Whether the Food and Drug Administration Has Jurisdiction over Articles Intended for Use in Lawful Executions

(Slip Opinion)

Whether the Food and Drug Administration

Has Jurisdiction over Articles Intended for

Use in Lawful Executions

May 3, 2019

Articles intended for use in executions carried out by a State or the federal government

cannot be regulated as “drugs” or “devices” under the Federal Food, Drug, and Cos-

metic Act. The Food and Drug Administration therefore lacks jurisdiction to regulate

articles intended for that use.

MEMORANDUM OPINION FOR THE ATTORNEY GENERAL

The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.

§ 301 et seq., grants the Food and Drug Administration (“FDA”) the

authority to regulate all “drugs” and “devices,” which include any “arti-

cles (other than food) intended to affect the structure or any function of

the body,” as well as any components of such articles. Id. § 321(g)(1)(C)–

(D), (h)(3). Your office has asked us whether FDA has authority to regu-

late articles used in historically accepted methods of execution. Some of

those articles—like electric chairs and gas chambers—exist for the sole

purpose of effectuating capital punishment. Others—like substances used

in lethal-injection protocols and firearms used by firing squads—have

other intended uses.

FDA has not historically exercised jurisdiction over articles intended to

carry out a lawful sentence of capital punishment. In connection with

challenges to FDA’s regulatory inaction, the federal courts have addressed

when the agency may lawfully decline to enforce the FDCA against such

articles. See, e.g., Heckler v. Chaney, 470 U.S. 821 (1985); Cook v. FDA,

733 F.3d 1 (D.C. Cir. 2013). Yet they have not squarely addressed

whether FDA has administrative jurisdiction in the first place. Congress

has repeatedly authorized the death penalty on the assumption that there

are lawful means to carry it out, but the regulation of such articles under

the FDCA would effectively require their prohibition because they could

hardly be found “safe and effective” for such an intended use. See FDA

v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137–39 (2000).

Consistent with the agency’s practice in this area for several decades

before 2017, we thus conclude that, when an article’s intended use is to

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Opinions of the Office of Legal Counsel in Volume 43

effectuate capital punishment by a State or the federal government, it is

not subject to regulation under the FDCA. 1

I.

The FDCA was first enacted in 1938. Act of June 25, 1938, ch. 675, 52

Stat. 1040. Then, as well as now, the United States and several States

authorized the imposition of capital punishment for the most serious

offenses. From the time of the FDCA’s enactment until very recently,

FDA had never claimed authority over the methods by which the federal

and state governments carry out executions. That is in no small part

because one of the FDCA’s fundamental purposes is to ensure that drugs

and devices marketed in interstate commerce are safe and effective for

their intended uses—a goal that markedly conflicts with the purpose of an

execution. In this Part, we summarize the regulatory structure of the

FDCA and the history of its intersection with capital punishment.

A.

The FDCA authorizes FDA to regulate drugs and devices. The FDCA

defines “drug” to mean:

(A) articles recognized in the official United States Pharmacopoeia,

official Homeopathic Pharmacopoeia of the United States, or offi-

cial National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treat-

ment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any

function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified

in clause (A), (B), or (C).

21 U.S.C. § 321(g)(1) (paragraph breaks added). Congress has made only

superficial changes to this definition since 1938. Compare Act of June 25,

1938, § 201(g), 52 Stat. at 1041.

1 In reaching this conclusion, we have solicited and considered the views of FDA and

of the Office of the Associate Attorney General.

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

The FDCA defines “device” as any “instrument, apparatus, implement,

machine, contrivance, implant, in vitro reagent, or other similar or related

article” that does not “achieve its primary intended purposes through

chemical action within or on the body”; is not “dependent upon being

metabolized for the achievement” of those purposes; and is:

(1) recognized in the official National Formulary, or the United

States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions,

or in the cure, mitigation, treatment, or prevention of disease, in

man or other animals, or

(3) intended to affect the structure or any function of the body of

man or other animals.

21 U.S.C. § 321(h) (paragraph breaks added). The definition of “device”

also includes “any component, part, or accessory” of such articles. Id. 2

As the statutory definitions indicate, whether FDA may regulate an

article as a “drug” or “device” often depends not just on that article’s

effect on a human or animal body, but also on whether that effect is

intended. Id. § 321(g)(1), (h). An article may be a “drug” or “device”

for some uses but not for others, depending on the manufacturer’s or

distributor’s intent. For instance, FDA regulates “medical gases,” but not

chemically identical industrial gases. As FDA has explained, “industrial

gases . . . are not drugs” because manufacturers and distributors of indus-

trial gases do not intend their products to treat disease or other conditions,

or to otherwise affect the structure or function of the body. Medical

Gas Containers and Closures; Current Good Manufacturing Practice

Requirements, 71 Fed. Reg. 18,039, 18,044 (Apr. 10, 2006); see 21 C.F.R.

§§ 201.161, 211.94(e). In a similar vein, FDA considers hot tubs, saunas,

and treadmills as “devices” only when they are “intended for medical

purposes.” Physical Medicine Devices; General Provisions and Class-

ification of 82 Devices, 48 Fed. Reg. 53,032, 53,034, 53,044, 53,051–52

2 Initially, the FDCA defined “device” as “instruments, apparatus, and contrivances,

including their components, parts, and accessories” if they were “intended” either “for use

in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other

animals” or “to affect the structure or any function of the body of man or other animals.”

Act of June 25, 1938, § 201(h), 52 Stat. at 1041. In 1976, Congress expanded the defini-

tion of “device” to its current scope. Medical Device Amendments of 1976, Pub. L. No.

94-295, sec. 3(a)(1)(A), § 201(h), 90 Stat. 539, 575.

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Opinions of the Office of Legal Counsel in Volume 43

(Nov. 23, 1983); see 21 C.F.R. §§ 890.5100, 890.5250, 890.5380. Thus,

powered treadmills intended “to redevelop muscles or restore motion

to joints” are “devices,” but those sold solely for recreational purposes

are not. 48 Fed. Reg. at 53,044, 53,052; 21 C.F.R. § 890.5380. Likewise,

FDA considers tape recordings as “devices” when they are “intended

for use in the mitigation, treatment, and cure of disease and other medical

conditions” (as in hypnotherapy), but not when they are intended

“for behavior modification, self-improvement, habit correction, learning

techniques, and simple relaxation.” FDA, Compliance Policy Guide

§ 335.300.

Many of the FDCA’s prohibitions are keyed to a product’s intended

use. The FDCA prohibits distribution of a “new drug” that FDA has

not approved as safe and effective for its intended use. See 21 U.S.C.

§ 355(a), (d)(1), (d)(5); United States v. Caronia, 703 F.3d 149, 152–53

(2d Cir. 2012). Similarly, the FDCA prohibits distribution of certain

devices that present “a potential unreasonable risk of illness or injury,”

unless FDA has approved them as safe and effective for their intended

uses. 21 U.S.C. § 360c(a)(1)(C); see id. §§ 331(a), 351(f )(1), 360e(a),

(d)(2)(A)–(B). The FDCA also bars distribution of “misbranded” drugs

and devices, including those whose labeling lacks adequate directions for

their intended uses, id. § 352(f )(1), or adequate warnings against unsafe

dosages or methods of administration for those uses, id. § 352(f )(2).

Finally, the FDCA provides that FDA “shall” block the importation of

drugs and devices that appear to be unapproved for their intended use or

misbranded. Id. § 381(a)(3).

Even if FDA has approved an article for one intended use, it still may

not be imported, sold, or distributed for another, unapproved use. See

Wash. Legal Found. v. Henney, 202 F.3d 331, 332–33 (D.C. Cir. 2000).

