3567. Misbranding of Halox Therapeutic Generator.   U. S. v. 22 Devices   *   *   *.
Tried to the court.   Decree of condemnation.    (F. D. C. No. 24848.
Sample No. 31725-K.)
LIBEL FILED :   May 20,1948, Southern District of California.
ALLEGED SHIPMENT : On or about April 30, May 9 and 14, July 24, and December
3, 1947, by the Halox Therapeutic Generator Co., from Central, N. Mex.
PRODUCT : 22 devices known as Halox Therapeutic Generator at Los Angeles,
Calif. Examination showed that the device was designed to produce chlorine
gas by means of electrolysis.
NATURE OF CHARGE : Misbranding, Section 502 (f) (1), the labeling of the article
failed to bear adequate directions for use in the conditions for which it was
intended, and it failed also to bear adequate directions for use by reason of
its failure to state all of the disease conditions for which the article was in-
tended, namely, arthritis, sinusitis, hay fever, bronchitis, neuritis, sciatica,
rheumatism, asthma, and nervous disorders.
Co., claimant, having filed an answer denying that the devices were mis-
branded, the case came on for trial before the court on the basis of a stip-
ulated record.   After consideration of the evidence and the briefs of counsel,
?    the court, on July 27, 1951, handed down the following opinion:
BYBNE, District Judge: "This proceeding in rem was instituted by the
United States pursuant to the provisions of the Federal Food, Drug and Cos-
metic Act, 52 Statutes 1040, 21 U. S. C. A., section 301 et seq., seeking a decree
condemning 22 devices, more or less, labeled in part 'Halox Therapeutic Gen-
erator.' The particular authority for this action is to be found in section
334 (a) of 21 U. S. C. A., which provides in part:
(a) Any article of food, drug, device, or cosmetic that is . . . mis-
branded when introduced into or while 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 within the jurisdiction of which the article is
found . . . [Emphasis added.]
"It is the libelant's position that the 22 articles of device (hereinafter
referred to as the 'devices' or 'generators') are liable to condemnation in that
the generators were misbranded when introduced into, and while in, interstate
commerce.
"These generators are devices for the electrolysis of sodium chloride (salt)
solution. The device is housed in a leatherette-covered plywood cabinet, its
base being approximately 12 inches by 15 inches, and its height approximately
12 inches. At the front of the cabinet is a control panel. Inside the cabinet
there is placed a glass jar which is partly filled with a saturated sodium chlo-
ride (salt) solution. Carbon electrodes extend into this solution. When
the generator is in operation, electricity is carried to these electrodes. As
a result of the electrolysis of the salt solution, chlorine gas is produced. A
small electric fan blows a current of air through the jar and out through a
rubber hose. Thus a mixture of air and chlorine gas goes into the tube. This
mixture is then administered to the person receiving the treatment known
as 'chlorine inhalation therapy.' This is accomplished by having the patient
hold the rubber tube to his nose and inhale the mixture.
"Subsequent to the filing of the libel, a monition issued directing the United
States Marshal to seize the generators. In pursuance thereof the generators
were seized and notice thereof was published, along with notice to all persons
interested in said generators to present their claims to this court.
"One Albert P. Mracek, doing business as Halox Generator Company, ap-
peared and made claim to the generators. Thereafter the claimant filed an
answer denying that the generators were misbranded when introduced into,
or while in, interstate commerce. The answer also sets up an affirmative
defense designed to bring these devices within the administrative exemptions
which will be discussed below. There is presently pending in the State of New
Mexico an action contesting Mracek's ownership of these generators, but it
has been stipulated that, for the purpose of the present action, Mracek shall be
deemed to be the proper party claimant.
"21 U. S. C. A. sec. 321 (h) defines a device as follows:
(h) The term "device" (except when used in paragraph (n) of this sec-
tion and in sections 331 (i), 343 (f), 352 (c) and 362 (c)) means instru-
ments, apparatus, and contrivances, including their components, parts, and
accessories, intended (1) for use in the diagnosis, cure, mitigation, treat-
ment, or prevention of disease in man or other animals; or (2) to affect the
structure or any function of the body of man or other animals.
