An Alternative Perspective: Homeopathic Drugs,
Royal Copeland, and Federal Drug Regulation

Suzanne White Junod, Ph.D.

I. Introduction

Since 1938, lawyers, doctors, homeopaths, historians, and Food and Drug Administration (FDA) officials have questioned the inclusion of the Homeopathic Pharmacopeia of the United States (HPUS) in the Federal Food, Drug, and Cosmetic Act (FDCA). [1] The FDCA defines drug in a number of ways, the simplest being: "articles recognized in the official United States Pharmacopeia, the official Homeopathic Pharmacopeia of the United States, or the official National Formulary or any supplement to any of them." [2] Many wonder why a new law that established the first premarketing scrutiny of new drugs, stimulated important new scientific advances in drug discovery, and offered the first glimpses of patient protection policies, simultaneously recognize such a seemingly regressive system of drug therapy as homeopathy [3].

Originally founded by German physician Samuel Hahnemann (1755-1843), homeopathy as a system of therapeutics was brought to the United States in the early nineteenth century by German immigrants [4]. Although homeopathy originated in Germany, there never were any homeopathic hospitals and medical schools there [5]. Rather, homeopathy flourished in the United States in the eclectic medical environment of the nineteenth century. Homeopathy is based on two key principles: the "law of similars" ("let like cure like") and the "law of infinitesimals" (the more dilute the drug, the more powerful its effects). By the early twentieth century, as clinical medicine began to develop and expand into a science-based profession in the United States, homeopathic reformers began to redefine their field as a "complementary" form of treatment-based therapy. A homeopathic product can be derived from any source substance. Such substances, once "discovered," are tested through "provings," in which they are administered to healthy volunteers in concentrations that provoke overt symptoms. The symptoms experienced by these volunteers are recorded and become the basis for the indications the product is used to treat. Employing the "law of similars," substances causing fevers, for example, might be used to treat fevers [6]. The "law of infinitesimals" dictates that the dose be as small as possible, and this commonly translates into doses undetectable by modern laboratory methods. According to the tenets of homeopathy, such minuscule doses impart a healing stimulus. Homeopathy has had its adherents through the years, including some prominent Americans during the late nineteenth century, but it has remained a controversial treatment option.

Senator Royal Copeland (D-NY), sponsor of the FDCA, was a homeopathic physician who undoubtedly supported inclusion of the HPUS in the Act. Little is known about how the provision made it into the FDCA, however. The legislative record is silent, and an examination of Copeland's papers demonstrate that, although he was a dedicated homeopathic reformer early in his career, he had become less involved in homeopathy as his career moved him into the field of public health. Homeopathy does not appear to have been one of his chief concerns in drafting the FDCA. On reflection, this absence of discussion seems to support a more skeptical (or at least more intricate) view of this provision as a mere concession to Copeland.

In 1951, George Harding lamented similarly that there was no discussion of the "causing" provision of the FDCA. The origin of this provision, which sanctioned prosecution of those accused of "causing" a violation of the FDCA, was at least as obscure as the HPUS provision. Even men who worked closely on the bill, Harding remarked, could not remember where or how the "causing" provision came to be included in the law [7]. But Harding rejected the view that the provision was inserted mechanically and without much thought to its meaning in the context of the law.

Such a pragmatic approach might have validity if applied to a bill that slipped through the legislative process in a short time and with little debate. But when one considers the hen-scratching that for five years went on in the Copeland bills it is difficult to believe that a single phrase escaped critical examination [8].

In the case of homeopathy, as in the case of the "causing" provision, food and drug officials had a strategy in mind when they accepted Senator Copeland's inclusion of the HPUS in an early draft of the FDCA. This strategy would have been withheld purposefully from the legislative record and would explain the silence surrounding the provision. In the case of homeopathy, it seems more plausible that FDA officials, principally Charles Crawford, a lawyer and draftsman of the FDCA, agreed to the inclusion of the HPUS in the FDCA. They did so not merely as a concession to Copeland, but rather as part of a strategy they hoped to employ against ineffective products masquerading as homeopathic drugs. Up to the mid-twentieth century, homeopathic drugs were obtained only from homeopathic physicians, who were also trained as regular physicians. As physicians, homeopaths could be counted on to adhere to a code of ethics in assessing and treating patients. Quacks and charlatans peddling homeopathic drug imitations, in contrast and by definition, did not. Thus, in 1934, when the HPUS was added to section 201 of the Copeland Bill, medical quackery, including all proprietary medicines, were of more concern than drugs prescribed by homeopathic physicians.

Once the HPUS was included as an official drug compendium in the FDCA it created some unanticipated regulatory challenges. Premarket drug approvals, first mandated in the FDCA, came to be based on placebo-controlled, blinded drug trials, and as FDA instituted reevaluations of both prescription and over-the-counter (OTC) drugs, homeopathy largely was ignored. FDA was forced to make important regulatory decisions regarding this complementary form of medical practice only when homeopathy began its own resurgence, asserting for the first time that self-treatment was consistent with homeopathic principles.

II. The First Drug Standard Compendia: The Food and Drugs Act of 1906

The nation's first federal food and drug statute recognized the U.S. Pharmacopeia (USP) and the National Formulary (NF) as official compendia of the nation's drug supply [9]. Although the two publications encompassed much that had characterized the eclectic therapeutic and medical practices of the nineteenth century, a move toward therapeutic precision was revising both publications [10]. The selection of these publications as standard references signified not only a commitment to high standards in the nation's therapeutic armamentarium, but also codified the emerging links between laboratory science and professional therapeutic practice [11].

Under the 1906 Act, preparations listed in these two standard references were defined as drugs [12]. Drugs sold under the names employed by the NF and USP either had to conform to the published standards, or state on the label how they differed [13]. The law did not recognize exclusively the standards of the NF and USP. Adopting a broad definition of the term "drug," the law required that all products marketed as drugs conform to a standard to which they could be held accountable [14]. Manufacturers and marketers could establish their own formal standards of quality and purity, but they had to conform to these standards or risk having their drugs deemed "adulterated." [15] The USP and NF, therefore remained more of a model than a mandate under the 1906 Act.

III. The Homeopathic Pharmacopoeia of the United States

Homeopaths at the 56th annual meeting of the American Institute of Homeopathy (AIH) in June 1908, resolved to bring their alternative therapeutic perspective into compliance with the new law [16]. Beginning in January 1909, all homeopathic pharmacists would be requested to prepare their remedies according to the HPUS to comply with the 1906 requirement. A statement acknowledging compliance with the HPUS would be affixed to the label of their products, and homeopathic physicians were urged to demand that their pharmacists comply with the HPUS "so that with remedies of a known uniform strength, we may have a more scientific and useful literature." [17] This progressive resolution was merely a prelude to the AIH's ultimate goal: securing an amendment to the 1906 Act that would recognize the HPUS alongside the USP and NF. AIH's reasoning was straightforward:

We would demand this in order that the standards in the Food and Drugs Act may be made complete by providing for the uniform strength and preparation of nearly three hundred fresh plant tinctures which are at present unprovided for and also that justice may be done to thousands of physicians whose scientific remedies are classed among the proprietary or quack remedies [18].

Although the HPUS began publication in 1897, it was not widely employed by most homeopathic physicians and pharmacists. Nonetheless, the very existence of such a compendia must be interpreted as a triumph for the reforming homeopaths, practitioners characterized as "new homeopaths" who were pushing to make homeopathic practice as scientific as possible [19]. American homeopaths during this period shared both the aspirations and the models of scientific medicine and many studied in Berlin [20]. Listerism and the bacteriology of Edward Koch and Louis Pasteur, for example, were embraced by American homeopaths that saw "antisepsis," as consistent with Hahnemann's call for a preventive approach to medicine [21]. Reformers perceived an opportunity to push for further homeopathic therapeutic reforms along the lines sanctioned in the law by the choice of the USP and NF. Thus, the 1906 Act provided homeopathic reformers with both a carrot and a stick with which to persuade fellow practitioners. Once the standards mandated under the law had been accepted and enacted, homeopaths then could petition for recognition of their alternative pharmacopoeia in the federal food and drugs statute.

IV. Royal S. Copeland: Homeopathic Reformer

Chief among the scientific reformers was Royal Samuel Copeland (1868-1938) [22]. Copeland made history a lifelong hobby, but he chose medicine as a profession inspired by a youthful preceptorship with Dr. F.E. Chase, a homeopath and family physician in his hometown near Dexter, Michigan [23]. To support his matriculation at the Homeopathic Medical College, then part of the medical school at Ann Arbor, he taught and his father sold some land [24]. In June 1889, he graduated and like many medical men of the era, did not consider his education complete until he had spent some time in medical institutions abroad [25]. Copeland embarked on a tour of German and European homeopathic institutions where he reportedly was intrigued with a glass eye factory in Halle, Germany [26]. Copeland returned to Michigan in 1890 and settled in Bay City where he spent the next five years establishing himself as an ophthalmologist, an eye and ear specialist, and a surgeon. In 1893, he became Secretary of the Homeopathic Medical Society of Michigan.

Copeland's specialty was a dynamic field for regular physicians and homeopathic physicians at the end of the nineteenth century as both moved into a specialty previously dominated by medical quackery [27]. The earliest homeopathic specialty society under the auspices of the AIH was, in fact, an eye, ear, and throat specialty. Likewise, early delineation of a specialty in ophthalmology among regular physicians ultimately led to the creation of the American Medical Association's (AMA's) first specialty board in that field in 1916 [28]. Copeland secured a place in society and in medicine providing treatment perceived at that time as "distinct," but not "inferior." [29] Copeland, like other homeopathically trained practitioners of the period, regarded himself as a physician first and foremost, albeit one skillfully trained to employ a complementary form of therapeutics [30].

In 1895, Copeland was drawn back to Ann Arbor in a departmental dispute and ultimately was appointed Professor of Ophthalmology, Otology, and Paedology at the Homeopathic Medical College [31]. From 1901 to 1903 he made his first foray into electoral politics, serving a term as the city Mayor. A difficult term of office reportedly "temporarily checked his enthusiasm for political life." [32] In 1904 he returned to medicine and was elected President of the American Homeopathic Ophthalmological, Otological, and Laryngological Society. His presidential address simply entitled "In Defense of the Attenuated Drug" was somewhat lackluster, but as spokesman for an enlightened and growing profession, Copeland wrote as a dedicated homeopathic reformer [33].