FDA’s regulations define the “intended use” of a drug or device with

reference to “the objective intent of the persons legally responsible for the

labeling” of the article. 21 C.F.R. §§ 201.128 (drugs), 801.4 (devices).

That intent “is determined by such persons’ expressions” or from “the

circumstances surrounding the distribution of the article.” Id. §§ 201.128,

801.4. The regulations emphasize that “[t]he intended uses of an article

may change after it has been introduced into interstate commerce by its

manufacturer.” Id. §§ 201.128, 801.4. “[F]or example, a packer, distribu-

tor, or seller [may] intend[] an article for different uses than those intend-

ed by the person from whom he received the” drug or device, in which

case “such packer, distributor, or seller is required to supply adequate

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

labeling in accordance with the new intended uses.” Id. §§ 201.128,

801.4. Likewise, a manufacturer could lawfully distribute an article in-

tending that it be used for an approved purpose, and then later violate the

FDCA by distributing the same article intending that it be used for a

different, unapproved purpose.

As a general matter, FDA does not regulate the practice of medicine,

which includes “off-label” prescribing—that is, when physicians prescribe

FDA-approved drugs or devices for non-FDA-approved uses. 3 As the

Supreme Court has explained in the context of medical devices, “‘off-

label’ usage . . . (use of a device for some other purpose than that for

which it has been approved by the FDA) is an accepted and necessary

corollary of the FDA’s mission to regulate in this area without directly

interfering with the practice of medicine.” Buckman Co. v. Plaintiffs’

Legal Comm., 531 U.S. 341, 350 (2001); see also Caronia, 703 F.3d at

153. Thus, while the FDCA bars a manufacturer or distributor from sell-

ing any drug or device for an unapproved use, physicians may, with

limited exceptions, prescribe and administer FDA-approved drugs and

devices for unapproved uses.

B.

Capital punishment in the United States predates the Republic. For

most of the Nation’s history, the federal government and the States em-

ployed the gallows. Starting in the late nineteenth century, States began

using the electric chair and, to a lesser degree, the gas chamber. At least

since Thomas Edison’s New Jersey laboratory supplied parts for New

York’s first electric chair in 1890, prison authorities have used interstate

suppliers to procure articles necessary for executions. 4 Today, every

3 See Citizen Petition Regarding the Food and Drug Administration’s Policy on Promo-

tion of Unapproved Uses of Approved Drugs and Devices; Request for Comments,

59 Fed. Reg. 59,820, 59,821 (Nov. 18, 1994) (“‘[O]nce a [drug] product has been ap-

proved for marketing, a physician may prescribe it for uses or in treatment regimens o[f ]

patient populations that are not included in approved labeling.’”) (quoting 12 FDA Drug

Bulletin 5 (Apr. 1982)); see also 21 U.S.C. § 396.

4 See Stuart Banner, The Death Penalty: An American History 183, 197 (2002) (de-

scribing New York’s purchase of electric-chair components, and Nevada’s purchase of

hydrocyanic acid for use in the gas chamber from a California source); Scott Christianson,

The Last Gasp: The Rise and Fall of the American Gas Chamber 6 (2010) (explaining that

Eaton Metal Products in Colorado built gas chambers for most of the States that used

them); Carol J. Williams, Maker of Anesthetic Used in Executions is Discontinuing Drug,

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Opinions of the Office of Legal Counsel in Volume 43

method of execution appears to involve some component that traveled in

interstate or foreign commerce.

Beginning in the late 1970s, many States and the federal government

adopted lethal injection as the preferred method of execution. Those

executions generally used sodium thiopental, a widely administrered

surgical anaesthetic. Although patients typically received a dose of around

300 milligrams of sodium thiopental during surgical procedures, the dose

in a lethal injection was anywhere from “seven to sixteen times higher.”

Mark Dershwitz & Thomas K. Henthorn, The Pharmacokinetics and

Pharmacodynamics of Thiopental as Used in Lethal Injection, 35 Ford-

ham Urb. L.J. 931, 932 (2008); see also Glossip v. Gross, 135 S. Ct. 2726,

2742 (2015) (noting that the dose of midazolam in Oklahoma’s more

recent execution protocol “is many times higher than a normal therapeutic

dose”).

In 1980, death-row inmates petitioned FDA to seize lethal-injection

substances from several States, arguing that, although the substances were

approved for other uses, their use in executions would violate the FDCA’s

prohibitions against the distribution of unapproved new drugs and mis-

branded drugs. FDA denied the petition, reasoning that it lacked authority

to regulate States’ use of FDA-approved drugs in capital punishment.

FDA also stated that, even if it had such authority, it would decline to

regulate in its enforcement discretion. When the issue reached the Su-

preme Court, the United States argued more broadly that FDA lacked

jurisdiction over articles intended for use in capital punishment. See

Heckler, 470 U.S. 821; Br. for Pet’r at 13–14, 44–46, Heckler v. Chaney,

470 U.S. 821 (1985) (No. 83-1878) (“Heckler Pet’r Br.”). The Court

found it “implausible . . . that the FDA is required to exercise its enforce-

ment power to ensure that States only use drugs that are ‘safe and effec-

tive’ for human execution.” 470 U.S. at 827. Rather than “address the

thorny question of the FDA’s jurisdiction,” however, the Court held that

FDA’s exercise of enforcement discretion is not subject to judicial review.

Id. at 828.

L.A. Times (Jan. 22, 2011), http://articles.latimes.com/2011/jan/22/local/la-me-execution-

drug-20110122 (discussing California’s use of sodium thiopental produced in North

Carolina); Deborah W. Denno, Getting to Death: Are Executions Constitutional?, 82 Iowa

L. Rev. 319, 354 & n.207 (1997) (explaining that the sole commercial suppliers of

electric-chair equipment were in Massachusetts and Arkansas).

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

In 2009, the sole American manufacturer of sodium thiopental ceased

production. See Glossip, 135 S. Ct. at 2733. Since then, several States

have imported sodium thiopental from foreign suppliers. Cook, 733 F.3d

at 4. In 2012, however, the U.S. District Court for the District of Colum-

bia held that, although FDA has unreviewable discretion when enforcing

the FDCA’s domestic prohibitions, FDA’s discretion is more limited with

respect to the Act’s importation provisions. The court issued a permanent

injunction requiring FDA to block the importation of sodium thiopental

on the grounds that it was unapproved and misbranded. See Beaty v. FDA,

853 F. Supp. 2d 30 (D.D.C. 2012), aff ’d, Cook, 733 F.3d 1. Neither the

parties nor the district court, however, addressed the government’s previ-

ous argument in Heckler that FDA lacks jurisdiction over articles intended

for use in capital punishment. See Beaty, 853 F. Supp. 2d at 34. Following

the Beaty injunction, FDA expressly stated in a letter ruling, apparently

for the first time, that it had jurisdiction over a substance intended for that

use, though, significantly, the State seeking the ruling had conceded the

point. See Letter from Todd W. Cato, Director, Southwest Import District

Office at 5 (Apr. 20, 2017).

As of December 31, 2016, there were over 2,750 inmates with state

death sentences. Elizabeth Davis & Tracy L. Snell, Bureau of Justice

Statistics, U.S. Dep’t of Justice, Capital Punishment, 2016, at 3 tbl.1

(2018). And there are now approximately 62 civilian prisoners with feder-

al death sentences. See Federal Bureau of Prisons, Statistics: Sentences

Imposed, https://www.bop.gov/about/statistics/statistics_inmate_sentences.

jsp (last updated Apr. 13, 2019). In response to difficulties in obtaining

appropriate substances for lethal injection, some States are considering

turning to different methods of execution, including the electric chair and

nitrogen gas. Tom Barton, SC Senators Resurrect Bill to Bring Back the

Electric Chair, Add Firing Squad, The State (Jan. 30, 2019), https://www.

thestate.com/news/politics-government/article225312765.html; Denise

Grady & Jan Hoffman, States Turn to an Unproven Method of Execution:

Nitrogen Gas, N.Y. Times (May 7, 2018), https://www.nytimes.com/

2018/05/07/health/death-penalty-nitrogen-executions.html.

