Scientology and the FDA: A Look Back, A Modern Analysis, And A ...

This paper is submitted in satisfaction of the
course requirement for Food and Drug Law (Winter 2003) and Harvard
Law School’s third year written work requirement.
ABSTRACT
Clashes between the government’s power to
regulate activity and religious adherents’ free exercise
right to practice their religion are frequent. However, for some
federal agencies, such as the Food and Drug Administration (FDA),
conflicts with religion are not commonplace and, when they do
occur, are arduous and complicated. This paper seeks to explore the
historical legal battle between the FDA and the Church of
Scientology (Scientology), an off-beat religious movement that
employs a device known as an E-meter in its activities. Scientology
alleges that the E-meter has therapeutic and curative properties.
The paper examines the conflict from three perspectives. First, it
provides a narrative account of the conflict between Scientology
and the FDA as well as an analysis of three significant legal cases
that arose during the conflict. Second, it examines how both
constitutional law and the Federal, Food, Drug and Cosmetic Act
(FDCA) have evolved since the clash between the FDA and Scientology
and how these changes in the law would alter the judicial analysis
if the Scientology cases were tried in the courts today. Finally,
this paper suggests an amendment to the FDCA that, if adopted and
applied to a religious device similar to that of the E-meter, would
satisfy the FDA’s asserted interest in regulating harmless
religious devices, would not significantly interfere with the free
exercise of religion, and would avoid the exorbitant expenditure of
time, money, and resources by the FDA.
Introduction
Like many groups arising outside of the
Judeo-Christian mainstream, the Church of Scientology (Scientology)
has faced a significant amount of prejudice while trying to
establish itself as a bona fide religion in the eyes of the
public and under the laws of the United States. It has been
ridiculed as a cult in the popular media and its beliefs have been
labeled as quackery by the courts.[1] Far more difficult for Scientology to contend
with than the personal insults and taunting, have been the legal
assaults waged against it by federal government agencies, including
the Food and Drug Administration (FDA). These assaults have
questioned Scientology’s religious status and its right to
claim religious protections from federal regulation under the First
Amendment to the U.S. Constitution.[2]
In the late 1950s, soon after it was founded,
Scientology became the subject of an investigation by the FDA and,
eventually, a series of lawsuits brought against it by the agency.
The FDA’s investigation and subsequent proceedings against
Scientology were focused on the organization’s use of a
harmless contraption known as a Hubbard Electrometer (E-meter)
during its religious activities and its claims that use of the
E-meter can alleviate physical illnesses. The FDA argued that under
the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA)
the E-meter was a misbranded and mislabeled medical device that
also lacked adequate directions for its intended uses.[3] With statutory jurisdiction, the FDA, with the
assistance of other federal agencies, sought to end the use of
E-meters in the United States by seizing the devices and seeking
their condemnation and destruction in the courts.
Unable to engage in their religious activities
without access to E-meters, Scientologists charged the FDA with
violating their right to practice religion freely under the Free
Exercise Clause of the First Amendment.[4] Specifically, the Scientologists argued that the
FDA’s application of the FDCA to the E-meters was prohibiting
their ability to engage in activities central to the practice of
Scientology. This clash between a federal regulatory statute and
the free exercise of religious activity generated a significant
constitutional dilemma and a substantial discourse in the
courts.
This paper seeks to accomplish three overlapping
goals while exploring Scientology’s contentious relationship
with the FDA. First, it provides a narrative account of the battle
between Scientology and the FDA as well as an analysis of three
significant legal cases that arose during the conflict (Parts I and
II). Second, it examines how both constitutional law and the FDCA
have evolved since the clash between the FDA and Scientology and
how these changes in the law would alter the judicial analysis if
the Scientology cases were tried in the courts today (Part III).
Finally, this paper suggests an amendment to the FDCA that, if
adopted and applied to a religious device similar to that of the
E-meter, would satisfy the FDA’s asserted interest in
regulating harmless religious devices, would not significantly
interfere with the free exercise of religion, and would avoid the
exorbitant expenditure of time, money, and resources by the FDA
(Part IV).
I. Scientology—A History
In May 1950, an article entitled “Dianetics:
A New Science of the Mind” appeared in Astounding Science
Fiction , a pulp magazine sold for twenty-five cents per
issue.[5] The author, Lafayette Ronald Hubbard (L. Ron
Hubbard) was an American war veteran and a prodigious producer of
science fiction stories. Remarkably, over the next few years,
Hubbard evolved the basic ideas presented in that article into the
scriptures of present-day Scientology. A knowledge of that
progression, along with the basic doctrines and practices of
Scientology, is useful for understanding the rise of conflict
between Scientology and the FDA.
A. L. Ron Hubbard
L. Ron Hubbard (Hubbard) was born in Tilden,
Nebraska on March 13, 1911.[6] He was the only child of Harry, a naval officer, and
Ledora Hubbard.[7] Like many children in military families, Hubbard
spent much of his youth moving between bases both within and
outside of the United States.[8] This constant moving and its consequent lack of
records has left substantial gaps in his biography. Not
surprisingly, Scientologists and critics disagree substantially on
the factual contents of those gaps.[9] Few details beyond the time and place of
Hubbard’s birth and death are undisputed.[10]
According to Scientology’s official
biographical sketch, Hubbard was a quick-witted, intelligent child
who befriended religious leaders, including Blackfoot Indian
medicine men and Buddhist priests, as he moved around the
world.[11] It is from these men that Hubbard first learned
about spirituality and human nature. As a teenager, Hubbard
received an extensive education in Freud’s theories of the
mind and dabbled in nuclear physics.[12] Seeking to live a life of adventure and
exploration, he eventually followed in his father’s footsteps
and joined the Navy.[13]
In 1945, Scientology’s account continues,
Hubbard was in the midst of a burgeoning military and writing
career when he ended up at Oak Knoll Naval Hospital crippled and
partially blind as a result of serious war injuries.[14] His recovery, according to his physicians, was
medically uncertain. During his year-long stay at Oak Knoll,
Hubbard became frustrated with the treatment he was receiving and
the pace of his medical progress. Eventually, he began treating
himself with a therapeutic technique he had created by integrating
his knowledge of Eastern religions, psychology, and nuclear
physics.[15] The technique focused on the ability of the mind
to effect the body.[16] Using this therapy, Hubbard found that he healed
faster, felt happier, and achieved physically and mentally in a
manner no one thought possible.[17]
After leaving Oak Knoll Naval Hospital, Hubbard
shared his new therapeutic technique and used it to save the lives
of patients in other physical and mental hospitals.[18] In 1950, he published several magazine articles
and books describing his “new science” and how it could
be used to improve the conditions of life.[19] He named this new science Dianetics.
B. Dianetics
Hubbard’s public introduction of Dianetics
was met with great success.[20]Dianetics: The Modern Science of Mental
Health , the fundamental text of Hubbard’s new movement
sold quickly; and, it has appeared on the New York Times bestseller
more than 150 times since.[21] The book describes Dianetics as a practical method
for approaching the human mind and harnessing its power to cure
mental anguish and physical illness. Hubbard offered this new
approach as an alternative to psychology and psychiatry.[22] The public, it seems, was eager to give it a
try.
As created by Hubbard, Dianetics is an explicitly
secular science.[23] Its fundamental theory rests on the idea that the
human mind consists of two subparts: the analytical and the
reactive minds.[24] The analytical mind houses a limitless factual
memory and serves as the center for information processing and
problem solving.[25] It is a source of endless power and the essence of
human perfection.[26] The reactive mind, on the other hand, serves as
the repository for emotions and emotional memories.[27] It records every painful experience that an
individual goes through during his lifetime, including those
suffered while in the womb.[28] These memories stored in the reactive mind are
referred to as “engrams.”
According to Hubbard, the presence of engrams
causes the analytical mind to work sub-optimally.[29] When an individual encounters a stimulus similar
to an element of an engram, the reactive mind sends physiological
signs to the individual indicating that he may be entering a
harmful situation.[30] This response is meant to prepare the individual
for an impending encounter with physical or mental pain and to
reduce the ultimate harm caused to the individual by the stimulus
that triggered the reaction. According to Hubbard, however, an
individual collects so many engrams over time that, unless he is
able to purge these memories, he will eventually spend all of his
mental and physical energy reacting to potentially harmful stimuli.
His analytical mind will have no energy with which to process
information. As a result, the individual will suffer from problems
such as weakness, confusion, psychosomatic illnesses, and
inadequate mental performance.[31] The goal of Dianetics is to eliminate engrams from
the reactive mind of an individual, thereby restoring the
analytical mind to its optimal level of performance and alleviating
many of the emotional, mental and physical conditions suffered by
the individual.[32]
The process of removing engrams is known as
“auditing.”[33] There are three tangible components involved in
every auditing session: the preclear, the auditor, and the E-meter.
The preclear is the individual seeking to remove engrams from his
reactive mind. During an auditing session, the preclear holds the
electrodes of a skin galvanometer known as an E-meter while he is
asked a series of prescribed questions by the trained
auditor.[34] These questions were specially designed by Hubbard
to identify engrams as efficiently as possible.[35] As the preclear answers the questions, the auditor
watches a needle-indicator on the E-meter for evidence that an
engram has been located. The presence of an engram is indicated by
rapid movements of the needle.[36] When an engram is encountered, the auditor uses a
technique similar to repressed memory therapy to help the preclear
recover and relive the traumatic experience that is captured in the
engram one or more times.[37] Re-experiencing the painful memory eventually
purges the engram from the reactive mind. Over time, as a preclear
eliminates accumulated engrams he progresses along a continuum
toward the state of “clear.”[38]
As noted earlier, Hubbard’s public
introduction of Dianetics was met with undisputed enthusiasm; but,
what happened in the aftermath of that introduction is a matter of
some debate. Critics of Scientology suggest that as Dianetics
gained in popularity, Hubbard lost control over the
movement’s monetary profits and grew hostile toward his
financial partners as well as the leaders of spin-off factions of
Dianetics.[39] According to this theory, to regain his
centralized power and his potential for financial gain, Hubbard
added some superficially religious elements to his secular theory
of Dianetics, renamed it Scientology, and presented it as a new
religion.[40] Not surprisingly, Scientology’s version of
the story is quite different. According to it, Hubbard had always
considered his theories to be spiritual and he simply revealed the
religious elements of his philosophy over time as he discovered
them himself.[41] With Hubbard’s death in 1986, it is unlikely
that anyone will ever know for certain what motivated Hubbard to
create Scientology.
C. Scientology
Hubbard founded Scientology soon after he
introduced Dianetics into the public domain, delivering his first
lectures on Scientology in 1952 and incorporating five Scientology
churches between 1953 and 1954.[42] Regardless of how or why Hubbard created
Scientology, its doctrines clearly grew out of his original secular
philosophy. The basic tenets of Scientology consist of the theory
and practice of Dianetics; however, Scientology integrates elements
of spirituality, cosmology, and religious ritual into its
doctrine.[43]
The spiritual element of Scientology centers on the
belief that every human body is a temporary holding space for an
immortal spirit known as a “thetan.”[44] Over the billions of years that the world has
existed, each thetan has occupied innumerable physical
bodies.[45] The actions and creations of individuals on Earth
are, and always have been, controlled by thetans.[46] The thetan is the mind of the individual; it
houses both the analytical and reactive minds. According to
Hubbard, the thetans currently inhabiting Earth were placed here 75
million years ago by a prince named Xenu.[47] At that time, Xenu ruled a cluster of overcrowded
planets known as the Galactic Federation and was desperate to
reduce their population.[48] As a permanent solution, Xenu banished a large
group of thetans to Earth, a planet that lay outside the Galactic
Foundation.[49] He implanted images of what life should be like on
Earth into the minds of the banished thetans and left them to
create a new civilization.[50]
Like Dianetics, the individual goal of Scientology
is to erase engrams through auditing. However, this process is much
longer and more intense in Scientology because each Scientologist
must recover and erase engrams created during his own lifetime as
well as those collected by the thetan inhabiting his body over the
course of thousands of lifetimes.[51] This arduous process is said to be worthwhile
because of its effects on the individual and on society.
