Letter from Lani Guinier to Professor Christopher F. Edley, Jr.

    3n t o  B v c a n m  (Eourt of t o  Hnttrii
V .jr .‘ *4 ’. . ‘- l i  _ - iL  f. _ r f .  ,■' - .>■*-••_• *••«'--' * *■• ■ r  - ~  % t*"

No. 83-1878

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT 
OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

BRIEF FOR THE PETITIONER

Rex E. Lee 
Solicitor General

T hom as Scarlett 
Chief Counsel

Richard K. Willard
Acting Assistant 

Attorney General
Kenneth 3. Geller 

Deputy Solicitor General
Samuel A. Alito, Jr.

Assist-ant to the Solicitor 
General

Leonard Sckaitman 
John M. Rogers 

A ttomeys
Department of Justice 
Washington. D.C. 2053V  
(202  ) 633-2217

M ichael  P. P eskoe
.4 ssr-ciai'. Ch sc;

for Dr.ip -
Food and Drug Administration 
Rockville, Maryland 20857



QUESTIONS PRESENTED

1. Whether the Administrative Procedure Act,, 5 
U.S.C. 701-706, authorizes judicial review of the 
Food and Drug Administration’s decision not to reg­
ulate the states’ use, in carrying out capital pun is! 
ment by lethal injection, of drugs that have been 
approved for other purposes but that have not been 
found to he “safe and effective” as a means of caus­
ing death.

2. If the Food and Ding Administration’s deci­
sion not to regulate the states’ use of drugs in carry­
ing out capital punishment by lethal injection is sub­
ject to judicial review, whether that decision was ar­
bitrary and capricious.

(i)



II

PARTIES TO THE PROCEEDING

Margaret M. Heckler, Secretary of Health and 
Human Services, is the only petitioner. In addition 
to Larry Leon Chaney, the respondents are Alton 
Franks, Carl Morgan, Charles W. Davis, Robyn 
Parks, Doyle Skillern, Jerry Joe Bird, and Henry 
Martinez Porter.

TABLE OF CONTENTS
Page

IOpinions below

Jurisdiction ...........     1

Statutes involved ........................................    2

Statement ...............................................     2

Introduction and summary of argument........................  9

Argument:

I. The Food and Drug Administration’s decision 
not to regulate the states’ use of lethal drugs for 
capital punishment is not subject to judicial re­
view under the Administrative Procedure Act l.r>
A. Prosecutorial and administrative enforce­

ment decisions are generally exempt from 
judicial review .......................... ........................  |f>

B. The FDA’s decision is exempt from review 
because the governing statutes do not limit
the agency’s discretion ..............  2f>
1. The FDCA does not limit the FDA’s en­

forcement discretion  ...............................  20
2. The preamble to a proposed hut. un­

adopted rule does not limit the FDA’s en­
forcement discretion ............................  28

3. The question whether there is law to ap­
ply does not. depend upon a. judicial as­
sessment of “pragmatic considerations”

C. The structure and legislative history of the
FDCA show that Congress intended the FDA 
to have unreviewable enforcement discretion 2.7

II. Even if reviewable, the FDA’s enforcement, de­
cision was rational and should have been sus­
tained ........................................................... . 12

(m)



IV

A. The FDA lacks authority to regulate the 
stales’ use of lethal injections for capital 
punishment .........       48

R. Oilier legitimate and substantial considera­
tions support the FDA’s determination not 
to initiate investigative or enforcement ac- 
livil.y .................................................................... 47

Conclusion ..... ..............................................- ....  ^0

Appendix *a

TARI-F OF AUTHORITIES
Cases:

American Broadcasting Companies v. FCC, 002
F.2d 1 nr, 22

American Broadcasting Companies v. FCC, 082
F.2d 25   22

American Fed'n of Gov't Employees V. Donovan,
088 F.2d 511   80

American Friends Service Committee v. Webster,
720 F.2d 28 ..............    80

Da eh on-:; In v. Brennan. 502 F.2d 70, rev’d and re­
manded sab now. Dunlop v. Bachowski, 421 U.S.
r,r,o ...........  ................................. ..........28, 24, 25, 48

Batter!on V. Francis, 482 U.S. 410 ........  ................. 88
Block v. Community Nutrition Institute, No. 88-

458 (June 4, 1084) ........    1fi
Borilenkireher V. Hayes, 484 U.S. 857 18
Bn •nnan V. Are Hardware Corp., 405 F.2d 808 84
But~ v. Economon. 488 U.S. 478 18
Center for Auto Safety V. NHTSA. 710 F.2d 842 81
('herran C.S.A. Inc. v. NRDC, No. 82-1005 (dune

25. 1081) 17,80,48
Clirush r Corp. v. Brown, 441 U.S. 281 84
Citizens to I’reserve Overton Bark V. Volpe, 401

XT.S. 402 ........................  11,15,10,80
Cifii of ('liieaao v. United Slates, 800 U.S. 102 21

Argument -Continued: Pape
Cases Continued:

v
P a g e

City of Seabroolc v. (Jostle, 059 F.2d 1871 21,22
Confiscation Cases, 74 U.S. (7 Wall.) 454 18
Earvin V. State, 582 S.W.2d 704, cert, denied, 444

U.S. 919 ......................................................  25
Fallcowslci v. EEOC, 719 F.2d 470, petition for

cert, pending, No. 83-2084 .............................  30
FPC V. United Gas Pipe. Line Co., 393 U.S. 71 30
FTC V. Klesner, 280 U.S. 19 ........................ 18. 10
FTC V. Sperry & Hutchinson Co., 405 U.S. 233 30
Gat ter v. Nimmo, 072 F.2d 343 ................................  3 1
Granviel, Ex parte, 501 S.W.2d 503 25
Gregg V. Georgia, 428 U.S. 153 .... ............. 24
Inmates of Attica, Correctional Facility v. Rocke­

feller, 477 F.2d 375 ........................ .......... 17
Investment Co. Institute v. FDIC, 728 F.2d 518 28, 30
Kemmler, In re, 130 U.S. 430 .................. ...... ....... 24
Kixmiller v. SEC, 492 F.2d 041 ................................  22
Linda R.S. V. Richard D., 410 U.S. 014 ___ 18
Mcllwain V. Hayes, 530 F. Supp. 073, aff’d, 000

F.2d 1041 .........................................  ................ 33
Moog Industries, Inc. v. FTC, 355 U.S. 411 10. 2<>
Morton V. Ruiz, 415 U.S. 100 ........... . ....  84
Motor Vehicle Mfrs. Ass'n V. State Farm Mutual.

No. 82-354 (June 24, 1083) 30
NLRB V. Sears, Roebuck & Co., 421 U.S. 182 10
National Milk Producers v. Harris, 053 F.2d 830 21
Natural Resources Defense Council, Inc. v. SEC,

GOG F.2d 1031 ......... ....... ........................ 30
New Jersey V. United States, 108 F. Supp. 821,

air’d, 359 U.S. 27   2"
Newman V. United States, 382 F.2d 470 17. 18
O’Bryan V. Heckler, Civ. No. 84-000 (D.D.C. Mar.

30, 1984), vacated. No. 84-900 (D.C. Cir. Mar.
30, 1084), stay denied, No. A-701 (Mar. .00,
1084) ........................    47

Oyler V. Boles, 308 U.S. 448 18
Pacific Gas <f: Electric Co. v. FPC, 500 Ir.2d 88 <
Panama Canal Co. V. Grace Line, Inc., 350 U.S.

300 .......     20
SEC V. Chenery Corp., 318 U.S. 8 0 .........................  38



Schn'ciker v. Hansen, 450 U.S. 785 ........................... 34
Servin' v. Halles, 854 U.S. 308 .............  .............— 34
Southern Rn. V. Seaboard Allied Millinp Carp.,

442 U.S. 444 .      20,21,26,37
Sullivan V. I ’ailed Stales, 848 U.S. 170 .....  ...... ...... 34
(Jailed Slales v. Articles of Drops, 025 F.2d 005 10
United Slales v. Articles of Drops * * * Promise 

Toothpaste. No. 83-C-0129 (N.D. 111. duly 30,
1984)    32

United Stales V. Hatrlielder. 442 U.S. 114 .............. 18
United States v. Urath.anasia.-D Popular, | 1979 

Transfer Kinder| Food, Drue, Cosm. U. Rep.
(CCU) '| 88.205 .... .............................. - 40

United Stalls v. Caoeres, 440 U.S. 741 ............. .. 33,35
United Stales v. Diapalse Corp., 514 F.2d 1097,

cert, denied, 423 U.S. 838 ....................................... 45
United States v. Evers, 043 F.2d 1043 .................... 47
United. States v. Johnson, 577 F.2d 1304 ...... .........  10
(Jailed Slales v. Mendoza, No. 82-849 (Jan. 10,

1984) ................................................................-........  l f>
United Slates V. Nixon, 418 U.S. 083 ................... .. 18
United Stales v. Ross, 719 F.2d 615 ........................ 16
United States v. Sullivan, 332 U.S. 089 . ..... .........  11
United Stall's v. Torquato, 002 F.2d 564, cert, de­

nied, 444 U.S. 941 ....  ...........  ............... ..............  10
United States v. Varip Airlines, No. 82-1349 (June

19, 1984) . ........  ..............................................  17
Vara V. Sipes, 380 U.S. 171 ................... ............. ... 19
Vitarelli V. Seaton, 359 U.S. 535 ............. ..................  34
Wilkerson v. Utah, 99 U.S. 130 ................................  24

Constitution, statutes and regulations:
U.S. Const.:

Art. 11, § 8 .............................. ......... ................ 10
Amend. VIII   10

Act of .lone 25, 1988. rh. 075, § 201(c) and (d),
52 St at. to il ...... -..... 39

Administralive. Procedure Act, 5 U.S.C. 551 et
set/....................     2

5 U.S.C. 551(4) .......................    33
5 U.S.C. 701(a)(1) ...................... .......................  23, la

VI
Cases— Continued : Paj?©

VII

Constitution, statutes and regulations—Continuer!: Page
5 U.S.C. 701(a)(2) ...............  .......... 11, 15,23.30, In
5 U.S.C. 706(2) (A) . .............. ........................ 15

Federal Food, Drug, and Cosmetic Act, 21 U.S.C'.
301 et seq................................................................  2

21 U.S.C. 321(g)(1)(C ) .......................  44
21 U.S.C. 321(h) .......................................  13-14,44
21 U.S.C. 321(h)(3) .................................  14,44
21 U.S.C. 321 (p) ...................................................  3
21 U.S.C. 321 (p) (1) ................    10
21 U.S.C. 331 (k) .....................................2, 0, 10, 45, 40
21 U.S.C. 332 ...........  ...........................................  20, 38
21 U.S.C. 332(a) .................................................... 28
21 U.S.C. 333 .................................  38
21 U.S.C. 334..........................................................  20,28
21 U.S.C. 334(a)(1) ......   42
21 U.S.C. 335 ....................................................  27. 28
21 U.S.C. 336 .............................................. 27, 28, 40. 41
21 U.S.C. 346a (i ) .................     28
21 U.S.C. 348 ........................................    28
21 U.S.C. 352 ..............................................   2
21 U.S.C. 352(f)
21 U.S.C. 355 ............
21 U.S.C. 355(a)
21 U.S.C.355(h) .....
21 U.S.C. 355 (i) ......
21 U.S.C. 357(d) ......
21 U.S.C. 360 ( j ) (g) 
21 U.S.C. 300b(a) (1)
21 U.S.C. 360g .........
21 U.S.C. 371(f) (1) 
21 U.S.C. 371 (f) (3) 
21 U.S.C. 372 ...........

2, 10, 45, la 
8, 10
2, la

28
10. 40 

40 
40 
40 
28 
42 
42

20. to
Labor-Management Reporting and Disclosure Act

of 1959, 29 U.S.C. 153 et seq.:
29 U.S.C. 153(d) ..........................................  19
29 U.S.C. 482(a) ...................................... .... ...... 23
29 U.S.C. 482(b) ..... .................................. ......... 22

42 U.S.C. (Supp. V) 7413 ..........................................  22



VIII

Ark. Slat. Ann. § 41-1.152 (Supp. 1083) ..... ............  2
Idaho Code § 10-27IG (Supp. 1083) ..........................  2
III. Ann. Stal, eh. 2.8, § 110-5 (Smilh-IIurd Supp.

1084)    2
Mass. Ann. Laws eh. 270, §(51 (Law. Coop. Supp.