II.

With this background in mind, we turn to whether FDA may regulate

articles intended for use in capital punishment. The Supreme Court recog-

nized some time ago that “Congress fully intended that the [FDCA]’s

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Opinions of the Office of Legal Counsel in Volume 43

coverage be as broad as its literal language indicates—and equally clearly,

broader than any strict medical definition might otherwise allow.” United

States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969). Nevertheless, in Brown

& Williamson, the Court recognized one limitation to such coverage in the

context of reviewing FDA’s authority to regulate tobacco products.

In Brown & Williamson, the Court considered whether FDA had

properly determined that tobacco products as customarily marketed could

be regulated as “drugs” or “devices” under the FDCA. FDA had conduct-

ed a rulemaking in which it concluded that the definitional phrase, “in-

tended to affect the structure or any function of the body,” is “broad in

scope and encompass[es] a range of products wider than those ordinarily

thought of as drugs or medical devices.” Analysis Regarding the Food and

Drug Administration’s Jurisdiction over Nicotine-Containing Cigarettes

and Smokeless Tobacco Products, 60 Fed. Reg. 41,453, 41,463 (Aug. 11,

1995); Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These

Products Are Nicotine Delivery Devices Under the Federal Food, Drug,

and Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44,619,

44,658 (Aug. 28, 1996). FDA deemed nicotine to be regulable as a “drug”

because it was “intended” to have “psychoactive, or mood-altering, ef-

fects on the brain” that foster addiction, stimulate and depress the nervous

system, and suppress appetite, thus mirroring the effects of tranquilizers,

stimulants, weight-loss drugs, and other articles long subject to FDA

jurisdiction. 61 Fed. Reg. at 44,631–32.

The Supreme Court rejected FDA’s conclusion, holding that the

FDCA’s jurisdictional provisions must be read in the context of the entire

statute, and of later-enacted laws, to ensure “a symmetrical and coherent

regulatory scheme.” Brown & Williamson, 529 U.S. at 133. “Viewing the

FDCA as a whole,” the Court concluded that it would “contravene[] the

clear intent of Congress” to treat tobacco products as subject to FDA

regulation. Id. at 132, 133. Were tobacco products regulated as “drugs” or

“devices,” the FDCA would prohibit their sale, because they could not be

“safe” or “effective” for their intended use. Id. at 134–37. Yet such “a ban

would contradict Congress’s clear intent as expressed in its more recent,

tobacco-specific legislation,” which reflected the “collective premise . . .

that cigarettes and smokeless tobacco will continue to be sold in the

United States.” Id. at 137, 139, 143–56. Furthermore, Congress had enact-

ed this tobacco-specific legislation “against the background of the FDA

repeatedly and consistently asserting that it lacks jurisdiction under the

FDCA to regulate tobacco products as customarily marketed.” Id. at 155–

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

56. The Court concluded: “The inescapable conclusion is that there is no

room for tobacco products within the FDCA’s regulatory scheme. If they

cannot be used safely for any therapeutic purpose, and yet they cannot be

banned, they simply do not fit.” Id. at 143. 5

Congress subsequently ratified the Court’s conclusion in the Tobacco

Control Act, 21 U.S.C. § 387 et seq., which confirmed that tobacco prod-

ucts as customarily marketed are not regulable as “drugs” or “devices”

under the FDCA. See id. § 321(rr)(1)–(2). At the same time, Congress

granted FDA the authority to impose other regulations on tobacco prod-

ucts. See id. § 387a(a) (“Tobacco products . . . shall be regulated . . .

under this subchapter and shall not be subject to the [drug-and-device]

provisions of subchapter V.”); Sottera, Inc. v. FDA, 627 F.3d 891, 898

(D.C. Cir. 2010).

Under Brown & Williamson, FDA lacks jurisdiction to regulate articles

intended for a use not traditionally regulated by FDA, when those articles

cannot be safe and effective for such intended use, and Congress has

otherwise made clear its expectation that at least some of those articles

shall remain lawful and available for that use. See Sottera, 627 F.3d at

896 (interpreting Brown & Williamson); see also Massachusetts v. EPA,

549 U.S. 497, 530–31 (2007) (explaining that Brown & Williamson rested

on “the unlikel[ihood] that Congress meant to ban tobacco products” and

“an unbroken series of congressional enactments that made sense only if

adopted against the backdrop of the FDA’s consistent and repeated state-

ments” disclaiming jurisdiction (internal quotation marks omitted));

Verizon v. FCC, 740 F.3d 623, 638 (D.C. Cir. 2014) (similar).

III.

Applying Brown & Williamson, we conclude that the FDCA does not

allow FDA to regulate an article intended for use in capital punishment in

the United States. The FDCA’s regulatory framework for “drugs” and

5 The Brown & Williamson Court declined to give the agency deference under Chev-

ron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984), because “Congress

could not have intended to delegate a decision of such economic and political significance

to an agency in so cryptic a fashion.” 529 U.S. at 160; see also King v. Burwell, 135 S. Ct.

2480, 2489 (2015) (similarly concluding that “[w]hether [tax] credits are available on

Federal [Health Insurance] Exchanges is . . . a question of deep ‘economic and political

significance’” that Congress did not implicitly delegate to the agency) (quoting Brown &

Williamson, 529 U.S. at 160)).

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Opinions of the Office of Legal Counsel in Volume 43

“devices” cannot sensibly be applied to such articles. If the FDCA applied

to electric chairs, gallows, gas chambers, firearms used in firing squads,

and substances used in lethal-injection protocols, the statute would effec-

tively ban those articles. Yet the Constitution and laws of the United

States presuppose the continued availability of capital punishment for the

most heinous federal and state crimes. FDA did not expressly assert the

authority to regulate articles intended for use in executions at any time

before 2017, and we believe that such an assertion cannot be reconciled

with the FDCA and other federal law.

A.

Articles used in capital punishment do literally “affect the structure or

any function of the body” by causing all bodily functions to cease. 21

U.S.C. § 321(g)(1)(C), (h)(3). Hanging, gas asphyxiation, a firing squad,

lethal injection, and electrocution are all intended to achieve the same

effect: they cause death. When a prison official seeks to purchase an

article essential to one of these methods of execution, the seller will often

know that the item will be used in an execution and is thus “intended”

to affect the structure or any function of the body. Id.; see 21 C.F.R.

§ 201.128 (a drug’s “intended use” can “be shown by the circumstances

surrounding the distribution of the article”); id. § 801.4 (same for devic-

es); cf. United States v. Kaminski, 501 F.3d 655, 671 (6th Cir. 2007)

(concluding that egg powders were “drugs” because defendants “distrib-

uted them to consumers for the express purpose of treating and/or pre-

venting diseases” as evidenced by, among other things, “the methods of

sale and distribution”).

Nevertheless, Brown & Williamson prevents us from interpreting the

FDCA in a manner that would depart from its “symmetrical and coherent

regulatory scheme,” 529 U.S. at 133, and interpreting the FDCA to au-

thorize regulation of articles intended for use in executions would do

exactly that. See also Weyerhaeuser Co. v. U.S. Fish & Wildlife Serv.,

139 S. Ct. 361, 368 (2018) (“[S]tatutory language cannot be construed in

a vacuum . . . so we must also consider [the term] in its statutory context.”

