Xiulu Ruan v. United States

(Slip Opinion) OCTOBER TERM, 2021 1

Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

being done in connection with this case, at the time the opinion is issued.

The syllabus constitutes no part of the opinion of the Court but has been

prepared by the Reporter of Decisions for the convenience of the reader.

See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

Syllabus

XIULU RUAN v. UNITED STATES

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

THE ELEVENTH CIRCUIT

No. 20–1410. Argued March 1, 2022—Decided June 27, 2022*

Petitioners Xiulu Ruan and Shakeel Kahn are medical doctors licensed

to prescribe controlled substances. Each was tried for violating 21

U. S. C. §841, which makes it a federal crime, “[e]xcept as authorized[,]

. . . for any person knowingly or intentionally . . . to manufacture, dis-

tribute, or dispense . . . a controlled substance.” A federal regulation

authorizes registered doctors to dispense controlled substances via

prescription, but only if the prescription is “issued for a legitimate

medical purpose by an individual practitioner acting in the usual

course of his professional practice.” 21 CFR §1306.04(a). At issue in

Ruan’s and Kahn’s trials was the mens rea required to convict under

§841 for distributing controlled substances not “as authorized.” Ruan

and Kahn each contested the jury instructions pertaining to mens rea

given at their trials, and each was ultimately convicted under §841 for

prescribing in an unauthorized manner. Their convictions were sepa-

rately affirmed by the Courts of Appeals.

Held: Section 841’s “knowingly or intentionally” mens rea applies to the

statute’s “except as authorized” clause. Once a defendant meets the

burden of producing evidence that his or her conduct was “authorized,”

the Government must prove beyond a reasonable doubt that the de-

fendant knowingly or intentionally acted in an unauthorized manner.

Pp. 4–16.

(a) Criminal law generally seeks to punish conscious wrongdoing.

Thus, when interpreting criminal statutes, the Court “start[s] from a

longstanding presumption . . . that Congress intends to require a de-

fendant to possess a culpable mental state.” Rehaif v. United States,

——————

* Together with No. 21–5261, Kahn v. United States, on certiorari to

the United States Court of Appeals for the Tenth Circuit.

2 XIULU RUAN v. UNITED STATES

Syllabus

588 U. S. ___, ___. This culpable mental state, known as scienter, re-

fers to the degree of knowledge necessary to make a person criminally

responsible for his or her acts. See ibid. The presumption of scienter

applies even when a statute does not include a scienter provision, and

when a statute does “includ[e] a general scienter provision,” “the pre-

sumption applies with equal or greater force” to the scope of that pro-

vision. Ibid. The Court has accordingly held that a word such as

“knowingly” modifies not only the words directly following it, but also

those other statutory terms that “separate wrongful from innocent

acts.” Id., at ___.

Here, §841 contains a general scienter provision—“knowingly or in-

tentionally.” And in §841 prosecutions, authorization plays a “crucial”

role in separating innocent conduct from wrongful conduct. United

States v. X-Citement Video, Inc., 513 U. S. 64, 73. Moreover, the regu-

latory language defining an authorized prescription is “ambiguous”

and “open to varying constructions,” Gonzales v. Oregon, 546 U. S. 243,

258, meaning that prohibited conduct (issuing invalid prescriptions) is

“often difficult to distinguish” from acceptable conduct (issuing valid

prescriptions). United States v. United States Gypsum Co., 438 U. S.

422, 441. A strong scienter requirement helps reduce the risk of “over-

deterrence,” i.e., punishing conduct that lies close to, but on the per-

missible side of, the criminal line. Ibid.

The statutory provisions at issue here are also not the kind to which

the Court has held the presumption of scienter does not apply. Section

841 does not define a regulatory or public welfare offense that carries

only minor penalties. Cf. Rehaif, 588 U. S., at ___; Staples v. United

States, 511 U. S. 600, 618–619. Nor is the “except as authorized”

clause a jurisdictional provision. Cf. Rehaif, 588 U. S., at ___. Pp. 5–

8.