In a revealing entry for a Reference Handbook of the Medical Sciences, for example, Copeland wrote a lengthy, defensive, and reformist explanation of homeopathy premised on the simple declaration that "[h]omeopathy is not a system of medicine." [34] Espousing and elaborating on homeopathy as a complementary form of medicine, Copeland defined it as a "method of therapeutic procedure" in which "the facts of the sciences of pathology and pharmacology are brought into correspondence for the purpose of cure when cure is possible." [35] In what a previous generation of practitioners might have considered heresy, Copeland downplayed the significance of homeopathic dosing in modern practice. "The size of the dose prescribed and the repetition of the remedy have little to do with homeopathy. Whether a given prescription is homeopathic or not depends purely and simply upon the means of its selection." [36]

More than any other aspect of homeopathy, it was homeopathy's "law of infinitesimals" that had attracted the derision of regular physicians and others amidst accusations of quackery throughout the nineteenth century [37]. Then and now, it is difficult to convince skeptics that a one part per million concentration (or less) of any substance can produce a therapeutic effect [38]. Reformers like Copeland, however, rejected Hahnemann's concept of a "spirit like force" that maintained and enhanced the potency of homeopathic drug products through successive shakings and dilutions of the source product (percussion and succession). Copeland, in particular, rejected the idea that drugs themselves possessed any mystic force, and instead adopted a quasi-scientific perspective holding that a drug exhibits a dose response [39]. He did not, however, accept the view of critics who charged that homeopathy's minuscule doses were ineffective or that they acted only as placebos.

With a remedy prescribed for symptoms similar to its physiological action, it follows that too large a dose would produce an aggravation of the disease. It is desirable to prescribe a dosage short of one producing actual physiological effect. It is aimed to get what the homeopathist calls the "dynamic" effect of the drug, in contradistinction to its physiological or poisonous effect [40].

Copeland considered dosage less critical than symptomatic treatment. Generally, he treated patients with homeopathic preparations as well as some conventional drugs, but on occasion, he used placebos ("unmedicated pellets") in his practice [41]. In his defense of homeopathy, Copeland was trying to move past what he perceived to be critics' preoccupation with spiritual essences and quantification in homeopathy to promote a more scientific appreciation of the importance of treating a patient's symptoms with a therapeutic substance.

Copeland's explanation of homeopathy as a complementary medical discipline, while downplaying Hahnemann's "law of infinitesimals" did, however, embrace Hahnemann's first law "similia similibus curentur." [42] Homeopathy, according to Copeland, was a "method of therapeutic procedure" founded on the homeopathic "hypothesis" that the symptoms of disease could be removed by a remedy producing similar symptoms in a healthy person [43]. "Unfortunately," Copeland noted by way of introduction, "disease, as it is met in practice, does not present clear-cut indications for this or that remedy." [44] Rather, "it necessitates us . . . to study our patient carefully in order that we may be led to the selection of the curative drug." [45] A homeopathic prescriber must "forget the name of the disease, and choose the remedy for the one and only reason that it is the similimum for that particular case." [46] In contrast with the average physician, homeopathic prescribers were accustomed to taking into account a patient's "moods" and "mental condition" when choosing a remedy and often prescribed for the removal of "purely subjective symptoms." [47] Copeland noted, for example, the iatrogenic effects produced by drugs with alcohol and morphine (exhilaration and sedation) and suggested that homeopaths would act to counteract these effects and prescribe "remedies to restore normal function to a disturbed mind." [48] In short, Copeland claimed, where the regular physician "elicited" symptoms to identify a disease, the homeopathic physician used them to prescribe a remedy. In an era in which the causes of most disease still were unknown and self-medication had created an appalling number of "toadstool millionaires," Copeland seemed to be offering something that would appeal to those impressed with the potential of scientific medicine but well aware of its practical limitations [49].

Copeland believed that it was in the realm of treatment that homeopaths excelled over regular physicians [50]. At the turn of the century, the distinctions between homeopathy and alternative therapies were clearer, if only because the prevalence of patent medicines and the evils of adulterated drugs were documented well [51]. According to Copeland, homeopathy embodied and represented to the public "faith in therapeutics," and was, in fact, "the therapeutic specialty." [52] Homeopaths, for example, could claim accurately that they created no drug addicts and were early advocates of "pleasant" medicines. Adulteration of homeopathic drugs, delays in filling prescriptions, and carelessness in drug preparation were charges generally not leveled against homeopathic practitioners. Copeland boasted of the breadth and inclusiveness of the homeopathic therapeutic arsenal. In the homeopathic materia medica, according to Copeland, "every possible source of information has been visited—poisonings accidental or intentional, pharmacological tests, animal experiments, postmortem findings, and [homeopathic] provings." [53] Because the homeopathic physician usually dispensed medicines, this was promoted as a distinct benefit to those who distrusted pharmacists and the "unsatisfactory directions written on the label." [54] Homeopaths promoted this salutary view of their distinctive prescribing methods. Copeland, for example, noted in one speech that not only did this save on drug bills, but it avoided errors because "many a mistake has come from depending on the indirect methods of the pharmacist and the brief unsatisfactory directions written on the label of the medicine." [55]

Many early homeopathic claims citing careful laboratory methods and "exact prescribing," however, seem to have been composed of at least equal portions of scientific ambitions and wishful thinking [56]. In his 1901 address to the Homeopathic Medical Society of Michigan, Copeland chides his colleagues, concluding: "[w]e are not so far in the lead in the procession of successful medical practice as we were a score of years ago. The laboratory and pharmaceutical experts have taught our rivals some very important lessons . . . their speed has become accelerated." [57] Copeland led a campaign for a universal scale of notation in homeopathy beginning in a 1904 speech. By 1906, in a speech to the World Homeopathic Congress, Copeland was specific and practical. In "Homeopathy and Posology: A Discussion of the Potency Problem," Copeland bluntly criticized his colleagues for their lack of a scientific scale of attenuation noting that "unscientific, non-uniform" scales of measurement had evolved so that "one millionth of one equals one tenth of another." [58] Congress then determined that a uniform scale of notation should be used. Thus, in the same year that the USP and NF were adopted in the 1906 Act, homeopaths initiated efforts to standardize measurements used in their drug preparations.

V. Congress, Homeopathy, and the HPUS

Shortly after the AIH acted in 1908 to strengthen the HPUS, Senator Jacob H. Gallinger (R-NH) a prominent antivivisectionist and champion of various reform causes, sponsored an amendment to the 1906 Act that would have recognized the HPUS alongside the NF and USP [59]. Gallinger was a homeopathic physician with a degree from the New York Homeopathic College and served as New Hampshire's surgeon general before entering politics [60]. Although the amendment was defeated, Gallinger became minority leader of the Senate in 1912. At that time, there was a concerted effort to repeal the variation clause that had authorized standards other than those of the USP and NF under the law [61]. He reintroduced the amendment recognizing the HPUS following hearings on the variation clause. The HPUS amendment was rejected by the medical profession and scorned by Harvey Wiley, father of the 1906 Act, and neither it nor the repeal of the variation clause was enacted [62]. Gallinger's death in 1918 left the AIH without a prominent sponsor to continue the political fight for recognition of the HPUS. It was not until another homeopath arrived in Congress, nearly a decade later, that the initiative was revived.

Meanwhile, in 1908, Copeland took over as Dean of the New York Homeopathic Medical College and its teaching hospital, Flower Hospital in New York City. Copeland was one of the few homeopathic administrators who retained his position in the wake of the 1910 Flexner Report, which paved the way for important reforms in the training of American physicians [63]. Many of his counterparts at other institutions lost their jobs in the wave of controversy, and eventually mergers and closings were set in motion by the highly critical report on medical education in the United States. Inasmuch as any homeopathic institution found any favor with Flexner, New York Homeopathic College did so largely because it was the only homeopathic institution that owned the hospital connected to it. Homeopathic patients generally were not charity patients and this, in particular, made it difficult to train students. The Flexner Report cited the Homeopathic Medical College and Flower Hospital as one of only three homeopathic institutions with the necessary equipment for teaching [64]. Flexner predicted that only four homeopathic schools would survive the coming decades and this institution was one of them [65]. Copeland, in defense of the College, boasted that all of the Flowers' class of 1910 graduates had been placed by graduation day, reportedly receiving three offers for every one available position [66].

In 1918, Copeland's perspective on medicine was altered profoundly with his appointment as New York City's Health Commissioner [67]. No longer afforded the luxury of specialization, Copeland became involved with issues as broad and urgent as curbing an influenza epidemic threatening the city, and as narrow and pervasive as ensuring clean milk for the city's tenement babies [68]. His appreciation of public health problems broadened his perspective on scientific medicine considerably and his views became more widely known and influential after he began writing a column on "Your Health." [69] As he left his post in 1924, Copeland advocated health education to "make the American people realize the value of the wholesome plain foods of the earlier days." [70] Citing the values of good bread, fresh vegetables, plainly cooked, and plenty of milk, he concluded that they "are really more essential to the welfare of the American than medicines and drugs." [71]

VI. Copeland: Senator and Sponsor of the FDCA

Copeland was elected to the U.S. Senate in 1924 as a compromise candidate with Tammany support. He brought with him an unusual background in both medicine and public health. Copeland was a striking figure and an "eminently sociable man," easily recognized by the red carnation he wore on his lapel that he once explained as "the emblem of therapeutic perfection." In the words of a biographer, he wore it as a "constant memorial of his youthful idealism." [72] Copeland came to respect and support the work of FDA during its "turbulent twenties" in Congress, and offered a major amendment designed to bring cosmetics under regulation during this period [73]. It was Copeland's well-known sponsorship of a new food and drug law, later enacted as the FDCA, which both culminated and sadly capped his career. Copeland died four days after the bill was passed [74].