(internal quotation marks and citation omitted)). If such articles were

regulated as “drugs” or “devices,” the FDCA would effectively ban them

and FDA could seek fines or prosecutions against those involved in their

sale or distribution. The FDCA “generally requires the FDA to prevent the

marketing of any drug or device where the potential for inflicting death or

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

physical injury is not offset by the possibility of therapeutic benefit.”

Brown & Williamson, 529 U.S. at 134 (internal quotation marks omitted).

In the case of tobacco products, their short-term physiological effects

were greatly outweighed by their demonstrated carcinogenic qualities.

Id. at 134–35. Thus, if tobacco products had been regulated as “drugs”

or “devices,” the FDCA would have effectively rendered them unlawful.

Id. at 135–37.

The same conclusion follows here, because the articles used in capital

punishment are intended to cause death—for some articles that is their

sole purpose. Under the FDCA, a “new drug” may not go to market unless

FDA determines, based on “adequate and well-controlled investigations,”

that the substance is “safe” and “effective[]” for the “use . . . prescribed,

recommended, or suggested in the proposed labeling thereof.” 21 U.S.C.

§ 355(d)(1), (5); see also 21 C.F.R. § 314.50(d)(5). To approve a sub-

stance for use in a lethal-injection protocol, then, FDA would have to find

that clinical-trial data established that the substance was “safe” for execu-

tions—that is, that the harm inflicted by the product would be “offset by

the possibility of therapeutic benefit” to the inmate. Brown & Williamson,

529 U.S. at 134. It would not be sufficient to show that the substance is

safer or more effective than other means of execution. Brown & William-

son dismissed such an interpretation of “safety” as involving a “qualita-

tively different inquiry” from that required by the FDCA. Id. at 140.

Instead, FDA must find “that the product itself is safe as used by con-

sumers.” Id. But there is no way products intended to carry out capital

punishment could ever satisfy that test, under which “a drug is unsafe

if its potential for inflicting death . . . is not offset by the possibility of

therapeutic benefit.” United States v. Rutherford, 442 U.S. 544, 556

(1979).

The same would be true if electric chairs, gallows, or firing squads’

firearms were regulated as “devices.” Those articles would require pre-

market approval because they “present[] a potential unreasonable risk of

illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii)(II). And FDA could

approve them only if the applicant provided “reasonable assurance” that

they were “safe” and “effective” for the intended use of carrying out

capital punishment, id. § 360e(d)(1)(A), (2)(A)–(B), after “weighing any

probable benefit to health from the use of the device against any probable

risk of injury or illness from such use,” id. § 360c(a)(2)(C). Again, FDA

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Opinions of the Office of Legal Counsel in Volume 43

could not possibly approve “devices” that are intended to effectuate

executions as “safe” and “effective.” 6

Nor would it matter whether an article intended for use in capital pun-

ishment was designed solely for that purpose or had other, FDA-approved

uses. 7 Either way, whenever manufacturers or distributors intended that

an article be used in capital punishment, the FDCA would prohibit dis-

tributing it for that use. For example, FDA has approved midazolam for

use as a sedative and anesthetic in certain procedures. But if a manufac-

turer or distributor of midazolam sold it to prison officials specifically for

use in capital punishment, the drug’s “intended use” would be different

from any approved use. See 21 C.F.R. § 201.128. A drug’s labeling must

bear adequate directions for use for all of its intended uses; otherwise it

is misbranded. See 21 U.S.C. § 352(f )(1); 21 C.F.R. § 201.128. Accord-

ingly, the manufacturer or distributor would violate the FDCA’s new drug

prohibition where the product’s labeling suggested its use in capital

punishment. Drugs intended for use in lethal injection that were FDA-

approved only for other uses would also be misbranded because their

FDA-approved labeling would, by definition, lack adequate warnings

against unsafe dosages or methods of administration for use in capital

punishment. See 21 U.S.C. § 352(f )(2). 8 In sum, if articles intended for

6 Applications to market drugs and devices both require the submission of well-

controlled clinical investigations. 21 U.S.C. §§ 355(d), 360c(a)(2), (3)(A)–(B); 21 C.F.R.

§ 860.7(c). Given that the articles at issue here are intended to cause death during lawful

executions, it is difficult to envision how the articles could be studied in clinical investi-

gations involving humans.

7 The FDCA’s practice-of-medicine exception does not extend to articles used in exe-

cutions. That exception applies only when an article is “prescribe[d] or administer[ed]” to

treat a “condition or disease within a legitimate health care practitioner-patient relation-

ship.” 21 U.S.C. § 396 (devices); see James M. Beck & Elizabeth D. Azari, FDA, Off-

Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food &

Drug L.J. 71, 77–78 (1998) (discussing history behind section 396, which shows it was

enacted to extend to devices the practice-of-medicine exception that already applied to

drugs).

8 The law-enforcement exception in 21 C.F.R. § 201.125 exempts a drug from the

requirement in section 502(f )(1) of the FDCA that labeling include “adequate directions

for use.” 21 U.S.C. § 352(f )(1). That exception, however, does not extend to section

502(f )(2), which requires “adequate warnings . . . against unsafe dosage or methods or

duration of administration.” Id. § 352(f )(2). Thus, even if executions qualified as an

excepted law-enforcement use, substances used in executions would be misbranded under

subsection (f )(2).

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

use in capital punishment were regulated as “drugs” or “devices,” then the

FDCA would prohibit them altogether.

In the past, FDA has avoided such regulatory consequences by declin-

ing to regulate the domestic sale and distribution of articles intended for

use in executions as a matter of enforcement discretion. But the D.C.

Circuit recently upheld a district court order enjoining FDA from permit-

ting the importation of foreign-manufactured sodium thiopental, on the

grounds that it was misbranded and unapproved. Cook, 733 F.3d 1. And

the question now is whether FDA’s regulatory authority encompasses

articles intended for use in lethal injection or other methods of capital

punishment, not whether FDA may use its enforcement discretion to

alleviate the regulatory consequences. FDA equally had discretion not to

enforce the FDCA against domestic tobacco sales that, in FDA’s view,

would have violated the FDCA’s prohibitions on misbranding or unap-

proved new drugs or devices. What mattered in Brown & Williamson was

that the FDCA would have rendered the sale of tobacco products per se

unlawful, not that FDA could have tempered that ban by selectively

sparing particular manufacturers from civil and criminal penalties. See,

e.g., 529 U.S. at 136 (“[T]he Act admits no remedial discretion once it is

evident that the device is misbranded.”). The prospect that articles intend-

ed for use in capital punishment could be sold or distributed at FDA’s

sufferance does not alter the fact that the FDCA, by its terms, would

effectively require a ban of such articles if they were regulated under the

FDCA as “drugs” or “devices.”

B.

Even if the FDCA could be interpreted to authorize regulation of arti-

cles intended for use in executions without requiring them to be banned,

any attempt to do so would create serious tension with other provisions of

the Act. We do not conclude that, in order for FDA to have jurisdiction

over an article as a “drug” or “device,” every drug- or device-related

provision of the FDCA must apply neatly to the article’s intended use. But

the sheer number of FDCA provisions here that would make no sense as

applied reinforces the conclusion that FDA lacks jurisdiction over articles

intended for use in capital punishment. For example, with respect to

articles intended for use in capital punishment, FDA could not assess

“[t]he seriousness of the disease or condition that is to be treated with the

drug” or “[t]he expected benefit of the drug with respect to such disease

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Opinions of the Office of Legal Counsel in Volume 43

or condition.” 21 U.S.C. § 355-1(a)(1)(B)–(C). Execution drugs address

no “condition” suffered by, and produce no “benefit” for, the end user;

instead, they exclusively inflict harm upon that user. For the same reason,

when reviewing a new drug application for an article intended for use

in capital punishment, FDA could not provide for review of scientific

disputes by a “panel[] of experts” that includes members with “expertise

in the particular disease or condition for which the drug . . . is proposed

to be indicated.” Id. § 355(n)(1), (3)(D) (emphasis added); see also id.