"21 U. S. C. A. section 352 provides:
A drug or device shall be deemed to be misbranded . . . (f) unless its
labeling bears (1) adequate directions for use; and (2) such adequate
warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or
methods or duration of administration or application, in such manner and
form, as are necessary for the protection of users: Provided, That where
any requirement of clause (1) of this paragraph, as applied to any drug
or device, is not necessary for the protection of the public health, the
Administrator shall promulgate regulations exempting such drug or device
from such requirements.
"Pursuant to the proviso of the above sub-section, the Administrator has
promulgated certain regulations which may exempt devices from the require-'
ment that they bear adequate directions for use.   The regulation pertinent to
this case is to be found in 21 C. F. R., section 1.106 (e) which provides:
(e) Except as otherwise provided by paragraphs (h) and (i) of this
section, a shipment or other delivery of a drug or device also shall be
exempt from the requirements of section 502 (f) (1) of the act, (21
U. S. C. A. sec. 352 (f) (1)) if it complies with all the conditions set forth in
paragraphs (b) (3) and (6) of this section and if such shipment or de-
livery is made to a physician, dentist, veterinarian, hospital, or clinic to
be dispensed by or under the direction of physicians, dentists, or veterina-
rians in their professional practices.
"Paragraph (b) (3), referred to in the above regulation, requires that
information adequate for the use of such device by physicians, dentists, or
veterinarians must be readily available.
"The regulations in section 1.106 (k) (2) define a 'physician' as follows:
The terms "physician," "dentist," and "veterinarian," as used in relation
to the exemption of any drug or device, include only those physicians,
dentists, and veterinarians who are licensed by law to administer or
apply such drug or device.
"From this statement of the pertinent provisions of the Act and Regulations
we may now turn to the facts as stipulated to by the parties, to ascertain
whether the generators bore adequate directions for use or, if not, whether they
were exempt from such requirement by virtue of the above-quoted regulations.
"All twenty-two generators, which have been libelled, were manufactured
by the Halox Therapeutic Generator Company, at Central, New Mexico. They
were transported from New Mexico to California at various times during the
year 1947, and were seized within the County of Los Angeles, California, in
May 1948. No written, printed- or graphic matter accompanied any of the
generators except for the following statements on a metal plate affixed to each
generator:
Patent No. 2256212
Other patents pending
Type .... No. 704
Halox Therapeutic Generator Co.
Scientific Chlorine Inhalators
Volts 110 Amps. Cyc. 60
Central, New Mexico, U. S. A.
"All, save one, of these devices were shipped to Dr. W. G. Keys, D. C, who
held a valid license as a chiropractic doctor from the State of California.
Dr. Keys maintained several offices in Los Angeles County at which these
devices were used by him in his practice. The remaining generator was in the
possession of another chiropractor, Dr. C. J. Henaghan, D. C. On December
1, 1947, Dr. Keys leased his practice, offices, and equipment to three lessees,
one of whom was Dr. Henaghan, and these lessees were in possession of the
generators at the time they were seized.
"Prior to December 1947, the Halox Therapeutic Generator Company was
owned by Reverend Roger Aull. Father Aull also founded and owned a
second organization known as the 'Father Aull Foundation.' The company
manufactured the generators and the Foundation promoted the distribution
of them. The devices which were shipped to Dr. Keys were leased to him
under a printed lease agreement bearing the name of the Father Aull Foun-
dation, but which actually designated Reverend Roger Aull as the lessor.
"A bill of sale of the Halox Therapeutic Generator Company, including
the devices involved here, was executed by Reverend Roger Aull in favor of
the claimant, Mracek, under date of December 1, 1947. This bill of sale was
to be effective as of its date, but was not delivered to Mracek until after final
shipment of generators to Dr. Keys on December 3,1947.
devices under seizure were intended for use in the conditions of arthritis,
sinusitis, hay fever, and bronchitis.' The libelant also contends that the
generators were intended for use in other conditions, namely, neuritis, sciatica,
rheumatism, asthma, nervous disorders, ovarian conditions, prostate trouble,
and allergies. The claimant denies this contention. The government bases
its position on the fact that the Father Aull Foundation, in its lease agreement
with Dr. Keys, reserved the power to control all advertising. Samples of
the advertising disseminated by the chiropractors using the seized devices are
a part of the record. Such advertisements show that the generators were
advertised as being appropriate for the treatment of the conditions mentioned
above.' The failure of the Father Aull Foundation to object to such advertis-
ing, which it had reserved the power to control, is convincing evidence that
the generators were intended for use in such conditions.