The original bill proposing sweeping changes to the original 1906 Act was known as the Tugwell Bill. Approved by Assistant Secretary of Agriculture and prominent Brain Truster Rexford G. Tugwell, the bill was as radical as any New Deal measure proposed at the time [75]. This initial proposal, however, was rejected quickly and decisively by most of the affected food and drug industries [76]. When Tugwell distanced himself from the unpopular bill, Copeland stepped in as a sponsor to try and effect compromises that would create a new food and drug statute acceptable to industry and consumers. It was Copeland, who, in his initial revisions of the Tugwell bill, slipped in the provision originally proposed by the AIH in 1908—recognition of the HPUS along with the U.S. Pharmacopoeia, and the National Formulary, as official drug compendia.

Copeland's motives and intent in including the HPUS in the FDCA remain the subject of speculation. It is true that Copeland does not appear to have defended or even mentioned homeopathy on the record [77]. His early medical allegiances only could hurt him as sponsor of a new food and drug statute in 1933, and therefore they were ignored by the bill's supporters. Moreover, Copeland's experiences as Health Commissioner of New York City had made him sympathetic toward much of the work of FDA, especially in the area of pure foods [78]. Copeland's earliest justifications for the proposed new federal statute, however, does contain references to alternative practitioners such as osteopaths, hydrotherapists, and chiropractors. Copeland indicated that he merely wished to protect them from "interference" by regulators [79]. Politically, protecting alternative practitioners was a shrewd move that could have gained new and needed support for the proposed bill. At the very least, it would not have created new opposition from alternative practitioners.

It is clear that Copeland was not a fan of alternative medical practices. Chiropractors, in particular, enraged him as Health Commissioner of New York. He once responded to a query concerning chiropractic medicine by charging that "the average drugless healer (chiropractor) is ignorant of the fundamentals of medical knowledge and has no conception of the science of disease and fights against educational requirements." [80] In another instance, he testified:

I have found them to be a public menace and peril. They have treated typhoid fever patients as well as tuberculosis and others suffering from communicable diseases and have not merely endangered the lives of such patients but by their ignorance and denial of the germ origin of communicable diseases, they have imperiled the health of others and permitted such diseases to spread [81].

VII. Copeland and the "Textbook Provision"

In December 1933, as Copeland was preparing his first revision to the Tugwell Bill, he studied a proposal to include a subsection 4(e) of the food and drug bill [82]. Section 4 of the bill defined adulterated drugs and contained references to the USP and NF. Section 8 of S 1944 defined a misbranded drug as one calling itself a cure or "if its labeling bears any representation, directly or by ambiguity or inference, concerning the effect of such drug, which is contrary to the general agreement of medical opinion." [83] Section 9 of the bill on false advertisements, prohibited therapeutic claims "contrary to the general agreement of medical opinion." [84] When Copeland introduced the original draft food and drug bill in June 1933, he had not read it in its entirety, and when he finally did, he found some objectionable features in the bill [85]. One of these features undoubtedly would have been the provision prohibiting therapeutic claims for a drug without the support of "substantial medical opinion" or "demonstrable scientific facts." [86] In the earliest drafts of the FDCA, the term drug also encompassed medical devices [87]. Copeland supported the provision as it would have applied to osteopaths, chiropractors, and hydrotherapists, many of whom used devices rather than drugs, as well as to others considered charlatans or quacks. Yet, as written, it was equally applicable equally to homeopaths.

In December 1933, homeopaths proposed that Copeland include a section 4(e), which would declare that government officials could not determine "therapeutic values" contrary to those pronounced by the U.S. Pharmacopoeia, the National Formulary, or "any medical textbook approved for study in the curriculum of any recognized medical school or college in the United States." [88] This proposal was never enacted.

As important as the proposal's substance was its reasoning. Homeopaths found the therapeutic claims provisions of the bill particularly threatening, noting that "an honest but irresponsible official could exercise his own therapeutic whims to business detriment." [89] Homeopaths cited the case of virburnum, a staple homeopathic drug, in declining use among regulars, but still listed in the 1905 USP. They argued that "no group of officials, medical or otherwise, should have it in their power to say that drugs recorded of value in times past are now obsolete or of no medical worth." [90] Fearing that officials might "get around medical choice in therapy" and pronounce "that some new drug, perhaps synthetic, has supplanted an old, time-tested drug in efficacy and consequently should be used in place thereof," homeopaths pointed out that FDA's Chiefs of Drug Control had all come from the "regular" profession. Furthermore, every Chief of Drug Control to date had shown a tendency toward this "variability of therapeutic determinations." [91]

There is an instance of one chief establishing the therapeutic virtues of salicylic acid in rheumatic trouble; a following chief caused the manufacturer to use aspirin instead of the salicylates; while a third and succeeding chief caused the replacement of the aspirin with the salicylates original to the formula [92].

In addition to such general concerns, the document cites the specific example of a popular homeopathic cold remedy, "Humphrey's No. 77 for Colds."

A Chief of Drug Control of the Regular School, unless inhibited by some provision of the new law, could absolutely throw out such a medicine as totally inert; yet probably hundreds of thousands use that particular remedy and have so used it for years because of the results as given in aborting or shortening the duration of colds [93].

The proposed remedy, the "textbook provision" to be included as a subsection 4(e) in the bill, does not mention homeopathy by name. It would have sanctioned homeopathy alone, however, because none of the alternative medical practices—chiropractic, hydropathy, or osteopathy—was recognized through a text adopted by a recognized medical school [94]. Only homeopathy had a text (Hahnemann) used in its own medical schools [95]. Copeland, however, rejected this provision and could have done so for a number of reasons—its provisions were rather transparent; alternative groups would have discovered the ruse rather quickly and the bill already had enough enemies without creating new ones; if enacted, the provision might have encouraged alternative practitioners to author and seek adoption of a textbook, which was not Copeland's intent.

Copeland introduced S 2000 in January 1934. In his introductory remarks, he stated his opposition to "interference with various schools of healing such as chiropractic, osteopathy, hydrotherapy and the like." [96] Copeland rejected the homeopaths' "textbook" provision in favor of the simpler solution of recognizing substances in the HPUS as drugs in section 4 of S 2000 [97]. Copeland's proposal, however, and FDA's acceptance, may have been based on entirely different premises and understandings.

In addition to recognizing the HPUS as an official compendia, section 4 specifically provided that where a drug was recognized in both the USP and the HPUS, that the USP standards would prevail unless the drug specifically was labeled and sold as a homeopathic drug. This provision could have arisen from the example of virburnum and other substances listed in both the USP and the HPUS that was supplied to Copeland by the homeopaths. More likely, however, it protected and clarified a legal strategy that FDA officials hoped to employ against a particular group of quack products peddled by William Frederick Koch, for the treatment of cancer.

According to a recent article by historians James Harvey Young and Richard McFadyen, Koch possessed legitimate medical credentials [98]. Nonetheless, he devised three "synthetic antitoxins" in his laboratory and in 1923 began to distribute them to "restore natural immunity" in fighting human cancer, as well as other diseases. Glyoxylide, Malonide, and Benzoquinone all were diluted with distilled water to "about a trillion times their original volume" following Koch's consultation with, and ultimate employment of, the Dean of the Homeopathic Department at the University of Michigan [99]. FDA could not persuade either the Post Office or the Federal Trade Commission (FTC) to take on Koch, and FDA did not feel that the 1906 Act or the Sherley Amendment of 1912 allowed them to prosecute Koch [100]. His products bore no claims and were sent only to licensed physicians [101]. Young recalls that the records indicate that at one point the homeopaths and FDA worked together, ultimately unsuccessfully, to discredit the Koch Cancer Treatment's claims to cure cancer [102]. Had the HPUS been recognized as a legal drug compendia, action might have been initiated against Koch for marketing a nonstandard homeopathic product [103]. FDA agreed to Copeland's insertion into the law and kept silent about it to establish a means to act against Koch.

Although Copeland had rejected the homeopath's "textbook provision," he sympathized with at least some of their concerns. Copeland's revisions in S 2000 indicate his overall agreement with the homeopaths' admonition to him that the new bill "in its every part must carry self-contained justice, as far as possible leaving nothing to favorable or unfavorable misconstruction by agents executing the law." [104] Homeopaths, however, were far from unique in criticizing this aspect of the original proposal. In fact, the chief concern about the original Tugwell bill was a perception that extraordinary powers had been vested in the Secretary of Agriculture as administrator of the act [105]. For example, in section 4 of the original bill, under the definition of a drug, the Secretary was permitted to establish what later was explained to be "emergency tests" for purity, quality, or strength, to supplement those of the USP and NF [106]. Copeland's first revision, S 2000, was aimed primarily at meeting widespread industry concerns about "dictatorships" and "bureaucratic whims." The so-called "emergency" drug standard provision was modified, along with other similar provisions throughout the original draft [107]. All references to "consensus of medical opinion" were replaced with "general agreement of medical opinion" after it was astutely perceived by nearly everyone that it was unlikely that medical experts ever would achieve a consensus on anything [108]. Copeland's subsequent draft, S 2800, dropped all references to "medical opinion." [109] At that point, Copeland also announced that he had confined "regulation-making power" to those "few instances where the problems are so complex and so changing with scientific progress" that they were necessary to protect the public [110]. Elsewhere, he said he had added "definite" court review provisions, as well as a system of checks by "non-partisan committees of scientists whose members are affiliated with neither the enforcing agency nor the regulated industries," to satisfy all lingering concerns about excessive bureaucratic powers [111].