(b) Analogous precedent reinforces the Court’s conclusion here. In

Liparota v. United States, 471 U. S. 419, United States v. X-Citement

Video, 513 U. S. 64, and Rehaif v. United States, 588 U. S. ___, the

Court interpreted statutes containing a general scienter provision

(“knowingly”), and considered what mental state applied to a statutory

clause that did not immediately follow the “knowingly” provision. In

all three cases, the Court held that “knowingly” modified the statutory

clause in question because that clause played a critical role in separat-

ing a defendant’s wrongful from innocent conduct. See Liparota, 471

U. S., at 426; X-Citement Video, 513 U. S., at 72–73; Rehaif, 588 U. S.,

at ___. As in those cases, the Court today concludes that §841’s mens

rea applies to the “[e]xcept as authorized” clause, which serves to sep-

arate a defendant’s wrongful from proper conduct. Pp. 8–9.

(c) Neither the Government’s nor the concurrence’s contrary argu-

Cite as: 597 U. S. ____ (2022) 3

Syllabus

ments are convincing. First, the Government and the concurrence cor-

rectly note that the statutory clauses in the cases just described set

forth elements of an offense. Here, the Government and the concur-

rence say, §841’s “[e]xcept as authorized” clause does not set forth an

element of the offense. In support, they point to a separate statutory

provision—§885. Section 885 says that the Government need not “neg-

ative any exemption or exception . . . in any complaint, information,

indictment, or other pleading or in any trial,” and that “the burden of

going forward with the evidence with respect to any such exemption or

exception shall be upon the person claiming its benefit,” not upon the

prosecution. But even assuming that lack of authorization is unlike

an element in these two ways, §885 has little or nothing to do with

scienter requirements. Section 885 simply absolves the Government

of having to allege, in an indictment, the inapplicability of every stat-

utory exception in each Controlled Substances Act prosecution. Sec-

tion 885 also shifts the burden of production—but not the burden of

persuasion—regarding statutory exceptions to the defendant, thereby

relieving the Government of having to disprove, at the outset of every

prosecution, the inapplicability of all exceptions.

Section 885 thus does not provide a basis for inferring that Congress

intended to do away with, or weaken, ordinary and longstanding sci-

enter requirements. At the same time, the factors discussed above—

the language of §841; the crucial role authorization plays in distin-

guishing morally blameworthy conduct from socially necessary con-

duct; the serious nature of the crime and its penalties; and the vague,

highly general regulatory language defining the scope of prescribing

authority—all support applying normal scienter principles to the “ex-

cept as authorized” clause. And the Government does not deny that,

once a defendant satisfies his burden of production under §885 by in-

voking the authorization exception, the Government must then prove

lack of authorization by satisfying the ordinary criminal law burden of

proof—beyond a reasonable doubt.

The Government also offers a substitute mens rea standard. Instead

of applying the statute’s “knowingly or intentionally” language to the

authorization clause, the Government instead asserts that the statute

implicitly contains an “objectively reasonable good-faith effort” or “ob-

jective honest-effort standard.” Brief for United States 16–17. But

§841 uses the words “knowingly or intentionally,” not “good faith,” “ob-

jectively,” “reasonable,” or “honest effort.” And the Government’s

standard would turn a defendant’s criminal liability on the mental

state of a hypothetical “reasonable” doctor, rather than on the mental

state of the defendant himself or herself. The Court has rejected anal-

ogous suggestions in other criminal contexts. See Elonis v. United

States, 575 U. S. 723. And the Government is wrong to assert that the

4 XIULU RUAN v. UNITED STATES

Syllabus

Court effectively endorsed its honest-effort standard in United States

v. Moore, 423 U. S. 122, as that case did not address mens rea at all.

Nor does United States v. Yermian, 468 U. S. 63, support the Govern-

ment here, as that case dealt with a jurisdictional clause, to which the

presumption of scienter does not apply.

Finally, the Government argues that requiring it to prove that a doc-

tor knowingly or intentionally acted not “as authorized” will allow bad-

apple doctors to escape liability by claiming idiosyncratic views about

their prescribing authority. But the Court has often rejected this kind

of argument, see, e.g., Rehaif, 588 U. S., at ___, and does so again here.