Scientology guarantees that a preclear will begin thinking more
clearly, quickly, and logically as he undergoes auditing and
progresses towards the state of clear.[52] In addition, participation in auditing will
allegedly increase a person’s physical health and heal him of
any psychosomatic illnesses.[53] On a societal level, if every person on Earth
becomes clear and allows his analytical mind to work optimally,
Scientology assures that the world will be free of problems such as
crime, insanity, and war.[54]
Under Scientology’s fundamental
“doctrine of exchange,” an individual must pay for any
tangible or intangible thing of value that he receives, including
auditing and classes provided by Scientology churches.[55] To ease the application of this doctrine,
Scientology has established a fixed fee schedule for auditing and
other services it provides to members.[56] The prices on the schedule, which is not widely
available to the public, vary with the length and the level of
sophistication required to provide the service.[57] Auditing sessions are sometimes priced
individually, but discounts are offered for sessions purchased in
bulk. The most recent figures available are from the 1972 fee
schedule. At that time, the shortest package of auditing sessions
available bought twelve and one-half hours of auditing for $625,
the longest package bought 100 hours of auditing for
$4250.[58] The revenue collected through the provision of
auditing and other services comprises the bulk of
Scientology’s finances.[59]
D. The E-Meter
There are six elements involved in every
Scientology auditing session: “the preclear, the auditor, the
auditing process, communication, the Auditor’s Code and the
E-Meter.”[60] The E-meter is a simple skin galvanometer similar
to those used in lie detector tests.[61] It consists of two hand-held metal electrodes, a
battery, and a needle-indicator. When the machine is turned on and
the electrodes are held, the battery releases a weak electrical
current, and the needle-indicator reflects fluctuations in the
electrical resistance of the skin.[62] Outside of Scientology, E-meters are considered
completely harmless and useless for the diagnosis or treatment of
disease.[63]
During auditing, the auditor asks the preclear a
sequence of designated questions and watches the E-meter’s
needle-indicator for evidence that the preclear is discussing a
subject that holds the “charge” of an engram.[64] Charge is indicated by a surge in electrical
resistance caused by the reactive mind’s movement of mental
mass and energy.[65] After an engram has been identified, the auditor
takes the preclear through a series of mental exercises designed to
purge the engram from the reactive mind. Success in erasing the
engram and deactivating the reactive mind is indicated by the
rhythmic sweeping of the needle-indicator back and forth across its
dial.[66]
In keeping with its fundamental doctrine of
exchange, Scientology requires that trained auditors purchase their
E-meters from a Distribution Center. In 1968, E-meters were
available for $125; it can be assumed that, like the price of
auditing, the cost of E-meters has skyrocketed over the last
thirty-five years.[67]
E. Scientology’s Medical Claims
When L. Ron Hubbard set out the benefits that can
be derived from auditing, he did not limit himself to the
psychological and spiritual realms. He also made fantastic claims
about the ability of auditing to cure disease and improve physical
health. Among the texts authored by Hubbard and now considered the
doctrine of Scientology are claims that auditing can relieve
“arthritis, dermatitis, asthma, some coronary difficulties,
eye trouble, bursitis, ulcers, and sinusitis,”[68] “speed recovery and healing after operations
and accidents,”[69] end chronic illness,[70] and improve vision, hearing, colorblindness, and
balance.[71]
Almost since its founding, Scientology has fought
the notion that its doctrine makes direct medical claims. It states
prominently on its official website that it has a “firm
policy of not diagnosing or treating the sick.”[72] Rather, it argues, the assertions in its
literature are similar to those made by other religions regarding
the power of prayer to heal. The Church advises members to seek out
the help of a physician for any bacterial or trauma-related
illness.[73] Then, “once under medical treatment, a
Scientologist [can address] his illness or injury with auditing to
handle any spiritual trauma or other factors connected with the
physical condition which may have predisposed him to illness or
injury.”[74] In essence, Scientology posits that the presence
of engrams in the reactive mind both saps energy away from the
body’s immune system and causes the body to overreact to
everyday stimuli. The result is psychosomatic illness, illness
caused by the mind rather than by bacteria or trauma.[75] Therefore, by clearing the engrams out of the
reactive mind, psychosomatic illness can be mitigated or avoided
altogether.
Notwithstanding its disclaimers, Scientology
disseminates anecdotal testimony to the public that strongly
implies that auditing has the potential to heal, regardless of the
cause of illness. For example, testimony from one Scientologist
states:
My success ranks with biblical references to the
blind seeing, the lame walking and people being raised from the
dead! What the top medical authorities in the fields of internal
medicine, orthopedics, radiology and neurology could not handle in
three years, my auditor with L. Ron Hubbard’s technology
handled in one afternoon! I can move my previously debilitated left
arm with ease and comfort now. This morning I could not raise it
from my side without terrible pain! The spiritual cause of the
problem is resolved and the problem no longer exists.[76]
Ambiguous statements like this testimony, that
claim miraculous physical results from auditing and mention
spiritual healing only in passing, are at the root of the
FDA’s efforts to regulate the practice of auditing through
the E-meter. As described, Scientology does not assert that the
E-meter can directly cure or mitigate disease; rather, the E-meter
plays a vital role in the allegedly illness-alleviating process of
auditing by identifying the presence and location of the cause of
psychosomatic illnesses. Other systems work to actually accomplish
the discharge of illness-causing agents.
II. A Look Back—The Legal Battle Between
Scientology and the FDA
Not long after Hubbard founded Scientology, the FDA
became concerned with the medical claims made in
Scientology’s literature regarding the process of auditing
and the use of E-meters.[77] With these claims, the FDA believed Scientology
was representing the useless E-meter to its members and to the
public as a device capable of physically effecting the body. To
confirm this belief and to better understand the extent of the
medical claims made by Scientology, the FDA installed Inspector
Taylor Quinn as an undercover agent within the Founding Church of
Scientology of Washington, D.C. (Founding Church) in 1958.[78] Quinn posed as an individual interested in
Scientology and, using an alias, participated in classes and
engaged in auditing sessions at the Founding Church.[79] Quinn reported his observations back to the FDA
and transferred materials that he collected and purchased at the
Founding Church’s Distribution Center to the agency.
After several years of investigation and
evidence-gathering by Quinn and other agents, the FDA felt that its
suspicions had been adequately confirmed: Scientology, in general,
and the Founding Church, specifically, were misrepresenting the
E-meter as a medical device capable of detecting and treating
disease. Armed with the results of its lengthy investigation, the
FDA chose to pursue action against the Founding Church for
violations relating to the E-meter. On January 4, 1963 a group of
United States Marshals, FDA agents, and Washington, D.C. police
officers raided the Founding Church.[80] In their sweep through the church buildings, the
law enforcement agents seized more than 100 E-meters and over 200
separate pieces of literature containing approximately 20,000 pages
of text.[81] In conjunction with this raid, the FDA charged the
Founding Church with multiple violations of the FDCA and sought the
condemnation and destruction of the E-meters and their associated
literature.
Two cases with significant consequences for the
practice of Scientology arose directly out of this FDA raid:
Founding Church of Scientology of Washington, D.C. v. United
States[82] and United States v. Article or Device
(Hubbard Electrometer ).[83] Following on the heels of these two cases, but
arising from a separate set of charges by the FDA, Church of
Scientology of California v. Richardson also has significant
implications for the ability of Scientologists to engage in
auditing.[84]
A. Founding Church of Scientology of Washington,
D.C. v. United States[85]
In its case against the Founding Church, the FDA
utilized the evidence seized during its raid to allege two
violations of the FDCA. According to the FDA, the E-meters and
their accompanying literature were subject to condemnation and
destruction under Section 334(a) of the FDCA because together they
constituted devices that, under Section 352 of the FDCA, were 1)
accompanied by false and misleading labeling and 2) lacking
adequate directions for use.[86] At trial, the jury found for the FDA and a decree
of condemnation and destruction was entered by the District
Court.[87] The Founding Church immediately appealed the
judgment and the decree on three separate grounds. It asserted: 1)
that the FDA’s seizure of the E-meters and the literature
violated its Fourth Amendment rights, 2) that the FDA seizure and
proceedings interfered with its free exercise of religion, and 3)
that there was not sufficient evidence to sustain the
verdict.[88] For the purposes of this discussion, only the
Founding Church’s free exercise claim will be
examined.[89]
The Court of Appeals for the D.C. Circuit (Court of
Appeals) utilized a two-step approach to determine whether the
application of the FDCA’s mislabeling provision to the seized
E-meters and their accompanying literature violated the Founding
Church’s constitutional right of free exercise. The Court of
Appeals first reviewed the Supreme Court’s jurisprudence
regarding the Free Exercise Clause and examined whether the
mislabeling provisions of the FDCA had been applied to the E-meters
in compliance with these Supreme Court rulings. It then considered
whether Scientology is a religion warranting protection under the
Free Exercise Clause.
The Court of Appeals’ holding in Founding
Church did not reach the ultimate constitutional question
regarding the application of the mislabeling provisions of the FDCA
to the E-meter. Rather, the Court of Appeals held that, under the
Free Exercise Clause, literature setting forth religious doctrine
“cannot be considered ‘labeling’ of...an
instrument for purposes of the ‘false or misleading
labeling’ provisions of the [FDCA].”[90] With this holding, the Court of Appeals reversed
the judgment of the trial court and remanded the case, ordering the
District Court for the District of Columbia (District Court) to
determine whether any of the literature submitted as evidence by
the FDA was non-doctrinal and could be considered labeling for the
purposes of the FDCA.[91]
1. The Free Exercise Clause
At the time the Court of Appeals decided
Founding Church , the Supreme Court was employing a
compelling interest test to analyze free exercise claims.[92] Under this test, described to a greater extent in
Part III, a religious practice had to endanger a paramount
government interest or be a grave abuse of another’s
constitutional rights in order for government regulation of that
practice to be justified.[93] For the holding in this particular case, however,
the Supreme Court’s decision in United States v.
Ballard was most consequential.[94]Ballard held that the Free Exercise Clause
prohibits “regulation of religious action which involves
testing in court the truth or falsity of religious
belief.”[95] After reviewing the compelling interest test and
the Ballard decision, but before looking to the facts of
Founding Church , the Court of Appeals expressed serious
concern about the constitutionality of condemning E-meters and
their accompanying literature.[96]
Turning to the application of the FDCA’s
mislabeling provision to the E-meters, the Court of Appeals noted
that, in order for the E-meters to be mislabeled their accompanying
literature had to: 1) constitute labeling of the E-meters and 2)
set forth false medical claims.[97] The literature seized by the FDA was sold in the
Distribution Center, a bookstore in the Founding Church’s
basement that adjoined the area where auditing sessions were
conducted.[98] Although none of the literature was attached to or
sold as part of an E-meter, the lack of physical proximity did not
exempt the literature from being considered labeling under the
FDCA.[99] The Supreme Court decision in Kordel v. United
States established that written material need not be physically
attached to an object in order to constitute labeling.[100] It must simply be “designed for use in
the distribution and sale of the device and the two must be parts
of an integrated distribution program.”[101] Under this broad definition, the Court of
Appeals recognized that some, if not all, of the seized literature
might be considered labeling. However, if any of this literature
developed the doctrine of Scientology and if Scientology merited
religious status under the First Amendment, then a finding that the
literature set forth false medical claims would violate the Supreme
Court’s holding in Ballard . The Court of Appeals
concluded that religious doctrine can not be considered labeling
under the FDCA and, as a result, contingent on Scientology’s
religious status, much of the literature offered by the FDA as
evidence against the Founding Church might not constitute labeling
of the E-meters.
2. Scientology’s Religious Status
Any protection offered to Scientology under the
First Amendment depends on its ability to prove itself a valid
religion, rather than a secular organization clothed in religious
ornaments. Without this religious status, Scientology’s free
exercise claims would be groundless. Looking to the evidence
offered, the Court of Appeals held that the Founding Church had
established a prima facie case that Scientology is a bona
fide religion.[102]
To some extent, the Court of Appeals based its
decision on the Founding Church’s incorporation as a
religious institution and the characteristics that Scientology
shares with recognized religions. For example, Scientology has
ministers who perform marriages and burials and “its
fundamental writings contain a general account of man and his
nature.”[103] However, the real deciding factor for the
Court of Appeals was the government’s failure to rebut the
Founding Church’s evidence of Scientology’s religious
nature.[104] Acknowledging the substantial influence of
this oversight to its ultimate decision, the Court of Appeals noted
that it had not held that Scientology is a religion for all legal
purposes and that the government retained the opportunity to prove,
in another case, that Scientology was not a religion.[105] The government could disprove
Scientology’s claims by showing either that its beliefs are
not held in good faith or that the organization was “erected
for the sole purpose of cloaking a secular enterprise with the
legal protections of religion.”[106]
On remand from Founding Church , the
District Court took on the task of determining whether any of the
literature accompanying the E-meters could be considered labeling
and, if so, how the FDCA could be applied to the E-meters and their
labeling in a manner consistent with the Supreme Court’s free
exercise jurisprudence.[108] In an opinion written with obvious contempt
for Scientology, the District Court held: 1) that most of the
literature offered as evidence by the FDA was non-doctrinal and
could be considered labeling, 2) that all secular use of E-meters
must cease under the FDCA, and 3) that religious use of E-meters
must be allowed to continue, but only if all of the E-meters used
in the religious context bear specified disclaimers informing the
user that the E-meter has no medical or scientific
purpose.[109]
To reach its ultimate holdings, the District Court
first found that the E-meter is a device within the meaning of the
FDCA.[110] The E-meter is essential to the process of
auditing, which is advertised by Scientology as a method to remove
engrams from the reactive mind and to cure the conditions,
including physical ailments, caused by engrams.[111] As an apparatus that is part of a process
“used and intended to be used in the cure, mitigation, or
treatment, of disease,” the E-meter qualifies as a
device.[112] The District Court also held that the
harmless nature of the E-meter does not exempt it from the
FDCA.[113]
The District Court then sought to characterize the
literature seized by the FDA from the Founding Church.[114] As held by the Court of Appeals, any texts
setting forth religious doctrine could not be considered
labeling.[115] To be considered doctrine, the writing had to
be held out as making only “religious, as opposed to medical,
scientific, or otherwise secular claims.”[116] Upon examination, the District Court found
that “the bulk of the material is replete with false medical
and scientific claims devoid of any religious overlay or
reference.”[117] As such, the material did not qualify as
doctrine. With no discussion, the District Court also found that
the literature “‘accompanied’ the device within
the meaning of the [FDCA].”[118] The non-doctrinal literature was labeling
that made false medical claims regarding the E-meters.[119]
Turning to the available remedies for mislabeling
under the FDCA, the District Court dealt with secular and religious
use of E-meters separately. At the time of Hubbard
Electrometer , secular use of E-meters was abundant because of
the popularity of Dianetics and the aggressive advertising by
Scientology regarding the benefits of auditing. When the FDA
brought suit against the Founding Church, as many as one-third of
the E-meters in the United States “were being used by members
of the public without any religious control or
supervision.”[120] Without any special protection from the First
Amendment, secular use of the E-meters was vulnerable to the full
remedial effect of the FDCA for mislabeling of a medical device.
