590. Alleged misbranding  of   rabbins  alcohol compound.     U.   S.  v.  Adde,  Inc.
Plea of not guilty.    Case tried to the court sitting as a jury of one;
verdict of not guilty.    (P. D. C. No. 2092. Sample Nos. S21-E, 322-E, 13026-E.
13027-E, 64236-E.)
This case was instituted on charges that the product was, short of the declared
volume.
On August 1, 1940, the United States attorney for the District of Maryland
filed an information against Adde, Inc., a corporation, Baltimore, Md., alleging
shipment on or about November 1 and 29 and December 26 and 27, 1939, from
the State of Maryland into the States of North Carolina and Washington of
quantities of rubbing alcohol compound that was misbranded.
The article was alleged to be misbranded in that the following statements on
the carton and bottle labels, "Contents One Pint," "Contents 16 Fl. Ozs.," and
"Contents 16 Fluid Ozs.," were false and misleading since each of the bottles
did not contain 1 pint or 16 fluid ounces of rubbing alcohol, but did contain a
smaller amount.
On October 20, 1941, a plea of not guilty was entered on behalf of the de-
fendant and the case was tried before the court sitting as a jury of one. At
the conclusion of testimony the court ordered the entry of a verdict of not
guilty and delivered the following oral opinion:
COLEMAN, District Judge. "The court, sitting as a jury, concludes that the
defendant company is entitled to a directed verdict in its favor, for the following
reasons:
"The defendant company is charged with violating Section 502 (b) (2) of
the Act of June 25, 1938, 21 U. S. C. A. Sec. 352 (b) (2), known as the Federal
Food, Drug and Cosmetic Act, which provides that 'A drug or deviee shall be
deemed to be misbranded-(b) if in package form unless it bears a label con-
taining * * * (2) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count: Provided that under clause
(2) of this paragraph reasonable variations shall be permitted, and exemptions
as to small packages shall be established, by regulations prescribed by law.'
"Regulations have been prescribed under this section of the act and they
have the force of law, provided they are consistent with the statute. In other
words, rules promulgated .by an administrative body in support of the legisla-
tion which it is charged with enforcing, are always subject to judicial review.
In the present case the regulation here relied upon by the Government, namely,
subdivision (j) of the regulations prescribed by the Secretary pursuant to1
section 502 of the act, is found by the court to be a reasonable and proper
regulation. It reads as follows, insofar as its provisions relate to the present
inquiry: 'Where the statement expresses the minimum quantity, no variation
below the stated minimum shall be permitted except variations below the
stated weight or measure of a drug caused by ordinary and customary ex-
posure, after such drug is introduced into interstate commerce, to conditions
which normally occur in  good distribution  practice and which  unavoidably
* See also Nos. 546, 551, 554-556, 571, 582, 583, 396.
result in decreased weight or measure. Variations above the stated minimum
shall not be unreasonably large.   *??**.'
"All of the bottles involved in the present suit contain as part of their label
the words "Contents 16 fluid ounces," which this court believes must be con-
strued as expressing a minimum quantity. So the above-quoted regulation
applies.
"It is contended on the part of the Government that subsection (k) of this
same section of the regulations also applies. That reads as follows: 'Where
the statement does not express the minimum quantity-
"'(1) variations from the stated weight or measure of a drug shall be per-
mitted when caused by ordinary and customary exposure, after such drug is
introduced into interstate commerce, to conditions which normally occur in
good distribution practice and which unavoidably result in change of weight or
measure;
'"(2) variations from the stated weight, measure, or numerical count of a
drug or device shall be permitted when caused by unavoidable deviations in
weighing, measuring, or counting the contents of individual packages which
occur in good packing practices.
" 'But under subdivision (2) of this paragraph variations shall not be per-
mitted to such extent that the average of the quantities in the packages com-
prising a shipment or other delivery of the drug or device is below the quantity
stated and no unreasonable shortage in any package shall be permitted, even
though overage^ in other packages in the same shipment or delivery compensate
for such shortage.'
"Even if we assume this last quoted regulation to be applicable to the
present case, the testimony introduced clearly fails to establish that 'the average
of the quantities in the packages comprising a shipment' is *below the quantity
stated.' The Government has not introduced any testimony sufficiently exten-
sive to support that contention.
"The following regulation (1), prescribed under section 502, is also applicable
to the present case: 'The extent of variations from the stated quantity of the
contents permissible under paragraphs (J) and (k) of this regulation in the
case of each shipment or other delivery shall be determined by the facts in
such case.'
