LEDA at Harvard Law
Scientology and the FDA:
A Look Back, A Modern Analysis, And A New Approach
Class of 2004
Submitted April 27, 2004
Harvard Law School
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.
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.
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. 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.
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. 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. 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).
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. 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.
L. Ron Hubbard (Hubbard) was born in Tilden, Nebraska on March 13, 1911. He was the only child of Harry, a naval officer, and Ledora Hubbard. Like many children in military families, Hubbard spent much of his youth moving between bases both within and outside of the United States. 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. Few details beyond the time and place of Hubbard’s birth and death are undisputed.
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. 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. Seeking to live a life of adventure and exploration, he eventually followed in his father’s footsteps and joined the Navy.
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. 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. The technique focused on the ability of the mind to effect the body. Using this therapy, Hubbard found that he healed faster, felt happier, and achieved physically and mentally in a manner no one thought possible.
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. 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. He named this new science Dianetics.
Hubbard’s public introduction of Dianetics was met with great success. 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. 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. The public, it seems, was eager to give it a try.
As created by Hubbard, Dianetics is an explicitly secular science. Its fundamental theory rests on the idea that the human mind consists of two subparts: the analytical and the reactive minds. The analytical mind houses a limitless factual memory and serves as the center for information processing and problem solving. It is a source of endless power and the essence of human perfection. The reactive mind, on the other hand, serves as the repository for emotions and emotional memories. It records every painful experience that an individual goes through during his lifetime, including those suffered while in the womb. 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. 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. 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. 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.
The process of removing engrams is known as “auditing.” 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. These questions were specially designed by Hubbard to identify engrams as efficiently as possible. 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. 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. 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.”
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. 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. 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. With Hubbard’s death in 1986, it is unlikely that anyone will ever know for certain what motivated Hubbard to create 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. 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.
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.” Over the billions of years that the world has existed, each thetan has occupied innumerable physical bodies. The actions and creations of individuals on Earth are, and always have been, controlled by thetans. 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. At that time, Xenu ruled a cluster of overcrowded planets known as the Galactic Federation and was desperate to reduce their population. As a permanent solution, Xenu banished a large group of thetans to Earth, a planet that lay outside the Galactic Foundation. 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.
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. 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. In addition, participation in auditing will allegedly increase a person’s physical health and heal him of any psychosomatic illnesses. 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.
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. To ease the application of this doctrine, Scientology has established a fixed fee schedule for auditing and other services it provides to members. 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. 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. The revenue collected through the provision of auditing and other services comprises the bulk of Scientology’s finances.
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.” The E-meter is a simple skin galvanometer similar to those used in lie detector tests. 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. Outside of Scientology, E-meters are considered completely harmless and useless for the diagnosis or treatment of disease.
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. Charge is indicated by a surge in electrical resistance caused by the reactive mind’s movement of mental mass and energy. 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.
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.
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,” “speed recovery and healing after operations and accidents,” end chronic illness, and improve vision, hearing, colorblindness, and balance.
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.” 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. 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.” 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. 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.
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.
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. 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. Quinn posed as an individual interested in Scientology and, using an alias, participated in classes and engaged in auditing sessions at the Founding Church. 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. 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. 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  and United States v. Article or Device (Hubbard Electrometer ). 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.
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. At trial, the jury found for the FDA and a decree of condemnation and destruction was entered by the District Court. 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. For the purposes of this discussion, only the Founding Church’s free exercise claim will be examined.
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].” 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.
At the time the Court of Appeals decided Founding Church , the Supreme Court was employing a compelling interest test to analyze free exercise claims. 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. For the holding in this particular case, however, the Supreme Court’s decision in United States v. Ballard was most consequential. Ballard held that the Free Exercise Clause prohibits “regulation of religious action which involves testing in court the truth or falsity of religious belief.” 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.
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. 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. 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. 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. 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.” 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.
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.
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.” 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. 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. 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.”
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. 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.
To reach its ultimate holdings, the District Court first found that the E-meter is a device within the meaning of the FDCA. 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. 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. The District Court also held that the harmless nature of the E-meter does not exempt it from the FDCA.
