332 U.S.

689
68 S.Ct. 331
92 L.Ed. 297

UNITED STATES
v.
SULLIVAN.
No. 121.
Argued Dec. 9, 1947.
Decided Jan. 19, 1948.

Mr. Robert L. Stern, of Washington, D.C., for petitioner.

Messrs. Robert M. Arnold and J. Madden Hatcher, both of Columbus, Ga.,
for respondent.
Mr. Justice BLACK delivered the opinion of the Court.

Respondent, a retail druggist in Columbus, Georgia, was charged in two counts

of an information with a violation of 301(k) of the Federal Food, Drug, and
Cosmetic Act of 1938. That section prohibits 'the doing of any * * * act with
respect to, a * * * drug * * * if such act is done while such article is held for
sale after shipment in interstate commerce and results in such article being
misbranded.'1 Section 502(f) of the Act declares a drug 'to be misbranded * * *
unless its labeling bears (1) adequate directions for use; and (2) such adequate
warnings against use * * * dangerous to health, or against unsafe dosage * * *
as are necessary for the protection of users.' The information charged
specifically that the respondent had performed certain acts which resulted in
sulfathiazole being 'misbranded' while 'held for sale after shipment in interstate
commerce.'

The facts alleged were these: A laboratory had shipped in interstate commerce
from Chicago, Illinois, to a consignee at Atlanta, Georgia, a number of bottles,
each containing 1,000 sulfathiazole tablets. These bottles had labels affixed to
them, which, as required by 502(f)(1) and (2) of the Act, set out adequate
directions for the use of the tablets and adequate warnings to protect ultimt e
consumers from dangers incident to this use.2 Respondent bought one of these

properly labeled bottles of sulfathiazole tablets from the Atlanta consignee,

transferred it to his Columbus, Georgia, drugstore, and there held the tablets for
resale. On two separate occasions twelve tablets were removed from the
properly labeled and branded bottle, placed in pill boxes, and sold to customers.
These boxes were labeled 'sulfathiazole.' They did not contain the statutorily
required adequate directions for use or warnings of danger.
3

Respondent's motion to dismiss the information was overruled, a jury was

waived, evidence was heard, and respondent was convicted under both counts.
D.C., 67 F.Supp. 192.

The Circuit Court of Appeals reversed. 161 F.2d 629, 630. The court thought
that as a result of respondent's action the sulfathiazole became 'misbranded'
within the meaning of the Federal Act, and that in its 'broadest possible sense'
the Act's language 'may include what happened.' However, it was also of the
opinion that the Act ought not to be taken so broadly 'but held to apply only to
the holding for the first sale by the importer after interstate shipment.' Thus the
Circuit Court of Appeals interpreted the statutory language of 301(k) 'while
such article is held for sale after shipment in interstate commerce' as though
Congress had said 'while such article is held for sale by a person who had
himself received it by way of a shipment in interstate commerce.' We granted
certiorari to review this important question concerning the Act's coverage.

First. The narrow construction given 301(k) rested not so much upon its
language as upon the Circuit Court's view of the consequences that might result
from the broader interpretation urged by the Government. The court pointed out
that the retail sales here involved were made in Columbus nine months after
this sulfathiazole had been shipped from Chicago to Atlanta. It was impressed
by the fact that, if the statutory language 'while such article is held for sale after
shipment in interstate commerce' should be given its literal meaning, the
criminal provisions relied on would 'apply to all intrastate sales of imported
drugs after any number of intermediate sales within the State and after any
lapse of time; and not only to such sales of drugs, but also to similar retail sales
of foods, devices and cosmetics, for all these are equally covered by these
provisions of the Act.' The court emphasized that such consequences would
result in farreaching inroads upon customary control by local authorities of
traditionally local activities, and that a purpose to afford local retail purchasers
federal protection from harmful foods, drugs and cosmetics should not be
ascribed to Congress in the absence of an exceptionally clear mandate, citing
Federal Trade Commission v. Bunte Bros., 312 U.S. 349, 61 S.Ct. 580, 85
L.Ed. 881. Another reason of the court for refraining from construing the Act
as applicable to articles misbranded while held for retail sale, even though the

