CHURCH OF SCIENTOLOGY OF MINNESOTA et al., Plaintiffs,
DEPARTMENT OF HEALTH, EDUCATION AND WELFARE et al., Defendants.
No. 4-69 Civ. 86.
United States District Court,
July 20, 1971.
Misbranding case. On defendants' motion for reconsideration of order denying
motion to dismiss and for summary judgment, the District Court, Nordbye, J.,
held that in view of literature of organization attributing therapeutic value
to use of galvanometers imported from the United Kingdom, the galvanometers
were misbranded in that the devices did not bear adequate instructions for
Judgment affirmed 8 Cir., 459 F.2d 1044.
 DRUGS AND NARCOTICS
In view of literature of organization attributing therapeutic value to use of
galvanometers imported from the United Kingdom, the galvanometers were
misbranded in that the devices did not bear adequate instructions for their
use. Federal Food, Drug, and Cosmetic Act, s 502(f) (1), 21 U.S.C.A. s
 DRUGS AND NARCOTICS
Whether or not other religious institutions violated the Food and Drug Act by
making therapeutic claims for the use of certain metals, artifacts, symbols,
waters, etc., was immaterial in proceeding to determine whether galvanometers
imported from the United Kingdom were misbranded in failing to bear adequate
instructions for their use. Federal Food, Drug, and Cosmetic Act, s
502(f) (1), 21 U.S.C.A. s 352(f) (1).
 DRUGS AND NARCOTICS
A religious institution is not immune from provisions of the Food and Drug
Act. Federal Food, Drug, and Cosmetic Act, s 502(f) (1), 21 U.S.C.A. s
 DRUGS AND NARCOTICS
Disclaiming labels on galvanometers imported from the United Kingdom could not
be considered a labeling in conformity with the banding requirements of
misbranding statute in view of the numerous therapeutic uses made of the
machines in organization. Federal Food, Drug, and Cosmetic Act, s
502(f) (1), 21 U.S.C.A. s 352(f) (1).
*563 Craig W. Gagnon, of Oppenheimer, Hodgson, Brown, Wolff & Leach, St.
Paul, Minn., for plaintiffs.
Robert G. Renner, U. S. Atty., and Peter J. Thompson, Asst. U. S. Atty.,
Minneapolis, Minn., for defendants.
NORDBYE, District Judge.
The defendants have moved for reconsideration of the Court's order of June 11,
1969, denying their motion to dismiss the complaint herein and for summary
judgment in their behalf. Subsequent to the order denying defendants' motion,
there were filed with this Court excerpts of published material issued by the
Church of Scientology, one of the plaintiffs herein, and its founder, L. Ron
Hubbard, upon which the Government has renewed its motion for summary judgment.
These excerpts from literature put forth by the plaintiffs were obtained by the
inspectors of the Food and Drug Administration at the Church of Scientology
bookstore located at 3007 Nicollet Avenue, Minneapolis, or received through the
mail directly from the said bookstore. The only exception, according to the
affidavit of Robert W. Marrs, is exhibit numbered 176, which apparently was
mailed directly to an inspector in Minnesota, from Copenhagen, Denmark, where
Mr. Hubbard, for a *564 time at least, carried on some of his activities.
It is upon the basis of the literature distributed by these plaintiffs or L.
Ron Hubbard and the decision of the Court of Appeals of the Ninth Circuit in
Church of Scientology of California v. Richardson, 437 F.2d 214, dated
January 11, 1971, which constitute, in part, the basis for the defendants'
renewal of their motion for summary judgment. The California case sustained
the Government's refusal of admission of certain E-meters allegedly
manufactured in the United Kingdom to be used for auditing purposes by the
Church of Scientology in California. The Court of Appeals observed as to the
District Court's finding, p. 218,
"In determining the E-meter's intended use, the court could validly consider
the appellant's publications that discuss the device's applications. ***
Unlike the 'mislabeling' section involved in Founding Church, the court here
could determine the E-meter's intended use without evaluating the truth or
falsity of any related 'religious' claims. To the contrary, appellant's claims
in its literature regarding the applications of the device in the practice of
religion were presumed to be true for the purpose of determining its intended
use. We find no infringement of First Amendment rights."
In addition, the court made this observation, p. 216,
"*** The E-meter is manufactured in the United Kingdom and is, in fact, a
simple skin galvanometer that crudely measures changes in electrical resistance
in the human body."