Did no one challenge such a seemingly important insertion—recognition of the HPUS as an official drug compendium—in the draft food and drug bill? Apparently not. The HPUS appears to be the only organized group to have tested section seven of the 1906 Act that allowed self-professed quality standards [112]. Homeopaths undoubtedly were elated at their success. Ultimately, inclusion of the HPUS in the new 1938 statute became more significant when the final bill eliminated the variation clause and made HPUS alongside the USP and NF, exclusive rather than optional drug compendia [113]. Now, all drugs had to conform to the standards of one of the law's three recognized pharmacopeias, or state their deviations on the product label. The AMA, according to its then-president, Dr. Morris Fishbein, had no problems with Copeland or the recognition of the Homeopathic Pharmacopoeia because Fishbein believed, much like Flexner, that the more science that homeopaths learned, the less homeopathy they practiced [114]. Also, the AMA and the homeopaths at this time found themselves in a new posture of unity as they opposed the New Deal and proposals for "socialized medicine." [115] Copeland, a conservative Democrat, often was at odds with many New Deal measures, and his differences with the President at times made passage of the FDCA look remote [116]. Moreover, it seems that almost everyone, except homeopaths themselves, felt that homeopathy eventually would be absorbed into the mainstream of medicine [117]. Statistics supported this view: there were more homeopathic physicians in the AMA at that time than in the AIH and the children of many homeopaths who remained in medicine chose regular routes of study [118]. In 1934, as the Copeland Bill was debated, the eminent physician, Henry Sigerest characterized homeopaths in his book American Medicine as "thoroughly trained physicians," noting that "there are many competent practitioners among them." [119]

There was no need to test the new HPUS provisions of the act in prosecuting Koch after the law was enacted. Recognition of the HPUS merely ensured that Koch could not claim that his product was homeopathic because his allegedly active ingredients were not listed in the HPUS. FDA had several options under the new law for prosecuting Koch, however, and it ultimately used both its new authority to conduct factory inspections and its new drug authorities to proceed against Koch. FDA's early experience in conducting factory inspections and its successful use of factory inspection reports in court cases made this the simplest and most straightforward approach to gathering evidence against Koch [120]. Because nonofficial drugs under the FDCA had to declare all active ingredients on their labels, something that Koch proved both unwilling and unable to do, FDA acted against Koch beginning in 1940 [121]. There was no need to test the HPUS provisions, and in the end, the FTC took the lead in suppressing Koch's illegal activities [122]. Because FDA did not employ the HPUS provision against Koch, and does not appear to have tested it against any other product, homeopathic or otherwise, in court, the provision remained untested as a strategy against medical quackery.

VIII. The HPUS under the FDCA

The HPUS provision appeared in the Copeland Bill in 1934, a year before the first sulfa drug, Prontosil®, came on the market. Prontosil® launched a therapeutic revolution that called into question the therapeutic efficacy of all preceding drug products, homeopathic or otherwise. At the time the 1938 Act was enacted, sulfanilamide's revolution was underway. In the decades that followed, however, the "wonder drugs" began to revolutionize drug therapy and FDA's campaigns against both nutritional and medical quackery shifted the agency's entire perspective on effective medical therapy. In such a new therapeutic environment, regulators and skeptics found it increasingly incomprehensible that the FDCA formally recognized the HPUS.

Under the FDCA, homeopathic drug products in the HPUS were stipulated to be drugs, and as with products in the USP and NF, they were subject to the drug requirements of food and drug law. The most revolutionary drug feature of the FDCA was the final-hour provision requiring that new drug marketers file applications demonstrating their safety to FDA prior to marketing them [123]. This provision, enacted in the wake of the Elixir Sulfanilamide tragedy in 1938, virtually reinvented drug regulation in the United States [124]. In its charge to ensure the safety of all new drugs, however, the agency virtually ignored homeopathy. No one had charged that homeopathic drugs were unsafe and there were few, if any, "new homeopathic drugs."

As early as 1938 FDA differentiated between drugs that could be obtained only by a physician's prescription and those available for self-medication "over-the-counter." It was not until 1951, however, with the passage of the Durham-Humphrey Amendment, that the distinction was enacted into law [125]. In the wake of Durham-Humphrey, virtually all homeopathic drugs became prescription drugs. The AIH persuaded regulators that the tenets of homeopathy dictated that treatments were highly individualized. Most homeopathic drugs should be dispensed by a practicing homeopath, and therefore the AIH believed that they were categorized best as prescription drugs. Taken by surprise, FDA informed inquirers in 1953 that although Durham-Humphrey did "not appear to directly encompass homeopathic preparations as prescription drugs,"

The agency had no objection to their distribution with the prescription legend [126]. The agency did note, however, that it would not act against homeopathic products "without the prescription legend which are offered to the laity for minor ailments." [127] In defending the prescription requirement for homeopathic products, FDA generally advised inquirers that "it is our position that adequate directions for lay use of Homeopathic preparations cannot be devised." [128] Homeopathic drugs were restricted to sale on the written or oral order of a practitioner licensed by law to administer such drugs, and like other prescription drugs, they were required to be labeled [129]. The prescription labeling requirement for homeopathic drugs, however, was not enforced strictly, reportedly because some FDA officials believed that use of the Rx symbol lent undeserved credibility to homeopathic drugs [130].

While the safety of homeopathic drugs under the FDCA drew no regulatory scrutiny, passage of the 1962 Kefauver-Harris amendments in the wake of thalidomide, did generate questions about the extent to which homeopathic drugs should be required to conform to the law's new efficacy provisions [131]. Once the National Academy of Sciences and FDA had begun the Drug Efficacy Study Implementation (DESI) project, however, FDA felt that the expert criteria governing that study—"generally recognized among qualified experts as safe and effective"—would be difficult to apply to homeopathic remedies [132]. Because the HPUS was recognized in the FDCA, homeopathic drugs would have to be evaluated for efficacy by homeopathic experts according to homeopathic standards [133]. Homeopathic leaders did not believe that this was possible, and FDA was not inclined to establish a separate review panel or process for homeopathy [134]. Much of the literature on homeopathic drugs was written in the nineteenth century, and "provings" did not begin to resemble adequate and well-controlled double blind drug trials. Homeopathic practitioners themselves agreed that "because of the theories of various homeopathists and the individualized nature of their prescribing practices," evaluations of efficacy would be virtually impossible because "there is no real unanimity of opinion among homeopathists as to what remedies are specific for a particular symptom complex." [135] In short, without the assistance of homeopathic experts, an efficacy review of homeopathic products was deemed not feasible.

Technically, the agency was justified in not looking at homeopathic preparations during the DESI process because the 1962 Drug Amendments required re-review only of drugs originally approved between 1938 and 1962 on the basis of safety alone. Because they posed no safety concerns, homeopathic drugs had not been approved by FDA between 1938 and 1962. During this period, the agency began a policy of deeming some "safe" substances "unsafe" when promoted for serious and life-threatening conditions, such as cancer. This policy was not applied to homeopathic remedies or homeopathic practitioners, however, because there did not appear to be a problem with homeopathic drugs making serious curative claims [136].

IX. Exclusion of Homeopathic Products from OTC Review

In 1972, FDA's Chief Counsel, Peter Barton Hutt, met with homeopathic officials to consider review of homeopathic drugs under the OTC drug review process announced January 5, 1972 [137. Representatives of the AIH, the American Foundation for Homeopathy, and the American Association of Homeopathic Pharmacists (AAHP) agreed that about one-third of homeopathic drugs sold at that time were sold OTC [138]. By 1971, officials recognized that homeopathic preparations were attracting new OTC sales among laypersons. Health food stores, for example, provided a new outlet for homeopathic products. FDA's campaign against nutritional quackery encompassed these new outlets, and although officials questioned the "usefulness" of these products, FDA appears to have taken little action against OTC homeopathic drugs at the time [139]. Officials did, however, insist that imported homeopathic drugs meet the requirements of U.S. law. In 1971, for example, FDA informed a Canadian importer that his products did not meet the law's requirements because they contained ingredients not in the HPUS. Citing as "one of the fundamental principles of homeopathy" that the selected remedy should be administered singly, an official noted that "although several of the ingredients of each of the drugs [offered for import] are indeed recognized in the Homeopathic Pharmacopeia of the United States, not one of the combinations of the ingredients is recognized in that compendium." He concluded "the drugs [thus] appear to contravene one of the fundamental principles of homeopathy and would therefore require approved new drug applications before they could be imported." [140] In 1977, the U.S. District Court for the District of Nevada upheld the agency's detention of misbranded homeopathic drugs [141].

In a May 1972 commentary published in the Federal Register, FDA responded to the AIH's request for exclusion of homeopathic drugs from OTC review. "Because of the uniqueness of homeopathic medicine, the Commissioner has decided to exclude homeopathic drugs from this OTC drug review and to review them as a separate category at a later time after the present OTC drug review is complete." [142] This was not a difficult decision. In the context of a massive review of somewhere between 100,000 and 500,000 OTC drug ingredients, homeopathic drugs seemed trivial at best. FDA also was immersed in what would become a debacle over the regulation of vitamins and minerals [143]. Homeopathic drugs appeared to pose no direct health threat, and if they were being prescribed for serious or life-threatening diseases, however, this had not come to FDA's attention. In short, they enjoyed only a limited market. The decision made during this era to treat homeopathy as a special case was made under the continuing assumption that homeopathy was a dying specialty [144]. As FDA noted, "in light of competing regulatory priorities, homeopathy was a medical back-water." [145] The last class of homeopathic physicians graduating from a homeopathic medical school graduated in 1960 from the Hahnemann Institute in Philadelphia and few states had statutes recognizing the practice of homeopathy [146].

X. The Resurgence of Homeopathy

In the proposed 1979 Drug Reform Act, mention of the HPUS was omitted from the proposed rewriting of section 5 of the FDCA. Because the bill was defeated and no House hearings were held, it is unclear whether the omission was deliberate or inadvertent. Nonetheless, homeopathic organizations noted and protested the exclusion. Following meetings with these organizations, FDA announced that it would move to classify homeopathic drugs as prescription items [147]. Beginning in 1981, FDA surveyed twelve homeopathic drug manufacturers and was concerned to note that there had been tremendous growth in the market for OTC homeopathic preparations, some sold for treatment of serious medical conditions [148]. FDA no longer was regulating a few old, established firms such as Boericke and Taffel marketing a few hundred exclusively homeopathic products. Homeopathy was no longer an exclusive specialty of physicians that Henry Sigerest had pronounced "competent" in 1934. Far from a dying therapeutic practice, homeopathy as self-help appeared to be experiencing a worldwide regeneration [149]. Traffic in imported homeopathic drugs, for example, had increased exponentially. Attention was drawn to imports when FDA seized a shipment of homeopathic drugs imported from Switzerland in 1984 [150]. FDA officials charged that the drugs were imported illegally because they did not bear the Rx legend. The imports eventually were released when the Swiss Embassy claimed that the seizure violated a provision of the General Agreement on Tariffs and Trade (GATT). Officials initiating the seizure were chagrined to learn that FDA's requirement that homeopathic drugs bear the Rx legend had been unenforced since it was enacted. The AIH, moreover, reversed its previous position supporting the marketing of most homeopathic drugs through homeopathic practitioners and argued, instead, that the great majority of homeopathic drugs should be allowed onto the market as OTC drugs, just as cold, cough, and headache remedies were allowed on the market [151]. The AAHP was revising the HPUS, subjecting it to modern drug provings [152]. Such profound changes in the homeopathic marketplace invigorated discussions about establishing an agency policy regarding homeopathic drug regulation.