articles had previously been shipped in interstate commerce, was its opinion
that sc h a construction would raise grave doubts as to the Act's
constitutionality. In support of this position the court cited. National Labor
Relations Board v. Jones & Laughlin Steel Coroporation, 301 U.S. 1, 30, 57
S.Ct. 615, 620, 81 L.Ed. 893, 108 A.L.R. 1352; and Schechter Poultry
Corporation v. United States, 295 U.S. 495, 55 S.Ct. 837, 79 L.Ed. 1570, 97
A.L.R. 947.
6

A restrictive interpretation should not be given a statute merely because

Congress has chosen to depart from custom or because giving effect to the
express language employed by Congress might require a court to face a
constitutional question. And none of the foregoing cases, nor any other on
which they relied, authorizes a court in interpreting a statute to depart from its
clear meaning. When it is reasonably plain that Congress meant its Act to
prohibit certain conduct, no one of the above references justifies a distortion of
the congressional purpose, not even if the clearly correct purpose makes
marked deviations from custom or leads inevitably to a holding of
constitutional invalidity. Although criminal statutes must be so precise and
unambiguous that the ordinary person can know how to avoid unlawful
conduct, see M. Kraus & Bros., Inc., v. United States, 327 U.S. 614, 621, 622,
66 S.Ct. 705, 707, 708, 90 L.Ed. 894, even in determining whether such statutes
meet that test, they should be given their fair meaning in accord with the
evident intent of Congress. United States v. Raynor, 302 U.S. 540, 552, 58
S.Ct. 353, 358, 82 L.Ed. 413.

Second. Another consideration that moved the Circuit Court of Appeals to give
the statute a narrow construction was its belief that the holding in this case with
reference to misbranding of drugs by a retail druggist would necessarily apply
also to 'similar retail sales of foods, devices and cosmetics, for all these,' the
court said, 'are equally covered by these provisions of the Act.' And in this
Court the effect of such a possible coverage of the Act is graphically magnified.
We are told that its application to these local sales of sulfathiazole would
logically require all retail grocers and beauty parlor operators to reproduce the
bulk container labels on each individual item when it is taken from the
container to sell to a purchaser. It is even prophesied that, if 301(k) is given
the interpretation urged by the Government, it will later be applied so as to
require retail merchants to label sticks of candy and sardines when removed
from their containers for sale.

The scope of the offense which Congress defined is not to be judicially

narrowed as applied to drugs by envisioning extreme possible applications of its
different misbranding provisions which relate to food, cosmetics, and the like.

There will be opportunity enough to consider such contingencies should they

ever arise. It may now be noted, however, that the Administrator of the Act is
given rather broad discretionbroad enough undoubtedly to enable him to
perform his duties fairly without wasting his efforts on what may be no more
than technical infractions of law. As an illustration of the Administrator's
discretion, 306 permits him to excuse minor violations with a warning if he
believes that the public interest will thereby be adequately served. And the
Administrator is given extensive authority under 405, 503 and 603 to issue
regulations exempting from the labeling requirements many articles that
otherwise would fall within this portion of the Act. The provisions of 405
with regard to food apparently are broad enough to permit the relaxation of
some of the labeling requirements which might otherwise impose a burden on
retailers out of proportion to their value to the consumer.
9

Third. When we seek the meaning of 301(k) from its language we find that
the offense it creates and which is here charged requires the doing of some act
with respect to a drug (1) which results in its being misbranded, (2) while the
article is held for sale 'after shipment in interstate o mmerce.' Respondent has
not seriously contended that the 'misbranded' portion of 301(k) is ambiguous.
Section 502(f), as has been seen, provides that a drug is misbranded unless the
labeling contains adequate directions and adequate warnings. The labeling here
did not contain the information which 502(f) requires. There is a suggestion
here that, although alteration, mutilation, destruction, or obliteration of the
bottle label would have been a 'misbranding,' transferring the pills to nonbranded boxes would not have been, so long as the labeling on the empty bottle
was not disturbed. Such an argument cannot be sustained. For the chief purpose
of forbidding the destruction of the label is to keep it intact for the information
and protection of the consumer. That purpose would be frustrated when the
pills the consumer buys are not labeled as required, whether the label has been
torn from the original container or the pills have been transferred from it to a
non-labeled one. We find no ambiguity in the misbranding language of the Act.