It may be noted that the galvanometers in question in this proceeding were
manufactured in the United Kingdom and imported into the United States, but E-
meters are now manufactured in this country and apparently are available to the
adherents of the Church of Scientology. An examination of the literature
distributed by these plaintiffs in connection with the teachings of Dianetics
and the Church of Scientology discloses that it sets forth numerous statements
contradictory to the labels affixed to the E-meters, to wit, "Not intended or
effective for the diagnosis, treatment or prevention of any disease."
It appears from the showing here that L. Ron Hubbard, at one time at least,
maintained his headquarters in England, and according to the recital of facts
in Founding Church of Scientology v. United States, 133 U.S.App.D.C. 229,
409 F.2d 1146, he first developed certain teachings in the early 1950's which
he called "Dianetics". These teachings are significant in this case since many
of the therapeutic techniques in Dianetics are now found in the teachings of
the Church of Scientology. In the Founding Church case the court stated, p.
"The basic theory of Dianetics is that man possesses both a reactive mind and
an analytic mind. The analytic mind is a superior computer, incapable of
error, to which can be attributed none of the human misjudgments which create
social problems and much individual suffering. These are traceable rather to
the reactive mind, which is made up of 'engrams,' or patterns imprinted on the
nervous system in moments of pain, stress or unconsciousness. These imprinted
patterns may be triggered by stimuli associated with the original imprinting,
and may then produce unconscious or conditioned behavior which is harmful or
"Dianetics is not presented as a simple description of the mind, but as a
practical science which can cure many of the ills of man. It terms the ordinary
person, encumbered by the 'engrams' of his reactive mind, as a 'preclear,' by
analogy to a computer from which previously programmed instructions have not
been erased. The goal of Dianetics is to make persons 'clear,' thus freeing
the rational and infallible analytical mind. The benefits this will bring are
set out in considerable and alluring detail. All mental disorders are said to
be caused by 'engrams,' *565 as are all psychosomatic disorders, and that
concept is broadly defined. [Dianetics: The Modern Science of Mental Health,
"A process of working toward 'clear' is described as 'auditing.' This process
was explicitly characterized as 'therapy' in Hubbard's best-selling book
Dianetics: The Modern Science of Mental Health (1950). The process involves
conversation with an 'auditor' who would lead the subject or 'pre-clear' along
his 'time track,' [FN*] discovering and exposing 'engrams' along the way.
Though auditing is represented primarily as a method of improving the spiritual
condition of man, rather explicit benefits to bodily health are promised as
well. Hubbard has asserted that arthritis, dermatitis, asthma, some coronary
difficulties, eye trouble, bursitis, ulcers and sinusitis are psychosomatic and
can be cured, and further that tuberculosis is 'perpetuated by engrams.'
FN* In Exhibit 126, "time track" is defined as "The span of the individual
from conception to present time on which lies the sequence of events of his
"A few years after the appearance of Dianetics, Hubbard began to set forth
the broader theories of Scientology. Dianetics was explicitly endorsed as part
of Scientology, 'that branch *** that covers Mental Anatomy."'
The relationship of Dianetics to Scientology and the use of the E-meter in
each is repeatedly emphasized in the literature and advertising sent out by
Hubbard through the local Church of Scientology. One of plaintiffs' exhibits
herein noted as Exhibit 128 reads in part as follows:
"GET E-METER TRAINING
"Every level of training in Scientology from the Dianetic Auditor's Course
to the Academy Levels O, I, II, III, IV, and the Saint Hill Special Briefing
Course (Class VI) gives definite, expanded steps of E-Meter auditing
technology. Excellent understanding and handling of the E-Meter is thus easily
acquired on an exact gradient.
"Contact your nearest Hubbard Scientology Organization to begin your first or
next step in training in standard Scientology auditor technology.
"A student on all courses from the Dianetic Auditor's Course upward must own
a Mark V E-Meter."
On Page 14 of Exhibit 131, in discussing "auditing" generally appears the
"Paralysis, anxiety, stomachs, arthritis and many ills and aberrations have
been relieved by auditing them. An E-Meter shows them up and makes them
confess their misdeeds."
In Exhibit 132, the E-Meter essentials are listed beginning with the sentence:
"There is no known way to clear anyone without using a meter."
In Exhibit 156, the following appears in an advertisement pamphlet obtained
from the local Church of Scientology bookstore, which reads:
"ORDER YOUR E-METER TODAY!
"You need an E-Meter on every Dianetic or Scientology Course.
* * *
"*** the Mark V E-meter accurately measures the mental state and changes in
state of homo sapiens."