After considering a wide range of options, FDA's Center for Drug Evaluation and Research (CDER) issued a formal Compliance Policy Guide (CPG) in 1988 establishing new guidelines to govern the agency's regulation of homeopathic drugs [153]. Officials considered requiring homeopathic drugs to bear warnings similar to those it imposed on medical gases [154]. In the end, however, this was rejected in favor of accepting the AIH's request to have some homeopathic preparations bear the Rx legend, while others were allowed to be marketed as OTC products for mild and self-limiting conditions [155]. In distinguishing prescription from OTC homeopathic drugs, the CPG stated that "those products that are offered for treatment of serious disease conditions must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC." OTC homeopathic remedies were required to have labels listing the ingredients and dilutions, as well as instructions for safe use [156].

The CPG did warn, however, that a homeopathic drug offered or promoted "significantly beyond the recognized or customary practice of homeopathy" would be subject to the agency's priorities and procedures with regard to the prosecution of health fraud [157]. Pursuant to the new policy, FDA did act against several start-up homeopathic manufacturers marketing products to the public, including injectable products for such conditions as AIDS, strokes, and cancer [158]. Overall, the CPG complicated regulation of homeopathic products. The CPG was regarded, in the words of one anonymous industry official, as a "how-to-manual" that quickly spawned an entirely new industry [159]. OTC drug manufacturers, in particular, began to protest the easy market access enjoyed by homeopathic products. Popular smoking cessation aids, for example, were sitting next to homeopathic products on store shelves, sporting similar claims and similar packaging, but with strikingly different price tags. Concerns about unfair competition were the subject of several citizen petitions submitted to FDA during the late 1980s and early 1990s.

In 1990, FDA's Center for Biologics Evaluation and Research (CBER) took a very different stance from CDER on homeopathic products by refusing to sanction homeopathic poison ivy extract oral pills manufactured by the Washington Homeopathic Pharmacy in Washington D.C. Rhus toxicodendron, or rhus tox for short, is an extremely popular homeopathic tincture [160]. In 1966, under unusual circumstances related to the regulation of pharmacies in the District of Columbia, the Washington Homeopathic Pharmacy had been licensed under the Public Health Service Act to manufacture homeopathic poison ivy extract pills as a biologic [161]. In 1972, however, when responsibility for biologics (serums, vaccines, antitoxins, etc.) was transferred from the National Institutes of Health (NIH) to FDA, all biologic products became subject to additional provisions imposed under the FDCA [162]. When CBER reviewed test results from allergenic extracts, reviewers found "no evidence of effectiveness for either prophylactic treatment or treatment of active disease" in the case of rhus tox [163]. Although the reviewers noted that "FDA may wish to consider this product differently because it is a homeopathic remedy," CBER did not elect to do so, insisting that its regulations made no separate provision for standards of effectiveness for homeopathic drugs [164]. CBER placed rhus tox in category IIIB—subject to revocation until safety, potency, and effectiveness are proven [165]. In the end, a compromise was reached on the issue. Washington Homeopathic Pharmacy petitioned for a revocation of its license under the Public Health Service Act to avoid compliance issues related to that statute [166]. So far, however, CBER, has not taken steps to remove the rhus tox product from the market and it still is available as an OTC homeopathic drug.

In 1994, a citizen petition was submitted to FDA requesting that it hold homeopathic drugs to the same standards of safety and efficacy as other drugs regulated by the agency [167]. In the interim, the petitioners requested that consumers be warned that FDA does not consider homeopathic drugs effective. The petition called homeopathy a $250 million a year scam "equivalent to a car with no engine or a phony stock certificate."[168] The petition did not stimulate immediate action. For one thing, at only two pages, it was short on details as to how such a sweeping indictment might be issued or implemented. For another, its timing was particularly poor. In the late twentieth century there has been substantial growth in all fields of alternative and complementary medicine, not merely homeopathy [169]. In 1997, it was estimated that there were more visits made by patients to alternative medicine practitioners than to primary care physicians in the United States, and that more than sixty percent of patients did not report use of alternative therapies to their primary physicians [170]. In 1996, the industry estimated sales of homeopathic drugs to be between $100 and $200 million a year [171]. The effectiveness and value of such alternative and complementary therapies, however, are increasingly disputed, evidence is contradictory, and confusion rampant [172]. In the case of homeopathy, for example, a 1998 survey of pharmacists found that 27.4% of respondents deemed homeopathy "useful" while 18.3% found it "useless," and 54.3% were unsure [173]. Such confusion led some scientists and consultants to recommend more critical scientific evaluation of homeopathic therapeutic treatments [174].

At the time the citizen petition on homeopathy was submitted to FDA, Congress already had taken a controversial step in establishing an Office of Alternative Medicine (OAM) at the NIH. In January 1995, Dr. Wayne B. Jonas, a physician who believed in the efficacy of homeopathy, was appointed to head the office. Under Jonas' leadership, the NIH's OAM (now the National Center for Complementary and Alternative Medicine) expressed confidence that homeopathy could demonstrate some true scientific merit [175]. As Congress continued to increase the OAM's budget, the number of studies of homeopathic remedies increased, but results of the few published scientific studies to date have remained controversial [176].

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) [177]. DSHEA indicated that Congress wanted consumers to have broader rather than more restricted access to dietary supplements. Congress defined dietary supplement and established a regulatory framework to ensure that product labeling is accurate, and that FDA can remove products that are adulterated or pose a "significant or unreasonable" risk to consumers. Unlike new drugs or food additives, Congress did not subject dietary supplements to premarket review requirements, except where the supplement contained a "new dietary ingredient." DSHEA did require nutrition and ingredient labeling to provide guidance for consumers and sanctioned the establishment of good manufacturing practices for dietary supplements. One of the most revolutionary provisions of DSHEA, however, was the provision allowing dietary supplements to bear "structure or function" claims on labels, provided that a firm could substantiate that the claim was truthful and not misleading and that the claim was accompanied by a disclaimer [178].

Although DSHEA dealt only with dietary supplements, it was interpreted largely as a harbinger of a new era in regulation. In March 1999, FDA Commissioner Dr. Jane Henney testified before the House Committee on Government Reform that since 1994 the dietary supplement industry had grown "exponentially," with $12 billion a year in sales and over half of U.S. adults take dietary supplement products [179]. Although often marketed in the same fashion and through the same venues, the homeopathic drug market has not grown as spectacularly as have dietary supplements, per-haps because homeopathic products still are regulated as drugs. The public, however, perceives little distinction. An issue of Time, devoted to visions of the new century, discusses "ginseng, ginkgo biloba, and homeopathic potions" interchangeably [180]. In language reminiscent of that used by medical reformers during Flexner's era then speculating on the future of homeopathy, it has been predicted that "any alternative therapy that can be proved valid will swiftly be incorporated into mainstream medicine," but any medicine "based on myth, irrationality and deception will eventually be rejected." [181] As for homeopathy, the public will become disenchanted with it when consumers "finally wise up to the fact that in many cases they are paying big bucks for a highly diluted mixture that is essentially pure water." [182]

Today, the HPUS is published by the Homeopathic Pharmacopeia Convention of the United States, a private nonprofit organization. It contains hundreds of monographs for homeopathic ingredients. Although the organization requires that certain homeopathic drug products be marketed only by prescription, including those from dangerous or toxic sources, not all homeopathic drug ingredients are recognized in the HPUS. So long as there is some official documentation that an ingredient generally is considered homeopathic, it can be marketed in a homeopathic drug product. In recent years, in fact, few new homeopathic ingredients have been added to the HPUS, indicating that the modest monograph requirements imposed by the HPUS for new homeopathic drugs are not being met [183]. The entire regulatory system governing homeopathic drugs has been defended as appropriate to a class of drugs posing few safety concerns. Nonetheless, it stands in marked contrast to the well-honed new drug application/investigational new drug process applied to all other new drugs in the United States. There are some indications of increasing concern, but in the end, Royal Copeland may be judged to have succeeded in his quest to keep homeopathy from being regulated to the "quack heap." [184]

About the Author

Dr. Junod is an FDA Historian at the FDA History Office, Rockville, Maryland. This article won Society for History in the Federal Government (SHFG) Thomson Prize.