1081) ................................  ............................  2
Monl. Code. Ann. §40-10-103(3) (1083) ...............  2
N.J. Stal. Ann. §2C:40-2 (West. Supp. 1984-

1085)    2
Nov. Lev. Slat. § 17(5.355 (1070) ................  ... 2
N.C. Con. Slat. § 15-187 (1083)   2
Okla. Slat. Ann. tit. 22, § 1014 (Rupp. 1083) ... 2
S.n. Codified Laws § 23A-27A-32 (Supp. 1084). 2
Tex. Code. (Tim. Proc. Ann. art. 43.14 (Vernon

Supp. 1084)     2
Utah Code Ann. § 77-18-5.5 (1083) ... .................. 2
Wash. Uev. Code § 10.05.180 (Supp. 1084) ...........  2
21 C.F.K.:

Section 10.45(d) (2) (i) .........................  ........... 25, 20
Section 10.85(d) .......    .... 31
Seel ion 10.85(e) .... ................................. ...........  31, 32
Section 10.85(j) ...............  .................12, 32, 35
Section 201.100(c) (2) .........................   10

Miscellaneous:
80 Cone Hoc. (1030) :

pp. 10514-10510   42
p. 10(580   42

81 Cone. Kee. (1037) :
p. 2015   40
p. 201(5 . 40
pp. 201(5-2018      40
p. 2018      41
p. 2010 ...................................................    41

83 Coup. Hit. (1038) :
p. 7702 ....................................................................  27, 28
p. 7703    27
pp. 7703-7704 .   41
p. 7704 ................... 27

Constitution, statutes and regulations—Continued: Pape

IX

K. Davis, Administrative Law Text (1072) 33
2 K. Davis, Administrative Law Treatise (2d ed.

1070) .......................................     3.3.34
37 Fed. Rep. 16503-16505 (1072) ......  28
Gardner, Executions and Indignities: An Eighth 
Amendment, Assessment of Methods of Infliction

Capital Punishment, 30 Ohio St.. L.J. 06 (1078) . 0
II.R. Rep. 2755, 741 h Coup., 2d Sess. (1036) 42
H.R. Rep. 2130, 75th Conp., 3d Sess. (1038) 27
L. JafTe, Judicial Control, of Adminisrative Action

(1065) ........................................................................ 30
Kleinfeld, Legislative History of the Federal Food,

Drug, and Cosmetic Act, 1 Food Drup Cosm.
L.J. 532 (1946) ..................... ...............................  42

I/ee, The, Enforcement Provisions of the Food,
Drug, and Cosmetic Act, 6 Law & Contemp.
Prohs. 70 (1030) .........    42-43

Note, Criminal Procedure—Capital Punishment—- 
Texas Statutes Amended to Provide for Exe­
cution by Intravenous Injection of a Lethal 
Substance, 0 St. Mary’s L.J. 350 (1077) . 0

S. 5, 74th Conp., 2d Sess. (1036) ___ ... 41-12
S. Rep. 646, 74th Conp., 1st Sess. (1038) 11
S. Rep. 752, 70th Conp., 1st Sess. (1045) 6, II. 15
U.S. Dep’t of Justice, Attorney General's Manual

on the APA (1047)     33

Miscellaneous—Continued : Pape



3tt %  §ujim ttf (Emrrt nf tljr llluffrh IMatrn
October T erm , 1984

No. 83-1878
Margaret M. H eckler , Secretary of H ealth  

and  H u m an  Services, petitioner

v.
Larry Leon Ch a n e y , et al.

ON W RIT  OF CERT IORARI  TO THE  UNITED  S T A T E S  COURT  
OF A P P E A L S  FOR TH E  D IS TR IC T OF COLUMBIA CIRCUIT

BRIEF FOR THE PETITIONER

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a- 
58a) is reported at 718 F.2d 1174. The opinion 
on denial of rehearing (Pet. App. 59a-62a) is re­
ported at 724 F.2d 1030. The opinion of the district 
court (Pet. App. 63a-79a) and the decision of the 
Food and Ding Administration (Pet. App. 81a-88a ) 
are unreported.

JURISDICTION

The judgment of the court of appeals was entered 
on October 14, 1983. A petition for rehearing was 
denied on January 17, 1984 (Pet. App. 87a). P.v 
order of April 12, 1984, the Chief Justice extended 
the time in which to file a petition for a writ of cer-

( 1 )



2

tiorari to and including May It?, 1984. The petition 
was filed on that date and was granted on June 18, 
1984 (J.A. 122). The jurisdiction of this Court is 
invoked under 28 IJ.S.C. 1254(1 ).

STATUTES INVOLVED

Relevant, provisions of the Administrative Proce­
dure Act (APA), 5 IJ.S.C. 551 cl ncq., and the Fed­
eral Food, Drug, and Cosmetic Act (FDCA), 21 
IJ.S.C. 801 cl srr/., are reproduced in an appendix to 
this brief (App., infra,, la-2a).

STATEMENT

In recent years, numerous states have enacted stat­
utes prescribing lethal injection of drugs as the 
method for carrying out the death penalty.1 II * 1 In this 
case, prison inmates sentenced to death by lethal in­
jection in Texas and Oklahoma petitioned the Food 
and Drug Administration (FDA) to block their ex­
ecutions on the ground that the states proposed to 
employ drugs that had been approved by the FDA 
as safe and effective for medical purposes but not 
for human execution. J.A. l(?-83. Respondents as­

1 Those stnlules include: Ark. St.al.. Ann. §41-1352 (Supp. 
1982) : Millie ( '<>de § 19-2715 (Supp. 1982) : 111. Ann. Slat. di. 
28, § 119-5 (Smith-IIurd Snpp. 1984); Mass. Ann. Laws ch. 
279, § Gl (Law. Coop. Supp. 1984) : Mont. Code Ann. §49-19- 
10.2(2) (1982) (prisoner given choice of hanging or lethal 
injection) : Nev. Rev. S1,at. § 170.255 (1979) ; N..T. Slat. Ann. 
§2C:49-2 (West Supp. 1984-1985) ; N.M. Slat. Ann. §31-14-
II (Supp. 198.2) ; N.C. Gen. Slat.. § 15-187 (1982) (choice of 
lethal gas or lethal injection) ; Okla. Slat. Ann. fit. 22, § 1014 
(Supp. 198.2) ; S.D. Codified Laws Ann. § 2.2A-27A-.22 (Supp. 
1984) ; Tex. Code Critn. I’roc. Ann. art. 42.14 (Vernon Supp. 
1984); Utah Code Ann. § 77-18-5.5 (1982) (choice of firing 
squad or lelhal injection): Wash. Rev. Code §10.95.180 
(Supp. 1984) (choice of hanging or lethal injection).

3

sorted that their execution by this means would vio­
late the “misbranding” and “new drug” provisions 
of the Federal Food, Drug, and Cosmetic Act, 21 
IJ.S.C. 331 (k), 352, 355(a).2 3 J.A. 20-22. They re­
quested the FDA, among other things/' to “ |a|dopl

2 The FDCA prohibits “the doing of any act.” find result 
in a drug's being “misbranded” while it is “held for sale" (21 
U.S.C. 331 (k)) . The FDCA also provides that a drug is mis­
branded “ [ujnless its labeling bears * * * adequate direcl ion i 
for use” (21 U.S.C. 352(f)).

The FDCA prohibits the introduction of a “new drug" inlo 
interstate commerce or its delivery for introduction inlo inter­
state commerce unless it has been approved by the FDA a 
“safe and effective” (21 U.S.C. 355). A drug is considered 
to be a “new drug” if, inter alia, it is not, generally recognized 
as safe and effective for use under the conditions “proscribed, 
recommended, or suggested in [its| labeling.” 21 U.S.C 
321(p).

a Respondents requested that the FDA take the following 
actions (J.A. 32-33) :

1. Affix a boxed warning to the labels of the drugs speci­
fied in the State statutes stating that these drugs arc nol 
approved for use as a means of execution, arc nol con 
sidered safe and effective as a means of execution, and 
should not. be used as a means of execution.
2. Prepare and send to the manufacturers of the dem­
and to the prisons and departments of correction in 
Texas, Oklahoma, Idaho, and New Mexico noliccw ad 
vising that the drugs specified for use in an execution 
in those States’ statutes or prison policies are nol ap­
proved for use as a means of execution, are not con­
sidered safe and effective as a means of execution, and 
should not be used as a means of execution.
3. Place an article in the Drug Bulletin fan FDA medical 
newsletter sent to physicians] advising that the drugs 
specified for use as lethal injections are not approved for 
use as a means of execution, are not considered safe and



4

a policy and procedure for the seizure and condemna­
tion from prisons or state departments of correction 
of drops which are destined or held for use as a 
means of execution” and to recommend the criminal 
prosecution of prison officials and others who “know­
ingly buy, possess, [sell] or use drugs for the un­
approved use of lethal injections.” J.A. 32-33.

The FDA declined to take the requested enforce­
ment actions. It concluded ( l’et. A))]). 81a-8Ga) that 
it had no jurisdiction under the FDCA to investigate 
the states’ practice of administering lethal injections 
in capital punishment cases and that it would de­
cline to take action in any event as a matter of its 
enforcement discretion. The Commissioner of Food 
and Drugs stated {id. at 82a, 85a) :

Our conclusion that the use of lethal injection 
is not subject to our jurisdiction is supported 
by the relevant statutory provisions, by our cur­
rent policy on the use of approved drugs for un­
approved uses, and by a consideration of the 
propel1 role of the Federal Government with re­
spect lo the conduct of State criminal justice 
systems. * * * * *  * 4 5

effective as a means of execution, and should not be used 
as a means of execution.
4. Adopt, a policy and procedure for the seizure and con­
demnation from prisons or State departments of correc­
tion of drugs which are intended to he used as a means 
of execution.
5. Recommend the prosecution of manufacturers, whole­
salers, retailers, and pharmacists who knowingly sell 
drugs for the unapproved use of lethal injection and 
prison officials who knowingly buy, possess, or use drugs 
for the unapproved use of lethal injections.

Were FDA clearly to have jurisdiction in the 
area, moreover, we believe we would be author­
ized to decline to exercise it under our inherent 
discretion to decline to pursue certain enforce 
ment matters. The unapproved use of approved 
drugs is an area in which the case law is far 
from uniform. Generally, enforcement proceed­
ings in this area are initiated only when there 
is a serious danger to the public health or a 
blatant scheme to defraud. We cannot conclude 
that those dangers are present, under State 
lethal injection laws, which are duly authorized 
statutory enactments in furtherance of proper 
State functions.

Plaintiffs then brought this suit for injunctive and 
declaratory relief in the United States District Court 
for the District of Columbia. J.A. 5-14. The district 
court dismissed the complaint on the ground that the 
enforcement decisions of an agency are not. subject 
to judicial review. Pet. App. 63a-79a. Placing re­
liance on numerous cases involving enforcement, dis­
cretion, including cases specifically involving the 
FDA, the district court concluded that “ |i | l  is by 
now well-established that decisions of executive de­
partments and agencies to ref ram from institutin'- 
investigative and enforcement proceedings are essen­
tially unreviewable by the courts.” Pet. App. 74a 
(emphasis in original). The district court added (id. 
at 76a):

The record indicates that plaintiffs’ petition was 
accorded careful consideration by the Commis­
sioner, and his reasons for declining to initiate 
investigative and enforcement action were1 fully 
explained in a memorandum accompanying the 
denial of the petition. Whether the Commis­
sioner might have reached a different decision in



6

light. of ilio political, scientific, and ethical con­
troversy surrounding the use of prescription 
drugs to cause death hy lethal injection is of no 
moment; the salient point is that under estab­
lished authority the decision was his to make.

A divided panel of the court of appeals vacated the 
district court's judgment and remanded with direc­
tions “to order the agency to fulfill its statutory func­
tion” (Pet. App. 3Ga). The court of appeals con­
cluded that the FDA has authority under 21 U.S.O. 
331 (k) to regulate the use of drugs in administering 
capital punishment. That provision prohibits the 
“misbranding” of drugs while they are “held for 
sale.” The court apparently reasoned (Pet. App. 
14a-15a) that the states’ use of the drugs for an 
unapproved purpose constitutes “misbranding” and 
that the drugs are “held for sale” when they are 
injected into the person being executed.