The District Court then sought to characterize the literature seized by the FDA from the Founding Church. As held by the Court of Appeals, any texts setting forth religious doctrine could not be considered labeling. To be considered doctrine, the writing had to be held out as making only “religious, as opposed to medical, scientific, or otherwise secular claims.” 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.” 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].” The non-doctrinal literature was labeling that made false medical claims regarding the E-meters.
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.” 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.
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. 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.”
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.
Two years after Hubbard Electrometer was decided, the Court of Appeals reconsidered the requirements for religious use of E-meters. 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. According to the Court of Appeals, the District Court’s decision constituted an excessive entanglement of the government with religion. 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. 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.” 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:
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.
These reformulated disclaimers removed the District Court’s references to the judicial condemnation of E-meters. 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.
Neither Founding Church nor Hubbard Electrometer addressed the FDA’s claim that the seized E-meters lacked adequate directions for use. 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 . Richardson arose from the FDA’s seizure of a shipment of E-meters that were being imported into the United States from Britain. 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. 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. 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. 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. 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.” 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. 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.
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.
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. 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.
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.
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.” Few religions outside of mainstream Protestantism were granted constitutional protection under this definition.
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. 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. 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. 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.”
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.” 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.
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.” 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. 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. 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. 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.” 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.
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. In Christofferson , the Court of Appeals of Oregon held that Scientology is a religion for the purposes of the First Amendment. 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. 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. The religious character of a belief system must be based on consideration of its doctrine as an integrated whole. 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.”
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].” 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. 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. 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. After the IRS revoked its tax exempt status, Scientology filed a number of lawsuits against the IRS, hoping to gain back its preferential treatment. 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.
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. 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.
In 1993, without explanation, the IRS ended its longstanding legal battle with Scientology and re-granted its tax exempt status. Neither the IRS nor Scientology has ever discussed the terms of the settlement that brought about this change. 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.
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. 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.
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. “Scientology is a religion,” it states. “It holds in common many of the beliefs of other religions and philosophies.” To highlight this point, the website traces Scientology’s perception of its own religious heritage. 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. The timeline concludes with Scientology, which is portrayed as the amalgamation of all the religious knowledge preceding its creation.
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.” ) 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.” ).
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.
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.
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.
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. 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.
Assuming that Scientology is a religion for constitutional purposes, it is protected by the Free Exercise Clause of the First Amendment. 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. Two elements are understood to make up free exercise: the freedom to believe and the freedom to act on those beliefs. 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. 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. 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. Without this power, the government would lose control of society as people claimed expansive religious exemptions and became laws unto themselves. 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.
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. Rather, a religious activity must pose grave and immediate dangers to a legitimate government interest before regulation may interfere with the activity.
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. 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. Second, the court would consider whether the government had a compelling interest in regulating the religious activity. If so, the court would then determine whether exempting the religious activity from regulation would interfere significantly with the government’s interest. 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.
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.
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. 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.” South Carolina refused to recognize Sherbert’s religious beliefs as a “good cause.”
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. 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. 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. 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. 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. 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. 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. 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. 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. This home education sufficiently served the government’s interest in education for the purposes of Amish and Mennonite children. 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. The Supreme Court recognized the Church of Latter Day Saints as a valid religion and polygamy as one of its fundamental practices. 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. 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. The federal government was allowed to enforce a full ban on polygamy, despite the significant burden on religious behavior caused by this regulation.
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.
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. 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. 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.
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. 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.” 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. 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. 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. 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.” 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.”
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.”
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. 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.
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. 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. It recognized that “laws ‘neutral’ toward religion may burden religious exercise as surely as laws intended to interfere with religious exercise.” Congress then made three findings: (1) “governments should not substantially burden religious exercise without compelling justification;” (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; 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.
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.” 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.
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 . City of Boerne held that Congress had overstepped its powers under the Enforcement Clause of the Fourteenth Amendment by passing RFRA. 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. 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.
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.
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. 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. 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. 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 . The controls also involve postmarket surveillance of the device and user facility and manufacturer reporting requirements. The majority of Class I devices are not subject to the premarket notification requirements applied to Class II and Class III devices. 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.