Acknowledgments

References

  1. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-392 (1994)).
  2. 21 U.S.C. § 321(g) (FDCA § 201(g)).
  3. Throughout the twentieth century, drug standardization dramatically changed the regular practice of medicine. This change has been characterized by historian John Harley Warner as a shift from individualization in therapy during the nineteenth century, to universalism in the twentieth. Homeopathy, in contrast, maintained its devotion to individualized treatment regimes at least through the mid-twentieth century in the United States, leading many regular physicians to hold homeopathic practice in disdain. "Regressive" would have been one of the most complimentary terms used by skeptics to describe homeopathic practice. JOHN HARLEY WARNER, THE THERAPEUTIC PERSPECTIVE: MEDICAL PRACTICE, KNOWLEDGE, & IDENTITY IN AMERICA 1820-1885 161 (1986).
  4. TREVOR M. COOK, SAMUEL HAHNEMANN: THE FOUNDER OF HOMEOPATHIC MEDICINE 15, 183 (1981).
  5. NAOMI ROGERS, AN ALTERNATIVE PATH: THE MAKING AND REMAKING OF HAHNEMANN MEDICAL COLLEGE AND HOSPITAL OF PHILADELPHIA 6 (1998) [hereinafter ROGERS, HAHNEMANN MEDICAL].
  6. Hahnemann reportedly was led to this view by observing that Peruvian bark and quinine cured malaria, but in large doses they mimicked the disease. See COOK, supra note 4, at 59.
  7. The "causing provision" was the basis for criminal prosecutions against company officials and employees who "caused" illegal adulterations and misbranding of food and drug products under the law. Harding concluded that the causing provision was "very much in the mind of some member of the agency (FDA)." George E. Harding, 301(a): The "Causing" Provision and Jurisdictional Limits, 6 FOOD DRUG COSM. L.J. 597 (1951).
  8. Id.
  9. Food and Drugs Act, Pub. L. No. 59-384, 34 Stat. 768 (1906) (codified at 21 U.S.C. §§ 1-15 (1934)) (repealed in 1938 by 21 U.S.C. § 392(a)) (hereinafter "1906 Act").
  10. Glenn Sonnedecker, Drug Standards Become Official, in THE EARLY YEARS OF FEDERAL FOOD & DRUG CONTROL 28, 28-39(1982).
  11. Legal standards for food products were not included in the 1906 Act, in part because there was no foods organization with the same status as the U.S. Pharmacopeial Convention. Suzanne White, Chemistry & Controversy: Regulating the Use of Chemicals in Foods, 1883-1959, (1994) (unpublished Ph.D. dissertation, Emory University) (on file with Woodruff Library, Emory University) at 255-60.
  12. For discussion about debates concerning the authority and limits surrounding recognition of the NF and USP, see JAMES HARVEY YOUNG, PURE FOOD 207, 209 (1989).
  13. This frequently is referred to as the "variation clause." For examples, see John P. Swann, Evolution of the Drug Label, 15 FOOD DRUG COSM. & MED. DEVICE L. DIGEST 23, 23-31 (1998).
  14. A drug is defined as: 1) articles recognized in the official USP, official HPUS or official NF or any supplement to any of them; and 2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and 3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and 4) articles intended for use as a component of any article specified in clause 1, 2, or 3; but does not include devices or their components, parts, or accessories. 21 U.S.C. § 321(g) (FDCA § 201(g)).
  15. YOUNG, supra note 12, at 265.
  16. Royal Copeland, Speeches & Writings on Homeopathy, box 21, folder 6 (unpublished papers) (on file with the Bentley Historical Library, University of Michigan at Ann Arbor) [hereinafter Speeches & Writings].
  17. Id.
  18. Id. In the wake of the 1906 Act, most drugs came to be viewed as either ethical, quack, or proprietary. Labeling requirements led many "proprietary" drugs to change their labeling, their composition, or both. Reformed proprietary drugs occupied a perennial, but separate category preserving America's determination to self-medicate. Homeopathic drugs, however, blurred these distinctions and had a different history. Prescribed by educated physicians, "homeopathy was based on a scientific approach, an experimental pharmacology; in many ways it had a better claim to scientific accuracy than did the practice of bloodletting and the use of calomel." Martin Kaufman, Homeopathy in America: The Rise and Fall and Persistence of a Medical Heresy, in OTHER HEALERS: UNORTHODOX MEDICINE IN AMERICA 99 (Norman Gevitz ed. 1988).
  19. In the area of treatment, the "new homeopaths" sought to modify a central tenet of traditional homeopathic medical practice—its adherence to highly individualized and personalized therapy. The acceptance of the HPUS and the need for drug standardization after the 1906 Act was enacted reflects not only the central role of therapy in homeopathic practice, but the degree with which the "new homeopaths" supported the "scientific" goal of gaining greater precision in therapeutic practice. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 83.
  20. Naomi Rogers American Homeopathy Confronts Scientific Medicine, in CULTURE, KNOWLEDGE AND HEALING: HISTORICAL PERSPECTIVES OF HOMEOPATHIC MEDICINE IN EUROPE AND NORTH AMERICA 31-64 (Juette, Risse & Woodward eds. 1998) [hereinafter Rogers, HISTORICAL PERSPECTIVES].
  21.  
  22. Raymond Joseph Potter, Royal Samuel Copeland 1868-1938: A Physician in Politics, (1967) (unpublished Ph.D. dissertation, University of Cleveland) (on file with University Microfilms). This biography is the only full-length work on Copeland.
  23. Id. at 21, 24.
  24. See id. at 24.
  25. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; JOHN HARLEY WARNER, AGAINST THE SPIRIT OF SYSTEM: THE FRENCH IMPULSE IN NINETEENTH CENTURY AMERICAN MEDICINE (1998); Potter, supra note 22, at 30.
  26. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; Potter, supra note 22, at 29-31. Like many homeopaths, Copeland pursued specialist training in Europe, rather than additional homeopathic training.
  27. For a discussion of the evolution of Ophthalmology, Optometry, and the AMA's first specialty board, the American Board for Ophthalmic Examinations, see ROSEMARY STEVENS, AMERICAN MEDICINE AND THE PUBLIC INTEREST 98-114 (1998). Rogers notes that a group of homeopathic eye, ear, and throat specialists organized in 1877, publishing their own set of Transactions, later renamed the HOMEOPATHIC EYE, EAR, & THROAT J. In 1889, a separate homeopathic organization began publishing the J. OPHTHALMOLOGY, OTOLOGY, & LARYNGOLOGY. It was this latter group with which Copeland was associated. In 1910, the journals merged.
  28. Naomi Rogers, The Public Face of Homeopathy in the US 1900-1950, Address at the Second International Conference on History of Homeopathy, Bosch Institute, Stuttgart (July 1999) at 6, n.13.
  29. Id. at 80.
  30. In 1895, the AIH rewrote its official definition of a homeopathic physician as "one who adds to his knowledge of medicine a special knowledge of homeopathic therapeutics." Copeland accepted, elaborated on and ultimately embodied this vision of his profession.
  31. Potter, supra note 22, at 35, 41.
  32. Id. at 35.
  33. In Defense of the Attenuated Drug, Homeopathic Medical Society of the State of Ohio, Speeches & Writings, supra note 16, box 7 (May 10-11, 1904).
  34. Id., box 21. In 1899, the AIH accepted a new consensus that envisioned homeopathy as a complementary, rather than an alternative medical profession. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland was elaborating on the thinking that had gone into the passage of the resolution. For an account of similar reformist thinking in Britain, see GLYNIS RANKIN, Professional Organization & the Development of Medical Knowledge: Two Interpretations of Homeopathy, in STUDIES IN THE HISTORY OF ALTERNATIVE MEDICINE 46-62 (Roger Cooter ed. 1988).
  35. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES, Speeches & Writings, supra note 16, box 21.
  36. Id.
  37. See, e.g., OLIVER WENDELL HOLMES, HOMEOPATHY & ITS KINDRED DELUSIONS (1899); KAUFMAN, supra note 18.
  38. Homeopathy: Much Ado About Nothing, CONSUMER REP. 59, 201 (Mar. 1994); Homeopathy, MEDICAL LETTER ON DRUGS AND THERAPEUTICS, 41, 20-21 (Feb. 26, 1999).
  39. Kaufman notes that it was difficult to practice classical homeopathy by the end of the nineteenth century, so some homeopaths "simplified their work and bolstered their income by using allopathic remedies and by increasing the dosage of their homeopathic treatments." In short, "it was much easier to be an allopath, relying upon a specific remedy for each ailment." KAUFMAN, supra note 18, at 106.
  40. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
  41. Potter, supra note 22, at 33.
  42. In 1899, the AIH redefined homeopathy's law of similars as "let like be cured by like," and made it "less a law than a guide to therapy." ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland refers to it as a "hypothesis." REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
  43. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
  44. Id.
  45. Id.
  46. Id.
  47. Id.
  48. Id.
  49. JAMES HARVEY YOUNG, THE TOADSTOOL MILLIONAIRES: A SOCIAL HISTORY OF PATENT MEDICINES IN AMERICA BEFORE FEDERAL REGULATION (1961). Homeopaths struggled with the issue of homeopathic patent medicines. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 42-44.
  50. Charles S. Cameron, M.D., Homeopathy in Retrospect, TRANSACTIONS AND STUDIES OF THE COLLEGE OF PHYSICIANS IN PHILADELPHIA, at 29 (July 1959) (noting that homeopaths did pioneering work in drug therapy with the insane and helped simplify prescriptions).
  51. Mark Sullivan, The Patent Medicine Conspiracy Against the Freedom of the Press, COLLIER'S MAG. 13-16 (Nov. 3, 1905); SAMUEL HOPKINS ADAMS, THE GREAT AMERICAN FRAUD (1906); YOUNG, supra note 49, at 197.
  52. What is Homeopathy?, Speeches & Writings, supra note 16, box 21, folder 2.
  53. Id.
  54. Id.
  55. Id.
  56. Id., box 21, folders 2, 6. In 1902, the First International Agreement for the Unification of the Formulas for Potent Drugs was adopted and ratified. C.H. Hampshire, League of Nations Bulletin of the Health Organization, 12 112-79 (1945-46), as quoted in George Urdang, The Development of Pharmacopeias, 8 FOOD DRUG & COSM. L.J. 90, note 12 (1953).