The District Court condemned all non-religious use of the E-meter
and its labeling.[121]
The application of the FDCA’s remedies to
religious use of the E-meter and its labeling was complicated by
the protection offered to religions from government regulation
under the Free Exercise Clause. Under the prevailing free exercise
analysis, the District Court could apply the FDCA to the use of
E-meters in only the narrowest manner possible to achieve the
legitimate non-religious end of the statute.[122] This would permit Scientologists freedom to
act on their beliefs in the power of auditing, while also allowing
the government to serve its role as society’s protector. The
government’s legitimate end in enforcing the mislabeling
provisions of the FDCA is to protect “the public against
misrepresentation.”[123]
Balancing the government’s goal and the free
exercise rights of Scientology, the District Court formulated a
solution. It allowed E-meters to be used only for the purposes of
bona fide religious counseling and only if their use
complied with the following conditions: (1) Every E-meter had to
bear a “prominent, clearly visible notice warning...that the
device has been condemned by a United States District Court for
misrepresentation and misbranding under the Food and Drug laws,
that use is permitted only as part of religious activity, and that
the E-meter is not medically or scientifically capable of improving
the health or bodily functions of anyone”; (2) Every user,
purchaser, distributee, of E-meters had to acknowledge on paper
that he had read the warning, understood it, and would preserve it;
(3) All literature that qualified as labeling and referred to the
process of auditing or to E-meters had to contain a notice similar
to that required to be located on the E-meter; (4) Every person
undergoing the auditing process had to sign a written contract
including a similar written notice.[124]
Two years after Hubbard Electrometer was
decided, the Court of Appeals reconsidered the requirements for
religious use of E-meters.[125] The Court of Appeals concluded that, although
the District Court was correct in its substantive decisions in
Hubbard Electrometer , the assigned requirements were not
the least restrictive means necessary to meet the
government’s legitimate end.[126] According to the Court of Appeals, the
District Court’s decision constituted an excessive
entanglement of the government with religion.[127] In restructuring the requirements, the Court
of Appeals upheld the necessity for disclaimers on E-meters and on
their accompanying literature, but eliminated the need for
individuals using, purchasing, or distributing E-meters to
acknowledge their receipt of the disclaimers in writing.[128] The Court of Appeals also made slight
alterations to the required text of the disclaimers.
Under the Court of Appeals’ decision, which
remains in force today, every E-meter must bear on its front panel
a warning that states, “The E-meter is not medically or
scientifically useful for the diagnosis, treatment, or prevention
of any disease. It is not medically or scientifically capable of
improving the health or bodily functions of anyone.”[129] In addition, the Court of Appeals demanded
that all literature that “directly or indirectly refers to
the E-meter or to Dianetics and/or Scientology and/or auditing or
processing” bear a label on its front cover or title page
stating:
Warning
The device known as a Hubbard Electrometer, or
E-meter, used in auditing, a process of Scientology and Dianetics,
is not medically or scientifically useful for the diagnosis,
treatment, or prevention of any disease. It is not medically or
scientifically capable of improving the health or bodily functions
of anyone.[130]
These reformulated disclaimers removed the District
Court’s references to the judicial condemnation of
E-meters.[131] That the Court of Appeals put forth the
effort to make this slight change to the text indicates a belief
that the mention of government activities in the disclaimers placed
a greater burden on the practice of Scientology than was necessary
to protect the public from misrepresentation. By removing these
references, the Court of Appeals understood its disclaimer
requirements to be in compliance with the Free Exercise Clause.
For the purposes of discussion in this paper, the
Court of Appeals’ revised disclaimers are referred to as the
Hubbard Electrometer disclaimer requirements.[132]
Neither Founding Church nor Hubbard
Electrometer addressed the FDA’s claim that the seized
E-meters lacked adequate directions for use.[134] However, in the same year that Hubbard
Electrometer was decided, the Ninth Circuit Court of Appeals
(Ninth Circuit) tackled the issue of adequate directions for
E-meters in Church of Scientology of California v.
Richardson .[135]Richardson arose from the FDA’s
seizure of a shipment of E-meters that were being imported into the
United States from Britain.[136] The FDA refused entrance to the E-meters to
the United States because, it claimed, they were medical devices
lacking adequate directions for use in violation of Section
352(f)(1) of the FDCA.[137] The Church of Scientology of California filed
suit against the FDA to prevent the forced return of the E-meters
to Britain.
Under the FDCA, a device is misbranded if its
labeling does not bear adequate directions for its intended
uses.[138] In Richardson , the FDA offered much
of the same Scientology literature as evidence of the intended uses
of the E-meter as was offered as labeling in Founding Church
and Hubbard Electrometer . However, in Richardson ,
all of the medical and scientific claims contained in the
literature were assumed to be true.[139] Therefore, the E-meters could not be properly
labeled unless they were accompanied by directions for using them
to cure arthritis, dermatitis and asthma, among other illnesses.
Scientology had conceded in earlier cases that the E-meter has no
medical or scientific value, so the Church of Scientology of
California could not legally or in good faith place directions on
the machine for medical use.[140] At the same time, directions for using an
E-meter to spiritually heal physical ailments would not satisfy the
requirements of the FDCA. Therefore, within this confluence of the
laws, E-meters could never bear adequate directions for their
intended uses. As a result, the Ninth Circuit affirmed the
FDA’s seizure and refusal of entrance to the E-meters.
When deciding Richardson , the Ninth Circuit
summarily dismissed the Church of Scientology of California’s
argument that the application of the misbranding provisions of the
FDCA violated its right to free exercise under the First Amendment.
To explain its dismissal, the Ninth Circuit did not apply the
applicable Supreme Court analysis of free exercise claims, but
rather stated, “the exercise of religious freedom does
not include the freedom to violate the Federal Food, Drug,
and Cosmetic Act.”[141] As will be discussed further in Part III of
this paper, the abrupt dismissal of Scientology’s free
exercise claims by the Ninth Circuit was contrary to the free
exercise jurisprudence applicable when Richardson was
decided. In fact, if the proper analysis had been followed, the
holding in Richardson would likely have been very different.
The E-meters would not have been prohibited from entering the
United States for lack of adequate directions for use.
While considering the impact of the holding in
Richardson , it is interesting to note that although the
seized E-meters carried the disclaimers mandated by the District
Court in Hubbard Electrometer , the Ninth Circuit ruled that
the disclaimers could not fulfill the statutory requirement for
adequate directions.[142] Under the FDCA, medical devices are required
to bear labeling including directions for use. Therefore, combined
with the ruling in Hubbard Electrometer , the E-meters were
required to bear both disclaimers and directions. Following this
logic, it appears that the Ninth Circuit’s ruling demands
that an individual seeking to import E-meters to the United States
for use in a religious context must place on each device (1) a
disclaimer explaining that it has no medical or scientific
function, and (2) adequate directions for using the E-meter to
achieve its intended medical or scientific use. This result is,
quite clearly, absurd, illogical, and unfair. The Ninth
Circuit’s ruling leaves importers of E-meters no legal path
for acquiring the devices from an international source and thereby
unnecessarily reduces the ability of Scientologists to engage in
auditing. A potential statutory solution for this problem is
presented in Part IV.
III. A Modern Analysis—Regulation of
Scientology and the E-Meter
As indicated by Founding Church , Hubbard
Electrometer , and Richardson , the FDA’s ability
to regulate use of the E-meter and its accompanying literature
depends on three elements: 1) Scientology’s status as a valid
religion meriting protection from government regulation under the
First Amendment, 2) the government’s power to regulate
religious activity under the Free Exercise Clause, and 3) the
FDCA’s provisions and their application to E-meters and their
accompanying literature.
As with all legal concepts, the understanding of
these elements has evolved over time and continues to evolve as
courts confront new, complicated factual situations that require a
deeper consideration of the legal and constitutional issues
underlying rulings concerning religion and government regulation of
its practice. These changes in judicial analysis could have a
significant impact on Scientology and its use of the E-meter if
cases similar to Founding Church , Hubbard
Electrometer , or Richardson were to arise again.
Part III of this paper explores recent changes in
both the case law and the statutory texts concerning the
judicially-created definition of religion, the ability of the
government to regulate religious activity under the Free Exercise
clause, and the application of the FDCA to the E-meter and its
accompanying literature. The effect of this legal evolution on
Scientology and the FDA’s regulation of the E-meter is also
considered.
A. Scientology’s Status as a Religion for
the Purposes of the First Amendment
Scientology’s status as a religion is
essential to any protection it seeks from government regulation of
the E-meter under the FDCA. Without this status,
Scientology’s activities can be regulated to the same extent
as secular activities. For example, in both Founding Church
and Hubbard Electrometer , Scientology was granted religious
status under the First Amendment.[143] Without this status, the holdings in those
two cases would have been significantly different. In Founding
Church , all of the literature seized by the FDA would have
constituted labeling and, in Hubbard Electrometer use of the
E-meter in any context, secular or religious, would have been
condemned. In neither of those cases, however, did the court hold
that Scientology was a religion for all legal purposes. Rather,
each court recognized Scientology as a religion for the purpose of
the case before it and, at the same time, explicitly preserved the
government’s opportunity to disprove Scientology’s
religious status in a future case.[144]
With its religious status so precariously held,
Scientology has a vested interest in the Supreme Court’s
definition of religion. This definition has changed significantly
over time and continues to evolve today. Here, Scientology’s
status as a religion for the purposes of the First Amendment is
examined through Supreme Court jurisprudence, recent case law
concerning Scientology, and the characteristics of Scientology
that, for some courts, bolster its religious claims.
1. The Supreme Court’s Evolving Definition
of Religion
With no constitutional explanation as a guidepost,
the Supreme Court has been charged with creating a definition of
religion that protects legitimate beliefs but, at the same time,
does not provide special status to secular beliefs cloaked in
religious veneer. It has yet to accomplish this task. Over time,
the Supreme Court’s concept of religion has changed
substantially. In the late eighteenth and nineteenth centuries, its
understanding of religion was focused primarily on a Christian
version of God or, at its most inclusive, the “relationship
between a person and some Supreme Being.”[145] Few religions outside of mainstream
Protestantism were granted constitutional protection under this
definition.[146]
As American society has become more diverse, the
Supreme Court has broadened its definition of religion to encompass
a wider variety of legitimate beliefs. The landmark decision of
United States v. Ballard forced the initial shift in the
judicial approach to religion.[147] In Ballard , the Supreme Court held
that the judiciary may not inquire, or be forced by statute to
inquire, into the truth or falsity of an individual’s
religious beliefs, no matter how bizarre those beliefs may
seem.[148] This decision, therefore, attempted to do
away with judicial scrutiny of the content of religious beliefs to
determine their legitimacy.
After Ballard , the Supreme Court shifted to
a more functional concept of religion that focused on the role
played by the claimed religious doctrine in the lives of its
adherents.[149] Emphasis was no longer placed on the presence
or absence of a deity. Rather, the Supreme Court recognized as
religious all beliefs that are held in good-faith and “based
upon a power or being, or upon a faith, to which all else is
subordinate or upon which all else is ultimately
dependent.”[150]
While considering the alleged religious beliefs of
conscientious objectors during the Vietnam War, the Supreme Court
broadened its definition of religion further to include
“sincere and meaningful belief which occupies in the life of
its possessor a place parallel to that filled by the God of those
admittedly qualifying for the exemption.”[151] This functional approach is the current
analysis used by the Supreme Court. With its reduced emphasis on
content, this approach has allowed the Supreme Court to grant First
Amendment protection to many religions that fall outside of the
Judeo-Christian mainstream including Buddhism, Taoism, Ethical
Culture, Secular Humanism, and other non-theistic
organizations.[152]
However, the functional approach has neither
completely eroded the distinction between secular and religious
pursuits nor totally eliminated judicial scrutiny of the content of
alleged religious beliefs. The Supreme Court has prohibited the
application of the religious label to secular belief systems, even
those that occupy a major role in an individual’s life. For
example, in Wisconsin v. Yoder , the Supreme Court drew a
distinction between the simple, isolated lifestyle of the Amish
based on “deep religious conviction, shared by an organized
group, and intimately related to daily living” and the
similar lifestyle of Henry Thoreau based on “a matter of
personal preference.”[153] Under the Supreme Court’s analysis, the
Amish lifestyle was protected by the First Amendment from
unreasonable infringement by the federal government, while
Thoreau’s lifestyle was not protected.[154] Although Thoreau’s lifestyle was
all-encompassing, it was not based on a set of religious beliefs
held in good-faith; rather, it was based on his own secular
ideals.[155] As such, it was not protected by the First
Amendment.
Looking at the Supreme Court’s evolving
definition of religion, two fundamental factors appear necessary,
but not entirely sufficient, for a belief system to qualify as
religious for the purposes of the First Amendment. First, although
a belief in God or another deity is not required, there must be a
moral belief component to the proffered religion.[156] Second, the system of beliefs must be central
to the believer’s identity and must give “meaning and
orientation to a person’s whole life.”[157] However, as Thoreau’s lifestyle
seemingly possessed both of these elements, additional less-defined
factors must also be required. Although not a Supreme Court
decision,Founding Church implies that if an alleged religion
shares some practices and characteristics with accepted mainstream
religions, such as the employment of ministers, a court may be
swayed to accept its religious status.
2. Case Law Concerning Scientology’s Status
as a Religion
In addition to the Supreme Court’s general
considerations, other courts have specifically contemplated the
religious status of Scientology. A brief examination of a few of
these decisions provides a more pointed indication of whether a
modern court would grant Scientology religious status. For example,
Scientology has faced lawsuits for fraud brought by former
adherents and their families. In fraud cases where the defendant
claims religious status, courts must determine whether the religion
is bona fide before considering any allegedly fraudulent
statements. If the court concludes that the religion is legitimate,
no fraud analysis can be performed because, under Ballard ,
religious doctrine can not be examined for truth or falsity.
Therefore, fraud cases against Scientology contain considerable
judicial reflection regarding Scientology’s religious
status.