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.”  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. 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.
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. 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.”
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.”
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. 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.
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.” 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. 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. 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. 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. 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.” 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.”
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. As in Kordel , the Supreme Court held that it was immaterial whether the advertising material was shipped along with the device. Rather, if the literature was designed to serve a purpose identical to that of standard labeling attached to a device, it is labeling. 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. 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. 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. According to the court in Hanafy , labeling must “be intended to provide substantial information about the use or benefits of the article.” 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.” Under Section 352(a) of the FDCA, a device is misbranded if its label contains false or misleading statements. 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.
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 . 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. Definitive proof of misbranding is not required. A device is misbranded if it lacks adequate directions for use.
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. 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 . 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.
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.
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.” 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.’” 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. No court has ever granted a mandated exemption to a harmless device from the adequate directions for use provisions of the FDCA.
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.” Use of the E-meters was also limited to religious purposes. 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.
The FDA’s attempt to regulate the religious use of E-meters was long and arduous. 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. 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. 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. 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.” 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.” 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. 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.
 See, e.g., Richard Behar, The Thriving Cult of Greed and Power , TIME MAGAZINE , May 6, 1991, at 50; United States v. An Article Or Device , 333 F. Supp. 357, 359 (D.D.C. 1971) [hereinafter Hubbard Electrometer ].
 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.
 21 U.S.C. § 301 et seq. (2004).
 The Free Exercise Clause states, “Congress shall make no law prohibiting the free exercise [of religion].” U.S. CONST. amend. I.
 Paul Horwitz, Scientology in Court: A Comparative Analysis and Some Thoughts on Selected Issues in Law and Religion , 47 DEPAUL L. REV . 85, 90 (Fall 1997). See also illustration available at http://www.xenu.net/archive/fifties/ (last visited Apr. 26, 2004).
 Church of Scientology Int’l, L. Ron Hubbard, A Chronicle , available at http://www.scientology.org/html/en_US/l-ron-hubbard/chronicle/index.html (last visited Apr. 21, 2004) [hereinafter A Chronicle ].
 Id .
 Id .
 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).
 Hubbard died in Creston, California in 1986. Id .
 A Chronicle , supra note 6.
 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).
 A Chronicle , supra note 6.
 Id .
 Id ; Horwitz, supra note 5, at 90.
 A Chronicle , supra note 6.
 Id .
 Id .
 Id .
 Ronald B. Flowers, Religion in Strange Times: The 1960s and 1970s 96 (1984); Russell Miller, Bare-faced Messiah: the True Story of L. Ron Hubbard 159 (1987); Browne, supra note 9, at 159.
 L. Ron Hubbard, Dianetics: The Modern Science of Mental Health 62 (3d ed. 1990) [hereinafter Dianetics]; BookFlash, Six New Releases Add to Dianetics’ Groundbreaking Technology (May 2002), available at http://www.bookflash.com/releases/100592.html.
 Horwitz, supra note 5,at 90.
 Id .
 Dianetics, supra note 21, at 62.
 Id .
 Browne, supra note 9, at 158.
 Dianetics, supra note 21, at 82.
 Id .
 “The engram is the single and sole source of aberration...” Dianetics, supra note 21, at 91.
 Horwitz, supra note 5, at 91-92.
 Browne, supra note 9, at 158; Dianetics, supra note 21, at 91.
 Horwitz, supra note 5, at 92.
 Id .
 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).
 “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).
 Id .
 Horwitz, supra note 5, at 92.
 Id at 96.
 Id at 93.
 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 .
 L. Ron Hubbard, Mission Into Time 16 (1973).
 Horwitz, supra note 5, at 93.
 “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.
 L. Ron Hubbard, Ceremonies of the Founding Church of Scientology 9 (1959).
 Horwitz, supra note 5, at 96.
 Id .
 Richard Behar, supra note 1, at 50.
 Horwitz, supra note 5, at 97.
 Id .
 Id .
 Horwitz, supra note 5, at 96 (citing L. Ron Hubbard, Have You Lived Before This Life?: A Scientific Survey 13 (1958)).