The court of appeals also held that the FDA’s de­
cision not to initiate enforcement activity was sub­
ject to judicial review (Pet. A])]). 17a-30a). In the 
court’s view ( id. at 18a-22a), all agency action, in­
cluding a decision not to begin enforcement proceed­
ings, is presumptively reviewable except in those sit­
uations “where the governing statute is ‘drawn in 
such broad terms that in a given case there is no law 
to apply’ ” (quoting S. Rep. 752, 79th Cong., 1st 
Sess. 20 (1915)). The court observed (Pet. App. 24a) 
that the “determination of whether there ‘is law 
to apply’ turns on such pragmatic considerations as 
whether judicial supervision is necessary to safe­
guard plain!ill's’ interests, whether judicial review 
will unnecessarily impede the agency in effectively 
carrying out its congressionally assigned role, and 
whether the issues are appropriate for judicial re­

7

view.” In this case, the court found “law to apply” 
in the preamble to an FDA rule proposed for untie-1 
and comment in 1972 but never promulgated. The 
preamble stated (id. at 24a) :

Where the unapproved use of an approved 
new drug becomes widespread or endangers the 
public health, the [FDA] is obligated to investi­
gate it thoroughly and to take whatever act inn is 
warranted to protect the public. * * ‘ When 
necessary the [FDA] will not hesitate to take 
whatever action * * * may he required to bring 
possible harmful use of an approved drug under 
control.

The court concluded (id. at 31a-35a) that the FD A’s 
reasons for declining enforcement were irrational in 
light of the preamble and warned (id. at 37a) : “We 
must be prepared to compel FDA to take action with 
respect to the [plaintiffs’] prayer for relief where an 
acceptable explanation of [FDA’s] inaction is not 
promptly forthcoming.” 4

Judge Scalia dissented (Pet, App. 39a-58a), slat­
ing (id. at 39a) that the majority’s decision con­
stituted “a clear intrusion upon powers that belong 
to Congress, the Executive Branch and the states." 
He pointed out (id. at 4fia) that “far from there be­
ing a ‘presumption of reviewability’ with regard to 
enforcement determinations, the well known pre­

4 Although the court of appeals acknowledged (hat “Uto 
state may take the life of a person as punishment." and dial, 
the “FDA is not responsible for the execution of these 
prisoners," the court observed that the “FDA’s impermissible 
refusal to exercise enforcement discretion over the use of 
drugs for lethal injection * * * may also implicate the Figlilh 
Amendment's prohibition of cruel and unusual punishmenl." 
Pet, App. 37a, 38a.



8

sumption is precisely the contrary.” Finding no spe­
cial circumstances justifying review in this case, 
Judge Scalia concluded that review was unavailable. 
He noted (id. at 48a-51a) that the preamble on 
which the majority relied was “full of flexible terms, 
the precise application of which was obviously in­
tended to be, and could properly be, left to the discre­
tion of the agency—for example, whether an unap­
proved use has become ‘widespread.’ ”

Moreover, assuming that the FDA’s decision not to 
undertake enforcement action was judicially review- 
able, Judge Scalia found (Pet. App. 51a-58a) that 
the FDA’s actions were not arbitrary and capricious. 
He concluded that the FDA had no statutory au­
thority to take the requested action because “ [ujnder 
no conceivable interpretation of the English language 
could [the drugs used in lethal injections] be deemed 
‘held for sale’ ” (id. at 55a).

P.y a live-to-five vote, the court of appeals denied 
the government’s suggestion for rehearing en banc 
(Pet. App. 5fla-60a)/' In a statement joined by 
Judges Wilkev, Pork, and Starr, Judge Scalia 
stressed ( id. at GOa) the significance of the holding 
of this case to “the enforcement authority of all fed­
eral agencies.” Judge Scalia stated (ibid.) that the 
panel's finding of a “general presumption of review- 
ability” of enforcement decisions “distorts the law 
and usurps the authority of the Executive Branch.” 
He also noted (id. at Ola) that the “pragmatic con­
siderations” test referred to by the court of appeals 
was “not an application of the Supreme Court’s 5 *

5 Judges Wilkey, Ginsburg, Rork, Scalia, and Starr voted 
to grant rehearing en banc; Judges Wright, Tamm, Wald, 
Mikva, and Robinson voted against rehearing en banc. Judge
Edwards abstained.

9

guidance, but the substitution of an entirely diflVreni 
test—which can l>e summarized by saying that v  
intervene when we think it a good idea.”

INTRODUCTION AND SUMMARY OF ARGUMENT

A. In recent years, many state legislatures h a \e  
concluded that the most painless and humane method 
of capital punishment is the use of lethal injections." 
An increasing number of states have accordingly en­
acted statutes prescribing this method of execution. 
Respondents petitioned the Food and Drug Admini 
tration to block the use of lethal injections, but the 
FDA declined to intervene. However, the I foiled 
States Court of Appeals for the District of Columbia 
Circuit reviewed the FDA’s decision under tln> Ad­
ministrative Procedure Act and concluded that the 
agency’s reasons were arbitrary and capricious.

The impact of this decision on all administrative 
agencies can hardly be overstated. Prosecutorial and 
administrative enforcement decisions have tradition 
ally been exempt from judicial review except in un­
usual circumstances. Thus, affirmance of the court 
of appeals’ decision would cause substantial disrup­
tion of settled administrative practices and would 
“almost certainly result in the substitution of tin* 
preferences of the judicial branch for those of the 
executive.” Pet. App. 89a (Scalia, J., dissenting).

fl See, e.q., Note, Criminal Procedure—Capital Punish went 
—Texas Statutes Amended In Provide for Execution Ini Intra­
venous Injection of a Lethal Substance, 9 St. Mary’s f,1 gr.o, 
301 (1977) (Texas lethal inject ion statute introduced “pri­
marily because of a belief by proponents that death bv lethal 
injection is more humane and more dignified than death by 
electrocution”); Gardner, Executions and Indignities: An 
Eighth Amendment Assessment of Methods of lnHirljn<i 
Capital Punishment, 39 Ohio St. L.J. 90, 128-129 (1978).



10

Even if narrowly confined, affirmance would have 
deleterious consequences. The effect of the court of 
appeals' decision is to require the FDA to intervene 
in a highly controversial area far removed from its 
mission of protecting the consuming public from un­
safe and improperly labeled drugs. Furthermore, un­
less reversed, that decision is likely to interfere with 
state enforcement of capital punishment statutes that 
satisfy Eighth Amendment standards. At a mini­
mum, the use of lethal injections will he prevented 
until a manufacturer or other party seeks FDA ap­
proval for the use of the drugs in executions and 
demonstrates that they are “safe and effective” in 
causing death (21 U.S.C. 355(a)).' It is doubtful 
whether any manufacturer would seek such approval 
in view of the expense involved, the organized opposi­
tion to capital punishment, and the very small quan­
tities of drugs that would he sold for this new use. 
Thus, the practical effect of affirming the court of 
appeals’ decision might well he to prevent executions 7

7 The cnurl of appeals held that (he FDCA’s misbranding 
provisions (21 U.S.C. 22.1 (k), 252(f)) are violated when 
prescription drugs approved by the FDA for other purposes 
are employed for capital punishment, a use for which FDA 
approval has not, been sought or granted. The court appar­
ently concluded that the drugs are misbranded because their 
labeling does not bear "adequate directions for use” (21 
U.S.C. 252(f) » in causing death. Such labeling could not, 
accompany the drugs, however, absent the approval of a new 
drug application (21 U.S.C. 221 (p) (1). 255: see also page 2 
note 2, supra). I’.y regulation (21 C.F.R. 201.100(c)(2)) a 
new drug must generally bear the labeling “authorized by |it.s| 
approved new drug application.” See also United Stairs v. 
Articles nf Dnifis (Hacker), (125 F.2d 0(15, 075 (5th Cir. 1080). 
Accordingly, the drugs would have to l»o approved as safe and 
effective in causing death (21 U.S.C. 255) before they could 
bo lawfully labeled for that purpose.

11

by lethal injection altogether. In that event, mnin­
states would probably return to what they have eon 
eluded are potentially more painful methods of eapi 
tal punishment.

IF These adverse consequences need nut be suf 
fered, because the court of appeals’ decision is pin ini 
wrong. In holding that the FDA’s exercise of en ­
forcement discretion was subject to judicial rc\ mv. 
the court departed dramatically from settled prin 
ciples of administrative law.

The Administrative Procedme Act, 5 U.S.C. 7<>t 
(a)(2), provides that final agency action is not sub­
ject to judicial review if it is “committed to agency 
discretion by law.” This bar to judicial review ap 
plies where the governing “statutes are drawn in 
such broad terms that in a given case there is m> law 
to apply.” Citizens to Preserve Overton I’orl; \. 
Volpe, 401 U.S. 402, 410 (1971) (quoting S. Hep. 
752, 79th Cong., 1st Sess. 26 (1945)).

This is a paradigmatic case in which there is “no 
law to apply.” The Federal Food, Drug and Cosmetic 
Act does not command the FDA to take investigative 
or enforcement action whenever a statutory violation 
is alleged or found. Indeed, the Act does not even 
suggest the standards to be used by the FDA in de­
termining whether and when to undertake such ac­
tion. Instead, the Act confers upon the Commissioner 
of Food and Drugs a “broad discretion—broad 
enough undoubtedly to enable him to perform his du­
ties fairly without wasting his efforts on what may 
be no more than technical infractions of law.” 
United States v. Sullivan, 332 U.S. 689, 694 (19 18 ). 
Because most statutes granting enforcement powers 
to administrative agencies are cast in similar terms, 
it is well established that agency enforcement deci­
sions are rarely subject to judicial review.



12

The court of appeals held that the FDA’s decision 
was reviewahle because, in the court’s view, the 
agency had “made law to govern and guide its discre­
tion in regulating the unapproved use of approved 
drugs” (I’et. App. 24a). But the “law” upon which 
the court relied was the preamble to a rule that was 
issued for notice and comment but was never adopted 
by the agency. This preamble does not place any re­
strictions on the FDA’s enforcement discretion. In 
the first place, the preamble has nothing to do with 
the subject of enforcement discretion. Its sole sul)- 
ject is tin' interpretation of the FDCA’s provisions 
regarding the lawful use of approved drugs for unap­
proved purposes. In an effort to show that the pre­
amble limits the agency’s enforcement discretion, the 
court of appeals seized upon a single sentence of the 
preamble and took that language completely out of 
context.

Even if the preamble had discussed the issue of en­
forcement discretion, it would not have bound the 
agency or furnished a sufficient basis for judicial re­
view. The preamble is not a legislative nde, and the 
FDA’s regulations clearly provide that pronounce­
ments such as the preamble do not impose any gen­
eral legal requirements on the agency. 21 C.F.It. 
10.85(j). Similarly, under accepted principles of ad­
ministrative law, an agency is generally not bound by 
statements of this type, and there is no good reason 
for holding (lie FDA bound here. On the contrary, 
if informal agency statements regarding enforcement 
policy provided sufficient grounds for judicial review 
of enforcement decisions, agencies would he discour­
aged from explaining their enforcement policies or 
from issuing internal guidelines to ensure that their 
enforcement decisions are rational and consistent.

13

The structure and legislative history of the FIX'A 
reinforce the conclusion that FDA enforcement do 
cisions are not reviewable. Judicial review of such 
decisions would place an intolerable burden on I In- 
agency and would divert scarce resources from tin- 
agency’s important regulatory responsibilities. In 
addition, the legislative history of the FDCA un­
equivocally shows that Congress intended the FDA F> 
have unreviewable enforcement discretion.

C. Even if the FDA’s decision was judicially re 
viewable, the decision was rational and should have 
been upheld.

1. The FDA concluded that it lacked authority 
under the FDCA to regulate the states’ use of lethal 
injections for capital punishment. The agency’s in­
terpretation of the statute it administers is entitled 
to considerable deference and should have been sus­
tained. Instead, the court of appeals held that the 
FDA had authority under the provisions of the 
FDCA prohibiting the “misbranding” of drugs or de­
vices while they are “held for sale.” The court 
theorized that the drugs are “held for sale” when 
they are forcibly injected into the person being ex­
ecuted. The statutory language lends no support to 
this surprising construction, and there is not a hint 
in the legislative history that Congress had any in­
tention to regulate the methods used by states in 
carrying out lawful death sentences.

The peculiar nature of the court of appeals’ con­
struction is highlighted by the fact that the mis­
branding provisions apply equally to “drugs” and “de­
vices” and the fact that the statutory definition of a 
device seems clearly to encompass many of the para­
phernalia traditionally used for executions, such as 
the gallows and the electric chair. See 21 U.S.C.



14

321(h), 2,31 (k). By the court’s reasoning, the 
FDA presumably would he obliged to regulate the 
use of these devices as well.