Christofferson v. Church of Scientology of
Portland provides a representative example of the judicial
consideration of Scientology in the fraudulent claim
context.[158] In Christofferson , the Court of
Appeals of Oregon held that Scientology is a religion for the
purposes of the First Amendment.[159] In reaching its decision, the court noted
that a belief in God is not a necessary prerequisite to finding
that an organization is religious and that Scientology’s
recent origin should not factor into the First Amendment
decision.[160] The court also recognized that some of
Scientology’s theories appear to be more psychological than
religious, but concluded that it could not dissect
Scientology’s body of beliefs into pieces.[161] The religious character of a belief system
must be based on consideration of its doctrine as an integrated
whole.[162] In the end, the court concluded that
Scientology is a religion because it “is incorporated as
a...religious organization; it has ordained ministers and
characterizes itself as a church. It has a system of beliefs, or
creed, which encompasses beliefs which are religious in
character.”[163]
Scientology has also waged an uphill, and
ultimately successful, legal battle against the Internal Revenue
Service (IRS) for recognition as a tax-exempt religious
organization under the Internal Revenue Code (the Code). The IRS
granted Scientology tax exemption in 1957, but revoked that status
in 1967 after determining that Scientology was “engaged in
business for profit” and “operated in a manner whereby
a portion of its earnings inured to the benefit of a private
individual, [L. Ron Hubbard].”[164] As such, Scientology was not in compliance
with the requirements of Section 501(c)(3) of the Code and could
not qualify as tax exempt, regardless of its religious
purposes.[165] To qualify as a tax exempt organization under
Section 501(c)(3), an organization must show that it is organized
and operated exclusively for religious or charitable
purposes.[166] Not even the smallest portion of a tax exempt
religion’s income may inure to a private individual; the sole
beneficiary of the organization must be the public.[167] After the IRS revoked its tax exempt status,
Scientology filed a number of lawsuits against the IRS, hoping to
gain back its preferential treatment.[168] However, all of the courts upheld the
decision of the IRS, each finding that L. Ron Hubbard profited
handsomely from his single-handed control over Scientology and its
finances.[169]
The revocation of Scientology’s tax exempt
status does not control its recognition as a religion for the
purposes of the First Amendment. An organization can be founded for
religious purposes, but denied tax exemption under Section
501(c)(3) of the Code.[170] However, the revocation of
Scientology’s tax exempt status by the IRS and the subsequent
judicial support of this decision do generate serious doubt
regarding Hubbard’s good faith belief in the tenets of
Scientology and the beliefs of those who currently run and profit
from the organization. With the revenue from auditing and other
services flowing directly into his hands, it is reasonable to
wonder whether Hubbard simply founded Scientology as a ploy to make
money.[171]
In 1993, without explanation, the IRS ended its
longstanding legal battle with Scientology and re-granted its tax
exempt status.[172] Neither the IRS nor Scientology has ever
discussed the terms of the settlement that brought about this
change.[173] However, with a constant stream of lawsuits
filed against it by Scientology, it seems likely that the IRS
concluded that it was simply cheaper to grant Scientology tax
exemption than to continue defending its revocation in the courts.
To this day, Scientology enjoys tax exempt status under Section
501(c)(3) of the Code as an organization operated exclusively for
religious purposes.[174]
Despite the mysterious grant of its tax exempt
status, Scientology can now assert that it has passed the scrutiny
of the IRS as a religious organization. This implies that the IRS
has deemed the religious tenets of Scientology to be truly and
sincerely held and the practices and rituals associated with
Scientology to be legal and in harmony with defined public
policy.[175] Although this vote of confidence from the IRS
does not guarantee Scientology’s religious status under the
First Amendment, it would influence a court’s decision
significantly.
3. The Religious Characteristics of
Scientology
As indicated by the judicial commentary in
Founding Church and Christofferson , any
characteristics that Scientology shares with mainstream religions
will strengthen its legal argument for religious status. Some, but
not all of these characteristics, are doctrinal. Non-doctrinal
characteristics, such as the provision of marriage ceremonies and
weekly church services, are not described in Scientology’s
fundamental texts but evidence of them may be found in its public
advertisements.
Scientology’s official website could not be
more clear regarding its self-conception.[176] “Scientology is a religion,” it
states. “It holds in common many of the beliefs of other
religions and philosophies.”[177] To highlight this point, the website traces
Scientology’s perception of its own religious
heritage.[178] It provides a brief history of religion,
including major religious movements (for example, Judaism, Taoism,
and Christianity), philosophical icons (Socrates, Galileo, and
Darwin), and stages of religious “health” such as
tolerance, materialism, and totalitarianism.[179] The timeline concludes with Scientology,
which is portrayed as the amalgamation of all the religious
knowledge preceding its creation.[180]
In addition to the heritage it purportedly shares
with mainstream religions, Scientology’s website also
emphasizes the aspects of its doctrine that conform to the Supreme
Court’s current definition of religion. It discusses the
concept of morality that is woven into Scientology’s doctrine
(“Scientology believes that man advances to the degree he
preserves his spiritual integrity and values, and remains honest
and decent.”[181] ) and the centrality of Scientology to an
adherent’s life (“Scientology offers a practical
technology...that can be applied to actually improve conditions in
life. As one applies this technology to day-to-day concerns to
better himself and others, he finds he is now more able to continue
his journey to higher levels of spiritual awareness and
ability.”[182] ).
Finally, Scientology’s website is replete
with statements drawing parallels between its beliefs and
activities and those of mainstream religions. These statements tend
to reflect the objective elements referenced as indicators of
religious status in Founding Church . For example, an
explanation of the role of ministers on the website states:
Churches have always provided guidance and succor
to their parishioners in times of need. In fact, beyond strictly
spiritual concerns, churches traditionally have seen their mission
as easing temporal suffering, helping where help is required and
restoring dignity to men and women at pivotal points in their
lives. By longstanding tradition, Scientology ministers also have
acted to ease suffering and provide counsel and succor to those in
need, whether a member of their congregation or simply someone in
the community who may need help.[183]
Similarly, the website contains information on
Scientology activities, which are described as “the same
types of ceremonies and services that ministers and priests of
other religions perform,” including weddings, christenings,
and funerals.[184]
It is unclear whether the elements that Scientology
claims to share with established religions have always been part of
its practice or have been developed over time to correspond with
the evolving judicial definition of religion. However, regardless
of their origins, these shared characteristics are likely to
influence a court’s decision regarding Scientology’s
religious status.
4. Would Scientology Be Considered a Religion by a
Modern Court?
A modern court would almost certainly grant
Scientology full religious status for the purposes of the First
Amendment, even if the government put forth an argument against it.
Scientology’s doctrine does not include a belief in a
specific deity, but it does contain elements of a moral code of
conduct. It encourages adherents to undergo auditing so that they
may live a virtuous life focused on honesty and free of drug and
alcohol abuse, crime, and other immoral behaviors. It also provides
its members with a system of beliefs that are meant to play a role
in their lives on a daily basis. The desire to avoid the buildup of
new engrams provides Scientologists with an incentive to avoid
getting involved in or creating emotionally painful situations. As
such, the practice of Scientology gives meaning and orientation to
the lives of its members. Scientology has also been recognized as a
religion by a federal agency and by other courts and it shares a
variety of activities and practices with recognized religions.
Potentially even more influential for a court’s decision,
however, is the existence of more than 50,000 individuals who
actively participate in Scientology and claim it as their religious
faith.[185] It seems unlikely that a court would tell
these individuals that they are mistaken. Even if Scientology was
not a religion when it was founded by Hubbard, it would likely be
granted protection as a religion under the Free Exercise Clause by
a modern court.
B. The Free Exercise Clause
Assuming that Scientology is a religion for
constitutional purposes, it is protected by the Free Exercise
Clause of the First Amendment.[186] The extent of this protection, as determined
by the Supreme Court, establishes the level of restriction that may
be constitutionally placed on the religious use of E-meters and
their accompanying literature under the FDCA.
The Free Exercise Clause is intended to restrict
government involvement in religion and to promote religious life in
the United States.[187] Two elements are understood to make up free
exercise: the freedom to believe and the freedom to act on those
beliefs.[188] Under the Free Exercise Clause, the freedom
to believe in a religious organization and its form of worship is
absolute and cannot be restricted by law.[189] For example, the FDA could not
constitutionally force Scientologists to stop believing that
E-meters can help to cure physical ailments. The freedom to act, on
the other hand, is conditional.[190] In spite of the Free Exercise Clause, the
government retains its ability to reasonably regulate activities to
protect the public’s health, safety, morals and welfare, even
if that regulation infringes on religious practices.[191] Without this power, the government would lose
control of society as people claimed expansive religious exemptions
and became laws unto themselves.[192] How to strike the proper balance between an
individual’s freedom to act on religious beliefs and the
government’s police power is an issue that has caused, and
continues to cause, controversy in the Supreme Court and in
Congress.
Since the decisions in Founding Church ,
Hubbard Electrometer , and Richardson constitutional
analysis of free exercise claims by a valid religion has gone
through two major revisions. These changes could have a significant
impact on the FDA’s ability to regulate the E-meter and its
accompanying literature if the issue were to arise again in the
courts. Here, the development of free exercise analysis from the
time of Founding Church to the present is reviewed and the
potential application of the FDCA to the use of E-meters and their
accompanying literature under the different analyses is considered.
The application of the relevant free exercise analysis in
Hubbard Electrometer and Richardson is also examined
and critiqued.
1. Compelling Interest Test
For much of the twentieth century, the
government’s ability to regulate religious activities using
generally applicable laws was based on the importance of the
regulation to the welfare of society. This analysis is known as the
“compelling interest test.” Under this test, a rational
basis for the regulation of an activity is not sufficient to
warrant government infringement on religion.[193] Rather, a religious activity must pose grave
and immediate dangers to a legitimate government interest before
regulation may interfere with the activity.[194]
While it remained good law, the compelling interest
test was applied by courts in a consistent, methodical manner every
time the application of a regulation to a religious activity was
challenged under the Free Exercise Clause. First, the court would
determine if the law substantially interfered with important
activities of a valid religion.[195] This decision entailed an assessment of the
alleged religion’s status under the First Amendment, an
investigation of the importance of the regulated activity to the
asserted religion, and an evaluation of the burden placed on the
religious activity by the regulation. To qualify for protection
under the Free Exercise Clause, the burden of the regulation had to
be more than an inconvenience; it had to force the religious actor
to refrain from religiously motivated conduct or compel him to
engage in activities or to make statements that were contrary to
his religious beliefs.[196] Second, the court would consider whether the
government had a compelling interest in regulating the religious
activity.[197] If so, the court would then determine whether
exempting the religious activity from regulation would interfere
significantly with the government’s interest.[198] Finally, the court would consider whether any
means of accomplishing the government interest existed that were
less restrictive than enforcing the regulation on the religious
activity.[199]
a) The Supreme Court’s Application of the
Compelling Interest Test
The Supreme Court developed the compelling interest
test through a series of free exercise cases, but its decisions in
Sherbert v. Verner and Wisconsin v. Yoder are often
cited as containing the most comprehensive descriptions and
applications of the test.[200]
In Sherbert , the Supreme Court held that it
was unconstitutional for South Carolina to deny unemployment
benefits to a Seventh-Day Adventist who lost her job because she
refused to work on Saturday, her Sabbath, and who could not find
new work for the same reason.[201] Under the South Carolina Uncompensation Act
(the Act), an individual was ineligible for benefits if he
“failed, without good cause...to accept available suitable
work when offered him by the employment office or the
employer.”[202] South Carolina refused to recognize
Sherbert’s religious beliefs as a “good
cause.”[203]
Applying the compelling interest test in
Sherbert , the Supreme Court found that the Act burdened
Sherbert’s free exercise because it pressured her to go
against her religious beliefs and work on Saturdays.[204] After noting that “only the gravest
abuses, endangering paramount interests” can justify an
imposition on the performance of religious activities, the Supreme
Court held that there was no compelling government interest to
justify the Act’s infringement on Sherbert’s religious
freedoms.[205] It deemed unconvincing the government’s
asserted interests of avoiding the filing of fraudulent
unemployment claims by unscrupulous individuals feigning religious
objections to Saturday work, maintaining the value of South
Carolina’s unemployment compensation fund, and preventing
problems for employers seeking to hire workers for Saturday
shifts.[206] With no compelling government interest to
justify the state-imposed burden on Sherbert’s practice of
her religion, the Act was deemed unconstitutional as applied under
the Free Exercise Clause.
In Yoder , the Supreme Court applied the
compelling interest test to invalidate the enforcement of a
Wisconsin law mandating that children attend school until the age
of sixteen against members of the Amish and Mennonite
religions.[207] Upon investigation, the Supreme Court found
that a fundamental belief of the recognized Amish and Mennonite
religions is that an individual must remain “aloof from the
world” in order to maintain his purity.[208] In keeping with this belief, the Amish and
the Mennonites had developed a practice of withdrawing their
children from the public school system after they completed the
eighth grade.[209] Looking to its compelling interest test, the
Supreme Court determined that the Wisconsin law burdened a
fundamental religious belief, but it also served the compelling
government interest of educating children residing in the state in
order to produce hard working, highly productive adult
citizens.[210] Continuing with its analysis, the Supreme
Court held that exempting Amish and Mennonite children from the law
would not substantially interfere with the state’s ability to
achieve its compelling interest.[211] After the Amish and Mennonite children left
the public school system, they were educated at home in the
practical pursuits required for them to be functioning adults in
their secluded societies.[212] This home education sufficiently served the
government’s interest in education for the purposes of Amish
and Mennonite children.[213] Therefore, the Supreme Court held that the
Wisconsin law was unconstitutional, as applied to members of the
Amish and Mennonite religions.