"At the outset it is clear that the generators did not bear adequate direc-
tions for use. In fact they bore no directions for use. This much is ad-
mitted by the claimant who rests his case on the proposition that the devices
were exempt from this requirement by virtue of the exemption regulations
set out above. It is the claimant's position that the devices were shipped or
delivered to physicians to be dispensed by physicians in their professional
practice. It is at once apparent that the claimant can succeed only if a
chiropractor is a 'physician' within the meaning of the regulations.
"As was pointed out earlier, the regulation provides that the term 'physician'
includes only those physicians who are licensed by law to administer or apply
the drug or device in question. Thus, the persons to whom the devices were
shipped must, first of all, be physicians. Only if they be physicians is it neces-
sary to inquire into the matter of their authority to administer or apply the
device.
"In its broadest sense the term 'physician' includes anyone exerting a
remedial or salutary influence; as a physician of the soul. However, I do not
believe the term as used in the regulation was intended in the broad sense.
In Webster's New International Dictionary (unabridged), 2nd ed., 1949, one
definition of 'physician' is: 'A person skilled in physic or the art of healing.'
In the same volume 'chiropractic' is defined as: 'A system for the practice
of adjusting the joints, especially at the spine, by hand, for the curing of
disease.' Thus a chiropractor is one skilled in the art of healing, in a limited
manner, although not one skilled in physic, since this latter term refers to the
practice of medicine. In Webster's Dictionary, supra, a second definition of
'physician' is: 'one duly authorized to treat diseases especially by medicines; a
doctor of medicine; often distinguished from a surgeon.' [Emphasis added.]
Section 15 of the Chiropractic Law of the State of California, Deering's General
Laws, 1944 ed., Act 4811; provides in part: '. . . any licensee under this act who
uses . . . the term "physician," ... or any other letters, prefixes or suffixes,
the use of which would indicate that he or she was practicing a profession for
which he held no license from the state of California, . . . shall be guilty of a
misdemeanor . . .' [Emphasis added.] It follows that one who is licensed to
practice chiropractic in the state of California is not a physician by virtue of
such license. The record is devoid of any evidence attributing qualifications as
physicians to the chiropractors concerned here.
"There is, in addition, a more compelling reason for holding that the seized
generators were not exempt from the requirement that they bear adequate
directions for use. The exemption regulations define a physician as a physician
who is licensed by law to administer or apply the drug or device in question.
Thus, even if the term 'physician' is broad enough to include chiropractors, it
includes only those chiropractors who are licensed by law to administer or
apply the drug or device.
"The authority of a licensed chiropractor is defined by section 7 of the
Chiropractic Law, supra, which provides:
sec. 7. Certificate to practice. One form of certificate shall be issued by
the board of chiropractic examiners, which said certificate shall be desig-
nated "License to practice chiropractic," which license shall authorize the
holder thereof to practice chiropractic in the state of California as taught
in chiropractic schools or colleges; and, also, to use all necessary mechani-
but shall not authorize the practice of medicine, surgery, osteopathy,
dentistry or optometry, nor the use of any drug or medicine now or here-
after included in materia medica.
"The scope of this authority has not been denned by the Supreme Court of
California, but other appellate courts of the state have had occasion to consider
the question. In People v. Fowler, 32 Cal. App. Supp. 737, 84 P. 2d 326, the court
first considered the meaning of the authorization 'to practice chiropractic . . .
as taught in chiropractic schools or colleges.' The court held that this section
authorized licensees to practice chiropractic as taught in chiropractic schools
or colleges at the time of the enactment of the Chiropractic Law. The court
observed that the term 'chiropractic' had a well-established and quite definite
meaning when the statute was enacted, that is, that chiropractic is a system for
the practice of adjusting the joints, especially at the spine, by hand, for the
curing of disease. The court further held that the words 'as taught in chiro-
practic schools or colleges' did not set at large the meaning of 'chiropractic'
and thereby leave the schools and colleges free to enlarge its meaning by
changes in their curriculum. It at once is obvious that chlorine gas inhalation
therapy administered by a machine does not fall within the meaning of 'chiro-
practic' as set out above, since it in no way involves the manipulation of joints
by hand or otherwise. Furthermore the record contains the affidavits of two
licensed chiropractors who are presently engaged in the training of students
at the Los Angeles College of Chiropractic. One affiant is the Dean of the
College and the other is the Director of the College Clinic. Both state that
they do not know of any school of chiropractic that teaches or has taught
chlorine gas inhalation therapy.
