the layman who was accumulating unnecessary pounds, therefore, to diagnose his own problem as hypothyroidism and start taking Marmola was ridiculous.

it was worse than ridiculous, the experts testified, it was a dire threat to health, For hyperthyroidism was a disease, dangerous in itself and in its possible consequences. Small doses of desiccated thyroid might actually act as a tonic, increasing appetite and therefore weight. Large enough doses to cause weight loss could achieve this result only by producing the disease of hyperthyroidism. From person to person, the border of danger would differ, since the metabolic rates of individuals differed. No lay person could himself know when the amount of thyroid he was taking had reached point of threatening his physical reserves. These factors of safety in his kidneys, nerves, pancreas, blood vessels, and heart might reach severe depletion because of excessive thyroid while a person still looked healthy and felt fine. The Marmola dosage was enough, the medical scientists said, to activate latent diabetes, spur on borderline pellagra, precipitate incipient tuberculosis, cue a severe emotional disturbance, or bring on—especially in an overweight person—a heart attack. Even without these direst of results, the symptoms of hyperthyroidism were grim enough: vertigo, nausea, headache, nervousness, trembling, palpitation, labored breathing, menstrual suppression.

Ninety-eight per cent of some 2,000 members of the American College of Physicians who answered a mail inquiry arranged by the FDA believed that the indiscriminate use of two grains of thyroid a day—the recommended Marmola dosage—for a period of one to two months posed danger to health. Some of the government witnesses had sought to induce experimentally a carefully controlled byperthyroidism. A fifth of the patients in the experiment developed distressing, and sometimes hazardous, symptoms, with dosages of two daily grains of desiccated thyroid or less. In some cases injury resulted from dosages as low as one-fifth, or even one-tenth, a grain a day.

What had occurred in the clinic, under the most cautious controls, also took place within the large number of Marmola's customers, who used its thyroid extract in the random way customary among those practicing self-dosage. Six women, serving as government witnesses, gave from the stand their tragic testimony.

One Chicago woman of 24, growing up in an unhappy home, had weighed 165 pounds by the time she was 18. Called "Fatty' and subject to the crude jokes and ostracism of her schoolmates, she had sought to remedy her pligbt. Secretly purchasing Marmola, she used it according to directions, but without a very great restriction on her eating. Thus, although she began to vomit occasionally and developed dizziness, headaches, and muscular pains, she lost very little weight. After three months she decided on an even more rigorous regimen. Taking five Marmola tablets a day, she cut her breakfast to a cup of coffee and a piece of unbuttered toast, her lunch to a bottle of pop. She ate no supper at all. Her spells of vomiting increased, and at last she began to lose weight rapidly. After seven months, when her stepmother discovered what she was doing and forbade further use of Marmola, the girl's weight was down to 90 or 95 pounds. Even without more thyroid extract, her weight continued to plummet, reaching a low of 50 pounds, and her unpleasant symptoms continued. At the time of her testimony in court, though having gotten her weight back up to 70 pounds, she still was very ill.

When the young woman had finished her story, noted a Food and Drug medical officer, there was "not a dry handkerchief in the house." [40]

Marmola had its own medical experts who challenged the validity of the case made by the government's witnesses. Thyroid in the Marmola dosage was safe, they argued, and would cause no permanent damage. The symptoms of hyperthyroidism were admittedly unpleasant, they said, but transitory, and not too high a price to pay for the reduction of excess weight by people who lacked the will power to diet.

Besides defending its tablets, the Marmola company sought in its case to attack both the Food and Drug Administration and the new law the Administration was seeking to enforce. The agency was trying to use the law, a trial brief argued, to secure "bureaucratic" powers over the public's "inalienable right" of self-medication. This power grab was being undertaken in cooperation with the group that would profit most from its success, the "inner circle" of the American Medical Association. Should the FDA prevail in its interpretation of the law, "the proprietary medicine industry . . . must ultimately go out of business and the general public must henceforth obtain all of its medicaments by virtue of a special dispensation in the form of a doctor's prescription, if at all. Gone forever are the days of the family medicine chest. . . ."

In any case, Marmola's promoters insisted, the 1938 act was unconstitutional. Its provisions were too uncertain and indefinite, permitting unwarranted search and seizure, and unlawfully delegating legislative powers to an agency within the executive branch.