Pp. 9–15.

(d) The Court of Appeals in both cases evaluated the jury instruc-

tions relating to mens rea under an incorrect understanding of §841’s

scienter requirements. On remand, those courts may address whether

the instructions complied with the mens rea standard set forth here,

as well as whether any instructional error was harmless. P. 15.

966 F. 3d 1101 and 989 F. 3d 806, vacated and remanded.

BREYER, J. delivered the opinion of the Court, in which ROBERTS, C. J.,

and SOTOMAYOR, KAGAN, GORSUCH, and KAVANAUGH, JJ., joined. ALITO,

J., filed an opinion concurring in the judgment, in which THOMAS, J.,

joined, and in which BARRETT, J., joined as to Parts I–A, I–B, and II.

Cite as: 597 U. S. ____ (2022) 1

Opinion of the Court

NOTICE: This opinion is subject to formal revision before publication in the

preliminary print of the United States Reports. Readers are requested to

notify the Reporter of Decisions, Supreme Court of the United States, Wash-

ington, D. C. 20543, of any typographical or other formal errors, in order that

corrections may be made before the preliminary print goes to press.

SUPREME COURT OF THE UNITED STATES

_________________

Nos. 20–1410 and 21–5261

_________________

XIULU RUAN, PETITIONER

20–1410 v.

UNITED STATES

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE ELEVENTH CIRCUIT

SHAKEEL KAHN, PETITIONER

21–5261 v.

UNITED STATES

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE TENTH CIRCUIT

[June 27, 2022]

JUSTICE BREYER delivered the opinion of the Court.

A provision of the Controlled Substances Act, codified at

21 U. S. C. §841, makes it a federal crime, “[e]xcept as au-

thorized[,] . . . for any person knowingly or intentionally . . .

to manufacture, distribute, or dispense . . . a controlled sub-

stance,” such as opioids. 84 Stat. 1260, 21 U. S. C. §841(a)

(emphasis added). Registered doctors may prescribe these

substances to their patients. But, as provided by regula-

tion, a prescription is only authorized when a doctor issues

it “for a legitimate medical purpose . . . acting in the usual

course of his professional practice.” 21 CFR §1306.04(a)

(2021).

2 XIULU RUAN v. UNITED STATES

Opinion of the Court

In each of these two consolidated cases, a doctor was con-

victed under §841 for dispensing controlled substances not

“as authorized.” The question before us concerns the state

of mind that the Government must prove to convict these

doctors of violating the statute. We hold that the statute’s

“knowingly or intentionally” mens rea applies to authoriza-

tion. After a defendant produces evidence that he or she

was authorized to dispense controlled substances, the Gov-

ernment must prove beyond a reasonable doubt that the de-

fendant knew that he or she was acting in an unauthorized

manner, or intended to do so.

I

The question we face concerns §841’s exception from the

general prohibition on dispensing controlled substances

contained in the phrase “[e]xcept as authorized.” In partic-

ular, the question concerns the defendant’s state of mind.

To prove that a doctor’s dispensation of drugs via prescrip-

tion falls within the statute’s prohibition and outside the

authorization exception, is it sufficient for the Government

to prove that a prescription was in fact not authorized, or

must the Government prove that the doctor knew or in-

tended that the prescription was unauthorized?

Petitioners Xiulu Ruan and Shakeel Kahn are both doc-

tors who actively practiced medicine. They both possessed

licenses permitting them to prescribe controlled sub-

stances. The Government separately charged them with

unlawfully dispensing and distributing drugs in violation of

§841. Each proceeded to a jury trial, and each was con-

victed of the charges.