 Id at 92.
 Id .
 Browne, supra note 9, at 161.
 Hernandez v. Commissioner , 490 U.S. 680, 685 (1989); Graham v. Commissioner , 822 F.2d 844, 847 (1987); Church of Spiritual Technology v. United States , 26. Cl. Ct. 713, 715 (1992).
 “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).
 Hernandez , 490 U.S. at 685.
 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).
 Hernandez , 490 U.S. at 685.
 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).
 Founding Church , 409 F.2d at 1153.
 Id .
 “It is completely harmless and ineffective in itself.” Hubbard Electrometer , 333 F.Supp. at 358.
 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.
 See note 35.
 Scientology, What is Scientology Auditing: How an Auditing Session is Conducted , supra note 60.
 Founding Church , 409 F.2d at 1153.
 Miller, supra note 20, at 146.
 Church of Scientology of Minnesota v. Dep’t of Health, Education & Welfare , 341 F. Supp. 563, 565-66 (1971) (quoting Scientology pamphlet).
 Id .
 Church of Scientology Int’l, What is Scientology Auditing: Validation of Results , available at http://www.scientology.org/en_US/religion/auditing/pg008.html (last visited Apr. 21, 2004).
 Church of Scientology Int’l, Frequently Asked Questions: Medical Doctors , available at http://www.scientology.org/en_US/news-media/faq/pg020.html (last visited Apr. 21, 2004).
 Id ; Horwitz, supra note 5, at 101 (citing Church of Scientology Int'l, Assists for Illnesses and Injuries).
 Scientology, Frequently Asked Questions: Medical Doctors , supra note 72.
 Horwitz, supra note 5, at 91.
 Church of Scientology Int’l, What is Scientology Auditing: Results , available at http://www.scientology.org/en_US/religion/auditing/pg010.html (quoting P.W.) (last visited Apr. 21, 2004).
 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).
 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).
 Interview with William W. Goodrich, supra note 78.
 Garrison, supra note 77, at 25.
 Hubbard Electrometer , 333 F. Supp. at 360.
 409 F.2d 1146 (D.C. Cir. 1969).
 333 F. Supp. 357 (D.D.C. 1971).
 437 F.2d 214 (9th Cir. 1971).
 409 F.2d 1146.
 Id at 1148.
 Id .
 Id .
 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.
 Id at 1162.
 Founding Church , 409 F.2d 1146.
 See Sherbert v. Verner , 374 US 398 (1963).
 Id at 406.
 322 U.S. 78 (1944).
 Founding Church , 409 F.2d at 1156 (discussing Ballard ).
 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.
 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).
 Founding Church , 409 F.2d at 1157.
 Id .
 335 U.S. 345, 350 (1948).
 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.
 Founding Church , 409 F.2d at 1160.
 Id .
 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.
 Id at 1162.
 Id .
 Hubbard Electrometer , 333 F. Supp. 357.
 Hubbard Electrometer was heard as a bench trial before the District Court. Id .
 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.
 Id at 360.
 Id .
 Id . The District Court also noted that an apparatus can qualify as a device for the purposes of the FDCA without being “the only agent in an allegedly curative process.” Id .
 Id .
 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.
 Founding Church , 409 F.2d 1146.
 Hubbard Electrometer , 333 F. Supp. at 361.
 Id .
 Id .
 Id .
 Id at 362.
 Id .
 Id at 363.
 Id .
 Id at 364-65.
 United States v. An Article Or Device , 1969-1974 FDLI Jud. Rec. 131 (D.C. Cir. 1973) (per curiam).
 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 .
 Id .
 Id .
 Id at 132.
 Id .
 The Court of Appeals’ disclaimers also removed references to statements regarding the illegality of implications that E-meters have scientific or medical effects. Id .
 Because the Court of Appeals changed the District Court’s requirements so minimally, it is not necessary for the purposes of this discussion to separately analyze the two sets of disclaimers.
 437 F.2d 214 (9th Cir. 1971).
 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.