2. Even if the FDCA could somehow he stretched 
to reach the administration of lethal injections for 
purposes of capital punishment, the FDA articulated 
sound reasons for declining to intervene. Regulating 
the methods of capital punishment used by the states, 
whether or not technically within the scope of the 
FDCA, is certainly far removed from the FDA’s cen­
tral responsibilities. The FDA acted reasonably in 
conserving its limited enforcement resources for mat­
ters more closely related to its principal mission. The 
FDA also declined to intervene based upon a proper 
respect for principles of federalism. Enforcement 
of the criminal laws is of course one of the oldest and 
most important state functions.

Finally, the FDA acted reasonably in relying on 
the absence of a “serious danger to the public health” 
(Pet. App. 85a). Unless the agency was prepared to 
regulate all forms of execution, the issue posed by re­
spondents was not a question of “pain versus no pain, 
but rather pain of one sort substituted for pain of 
another—and in <ill likelihood substitution of a lesser 
pain, since that is the principal purpose of the lethal 
injection statutes” (Pet. App. 51a (Scalia, J., dis­
senting) (emphasis in original)).

15

ARGUMENT

I. THE FOOD AND DRUG ADMINISTRATIONS DE­
CISION NOT TO REGULATE THE STATES’ USE 
OF LETHAL DRUGS FOR CAPITAL PUNISHMENT 
IS NOT SUBJECT TO JUDICIAL REVIEW UNDER 
THE ADMINISTRATIVE PROCEDURE ACT

A. Prosecutorial And Administrative Enforceim nf De­
cisions Are Generally Exempt From Judicial Review

Under the Administrative Procedure Act, 5 U.S.C. 
701(a)(2), final agency action is not subject to ju­
dicial review if it is “committed to agency discretion 
by law.” This bar to judicial review applies where 
the governing “ ‘statutes are drawn in such brood 
terms that in a given case there is no law to apply.’ ’’ 
Citizens to Preserve Overton Park, Inc. v. Volpc, 401 
U.S. 402, 410 (1971) (quoting S. Rep. 752, 79th 
Cong., 1st Sess. 26 (1945)).

Where statutes explicitly or implicitly impose 
standards governing the exercise of an agency’s dis­
cretion, there is “law to apply,” and judicial review 
is available under the APA to determine whether the 
agency has abused its discretion. 5 U.S.C. 706(2) 
(A). In Overton Park, for example, this Court held 
that the Secretary of Transportation’s decision to 
route an interstate highway through a municipal park 
was subject to judicial review because the governing 
statutes specified the factors that had to he con­
sidered in making the decision. Indeed, the statutes 
expressly prohibited the use of parkland except in 
“the most unusual situations” (401 U.S. at 411 t.

Because the statutes empowering administrative 
agencies usually provide some law to apply, this 
Court has noted that Section 701(a)(2) represents 
a “very narrow exception” to the provisions of the



16

ADA authorizing judicial review. Overton Park, 401 
IJ.S. at 410. As the court of appeals correctly noted 
(Pet. App. 18a-19a), final agency action in general 
is presumptively reviewahle. The court below erred, 
however, in refusing to recognize that this presump­
tion does not apply in certain circumstances, includ­
ing where efforts are made to obtain review of prose­
cutorial and administrative enforcement decisions. 
As Judge Scab a noted in dissent (Pet. App. 46a), 
"far from there being a ‘presumption of review- 
ability’ with regard to enforcement determinations, 
the well known presumption is precisely the con­
trary.” Cf. Work v. Community Nutrition Institute, 
No. 83-458 (June 4, 1684), siip op. 8 ("The pre­
sumption favoring judicial review of administrative 
action is just that—a presumption” and may be 
overcome.).

Prosecutorial and administrative enforcement de­
cisions have traditionally lreen committed to unre- 
viewable executive discretion for two principal rea­
sons. The first is the doctrine of separation of 
powers.” Under the Constitution (Art. II, §3), it 
is the duty of the Executive, not. the courts, to “take 
Care that the Laws be faithfully executed.” Dis­
charging this responsibility often involves making 
basic policy choices. An agency may decide that en­
forcement is most needed in certain areas rather than 
others and may target its efforts accordingly. An 
agency may also decide on policy grounds that one 
method of enforcement is preferable to available al­
ternatives or that the previous pace of enforcement

"See. 1 'nilrrt Stairs V. Ross, 710 F.2d (515, 020 (2d dir. 
1082) ; United Slates v. Torquato, 002 F.2d 504, 509 (3d Cir.), 
cert, denied, 444 U.S. 041 (1070) ; Uuitrd States v. Johnson. 
577 F.2d 1301, 1307 (5th Cir. 1078).

17

should be accelerated or slowed down. “It would he 
idle to pretend that the conduct of government bliga 
tion * * is a wholly mechanical procedure which in 
volves no policy choices whatever.” United Stairs \. 
Mendoza, No. 82-849 (Jan. 10, 1984), slip op. 7. Our 
system of government entrusts such choices not to 
the judiciary but to officials accountable directly or 
indirectly to the electorate. See Chevron U.S.A. fn<\ 
v. NRDC, No. 82-1005 (June 25, 1984), slip op. 27. 
Judicial review of enforcement decisions thus has 
been precluded to avoid “judicial ‘second-guessing’ 
of * * * administrative decisions grounded in social, 
economic, and political policy.” United States v. 
Variq Airlines, No. 82-1349 (June 19, 1984), slip op. 
16 (discussing discretionary function exception to 
Federal Tort Claims Act).

Enforcement decisions are also committed to ex­
ecutive discretion because they characteristically in­
volve complicated questions of administration that are 
ill-suited for review by the courts.” In deciding 
whether to undertake enforcement action, an agency 
must do far more than merely determine whether 
there is a sound factual and legal basis for proceed­
ing. The agency must decide which enforcement 
strategy will best carry out its statutory mandate 
and must decide how to allocate its scarce resources. 
It must compare the importance and cost of various 
potential cases, as well as the likelihood of success in 
each of those endeavors. It must consider both (lie 
benefits of undertaking a particular enforcement ac­
tion and the potential for deleterious consequences if

n See, e.q., Inmates of Attica Correctional Facilit,/ v. Rocke­
feller, 477 F.2d 375, 380 (2d Cir. 1973) ; Newman v. Unite,1 
States, 382 F.2d 479, 480 (D.C. Cir. 1967).



18

the effort, proves unsuccessful. After considering 
these and other factors, an agency may rationally de­
cide to pursue any of a number of different enforce­
ment policies. For example, it may concentrate on a 
few of (he most important or most highly visible 
cases. Or it may decide to undertake action in a 
much larger number of cases. Evaluating the rele­
vant factors and developing a sound enforcement 
strategy are quintessentially the functions of a regu­
latory agency. They are not appropriate for judicial 
review.

Because of these considerations, it has long been 
the rule that prosecutorial and administrative en­
forcement decisions generally are not reviewable. 
This Court has repeatedly held that prosecutorial de­
cisions are exempt from judicial review. United 
Slates v. Ratchelder, 442 U.S. 114, 124 (1979); 
Bordenki roher v. Hayes, 484 U.S. 857, 364 (1978); 
United Stairs v. Nixon, 418 U.S. 683, 693 (1974); 
Linda R.S. v. Richard II, 410 U.S. 614, 619 (1973). 
See also Newman v. United Stales, 382 F.2d 479 
( D.C. Cir. 1907) (Burger, J.). Cf. Oyler v. Roles, 
368 U.S. 448, 456 (1962).

The Court lias treated civil and administrative en­
forcement decisions in like manner, since “ [t]he de­
cision to initiate administrative proceedings * * * is 
very much like the prosecutor’s decision to initiate 
or move forward with a criminal prosecution.” Blitz 
v. Fconammt, 188 U.S. 478, 515 (1978). As long 
ago as the Can fiscal inn Cases, 74 U.S. (7 Wall.) 
451 (1809), this Court held that the Attorney Gen­
eral had unreviewahle discretion to decline to bring 
suit seeking condemnation of a vessel used to aid the 
Confederacy during the Civil War. In FTC v. Kles- 
ner, 280 F.S. 1!) (1929), the Court concluded that

19

the Federal Trade Commission had unreviewahle di 
eretion to decline to pursue a citizen complaint <>f an 
alleged unfair trade practice. Writing for the Com 1. 
Justice Brandeis observed that “ [a] person win 
deems himself aggrieved by the use of an unfair 
method of competition * * * may of course bring the 
matter to the Commission’s attention and request it 
to fde a complaint. But a denial of his request is 
final. And if the request is granted and a proceed­
ing is instituted, he does not become a party to it or 
have any control over it.” Id. at 25-26 (footnote 
omitted).

Enactment of the APA did not change this rule. 
The Court has concluded that the general counsel of 
the National Labor Relations Board has unreview- 
able discretion to decide whether to bring an unfair 
labor practice complaint before the Board. NLRB v. 
Scars, Roebuck <£ Co., 421 U.S. 132, 138 (1975); 
Vaca. v. Sipes, 386 U.S. 171, 182 (1967)."' In Many 
Industries, Inc. v. FTC, 355 U.S. 411 (1958), the 
Court observed that the FTC was not required to 
proceed against all companies suspected of similar 
antitrust violations. The Court stated (id, at 413) :

"’The court of appeals erroneously stated (Pot.. App. 28a. 
n.35) that the general counsel’s decisions are unreviewahle 
because 29 U.S.C. 153(d) explicitly precludes review. Thai 
provision states that “ ft]he General Counsel * * * shall have 
final authority, on behalf of the Hoard, in respect of Die in­
vestigation of charges and issuance of complaints” (emphasis 
added). The meaning of that provision is that Ihe general 
counsel’s decision is not subject lo administrative review. The 
Board has delegated to him the authority to make Ihe final 
administrative decision on its behalf. The opinion in NIMH 
V. Sears, Roebuck & Co., 421 U.S. at 138, cited the stabile to 
support tliis point, and it cited Vaca v. Sipes, supra, on Ihe 
issue of judicial review.



20

\AJlthough an allegedly illegal practice may ap­
pear to be operative throughout an industry, 
* * * whether all firms in the industry should he 
dealt with in a single proceeding or should re­
ceive individualized treatment are questions that 
call for discretionary determination by the ad­
ministrative agency. * * * [T] he Commission 
alone is empowered to develop that enforcement 
policy best calculated to achieve the ends con­
templated by Congress and to allocate its avail­
able funds and personnel in such a way as to 
execute its policy efficiently and economically.1" 1

See also Neie Jcruet/ v. United States, 168 F. Supp. 
324 (D. N.J. 1958), aff’d, 359 U.S. 27 (1959);12 
Panama Canal Co. v. Grace Line, Itic., 356 U.S. 309 
(1958).

More recently, in Southern. lit/, v. Seaboard Allied 
Milling Carp., 442 U.S. 444 (1979), this Court held 
that the courts could not review the Interstate Com­
merce Commission’s decision not to investigate charges

" The Court stated (.355 U.S. at 414) that the question 
whether the proceedings in a particular case should he held in 
abeyance pending anticipated future proceedings against com­
petitors was reviewahle to determine whether there had been 
a “patent, abuse of discretion.’’ Obviously the timing of such 
proceedings might ailed, the companies’ relative competitive 
advantage. That is an entirely different, question from whether 
a decision not to take enforcement action is reviewahle.

'"In New .Irrsc.if V. United States, supra., the Court sum­
marily affirmed a decision holding that the Interstate Com­
merce Commission had unreviewable discretion to decline to 
investigate a railroad’s proposer! suspension of service. The 
three-judge court had held (ICR F. Supp. at 329) that the 
JCC’s decision was agency action committed by law to agency 
discretion.

21

by shippers that certain railroad rates were illegal 
See also City of Chicago v. United Stales, 396 U.S. 
162, 165 (1969). The Court in Southern, Ity. noted 
(442 U.S. at 455) that the statutory provision gov­
erning the ICC’s investigative power “is written in 
the language of permission and discretion” and tlud 
“ [t]he statute is silent on what factors should guide 
the Commission’s decision.” The Court also relied 
on the structure and legislative history of the Inter­
state Commerce Act (id. at 456-460). As we will 
show, these same factors clearly demonstrate that 
the FDA’s decision in the present case is likewise 
exempt from judicial review under the APA.

The weight of lower court authority also holds that, 
administrative enforcement decisions are not subject 
to judicial review. For instance, in National Milk- 
Producers Federation v. Hands, 653 F.2d 339 (8th 
Cir. 1981), dairy producers sought to compel the FDA 
to initiate “investigative, enforcement, or prosecu­
torial” proceedings against persons alleged to he vio­
lating the FDCA by selling misbranded cheese sub­
stitutes in interstate commerce. The court of appeals 
held (id. at 343):

The executive branch and its departments en­
joy a discretion in the initiation of * * + enforce­
ment * * * actions limited only by constitutional 
strictures and relevant statutory directives.