10

Furthermore, it would require great ingenuity to discover ambiguity in the

additional requirement of 301(k) that the misbranding occur 'while such
article is held for sale after shipment in interstate commerce.' The words
accurately describe respondent's conduct here. He held the drugs for sale after
they had been shipped in interstate commerce from Chicago to Atlanta. It is
true that respondent bought them over six months after the interstate shipment
had been completed by their delivery to another consignee. But the language
used by Congress broadly and unqualifiedly prohibits misbranding articles held
for sale after shipment in interstate commerce, without regard to how long after
the shipment the misbranding occurred, how many intrastate sales had

intervened, or who had received the articles at the end of the interstate
shipment. Accordingly we find that the conduct of the respondent falls within
the literal language of 301(k).
11

Fourth. Given the meaning that we have found the literal language of 301(k)
to have, it is thoroughly consistent with the general aims and purposes of the
Act. For the Act as a whole was designed primarily to protect consumers from
dangerous products. This Court so recognized in United States v. Dotterweich,
320 U.S. 277, 282, 64 S.Ct. 134, 137, 88 L.Ed. 48, after reviewing the House
and Senate Committee Reports on the bill that became law. Its purpose was to
safeguard the consumer by applying the Act to articles from the moment of
their introduction into interstate commerce all the way to the moment of their
delivery to the ultimate consumer. Section 301(a) forbids the 'introduction or
delivery for introduction into interstate commerce' of misbranded or adulterated
drugs; 301(b) forbids the misbranding or adulteration of drugs while 'in
interstate commerce'; and 301(c) prohibits the 'receipt in interstate commerce'
of any misbranded or adulterated drug, and 'the delivery or proffered delivery
thereof for pay or otherwise.' But these three paragraphs alone would not
supply protection all the way to the consumer. The words of paragraph (k)
'while such article is held for sale after shipment in interstate commerce'
apparently were designed to fill this gap and to extend the Act's coverage to
every article that had gone through interstate commerce until it finally reached
the ultimate consumer. Doubtless it was this purpose to insure federal
protection until the very moment the articles passed into the hands of the
consumer by way of an intrastate transaction that moved the House Committee
on Interstate and Foreign Commerce to report on this section of the Act as
follows: 'In order to extend the protection of consumers contemplated by the
law to the full extent constitutionally possible, paragraph (k) has been inserted
prohibiting the changing of labels so as to misbrand articles held for sale after
interstate shipment.'3 We hold that 301(k) prohibits the misbranding h arged
in the information.

12

Fifth. It is contended that the Act as we have construed it is beyond any

authority granted Congress by the Constitution and that it invades the powers
reserved to the States. A similar challenge was made against the Pure Food and
Drug Act of 1906, 34 Stat. 768, 21 U.S.C.A. 1 et seq., and rejected, in
McDermott v. State of Wisconsin, 228 U.S. 115, 33 S.Ct. 431, 57 L.Ed. 754, 47
L.R.A.,N.S., 984, Ann.Cas.1915A, 39. That Act did not contain 301(k), but it
did prohibit misbranding and authorized seizure of misbranded articles after
they were shipped from one State to another, so long as they remained 'unsold.'
The authority of Congress to make this requirement was upheld as a proper
exercise of its powers under the commerce clause. There are two variants