Fifteen months after the taking of testimony, the district judge delivered his decision. In this first court test of the 1938 law's constitutionality, he thoroughly explored the issues and found no conflict between the law's provisions and the Constitution. Nor did be agree with the Marmola contention that the act, or the FDA's interpretation of the act, was aimed at the elimination of self-medication. The law "was enacted to make self-medication safer and more effective," he ruled, "and to require that drugs moving in interstate commerce be properly labeled so that their use as prescribed may not be dangerous to the health of the user." Marmola was not so labeled. "The substantial portion of the public, after reading the labeling . . . the judge said, "would conclude that Marmola is a safe and efficient remedy for obesity, which is not a fact." Testimony by the government witnesses had been most persuasive. In Marmola there was "an inherent and potential danger that may reasonably be expected to attend its use when one considers that it will be used by the strong, the weak, the old, the young, the well ' and the sick, without first having a physical examination or a diagnosis of their condition by a competent physician."

The 1938 act had not been passed to safeguard "experts," the judge stated, rendering another judgment significant for the future application of the law. "The purpose was "to protect the public, the vast multitude which includes the ignorant, the unthinking, and the credulous who, when making a purchase, do not stop to analyze."

Such a purchaser had been the young woman from Chicago, whose pitiful testimony had so impressed the court.

So 62 packages of Marmola, seized by the government, were condemned under the law. The circuit court in due course affirmed this decision, and the Supreme Court, by denying certiorari, let it stand. While the district judge was still weighing his judgment, the Supreme Court had already looked at Marmola advertising and found it bad. Reversing the circuit court's decision in the Federal Trade Commission case, the highest court restored the Commission~s cease and desist order [41]. Following up its part of this double victory, the Food and Drug Administration attacked Marmola throughout the country with multiple seizures [42].

Four years had elapsed between the initial seizure of Marmola and the Supreme Court's denial of certiorari ending the case. Uncounted thousands of dollars had been expended, and hundreds of hours by legal and medical experts. The victory was one measure of the skillfulness of the Food and Drug Administratioin preparation. During the trial a medical specialist paid tribute to the government's case. "This is better, he said, "than a post graduate course on thyrotoxicosis." [43] Such elaborate and careful preparation was required for all the major contested cases—Colusa Oil and Nutrilite, Kordel and Urbeteit. With personnel short and resources scanty, the FDA could in any fiscal year work up only a relatively few important cases in the fringe area of self-medication. Many promoters of dubious drugs and devices were left to wait their turn.