At their separate trials, Ruan and Kahn argued that their

dispensation of drugs was lawful because the drugs were

dispensed pursuant to valid prescriptions. As noted above,

a regulation provides that, “to be effective,” a prescription

“must be issued for a legitimate medical purpose by an in-

Cite as: 597 U. S. ____ (2022) 3

Opinion of the Court

dividual practitioner acting in the usual course of his pro-

fessional practice.” 21 CFR §1306.04(a). We assume, as did

the courts below and the parties here, that a prescription is

“authorized” and therefore lawful if it satisfies this stand-

ard. At Ruan’s and Kahn’s trials, the Government argued

that the doctors’ prescriptions failed to comply with this

standard. The doctors argued that their prescriptions did

comply, and that, even if not, the doctors did not knowingly

deviate or intentionally deviate from the standard.

Ruan, for example, asked for a jury instruction that

would have required the Government to prove that he sub-

jectively knew that his prescriptions fell outside the scope of

his prescribing authority. The District Court, however, re-

jected this request. The court instead set forth a more ob-

jective standard, instructing the jury that a doctor acts law-

fully when he prescribes “in good faith as part of his medical

treatment of a patient in accordance with the standard of

medical practice generally recognized and accepted in the

United States.” App. to Pet. for Cert. in No. 20–410, p.

139a. The court further instructed the jury that a doctor

violates §841 when “the doctor’s actions were either not for

a legitimate medical purpose or were outside the usual

course of professional medical practice.” Ibid. The jury con-

victed Ruan, and the trial court sentenced him to over 20

years in prison and ordered him to pay millions of dollars

in restitution and forfeiture.

The Eleventh Circuit affirmed Ruan’s convictions. See

966 F. 3d 1101, 1120, 1166–1167 (2020). The appeals court

held that a doctor’s “subjectiv[e] belie[f] that he is meeting

a patient’s medical needs by prescribing a controlled sub-

stance” is not a “complete defense” to a §841 prosecution.

Id., at 1167. Rather, the court said, “ ‘[w]hether a defendant

acts in the usual course of his professional practice must be

evaluated based on an objective standard, not a subjective

standard.’ ” Id., at 1166 (quoting United States v. Joseph,

4 XIULU RUAN v. UNITED STATES

Opinion of the Court

709 F. 3d 1082, 1097 (CA11 2013); emphasis added; altera-

tion in original).

Kahn’s trial contained similar disagreements over the

proper mens rea instructions. Ultimately, the District

Court instructed the jury that it should not convict if it

found that Kahn acted in “good faith,” defined as “an at-

tempt to act in accordance with what a reasonable physi-

cian should believe to be proper medical practice.” App.

486. The court added that to find “good faith,” the jury must

conclude that Kahn “acted in an honest effort to prescribe

for patients’ medical conditions in accordance with gener-

ally recognized and accepted standards of practice.” Ibid.

The court also told the jury that “good faith” was a “com-

plete defense” because it “would be inconsistent with know-

ingly and intentionally distributing and/or dispensing con-

trolled substances outside the usual course of professional

practice and without a legitimate medical purpose.” Ibid.

The jury convicted Kahn of the §841 charges, and he was

sentenced to 25 years in prison.

The Tenth Circuit affirmed Kahn’s convictions. See 989

F. 3d 806, 812, 824–826 (2021). In doing so, the court held

that to convict under §841, the Government must prove

that a doctor “either: (1) subjectively knew a prescription

was issued not for a legitimate medical purpose; or (2) is-

sued a prescription that was objectively not in the usual

course of professional practice.” Id., at 825.

Both Ruan and Kahn filed petitions for certiorari. We

granted the petitions and consolidated the cases to consider

what mens rea applies to §841’s authorization exception.

II

As we have said, §841 makes it unlawful, “[e]xcept as au-

thorized[,] . . . for any person knowingly or intentionally . . .

to manufacture, distribute, or dispense . . . a controlled sub-

stance.” We now hold that §841’s “knowingly or intention-

ally” mens rea applies to the “except as authorized” clause.

Cite as: 597 U. S. ____ (2022) 5

Opinion of the Court

This means that once a defendant meets the burden of pro-

ducing evidence that his or her conduct was “authorized,”

the Government must prove beyond a reasonable doubt

that the defendant knowingly or intentionally acted in an

unauthorized manner. Our conclusion rests upon several

considerations.