Because the FDCA does not mandate enforcement 
actions, the court concluded (id. at 344) that a “com­
plaint which seeks the initiation of investigative, en­
forcement, or prosecutorial proceedings fails lo stale 
a claim upon which * * * relief can he granted.”

In City of Seabroolc v. Costlc, 659 F.2d 1371, B',74 
1375 (5th Cir. 1981), the court held that the fat 
vironmental Protection Agency has unreviewable dis



22

cretion to decline to find that a state implementation 
plan violates the Clean Air Act.1'1 The court correctly 
reasoned (id. at 1274 (citations omitted)):

The branches of government charged with the 
investigation of violations of the law and with 
enforcement of the law have traditionally been 
afforded broad discretion in carrying out these 
duties. We have held, for example, that the At­
torney General’s discretion “in choosing whether 
to prosecute or not to prosecute . . .  is absolute.” 
* * * The courts have recognized that, at least 
in the absence of a contrary statutory command, 
administrative agencies should be afforded simi­
larly broad discretion. * * * This principle of 
almost absolute discretion in initiating enforce­
ment action should apply with equal foiee to the 
decision to take the preliminary investigatory 
steps that would provide the basis for enforce­
ment. act ion.

See also American Broadcast hi;/ Companies v. FCC, 
(562 F.2d 155, If,7-159 (2d Cir. 1981), and American 
Broadcastini/ Companies v. FCC, (582 F.2d 25, 30-31 
(2d Cir. 11*22) (no judicial review of Federal Com­
munication Commission’s refusal to suspend and in­
vestigate' tariff filings).

The District of Columbia Circuit itself has simi­
larly refused to permit judicial review of determina­
tions by regulatory agencies not to initiate enforce­
ment proceedings. In KixmiUcr v. SFC, 492 F.2d 
(541 (D.C. Cir. 1974), the court held that the Securi­
ties and exchange Commission’s decision not to in­
vestigate the exclusion of certain materials from eor- 13

13 Such a finding enables the EF’A to issue a compliance 
order or initiate a civil action for injunctive relief or the 
assessment of a civil penalty. 42 U.S.C. (Supp. V) 7413.

23

porate proxy materials was not reviewable. Tin* 
court wrote (id. at 645 (footnotes omitted)): “An 
agency’s decision to refrain from an investigation or 
an enforcement action is generally unreviewable.” In 
Investment Co. Institute v. FDIC, 728 F.2d 518 (D.C. 
Cir. 1984), the court refused to permit review of a 
determination by the Federal Deposit Insurance Cor­
poration not to initiate cease and desist proceedings 
against a regulated bank for selling mutual fund 
shares through wholly owned subsidiaries. Holding 
that the matter was committed to agency discretion 
by law, the court noted (id. at 527) that “there is 
‘no law to apply’ in reviewing a simple refusal to 
take enforcement action.”

In departing from this longstanding authority hold­
ing that prosecutorial and administrative enforcement 
decisions are not subject to judicial review, the court 
of appeals relied principally upon Dunlop v. Baehow- 
ski, 421 U.S. 560 (1975). This Court’s opinion in 
Bachowski did not even discuss Section 701 (a) (2) of 
the A PA, but in any event that case is easily dis­
tinguishable from the present case.

In Bachowslci, a defeated candidate for union of­
fice sought to compel the Secretary of Labor to bring 
suit under provisions of the Labor-Management Re­
porting and Disclosure Act of 1959 (LMRDA), 29 
U.S.C. 482(a) and (b), to have the election set. aside. 
The Secretary argued that his decision was exempt 
from review under the APA both because “statutes 
preclude[d] judicial review” (5 U.S.C. 701(a)(1)) 
and because his decision was a matter “committed l<> 
agency discretion by law” (5 U.S.C. 701 (a )(2 )). In 
holding that the Secretary’s refusal to bring soil wn 
reviewable, this Court did not discuss the Secretary’s 
contention that the decision was an unreviewable



24

exercise of prosecutorial discretion, but instead 
merely expressed agreement (421 U.S. at 567 n.7) 
with the court of appeals’ treatment of the issue. 
See Iiachowslci v. Brennan, 502 F.2d 79 (3d Cir. 
1974).

The court of appeals, in turn, had begun by noting 
numerous cases holding the exercise of enforcement 
discretion to be unreviewable (see 502 F.2d at 86- 
87), but the court distinguished the case before it 
on three grounds. First, the court concluded (id. at 
87), based on tbe legislative history of the LMRDA, 
that in empowering the Secretaiy to bring suit to set 
aside an election, Congress intended the Secretaiy to 
act on behalf of aggrieved union members rather 
than merely on behalf of the public. Second, it noted 
(id. at 87-88) that union members have no remedy 
if the Secretaiy does not act. And third, the court 
observed (id. at 88) that the Secretary’s discretion 
was restricted by statute because he was required to 
bring suit whenever there was probable cause to be­
lieve that there had been a violation affecting the out­
come of the election and no settlement was reached.

None of these factors applies in the instant case. 
FDA enforcement is intended to protect the general 
public, not to redress individual wrongs; persons fac­
ing execution by lethal injection can challenge the 
legality of that method of capital punishment in other 
proceedings; H and under the FDCA, the FDA has

M The primary purpose of the Eighth Amendment is to 
proscribe “tortures” and other “barbarous” methods of pun­
ishment. (iVe/o V. <irorr/ia, 428 U.S. 15a, 170 (1970) (plurality 
opinion) : In re Krmnilrr, 130 U.S. 430, 447-449 (1890) (hold­
ing electrocution not cruel and unusual method of execu­
tion); Will,-mu,,, v. Utah, 99 U.S. 130, 130 (1879) (holding 
firing squad not cruel and unusual method of execution). 
Lethal injection statutes have been challenged under the

25

the traditional broad scope of enforcement discretion. 
See 21 C.F.R. 10.45(d) (2) (i).,B Thus, this Court’s 
summary treatment of the issue in Baclwwski pro­
vides no basis for departing from the well-established 
rule that prosecutorial and administrative enforce­
ment decisions are generally not subject to judicial 
review.

II. The FDA’s Decision Is Exempt From Review De­
cause The Governing Statutes Do Not Limit The 
Agency’s Discretion

Fiven if the presumption against judicial review of 
enforcement decisions is cast aside, there is still no 
basis for review in this case. As noted, agency action 
is exempt from review under the APA where the gov­
erning statutes do not impo.se standards restricting 
the agency’s discretion. This case falls squarely with­
in that exemption. * 15

Eighth Amendment on direct appeal from the judgment im­
posing the death sentence (see, e.q., Earvin v. Stair, 582 
S.W.2d 794, 799 (Tex. Crim. App.) (execution by lethal 
injection not cruel and unusual punishment)), cert, denied. 
444 U.S. 919 (1979), and in habeas corpus proceedings t  ee, 
e.q., Ex parte Granviel, 561 S.W.2d 503 (Tex. Crim. App. 
1978) (execution by lethal injection not cruel and unusual 
punishment)).

15 21 C.F.R. 10.45(d)(2) and (i) provides:
(2) The Commissioner shall object to judicial review 

of a matter i f :
(i) The matter is committed by law to tho discrelion 

of the Commissioner, e.g., a decision to recommend or 
not to recommend civil or criminal enforcement ad ion 
under sections 302, 303, and 304 of the act * ♦ *.



26

1. The FDCA Docs Not Limit The FDA's Enforce­
ment. Discretion, It is perfectly clear that the FDCA 
provides no “law to apply” in this case. The provi­
sions of the Act granting the FDA investigative and 
enforcement authority are “written in the language 
of permission and discretion.” Southern Ily., 442 U.S. 
at 455. The Secretary of Health and Human Ser­
vices is expressly “authorized to conduct examinations 
and investigations for the purposes of [the FDCA]” 
(21 U.S.C. 272). The Secretary is also implicitly em­
powered to initiate civil actions to enjoin statutory 
violations (21 U.S.C. 222) and to condemn adulter­
ated or misbranded foods, drugs, devices, and cos­
metics (21 U.S.C. 2,24). However, no provision of 
the FDCA commands the FDA to initiate investiga­
tive or enforcement activity whenever a statutory 
violation is alleged or found.

Nor does the Act provide standards to be used by 
the FDA in determining whether or when to under­
take such activity. “The statute is silent on what 
factors should guide the [agency’s] decision; * * * on 
the face of the statute there is simply ‘no law to ap­
ply’ in determining if the decision is correct.” South­
ern III/., 442 U.S. at 455.

The court of appeals made only the most perfunc­
tory effort to show that the FDCA provides law to 
apply, although in our view that is the dispositive 
question in this case. The court of appeals observed 
in a footnote (I’et. App. 26a n.2!)) that provisions of 
the FDCA specify that violators “shall” receive speci­
fied penalties. The insubstantial nature of this argu­
ment was demonstrated by Judge Scalia’s obseiwation 
in dissent that “ [m’Jost of the criminal code is cast 
in such mandatory terms, and yet prosecutors’ dis­

27

cretion not to indict is the archetype of unreviewable 
enforcement discretion” (Pet. App. 48a).

,n The court of appeals also relied (Pot. App. 20a n.29) 
on 21 U.S.C. 2.26. which provides that the Secret ary of 1IUS 
is not required “to report for prosecution, or for the insti­
tution of libel or injunction proceedings, minor violations 
* * * whenever he lielieves that t.he public interest; will he 
adequately served by a suitable written notice or warning.” 
This provision does not impliedly require the FDA to take 
enforcement action whenever there is a violation that is not. 
“minor.” Insofar as respondents requested that the FDA take 
purely administrative action, the provision does not apply be­
cause it pertains only to the reference of cases to the Depart­
ment of Justice for litigation. And insofar as respondents 
sought, the initiation of litigation, the provision is equally 
inapplicable because the legislative history makes clear that it 
was not intended to alter the .Justice Department’s traditional 
prosecutorial discretion. See 82 Cong. Rec. 7702 (1028) 
(remarks of Rep. Lea) (“I call attention * * * to the fact 
that the mere circumstance that the Secretary does not report, 
the ofTense does not excuse the accused from prosecution. Hie 
Attorney General may proceed in case he desires to do so ”) : 
id. at 7704 (“ fTjhere is nothing more common in the adminis­
tration of justice than the exercise of the discretion of a 
prosecuting attorney where he knows it, is impracticable to 
prosecute purely technical violations of the law.”). Rather, 
the legislative history shows that the provision was intended 
to give statutory recognition to one aspect of the FDA' 
much broader enforcement discretion. During floor debate, 
it was noted that “there will be * * * thousands of technical 
violations of the food and drug law which cannot, as a prac­
tical matter be prosecuted.” 82 Cong. Rec. 77512 ( 15)28) < re­
marks of Rep. I/Ca). The House Report stated (ll.lt. Rep. 
2120. 75th Cong., 2d Sess. 5 (1928)) that 21 U.S.C. 226  r i v e  
“definite legislative sanction to the procedure."

It should also be noted that 21 U.S.C. 226 was enacted a 
companion provision to 24 U.S.C. .225, which provides that lh< 
Secretary of TTTIS must give potential criminal defendant an 
opportunity for a hearing before referring a case In llm 
Justice Department for prosecution. In light of this some­
what; unusual provision, 21 U.S.C. 236 was designed simply t<*



28

2. The Preamble To A Proposed But Unadopted 
Rule Does Not Limit The FDA's Enforcement Dis­
cretion. Without any “law to apply” in the FDCA, 
the court of appeals turned to the preamble to a regu­
lation that was proposed for notice and comment but 
was never adopted by the agency. See 87 Fed. Reg. 
10503-1(5505 (1072).' The entire weight of the court 
of appeals decision rests on this slender reed. The 
preamble, however, plainly does not provide a basis 
for judicial review.

a. In the first place, the preamble cannot fairly lie 
read to restrict the agency’s enforcement discretion. 
The subject of the preamble and the proposed regula­
tion was not the FDA’s exercise of enforcement dis­
cretion but a question regarding the interpretation of 
the FDCA’s drug approval provisions. Specifically, 
the question addressed was the application of the 
drug approval provisions when approved drugs are 
prescribed by physicians for an unapproved use after 
shipment in interstate commerce. The preamble con­
cluded that physicians are not prohibited from pre­
scribing approved drugs for unapproved uses but 
that in certain circumstances the unapproved use of 
an approved drug may justify FDA enforcement ac-

make Hoar Ilia! even if fho Secretary finds after the hearing 
that (here has been a “minor” or technical violation, ihe Sec­
retary is imt obligated to report Ihe case to Ihe Justice De­
partment. See 83 Cong. Rec. 7792 (1938) (remarks of Rep. 
1,0a) (discussing Sections 335 and 33(5 as interrelated pro­
visions) .