References

  1. 48 Fed. Supp. 878. Court decisions under the 1938 law have been conveniently reprinted in a Food Law Institute Series, edited by Vincent A. Kleinfeld and Charles Wesley Dunn, each volume entitled Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record, with the covering dates, 1938-1949 (Chicago, 1949); 19491950 (Chicago, 1951); 1951-1952 (Chicago, 1953), etc. This case appears in 1938-1949, 34-44, the quotation at 43.
  2. Walter Campbell to R. M. Allen, July 18, 1939, FDA Records, R. M. Allen 1936-37-38, Decimal file .062, 1938, Federal Records Center, Alexandria; F&D Rev., 22 (1938), 147.
  3. James F. Hoge, "An Appraisal of the New Drug and Cosmetic Legislation from the Viewpoint of Those Industries," Law and Contemporary Problems, 6 (1939), 127; FDC Reports, I (Feb. 11, 1939), pink 4, (Feb. 25, 1939), pink 1; 7 (Apr. 14, 1945), white 6-7; F&D Rev., 23 (1939), 98; PI, 207 (May 19, 1944), 60; Proprietary Assoc., Code of Advertising Practices (Wash., 1944); Crawford, "Problems of Compliance and Enforcement under the Drug Law," FDC Law Qtly.,2 (1947), 445.
  4. Ibid.; Buffalo District Annual Report, 1951, FDA Decimal file .053, Dept. of Health, Education, and Welfare storage. A 1936 survey of medicine makers in the Los Angeles area revealed that the number of concerns in operation varied from day to day. Western District Annual Report, 1936, FDA Decimal file .053, RG 88, NA. Judge Mathes cited in Los Angeles District Annual Report, 1949, FDA Decimal file .053, HEW storage.
  5. F&D Rev., 24 (1940), 204; 1939 Report of Food and Drug Administration, 5.
  6. Trade Correspondence-2, TC~3, TC4, TC-14, TC-301, reproduced in Kleinfeld and Dunn, Judicial and Administrative Record, 1938-1949, 561-63, 574-78, 687; 1939 Food and Drug Administration Report, 1; 1940 Report, 15; 1941 Report, 15; Business Week, Mar. 18, 1939, 8; F&D Rev., 24 (1940), 35; Bromo-Seltzer, FDA Drugs and Devices Notice of judgment [DDNJ1 81. Reports by the FDA District chiefs indicate the large-scale way in which analgesic manufacturers changed their formulas shortly after visits by FDA inspectors. Eastern and Western District Annual Reports, 1939, FDA Decimal file .053, RG 88, NA. 71942-1943 Report of Food and Drug Administration, 38; W. R. M.
  7. Wharton, "Wartime and Postwar Food and Drug Adulteration," FDC Law Qtly., 1 (1946), 465.
  8. 1941 Report of Food and Drug Administration, 16-17; Western District Annual Report, 1939, FDA Decimal file .053, RG 88, NA.
  9. JAMA, 115 (1940), 387-88, 937-38; TC-14, Kleinfeld and Dunn, 1938-1949, 574-78.
  10. A series of Trade Correspondence items was issued, especially TC-361, ibid., 713-14; Edward B. Williams, "Exemption from the Requirement of Adequate Directions for Use in the Labeling of Drugs," FDC Law Qtly., 2 (1947), 155-65; Western District Annual R ort 1942, FDA Decimal file .053, Federal Records Center, Alexanlria; ibid., 1939, FDA Decimal file .053, RG 88, NA.
  11. TC-13 and TC-376, Kleinfeld and Dunn, 1938-1949, 574, 721; F&D Rev. 32 (1948), 282; FDC Reports, 16 (1954), white 13-14.
  12. Kleinfeld, "Applicability of the Federal Food, Drug, and Cosmetic Act to Drug Advertising," FDC Law Int. (1950), 48; Maurice L. Stewart, "Therapeutic Claims under the Federal Food, Drug, and Cosmetic Act," FDC Law Qtly., 4 (1949), 538; Hoge, "A Significant Aspect of Food and Drug Law Enforcement," ibid., 2 (1947), 49.
  13. These early regulations are cited in Chester W. Colgrove . . . v, U.S., 178 Fed. (2d) 614, in Kleinfeld and Dunn, 1949-1950, 240n.
  14. The account of Colgrove's litigious career is based on FDA Drugs and Devices Notices of judgment 380, 381, 1040, 1384, 2087, 2131, 2782, 2833, 2922, 3009, 3045, 3061, 3989; 1949 Food and Drug Administration Report, 27; F&D Rev., 26 (1942), 161; Western District Annual Report, 1945, FDA Decimal file .053, Federal Records Center, Alexandria; FDC Law Qtly., 2 (1946), 274; and court decisions. The decisions, reproduced in Kleinfeld and Dunn, 1938-1949, 218-21, and 1949-1950, 114-20, 237-41, are U.S. v. 9 Bottles . . . Colusa Natural Oil, 78 Fed. Supp. 721; Colusa Remedy Company v. U.S., 176 Fed. (2d) 554, certiorari denied, 338 U.S. 911; U.S. v. Colgrove et al., 83 Fed. Supp. 880; Chester Walker Colgrove . . . v. U.S., 176 Fed. (2d) 614, certiorari denied, 338 U.S. 911.
  15. FDC Law Jnl., 8 (1953), 222-23.
  16. U.S. v. Royal Lee, 40 Fed. Supp. 801, in Kleinfeld and Dunn, 1938-1949, 443-45.
  17. U.S. v. 7 Jugs . . . of Dr, Salsbury's Rakos, 53 Fed. Supp. 746, In ibid., 64-77.
  18. U.S. v. Kordel, 164 Fed. (2d) 913, and Fred Urbeteit . . . v. U.S., 164 Fed. (2d) 245, in ibid., 343-48 and 212-15.