  57. Homeopathy in the Twentieth Century, Speeches & Writings, supra note 16, box 21, folder 1 (May 21, 1901).
  58. Potter, supra note 22, at 91-94; Homeopathy & Posology, Speeches & Writings, supra note 16, box 21, folder 6.
  59. Sonnedecker, supra note 10, at 35.
  60. SUSAN E. LEDERER, SUBJECTED TO SCIENCE: HUMAN EXPERIMENTATION IN AMERICA BEFORE THE SECOND WORLD WAR 52-53 (1995). After criticizing Gallinger's medical credentials and his opposition to the Owens Bill, the Children's Bureau, and "anything endorsed by the AMA," an editorialist quipped: "[n]obody takes Senator Gallinger seriously as a senator. Why not let him strut about as an authority on medical subjects?" Editorial, Old Doc Gallinger, 62 JAMA 1354-55 (1914).
  61. Sonnedecker, supra note 10, at 35; GUIDE TO RECORDS OF US SENATE AT THE NATIONAL ARCHIVES (1789-1989) 266 (1989).
  62. Id.
  63. Rogers, supra note 28, at 27, 90. Copeland's papers reveal that he was in a strong position during and after Abraham Flexner's visit to the institution. While he disagreed with Flexner's views about homeopathy, he approved of Flexner's overall objectives. In addition, he heeded many of Flexner's suggestions including the admonition to strengthen research at the institution. In response, alumni promptly contributed $9000 of $10,000 needed to erect a new bacteriological laboratory. In 1911 Copeland's contract was renewed for $9000 a year. Potter, supra note 22, at 123.
  64. Abraham Flexner, Report on Medical Education in the U.S. and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching, 159-61 (1910).
  65. Id.
  66. The Future of Homeopathy, Speeches & Writings, supra note 16, box 21, at 4.
  67. Copeland essentially was commandeered in 1918 to serve as New York City's Health Commissioner by the city's mayor. Potter, supra note 22, at 140.
  68. Correspondence to Rita E. Dunlevy, May 9, 1918, Speeches & Writings, supra note 16, box 22; see also id., New York Board of Health, Saving the Babies in a Great City.
  69. Potter, supra note 22, at 214-15.
  70. Id.
  71. U.S. Senate, Food and Drugs, The Health of the Nation, Speeches & Writings, supra note 16, box 25, at 7.
  72. Potter, supra note 22, at 96, 275.
  73. U.S. Senate, Food and Drugs, Text of National Cosmetic Bill Sept. 1927, Speeches & Writings, supra note 16, box 25; Gwen E. Kay, Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetic Act (1997) (unpublished Ph.D. Thesis, Yale University) (on file with Yale University); JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS 164 (1967); CHARLES O. JACKSON, FOOD & DRUG LEGISLATION IN THE NEW DEAL 14 (1970); Potter supra note 22, at 153.
  74. David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 J.L. & CONTEMP. PROBS. 10 (1939).
  75. Interview between Charles O. Jackson and Rexford G. Tugwell, June 7, 1968, FDA Oral History Collection, National Library of Medicine; 73 CONG. REC. S1944 (1933); see infra note 106.
  76. Wallace F. Janssen, Propaganda Guns Try to Force Tugwell Bill Passage, GLASS PACKER 760-62 (Dec. 3, 1933). Cavers notes that "Tugwellomania" became an industrial disease around this time. The symptoms he characterized as "cold feet, red spots before the eyes, a loss of the sense of proportion and delusions of persecution." David Cavers, Tugwellomania, 9 FOOD INDUSTRIES 2 (1934); JACKSON, supra note 73, at 36.
  77. Food, Drugs, and Cosmetics, Hearings on S. 1944 Before the Senate Comm. on Commerce, 73rd Cong., 2d Sess. (1933) [hereinafter Senate Hearings].
  78. Copeland, as NYC Health Commissioner, had been forced to work around the deficiencies in the 1906 Act, including the absence of federal food standards which forced local jurisdictions to formulate their own legal standards. U.S. Senate, Food and Drugs, The Health of the Nation, Speeches & Writings, supra note 16, box 25, at 5-6.
  79. 78 CONG. REC. 5: 5467-73 (1934).
  80. Public Statement, Speeches & Writings, supra note 16, box 21, folder 1, at 4.
  81. Id. at 7.
  82. It is likely that this was a proposal submitted to Copeland by the homeopathic profession. It is unlikely that Copeland was in close enough touch with homeopathic organizations to have authored this provision himself, at this time.
  83. Senate Hearings, supra note 77, at 4.
  84. Id.
  85. YOUNG, supra note 49, at 164; JACKSON, supra note 73, at 27.
  86. "Demonstrable scientific facts" appears in Copeland's statement introducing S 2000. U.S. Senate, Food and Drug, Senator Copeland's Statement About New Food and Drug Bill, Speeches & Writings, supra note 16, box 25.
  87. Senate Hearings, supra note 77, at 12. In the FDCA, therapeutic devices specifically were covered and subjected to the same general requirements as established for drugs. Drugs or devices deemed dangerous to health under the conditions of use prescribed in the labeling were prohibited from interstate commerce. 21 U.S.C. §§ 321, 352 (FDCA §§ 201(g)(2), (3), 502(j)).
  88. U.S. Senate, Food and Drug, Why Submitted Section 4(e) Should Be Included in Any Food and Drug Bill, Speeches & Writings, supra note 16, box 25 (Dec. 19, 1933).
  89. Id.
  90. Id.
  91. Id.
  92. Id. Although this charge cannot be substantiated, the headache remedies employing various ingredients were troublesome products for early drug regulators. YOUNG, supra note 49, at 1-14; CHARLES C. MANN & MARK L. PLUMMER, THE ASPIRIN WARS: MONEY, MEDICINE & 100 YEARS OF RAMPANT COMPETITION 123-37 (1991).
  93. U.S. Senate, Food and Drug, Why Submitted Subsection (e) Should Be Included in Any Food and Drug Bill, Speeches & Writings, supra note 16, box 25.
  94. NORMAN GEVITZ, OTHER HEALERS: UNORTHODOX MEDICINE IN AMERICA 94, 136, 168 (1988); WILLIAM G. ROTHSTEIN, AMERICAN MEDICAL SCHOOLS & THE PRACTICE OF MEDICINE 153-59 (1987); KEN M. LUDMERER, LEARNING TO HEAL: THE DEVELOPMENT OF AMERICAN MEDICAL EDUCATION 88 (1985).
  95. It is interesting to speculate as to the effect of this provision had it been enacted. In 1935, the AMA Council on Medical Education and Hospitals voted to exclude the graduates of "sectarian" institutions from hospital internships. Rather than having its students excluded, most institutions quickly dropped their sectarian affiliations. New York Homeopathic Medical College, for example, became New York Medical College. KAUFMAN, supra note 18, at 177; ROGERS, HAHNEMANN MEDICAL, supra note 5, at 129-32.
  96. Senate Hearings, supra note 77 at 5: 5467-73.
  97. It is not clear how Copeland arrived at his proposal or even that he, rather than FDA, initiated insertion of the HPUS into the law. American Institute of Homeopathy, Speeches and Writings, supra note 16, box 21, folder 6.
  98. James Harvey Young & Richard E. McFadyen, The Koch Cancer Treatment, 53 J. HIST. MED. 255 (1998).
  99. Id. at 258.
  100. The Sherley Amendment required FDA to demonstrate fraudulent intent in the marketing of a drug.
  101. Young & McFadyen, supra note 98, at 264.
  102. The Koch papers, cited by Young and McFadyen, cannot be located in the federal records system for verification.
  103. It would be difficult, if not impossible, to devise a legally accurate label for such a dilute preparation. If the product listed an active ingredient and such an ingredient could not be detected in the preparation, the product would be illegal. Likewise, the product could not meet the law's requirement to specify its own standard on the label if the concentration of its active ingredient could not be defined or verified.
  104. Speeches & Writings, supra note 16, box 25 (Dec. 19, 1933).
  105. Copeland noted that "the original bill which I presented met with violent opposition from every section of the country . . . " 78 CONG. REC. 59 (Jan. 4, 1934) in CHARLES WESLEY DUNN, FEDERAL FOOD, DRUG, & COSMETIC ACT: A STATEMENT OF ITS LEGISLATIVE RECORD 51 (1938). "[T]he discretionary power of S. 1944 was a fearful thing." JACKSON, supra note 73, at 34.
  106. Senate Hearings, supra note 77, at 121 (indicating that these were considered "emergency" provisions). S. 1944 stated that a drug would be deemed adulterated where it purports to be a USP or NF drug "except thatwhenever tests or methods of assay have not been prescribed therein or such tests or methods of assay as are prescribed are found by the Secretary to be insufficient, he is hereby authorized to prescribe by regulations, tests, or methods of assay for determining whether or not such drug complies with such standards." A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 5 (vol. 1, 1979) [hereinafter LEGISLATIVE HISTORY].
  107. It remained in S 2000, but was subject to the regulatory restrictions enumerated in a new section 22 of the bill that would have required all regulations to be recommended by an "appropriate committee." LEGISLATIVE HISTORY, supra note 106, at 601, 629.
  108. In recent time, however, the NIH does seem to have enjoyed some degree of success with its "Consensus Conferences."
  109. The Tugwell Bill: An Analysis and Proposed Amendments, Speeches & Writings, supra note 16, box 25, at 7-8. Analysis of section 8 (a)(2) recommended striking it. "There is in fact, and as a matter of common knowledge no such thing as 'general agreement of medical opinion' and there is no recorded case in legal history where there has ever been established a 'consensus' or 'general agreement of medical opinion' on any subject." Id.
  110. Id.
  111. Id.
  112. Sonnedecker, supra note 10, at 35. Section 7, part 2 defined a drug as adulterated "[i]f its strength or purity fall below the professed standard or quality under which it is sold."
  113. JACKSON, supra note 73, at 196. Nonofficial drugs were illegal unless their labels listed all active ingredients.
  114. Oral Interview between Charles O. Jackson and Morris Fishbein, Mar. 12, 1968, FDA Oral History Collection, National Library of Medicine, 59, 84, 85.
  115. Both regular and homeopathic physicians were opposed to osteopaths, chiropractors, and Christian Science healers. Copeland referred to these groups as "drugless" healers. KAUFMAN, supra note 18, at 114.
  116. David F. Cavers, LEGISLATIVE HISTORY, supra note 76, at 10.