 437 F.2d 214 (9th Cir. 1971).
 Id at 216. The FDA has the power to refuse admission to the United States to any imported device that “appears” to be misbranded. 21 U.S.C. § 381(h) (2004).
 21 U.S.C. § 352(f)(1) (2004); Richardson , 437 F.2d at 216.
 21 U.S.C. § 352(f)(1) (2004).
 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 .
 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.
 Richardson , 437 F.2d at 217.
 Id at 218.
 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.
 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.
 Browne, supra note 9, at 166; Davis v. Beason , 133 U.S. 333, 342 (1890).
 Browne, supra note 9, at 166.
 322 U.S. 78 (1944).
 Id .
 Browne, supra note 9, at 167.
 Id at 168-69.
 United States v. Seeger , 380 U.S. 163, 176 (1965).
 Torcaso v. Watkins , 367 U.S. 488, 495 (1961).
 406 U.S. 205, 215-16 (1971).
[154 ] Id .
 Id .
 John C. Knechtle, If We Don’t Know What It Is, How Do We Know If It’s Established? , 41 BRANDEIS L.J . 521, 526 (Spring 2003).
 Id at 526-27.
 Christofferson v. Church of Scientology of Portland , 57 Ore. App. 203 (1982).
 Id .
 Id at 240.
 Id at 241.
 Id .
 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 .
 Church of Scientology of California v. Commissioner , 823 F.2d 1310, 1312 (1987).
 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).
 26 U.S.C. § 501(c)(3)(2004).
 Church of Scientology of California v. Commissioner , 823 F.2d at 1316.
 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).
 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 .
 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).
 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.
 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.
 Alison H. Eaton, Can the IRS Overrule the Supreme Court? , 45 EMORY L.J . 987, 1012 (1996).
 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.
 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).
 Scientology’s official website can be located at http://www.scientology.org (last visited Apr. 26, 2004).
 Church of Scientology Int’l, Scientology: Its Backgrounds and Origins: The Scientology Religion , available at
http://www.scientology.org/en_US/religion/background-origins/pg001.html (last visited Apr. 22, 2004).
 Church of Scientology Int’l, The Religious Heritage of Scientology , available at http://www.scientology.org/en_US/religion/heritage/index.html (last visited Apr. 22, 2004).
 Id .
 Id .
 Church of Scientology Int’l, Scientology: Its Backgrounds and Origins: Scientology Beliefs , available at http://www.scientology.org/en_US/religion/background-origins/pg002.html (last visited Apr. 22, 2004).
 Church of Scientology Int’l, What is Scientology Auditing? Life Improvement Courses , available at http://www.scientology.org/en_US/religion/auditing/pg012.html (last visited Apr. 22, 2004).
 Church of Scientology Int’l, What is Scientology Auditing? Chaplain and Ministerial Services , available at http://www.scientology.org/en_US/religion/auditing/pg017.html (last visited Apr. 22, 2004).
 Id .
 Behar, supra note 1.
 See note 2; U.S. CONST. amend. I.
 Browne, supra note 9, at 163.
 Cantwell v. Connecticut , 310 US 296 (1940).
 Id .
 Id .
 Reynolds v. United States , 98 U.S. 145 (1878).
 West Virginia State Board of Education v. Barnette , 319 US 624 (1943).
 Id .
 See e.g., Id ; Sherbert v. Verner , 374 U.S. 398; Wisconsin v. Yoder , 406 U.S. 205 (1972).
 See e.g., Midrash Sephardi, Inc. v. Town of Surfside , 2004 U.S. LEXIS 7706, 26-27 (11th Cir. 2004) (stating, “a ‘substantial burden’ must place more than an inconvenience on religious exercise; a ‘substantial burden’ is akin to significant pressure which directly coerces the religious adherent to conform his or her behavior accordingly. Thus, a substantial burden can result from pressure that tends to force adherents to forego religious precepts or from pressure that mandates religious conduct.”) U.S. v. Jefferson , 175 F. Supp. 2d 1123 (N.D. Ind. 2001); Worldwide Church of God v. Philadelphia Church of God, Inc. , 227 F.3d 1110 (9th Cir. 2000); Guam v. Guerrero , 290 F.3d 1210 (9th Cir. 2002).