between the circumstances of that case and this one. In the McDermott case the
labels involved were on the original containers; here the labels are required to
be put on other than the original containersthe boxes to which the tablets
were transferred. Also, in the McDermott case the possessor of the labeled cans
held for sale had himself receive them by way of an interstate sale and
shipment; here, while the petitioner had received the sulfathiazole by way of an
intrastate sale and shipment, he bought it from a wholesaler who had received it
as the direct consignee of an interstate shipment. These variants are not
sufficient we think to detract from the applicability of the McDermott holding
to the present decision. In both cases alike the question relates to the
constitutional power of Congress under the commerce clause to regulate the
branding of articles that have completed an interstate shipment and are being
held for future sales in purely local or intrastate commerce. The reasons given
for the McDermott holding therefore are equally applicable and persuasive
here. And many cases decided since the McDermott decision lend support to
the validity of 301(k). See, e.g., United States v. Walsh, 331 U.S. 432, 67
S.Ct. 1283; Wickard v. Filburn, 317 U.S. 111, 63 S.Ct. 82, 87 L.Ed. 122;
United States v. Wrightwood Dairy Co., 315 U.S. 110, 62 S.Ct. 523, 86 L.Ed.
726; United States v. Darby, 312 U.S. 100, 657, 61 S.Ct. 451, 85 L.Ed. 609,
132 A.L.R. 1430; see United States v. Olsen, 9 Cir., 161 F.2d 669.
13

Reversed.

14

Mr. Justice RUTLEDGE, concurring.

15

This case has been presented as if the Federal Food, Drug, and Cosmetic Act of
1938 had posed an inescapable dilemma. It is said that we must either (1)
ignore Congress' obvious intention to protect ultimate consumers of drugs
through labeling requirements literally and plainly made applicable to the sales
in this case or (2) make criminal every corner grocer who takes a stick of candy
from a properly labeled container and sells it to a child without wrapping it in a
similar label.

16

The trouble-making factor is not found in the statute's provisions relating

specifically to drugs. Those provisions taken by themselves are clear and
unequivocal in the expressed purpose to protect the ultimate consumer by the
labeling requirements. So is the legislative history. Standing alone, therefore,
the drug provisions would cover this case without room for serious question.

17

However, those provisions do not stand entirely separate and independent in the
Act's structure. In some respects, particularly in 301(k), they are interlaced

with provisions affecting food and cosmetics. And from this fact is drawn the
conclusion that this decision necessarily will control future decisions
concerning those very different commodities.
18

If the statute as written required this, furnishing no substantial basis for

differentiating such cases, the decision here would be more difficult than I
conceive it to be. But I do not think the statute has laid the trap with which we
are said to be faced. Only an oversimplified view of its terms and effects could
produce that result.

19

The Act is long and complia ted. Its numerous provisions treat the very
different subjects of drugs, food and cosmetics alike in some respects,
differently in others. The differences are as important as the similarities, and
cannot be ignored. More is necessary for construction of the statute than
looking merely to the terms of 301(k) and 502(f).

20

It is true that 301(k) deals indiscriminately with food, drugs, devices and
cosmetics, on the surface of its terms alone. Hence it is said that the transfer of
sulfathiazole, a highly dangerous drug, from a bulk container to a small box for
retail sale, could not be 'any other act' unless a similar transfer of candies,
usually harmless, also would be 'any other act.' From this hypothesis it is then
concluded that the phrase must be interpreted with reference to the
particularities which precede it, namely,' alteration, mutilation, destruction,
obliteration or removal' of any part of the label, and must be limited by those
particularities.

21

That construction almost, if not quite, removes 'any other act' from the section.
And by doing so it goes far to emasculate the section's effective enforcement,
especially in relation to drugs. Any dealer holding drugs for sale after shipment
in interstate commerce could avoid the statute's effect simply by leaving the
label intact, removing the contents from the bulk container, and selling them,
however deadly, in broken parcels without label or warning.

22

I do not think Congress meant the phrase to be so disastrously limited. For the
'doing of any other act with respect to, a food, drug, device, or cosmetic' is
prohibited by 301(k) only 'if such act * * * results in such article being
misbranded.' And the statute provides, not a single common definition of
misbranding for foods, drugs and cosmetics, but separate and differing sections
on misbranded foods, misbranded drugs and devices, and misbranded
cosmetics. 403, 502, 602.