"When we apply the rule laid down in regulations (j) and (1) just referred
to, the court is completely satisfied that the Government has failed to sustain
the burden, imposed upon it in a case of this kind, of proving beyond a
reasonable doubt that the defendant company is guilty of violating the act.
"It is true that proof of intent on the part of an alleged offender to do the
forbidden act is not a condition precedent. The act prohibits doing certain things,
and if the Government proves that they have been done then the person or firm
shown to have been guilty of the violation, is liable under the act for the penalties
imposed, regardless of intent. However, it seems to the court in the present
case that the Government is taking what is, in substance, a contradictory position.
First, it says that it believes the variation or deficiency in the weights of the
samples taken is a clear violation of the law, as interpreted by the regulations
which have just been referred to. and yet, at the same time, the Government
admits that following these alleged violations, the loading facilities of the
defendant company were never inspected, but that the Government accepted
statements made by State of Maryland inspectors that such facilities were
adequate and satisfactory. And what is more important, the record in the
present case is totally devoid of any testimony tending to show what might be
the shrinkage or evaporation in samples taken promptly after the bottles are
loaded, and laid aside for a period of time approximating the time that elapsed
between the shipment and the examination of the bottles that were actually
sampled.   This lack of testimony seems to the court to be very vital.
"It is clear that under some conditions, merely through evaporation greater
shrinkages than those with respect to which Government witnesses have testified,
occur in alcohol preparations of this character. This is proved by the analysis,
made in the course of this trial at the court's request, of the contents of one of
the bottles taken from one of the very shipments from which the Government
took samples and made its measurements.
"The Government has not itself arrived at a standard by percentages which it is
prepared to adopt. It simply says that the shrinkage here is on the average too
great, after sampling some 7(Kodd samples out of many hundreds of bottles. There
is no proof but what the deficiency complained of may just as well have been
caused by the very sort of thing which the regulations allow to be taken into
account, namely, 'ordinary and customary exposure, after such drug is introduced
into interstate commerce, to conditions which normally occur in good distribution
practice and which unavoidably result in decreased weight or measure,' as by
short loading.
"To repeat, it seems to the court that if the Government desires to prosecute
defendants in a case of this kind, it should support its case with more accurate
data. The court realizes that it is not possible to lay down a rule of thumb
requirement. There is bound to be some tolerance. In the present case the
Government asserts that a proven shrinkage in the samples taken in the neigh-
borhood of 1 ounce for every 16 ounces, which is the minimum quantity each
bottle is labeled to contain, is an excessive shrinkage. Yet, as has just been
noted, the measurement in open court indicates that perhaps such a shrinkage is
due 'to ordinary and customary exposure.' There is no testimony in the present
case as to what the actual extent of the evaporation of alcohol, or water, or both,
would be over a given period of time in a preparation of this kind, under stated
temperature conditions. Perhaps any such' tests would produce variations which
would not enable one to adopt a percentage rule, in any event. But the sum
and substance of this court's conclusion is that the Government can not properly
rely solely upon samples taken long after the shipments had been made, under
variable temperature conditions, which do; not represent an average of anything
like an entire shipment, or shipment, especially since the Government has given
to this defendant a clean bill of health as to its present loading facilities, without
having its own representatives inspect such facilities and determine, and be pre-
pared to prove that there has been short loading.
"At first blush it would seem that if a man says to the public, by the label on his
bottle, that he has^ put 16 ounces of his preparation in that bottle when as a
matter of fact when the bottle reaches the consumer there are only 15 or 14-
ounces in it, there is something wrong. But in the present case the evidence
shows that a considerable portion of the liquid is highly volatile, being alcohol.
It also shows that the Government has failed to determine by direct evidence
whether the shortage actually occurred in the loading or by evaporation. It
merely draws the conclusion from a relatively small number of samples that this
shortage could not have occurred except in the loading. If the Government had
investigated defendant's loading methods, and had immediately laid aside a
number of the loaded bottles under conditions similar to the conditions which
existed with respect to the samples that were tested, it could then be determined
with accuracy whether there was shrinkage after loading, and to what extent, if
any, there was short loading.
"What the court has said is not to be taken as meaning that one who prepares
and sells a volatile preparation is not himself required to take that characteristic
into account in bottling his preparation. Of course he is. But he is given the
"benefit of the tolerance rule contained in the regulations just referred to. And
since this is a criminal case, and the burden of proof is upon the Government to
establish to the satisfaction of the court sitting as a jury beyond a reasonable
doubt that the law has been violated, that rule must be given full force and
effect also.
.   "The verdict is accordingly not guilty."