§ 360bbb-1; 8 C.F.R. § 10.75(b)(2). In the context of an execution, there

is no applicable “disease or condition.”

Further, with respect to articles intended for use in capital punishment,

“patient experience data”—which includes “information about patients’

experiences with a disease or condition,” such as “patient preferences

with respect to treatment of such disease or condition”—would never be

available. 21 U.S.C. § 360bbb-8c(b)(1), (c)(2). Other FDCA provisions

treat death as a serious side effect that triggers mandatory reporting and

FDA oversight. See, e.g., id. § 355(k)(3)(C)(i)(II) (requiring drug manu-

facturers to “report[] . . . on all serious adverse drug experiences,” includ-

ing death); 21 C.F.R. § 314.80 (detailing exhaustive reporting require-

ments for each “adverse drug experience,” including those resulting in

death). These provisions cannot sensibly be read to allow an article’s

intended use to be the causing of death in an execution.

Other provisions presuppose that an approved device may not be in-

tended to effectuate an execution. A manufacturer’s application for FDA

approval “shall include” a “description of any pediatric subpopulations

that suffer from the disease or condition that the device is intended to

treat, diagnose, or cure,” 21 U.S.C. § 360e-1(a)(2)(A), which suggests that

a device must be intended to improve a patient’s circumstances. FDA

must also submit any new device to a panel of experts with “adequate

expertise . . . to assess . . . the disease or condition which the device is

intended to cure, treat, mitigate, prevent, or diagnose.” Id. § 360c(b)(1),

(5)(B)(i)(I). But again, it would make no sense to apply those provisions

to articles for use in executions, which are not intended to produce any

benefit for the end user.

Congress has treated certain articles intended to cause death as falling

outside FDA’s jurisdiction. For instance, the Federal Insecticide, Fungi-

cide, and Rodenticide Act (“FIFRA”) expressly gives the Environmental

Protection Agency rather than FDA jurisdiction over “pesticides,” which

include “any substance . . . intended for preventing, destroying, repelling,

14

Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

or mitigating any pest” but exclude “any article that is a ‘new animal

drug’ within the meaning” of the FDCA. 7 U.S.C. § 136(u). FIFRA thus

suggests that Congress generally views substances intended to harm or

kill pests (such as mosquitos and rats, see id. § 136(t)) as outside FDA’s

jurisdiction.

Over the years, FDA has disclaimed jurisdiction over several other arti-

cles intended to kill or harm humans or animals. In 1969, for instance,

FDA’s Chief Counsel testified that even though “pistols and bullets are

intended to affect the function or structure of the body in the same way”

as mace, the agency “concluded that the products could not properly be

classified as drugs under the definition” in the FDCA. Public Sale of

Protective Chemical Sprays: Hearings Before the Consumer Subcomm. of

the S. Comm. on Commerce, 91st Cong. 37 (1969) (statement of William

Goodrich). FDA reiterated that position when asserting jurisdiction over

tobacco products in 1996, explaining that it “has never construed the

structure-function provision to include products such as guns, airbags, and

chemical sprays,” despite their intended effects on the structure or func-

tion of the body. 61 Fed. Reg. at 44,684. That same rationale extends to

articles intended for use in executions. 9

9 Since 1977, FDA has asserted jurisdiction over articles intended for animal euthana-

sia. FDA first asserted jurisdiction over Beuthanasia-D. See United States v. Articles

of Drug Beuthanasia-D Regular, Food Drug Cosm. L. Rep. (CCH) ¶ 38,265 (D. Neb.

Aug. 1, 1979). A district court agreed that FDA had jurisdiction, both because Beutha-

nasia-D’s two active ingredients were listed in the United States Pharmacopoeia (a

different component of the FDCA’s definition of “drug”), id. ¶ 39,129 (citing 21 U.S.C.

§ 321(g)(1)(A) (1972)), and because “euthanasia—the cessation of all bodily functions—

. . . constitute[s] an effect on the function, if not the structure, of the animal’s body,” id.

¶ 39,130 (citing 21 U.S.C. § 321(g)(1)(C) (1972)). In 1980, FDA issued a two-paragraph

guidance statement, opining that “products intended for animal euthanasia . . . conform

to the definition of a drug” under the FDCA “since they are clearly intended to affect

the function of the body by inducing death.” FDA, Compliance Policy Guide § 650.100

(Oct. 1, 1980). FDA’s guidance in this area predates Brown & Williamson, and no court

has revisited the matter. Although it may be difficult to view animal-euthanasia articles as

“safe” for their intended use (at least where such articles are used on healthy but unwant-

ed animals), FDA has regulated such articles since 1977; it has approved five applications

for these articles; its regulation does not raise constitutional concerns; and we are aware

of no legislation that suggests FDA’s assertion of jurisdiction over articles intended for

animal euthanasia is contrary to the intent of Congress. Additionally, animal euthanasia

has long been an accepted part of veterinary practice, whereas capital punishment has not

been a part of medical practice. Therefore, whether or not animal euthanasia may be

distinguishable from executions, we do not view FDA’s practice of regulating the former

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Opinions of the Office of Legal Counsel in Volume 43

C.

The FDCA cannot be read as authorizing FDA to effectively ban capital

punishment, because that reading would contravene or render moot a host

of federal statutes that presuppose the lawfulness of capital punishment.

In Brown & Williamson, the Court held that FDA was not authorized to

prohibit tobacco products because Congress had repeatedly confirmed that

such products would remain available. That reasoning applies equally

well to articles intended for use in capital punishment. The Constitution

and numerous federal statutes presuppose that capital punishment will

remain available and that the federal government will defer to States over

methods of execution. Interpreting the FDCA to bar the importation, sale,

and distribution of articles intended for use in executions would conflict

with that settled understanding. By contrast, the conclusion that articles

intended for use in executions cannot be regulated under the FDCA would

be consistent with how FDA has traditionally exercised its authority; and

it would avoid the serious federalism concerns that would arise from a

contrary interpretation.

1.

As the Supreme Court recently observed, the Constitution expressly

“allows capital punishment.” Bucklew v. Precythe, 139 S. Ct. 1112, 1122

(2019). Indeed, “the Fifth Amendment, added to the Constitution at the

same time as the Eighth, expressly contemplates that a defendant may be

tried for a ‘capital’ crime and ‘deprived of life’ as a penalty, so long as

proper procedures are followed.” Id. Federal law, accordingly, has au-

thorized the imposition of the death penalty since 1790, when the First

Congress mandated that several federal crimes, including treason and

murder on federal land, be punished by death. Act of Apr. 30, 1790, ch. 9,

§§ 1, 3, 33, 1 Stat. 112, 112, 113, 119. By 1938, federal statutes autho-

rized the death penalty for dozens of offenses. And, in the decades since

the FDCA’s enactment, Congress has acted numerous times to make

additional federal crimes punishable by death. 10 In providing that the

as sufficient to overcome the force of the arguments against FDA’s authority to regulate

the latter.

10 See, e.g., Act of June 8, 1940, ch. 286, 54 Stat. 255, 255–56 (authorizing capital

punishment if anyone is killed by the willful derailment of any train in interstate com-

merce); Uniform Code of Military Justice, Act of May 5, 1950, ch. 169, 64 Stat. 107,

16

Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

death penalty is an available punishment for dozens of federal crimes,

Congress has presupposed there would be a lawful means for carrying out

such a sentence.