Exhibit 162, headed "GET PROCESSED," contains the following:
"DIANETIC PROCESSING-Become a happy, well human being. Dianetic processing
(pastoral Counseling) is The Mental Technology which handles psychosomatic
ills. If you have emotional problems or psychosomatic ills, GET DIANETIC
AUDITING. 5 hour Intensive-$175 25 hour Intensive-$725.00"
Exhibit 170, a pamphlet sent through the mails from the local Church of
Scientology in 1970, outlines the services *566 available in Dianetics
training in Minneapolis, and then lists a few of the uses of auditing as
"To increase IQ
"To help cure any body problem that is not purely physical in nature or cause
such as helping mothers give easier birth and faster recovery after birth
"To speed recovery and healing after operations and accidents
* * *
"Almost any human situation containing pain and misemotion should be handled
by auditing. Auditing is the answer to human disability and travail. It can
make life worth living. Auditing is not a limited action. There is no limit
to what good auditing can do."
In L. Ron Hubbard's pamphlet issued in 1970 called "The Auditor," Exhibit 176,
he discusses the effect of his book called "Standard Dianetics" issued in the
middle of 1969, and he commented upon its wide success compared to Scientology
"You see there have always been, since 1950, these TWO subjects-Dianetics and
"DIANETICS addressed the body, the direct effect of thought on the body.
"SCIENTOLOGY addressed the world of thought, of life itself."
* * *
"Anyway, Dianetics is what you use to handle material matters. Scientology is
used to handle thought, ability, further awareness.
* * *
"People who are medically ill, we send to the medical doctor. People who are
physically ill from pscho-somatic causes are processed on Dianetics.
"Those who are not medically ill or psycho-somatically ill can be entered
directly into Scientology grades and should be.
"Dianetics has many uses-accidents, injuries heal much more quickly-chronic
illness ends when so assisted. Drug addition or drug troubles can be erased.
"The road out, of course, is Scientology.
"But a preclear can be audited on either Dianetics or Scientology at any
stage of his auditing.
"Scientology is said to be easier to confront for most preclears at first."
It is to be gathered from other literature distributed by the Church of
Scientology that in order to be efficient in auditing in Scientology, one
should first become efficient in Dianetics. Reference may be made to Exhibit
121, which is an advertising sheet issued by Hubbard in 1969, which reads, in
"SEND FOR YOUR MARK V E-METER TODAY
"You need a Hubbard Mark V E-Meter (Electrometer) on the Hubbard Dianetic
Auditor's Course and on every Scientology Course from the Hubbard Recognized
Scientologist Course onwards.
"YOU NEED AN E-METER on your Road to Total Freedom.
"Precision built to Ron's exact specifications, the Mark V E-Meter accurately
indicates mental states and changes in these states. It is indispensable to
your progress in Scientology.''
As stated in the case of Church of Scientology of California, 437 F.2d p.
"The 'Hubbard E-meter' is an instrument that is allegedly essential in the
practice of Scientology. The E-meter is manufactured in the United
Kingdom *** . The Food and Drug Administration refused to allow the
importation of the E-meters because they were deemed to be 'devices' (21
U.S.C. s 321(h)) that appeared *567 to be 'misbranded' in that they did not
bear adequate instructions for use (21 U.S.C. s 352(f) (1))."
In the California case, p. 217, the District Court held that the E-meter was
a "device" within Section 321(h) because it is intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man, and
further held that Section 381(a) requires only that the device appears to be
misbranded and vests such determination in the discretion of the Secretary of
Health, Education and Welfare. Moreover, the court held that the "Secretary's
determination of misbranding is not subject to judicial alteration unless it
was arbitrary and capricious." And, as here, the court noted that there were
no allegations in the complaint that the Secretary's determination of
misbranding was arbitrary or capricious and held that the real issue tendered
by the complaint was a claimed violation of civil rights, to wit, religious
The plaintiffs assert that the only use of the E-meter is in connection with
the religious ceremony called "auditing" and that the Church of Scientology in
its religious ceremony does not in any way relate to the alleviation of any
disease or ailment, mental or physical, but that the E-meter is used in a
religious rite similar to the orthodox confession which is formalized in some
of the churches which adhere to many religious creeds. Although the E-meter is
used in auditing in Dianetics, it seems clear that the literature distributed
by the Church teaches primarily that higher skill and longer experience are
demanded in successfully auditing a person with the E-meter in the Church of
Scientology. Moreover, it seems reasonably clear upon the entire showing
herein that the principal purpose of auditing in the Church with the E-meter is
to delve more effectively into the mental and physical stresses of the
individual audited, resulting in the person audited ultimately becoming a
"clear" and thus free from any pschosomatic or similar ailments of the human
In commenting upon the purposes of Scientology and the progress being made in
its various fields of activity, Mr. Hubbard distributed many circulars. That
inconsistencies and seeming contradictions appear in the field of Dianetics and
the purposes of Scientology is evident. In Exhibit 114, he refers to the five
levels of Scientology. As to Scientology No.2, that is, the second level, he
"Academy HPA/HCA accomplishment level. Scientology for use in spiritual
healing. This is a healing strata, using the wealth of past processes which
produced results on various illnesses. I am shortly sending out questionaires
to get all Healing process results as a research project. The auditing level
is Reach and Withdraw and Repetitive Processes. The target is human illness.
