An Alternative Perspective Homeopathic Drugs and FDA Regulation

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1 An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
1.1 I. Introduction
1.2 II. The First Drug Standard Compendia: The Food and Drugs Act of 1906
1.3 III. The Homeopathic Pharmacopoeia of the United States
1.4 IV. Royal S. Copeland: Homeopathic Reformer
1.5 V. Congress, Homeopathy, and the HPUS
1.6 VI. Copeland: Senator and Sponsor of the FDCA
1.7 VII. Copeland and the "Textbook Provision"
1.8 VIII. The HPUS under the FDCA
1.9 IX. Exclusion of Homeopathic Products from OTC Review
1.10 X. The Resurgence of Homeopathy
1.11 About the Author
1.12 Acknowledgments
1.13 References
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
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"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
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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
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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
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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 visitedâ€”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
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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
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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
1908â€”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
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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 practicesâ€”chiropractic, hydropathy, or osteopathyâ€”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
reasonsâ€”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
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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 insertionâ€”recognition of the HPUS as an official drug
compendiumâ€”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
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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, ProntosilÂ®,
came on the market. ProntosilÂ® 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 studyâ€”"generally recognized among qualified
experts as safe and effective"â€”would be difficult to apply to homeopathic remedies [132]. Because the
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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
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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
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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 IIIBâ€”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
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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
The article is was published in the Food and Drug Law Journal 55:161-183, 2001, and is reproduced
with the kind permission of the author and the American Institute of the History of Pharmacy
(http://www.aihp.org/)
The author gratefully acknowledges helpful comments received on earlier drafts from Linda Horton,
Peter Barton Hutt, John Parascandola, Naomi Rogers, Linda Suydam, John Swann, and James Harvey
Young.
References
1. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. Â§Â§ 301-392 (1994)).
2. 21 U.S.C. Â§ 321(g) (FDCA Â§ 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.
14 of 23 10/26/2017, 7:12 PM
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. Â§Â§ 1-15
(1934)) (repealed in 1938 by 21 U.S.C. Â§ 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. Â§ 321(g) (FDCA Â§ 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
15 of 23 10/26/2017, 7:12 PM
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 practiceâ€”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.
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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
17 of 23 10/26/2017, 7:12 PM
(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.
18 of 23 10/26/2017, 7:12 PM
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. Â§Â§ 321, 352 (FDCA Â§Â§ 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.
19 of 23 10/26/2017, 7:12 PM
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. Â§Â§ 333, 353 (1951)).
20 of 23 10/26/2017, 7:12 PM
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. Â§Â§ 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, [../reg/conference_1972.html 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
21 of 23 10/26/2017, 7:12 PM
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. Â§ 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. Â§ 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
22 of 23 10/26/2017, 7:12 PM
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. Â§ 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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Junod Alternate Perspective - Society for Science-Based Medicine Wiki http://sfsbm.org/wiki2/index.php?

From Society for Science-Based Medicine Wiki

Suzanne White Junod, Ph.D.

Originally founded by German physician Samuel Hahnemann (1755-1843), homeopathy as a system of

III. The Homeopathic Pharmacopoeia of the United States

IV. Royal S. Copeland: Homeopathic Reformer

Copeland's explanation of homeopathy as a complementary medical discipline, while downplaying

V. Congress, Homeopathy, and the HPUS

VI. Copeland: Senator and Sponsor of the FDCA

VII. Copeland and the "Textbook Provision"

VIII. The HPUS under the FDCA

IX. Exclusion of Homeopathic Products from OTC Review

practice of homeopathy [146].

X. The Resurgence of Homeopathy

About the Author

IN AMERICA 99 (Norman Gevitz ed. 1988).

This page was posted on September 7, 2003

Retrieved from "http://sfsbm.org/wiki2/index.php?title=Junod_Alternate_Perspective&oldid=3293"

This page was last modified on 14 February 2014, at 15:18.

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