  19. Kordel v. U.S., 335 U.S. 345, and U.S. v. Fred Urbeteit, 335 U.S. 355, in ibid., 382-86 and 249-51. For a critical reaction by the lawyer who handled the appeal for Kordel, see Arthur D. Herrick, "Some Implications of the Kordel Decision," FDC Law Qtly., 4 (1949), 94-104.
  20. U.S. v. 4 Devices, Labeled in Part "Color-Therm," 176 Fed. (2d) 652, in Kleinfeld and Dunn, 1949-1950, 112-14; Ruth B. Drown . . . v. U.S., 198 Fed. (2d) 999, in Kleinfeld and Dunn, 1951-1952, 165-71.
  21. Maurice L. Stewart, "Therapeutic Claims under the Federal Food, Drug, and Cosmetic Act," FDC Law Qtly., 4 (1949), 536-51; Gold Lax Tonic, Painesville, 0., Buffalo Station Annual Report, 1948, FDA Decimal file .053, Federal Records Center, Alexandria; Research Laboratories, Inc. v. U.S., 167 Fed, (2d) 410, in Kleinfeld and Dunn, 19381949, 227-38; U.S. v. Six Dozen Bottles . . . of "Dr. Peter's Kuriko," 158 Fed. (2d) 667, in ibid., 197-99; U.S. v. 17 Cases ... of Ntie-Ovo, in Kleinfeld and Dunn, 1949-1950, 124-26; Muscle Rub, FDC Reports, 16 (1954), 11 white.
  22. U.S. v. Dotterweich, 320 U.S. 277, in Kleinfeld and Dunn, 19381949, 278-85, quotation at 280.
  23. Ibid., Introduction, xv-xvi; Stewart, "Therapeutic Claims under the Federal Food, Drug, and Cosmetic Act," 530.
  24. 1946 Food and Drug Administration Report, 35, Central District Annual Report, 1946, FDA Decimal file .053, Federal Records Center, Alexandria; F&D Rev., 34 (1950), 251, 265; DDNJ 3297.
  25. Larrick, "Some Current Problems of Enforcement," FDC Law Qtly., 3 (1948), 26-65.
  26. Joseph R. Bell, "Let 'em Eat Hay," Today's Health, 36 (1958), 24.
  27. Ibid.; F&D Rev., 31 (1947), 219; DDNJ 2405, concerning the products of health lecturer David V. Bush.
  28. U.S, V. 91 Packages . . . "Nutrifite Food Supplement," 93 Fed.Supp. 763, in Kleinfeld and Dunn, 1949-1950, 189-90; Mytinger & Casselberry, Inc. v. Oscar R. Ewing, 87 Fed. Supp. 650, in ibid., 25665; Oscar R. Ewing . . . v. Mytinger & Casselberry, 339 U.S. 594, in ibid., 275-80; U.S. v. Mytinger & Casselberry, in ibid., 1951-1952, 20413; FDC Law Jnl., 6 (1951), 473; Lester L. Lev "The Nutrilite Consent Decree," ibid., 7 (1952), 56-69; DDNJ 338i, 3382, 3383.
  29. U.S. v. Mytinger & Casselberry, in Kleinfeld and Dunn, 1951-1952, 204-13, quotation at 209.
  30. Western District Annual Report, 1943, FDA Decimal file .053, Federal Records Center, Alexandria; Kansas City District Annual Report, 1949, FDA Decimal file .053, HEW storage; Business Week, Nov, 12, 19M, 24, 29; Melvin E. Mensor, "'SNAF ' in State Food Laws," FDC Law Jnl., 12 (1957), 690-704.
  31. Eastern District Annual Report, 1947, FDA Decimal file .053, Federal Records Center, Alexandria; F&D Rev., 32 (1948), 1; N.Y. District Annual Report, 1949, FDA Decimal file .053, HEW storage.
  32. Francis E. McKay and Benjamin Frauwirth, "The Penalty Provisions of the Federal Food, Drug, and Cosmetic Act," FDC Law Jnl., 6 (1951), 575-92.
  33. William W. Goodrich, "Judicial Highlights of 50 Years' Enforcement," FDC Law Jnl., 11 (1956), 75; chart "Enforcement: Personnel and Appropriations, Fiscal Years 1941-56," accompanying mimeographed text of Jan. 27, 1955, address by Bradshaw Mintener, "Industry and the Food and Drug Administration"; Business Week, May 6, 1944, 3335; Larrick, "Our Unfinished Business," mimeographed text of Dec. 8, 1954, address.
  34. 1955 Annual Report of the U.S. Department of Health, Education, and Welfare (FDA), 171.
  35. The discussion of Mannola is based mainly on the FDA case record, Interstate Office Seizure No. 48304-D, DDNJ 1251, which includes newspaper clippings on the trial and a helpful ms. summary of the testimony by K. W. Brimmer, M.D., entitled "Michigan's Marmola Menace." The district and circuit court decisions were U.S. v. 62 Packages, More or Less, of Marmola Prescription Tablets, 48 Fed. Supp. 878, and 142 Fed. (2d) 107, in Kleinfeld and Dunn, 1939-1948, 34-44 and 107-10; the Supreme Court denied certiorari, Raladarn Co. v. U.S., 323 U.S. 731. Also useful was the Marmola folder, AMA Dept. of Investigation.
  36. Marmola pamphlet in "Advertisements of Medicinal Preparations and Devices, 1933-7," FDA Records, RG 88, NA.
  37. FTC Docket 2406; In the Matter of Raladam Company, 24 FTC Decisions 475 (complaint and order); Raladam Co. v. FTC, 123 Fed. (2d) 34 (circuit court decision).
  38. W.B. Simmons memorandum, Feb. 27, 1940, in FDA file, Interstate Office Seizure No. 48304-D.
  39. DDNJ 1251.
  40. Undated Karl W. Brimmer memo, in Interstate Office Seizure No. 48304-D file.
  41. FTC v. Raladam Company, 316 U.S. 149.
  42. DDNJ 1252.
  43. Undated Karl W, Brimmer memo, in Interstate Office Seizure No. 48304-D file.

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