From 1790 until 1937, federal law prescribed hanging as the method of

execution. Act of Apr. 30, 1790, § 33, 1 Stat. at 119; Andres v. United

States, 333 U.S. 740, 745 n.6 (1948). Congress then mandated that each

federal execution be carried out in “the manner prescribed by the laws of

the State within which the sentence is imposed,” or, if that State did not

have the death penalty, in accordance with the laws of another State

designated by the sentencing court. Act of June 19, 1937, ch. 367, 50 Stat.

304, 304 (repealed 1984). At the time, nearly 30 States were using cya-

nide gas or the electric chair, but the States adopted at least six different

methods of execution between then and the early 1980s. See Deborah A.

Denno, Getting to Death: Are Executions Constitutional?, 82 Iowa L.

Rev. 319, 439–64 (1997). After that provision was repealed in 1984,

federal regulations required the government to propose to the sentencing

court that any death sentence be carried out by lethal injection. 28 C.F.R.

§ 26.2(a)(2). Unless the court ordered otherwise, they required the Direc-

tor of the Federal Bureau of Prisons to “determine[]” which “substance or

substances” to use. Id. § 26.3(a)(4).

Today, capital sentences imposed under the Federal Death Penalty Act

of 1994 are again required to be implemented “in the manner prescribed

by” either (i) “the law of the State in which the sentence is imposed,” or

(ii) if that State does not have the death penalty, the law of another State

designated by the sentencing court. 18 U.S.C. § 3596(a). The Army’s

executions are by “intravenous administration of a lethal substance, or

substances, in a quantity sufficient to cause death.” Army Regulation 190-

55, U.S. Army Corrections System: Procedures for Military Executions

§ 3-1, -2 (Jan. 17, 2006).

135–40 (articles 85, 90, 94, 99, 100, 101, 102, 104, 106, 110, 113, 118, and 120, estab-

lishing 13 military offenses punishable by death); Organized Crime Control Act of 1970,

Pub. L. No. 91-452, sec. 1102, § 844(d), 84 Stat. 922, 957 (authorizing capital punishment

if death results from the use of explosives to maliciously destroy government property);

Anti-Drug Abuse Act of 1988, Pub. L. No. 100-690, § 7001(a), 102 Stat. 4181, 4387–88

(codified at 21 U.S.C. § 848(e)) (authorizing capital punishment for intentional killing

while engaging in criminal enterprises or drug felonies); Federal Death Penalty Act of

1994, Pub. L. No. 103-322, §§ 60001–60026, 108 Stat. 1796, 1959–82 (codifying proce-

dures for federal death sentences and authorizing capital punishment for 60 offenses

under 13 existing and 28 new federal statutes).

17

Opinions of the Office of Legal Counsel in Volume 43

This extensive backdrop of legislative and regulatory action precludes

any suggestion that the FDCA prohibits the importation, sale, or distribu-

tion of articles intended for use in executions; to the contrary, these statu-

tory and regulatory schemes unambiguously assume the continued availa-

bility of such articles. Before and after the FDCA’s enactment, Congress

extended the federal death penalty and required the federal government

to adopt States’ preferences as to methods of execution. Such provisions

would be nonsensical if the FDCA had rendered it a crime to distribute

in interstate commerce, including through importation (see 21 U.S.C.

§ 321(b)), the very articles that States and the federal government need to

effectuate capital sentences. By expressly recognizing States’ discretion to

select methods of execution (subject to constitutional limits), Congress

precluded any role for FDA in supplanting States’ judgments about those

methods.

2.

In addition, as in Brown & Williamson, “[t]he consistency of the FDA’s

prior position” concerning the absence of regulatory jurisdiction over

methods of execution, coupled with a corresponding history of non-

enforcement, “provides important context” for interpreting federal death-

penalty legislation postdating the FDCA. 529 U.S. at 157. Just as FDA

“asserted authority to regulate tobacco products as customarily marketed”

only late in its history, id. at 146, FDA does not appear to have asserted

jurisdiction to regulate articles intended for use in executions before 2017.

Between 1981 and 1985, FDA directly addressed its jurisdiction in the

proceedings associated with Heckler, 470 U.S. 821. The challenge in

Heckler involved state lethal-injection protocols, which required the

unapproved use of drugs that were FDA-approved for other purposes.

Although the Heckler Court found it “implausible . . . that the FDA is

required to exercise its enforcement power to ensure that States only use

drugs that are ‘safe and effective’ for human execution,” id. at 827, the

Court ultimately declined to resolve the “thorny question of the FDA’s

jurisdiction” in that circumstance, id. at 828. Instead, the Court held

that FDA’s decision not to enforce the FDCA was unreviewable. Id. at

837–38. Even so, we find instructive FDA’s own statements about its

jurisdiction in the Supreme Court and in the underlying administrative

proceeding.

18

Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

In 1981, FDA rejected a petition from death-row inmates asking FDA

to adopt a procedure for the seizure and condemnation of drugs destined

or held for use in executions. See Letter for David E. Kendall, from Ar-

thur Hull Hayes, Commissioner of Food and Drugs at 1 (July 7, 1981)

(“Heckler Petition Response”). The inmates contended that the States’

acquisition of FDA-approved drugs for capital punishment constituted

misbranding because the drugs lacked adequate directions or warnings

for that use. Id. at 1–2. FDA denied the petition in the first instance be-

cause “the use of lethal injection by State penal systems is a practice over

which FDA has no jurisdiction.” Id. at 2. FDA concluded that the States’

off-label use of FDA-approved drugs in lethal-injection protocols was

sufficiently analogous to the practice of medicine, including physicians’

lawful off-label use of FDA-approved drugs, to fall outside the FDCA’s

ambit. Id. at 3–4. But FDA also emphasized that its lack of jurisdiction

flowed from “a consideration of the proper role of the Federal Govern-

ment with respect to the conduct of State criminal justice systems.” Id.

at 2. FDA further recognized that, “[b]ecause . . . the [FDCA] does not

provide us with authority to declare unlawful the use by State govern-

ments of drugs for lethal injection,” concerns about the safety of lethal-

injection protocols would “more appropriately [be] addressed to the State

legislatures.” Id. at 4. 11

11 FDA did contend that, “[u]nder the Supremacy Clause,” “a State could not legiti-

mize the unlawful shipment of an unapproved new drug in interstate commerce or prevent

its misbranding after shipment in interstate commerce by authorizing its use,” including

for purposes of execution. Heckler Petition Response at 3. But that reflected a general

observation that state law cannot trump the FDCA’s provisions to the extent they apply to

a given drug or device, or effectively immunize prior conduct that violated the FDCA by

approving a product’s use at a later time. The government’s opening brief in the Supreme

Court also represented in a footnote that “[t]his case concerns the FDA’s authority to

regulate the states’ use of drugs, lawfully in interstate commerce, for the unapproved

purpose of causing death, and not the marketing of drugs for an unapproved use.” Heckler

Pet’r Br. at 45–46 n.34; accord Reply Br. at 8, Heckler v. Chaney, 470 U.S. 821 (1985)

(No. 83-1878) (“Heckler Reply Br.”) (“FDA lacks jurisdiction over the use of approved

drugs by state authorities for capital punishment purposes.”). The brief asserted that an

FDCA violation would occur “if a drug were marketed for the purpose of causing death

without being approved for that use,” but it noted that no one was alleged to have “direct-

ly or indirectly promote[d] the use of the drugs at issue” for executions. Heckler Pet’r Br.

at 45–46 n.34. Those statements did not reserve FDA jurisdiction over unapproved

articles used in executions because the government’s briefs categorically disclaimed FDA

jurisdiction over any method of execution. See infra notes 12–13 and accompanying text.