23

The term 'misbranded' as used in 301(k) therefore is not one of uniform

connotation. On the contrary, its meaning is variable in relation to the different
commodities and the sections defining their misbranding. So also necessarily is
the meaning of 'any other act,' which produces those misbranding
consequences. Each of the three sections therefore must be taken into account
in determining the meaning and intended scope of application for 301(k) in
relation to the specific type of commodity involved in the particular sale, if
Congress' will is not to be overridden by broadside generalization glossed upon
the statute. As might have been expected, Congress did not lump food, drugs
and cosmetics in one indiscriminate hopper for the purpose of applying
301(k), either in respect to misbranding or as to 'any other act' which produces
that consequence. Brief reference to the several misbranding sections
incorporated by reference in 301(k) substantiates this conclusion.

24

The three sections contain some common provisions. 1 But the fact that each
section is also different from the other two in important respects indicates that
each broad subdivision of the Act presents different problems of interpretation.
Neither the misbranded foods section nor the misbranded cosmetics section
contains any provision directly comparable to 502(f), which the respondent
here has violated. That section, however, is to be contrasted with 403(k), one
of the subsections dealing with misbranded foods. Comparison of the two
provisions indicates that the doing of a particular act with respect to a drug may
result in misbranding, whereas the same method of selling food would be
proper.

25

Section 502(f) provides that a drug shall be deemed to be misbranded:

26

'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 requirement.'

27

This provision, dealing with directions for use and warnings against improper
use, in terms is designed 'for the protection of users.' To be effective, this
protection requires regulations of the label which the container bears when the
drug reaches the ultimate consumer.2 The legislative history leaves no doubt
that the draftsmen and sponsors realized the importance of having dangerous

drugs properly labeled at the time of use, not just at the time of sale.3 The intent
to protect the public health is further emphasized by the limited scope of the
proviso, which directs the Administrator to make exemptions only when
compliance with clause (1) 'is not necessary for the protection of the public
health.'
28

Section 403(k), which contains the principal basis for 'making every retail
grocer a criminal,' is very different. By its terms food is deemed to be
misbranded:

29

'If it bears or contains any artificial flavoring, artificial coloring, or chemical

preservative, unless it bears labeling stating that fact: Provided, That to the
extent that compliance with the requirements of this paragraph is impracticable,
exemptions shall be established by regulations promulgated by the
Administrator. The provisions of this paragraph and paragraphs (g) and (i) with
respect to artificial coloring shall not apply in the case of butter, cheese, or ice
cream.'

30

The section, in contrast to 502(f)'s coverage of drugs, applies not to all foods
shipped interstate, but only to the restricted classes containing artificial
flavoring, or coloring, or chemical preservatives. The labeling requirement is
much simpler. And the proviso confers a much broader power of exemption
upon the Administrator than does the proviso of 502(f). Under the latter he is
given no power to exempt on the ground that compliance is impracticable. He
cannot weigh business convenience against protection of the public health.
Only where he finds that labeling is not necessary to that protection is he
authorized to create an exemption for drugs and devices. Health security is not
only the first, it is the exclusive, criterion.

31

Under 403(k), however, in dealing with foods the Administrator can dispense
with labels much more broadly. In terms the criterion for his action becomes
'the extent that compliance * * * is impracticable' rather than, as under 502(f),
'where any requirement of clause (1) (adequate directions for use) * * * is not
necessary for the protection of the public health.' Practical considerations
affecting the burden of compliance by manufacturers and retailers, irrelevant
under 502(f), become controlling under 403(k). Thus under the statute's
intent a much more rigid and invariable compliance with the labeling
requirements for drugs is contemplated than for those with foods, apart from its
greatly narrower coverage of the latter. And the difficulty of compliance with
those requirements for such articles as candies explains the difference in the
two provisos.4

32

These differences, and particularly the differences in the provisos, have a direct
and an intended relation to the problem of enforcement. The labeling
requirements for foods are given much narrower and more selective scope for
application than those for drugs, a difference magnified by the conversely
differing room allowed for exemptions. What is perhaps equally important, the
provisos are relevant to enforcement beyond specific action taken by the
Administrator to create exemptions.