Although Sherbert and Yoder are the
most frequently cited cases involving the compelling interest test,
the Supreme Court’s application of this test in a series of
cases concerning the government’s ability to regulate
polygamy provide a closer factual parallel to the application of
the FDCA to E-meters and their accompanying literature. When the
federal government outlawed the practice of polygamy, members of
the Church of Latter Day Saints (Mormons) asserted that, under the
Free Exercise Clause, they should be exempted from the law because,
at that time, the practice of polygamy was central to their
religious beliefs.[214] The Supreme Court recognized the Church of
Latter Day Saints as a valid religion and polygamy as one of its
fundamental practices.[215] However, it also found that the federal
government has a compelling interest in maintaining peace, good
order, and the morals of society and that the practice of polygamy
destroys the sanctity of marriage, disturbs the peace of families,
degrades women, and debases men.[216] Exempting Mormons from the law prohibiting
polygamy, the Supreme Court believed, would allow secondary effects
of the practice to leak into and poison society in general.
Therefore, according to the Supreme Court, there was no less
restrictive way for the government to avoid the immoral influence
of polygamy on society than to apply the anti-polygamy law to
Mormons.[217] The federal government was allowed to enforce
a full ban on polygamy, despite the significant burden on religious
behavior caused by this regulation.
b) Application of the Compelling Interest Test in
Hubbard Electrometer and Richardson
Founding Church , Hubbard
Electrometer , and Richardson were all decided while the
compelling interest test prevailed as the analysis applied under
the Free Exercise Clause when a government regulation allegedly
constrained the practice of an individual’s religion.
However, only the Hubbard Electrometer and Richardson
decisions required application of the test.[218]
In Hubbard Electrometer , the District Court
applied the compelling interest test, but in reverse. That is,
rather than determining whether the FDCA was correctly applied to
the seized E-meters, the District Court formulated an application
of the FDCA to the religious use of E-meters that would satisfy the
compelling interest test if challenged under the Free Exercise
Clause. As its first step in applying the test, the District Court
noted that it remained bound by the decision in Founding
Church that Scientology had established a prima facie
case for religious status.[219] It then found that auditing and the E-meter
play a central role in the practice of Scientology and deserve
protection from unjustified government encroachment.[220] Next, the District Court considered the
consequences of applying the FDCA to religious use of the E-meter
in the same manner as it was applied to secular use. It
concluded:
Serious interference indeed results if the Church
is entirely prohibited from using the E-meter by condemnation or if
the Court orders the Food and Drug Administration to oversee a
general rewriting of all the writings the Church purveys. Where
there is a belief in a scientific fraud there is nonetheless an
interference with the religion that entertains that belief if its
writings are censored or suppressed. Similarly, if a church uses a
machine harmless in itself to aid its ministers in communicating
with adherents, the destruction of that machine intrudes on
religion.[221]
After establishing that a substantial burden on
religious activity existed, the District Court took on the task of
designing the application of the FDCA that was the least
restrictive on the religious use of E-meters but that also achieved
the legitimate non-religious purpose of the FDCA.[222] The District Court identified the purpose of
the FDCA as applied to the E-meters as protecting “the public
against misrepresentation since the E-meter is harmless in
itself.”[223] Only the narrowest possible remedy to achieve
this goal would satisfy the compelling interest test. The District
Court’s solution was to allow religious use of E-meters to
continue, but to require that disclaimers be displayed on all
E-meters and their accompanying literature and that users and
purchasers of E-meters acknowledge their receipt of the information
provided in those disclaimers.[224] This, according to the District Court, was
the solution that left the FDA with the least amount of power to
interfere with Scientologists’ free exercise of their
religion.
As noted earlier, subsequent to the District
Court’s decision in Hubbard Electrometer , the Court
of Appeals did away with the requirement that users of the E-meter
acknowledge their receipt of the mandated E-meter warnings and
reformulated the text of the District Court’s disclaimers.
These modifications by the Court of Appeals represented that
court’s judgment that a slightly narrower remedy was
available to meet the government’s legitimate goal.
The District Court’s application of the
compelling interest test in Hubbard Electrometer , along
with the Court of Appeals’ revisions, was appropriate. Under
the application of the FDCA crafted by the District Court and the
Court of Appeals, Scientologists retained their ability to undergo
and conduct auditing sessions in search of spiritual clarity and
health, while individuals confronted with E-meters received the
valuable information that the devices are not medically or
scientifically useful. It could be argued that protecting the
public from the misrepresentation of a harmless device is not a
compelling justification for infringing on religious activities.
However, as identified by the Ninth Circuit in Richardson ,
providing valid information regarding the effective uses, or lack
thereof, of a medical device is important for the protection of
ignorant and gullible people who would otherwise rely on the device
rather than seeking out professional advice for physical ailments
the device is represented to relieve or prevent.[225] With Scientology’s emphasis on
advertising, the District Court, along with the Court of Appeals,
reasonably considered the misrepresentation of the harmless E-meter
to be a public health risk and the prevention of this risk to be a
compelling government interest.
Unlike the courts in Hubbard Electrometer ,
the Ninth Circuit fundamentally erred in its application of the
compelling interest test in Richardson . In that case, the
Ninth Circuit denied all of the non-Ballard related Free
Exercise claims of the Church of Scientology of
California.[226] To explain this denial, it stated only,
“the exercise of religious freedom does not include
the freedom to violate the Federal Food, Drug, and Cosmetic
Act.”[227] With this simple and uninformative statement,
the Ninth Circuit denied the application of the compelling interest
test to the facts of Richardson , despite the burden placed
on the practice of Scientology by the blocked importation of
E-meters under the FDCA.
The Ninth Circuit should have applied the
compelling interest test to the facts of Richardson in the
same manner as it was applied in Sherbert , Yoder ,
and Hubbard Electrometer . At the time Richardson was
decided, religions did not have the absolute right to violate
generally applicable statutes, but they did have the right, if an
activity central to their practice was burdened by a government
regulation, to be subjected to no more restriction than necessary
to fulfill the governmental purpose embodied in the statute.
Therefore, the Ninth Circuit was only partially correct when it
stated that “the exercise of religious freedom does
not include the freedom to violate the Federal Food, Drug,
and Cosmetic Act.”[228]
The Ninth Circuit should have begun its application
of the compelling interest test with the recognition that
Scientology is a valid religion for the purposes of the First
Amendment, that auditing with E-meters is a fundamental part of the
doctrines and practices of that religion, and that preventing the
importation of E-meters into the United States places a substantial
burden on the religious activities of Scientologists. Then, the
Ninth Circuit should have looked to the specific purpose of the
FDCA’s importation provisions as applied to the religious use
of E-meters. That purpose is the same as the stated purpose in
Hubbard Electrometer , “to protect the public against
misrepresentation since the E-meter is harmless in
itself.”[229]
Finally, the Ninth Circuit should have crafted a
remedy for the lack of adequate directions on the E-meters that
served the government’s purpose, but also restricted
Scientologists’ ability to engage in auditing to the minimum
degree possible. Refusing admission to the E-meters was not the
narrowest remedy available; neither was requiring that the E-meters
bear adequate directions in compliance with the FDCA. Composing
adequate directions for the use of a medical device that is
scientifically and medically useless is an impossible task.
Therefore, a judicial order demanding that imported E-meters bear
adequate directions for use is equivalent to banning importation.
The narrowest possible remedy available to the Ninth Circuit was a
reassertion of the disclaimers ordered by Hubbard
Electrometer . Labels restricting the use of the E-meter to
religious activity should have served as sufficient directions for
use. The E-meter is physically harmless and, therefore, more
specific directions for use were unnecessary.
In 1990, free exercise analysis changed drastically
when a sharply divided Supreme Court overturned Sherbert and
Yoder , eliminated the compelling interest test, and adopted
a government-friendly analysis for evaluating claims that a
government regulation was unconstitutionally interfering with
religious conduct. In Employment Division v. Smith , the
Supreme Court upheld the application of an Oregon law denying
unemployment benefits to employees discharged for work-related
misconduct to individuals fired because of their religious use of
peyote.[231] Justice Stevens, writing for the majority,
held that generally applicable laws that do not purposefully target
a particular religious activity, but incidentally effect it, are
constitutional, regardless of how severely the regulation restricts
the practice of religion.[232]
With its decision in Smith , the Supreme
Court eliminated the government’s responsibility to justify
any burdens placed on religious conduct by its neutral laws. In
essence, the decision tacitly advocated government infringement on
religious activities, as long as that infringement is cloaked in
neutral language. A rationale for this radical decision can be
imagined. Ordered society could suffer from a system in which an
individual’s responsibility to act in a lawful manner is
contingent on his religious beliefs. Such a system would allow each
individual to behave according to his own body of laws and would
require law enforcement agents to question suspects about their
religious beliefs before charging them with violations of
established law.
If a case similar to Hubbard Electrometer
was decided under the Smith analysis, its result would place
immense restrictions on the practice of Scientology. The FDCA is a
generally applicable law that does not target religion and only
secondarily impacts the religious activities of Scientology.
Therefore, the FDCA would be applied in full to religious use of
the E-meter, regardless of the burden placed on auditing by this
regulation. After Smith , religions no longer receive any
special treatment under generally applicable laws. As established
in Hubbard Electrometer , E-meters are mislabeled medical
devices; therefore, under the FDCA and Smith , E-meters used
for both secular and religious purposes would be condemned and
destroyed and auditing would effectively be prohibited.
If a case similar to Richardson was tried
under a Smith analysis, the resolution would be identical to
the holding of the Ninth Circuit. The FDCA’s importation
provisions would be applied to the E-meters in the same manner as
they would be applied to a secular medical device. Importation of
E-meters lacking adequate directions for use would be banned. As
discussed earlier, crafting adequate directions for use of E-meters
under the FDCA is impossible. Therefore, under a Smith
analysis, the importation of E-meters into the United States would
be, for all intents and purposes, banned. Any E-meters caught at
the borders would be seized and returned to their country of origin
or destroyed.
As illustrated, the application of the free
exercise analysis developed under Smith to the facts of
Hubbard Electrometer and Richardson restricts the
practice of Scientology far more than is needed to meet the
government’s purpose in enforcing the FDCA against harmless
religious devices. To take the drastic step of completely
eradicating E-meters and the practice of auditing is not necessary
to prevent gullible individuals from being duped into believing the
E-meter is medically effective. The effect of a Smith -based
free exercise analysis on the practice of Scientology is adverse to
the purposes of the Free Exercise Clause; allowing the FDA to get
rid of all E-meters not only involves the government in the
practice of religion, but also works against the promotion of
religious life in the United States.
It is not currently clear whether the compelling
interest test or the Smith analysis would apply to
Scientology’s free exercise claim if a case similar to
Hubbard Electrometer or Richardson was to arise in
the courts. Under the Religious Freedom Restoration Act of 1993
(RFRA), Congress explicitly invalidated the Supreme Court’s
decision in Smith, reestablished the compelling interest
test for free exercise claims, and created a private right of
action for any individual “whose religious exercise has been
burdened” by the government.[234] However, as discussed below, the validity of
RFRA has been questioned by the Supreme Court.
When laying out the logical reasoning that led it
to create and pass RFRA, Congress first noted that the free
exercise of religion has been recognized as an inalienable right
since the founding of the United States and that free exercise is
protected under the First Amendment of the Constitution.[235] It recognized that “laws
‘neutral’ toward religion may burden religious exercise
as surely as laws intended to interfere with religious
exercise.”[236] Congress then made three findings: (1)
“governments should not substantially burden religious
exercise without compelling justification;”[237] (2) the Supreme Court’s decision in
Employment Division v. Smith eliminates the
government’s responsibility to justify the burdens it imposes
on religious exercise through religion-neutral laws;[238] and (3) the compelling interest test set
forth in Sherbert and Yoder is the fairest and most
reasonable way to strike a balance between the protection of free
exercise and the ability of government to achieve its legitimate
goals.[239]
Congress then set out the two specific purposes of
RFRA: (1) “to restore the compelling interest test as set
forth in Sherbert v. Verner ...and Wisconsin v. Yoder
... and to guarantee its application in all cases where free
exercise of religion is substantially burdened” and (2)
“to provide a claim or defense to persons whose religious
exercise is substantially burdened by government.”[240] To ensure that the compelling interest test
was restored in its proper form, Congress described the test in
detail in RFRA’s text:
Government shall not substantially burden a
person's exercise of religion even if the burden results from a
rule of general applicability...[unless] government...demonstrates
that application of the burden to the person (1) is in furtherance
of a compelling governmental interest; and (2) is the least
restrictive means of furthering that compelling governmental
interest.[241]
Confident that it had restored the proper judicial
analysis, Congress was shocked in 1997 when the Supreme Court
invalidated RFRA, at least partially, in City of Boerne v.
Flores .[242]City of Boerne held that Congress had
overstepped its powers under the Enforcement Clause of the
Fourteenth Amendment by passing RFRA.[243] RFRA was an unconstitutional intrusion by
Congress into areas of autonomy preserved to state governments.
City of Boerne ’s impact on the enforceability of RFRA
against action by the federal government has been the subject of
much debate. The consensus among the courts, at this time, is that
City of Boerne held only that RFRA was unconstitutional as
applied to the states and that RFRA remains constitutional as
applied to the federal government and its agencies.[244] Therefore, until the Supreme Court states
otherwise, RFRA can be applied to actions taken by the FDA and
applications of the FDCA that burden religious activities.
Whether a Smith or a RFRA analysis would
apply in a case similar to Hubbard Electrometer or
Richardson makes a significant difference in the ability of
Scientologists to practice their religion. Under a RFRA analysis,
secular use of E-meters would be prohibited as in Hubbard
Electrometer , but religious use would be allowed as long as
the E-meters and their accompanying literature carried specified
disclaimers regarding their capabilities. In addition, E-meters
that bore disclaimers, but not adequate directions for their
intended uses, could be imported into the United States. With the
special status afforded to religion under the First Amendment, this
RFRA-generated solution to the mislabeling of E-meters is far more
reasonable than the solution under Smith . As required by
the compelling interest test, the government’s purpose in
enforcing the FDCA is fulfilled while the infringement on the
practice of Scientology is minimized.