Respondents rely (Rr. in Opp. 21) on provisions of the 
FDCA authorizing judicial review of various FDA regulations 
and orders. See 21 IJ.S.C. 34<5a(i), 348(g), 355(h), 3G0g. 
They also rely on 21 U.S.C. 332(a), which gives the district 
courts jurisdiction to restrain certain statutory violations. 
Obviously none of these statutes places the slightest restric­
tion on FDA's enforcement discretion.

29

tion. The preamble was solely concerned with this 
question of statutory interpretation and did not pur­
port to address the issue of the FDA’s enforcement 
discretion.

The court of appeals, however, seized upon a single 
sentence in the preamble and wrenched it out of con­
text.17 The sentence stated (see Pet. App. 24a (em­
phasis added)) that “ [wjhere the unapproved use of 
an approved new drug becomes widespread or endan­
gers the public health, the Food, and■ Drug Adminis­
tration is obligated to investigate it thoroughly and 
to take whatever action is warranted to protect the 
public,.” In context, this sentence meant only that, 
when a possible violation occurs, the FDA is obli­
gated to fulfdl its statutory mandate. But as previ­
ously observed, an agency may fulfill its statutory 
enforcement responsibilities by pursuing any of a 
number of enforcement strategies. An agency is not 
generally required to investigate or initiate enforce­
ment action whenever a possible violation is reported 
or suspected. The FDA has always exercised the tra­
ditional broad scope of enforcement discretion. In­
deed, its rules specify that the agency regards its en­
forcement discretion to be unreviewable. 21 C.F.R. 
10.45(d) (2) (i). See page 25 note 15, supra. It is 
far-fetched to suggest that the sentence in the pre­
amble was meant to surrender any portion of that 
discretion.

17 The court quoted (Pot. App. 24a, 25a) two other sentences 
from the preamble, but neither can possibly txi rend to limit 
the FDA’s enforcement discretion. The first, of these staled 
merely that the FDA would not “hesitate to take whatever 
action * * * may tie required.” The second stated that certain 
conduct constituted a statutory violation and “is punishable 
accordingly.”



30

The wording of the preamble also refutes the sug­
gestion that it was intended to limit the FDA’s dis­
cretion. As -lodge Scalia noted (Pet. App. 4<8a-49a), 
the sentence on which the court of appeals relied 
is full of flexible terms that do not provide a work­
able basis for judicial review. The sentence stated 
(see id. at 24a (emphasis added)) that “ [wjhere 
the unapproved use of an approved new drug be­
comes widespread- or endangers flic public health, the 
Food and Drug Administration is obligated to in­
vestigate' it thoroughly and to take iclialcvcr action 
is warrantat to protect the public.” What is “wide­
spread” use? What constitutes a sufficient danger 
to the public health? And in a given case, what ac­
tion is “warranted”? It is evident that these ques­
tions cannot be answered intelligently without sur­
veying th(> potential dangers posed by all the foods 
and drugs marketed in this country and all the re­
sources at the FDA’s command. We do not see how 
the courts could perform that function without tak­
ing over day-to-day operation of the agency.

Moreover, the preamble addressed only one small 
portion of the FDA’s investigative and enforcement 
responsibilities: the unapproved use of approved
drugs. ’Phis is an area in which the agency’s author­
ity to proceed is less well settled than in cases involv­
ing more common types of violations,1" such as the 
promotion and sale of products for unproven uses. 
Neither the court of appeals nor respondents have 
suggested that the courts can review every FDA en­
forcement decision or even every decision involving 
the issue of misbranding. It is thus most unlikely 
that the FDA would have obligated itself to take in-

,n See United Slates v. Fivers, 043 F.2d 1043 (5th Cir. 
1081).

31

vestigative or enforcement action in all cases iri an 
area near the fringes of the law, while reserving the 
discretion not to proceed in cases where its authority 
is far more (irmly established.

b. Even if the unadopted preamble had discussed 
the FDA’s enforcement discretion, it would not bind 
the agency. Under most circumstances, of course, a 
rule that is proposed but not adopted has no legal ef­
fect. It cannot be judicially enforced any more than 
a bill that is not enacted into law.

The court of appeals justified its reliance on the 
preamble on two grounds. First, the court stated 
that the PDA itself considers the preamble to be 
“binding” and “authoritative” (Pet. App. 25a & 
n.28). Second, the court observed that the preamble 
fell within the APA’s definition of a rule, which it. 
construed as “broad enough to include nearly every 
statement an agency may make” (id. at 25a, quoting 
Center for Auto Safety v. NUTSA, 710 F.2d 842, 
846 (D.C. Cir. 1983)). Neither of these grounds is 
valid.

The court of appeals’ description of the status of 
the preamble in the FDA’s eyes is misleading at best. 
Under the FDA’s rules, a policy statement accom­
panying an unadopted regulation is considered to be 
an advisory opinion unless subsequently repudiated 
by the agency or overruled by a court. 21 C.F.P. 
10.85(d).1" Advisory opinions are usually requested

,n 21 C.F.R. 10.85(d) provides in pertinent part:
(d) A statement of policy or interpretation made in 

the following documents, unless subsequently repudiated



32

by persons who may be affected by FDA action. Ad­
visory opinions bind the agency in the sense that the 
agency is usually precluded from taking action 
against a person or firm that has relied on such an 
opinion. See 21 C.F.R. 10.85(e)."" However, the 
FDA’s rules make clear that an advisory opinion does 
not establish legal standards or requirements that 
are binding in other contexts. The rules unequivo­
cally state (21 C.F.R. 10.85(j ) (emphasis added)):

An advisory opinion may be used in administra­
tive or court proceedings to illustrate acceptable 
and unacceptable procedures or standards, but 
not as a ler/al requirement.

Accordingly, under its own rules, the FDA does not 
regard the unadopted preamble as a generally bind­
ing legal requirement.21

by the agency or overruled by a court, will constitute an 
advisory opinion:

(]) Any portion of a Federal Register notice other 
than the text of a proposed or final regulation, e.g., a 
notice to manufacturers or a preamble to a proposed or
final regulation.

m 21 C.F.R. 10.85(e) provides (emphasis added) :
(e) An advisory opinion represents the formal position 

of FDA on a matter and except as provided in paragraph
(f) of this section, obligates the agency to follow it until 
it is amended or revoked. The Commissioner may not 
recommend loyal notion aqainst a prison or product with 
respect to nn notion token in conformity with an advisory 
opinion which lias not been amended or revoked..

21 See United States V. Articles of Urn a * * * * Promise 
Toothpaste, No. 83-U-6129 (N.D. III. .July 30, 1984), slip op. 
11-15 (portions of unadopted preamble, particularly those

33

The other basis for the court of appeals’ reliance 
on the preamble—that it falls within the APA’s defi­
nition of a rule—is equally unsound. Assuming for 
the sake of argument that the preamble is a “rule” 
within the APA definition,22 “as a matter of admin­
istrative law, * * * it seems clear that agencies are 
not required, at the risk of invalidation of their ac­
tion, to follow all of their rules.” United Stales v. 
Caceres, 440 U.S. 741, 754 n.18 (1979). Legislative 
rules 2:1 have the force and effect of law and thus gen­

dealing with enforcement decisions, should not be regarded as 
advisory opinion; at most, advisory opinion restricts FDA 
authority to proceed against persons who have relied on opin­
ion) ; Mcllwain v. Hayes, 530 F. Rupp. 973, 977-978 n.H 
(I).D.C. 1981), afT’d, 690 F.2d 1041 (D.C. Cir. 1982).

22 The APA’s definition of a rule is broad and ambiguous. 
The APA states (5 U.R.C. 551(4)) that a ‘‘ ‘rule’ means Iho 
whole or a part of an agency statement of general or partic­
ular applicability and future effect designed to implement
* * * law or policy.” Whether an advisory opinion falls within 
the APA’s definition of a rule is subject to dispute and may 
vary from case to case. See 2 K. Davis, Administrative Law 
Treatise §7.4 (2d ed. 1979). Because the definition of a rut' 
is so unclear, questions of administrative law can seldom he 
answered simply by applying that definition. As Professor 
Davis has observed, “ [o]ften the best solution * * * is * * ‘ to 
skip the labeling and to proceed directly to the problem 
at hand.” K. Davis, Administrative Law Text §5.01, at 12." 
(1972).

2,1 “Legislative rules” have been defined as rules that an' 
“ ‘issued by an agency, pursuant to statutory authority and
* * * implement the statute. * * * Such rules have the force 
and efTect of law.’ ” Batterton V. Francis, 432 U.S. 416. 425 
n.9 (1977) (quoting U.S. Dep’t of Justice, Attorney Cenernl'. 
Manual on the APA 30 n.3 (1947)). “Interpretative rules."



34

erally bind an agency. Vilarelli v. Seaton, 359 IJ.S. 
535 (1959): Service v. Dulles, 354 U.S. 363 (1957); 
2 K. Davis, Administrative Law Treatise § 7.21 
(2d ed. 1979). By contrast, interpretative rules and 
other agency pronouncements—guidelines, policy 
statements, advisory opinions, handbooks, manuals, 
instructions to stall'—are generally not binding and 
thus do not furnish law to apply under 5 U.S.C. 
701(a)(2). See, c.<j., Schweiker v. Hansen, 450 U.S. 
785 (1981); Chri/sler Carp. v. Brown, 441 U.S. 281, 
301-302 (1979); Sullivan v. United Stales, 348 U.S. 
170, 173 (1954); Gaiter v. Nimmo, 672 F.2d 343, 
347 (3d Cir. 1982); Pacific Gas <£• Electric Co. v. 
FPC, 506 F.2d 33 (D.C. Cir. 1974); Brennan v. Ace 
Hardware Carp., 495 F.2d 368, 376 (8th Cir. 1974); 
2 K. Davis, supra, § 7.21, at 100. As Professor Davis 
has written (2 K. Davis, supra, §7.21, at 105): 
“ [w]hen a non-legislative rule explicitly states that 
it does not confer rights or impose obligations, the 
explicit statement should control in absence of a good 
reason to the contrary.”

The unadopted preamble at issue here is certainly 
not a legislative rule,"' and as previously shown, FDA 
regulations explicitly stale that informal pronounce- * 24

which lack tin- force and effect of law, have been defined a* 
“rules or statements issued by an agency to advise the public 
of the agency's construction of the statutes and rules which it 
administers.” Ibid. See also Chrysler Corp. v. Brown, 441 
U.S. 281. 802 n.21 (1070) ; 2 K. Davis, supra, §7.8.

24 Nor is this a case involving the extinguishment of rights 
that would otherwise have been available by statute. Compare 
Morion v. h'uiz, 415 U.S. 100. 230 (1074). Neither respond­
ents nor any other member of the public ever had a statutory 
right, to insist that the FDA pursue every possible case.

35

ments such as the preamble do not impose generally 
binding legal requirements. 21 C.F.R. 10.85(j). 
Thus, in the absence of a good reason to the contrary 
—and there is none—the preamble should not be held 
to bind the agency.

Certainly this is not a case in which there has been 
detrimental reliance on the preamble." Respondents 
make no claim that they relied on the preamble when 
they decided to commit their capital offenses. More­
over, judicial enforcement of the preamble would 
have highly undesirable practical consequences. As 
noted, the preamble is, at most, an informal state­
ment of policy that the agency itself does not regard 
as binding except in narrow circumstances. I he 
court of appeals’ holding boils down to the proposi­
tion that any such agency statement regarding its en­
forcement policy provides a sufficient basis for judi­
cial review of the agency’s enforcement decisions. 
Adoption of this view would penalize an agency for 
explaining its enforcement policies to the public or 
for promulgating internal guidelines in an effort to 
ensure that its enforcement decisions are rational and 
consistent. Yet both of those activities are beneficial 
and should be encouraged.2"

3. The Question Whether There Is Lair To Apply 
Does Not Depend Upon A Judicial Assessment Of 
“Pragmatic Considerations.” Since neither the FDD A 
nor the preamble provides any “law to apply” in Ibis; 
case, the only possible basis for the decision below is 
the court of appeals’ conclusion (Pet. App. 2-1 a ) that

-r’ See United States v. Cneeres, 440 U.S. at 752-753 & n I V
2,1 See 2 K. Davis, supra, chs. 0, 10 (statements by enforce- 

mont officers concerning bow enforcement discretion will In- 
exercised are generally not binding).



