27130. Misbranding of thyroid tablets. IT. S. v. Armour & Co., a corporation. 
Plea of nolo contendere. Fine, $25 and costs. (F. & D. no. 36089. 
Sample nos. 2S392-B, 28393-B.)
These tablets contained thyroid powder U. S. P. in excess of the quantity 
stated on the label. The %-grain tablets contained not less than % grain of 
thyroid powder U. S. P., and the Mo-grain tablets contained not less than % 
grain and % grain of thyroid powder U. S. P.
On April 22, 1936, the United States attorney for the Northern District of 
Illinois, acting upon a report by the Secretary of Agriculture, filed in the dis- 
trict court an information against Armour & Co., Chicago, Ill., charging ship- 
ment by said corporation in violation of the Food and Drugs Act on or about 
February 23 and March 11, 1935, from the State of Illinois into the State of 
Texas of quantities of thyroid tablets that were misbranded.
The article in the first of the two consignments was alleged to be misbranded 
in that the statement "Thyroid Tablets *4 Grain", borne on the cartons en- 
closing the bottles, and the statement "Thyroid Tablets * * * Each Tablet 
Contains M Grain Thyroid Powder U. S. P." borne on the bottle labels, were 
false and misleading in that they represented that each of the tablets contained 
% grain of thyroid, and that each of the tablets contained M, grain of thyroid 
powder U. S. P. having 0.2 percent iodin in thyroid combination; whereas in 
fact each of the tablets contained more than M grain, namely, not less than 
% grain of thyroid, and each of the tablets contained more than *4 grain of 
thyroid powder U. S. P. having 2 percent iodin in thyroid combination.
The article in the second of the two consignments was alleged to be mis- 
branded in that the statement "Thyroid Tablets Mo Grain", borne on the cartons 
and the statement, "Thyroid Tablets * * * Each Tablet Contains Mo Grain 
Thyroid Powder U. S. P.", borne on the bottle labels, were false and misleading 
in that they represented that each of the tablets contained Mo grain of thyroid, 
and that each of the tablets contained Mo grain of thyroid powder U. S. P.; 
whereas in fact each of the tablets contained more than Mo grain of thyroid, 
and each of the tablets contained more than Mo grain of thyroid powder U. S. P.
On June 26, 1936, a motion to quash the information was filed on behalf of 
the defendant corporation. On December 23, 1936, the court denied the motion 
to quash in an opinion as follows:
SULLIVAN, District Judge: This case involves the interstate shipment by 
Armour & Company of thyroid tablets which the Government alleges are 
adulterated and misbranded, the theory being that the tablets contain a greater 
amount of thyroid powder than is indicated on the label, thus constituting 
adulteration and misbranding within the meaning of Sec. 7 and Sec. 8 of the 
Act of June 30, 1906, known as the Food and Drugs Act. (USCA Title 21, 
Sections 8 and 9.)
The information as amended contains four counts, counts I and III charging 
adulteration, and counts II and IV charging misbranding.
On the adulteration charge the information alleges that the bottles contain- 
ing the tablets bear the following label: "100 Thyroid Tablets, M grain. Each 
Tablet contains %. grain thyroid powder U. S. P. having 0.2 per cent iodin in 
thyroid combination." 
-Count I of the information then goes on to allege that the said article of 
drugs was adulterated: "In that its strength and purity fell below the pro- 
fessed standard and quality under which it was sold, in that each of said tablets 
was represented to contain % grain of thyroid powder U. S. P., having 0.2 
percent iodin in thyroid combination; whereas in truth and in fact each of said 
tablets contained more than M grain thyroid powder U. S. P., having 0.2 
percent iodin in thyroid combination."
Count III is the same as count I, except that it refers to tablets represented 
as containing Mo grain of thyroid powder U. S. P., having 0.2 percent iodin 
in thyroid combination; whereas in fact each of said tablets contains more 
than Mo grain.
As to the misbranding charge, the information alleges, (count II) "That 
said article of drugs, when shipped and delivered for shipment as aforesaid, was 
then and there misbranded within the meaning of said Act of Congress, in that 
the statements, to wit, "Thyroid tablets *4 grain" borne on the cartons as 
aforesaid, and "Thyroid tablets *4 grain, each tablet contains % grain thyroid 
powder U. S. P. having 0.2 percent iodin in Thyroid combination," borne on 
the label attached to the bottles containing the article, as aforesaid, regarding 
the article, and the substance contained therein, were false and misleading in
this, that they represented that each of said tablets contained ^4 grain of 
thyroid, and that each of said tablets contained % grain of thyroid powder 
U. S. P., having 0.2 percent iodin in thyroid combination; whereas in truth 
and in fact, each of said tablets contained more than % grain of thyroid, and 
each of said tablets contained more than \i grain of tnyroid powder U. S. P., 
having 0.2 percent iodin in thyroid combination."
Count IV is identical, except that the tablets therein referred to were repre- 
sented to contain it grain thyroid powder. The case is now before me on de- 
fendant's motion to quash the Amended Information. Section 7, Par. 2 of the 
Food and Drugs Act (Sec. 8, Title 21 USCA) provides: "That for the purposes 
of this Act an article shall be deemed to be adulterated: In case of 
drugs: * * * Second. If its strength or purity falls below the professed 
standard or quality under which it is sold."
Defendant sets out that the Eleventh Decennial Revision of the Phar- 
macopoeia of the United States, published by authority of the United States 
Pharmacopoeia Convention held in 1930, and which has not been superseded 
by any subsequent edition, does not define Thyroid powder, but does define 
Thyroideum (thyroid).