A

First, as a general matter, our criminal law seeks to pun-

ish the “ ‘vicious will.’ ” Morissette v. United States, 342

U. S. 246, 251 (1952); see also id., at 250, n. 4 (quoting F.

Sayre, Cases on Criminal Law, p. xxxvi (R. Pound ed.

1927)). With few exceptions, “ ‘wrongdoing must be con-

scious to be criminal.’ ” Elonis v. United States, 575 U. S.

723, 734 (2015) (quoting Morissette, 342 U. S., at 252). In-

deed, we have said that consciousness of wrongdoing is a

principle “as universal and persistent in mature systems of

[criminal] law as belief in freedom of the human will and a

consequent ability and duty of the normal individual to

choose between good and evil.” Id., at 250.

Consequently, when we interpret criminal statutes, we

normally “start from a longstanding presumption, traceable

to the common law, that Congress intends to require a de-

fendant to possess a culpable mental state.” Rehaif v.

United States, 588 U. S. ___, ___ (2019) (slip op., at 3). We

have referred to this culpable mental state as “scienter,”

which means the degree of knowledge necessary to make a

person criminally responsible for his or her acts. See ibid.;

Black’s Law Dictionary 1613 (11th ed. 2019); Morissette,

342 U. S., at 250–252.

Applying the presumption of scienter, we have read into

criminal statutes that are “silent on the required mental

state”—meaning statutes that contain no mens rea provi-

sion whatsoever—“ ‘that mens rea which is necessary to sep-

arate wrongful conduct from “otherwise innocent con-

duct.” ’ ” Elonis, 575 U. S., at 736 (quoting Carter v. United

6 XIULU RUAN v. UNITED STATES

Opinion of the Court

States, 530 U. S. 255, 269 (2000); emphasis added). Unsur-

prisingly, given the meaning of scienter, the mens rea we

have read into such statutes is often that of knowledge or

intent. See, e.g., Staples v. United States, 511 U. S. 600, 619

(1994); United States v. United States Gypsum Co., 438

U. S. 422, 444–446 (1978).

And when a statute is not silent as to mens rea but in-

stead “includes a general scienter provision,” “the presump-

tion applies with equal or greater force” to the scope of that

provision. Rehaif, 588 U. S., at ___ (slip op., at 3) (emphasis

added). We have accordingly held that a word such as

“knowingly” modifies not only the words directly following

it, but also those other statutory terms that “separate

wrongful from innocent acts.” Id., at ___ (slip op., at 6); see,

e.g., ibid.; United States v. X-Citement Video, Inc., 513 U. S.

64, 72 (1994); Liparota v. United States, 471 U. S. 419, 426

(1985).

Section 841 contains a general scienter provision—

“knowingly or intentionally.” And in §841 prosecutions, a

lack of authorization is often what separates wrongfulness

from innocence. Defendants who produce evidence that

they are “authorized” to dispense controlled substances are

often doctors dispensing drugs via prescription. We nor-

mally would not view such dispensations as inherently ille-

gitimate; we expect, and indeed usually want, doctors to

prescribe the medications that their patients need. In §841

prosecutions, then, it is the fact that the doctor issued an

unauthorized prescription that renders his or her conduct

wrongful, not the fact of the dispensation itself. In other

words, authorization plays a “crucial” role in separating in-

nocent conduct—and, in the case of doctors, socially benefi-

cial conduct—from wrongful conduct. X-Citement Video,

513 U. S., at 73. Applying §841’s “knowingly or intention-

ally” mens rea to the authorization clause thus “helps ad-

vance the purpose of scienter, for it helps to separate wrong-

ful from innocent acts.” Rehaif, 588 U. S., at ___ (slip op.,

Cite as: 597 U. S. ____ (2022) 7

Opinion of the Court

at 6); see also X-Citement Video, 513 U. S., at 72–73.