C. The Federal Food, Drug and Cosmetic Act
Before the Free Exercise Clause became relevant to
the FDA’s cases against Scientology, the provisions of the
FDCA had to be applied appropriately to the E-meters and their
accompanying literature. Like the Supreme Court’s definition
of religion and its free exercise analysis, the FDCA has undergone
significant changes since Founding Church , Hubbard
Electrometer , and Richardson . However, unlike those
previously discussed legal analyses, the changes to the FDCA do not
effect its application to E-meters and their accompanying
literature. For this reason, only a brief review of the changes to
the FDCA and the recent application of the provisions relevant to
E-meters and their accompanying literature is provided here.
1. Medical Device Regulation and the E-Meter
The FDA’s regulation of medical devices under
the FDCA has changed substantially since the decisions in
Founding Church , Hubbard Electrometer , and
Richardson . The medical device regulations underwent
significant modifications in 1976, 1990, and 1997.[245] These changes were meant to increase the
effectiveness and safety of medical devices sold, distributed, and
used in the United States. However, it does not appear that any of
these revisions would change the FDCA-based analysis of the
harmless E-meter.
As part of the Medical Device Amendments of 1976,
the FDA adopted a three-tiered classification system.[246] Under this system, the controls and
notification requirements for each medical device are determined
according to the class in which the device is placed by the FDA.
Placement in a particular class is based on the public safety risk
posed by the device. Class I devices are least risky; they include
surgical bandages, tongue depressors and, most likely,
E-meters.[247] The traditional controls applied by the FDCA
to medical devices are sufficient to protect the public from the
“dangers” of Class I devices. These controls include
the standard prohibitions against adulteration and misbranding as
well as the labeling requirements employed by the FDA in
Founding Church , Hubbard Electrometer , and
Richardson .[248] The controls also involve postmarket
surveillance of the device and user facility and manufacturer
reporting requirements.[249] The majority of Class I devices are not
subject to the premarket notification requirements applied to Class
II and Class III devices.[250] Manufacturers of Class I devices neither need
to inform the FDA of their intention to sell and distribute their
devices, nor need to receive approval from the FDA before marketing
their devices. The Medical Device Amendments also preserved the
remedies available to the FDA under the mislabeling, misbranding,
and importation provisions of the FDCA; long-standing seizure,
injunction, criminal prosecution, and administrative detention all
remain viable options.[251]
Although the Medical Device Amendments and other
FDCA revisions have modified the FDA’s approach to medical
devices, this new classification system would not effect the
application of the FDCA to E-meters. As Class I devices, E-meters
are subject essentially to the same provisions of the FDCA as in
Founding Church , Hubbard Electrometer , and
Richardson .
The E-meter has consistently been recognized by
courts as a medical device under Section 321(h)(2) of the FDCA,
which defines a medical device as “an instrument, apparatus,
implement, [or] machine...which is...intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other
animals.” [252] Historically, the FDA has recognized
galvanometers as medical devices under the FDCA when they are used
to measure the electric flow from an individual’s body for
the purpose of diagnosing, treating, curing, or preventing
disease.[253] For example, in United States v. An
Article of Device , the court agreed with the FDA’s
determination that a string galvanometer advertised as being
capable of detecting a variety of serious physical ailments was a
device under the FDCA and, therefore, within the jurisdiction of
the FDA.[254]
Under Section 321(h)(2), the definition of a
medical device relies on the intended, and not the effective, use
of the machine. The objective intent of the person responsible for
labeling the device defines the intended use of the device; the
intent of that individual is gleaned from the device’s
labels.[255] Scientology literature associated with the
E-meter suggests that the contraption is to be used during auditing
to locate and remove the root cause of physical diseases.
Scientology’s objective intent, then, is for the E-meter to
be used in “the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of
disease.”[256]
The fact that the E-meter is not the only element
in the process of auditing does not exclude it from the
FDCA’s definition of a medical device. As stated by the
District Court in Hubbard Electrometer , “The device
plays a key part in both the secular and religious auditing process
which is used and intended to be used in the cure, mitigation or
treatment of disease. It need not be the only agent in an allegedly
curative process to be a device within the
definition.”[257]
Courts have traditionally interpreted the medical
device definition of the FDCA broadly and have consistently applied
that definition to galvanometers that claim to have medical
properties.[258] With no significant changes made to the
judicial interpretation of the FDCA’s medical device
definition as it applies to harmless devices, it is almost certain
that a modern court would categorize E-meters as medical devices
that fall under the regulatory provisions of the FDCA.
2. The Labeling Provisions
Labeling is defined in Section 321(m) of the FDCA
as “all labels and other written, printed, or graphic matters
(1) upon any article or any of its containers or wrappers, or (2)
accompanying such article.”[259] None of the literature seized by the FDA and
presented as evidence in Founding Church and Hubbard
Electrometer was attached to the E-meters or their wrappings.
Rather, the literature was sold from a bookstore located within the
same building where Scientology auditing sessions were conducted.
The first question for courts concerning the labeling of E-meters
then is whether this literature is “accompanying” the
E-meters, as that term is understood under the FDCA.
In Kordel v. United States , the most
influential FDCA labeling case, the Supreme Court held that
literature shipped separately from a product can be considered
labeling.[260] The Supreme Court reasoned that when a
product and literature share a common origin and destination and
when the literature explains the product’s uses and is used
in the sale of the product, the literature is labeling for the
purposes of the FDCA.[261] Labeling is not restricted to text adhered to
a device or its packaging. In Kordel , pamphlets detailing a
variety of uses for a drug product were shipped by the
manufacturer, independently of the drugs, to vendors.[262] The vendors distributed the pamphlets to
consumers by displaying them in their stores, giving them away to
purchasers of the drugs, selling the pamphlets independently of the
drugs, or mailing the pamphlets to customers.[263] The Supreme Court held that the pamphlets
were labeling of the drugs because “One article or thing is
accompanied by another when it supplements or explains it, in the
manner that a committee report of the Congress accompanies a bill.
No physical attachment one to the other is necessary. It is the
textual relationship that is significant.”[264] The Supreme Court also noted that attaching a
cost to the pamphlets, rather than giving away a pamphlet each time
a drug is purchased, does not save the pamphlets from the labeling
provisions of the FDCA. “The [FDCA] cannot be circumvented by
the easy device of a “sale” of the advertising matter
where the advertising performs the function of
labeling.”[265]
On the same day that Kordel was decided, the
Supreme Court held in United States v. Urbuteit that a
leaflet misrepresenting the usefulness of an electrical device in
the diagnosis and cure of various diseases, which was shipped
separately from the electrical device, was labeling within the
meaning of the FDCA.[266] As in Kordel , the Supreme Court held
that it was immaterial whether the advertising material was shipped
along with the device.[267] Rather, if the literature was designed to
serve a purpose identical to that of standard labeling attached to
a device, it is labeling.[268] The device examined in Urbuteit had no
labels itself, so the leaflet was required for a consumer to
understand the intended purpose and use of the device.[269] As a necessary companion of the device, the
Supreme Court deemed the leaflet to be labeling.
Since Kordel and Urbuteit were
decided, courts have continued to apply a broad definition of
literature “accompanying” an article for the purposes
of the FDCA. For example, United States v. Pro-Ag, Inc. held
that “previously distributed promotional literature may be
considered [labeling] if it can be shown that customers relied on
the representations made in the literature when purchasing the
product” even if the literature was distributed years before
the purchase.[270] The courts have not, however, expanded the
definition of labeling beyond reasonable limits. In United
States v. Hanafy , a piece of paper that served only to
identify the contents of a shipping tray and contained no
information additional to what was displayed on the articles
themselves was held not to constitute labeling for the purposes of
the FDCA.[271] According to the court in Hanafy ,
labeling must “be intended to provide substantial information
about the use or benefits of the article.”[272] Purely descriptive literature is not
labeling.
Under the broad judicial interpretation of
labeling, most, if not all, of the non-doctrinal literature
collected by the FDA and presented as evidence in Founding
Church and Hubbard Electrometer would be found to
constitute labeling of the E-meters in a similar case. The
literature presented by the FDA contained descriptions of the
intended uses of the E-meter, the potential benefits of using the
device, and the process by which the device should be used. The
E-meters themselves bore no similar labels. As such, the literature
was designed to serve a purpose identical to that of labeling that
is typically attached to a device.
If the literature constitutes labeling, there is
little doubt that it would qualify as “false or
misleading.”[273] Under Section 352(a) of the FDCA, a device is
misbranded if its label contains false or misleading
statements.[274] Claims that use of the E-meter can identify
and cure disease are clearly false and misleading in the medical
and scientific context of the FDCA. As a misbranded device, the
E-meters would remain subject to seizure under Section 334(a) of
the FDCA.[275]
3. The Importation Provisions
In Richardson , the Ninth Circuit repeatedly
emphasized that the E-meters presented for importation were denied
access to the United States under Section 381(a) of the FDCA, and
not under the mislabeling provisions at issue in Founding
Church and Hubbard Electrometer .[276] Under Section 381(a), the federal government
must refuse admission to the United States to any medical device
that appears at examination to be adulterated or
misbranded.[277] Definitive proof of misbranding is not
required. A device is misbranded if it lacks adequate directions
for use.[278]
In Richardson , the seized E-meters were
eventually denied admission to the United States because adequate
directions could not be drafted for them to accomplish their
intended use of detecting and curing disease.[279] A similar reasoning was used to deny entrance
to the United States to E-meters in Church of Scientology of
Minnesota v. Department of Health, Education and Welfare
.[280] In that case, the court reasoned its denial
for importation with the following argument:
This Court in passing upon defendants' motion does
not assume to find or determine the actual effects of the use of
the E-meter in auditing in the ceremony of the Church. That is, the
question of the truth or the falsity of the claims made by the
Church in the process of auditing in the Church of Scientology is
not herein determined and is not before the Court for
determination. The Court merely finds that the E-meter as used in
the auditing ceremony is an instrument which is used by the Church
for certain diagnostic and therapeutic purposes in improving the
health of the person audited, usually after Dianetic auditing, and
therefore the machine and the use thereof come within the scope of
Section 352(f)(1), 21 U.S.C., and finds that the machines
transported from the United Kingdom to this country and seized by
the defendants do not bear adequate instructions for their
use.[281]
There have been no recent, significant changes in
the application of Section 381(a) of FDCA. If a factual situation
similar to Richardson arose again, the E-meters would be
detained at the borders for their lack of adequate directions to
accomplish their intended uses.
4. Harmless Device Exception
Although the argument was not accepted by the Ninth
Circuit, the Church of Scientology of California argued in
Richardson , that the E-meter should be exempted from the
FDCA’s provisions mandating adequate labeling and directions
for use because the E-meter is a harmless device. Under Section
352(f)(2) of the FDCA, a device shall be exempted from the labeling
requirements if labeling “is not necessary for the protection
of the public health.”[282] Although E-meters are concededly physically
harmless, the Ninth Circuit held that they are not harmless for the
purposes of the FDCA because “their danger lies in the
possibility that 'ignorant and gullible persons...[will] rely upon
them instead of seeking professional advice for conditions they are
represented to relieve or prevent.’”[283] This broad interpretation of what is
necessary for the protection of the public health, in conjunction
with a similar interpretation in Drown v United States , has
served to read any mandated exemption for harmless devices out of
the FDCA and to grant discretionary control of harmless device
exemptions to the FDA.[284] No court has ever granted a mandated
exemption to a harmless device from the adequate directions for use
provisions of the FDCA.[285]
From a public policy perspective, limiting the
number of harmless device exemptions to the labeling provisions of
the FDCA is a good idea. The public assumes that medical devices
are useful for the purposes they are advertised to serve.
Mislabeled physically harmless devices are likely to dupe the
average user into believing they are having an effect, particularly
if the expected consequence of using the device is not obvious to
the user, such as reducing the size of a tumor.
In the case of the E-meter, however, a
conditionally-granted exemption would have better served the
government’s purpose and would have greatly reduced the
burden placed on the religious exercise of Scientologists. The
E-meters seized in Richardson bore disclaimers stating that
the E-meters were “not intended or effective for the
diagnosis, treatment, or prevention of any disease.”[286] Use of the E-meters was also limited to
religious purposes.[287] These preexisting conditions satisfied the
FDA’s purpose in enforcing the FDCA against the E-meter.
Therefore, the Ninth Circuit’s holding in Richardson
did not reflect the intent of Congress when it chose to include a
harmless device exception to the adequate directions provision.
However, because no court has ever mandated an exemption, it is
unlikely that a court would force the FDA to exempt E-meters from
the adequate directions requirement if a case like
Richardson were to arise again.
IV. A New Approach—A Religious Device
Amendment to the FDCA
The FDA’s attempt to regulate the religious
use of E-meters was long and arduous.[288] While working towards this goal, the FDA
expended an immense amount of time, energy, and money on the
prosecution of Scientologists using, selling, and/or distributing
E-meters. This choice by the FDA to allocate its limited resources
to the regulation of a harmless device has been sharply
criticized.[289] At the time, the FDA believed the this action
was necessary because, unless the E-meters were brought into
compliance with the FDCA, gullible individuals might depend on the
devices to cure their physical ailments. As such, the FDA’s
action was within its established mission of protecting the public
health by ensuring the efficacy of medical devices.[290] However, not all actions that fall within the
FDA’s jurisdiction can be pursued. The FDA has significant
discretion in choosing which violations of the FDCA it seeks to
prosecute.[291] It must allocate its resources to the
activities that it considers most vital to serving the
agency’s purposes. Justification for the FDA’s decision
to prosecute use of the E-meter and not to pursue other, more
serious and potentially harmful FDCA infractions is
questionable.
