The opinion of the court was delivered by: Miller, Chief Judge.
This is a civil in rem seizure action instituted by the United
States under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301
et seq. The original libel was filed on April 30, 1965, but
described a device or devices that were not then in the
possession of the claimant.
On May 21, 1965, the court granted leave to Harold M. Shock,
Sr., to intervene in this case. The intervention was filed on
June 14, 1965, and called the attention of the court to the fact
that the devices listed in the libel of information were not
within the jurisdiction of the court and were not in the
possession of the claimant. Upon the filing of the intervention,
the court granted the United States leave to amend the original
libel, and on July 26, 1965, the libelant amended the description
of the devices as set forth above, and the devices described in
the caption hereof were seized and have been in the possession of
the United States Marshal since that time.
Generally speaking, the devices consist of two separate
articles or machines for the treatment of ailments, diseases and
maladjustments of the human body by the use of ultrasound.
The articles enumerated in the caption were shipped in
interstate commerce from R.J. Lindquist Company, 2419 West Ninth
Street, Los Angeles, California, to Harold M. Shock, Sr., D.C.,
1612 Main Street, Malvern, Arkansas, during the period between
1965, and May 10, 1965, and it is alleged:
"3. The aforesaid article of device was misbranded
while held for sale after shipment in interstate
commerce, within the meaning of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. § 352(f)(1) in that
its labeling fails to bear adequate directions for
use and it is not exempt from such requirement since
it fails to comply with all of the conditions for
exemption prescribed by regulations
21 C.F.R. § 1.106(d)."
The prayer of the libel is that the court decree the
condemnation of the articles and grant libelant the cost of this
proceeding against the claimant; and that the article be disposed
of as the court may direct pursuant to the provisions of the Act.
The case was tried to the court on May 3, 1966. At the
conclusion of the trial it was submitted subject to the
submission of briefs by counsel in support of their respective
contentions. The briefs have been received and considered along
with all of the evidence and exhibits adduced at the trial.
In the brief submitted by counsel for libelant, it is stated:
"The contested issue is whether the devices were
misbranded because their labeling did not bear
adequate directions for use, within the meaning of
21 U.S.C. § 352(f)(1), and whether the exemption of
21 C.F.R. § 1.106 applies."
The devices bear the following label:
"Caution: Federal law restricts this device to sale
by, or on the order of a practitioner licensed by the
law of the State in which he practices, to use or
order the use of the device."
It is uncontradicted that the devices were shipped by the R.J.
Lindquist Company of Los Angeles, California, to the claimant at
Malvern, Arkansas, during the period between March 11, 1965, and
May 10, 1965; that the devices contain the label above set forth;
and that the claimant is a duly licensed chiropractor with
offices at Malvern, Arkansas.
In answer to an interrogatory submitted by the libelant the
claimant testified that "the intended use by claimant of the
devices seized was to prepare the patient for adjustment. The
devices seized have been used only to prepare patients for
adjustment and to help patients relax after adjustment." The
claimant does not admit any potentiality for harmful effect
through the use by him of the devices for such purposes. In
answer to Interrogatory No. 16 the claimant stated that he is not
licensed to practice medicine in the State of Arkansas; that he
is licensed as a chiropractor in the State of Arkansas; and
denied that the use of ultrasound devices does not come within
the activities permitted by a chiropractor in the State of
The devices proceeded against fall within the definition of the
term "device" as set forth in 21 U.S.C. § 321(h). The term
"labeling" as used in the Act is sufficiently broad to include
all written, printed, or graphic matter appearing upon any
article or upon any of its containers or wrappers, or which
accompanies the article in interstate commerce. 21 U.S.C. § 321(m).
The devices were in the possession of the claimant at the
time the libel was filed, and if they are misbranded, they are
liable to condemnation, 21 U.S.C. § 334(a).
Title 21, U.S.C. § 352(f) provides that a device shall be
deemed to be misbranded "[u]nless its labeling bears (1) adequate
directions for use * * *." Section 1.106 of 21 C.F.R. of the
regulations for the enforcement of the Act defines "adequate
directions for use" as follows:
"`Adequate directions for use' means directions under
which the layman can use a drug or device safely and
for the ...