The Government contends that the Pharmacopoeia involved is the Tenth 
Revision rather than the Eleventh, but admits that the standard for thyroid 
set up in both is identical.
Defendant urges that there is no claim in the information that the thyroid 
contained in the thyroid powder fails to comply with the standard set forth 
in the United States Pharmacopoeia, but only that its strength and purity fell 
below the professed standard and quality under which it was sold. That 
thyroid powder is the subject of the sale and shipment, and if the thyroid 
contains "0.2 per cent iodin in thyroid combination" as stated on the label, be- 
cause that is the only claim made as to strength, purity, or quality, then 
there is no adulteration. That the fact that it contains an excess of the amount 
claimed on the label is not a false or misleading statement within the meaning 
of the Food and Drugs Act, unless it is shown that the buyer is injured 
thereby.
On this question the Government takes the position that an excessive amount 
of thyroid, which the Information charges these tablets contain—as well as 
a deficiency thereof—should be construed as falling below the professed stand- 
ard, as set out on the label, thereby constituting adulteration under the 
Statute.
In the case of George A. Breon & Co., vs. United States, 74 Fed. (2) 4, cited 
by defendant in its reply brief, one of the questions involved was whether or 
not the Adulteration Section of the Statute covered drugs containing an excess 
of any ingredient (in that case dessicated thyroid) as well as those where 
strength or purity fall below the professed standard or quality under which it 
was sold. Commenting on this phase of the case the court said: "In the view 
we have taken of the other issues involved however, we do not deem it neces- 
sary to pass upon this question." In the case of United States vs. Resnick, 
et al., and United States vs. Acme Can Company, decided by the Supreme Court 
of the United States on December 7, 1936, defendants were indicted for viola- 
tion of the Standard Container Act, on the ground that they sold two quart 
metal hampers which did not comply with the Act, in that they were not of 
any standard size authorized by the Act, which defined various sized hampers, 
but did not include two quart metal hampers. Defendants demurred on the 
ground that the facts alleged were not sufficient to constitute a violation of the 
Act. The trial court sustained the demurrers and discharged defendants, and 
the United States appealed. The Supreme Court in passing on the case said: 
"It follows that unless the clause of section 5 which forbids manufacture or 
sale of containers 'that do not comply with this Act' makes criminal the manu- 
facture or sale of two-quart hampers, the facts alleged do not constitute any 
defense. Statutes creating crimes are to be strictly construed in favor of the 
accused; they may not be held to extend to cases not covered by the words 
used. United States v. Wiltberger, 5 Wheat. 76. Fasulo v. United States, 
272 U. S. 620. The clause (5) just quoted is crucial; its words are plain and 
having regard to the connection in which they are used, must be given the 
meaning naturally attributable to them. It is obvious that they do not extend 
to hampers other than the nine classes defined in Section 1. The Act applies 
to none of capacity less  than four  quarts.    *   *    *   It  expresses  no   con-
demnation of two-quart hampers. Before one may be punished, it must appear 
that his case is plainly within the statute; there are no constructive offenses." 
The judgment sustaining the demurrers was sustained.
Under the ruling in the above case I am of the opinion that the facts alleged 
in Counts I and III do not constitute adulteration, therefore the Motion to 
Quash as to Counts I and III will be allowed.
I now come to Counts II and IV which charge misbranding.
Section 8 of the Food and Drugs Act (Sec. 9 Title 21 USCA) provides: "That 
the term misbranded as used herein, shall apply to all drugs, or articles of 
food, or articles which enter into the composition of food, the package or label 
of which shall bear any statement, design, or device regarding such article, or 
the ingredients or substances contained therein which shall be false or mis- 
leading in any particular.   *   *   *"
In United States vs. Lexington Mill & Elevator Company, 232 U. S., 399, the 
court said: "The statute upon its face shows that the primary purpose of 
Congress was to prevent injury to the public by the sale and transportation in 
interstate commerce of misbranded and adulterated foods. The legislation 
against misbranding intended to make it possible that the consumer should 
know that an article purchased was what it purported to be; that it might 
be bought for what it really was, and not upon misrepresentations as to 
character and quality."
The Food and Drugs Act was passed for the purpose of protecting the general 
public, to preserve their health and to prevent their being deceived by label 
or brand as to the real character of the article offered for sale. United States 
vs. 95 Barrels of Vinegar, 265 U. S. 438.
Again in the case of United States vs. 95 Barrels of Vinegar, supra, the court 
said: "The statute is plain and direct. Its comprehensive terms condenmn 
every statement, design, and device which may mislead or deceive. Deception 
may result from the use of statements not technically false or which may be 
literally true. The aim of the statute is to prevent that resulting from indirec- 
tion and ambiguity, as well as from statements which are false. It is not 
difficult to choose statements, designs, and devices which will not deceive. 
Those which are ambiguous and liable to mislead should be read favorably to 
the accomplishment of the purpose of the Act. * * * If an article is not 
the identical thing that the brand indicates it to be, it is misbranded."
It is agreed that the tablets here in question contain thyroid, a more or less 
powerful drug used in the treatment of certain diseases. These tablets are 
susceptible of analysis to determine just what ingredients and how much of 
each they do contain, in order that they may be accurately labeled.
I am of the opinion that a drug being here involved, the Act requires a 
correct statement thereof on the label.
The Motion to Quash as to Counts II and IV is denied, and defendant is 
given ten days in which to plead.
On February 25, 1937, a plea of nolo contendere was entered on behalf of 
the defendant corporation and the court imposed a fine of $25 and costs.
HARRY L. BROWN, 
Acting Secretary of Agriculture.