33

His duty under both sections is cast in mandatory terms. Whether or not he can
be forced by mandamus to act in certain situations, his failure to act in some
would seem to be clearly in violation of his duty. Obviously there must be
many more instances where compliance with the labeling requirements for
foods will be 'impracticable' than where compliance with the very different
requirements for drugs will not be 'necessary for the protection of the public
health.' That difference is obviously important for enforcement, particularly by
criminal prosecution. I think it is one which courts are entitled to take into
account when called upon to punish violations. The authors of the legislation
recognized expressly that 'technical, innocent violations * * * will frequently
arise.' S.Rep.No. 152, 75th Cong., 1st Sess. 4. In other words, there will be
conduct which may be prohibited by the Act's literal wording, but which
nevertheless should be immune to prosecution.

34

When that situation arises, as it often may with reference to foods, by virtue of
the Administrator's failure to discharge his duty to create exemptions before the
dealer's questioned action takes place, that failure in my judgment is a matter
for the court's consideration in determining whether prosecution should
proceed. Whenever it is made to appear that the violation is a 'technical,
innocent' one, an act for which the Administrator should have made exemption
as required by 403(k), the prosecution should be stopped. This Court has not
hesitated to direct retroactive administrative determination of private rights
when that unusual course seemed to it the appropriate solution for their
determination. Addison v. Holly Hill Fruit Products, 322 U.S. 607, 64 S.Ct.
1215, 88 L.Ed. 1488, 153 A.L.R. 1007. If that is permissible in civil litigation,
there is much greater reason for the analogous step of taking into account in a
criminal prosecution an administrative officer's failure to act when the
commanded action, if taken, would have made prosecution impossible.

35

It is clear therefore that the corner grocer occupies no such position of jeopardy
under this legislation as the druggist, and that the meaning of 301(k) is not
identical for the two, either as to what amounts to misbranding or as to what is
'the doing of any * * * act' creating that result. The supposed dilemma is false.
Congress had power to impose the drug restrictions, they are clearly applicable

to this case, the decision does not rule the corner grocer selling candy, and the
judgment should be reversed. I therefore join in the Court's judgment and
opinion to that effect.
36

Mr. Justice FRANKFURTER, dissenting.

37

If it takes nine pages to determine the scope of a statute, its meaning can hardly
be so clear that he who runs may read, or that even he who reads may read.
Generalities regarding the effect to be given to the 'clear meaning' of a statute
do not make the meaning of a particular statute 'clear.' The Court's opinion
barely faces what, on the balance of considerations, seems to me to be the
controlling difficulty in its rendering of 301(k) of the Federal Food, Drug, and
Cosmetic Act, 52 Stat. 1040, 1042, 21 U.S.C. 331(k), 21 U.S.C.A. 331(k).
That section no doubtr elates to articles 'held for sale after shipment in interstate
commerce and results in such article being misbranded.' But an article is
'misbranded' only if there is 'alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing of any other act
with respect to, a food, drug, device, or cosmetic.' Here there was no 'alteration,
mutilation, destruction, obliteration, or removal' of any part of the label. The
decisive question is whether taking a unit from a container and putting it in a
bag, whether it be food, drug or cosmetic, is doing 'any other act' in the context
in which that phrase is used in the setting of the Federal Food, Drug, and
Cosmetic Act and particularly of 301(k).1

38

As bearing upon the appropriate answer to this question, it cannot be that a

transfer from a jar, the bulk container, to a small paper bag, without transferring
the label of the jar to the paper bag, is 'any other act' when applied to a drug,
but not 'any other act' when applied to candies or cosmetics. Before we reach
the possible discretion that may be exercised in prosecuting a certain conduct, it
must be determined whether there is anything to prosecute. Therefore, it cannot
be put off to some other day to determine whether 'any other act' in 301(k)
applies to the ordinary retail sale of candies or cosmetics in every drug store or
grocery throughout the land, and so places every corner grocery and drug store
under the hazard that the Administrator may report such conduct for
prosecution. That question is now here. It is part of this very case, for the
simple reason that the prohibited conduct of 301(k) applies with equal force,
through the same phrase, to food, drugs and cosmetics insofar as they are
required to be labeled. See 403, 502, and 602 of the Act.