"However, section 7 of the Chiropractic Law contains a further authoriza-
tion, namely, 'to use all necessary mechanical, and hygienic and sanitary
measures incident to the care of the body.' In People v. Fowler, supra, the
court held that this phrase 'is not a definition of, but an addition to, chiro-
practic as used in the previous part of section 7 and authorizes chiropractors
to .use measures which would not otherwise be within the scope of their
licenses.'
"In Re Hartman, 10 Cal. App. 2d 213, 51 P. 2d 1104, the court, in referring
to this clause stated:
. . . that clause of the section refers to general hygienic and sanitary
measures, even though mechanical, and not to the treatment of diseases
and ailments.    [Emphasis added.]
"Thus it is clear that a chiropractor licensed by the State of California is
not authorized to treat diseases and ailments by mechanical means. As we
have seen, the parties are agreed that the generators under seizure were
intended for use in the conditions of arthritis, sinusitis, hay fever, and bron-
chitis. Furthermore, I find that the devices were intended for use in other
conditions. All these conditions, admitted or disputed, are diseases and as
such could not be treated by chiropractors by means of the Halox Therapeutic
Generator. It follows that the seized generators were not exempted by the
regulations since they were not shipped to physicians who were licensed by
law to administer them.
"There is yet a third reason why the seized devices were not exempted by
the administrative regulations. Those regulations require that information
adequate for the use of such device by physicians be readily available. The
record includes the results of an experiment conducted by Mr. Louis C. Weiss,
a chemist employed by the Food and Drug Administration. The purpose of
the experiment was to determine the chlorine concentration of the output of
one of the seized devices at various dial settings. The generator was operated
at each such varied dial setting for approximately three hours and the chlorine
output was measured six times during each three hour test. In all, some
eleven different tests were conducted, each at a different setting. It was
Mr. Weiss' conclusion that it 'was impossible to set the dials and provide for
a constant output of chlorine'. He stated further, 'For instance, during a
typical run, the chlorine output varied in a two-hour period from 407.0 to 12.2
parts per million, a variation of 3300?, although the dial settings were
unchanged.'
chairman of the Department of Pharmacology at the University of Southern
California Medical School. Dr. Thienes states that the use of chlorine gas in
an effective antiseptic concentration would be too irritating to be withstood
by the average individual and that concentrations less than this are ineffective
for any purpose. He states further that chlorine gas to be safely inhaled
for even a short time requires a concentration of less than ten parts per
million. The results of Mr. Weiss' test show that a constant output of such
a safe amount was obtained at only two dial settings. Yet nowhere in the
record is it shown that directions were available suggesting such dial settings.
Furthermore, at these settings the chlorine output varied throughout the three
hour period. Thus it is clear that adequate directions were not available for
the use of the generators.
"Dr. Thienes stated that on the basis of the Weiss affidavit he was of the
opinion that it would be extremely difficult to regulate the output of the Halox
Therapeutic Generator to consistently elicit a safe output of chlorine. He
further stated: 'I would consider the Halox Therapeutic Generator as being
incapable of effective operation in the treatment of any disorder and would
consider that it would be impossible to devise for it any adequate directions
for use.'
"It is not necessary to determine whether adequate directions could be de-
vised, although that possibility may be doubted. It is certain, however, that
adequate directions were not available to the persons to whom the seized
generators were shipped.
"The twenty-two devices, more or less, labeled in part 'Halox Therapeutic
Generator' must be condemned and disposed of by destruction in accordance
with the provisions of 21 U. S. C. A., Sec. 334 (d). Libelant shall recover
its costs.
"Libelant is requested to prepare findings of fact and conclusions of law in
conformity with this opinion."
In accordance with the foregoing opinion, findings of fact and conclusions
of law were handed down. On September 11,1951, judgment of condemnation
was entered, and the court ordered that 3 of the devices be delivered to the
Food and Drug Administration and that the remainder of the devices be
destroyed.
DRUGS  ACTIONABLE  BECAUSE   OF   CONTAMINATION WITH  FILTH