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Opinions of the Office of Legal Counsel in Volume 43

In the resulting litigation, the D.C. Circuit divided over whether FDA

had jurisdiction over drugs intended for use in executions. See Chaney v.

Heckler, 718 F.2d 1174 (D.C. Cir. 1983), rev’d, 470 U.S. 821 (1985). The

majority rejected FDA’s conclusions that administering capital punish-

ment fell within the FDCA’s “practice of medicine” exception or, in the

alternative, that actions taken by prison officials did not qualify as mis-

branding under the Act. See id. at 1179, 1181. Then-Judge Scalia, in

dissent, recognized the incongruity in treating “a law designed to protect

consumers against drugs that are unsafe or ineffective for their represent-

ed use” as “mandating federal supervision of the manner of state execu-

tions.” Id. at 1192 (Scalia, J., dissenting). He would have held that FDA

lacked jurisdiction because the drugs were not “held for sale” in interstate

commerce. Id. at 1199–1200. Because FDA did not press the point, nei-

ther opinion addressed whether “the unapproved use of drugs for lethal

injection is outside the general jurisdictional provisions of the Act”—that

is, whether drugs intended for use in lethal injection are subject to regula-

tion under the FDCA. Id. at 1179.

In the Supreme Court, the government contended that FDA categorical-

ly lacked jurisdiction over articles used in capital punishment, and that

FDA had denied the inmates’ petition because it had concluded “that it

lacked authority under the FDCA to regulate the states’ use of lethal

injections for capital punishment.” Heckler Pet’r Br. at 13; see id. at 4

(similar). The government repeatedly asserted that “Congress did not

intend the FDA to regulate capital punishment,” id. at 45, and emphasized

that the assessment of lethal injections would be “far removed from

[FDA’s] mission of protecting the consuming public from unsafe and

improperly labeled drugs,” id. at 10; see id. at 45 (similar). 12 The govern-

ment concluded that FDA jurisdiction over the unapproved use of FDA-

12 See also Heckler Reply Br. at 8 (“[T]here is not a scintilla of evidence that Congress

intended for the FDCA to regulate capital punishment.”); id. at 11 (“The FDA has no

experience or particular expertise in making a comparative assessment of different

methods of capital punishment, nor does it have a congressional mandate to venture into

this field.”); Heckler Pet’r Br. at 13 (“[T]here is not a hint in the legislative history that

Congress had any intention to regulate the methods used by states in carrying out lawful

death sentences.”); id. at 44 (“Neither the court of appeals nor respondents have produced

a shred of evidence that Congress wanted the FDA to regulate the methods of capital

punishment used by the states.”); id. at 46 (“[T]here 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 punishment.”).

20

Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

approved drugs in executions “would lead to the absurd result of requiring

the FDA to regulate such traditional means of capital punishment as the

gas chamber, electric chair, and gallows.” Heckler Reply Br. at 8. 13

Although Heckler did not resolve the question of the agency’s jurisdic-

tion, see 470 U.S. at 837–38, for more than three decades thereafter, FDA

continued to avoid regulating drugs intended for use in capital punish-

ment. In 2011, FDA explained that “[r]eviewing substances imported

or used for the purpose of state-authorized lethal injection clearly falls

outside of FDA’s explicit public health role,” and that as a matter of

“longstanding policy,” FDA would “continue to defer to law enforcement

on all matters involving lethal injection.” E-mail for Nathan Koppel, from

Shelly Burgess, FDA Public Affairs Specialist (Jan. 4, 2011), Doc. 13-3,

Beaty v. FDA, No. 11-cv-289 (D.D.C. Apr. 20, 2011).

In 2012, a group of death-row inmates sued FDA, alleging that it had

violated the FDCA by allowing shipments of a misbranded and unap-

proved new drug from an unregistered foreign establishment to enter the

United States. The U.S. District Court for the District of Columbia held

that, unlike in the domestic context where FDA has unreviewable discre-

tion when enforcing violations, the statutory scheme for imports under

21 U.S.C. § 381(a) is different, and the court enjoined FDA from permit-

ting entry of foreign-manufactured sodium thiopental, on the grounds that

it was unapproved and misbranded. Beaty, 853 F. Supp. 2d at 37–41. The

D.C. Circuit affirmed the injunction. Beaty and Cook, however, turned

solely on whether FDA could exercise enforcement discretion over the

imported sodium thiopental. Although the district court assumed that

“thiopental is both ‘misbranded’ and an unapproved ‘new drug’ under the

FDCA,” id. at 34 n.2, neither the district court, nor the D.C. Circuit,

addressed the broader question of FDA’s jurisdiction.

Following the Beaty injunction, in 2015, FDA blocked Texas’s attempt

to import sodium thiopental for use in capital punishment. FDA’s South-

west Import District Office detained and then refused the shipment on the

13 See also Heckler Pet’r Br. at 13–14 (if FDA had jurisdiction over FDA-approved

lethal-injection drugs, then the FDCA would also “encompass many of the paraphernalia

traditionally used for executions, such as the gallows and the electric chair,” and would

presumably oblige FDA “to regulate the use of these devices as well”); id. at 44 (“the

state and federal governments regularly used” the electric chair and gallows in 1938, and

“there is no indication that any member of Congress even considered the possibility that

enactment of the FDCA might affect these practices”).

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Opinions of the Office of Legal Counsel in Volume 43

grounds that the drug was misbranded and unapproved. See Letter from

Todd W. Cato, Director, Southwest Import District Office at 1–2 (Apr. 20,

2017). FDA’s 2017 notice of final action appears to be the first instance

in which FDA expressly asserted jurisdiction over a substance intended

for use in capital punishment. Even then, Texas conceded that sodium

thiopental “is a drug within the meaning of the [FDCA],” id. at 5, and

FDA’s decision was based upon the premise that “FDA is bound by the

terms of the order issued by the District Court” in Beaty, id. at 2; see also

id. at 6–7, 23, 24.

An agency may, of course, change its interpretation of an ambiguous

statute when the new interpretation falls within the permissible scope of

the agency’s discretion and the agency shows “that there are good reasons

for the new policy.” FCC v. Fox Television Stations, Inc., 556 U.S. 502,

515 (2009); see Brown & Williamson, 529 U.S. at 156–57. But for nearly

80 years after the FDCA’s enactment, FDA had never asserted jurisdiction

over articles intended for use in capital punishment, notwithstanding

thousands of cases that would have implicated FDA’s enforcement discre-

tion under such a theory. During that period, States carried out approxi-

mately 3,700 executions, and the federal government carried out approxi-

mately 192 civilian or military executions, employing a range of methods

(hanging, the electric chair, firing squads, gas chambers, and lethal injec-

tions). 14 FDA did not regulate the method of execution in any of those

instances or assert the authority to do so.

3.

Even if there were genuine ambiguity about whether FDA has jurisdic-

tion over articles intended for use in capital punishment, serious constitu-

tional concerns would arise if FDA could regulate and take enforcement

action against (including seizing and destroying) such articles. See Jen-

nings v. Rodriguez, 138 S. Ct. 830, 842 (2018) (“When a serious doubt is

raised about the constitutionality of an Act of Congress, it is a cardinal

principle that this Court will first ascertain whether a construction of the

14 See Glossip, 135 S. Ct. at 2732; Bureau of Justice Statistics, U.S. Dep’t of Justice,

Publications & Products: Executions, https://www.bjs.gov/index.cfm?ty=pbtp&tid=

182&iid=1 (last visited Apr. 29, 2019); M. Watt Espy & John Ortiz Smykla, Executions

in the United States, 1608-2002: The ESPY File, Inter-university Consortium for Political

and Social Research (July 20, 2016), https://www.icpsr.umich.edu/icpsrweb/NACJD/

studies/8451.