36

“ [t]he deterniinatinn of whether there ‘is law to ap­
ply’ turns on such pragmatic considerations as 
whether judicial supervision is necessary to safe­
guard plaintiffs’ interests, whether judicial review 
will unnecessarily impede the agency in effectively 
carrying out its congressionally assigned role, and 
whether the issues are appropriate for judicial re­
view’.” '-'7 However, this test, which the court of ap­
peals now regularly applies in cases in this area,2" 
is not faithful to the restrictions on judicial review 
imposed by Congress.

The question whether a matter is “committed to 
agency discretion by law (5 U.S.C. 701 fa) (2)) or 
whether there is “ ‘law to apply’ ” (Overton Park, 
401 U.S. at 110) is a straightforward question of 
statutory construction. It is not a policy question 
calling for judges to decide whether judicial super­
vision seems “necessary” or “appropriate” (Pet. App. 
24a) based upon their “personal policy preferences” 
(Chevron (J.S.A. hie. v. NRDC, slip op. 27). As Judge 
Scalia aptly put it (Pet. App. (51a), the court of ap- 27

27 The court did Tint, ‘‘delve into a detailed analysis” of 
these considerations because it believed that the preamble 
provided “law to apply” (Pet. App. 24a).

2R See Ealkmrski v. EEOC, 719 F.2d 470. 480 n.1C. (D.F. Fir. 
1983). petition for cert, pending, No. 83-2034; Investment. Co. 
Institute V. FD1C, 728 F.2d at 526 & n.6 (majority of panel 
expresses “discomfort with the test” to which circuit, is 
bound); American Friends Service Committee v. Webster, 
720 F.2d 29, 39-45 & n il .10, 13 (D.C. Cir. 1983) (literal 
application of Overton Park test provides “limited guidance” ; 
must be supplemented by "more pragmatic analysis”) ; Local 
1219, American Fed’n of Gov’t Employees v. Donovan, 683 
F.2d 511, 515 (D.C. Cir. 1982); Natural Resources Defense 
Council. Inc. v. SEC, 606 F.2d 1031, 1044 (D.C. Cir. 1979).

37

peals’ “pragmatic considerations” test means (hat 
the court is free to review discretionary administra­
tive determinations whenever it “thinkfs] it a good 
idea.” He added (id. at 61a-62a): “The recited
‘pragmatic considerations’ bear no rational relation­
ship to ‘whether there is law to apply.’ One could 
with equivalent logic recite them as the definition <»1 
‘injury in fact’—or of almost any other concept that 
needs evisceration.”

C. The Structure And Legislative History Of The 
FDCA Show That Congress Intended The FDA To 
Have Unreviewable Enforcement Discretion

Both the structure and legislative history of tlm 
FDCA reinforce the conclusion that the FDA was in­
tended to have unreviewable enforcement discretion.

1. In Southern lit/., this Court inferred from the 
structure of the Interstate Commerce Act that the 
ICC’s enforcement decision was not reviewable. The 
Court relied upon the disruptive effect of permitting 
review: “If the Commission * * * must, carefully 
analyze and explain its actions with regard to each 
component of each proposed schedule, and if it must 
increase the number of investigations it conducts, all 
in order to avoid judicial review and reversal, its 
workload would increase tremendously.” 4 12 U.S. at 
457. Similarly, court review of the FDA’s enforo - 
ment decisions would seriously impair the agency's 
ability to carry out its congressionally assigned role.

The FDA’s regulatory and enforcement duties are 
far reaching. The FDA bears either sole or primary 
regulatory responsibility for the safety of all of’ the 
nation’s human and veterinary drugs, most foods, 
biological products (e.g., vaccines and blood prod­
ucts), medical devices, and radiological products



38

(e.g., X-ray machines, color television sets, and 
microwave ovens). The FDA implements its regula­
tory authority through both pre-marketing approval 
(which applies to most human and veterinary drugs, 
food additives, biological products, and certain medi­
cal devices) and extensive post-marketing enforce­
ment programs, which consist primarily of scheduled 
inspections of manufacturing and holding facilities 
of all regulated products. Additionally, the FDA is 
the regulatory agency frequently called upon to deal 
with national emergencies such as the botulism scare 
of 1971 and, more recently, the Tylenol poisonings of 
1983.

Enforcement of the FDA’s regulatory authority 
takes place through seizures under 21 U.S.C. 334, 
injunctive actions under 21 U.S.C. 332, and criminal 
prosecutions under 21 U.S.C. 333. Administrative 
remedies are also widely utilized.

Judicial review of the FDA’s myriad enforcement 
decisions would interfere greatly with these responsi­
bilities. The court of appeals candidly admitted that 
review of such decisions requires a “searching and 
careful” scrutiny of “both the administrative record, 
particularly tin* uncontroverted evidence submitted 
by [respondents], and the agency’s stated reasons for 
its action” (Pet. App. 31a). There is little doubt 
that such exacting review would pressure agencies to 
respond to requests for enforcement action with care­
fully phrased and factually detailed written deci­
sions.2" Agencies would be forced by the threat of

'2V Where agency action is subject to judicial review, this 
Court has frequently observed that "the orderly functioning 
of the process of review requires that the grounds upon 
which the administrative agency acted be clearly disclosed.” 
SEC V. Clirurry Carp., .118 U.S. 80, 94 (1943) ; see also, r.p.,

39

burdensome court proceedings and possible reversal 
to disclose sensitive and privileged information re­
garding their broad enforcement plans. They would 
also be compelled to expend resources that could be 
put to far better use. See L. Jaffe, Judicial Control 
of Administrative Action 272 (1965) (“Enforcement 
would become impossible if an agency were required 
to justify its prosecutorial choices.” ).

2. The legislative history of the FDCA also 
strongly supports the nonreviewability of the FDA's 
enforcement determinations. During Senate consid­
eration of the bill that became the FDCA (S. 5, 75th 
Cong., 1st Sess. (1937)), Senator Moore observed (81 
Cong. Rec. 2013-2014 (1937)) that doctors in his 
home state were “much concerned about the bill” ( id. 
at 2014 (emphasis added)):

The doctors point otd that * * * the provision 
as to prosecution is permissive; that it mould not 
he necessary under the bill to enforce the lam. 
It would give the Secretary of Agriculture ,:m| 
the right to be judge, jury, and trial attorney. 
He might or might not decide that he should 
present evidence of any violation to the proper 
authorities.

Senator Moore was referring to a report of the 
Welfare Committee of the Medical Society of New 
Jersey, which was ordered printed in the Congres-

Motor Vehicle Mfrs. Ass’n V. State Farm Mutual, No. 82-3-91 
(June 24, 1983), slip op. 12-13; FTC V. Sperry *(’• Ifutchiiismi 
Co., 405 U.S. 233, 249 (1972) ; FPC V. United Gas Pipe Give 
Co., 393 U.S. 71, 73 (1908).

•™ Enforcement of the FDCA was originally Hie responsibil­
ity of the Secretary of Agriculture. Act of June 25, 1938, 
ch. 075, § 201(c) and (d), 52 Stat. 1041.



sional Record. The report stated (81 Cong. Rec. 
2015 (1087)):

The only part of the present S. 5 which is 
mandatory to the Secretary of Agriculture is 
chapter 8, Section 7, which requires the Secre­
tary to hold hearings for “persons against whom 
proceedings are contemplated in accordance with 
regulation prescribed by himself” * * * * * .

In the article by Dr. Woodward * * * * he un­
equivocally condemned the discretionary features 
of the bill.

The report continued (81 Cong. Rec. 201G (1937) 
(emphasis added)) :

Consider now the administrative features of 
S. 5 * * *. We find in section 25 of S. 5 [now 
21 U.S.C. 872] that “The Secretary is merely 
authorized to conduct examinations and investi­
gations for the purposes of this act.” Rut this is 
not the worst, because in section 8 [now 21 
U.S.C. 33G] we find that the Secretary or his 
agent is given the right to simply write a letter 
to an offender for whatever he may say that he 
“believes” to be a “minor violation.” A minor 
violation is legally undefinable in any court; a
man’s belief is equally undefinable in a statute * * *

Thus we find that this clause provides for an 
administrative arbitrator who may legally limit 
the definitions of offense and the infliction of 
penalty on each violation detected; who may 
'prosecute or withhold action as he sees fit, and 
thus may adjudicate each offense on camera; a 
combination of legislative, administrative, and 
judicial fund ions in one Cabinet official, to be 
delegated to a bureau chief.

In his detailed response (81 Cong. Rec. 2016-2018 
(1087)), Senator Copeland, the floor manager of the

40 41

bill, in no way contradicted this characterization of 
the bill. A substitute proposed by Senator Moore was 
defeated by the Senate (id. at 2018), and the I1 l)( A 
passed the Senate soon thereafter (id. at 2010). On 
the House side as well, it was recognized that the 
FDA would have broad discretionary authority, like 
that of a criminal prosecutor, in determining whether 
to seek enforcement.31 Congress thus clearly contem­
plated that the FDA would have no judicially cog­
nizable duty to initiate proceedings to enforce I lie 
Act.32 As a commentator wrote shortly after the

■!'1 Representative Lea, in connection with the section of the 
bill that became 21 U.S.C. 336, stated (83 Cong. Rec. 77513- 
7794 (1938)) :

ft]n this particular case we are dealing with the duties 
of a purely administrative official and this is far different 
from dealing with a judicial officer, even somewhat differ­
ent from dealing with the Department of Justice. How­
ever, there is nothing more common in the practice of 
criminal law than for the prosecuting attorney to exercise 
his judgment as to the cases he will prosecute. * * * 

* * * * *
|T]here is nothing more common in the administration 
of justice than the exercise of the discretion of a prose­
cuting attorney where he knows it is impracticable to 
prosecute purely technical violations of the law. This is 
a candid recognition of that practical situation, and 1 
believe it will work for the betterment of law enforre- 
ment. * * *

•12 The legislative history on which the court, of appeals 
relied (Ret. App. 26a n.29, citing S. Rep. 646, 74th Cong., 
1st Sess. 10 (1935)) relates to statutory language that was 
never enacted and, in fact, was specifically rejected bv Con­
gress. Several years liefore the enactment of the FDCA, a 
predecessor bill was introduced. S. 5, 74th Cong., 2d Sess.



42

Act’s passage: “Leaving aside the question of ‘multi­
ple seizures,’ 11:11 the exercise of discretion hy the fed­
eral authorities in determining whether to institute 
criminal or libel for condemnation proceedings or 
both is not subject to judicial interference.” Lee, 
The Enforcement Provisions of the Food, Drug, and

(1936). Ap reported by 1 tie Senate committee, Section 702 of 
that bill contained the following language (S. 5, supra, at 23 
(language marked out)) :

The district courts * * * are hereby vested with jurisdic­
tion, on petition by any interested person, * * * to grant 
appropriate injunctive relief from any act or omission 
of any officer, representative, or employee of the Depart­
ment in the administration of this Act, if it has been 
shown that such act or omission is unreasonable, arbi­
trary, or capricious, or not in accordance with the facts 
or law * * \

The House committee omitted this language altogether, stat­
ing (H.R. Rep. 2755, 74lh Cong., 2d Sess. 8 (1936)) that 
"It] he committee was not aware of any precedent for such a 
proposition.” See also Kleinfeld, Legislative History of the 
Federal Food ,  Drug, and Cosmetic Act, 1 Food Drug Cosm. 
D.J. 532, 564-565 (1946). The entire bill subsequently died 
l>ocause of a disagreement between the House and Senate over 
another issue. 80 Cong. Rec. 10514-10519, 10680 (1936) ; see 
Kleinfeld, supra, 1 Food Drug Cosm. L.J. at 566.

When a different Senate Bill 5 passed the 75th Congress to 
become the FDCA, the only express reference to review of the 
agency’s refusal to act was the provision (now 21 U.S.C. 
371 (f) (1) and (3)) for court of appeals review of the Secre­
tary's refusal to “issue, amend, or repeal” certain regulations 
—a limited provision clearly not applicable to the instant case.

M The FDCA limits the discretion of the FDA to institute a 
seizure proceeding for misbranding if another such proceed­
ing is pending in any court, based upon the same alleged 
misbranding. See 21 U.S.C. 334(a) (1). This limitation obvi­
ously does not. affect the FDA's discretion not to institute 
proceedings.

43

Cosmetic Act, 6 Law & Contemp. Probs. 71), 76 
(1939).