39

It is this inescapable conjunction of food, drugs and cosmetics in the

prohibition of 301(k) that calls for a consideration of the phrase 'or the doing
of any other act,' in the context of the rest of the sentence and with due regard

for the important fact that the States are also deeply concerned with the
protection of the health and welfare of their citizens on transactions peculiarly
within local enforcing powers. So considered, 'the doing of any other act'
should be read with the meaning which radiates to that loose phrase from the
particularities that precede it, namely 'alteration, mutilation, destruction,
obliteration or removal' of any part of the label. To disregard all these
considerations and then find 'a clear meaning' is to reach a sum by omitting
figures to be added. There is nothing in the legislative history of the Act,
including the excerpt from the Committee Report on which reliance is placed,
to give the slightest basis for inferring that Congress contemplated what the
Court now finds in the statute. The statute in its entirety was of course intended
to protect the ultimate consumer. This is no more true in regard to the
requirements pertaining to drugs than of those pertaining to food. As to the
reach of the statutethe means by which its ultimate purpose is to be achieved
the legislative history sheds precisely the same light on the provisions
pertaining to food as on the provisions pertaining to drugs. If differentiations
are to be made in the enforcement of the Act and in the meaning which the
ordinary person is to derive from the Act, such differentiations are
interpolations of construction. They are not expressions by Congress.
40

In the light of this approach to the problem of construction presented by this

Act, I would affirm the judgment below.

41

Mr. Justice REED and Mr. Justc e JACKSON join in this dissent.

'Sec. 301. The following acts and the causing thereof are hereby prohibited:
'(k) The alteration, mutilation, destruction, obliteration, or removal of the whole
or any part of the labeling of, or the doing of any other act with respect to, a
food, drug, device, or cosmetic, if such act is done while such article is held for
sale after shipment in interstate commerce and results in such article being
misbranded.' 52 Stat. 1042, 21 U.S.C. 331(k), 21 U.S.C.A. 331(k).

The following inscription appeared on the bottle labels as a compliance with

502(f)(1) which requires directions as to use: 'Caution.To be used only by or
on the prescription of a physician.' This would appear to constitute adequate
directions since it is required by regulation issued by the Administrator
pursuant to authority of the Act. 21 C.F.R.Cum.Supp. 2.106(b) (3). The
following appeared on the label of the bottles as a compliance with 502(f)(2)
which requires warnings of danger: 'Warning.In some individuals
Sulfathiazole may cause severe toxic reactions. Daily blood counts for

evidence of anemia or leukopenia and urine examinations for hematuria are

recommended.
'Physicians should familiarize themselves with the use of this product before it
is administered. A circular giving full directions and contraindications will be
furnished upon request.'
3

H.Rep. 2139, 75th Cong., 3d Sess., 3.

E.g., 403(a), 502(a) and 602(a) are in identical language.

See S.Rep.No.361, 74th Cong., 1st Sess. 19.

See H.R.Rep.No.2139, 75th Cong., 3d Sess. 8.

'The proviso of this paragraph likewise requires the establishment of

regulations exempting packages of assorted foods from the naming of
ingredients or from their appearance in the order of predominance by weight
where, under good manufacturing practice, label declaration of such
information is impracticable. This provision will be particularly applicable, for
example, to assorted confections, which under normal manufacturing practices
may vary from package to package not only with respect to identity of
ingredients but also in regard to the relative proportions of such ingredients as
are common to all packages.' S.Rep.No.493, 73d Cong., 2d Sess. (1912). The
proviso discussed is in 403(i), not in 403(k); but the discussion brings out
the sort of considerations which require exemption when compliance is
impracticable.

'The alteration, mutilation, destruction, obliteration, or removal of the whole or

any part of the labeling of, or the doing of any other act with respect to, a food,
drug, device, or cosmetic, if such act is done while such article is held for sale
after shipment in interstate commerce and results in such article being
misbranded.'