We have never entered this field but as we are not thanked for staying out of
it, we might as well dominate it. It is a good procurement area."
Granted that the claims for Dianetics in the cure and alleviation of disease
and various ailments with the aid of the E-meter are emphasized more frequently
in literature distributed by these plaintiffs than that which is circulated in
the field of Scientology. It may be argued that the Church with the use of the
E-meter in Scientology assumes to enter the field of psychiatry and
psychology with the limited claim of the mental improvement of the person
audited. However, it is unmistakably clear from the record that with the E-
meter the Church of Scientology contends that one of the primary purposes of
auditing in the Church is to improve the health of the person audited. For
instance, in Exhibit 118, in commenting upon Scientology in the chapter
entitled "Science Processing," appears the following:
"Scientology, used by the trained and untrained person, improves the health,
intelligence, ability, behavior, skill and appearance of people.
* * *
*568 "It is employed by an AUDITOR (a Scientology practitioner) upon
individuals or small or large groups of people in their presence. The Auditor
makes these people, at their choice, do various exercises, and these exercises
(processes) bring about changes for the better in intelligence, behaviour and
 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.
 It is to no purpose to urge, as plaintiffs do, that other religious
sects in their practices make certain therapeutic claims for the use of certain
medals, artifacts, symbols, waters, etc., in the alleviation and even cure of
certain human ailments, and therefore because these religious sects are in no
way molested by the Government in these teachings and the results thereof, the
Church of Scientology should be accorded the same religious freedom. Whether
or not other religious institutions violate the Food and Drug Act is immaterial
in this proceeding. A religious institution is not immune from the provisions
of the Food and Drug Act. This fact is recognized in the Founding Church
case where the court observed that the exercise of religious freedom does not
include the freedom to violate the Federal Act now under consideration. The
literature adopted by the plaintiffs contains an abundance of claims of
diagnostic and therapeutic values, particularly in the neurotic and psychotic
field in the use of the E-meter in auditing in the Church of Scientology,
and admittedly there are no instructions for the use of this machine by way of
any labeling thereof. As stated before, this Court does not assume to find
whether or not the auditing claims are true or false.
Moreover, this Court agrees with the statement of the Ninth Court of Appeals
in its California decision of January 11, 1971, wherein it held in considering
a similar state of facts in connection with the use of the E-meters by the
Church of Scientology of California that the E-meter should not be held
harmless and thus exempt under Section 352(f), 21 U.S.C., which reads, in
"Provided, That where any requirement of clause (1) of this subsection as
applied to any drug or device, is not necessary for the protection of the
public health, the Secretary shall promulgate regulations exempting such drug
or device from such requirement."
In that connection, the California court referred to Drown v. United
States, 198 F.2d 999, 1006, where the court stated,
"*** While the instruments may be harmless in themselves, their danger lies
in the possibility that 'ignorant and gullible persons are likely to rely upon
them instead of seeking professional advice for conditions they are represented
to relieve or prevent."' (Citing United States v. Kordel, 7 Cir., 1948, 164
F.2d 913, 916, affirmed 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52.
 That there is an absence of any instructions for the use of these
machines by way of any labeling is not contradicted. True, there are
disclaiming labels on the machines, but such an inscription cannot be
considered a labeling *569 of E-meters in conformity with the banding
requirements of Section 352(f) (1), 21 U.S.C., in light of the showing made
here as to the numerous therapeutic uses made of these machines by these
plaintiffs in auditing in the Church of Scientology.
The Court has not assumed to rest this decision solely upon the contention of
the defendants that the Court should grant summary judgment in their behalf
because plaintiffs are in privity with the Church of Scientology of
California v. Richardson. But clearly the holding in the California case is
strong authority in support of the analysis and the conclusions therefrom which
this Court has made of the various church publications as to the therapeutic
uses of the E-meter in the auditing ceremony in the Church of Scientology.
It follows from the foregoing that defendants' motion for summary judgment
must be granted, and judgment in their behalf may be entered dismissing the
complaint herein. It is so ordered. Exceptions are allowed.