A far more useful endeavor than contemplating the
past actions and possible mistakes of the FDA is formulating a
solution that will allow the FDA to reach its legitimate goal if a
similar situation with a religious device arises in the future, but
does not require an allocation of significant FDA resources.
Congressional adoption of a statutory amendment to the FDCA that
specifically deals with devices used in a religious context is the
most reasonable and satisfactory approach.
A religious device amendment to the FDCA must
comply with the free exercise jurisprudence currently applied by
the Supreme Court. For the purposes of the amendment proposed here,
RFRA is considered to be good law as applied to federal agencies
(the FDA) and federal statutes (the FDCA). In order to pass
constitutional scrutiny, the proposed amendment must not
substantially burden the exercise of religion unless that burden is
the least restrictive means of achieving a compelling government
interest. The District Court in Hubbard Electrometer has
already recognized that the FDA has a compelling interest in
protecting the public against misrepresentation of the
effectiveness of harmless, useless devices employed in religious
activities. As a result, to pass a constitutional analysis, the
religious device amendment either must place no substantial burden
on the exercise of religion or must be the least restrictive means
of protecting the public against misrepresentation.
When considering a religious device amendment to
the FDCA, it should be noted that it is not necessary for Congress
to exempt religious doctrine from consideration as labeling for
religious devices in order to avoid “an inquisition into the
validity of any personal religious beliefs, or the infliction of a
punishment upon any person for holding or disseminating such
beliefs.”[292] That is, in adopting a religious device
amendment, Congress does not need to abide by the decision in
Founding Church . Instead, the amendment can focus entirely
on the scientific or medical claims made by the religion in its
doctrine and its secular literature. The amendment must convey
clearly that any religious doctrine that meets the definition of
labeling under the FDCA will be examined for medical or scientific
claims made regarding the effectiveness or use of the device. The
doctrine will not be judged for its religious value, but the
validity of any medical or scientific claims put forth in the
doctrine will be considered for their medical or scientific
validity. If the device has not been medically or scientifically
proven to have the proposed effect, the FDA will have the power to
order that specified disclaimers, similar to those required in
Hubbard Electrometer , be displayed on the device.
The classification of religious doctrine as
labeling for the purposes of the religious device amendment will
not violate the Supreme Court’s decision in Ballard as
long as the amendment restricts the consideration of claims made in
the doctrine to their medical and scientific purposes. This way, a
court that finds a religious device to be mislabeled based on
statements made in religious doctrine holds only that secular
medical and scientific evidence does not support the claims made in
the doctrine regarding the effectiveness or use of the device. The
court’s holding does not reflect on the religious belief that
the device has the capabilities claimed in the doctrine. Religious
adherents are free to continue believing that use of the device has
medical implications. Allowing religious doctrine to be considered
labeling will not make the religious device amendment a
“regulation of religious action which involves testing in
court the truth or falsity of religious belief.”[293] Instead, as in Richardson , all of the
religious beliefs will be assumed true and their religious veracity
will remain unquestioned.
To avoid being labeled either a substantial burden
on religion or an overbroad means of regulation, the religious
device amendment to the FDCA should also alleviate the no-win
situation regarding adequate directions for use of a useless
religious device identified in Richardson . Under the
proposed amendment, harmless religious devices that are in
compliance with its disclaimer labeling requirements should be
exempted from the FDCA’s requirement of adequate directions
for use. To require manufacturers or distributors to label devices
that are concededly medically and scientifically useless with
adequate instructions for their religiously-motivated medical or
scientific use is to demand an impossibility. Alternately,
requiring that a religion label its device with instructions for
its religious use would excessively entangle the government with
religion. The FDA’s legitimate goal of protecting the public
from misrepresentation is met by mandated disclaimers declaring
that the device has no medical or scientific value; there is no
need for adequate directions for use.
The text of the proposed religious device amendment
could read as follows:
Labeling Requirements for Religious Devices.
The labeling requirements for a device (as defined in Section
321(h)) that is both physically harmless to users and employed as
an essential part of a religious activity are controlled by this
Section. If a religious device is accompanied by literature,
including religious doctrine, that sets out medical or scientific
claims regarding the effectiveness or use of the device, those
claims shall be examined for their medical or scientific validity
only. No evaluation of the religion’s beliefs or the
device’s religious capabilities shall occur. If sufficient
evidence to prove the medical or scientific validity of the claims
is not provided, a disclaimer shall be attached prominently and
visibly to each religious device before it is sold, distributed, or
used. The disclaimer shall read: “This device has no proven
medical or scientific capabilities. Use of this device is
restricted to religious activities and ceremonies.” Religious
devices that bear this disclaimer shall not be required to bear
adequate directions for use. The labeling requirements of this
provision apply only to religious devices used in a religious
setting. The labeling requirements for these same devices when used
in a secular setting are identical to the requirements applied to
all non-religious devices.
Individuals who sympathize with the decision in
Smith may criticize the proposed religious device amendment
for requiring the FDA and the courts to determine which devices are
employed as an essential part of religious activities or
ceremonies. This investigation into religious practices is similar
to an unconstitutional evaluation of the merits of a religious
belief. Although the amendment does give the FDA and the courts
some discretion in deciding what devices qualify for the special
labeling requirements, the ability of courts to distinguish between
religious and secular use of devices is evidenced in cases such as
Hubbard Electrometer . In addition, the discretion afforded
to the government and the courts through the religious device
amendment is no greater than the discretion afforded under
RFRA’s required decision regarding which regulations
constitute a “substantial burden” on religious
activities. Finally, even if the religious device amendment may be
wielded imperfectly by the FDA, the result of its application will
always be less restrictive than a Smith analysis. A small
amount of worrisome discretion in the hands of the FDA and the
courts is more acceptable than a total ban on certain
physically-harmless religious activities. The concerns considered
here should not stop Congress from passing a religious device
amendment.
The proposed religious device amendment complies
with the compelling interest test and with RFRA. The amendment
allows individuals to continue believing in the religious power of
harmless devices to heal despite the lack of scientific or medical
evidence to support their belief. At the same time, the proposed
amendment allows the FDA to meet its goal and its purpose of
protecting the American public from being misled regarding the
medical or scientific effectiveness of religious devices. The
amendment does not place a substantial burden on the practice of
religion; the mandated disclaimers on the side of religious devices
are no more than an inconvenience. A believer will not be troubled
by them. Only a religion trying to persuade the public that its
device has medical or scientific, rather than purely religious,
properties would be dismayed by the disclaimers. As a government
regulation that does not test the truth of religious belief and
places only the slightest inconvenience on religious activity, the
proposed religious device amendment does not violate the
Constitution.
Whether the FDA’s legal battle with
Scientology was an abuse of discretion and a pointed attempt to
destroy a disliked, but burgeoning religious organization is never
likely to be clear.[294] Regardless of the motivation behind the
FDA’s action, however, the holdings of the resulting cases
should provide inspiration for Congress to adjust the FDCA so that
new religious organizations are not required to face the same
arduous battle with the government in order to continue their
religious practices. The lesson in free exercise provided by
Scientology and the E-meter should not be overlooked.
[2] The First Amendment to the U.S. Constitution reads,
“Congress shall make no law respecting an establishment of
religion, or prohibiting the free exercise thereof; or abridging
the freedom of speech, or of the press; or the right of the people
peaceably to assemble, and to petition the government for a redress
of grievances.” U.S. CONST.
amend. I.
[9] Michael Browne, Should Germany Stop Worrying and
Love the Octopus? Freedom of Religion and the Church of Scientology
in Germany and the United States , 9 IND.
INT'L & COMP. L. REV. 155, 157 (1998).
[12] Charles Stafford, Individual Life Force is
Focus of Scientology , ST. PETERSBURG
TIMES , 1980, available at
http://www.lermanet.com/scientologynews/sptimes/spt-series2.htm
(last visited April 21, 2004).
[34] Church of Scientology Int’l, What is
Scientology Auditing: A Description of Auditing , available
at
http://www.scientology.org/en_US/religion/auditing/pg002.html (last
visited Apr. 21, 2004).
[35] “When the person holding the E-Meter
electrodes thinks a thought, looks at a picture, reexperiences an
incident or shifts some part of the reactive mind, he is moving and
changing actual mental mass and energy. These changes in the mind
influence the tiny flow of electrical energy generated by the
E-Meter, causing the needle on its dial to move. The needle
reactions on the E-Meter tell the auditor where the charge lies,
and that it should be addressed through auditing.” Church of
Scientology Int’l, What is Scientology Auditing: The
E-Meter , available at
http://www.scientology.org/en_US/religion/auditing/pg005.html (last
visited Apr. 21, 2004).
[40] Hubbard has often been quoted as having once
said, “if a man really wanted to make a million dollars, the
best way to do it would be to start his own religion.”
However, whether Hubbard actually made this remark is the subject
of much debate. Id .
[43] “While it retains many of the basic
principles of Dianetics, as well as the focus on auditing as a
course of therapy and self-improvement, it adds an overlay of
spirituality, a detailed and somewhat Byzantine cosmology, and a
patina of religious ritual.” Horwitz, supra note 5, at
95.
[44] L. Ron Hubbard, Ceremonies of the Founding
Church of Scientology 9 (1959).
[56] “The Church charges a ‘fixed
donation,’ also known as a ‘price’ or a
‘fixed contribution,’ for participants to gain access
to auditing and training sessions.” Hernandez , 490
U.S. at 685; Foley v. Commissioner , 844 F.2d 94, 96
(1988).
[58]Id . These fees represent a large jump in
price from the $500 for twenty-five hours of auditing cited in
Founding Church of Scientology of Washington, D.C. v. United
States , 409 F.2d 1146, 1152 (D.C. Cir. 1969).
[60] Church of Scientology Int’l, What is
Scientology Auditing: How an Auditing Session is Conducted ,
available at
http://www.scientology.org/en_US/religion/auditing/pg006.html (last
visited Apr. 21, 2004). The Auditor’s Code is the code of
ethics that governs an auditor’s actions during an auditing
session. The Auditor’s Code guarantees the greatest possible
spiritual gains for the preclear because it demands secrecy
regarding information divulged during the session. As a result, the
preclear can feel comfortable divulging even his most embarrassing
or damaging memories. Church of Scientology Int’l, What is
Scientology Auditing: The Auditor’s Code , available
at
http://www.scientology.org/en_US/religion/auditing/pg004.html (last
visited Apr. 21, 2004).
[64] The questions asked by the auditor were isolated
by Hubbard as those necessary to bring about spiritual freedom. In
Scientology, his development of these questions is thought to be a
great achievement. “An unlimited number of questions could,
of course, be asked — which might or might not help a person.
The accomplishment of Dianetics and Scientology is that L. Ron
Hubbard isolated the exact questions and directions to bring about
spiritual freedom.” Scientology, What is Scientology
Auditing: A Description of Auditing , supra note 34.
[77] One book lays out a conspiracy theory regarding
the FDA’s interest in the Church of Scientology and the
E-meter. According to Garrison, the FDA’s investigation was
part of a wider governmental conspiracy to destroy the Church.
OMAR GARRISON, PLAYING DIRTY
(1980).
[78]Id at 21; see also Interview with
William W. Goodrich, Office of the General Counsel, FDA,
available at
http://www.fda.gov/oc/history/oralhistories/goodrich/part2.html#scientology
(last visited Apr. 21, 2004).
[89] The Court of Appeals held that the FDA’s
search of the Founding Church and its seizure of the E-meters and
the literature was constitutional. The Court of Appeals did not
reach a decision regarding the Founding Church’s claim that
there was insufficient evidence to sustain the verdict. Founding
Church , 409 F.2d 1146.
[96] Before discussing Ballard , the Court of
Appeals stated, “The principles expressed in Cantwell
, Barnette and Sherbert at least raise a
constitutional doubt concerning the condemnation of instruments and
literature apparently central to the practice of religion. That
doubt becomes more serious when we turn to the decision of the
Supreme Court in United States v. Ballard .”
Founding Church , 409 F.2d at 1156.
[97] The Court of Appeals did not issue a holding
regarding the E-meter’s status as a device under the FDCA. 21
U.S.C. § 352(a) (2004).
[101]Id . The Court of Appeals did not
decide whether any of the literature presented by the government
constituted labeling under the FDCA, but it did suggest that under
the broad definition of labeling adopted by the Supreme Court
clearly secular literature regarding the E-meter would qualify as
labeling. “Were the literature here introduced clearly
secular, we might well conclude that under existing law it
constituted ‘labeling’ for the purposes of the [FDCA].
Such a conclusion might be justified by a broad reading of the
statute, consistent with its high purpose of protecting the public
health and pocketbook against health frauds.” Founding
Church , 409 F.2d at 1159.
[104] The government did not present any evidence
regarding Scientology’s religious status because it believed
that status was irrelevant to the case; it argued that once an
individual or organization acts, it is stripped of any First
Amendment protection, regardless of the religious or secular
motivation for the action. Id at 1154. By focusing on this
narrow theory, the government gave up its opportunity to prove that
Scientology is not a religion. As noted by the Court of Appeals,
“Since the Government chose not to contest appellants' claim
to religious status, and since in our view appellants have made a
prima facie case for such status, we conclude that for
purposes of review of the judgment before us they are entitled to
the protection of the free exercise clause.” Id at
1160.
[108]Hubbard Electrometer was heard as a
bench trial before the District Court. Id .
[109] District Judge Gesell spared no words in
expressing his dislike for Scientology. For example, Gesell
described the growth of Scientology as follows: “Hubbard, who
wrote much of the material, is a facile, prolific author and his
quackery flourished throughout the United States and in various
parts of the world.” Id at 358. Gesell also referred
to the Founding Church as a “religious cult.” Id
at 359.
[114] Because Hubbard Electrometer was heard
as a bench trial, the District Court did not need to examine each
item of literature for its religious or secular context; rather,
“a single false scientific nonreligious label claim [was]
sufficient to support condemnation...” Id at 361.