  117. In the 1930s homeopaths still left their training with an "alternative identity: a feeling that they were distinct from but not entirely outside the medical mainstream." ROGERS, supra note 5, at 81.
  118. Attrition and Homeopathy, Speeches & Writings, supra note 16, box 21, folder 5. In 1903, the AMA Code of Ethics was revised to allow homeopaths to become members of the AMA because both regular and homeopathic physicians were united in opposition to osteopaths, chiropractors, and Christian Science healers. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85.
  119. HENRY E. SIGERIST, AMERICAN MEDICINE 196 (1934).
  120. Suzanne White, Enforcing the 1938 Food, Drug, and Cosmetic Act: The Class of '39, 52 J. ASSOC. FOOD & DRUG OFFICIALS 18-19 (Oct. 1988).
  121. JACKSON, supra note 73, at 196.
  122. Young & McFadyen, supra note 98, at 266-67.
  123. JACKSON, supra note 73, at 153-71.
  124. In 1937, a company marketing a liquid preparation of the wonder drug sulfanilamide used diethylene glycol, a poison, as a solvent for the drug. Before an effective recall could be instituted, over 109 people died. The tragedy helped gain congressional support for enactment of the new food and drug statute. JAMES HARVEY YOUNG, Sulfanilamide & Diethylene Glycol, in CHEMISTRY AND MODERN SOCIETY: HISTORICAL ESSAYS IN HONOR OF AARON J. IHDE 105-25 (John Parascandola & James C. Whorton ed. 1983).
  125. John P. Swann, FDA & the Practice of Pharmacy: Prescription Drug Regulation to 1951, 36 PHARMACY IN HIST. 55-70 (1994); see also Harry Marks, Revisiting the Origins of Compulsory Drug Prescriptions, 85 AM. J. PUBLIC HEALTH 109-15 (1995); Humphrey-Durham Drug Prescription Act, ch. 578, 65 Stat. 648 (21 U.S.C. §§ 333, 353 (1951)).
  126. Administration Information Letter No. 269, July 3, 1953, 500.13 (homeopathic drugs are classified as prescription drugs under the Durham-Humphrey Amendment).
  127. Id.
  128. R.E. Hamilton to Standard Homeopathic (Nov. 20, 1970), FDA General Correspondence Files, 88-87-7, box 44, folder 239, decimal 546.
  129. "Caution: Federal law prohibits dispensing without a prescription."
  130. On file with the FDA History Office, Rockville, MD.
  131. Homeopathy File, FDA History Office, Rockville, MD; Pub. L. No. 87-781, 76 Stat. 780 (1962) (21 U.S.C. §§ 321 et seq).
  132. Id.
  133. In 1978, Congress included a provision that would have eliminated recognition of the HPUS in the FDCA as part of a larger reform package, but the bill was not enacted. Elimination of the HPUS could have allowed the agency to reconsider subjecting homeopathic drugs to the efficacy provision of the law.
  134. Pinco to Acting Director, Division of Data Management (May 28, 1974) GC 1980, 546, box 44, folder 239; Apodaca to Director, Division of Drug Labeling Compliance (Nov. 20, 1975) GC 546, box 44, folder 239.
  135. Lamar, Memorandum of Conference (Sept. 8, 1971) 88-87-7, GC 1980 546 American Institute of Homeopathy, box 44, folder 239.
  136. John P. Swann, Sure Cure: Public Policy on Drug Efficacy before 1962, in THE INSIDE STORY OF MEDICINES: A SYMPOSIUM 223-61 (Gregory J. Higby & Elaine C. Stroud eds. 1997).
  137. 37 Fed. Reg. 3176 (Feb. 12, 1972). Peter Barton Hutt and Commissioner Edwards felt, at the time, that FDA probably never would institute an OTC review of homeopathic preparations. Personal conversation between the author and Mr. Hutt (June 1999).
  138. Walters, Memorandum of Conference (Feb. 17, 1972) GC 1980, 88-87-7, 546, box 44, folder 239.
  139. Officials felt that OTC labeling indicated that they were marketed "generally for use in conditions which the layman may be able to recognize." Packscher to Sansbury (Dec. 3, 1971) 88-87-7, GC 546, box 44, folder 239.
  140. Kilburn to Hueper (July 19, 1971) 88-87-7, GC 1980, box 44, folder 239.
  141. Meserey v. United States, 447 F. Supp. 548 (D.Nev. 1977).
  142. 37 Fed. Reg. 9464 (May 11, 1972).
  143. RIMA D. APPLE, VITAMANIA: VITAMINS IN AMERICAN CULTURE 139-43 (1996).
  144. Personal conversation between the author and Peter Barton Hutt (June, 1999); see also MARTIN KAUFMAN, HOMEOPATHY IN AMERICA 183 (1971).
  145. Riding the Coattails of Homeopathy's Revival, FDA CONSUMER, 30-31 (Mar. 30 1985).
  146. Loftus to Cloninger (June 4, 1971) 88-87-7, GC 1980, box 44, folder 239; ROGERS, HAHNEMANN MEDICAL, supra note 5, at 161.
  147. American Homeopath 1 (May 1981) cited in KAUFMAN, supra note 18, at 118.
  148. FDA CONSUMER, supra note 145, at 32; KAUFMAN supra note 18, at 18; Chastoney to District Directors (Nov. 6, 1981) GC 1983, 88-89-16, box 33, folder 180, Decimal 546.
  149. Homeopathic Medications Available in More Than Half of Major Chains, F-D-C REP. ("The Tan Sheet"), Mar. 20, 1995, at 16.
  150. Michels to Associate Commission for Regulatory Affairs (Nov. 27, 1984) 88-89-16, GC 1987, box 33, folder 180, decimal 546.
  151. Concerns about lay homeopathy in the late 1970s and early 1980s led dissidents to form a new American Center for Homeopathy. Their newsletter, The American Homeopath, edited by Harris Coulter, argued in favor of self-medication in homeopathy. Questions about lay homeopathy "continue to pose a serious problem." KAUFMAN, supra note 18, at 115-16. HPUS Update, HOMEOPATHY TODAY 3-4 (June 1984).
  152. In the wake of Hecker v. Chaney, FDA began to rely increasingly on Compliance Policy Guides as a means of expressing and exercising its regulatory "discretion." Suzanne White Junod, Valor and the Judicious Exercise of Discretion, 4 FDLI UPDATE 9 (Aug. 1999).
  153. "For use under supervision of a licensed practitioner experienced in the use and administration of homeopathic drugs and familiar with indications, effects, dosages, methods, and frequency of duration of such drugs." FDA Compliance Policy Guide, Sec. 400.400, "Conditions Under Which Homeopathic Drugs May Be Marketed," CPG 7132.15 [hereinafter FDA Guide].
  154. Wyrth Baker, M.D., to Jerome Halperin, Dep. Director, Bureau of Drugs (Nov. 4, 1981) 88-89-16, GC 1983, box 33, folder 180, decimal 546; Isadora Stehlin, Homeopathy: Real Medicine or Empty Promises?, FDA CONSUMER, Dec. 1996, at 18.
  155. FDA Talk Paper on Homeopathy, Sept. 1988, available at FDA Press Office.
  156. FDA Guide, supra note 154.
  157. Id.
  158. Homeopathic Indications Based on Conventional Efficacy Criteria Urged, F-D-C REP. ("The Tan Sheet"), Mar. 20, 1995, at 15-16.
  159. It was made even more popular recently by publication in the British Medical Journal of a study indicating possible usefulness in primary fibromyalgia, a common rheumatic disease. P. Fisher, A. Greenwood,
  160. E.C. Huskisson, P. Turner & P. Belon, Effect of Homeopathic Treatment on Fibrositis, 299 BRIT. MED. J. 365-66 (1989).
  161. License # 392; Public Health Service Act, 42 U.S.C. § 262 (1994).
  162. FDA ANN. REP. 1950-1974 (1976), 813, 856-57.
  163. 50 Fed. Reg. 3270 (Jan. 23, 1985).
  164. Id.
  165. Id.
  166. Public Health Service Act, 42 U.S.C. § 262.
  167. OTC Homeopathic Drugs Safety and Efficacy Review by FDA Urged, F-D-C REP., Sept. 19, 1994, at 16.
  168. News Release (Aug. 29, 1994), Stephen Barrett, M.D., Homeopathy Files, FDA History Office, Rockville, MD.
  169. The National Council Against Health Fraud reported that a November 1997 survey showed that forty-two percent of the survey's 1500 respondents had used some form of alternative health care in the past year. The most widely reported alternative therapy was self-treatment with herbal therapies (seventeen percent), but a close second was the use of professional chiropractors (16.6%). The Council noted that this showed at least a six percent increase over survey results of chiropractic usage in previous years. This growth in chiropractic use may be linked to increased interest in homeopathy because chiropractors are the most common practitioners of homeopathy, constituting about 18,500 practitioners in 1993. NAT'L COUNCIL AGAINST HEALTH FRAUD NEWSL. (Mar./ Apr. 1998).
  170. Greg Plotnikoff, Complementary & Alternative Medicine, 3 BIOETHICS EXAMINER 1 (MAR. 1999).
  171. Robert G. Pinco & Paul D. Rubin, Homeopathic Drugs: What are They, and How are They Regulated in the United States & in the European Union?, 14 BIOLOGICAL THERAPY 140 (Jan. 1996).
  172. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan./Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms-Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
  173. Pharmacists Survey, 15 J. CLINICAL PHARMACY & THERAPEUTICS 131-39 (1990).
  174. Alternative Medicine: Expanding Medical Horizons: A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States, prepared under the auspices of the Work-shop on Alternative Medicine, Chantilly, VA at 83-85 (Sept. 14-16, 1992). In contrast, an outspoken critic of some alternative therapies, recently acknowledged that while they could be beneficial, "entrusting your health to certain alternative providers would be like taking a trip on a plane piloted by a pilot who uses alternative navigation, based on astrology an a flat-Earth map." John H. Renner (on file in the Homeopathy Files, 1997, FDA History Office).
  175. The NIH's Office of Alternative Medicine has been criticized internally by NIH's scientists, and also by outsiders. See James Harvey Young, The Development of the Office of Alternative Medicine in the National Institutes of Health, 1991-1996, 72 BULL. HIST. MED. 279-98 (1998).
  176. Leon Jaroff, What Will Happen to Alternative Medicine, TIME, Nov. 8, 1999, at 77.
  177. Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)).
  178. "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." For one critique of the agency's policies on dietary supplements, see James Harvey Young, Health Fraud: A Hardy Perennial, 9 J. POL'Y HIST. 117-40 (1997).
  179. Before the Comm. on Gov't Reform, 106th Cong., 1st Sess. 3 (Mar. 25, 1999) (statement of Dr. Henney, Commissioner of Food & Drugs, FDA).
  180. Jaroff, supra note 176, at 77.
  181. Id.
  182. Id.
  183. Pinco & Rubin, supra note 171, at 143.
  184. Homeopathic Indications Based on Conventional Efficiency Criteria Urged, F-D-C REP. ("The Tan Sheet"), 15 (Mar. 20, 1995); Homeopathy is Vulnerable, 20 NAT'L COUNCIL AGAINST HEALTH FRAUD NEWSL. 1 (1997).

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