II. EVEN IF REVIEWABLE, THE FDA’S ENFORCE­
MENT DECISION WAS RATIONAL AND SHOULD 
HAVE BEEN SUSTAINED

Even if the FDA’s decision not to regulate the 
states’ use of drugs in carrying out capital punish­
ment were reviewable, it nonetheless should have been 
upheld. In those special circumstances in which judi­
cial review of administrative enforcement decisions 
is allowed, the scope of review is limited to determin­
ing whether the agency has stated a rational basis 
for its decision. Dunlop v. Bachowski, 421 1J.S. at 
568, 572-573. That standard was easily met here.

A. The FDA Lacks Authority To Regulate The States’ 
Use Of Lethal Injections For Capital Punishment

The FDA denied respondents’ petition, (lest, lo­
calise it concluded (Pet. App. 82a) that “the use of 
lethal injection by State penal systems is a practice 
over which FDA has no jurisdiction.” An agency’s 
interpretation of the statute it administers is entitled 
to considerable deference. As this Court recently 
noted (Chevron U.S.A. Inc. v. NRDC, No. 82-l<>05 
(June 24, 1984), slip op. 4-5 (footnotes omitted)):

When a court reviews an agency’s construc­
tion of the statute which it administers, it is con­
fronted with two questions. First, always, is the 
question whether Congress has directly spoken 
to the precise question at issue. If the intent of 
Congress is clear, that is the end of the matter: 
for the court, as well as the agency, must give 
effect to the unambiguously expressed intent of 
Congress. If, however, the court determines Con-



44

gross has not directly addressed the precise ques­
tion at issue, the court does not simply impose 
its own construction on the statute, as would be 
necessary in the absence of an administrative 
interpretation. Rather, if the statute is silent or 
ambiguous with respect to the specific issue, the 
question for the court is whether the agency’s 
answer is based on a permissible construction of 
the statute.

Here, it certainly cannot be argued that “Congress 
has directly spoken to the precise question at issue.” 
Neither the court of appeals nor respondents have 
produced a shred of evidence that Congress wanted 
the FDA to regulate the methods of capital punish­
ment used by the states. Moreover, Congress’s silence 
on this point cannot be attributed to the fact that no 
state employed lethal injections when the FDCA was 
enacted in 1938. The provisions of the FDCA upon 
which the court of appeals relied apply to all “drugs” 
and “devices.” A “drug” is broadly defined to in­
clude any “articles (other than food) intended to 
affect the structure or any function of the body of 
man” (21 U.S.C. 321(g)(1)(C )). This definition 
arguably could encompass the cyanide tablets used 
in gas chambers. Likewise, a “device” is defined 
to include any “instrument, apparatus, implement, 
machine, contrivance * * * or other similar or re­
lated article * * * which is * * * intended to affect 
the structure or any function of the body of man” 
(21 U.S.C. 321(h) and (3)). The electric chair and 
gallows could also he argued to fall within this defi­
nition. In 1938, the state and federal governments 
regularly used these methods of capital punishment. 
Yet there is no indication that any member of Con­
gress even considered the possibility that enactment 
of the FDCA might affect these practices.

45

Since Congress did not intend the FDA to reg­
ulate capital punishment, the remaining question is 
whether the FDA’s construction of the statute is a. 
permissible one. In this case, the FDA's interpreta­
tion is plainly correct. The statutory provisions upon 
which the court of appeals relied, 21 U.S.C. 331 (k) 
and 352(f), prohibit the “misbranding” of drugs 
while they are “held for sale.” Without, exploring all 
of the elements needed to make these provisions ap­
plicable, it seems clear that Section 331 (k) and 
352(f) do not apply in the unique situation at issue 
here because the alleged act of misbranding does not 
occur while the drugs are “held for sale.” It is true 
that the phrase “held for sale” has been given an 
expansive reading by the courts in the context of the 
FDA’s traditional enforcement activity. See, e.a.. 
United States v. Diapulse Corp., 514 F.2d 1097 (2d 
Cir.), cert, denied, 423 U.S. 838 (1975). However, 
there is no basis to apply it in a context so far afield 
from the FDA’s traditional enforcement activity as 
the imposition of capital punishment. The court of 
appeals’ and respondent’s interpretation of this 
ph rase is not supported by either the statutory lan­
guage or a scintilla of evidence regarding Congress's 
intent.

According to respondents and the court of appeals, 
the misbranding takes place when the drugs are used 
by prison officials for a purpose (capital punishment.) 
that is not listed on their labels.34 See Pet. App. 16a-

34 This case concerns t.he FDA’s authority to regulate the 
states’ of drugs, lawfully in interstate commerce, for the 
unapproved purpose of causing death, and not the markrtiurj 
of drugs for an unapproved use. If a manufacturer or anyone 
else in the chain of distribution directly or indirectly were lo 
suggest that a drug may properly be used for an unapproved 
use, the Act would be violated. Thus, if a drug were marketed



46

17a. The court of appeals acknowledged (see id. at 
14a) that the drugs are not “held for sale” in any 
literal sense when they are injected into the con­
demned prisoner against his will. But the court re­
lied (id. at 14a-15a) upon legislative history showing 
that Section 331(k) was intended to exercise the full 
reach of federal power under the Commerce Clause 
for the purpose of protecting “consumers.” We 
readily agree that Congress’s purpose in enacting 
Section 331 (k) was to extend the greatest possible 
protection to persons to whom drugs may be admin­
istered for conventional purposes. But, as noted, 
there is absolutely no evidence that Congress intended 
to regulate the use of drugs or devices, pursuant to a 
lawful court order, for the purpose of capital punish­
ment. Unsupported by either the statutory language 
or any proof of congressional intent, the court of ap­
peals’ and respondents’ strained interpretation of the 
statute must fail."1 The “misbranding” provisions 
were not violated. * *

for the purpose of causing death without being approved for 
that use, a violation would occur. In this c;ise, however, it has 
not. been alleged or shown that, any manufacturer or distribu­
tor directly or indirectly promotes the use of the drugs at. issue 
for the purpose of carrying out death sentences.

*1' In concluding that the FDA possessed the authority to 
grant, respondents’ requested relief, the court of appeals re­
peatedly referred to the FDA’s actions regarding drugs used 
to destroy animals and drugs administered to prisoners par­
ticipating in research projects. Pet. App. 11 a-1.2a, 31a-32a. 
These situations, however, are clearly distinguishable. The 
FDA has special statutory authority in both of these areas. 
See 21 U.S.C. 355(i), 357(d), 360j (g) (research projects); 
21 U.S.C. 360b(a) (1) (animal drugs). The FDA has as­
serted authority over the marketing of drugs to destroy ani­
mals. See United States v. Beuthanasia-D Regular, [1979 
Transfer Hinder] Food. Drug, Cosm. L. Rep. (CCTI) 11 33, 205 
(D. Neb.). And the drugs dispensed to prisoners in research

47
It. Other Legitimate And Substantial C onsiderations 

Support The FDA’s Determination Not To Initiate 
Investigative Or Enforcement Activity

Even if the FDCA could somehow be stretched to 
reach the administration of lethal injections for pur­
poses of capital punishment, the FDA properly exer­
cised its “inherent discretion to decline to pursue cer­
tain enforcement matters” (Pet. App. 85a). In the 
first place, the FDA recognized that any efforts to 
assert jurisdiction would result in protracted-and 
quite possibly unsuccessful litigation with the states.™ 
See Pet. App. 32a, 82a-85a; United States v. Urcrs, 
643 F.2d 1043 (5th Cir. 1981). It is certainly within 
an administrative agency’s discretion to shun burden­
some cases where its jurisdiction appears dubious at 
best.

The FDA had three additional sound reasons for 
its decision. To begin with, regulating the method 
of capital punishment used by the states, whether or 
not technically within the scope of the FDCA, is fat- 
removed from the FDA’s central responsibilities. 
Surely the FDA acted reasonably in conserving its 
limited enforcement resources for matters more 
closely related to its principal mission.”7 * 30

projects, participation in which is voluntary, are administered 
for conventional purposes and not for the purpose of punish­
ment.

'"'Subsequent events have proven this prospect accurate. 
When a Texas prisoner sentenced to death by lethal injection 
obtained a district court, injunction requiring (be FDA to 
seize the State’s drugs (O’Bryan v. Hechter, Civ. No. 34-996 
(D.D.C. Mar. 30, 1934), vacated, No. 84-996 (D.U. Fir. Mar.
30, 1984), stay denied, No. A-791 (Mar. 30, 1984)), the Stale 
immediately sued the FDA to block the seizure. McKashlr v. 
United, States Food and Drug Administration, No. 11-84-1544 
(S.D. Tex.).

1,7 Respondents insist (Br. in Opp. 14 & n.8) that the FDA 
did not base its decision on the need to conserve its enforce-



48

The FDA’s decision also was based upon appropri­
ate respect for principles of federalism. The FDA 
stated (Pet. App. 82a) that its decision was “sup­
ported * * * by a consideration of the proper role of 
the Federal Government with respect to the conduct 
of State criminal justice systems.” See also id. at 
85a. Enacting laws to prevent and punish crime is 
among the most important powers of the states, and 
in prescribing lethal injection as the method of execu­
tion, the states acted within federal constitutional 
limits. The FDA was reasonable in deferring to the 
states’ authority in this field.

Finally, the FDA acted reasonably in relying (Pet. 
App. 85a) in the alternative on the absence of a 
“serious danger to the public health.” The court of 
appeals disagreed (id. at 5a), asserting that there 
was “a substantial threat of torturous pain to per­
sons being executed.” However, not only is the fac­
tual predicate for the court’s conclusion dubious (see 
id. at 51a-52a & n.5), but the court appears entirely 
to have missed the point. The proper inquiry is not 
whether death by lethal injection involves pain but 
whether it involves more pain than death by alterna­
tive methods of execution, such as the electric chair, 
the firing squad, or the gas chamber. As Judge Scalia

ment, resources for other endeavors. However, the FDA 
clearly and repeatedly invoked the well-known doctrine of 
prosecutorial discretion (see Pet. App. 85a), and one of the 
bases for that doctrine is the view that agencies must, have 
the freedom to concentrate their enforcement resources in a 
manner that, achieves optimum results. We do not believe 
that the FDA was obligated to spell out all the familiar 
grounds for this doctrine. Respondents’ close parsing of the 
FDA’s decision illustrates how burdensome it would be for 
agencies if their enforcement decisions were subject to judi­
cial review.

49

put it (id. at 51a (emphasis in original)), “it. is not 
a matter of pain versus no pain, but rather pain ol 
one sort substituted for pain of another—and in oil 
likelihood substitution of a lesser pain, since that is 
the principal purpose of the lethal injection statutes. 
Such comparisons were made by the legislatures that 
enacted the lethal injection statutes. The FDA acted 
responsibly in declining to review their determina­
tions on this unique subject.38 Thus, even if the 
FDA's decision not to initiate enforcement proceed­
ings were judicially reviewable, that decision was 
rational and should not have been disturbed.

•’'"Contrary to respondents’ suggestion (P»r. in Opp. 28-24), 
the Supremacy Clause does not preclude the FDA from de­
ferring to the states’ considered judgment that lethal injec­
tion is the least painful method of capital punishment. Stale 
law cannot interfere with lawful FDA action, but the Su­
premacy Clause does not command the federal government 
to take enforcement action in every possible case.



50

CONCLUSION

The judgment of the court of appeals should be 
reversed.

Respectfully submitted.

Rex R. Lee 
Solicitor General

Richard K. Willard
Acting Assistant, 

Attorney General
Kenneth S. Geller 

Deputy Solicitor General
Samuel A. Alito, ,Jr.

Assistant to the Solicitor 
General

Leonard Sciiaitman 
John M. Rogers

Attorneys
T homas Scarlett 

Chief Counsel
M ich a el  P. P eskoe 

Associate Chief Counsel 
for Drugs

Food and Drug Administration

August 1PB4

APPENDIX

5 U.S.C. 701(a) provides in pertinent part:
This chapter applies, according to the provi­

sions thereof, except to the extent that—
(1) statutes preclude judicial review; or
(2) agency action is committed to agency 
discretion by law.

21 U.S.C. 331 provides in pertinent part:
The following acts and the causing thereof are 

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 (whether or not the first sale) after ship­
ment in interstate commerce and results in such 
article being adulterated or misbranded.

21 U.S.C. 352 provides in pertinent part:
A drug or device shall be deemed to be mis­

branded—
*  *  *  *  *

(f) Directions for use and warnings on label
Unless its labeling bears (1) adequate direc­

tions 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

(la)