[126] The Court of Appeals sustained the complete
condemnation of all E-meters used in a secular context and
reaffirmed that the seized E-meters were misbranded under 21 U.S.C.
§§ 352(a) and (f)(1). Id .
[134] The Court of Appeals in Founding Church
lay the foundation for the claim in Richardson when it
stated, “We do not hold that public health laws in general,
or the Food, Drug and Cosmetic Act in particular, have no
application to the activities of religion. For instance, it may
well be that adulterated foods, drugs or devices used in religious
practices can be condemned under the Act. It may be that a drug or
device used in religion is subject to condemnation as "misbranded"
if its labeling is found to lack, for instance, adequate directions
for use, as was charged in this case. Our holding prevents only a
finding of false labeling on the basis of doctrinal religious
literature.” 409 F.2d at 1162.
[139]Richardson , 437 F.2d at 218. By
presuming that the medical and scientific claims made in the
literature were true, the Ninth Circuit avoided a conflict with the
Supreme Court’s decision in Ballard .
[140] In Founding Church , Scientology
“conceded that the E-meter is of no use in the diagnosis or
treatment of disease as such.” 409 F.2d at 1154.
[143] In Founding Church , the Court of
Appeals held that Scientology had made a prima facie case
for religious status. 409 F.2d at 1160, and see note 104. On
remand, in Hubbard Electrometer , the District Court
remained bound by the decision in Founding Church .
Hubbard Electrometer , 333 F. Supp. at 360.
[144] The Court of Appeals in Founding Church
stated explicitly, “We do not hold that the Founding Church
is for all legal purposes a religion. Any prima facie case
made out for religious status is subject to contradiction by a
showing that the beliefs asserted to be religious are not held in
good faith by those asserting them, and that forms of religious
organization were erected for the sole purpose of cloaking a
secular enterprise with the legal protections of religion.”
409 F.2d at 1162.
[163] The Court earlier noted that
Scientology’s beliefs are religious in character in part
because “the theories of Hubbard are interrelated and involve
a theory of the nature of the person and of the individual's
relationship with the universe.” Id .
[165]Id at 1319. Section 501(c)(3) of the
Internal Revenue Code exempts from taxation “Corporations,
and any community chest, fund, or foundation, organized and
operated exclusively for religious, charitable, scientific, testing
for public safety, literary, or educational purposes, or to foster
national or international amateur sports competition (but only if
no part of its activities involve the provision of athletic
facilities or equipment), or for the prevention of cruelty to
children or animals, no part of the net earnings of which inures to
the benefit of any private shareholder or individual, no
substantial part of the activities of which is carrying on
propaganda, or otherwise attempting, to influence legislation
(except as otherwise provided in subsection (h)), and which does
not participate in, or intervene in (including the publishing or
distributing of statements), any political campaign on behalf of
(or in opposition to) any candidate for public office.” 26
U.S.C. § 501(c)(3)(2004).
[168] Rather than focusing directly on the issue of
tax exemption under Section 501(c)(3), many of Scientology’s
cases against the IRS were based on Freedom of Information Act
(FOIA) document requests. This spate of FOIA claims has been cited
by some critics as an effort by Scientology to harass the IRS into
restoring its tax exempt status. See, e.g., Church of
Scientology v. IRS , 484 U.S. 9 (1987);Church of Scientology
Int’l v. IRS , 995 F.2d 916 (9th Cir. 1993).
[169] The IRS and the courts held repeatedly that
income from Scientology inured to L. Ron Hubbard because he used
the church to generate copyrighted literature, to promote royalty
payments, to receive excessive “debt repayments,” and
to aggressively market his personal products. When Scientology was
battling to regain its tax exempt status as a religious
organization, it was dealt another blow in Hernandez v
Commissioner , 490 U.S. 680 (1989). In Hernandez , the
Supreme Court held that “donations” made to Scientology
by adherents in exchange for auditing and other services are not
tax deductible. Id . According to the Court, the
“donations” are actually payments for services rendered
and not charitable contributions. Id .
[170] If any of a religious organization’s
money inures to an individual, even a very small amount, the
organization can not be granted tax exempt status. 26 U.S.C. §
501(c)(3)(2004).
[171] Some critics have pointed to
Scientology’s focus on collecting money from its members as
an indication that it is not a religion. However, the mere fact
that Scientology receives a substantial amount of money from its
followers does not make it unique or different from mamy mainstream
religions and therefore says nothing about Scientology’s
validity as a religion. Horwitz, supra note 5, at 102.
[172] The Revenue Ruling from the IRS overturning
its decision stated simply, “Church of Scientology. Revenue
Ruling 78-189 is obsoleted.” Rev. Rul. 93-73, 1993-2 C.B. 75.
There was no formal explanation provided. Varying accounts have
tried to explain why the IRS settled with Scientology. Some believe
Scientology’s extensive legal battles with the IRS eventually
wore it into submission. However, Scientology insists that it was
finally able to prove convincingly to the IRS that it was a
legitimate religion and that it acted in compliance with the
requirements of § 501(c)(3) of the Code. Browne, supra note 9,
at 192-93.
[174] Beyond the financial benefits, tax exempt
status under the Code also affords Scientology credence as a
religion in the eyes of the federal government. For example, the
State Department now regards Scientologists claims of persecution
abroad as human rights complaints. Browne, supra note 9, at
193.
[175] James Walsh, Tax Treatment of the Church of
Scientology in the United States and the United Kingdom , 19
SUFFOLK TRANSNAT'L L. REV . 331, 337
(Winter 1995).
[176] Scientology’s official website can be
located at http://www.scientology.org (last visited Apr. 26,
2004).
[177] Church of Scientology Int’l,
Scientology: Its Backgrounds and Origins: The Scientology
Religion , available at
[208] “As a result of their common heritage,
Old Order Amish communities today are characterized by a
fundamental belief that salvation requires life in a church
community separate and apart from the world and worldly influence.
This concept of life aloof from the world and its values is central
to their faith.” Id at 210.
[214] The Church of Latter Day Saints has since
removed the practice of polygamy from its doctrine and now
denounces the practice. For a general discussion of the Church of
Latter Day Saints and its doctrinal change regarding polygamy see
RICHARD N. OSTLING AND JOAN K. OSTLING, MORMON
AMERICA (1999).
[215]Reynolds v United States , 98 U.S. 145
(1878); Davis v Beason , 133 U.S. 333 (1890), and Late
Corp. of Church of Jesus Christ, etc. v United States , 136
U.S. 1 (1890).
[218] The Court of Appeals did not apply the
compelling interest test in Founding Church because it never
reached a point in its analysis that required the application of
the FDCA to Scientology or to the E-meter. When setting out its
holdings in Founding Church , the Court of Appeals noted
explicitly, “We do not hold that public health laws in
general, or the Food, Drug and Cosmetic Act in particular, have no
application to the activities of religion. For instance, it may
well be that adulterated foods, drugs or devices used in religious
practices can be condemned under the Act.” Founding
Church , 409 F.2d at 1163.
[234] In a remarkable showing of solidarity against
Justice Stevens’s reasoning and holding in Smith ,
Congress passed RFRA in near unanimity. RFRA was passed by the
House of Representatives unanimously. It passed the Senate with
only three votes against it. President Clinton signed RFRA into law
on November 16, 1993. John Gatliff, City of Boerne v. Flores
Wrecks RFRA: Searching For Nuggets Among the Rubble ,
23 AM. INDIAN L. REV. 285 , 298
(1998/1999). The text of RFRA states, “A person whose
religious exercise has been burdened in violation of this section
may assert that violation as a claim or defense in a judicial
proceeding and obtain appropriate relief against a government.
Standing to assert a claim or defense under this section shall be
governed by the general rules of standing under article III of the
Constitution.” 42 U.S.C.A. § 2000bb-1(c) (2004).
[244] Since City of Boerne was decided, many
courts have upheld the application of RFRA to actions by the
federal government and its agencies. See e.g. , Kikimura
v. Hurley , 242 F.3d 950, 959 (10th Cir. 2001) (“It is
well established that when a portion of a statute is declared
unconstitutional the constitutional portions of the statute are
presumed severable "unless it is evident that the Legislature would
not have enacted those provisions which are within its power,
independently of that which is not.”); Sutton v.
Providence St. Joseph Medical Center , 192 F.3d 826, 832 (9th
Cir. 1999) (“Not surprisingly, then, most courts that have
considered the issue have concluded that the Supreme Court
invalidated RFRA only as applied to state and local law.”);
Holy Land Foundation for Relief and Developlment v. Ashcroft
, 333 F.3d 156, 167 (D.C. Cir. 2003) (“Although the City
of Boerne case held the RFRA unconstitutional as applied to
state government action, we have held that without doubt ‘the
portion [of RFRA] applicable to the federal government...survived
the Supreme Court's decision striking down the statute as applied
to the States.’” (citations omitted). However, some
scholars and courts have argued that City of Boerne
invalidated RFRA as applied to both the states and the federal
government. See, e.g. , Marci A. Hamilton, The Religious
Freedom Restoration Act is Unconstitutional, 1 U. PA. J. CONST. L. 1, 2 (Spring 1998) (“RFRA
is a straightforward violation of separation of powers and the
Establishment Clause...RFRA is also a violation of the due process
required in lawmaking.”); Branch Ministries, Inc. v.
Richardson , 970 F. Supp. 11, 13 n.1 (D.D.C. 1997); Geltzer
v. Crossroads Tabernacle (In re Rivera) , 214 B.R. 101, 102 n.1
(Bankr. S.D.N.Y. 1997); In re Andrade , 213 B.R. 765, 772
(Bankr. E.D. Cal. 1997); In re Gates Community Chapel of
Rochester, Inc. , 212 B.R. 220 (Bankr. W.D.N.Y. 1997).
[245] John Y. Chai, Medical Device Regulation in
the United States and the European Union: A Comparative Study ,
55 FOOD DRUG L.J. 57, 60 (2003).
[252] 21 U.S.C. § 321(h)(2) (2004). The
District Court in Hubbard Electrometer suggested that no
court could reasonably find that the E-meter was not a medical
device when it stated, “It obviously meets the statutory
definition of an apparatus or contrivance intended for use in the
diagnosis, cure, mitigation or treatment of disease. Moreover, it
is held out as such in the constant promotion of E-meter auditing,
a process designed to effectuate cures of mental and physical
illnesses.” Hubbard Electrometer , 333 F. Supp. at
360.
[254] 224 F. Supp. 265 (E.D. Pa. 1963). Similarly,
in United States v Ghadiali 165 F.2d 957 (3rd Cir. 1943) and
United States v Ellis Research Laboratories, Inc. 300 F.2d
550 (7th Cir. 1962), the courts held that galvanometers advertised
and labeled as being instruments effective for detecting and curing
disease were devices within the scope of § 321(h)(2) of the
FDCA.
[275] 21 U.S.C. § 334(a)(1) (2004) states, in
part, “Any article of food, drug, or cosmetic that is
adulterated or misbranded when introduced into or while in
interstate commerce or while held for sale (whether or not the
first sale) after shipment in interstate commerce...shall be liable
to be proceeded against while in interstate commerce, or at any
time thereafter, on libel of information and condemned in any
district court of the United States or United States court of a
Territory within the jurisdiction of which the article is
found.”
[285] Because the Secretary has the authority to
grant exceptions under 21 U.S.C.A. § 352(f), harmless devices
may still be granted exceptions if the Secretary desires to grant
them. However, under the Court of Appeals’ reasoning no
physically harmless device could ever be proven harmless for the
purposes of the FDCA.
[287] “The device may be used or sold or
distributed only for use in bona fide religious counseling.”
Hubbard Electrometer , 333 F. Supp. at 364.
[288] At the time it was fought, the battle between
the FDA and Scientology over use of the E-meter was the longest
legal case ever fought by the FDA. Garrison, supra note 77, at
34.
[289] For example, one critic has stated, “It
should be kept in mind that while the FDA was thus expending many
thousands of dollars and countless man-hours in a campaign of
persecution against a minor religious sect, they were failing
dismally in the discharge of their one and only
responsibility—insuring the national safe medication and pure
food.” Id at 33.
[290] The FDA’s Mission Statement reads,
“The FDA is responsible for protecting the public health by
assuring the safety, efficacy, and security of human and veterinary
drugs, biological products, medical devices, our nation’s
food supply, cosmetics, and products that emit radiation. The FDA
is also responsible for advancing the public health by helping to
speed innovations that make medicines and foods more effective,
safer, and more affordable; and helping the public get the
accurate, science-based information they need to use medicines and
foods to improve their health.” U.S. Food and Drug
Administration, FDA’s Mission Statement , available
at http://www.fda.gov/opacom/morechoices/mission.html (last
visited Apr. 22, 2004).
[291] “Nothing in this chapter shall be
construed as requiring the Secretary to report for prosecution . .
. minor violations of this chapter whenever he believes that the
public interest will be adequately served by a suitable written
notice or warning.” 21 U.S.C. § 336 (2004); FDA is
“given rather broad discretion--broad enough undoubtedly to
enable [it] to perform [its] duties fairly without wasting [its]
efforts on what may be no more than technical infractions.”
United States v. Sullivan , 332 U.S. 689, 694 (1948).
[294] From the perspective of its former General
Counsel William W. Goodrich, the FDA sought condemnation of the
E-meter not because it disliked Scientology’s beliefs but
because it believed Hubbard was trying to avoid government
regulation by claiming his secular movement was a religion.
Goodrich has said, “With Scientology, our experience here was
that they established a place of business in downtown Washington in
a row house towards the center of town. In Hubbard's early
writings, in Dianetics and other things, he had espoused this
psychological theory and later hit on the idea that by making a
church, they would be exempt from any regulations, hoping that
they'd be exempt from Food and Drug and from tax regulation.”
Interview with William W. Goodrich, supra note 78.