 See e.g., Id ; Sherbert v. Verner , 374 U.S. 398; Wisconsin v. Yoder , 406 U.S. 205.
 Id .
 Id .
 Sherbert v. Verner , 374 U.S. 398; Wisconsin v. Yoder , 406 U.S. 205.
 Sherbert v. Verner , 374 U.S. 398.
 Id at 401.
 Id .
 Id at 404.
 Id at 406-07.
 Id at 407.
 Wisconsin v. Yoder , 406 U.S. 205.
 “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.
 Id at 207.
 Id at 213.
 Id at 224.
 Id .
 Id .
 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).
 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).
 Davis v Beason , 133 U.S. at 341.
 Id .
 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.
 Hubbard Electrometer , 333 F. Supp. at 360.
 “The E-meter is used by its ministers as part of the ritual and practice of the Church.” Id at 363.
 Id .
 Id .
 Id .
 Id at 364.
 Richardson , 437 F.2d at 217, quoting Drown v. United States , 198 F.2d 999, 1006 (9th Cir. 1952). In Drown , the Ninth Circuit rejected a chiropractor’s argument for a harmless device exemption using the same reasoning. Id .
 Richardson , 437 F.2d 214.
 Id at 217.
 Id .
 Hubbard Electrometer , 333 F. Supp. at 363.
 494 U.S. 872 (1990).
 Id .
 Id .
 42 U.S.C.A. §§ 2000bb et seq. (2004).
 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).
 42 U.S.C.A. § 2000bb(a)(1) (2004).
 42 U.S.C.A. § 2000bb(a)(2) (2004).
 42 U.S.C.A. § 2000bb(a)(3) (2004).
 42 U.S.C.A. § 2000bb(a)(4) (2004).
 42 U.S.C.A. § 2000bb(a)(5) (2004).
 42 U.S.C.A. § 2000bb(b) (2004).
 42 U.S.C.A. §§ 2000bb-1(a)-(b) (2004).
 521 U.S. 507 (1997).
 Id at 519.
 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).
 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).
 Id at 58.
 Id .
 Id .
 Id .
 Id .
 Id .
 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.
 Jay M. Zitter, Annotation, What Is “Device” Within Meaning of § 201(h) of Federal Food, Drug, and Cosmetic Act? , 129 A.L.R. Fed. 343 (2003).
 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.
 Jay M. Zitter, supra note 253.
 21 U.S.C. § 321(h)(2) (2004).
 Hubbard Electrometer , 333 F. Supp. at 360.
 Jay M. Zitter, supra note 253.
 21 U.S.C. § 321(m) (2004).
 335 U.S. 345 (1948).
 Id at 348.
 Id at 347.
 Id at 346-47.
 Id at 350.
 Id .
 335 U.S. 355 (1948).
 Id at 357.
 Id .
 Id .
 796 F. Supp. 1219, 1225 (D.C. Minn. 1991).
 302 F.3d 485 (5th Cir. 2002).
 Id at 490.
 21 U.S.C. § 352(a) (2004).
 Id .
 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.”
 21 U.S.C. § 381(a) (2004).
 Id (emphasis added).
 21 U.S.C. § 352(f)(1) (2004) states that a device is mislabeled unless it bears adequate directions for use.
 Richardson , 437 F.2d 214.
 341 F. Supp. 563 (D.C. Minn. 1971), aff’d , 459 F.2d 1044 (8th Cir. 1972).
 Id at 568.
 21 U.S.C. § 352(f)(2) (2004).
 Richardson , 437 F.2d at 217.
 198 F.2d 999 (9th Cir. 1952).
 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.
 Richardson , 437 F.2d at 218.
 “The device may be used or sold or distributed only for use in bona fide religious counseling.” Hubbard Electrometer , 333 F. Supp. at 364.
 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.
 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.
 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).
 “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).
 Founding Church , 409 F.2d at 1163 (McGowan, dissenting).
 Founding Church , 409 F.2d at 1156 (discussing Ballard ).
 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.