22

Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

statute is fairly possible by which the question may be avoided.” (internal

quotation marks omitted)). As the Supreme Court recently explained,

“because it is settled that capital punishment is constitutional, [i]t neces-

sarily follows that there must be a [constitutional] means of carrying it

out.” Glossip, 135 S. Ct. at 2732–33 (internal quotation marks omitted);

see Bucklew, 139 S. Ct. at 1122–23 (similar). It would present a serious

intrusion on state sovereignty if Congress sought, under the guise of drug-

safety regulation, to bar States from effectuating otherwise-lawful death

sentences.

The Supreme Court requires an unambiguous statement of congression-

al intent before it will construe a federal statute as effecting a significant

intrusion into an area of traditional state responsibility. Courts must “be

certain of Congress’ intent before finding that federal law overrides the

usual constitutional balance of federal and state powers.” Bond v. United

States, 572 U.S. 844, 858 (2014) (internal quotation marks omitted).

When States choose to impose and effectuate death sentences, they are

engaged in “the punishment of local criminal activity,” which is the

“clearest example of traditional state authority.” Id. 15

So long as a State employs a method of execution that comports with

the Fourteenth Amendment’s incorporation of the Eighth Amendment’s

Cruel and Unusual Punishments Clause, “the Constitution affords a

‘measure of deference to a State’s choice of execution procedures.’”

Bucklew, 139 S. Ct. at 1125 (quoting Baze, 553 U.S. at 51 n.2). Thus,

In re Kemmler, 136 U.S. 436 (1890), held that the New York statute

requiring execution by electrocution was “within the legitimate sphere of

the legislative power of the State.” Id. at 449. And the plurality opinion in

Baze v. Rees, 553 U.S. 35 (2008), explained that “[o]ur society has . . .

15 See also Danforth v. Minnesota, 552 U.S. 264, 280 (2008) (referring to “[t]he fun-

damental interest in federalism that allows individual States to define crimes, punish-

ments, rules of evidence, and rules of criminal and civil procedure in a variety of different

ways—so long as they do not violate the Federal Constitution”); State Farm Mut. Auto.

Ins. Co. v. Campbell, 538 U.S. 408, 422 (2003) (“A basic principle of federalism is that

. . . each State alone can determine what measure of punishment, if any, to impose on a

defendant who acts within its jurisdiction.”); Ewing v. California, 538 U.S. 11, 24 (2003)

(plurality opinion) (“Though three strikes laws may be relatively new, our tradition of

deferring to state legislatures in making and implementing such important policy deci-

sions is longstanding.”); Patterson v. New York, 432 U.S. 197, 201 (1977) (“[W]e should

not lightly construe the Constitution so as to intrude upon the administration of justice by

the individual States.”).

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Opinions of the Office of Legal Counsel in Volume 43

steadily moved to more humane methods of carrying out capital punish-

ment” because state legislatures have taken “the steps they deem appro-

priate, in light of new developments, to ensure humane capital punish-

ment.” Id. at 62 (opinion of Roberts, C.J.); accord Glossip, 135 S. Ct. at

2731–32 (similar). The Court has never endorsed an Eighth Amendment

standard that would “transform [federal] courts into boards of inquiry

charged with determining ‘best practices’ for executions,” because that

“would substantially intrude on the role of state legislatures in implement-

ing their execution procedures.” Baze, 553 U.S. at 51 (opinion of Roberts,

C.J.).

The FDCA does not reflect any clear statement of congressional intent

to regulate the States’ administration of capital punishment. Had Congress

sought to enable FDA to prohibit articles that States have chosen to use

for executions, it would have said so explicitly. But Congress did no such

thing. The FDCA’s definitions of “drug” and “device” are broad, but

breadth alone fails to manifest the intent needed to alter federal-state

relations so dramatically with respect to capital punishment. See, e.g.,

Bond, 572 U.S. at 860 (“insist[ing] on a clear indication that Congress

meant to reach purely local crimes [in a statute implementing a chemical-

weapons treaty] before interpreting the statute’s expansive language in a

way that intrudes on [States’] police power”). This principle of federalism

provides further support for the conclusion that the FDCA should not be

read to regulate—and therefore, effectively prohibit—the States’ admin-

istration of capital punishment.

D.

We emphasize the narrowness of our conclusion that articles intended

for use in capital punishment may not be regulated under the FDCA. We

are not concluding that the FDCA covers only “drugs” or “devices” that

have a medical or therapeutic purpose. For example, FDA has consistently

regulated other products that affect the structure or function of the human

body for an aesthetic, rather than medical or therapeutic, purpose (e.g.,

implants to augment breasts, dermal fillers to correct wrinkles, and sili-

cone injections to augment buttocks and breasts). Likewise, FDA has long

regulated drugs with non-therapeutic or recreational uses, including

narcotics, street drugs, and their alternatives. See, e.g., FDA, Guidance for

Industry: Street Drug Alternatives (Mar. 2000), https://www.fda.gov/

downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/

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Whether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions

ucm070343.pdf. Unlike with tobacco products or articles intended for

use in capital punishment, however, federal statutes evince no “collective

premise” that drugs intended to be used in achieving a recreational high

“will continue to be sold in the United States.” Brown & Williamson, 529

U.S. at 139. To the contrary, the manufacture and distribution of recrea-

tional drugs is already highly restricted by other federal statutes, such as

the Controlled Substances Act. See 21 U.S.C. § 812.

Nor do we address whether FDA has jurisdiction over drugs intended

for use in physician-assisted suicide. In marked contrast with capital

punishment and tobacco products, at the time of the FDCA’s enactment,

there was not—so far as we are aware—any history of federal or state

laws authorizing human euthanasia. As with recreational drugs, there is no

congressional determination that human-euthanasia drugs remain lawfully

on the market, nor has FDA historically disclaimed jurisdiction over them.

Cf. Brown & Williamson, 529 U.S. at 137–53. Accordingly, human-

euthanasia drugs lack the historical backdrop that weighs heavily against

FDA jurisdiction over capital punishment.

We further note that a contrary conclusion regarding articles intended

for use in capital punishment could sweep well beyond execution-related

articles. If FDA had jurisdiction over such articles simply because they

are “intended to affect the structure or any function of the body,” 21

U.S.C. § 321(g)(1)(C), (h)(3), such reasoning would likely mean that FDA

also had jurisdiction in a host of other areas that have long been consid-

ered well beyond its purview. Any type of firearm, when used for hunting

or by the military or law enforcement, is intended to affect the structure or

function of the body by killing or disabling a person or animal. But FDA

has never sought to regulate firearms when they are intended to be used

for hunting, police operations, or military purposes, and such an implausi-

ble interpretation of the FDCA would raise serious constitutional ques-

tions of its own.

Finally, there is nothing unusual about our conclusion that articles in-

tended for use in capital punishment fall outside FDA’s jurisdiction, even

though the same articles could be subject to regulation when intended for

other uses. For example, as noted above, FDA has classified articles such

as hot tubs, saunas, and treadmills as devices for some purposes, but not

for others. See supra pp. 3–4. Therefore, finding that substances fall

outside FDA’s jurisdiction when they are intended for use in capital

punishment does not bear upon FDA’s potential jurisdiction over other

intended uses of the same substances.

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Opinions of the Office of Legal Counsel in Volume 43

IV.

We conclude that articles intended for use in capital punishment by a

State or the federal government cannot be regulated as “drugs” or “devic-

es” under the FDCA. FDA accordingly lacks jurisdiction to regulate such

articles for that intended use.

STEVEN A. ENGEL

Assistant Attorney General

Office of Legal Counsel

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