In addition, the regulatory language defining an author-

ized prescription is, we have said, “ambiguous,” written in

“generalit[ies], susceptible to more precise definition and

open to varying constructions.” Gonzales v. Oregon, 546

U. S. 243, 258 (2006); see id., at 257 (regulation “gives little

or no instruction on” major questions); see also 21 CFR

§1306.04(a) (regulation defining “effective” prescription as

one “issued for a legitimate medical purpose by an individ-

ual practitioner acting in the usual course of his profes-

sional practice”). The conduct prohibited by such language

(issuing invalid prescriptions) is thus “often difficult to dis-

tinguish from the gray zone of socially acceptable . . . con-

duct” (issuing valid prescriptions). United States Gypsum,

438 U. S., at 441. A strong scienter requirement helps to

diminish the risk of “overdeterrence,” i.e., punishing ac-

ceptable and beneficial conduct that lies close to, but on the

permissible side of, the criminal line. Ibid.

The statutory provisions at issue here are also not the

kind that we have held fall outside the scope of ordinary

scienter requirements. Section 841 does not define a regu-

latory or public welfare offense that carries only minor pen-

alties. Cf. Rehaif, 588 U. S., at ___ (slip op., at 6); Staples,

511 U. S., at 606. Rather, §841 imposes severe penalties

upon those who violate it, including life imprisonment and

fines up to $1 million. See §841(b)(1)(C); see generally

§841(b). Such severe penalties counsel in favor of a strong

scienter requirement. See Staples, 511 U. S., at 618–619

(noting that “a severe penalty is a further factor tending to

suggest that . . . the usual presumption that a defendant

must know the facts that make his conduct illegal should

apply”); United States Gypsum, 438 U. S., at 442, n. 18.

Nor is the “except as authorized” clause a jurisdictional

provision, to which the presumption of scienter would not

apply. Cf. Rehaif, 588 U. S., at ___ (slip op., at 4); United

8 XIULU RUAN v. UNITED STATES

Opinion of the Court

States v. Yermian, 468 U. S. 63, 68–69 (1984). To the con-

trary, and as we have explained, a lack of authorization is

often the critical thing distinguishing wrongful from proper

conduct.

B

Analogous precedent reinforces our conclusion. In Lipa-

rota, we interpreted a statute penalizing anyone who

“ ‘knowingly uses [food stamps] in any manner not author-

ized by’ ” statute. 471 U. S., at 420. We held that “know-

ingly” modified both the “use” of food stamps element and

the element that the use be “not authorized.” Id., at 423,

433. We applied “knowingly” to the authorization language

even though Congress had not “explicitly and unambigu-

ously” indicated that it should so apply. Id., at 426. But if

knowingly did not modify the fact of nonauthorization, we

explained, the statute “would . . . criminalize a broad range

of apparently innocent conduct.” Ibid.

Similarly, in X-Citement Video, we interpreted a statute

penalizing anyone who “ ‘knowingly transports’ ” or “ ‘know-

ingly receives’ ” videos “ ‘involv[ing] the use of a minor en-

gaging in sexually explicit conduct.’ ” 513 U. S., at 68. We

held that “knowingly” applied not only to the element of

transporting or receiving videos but also to the elemental

fact that the videos involve “the use of a minor.” Id., at 66.

We recognized that this was not “the most grammatical

reading of the statute.” Id., at 70. But, we explained, “the

age of the performers is the crucial element separating legal

innocence from wrongful conduct,” for possessing sexually

explicit videos involving nonminors is protected First

Amendment activity. Id., at 72–73.

Finally, in Rehaif, we interpreted a statutory scheme in

which one statutory subsection provided penalties for any-

one who “knowingly violates” a separate subsection. 588

U. S., at ___–___ (slip op., at 3–4). This latter subsection

Cite as: 597 U. S. ____ (2022) 9

Opinion of the Court

made it “unlawful” for people with certain statuses (i.e., be-

ing a felon or being in the country unlawfully) to possess a

gun. Ibid. We held that the first subsection’s “knowingly”

language applied to the status element in the second sub-

section. Id., at ___ (slip op., at 5). To convict under the

statute, then, the Government had to prove that a defend-

ant knew he had one of the listed statuses. Ibid. “Without

knowledge of that status,” we reasoned, “the defendant may

well lack the intent needed to make his behavior wrongful,”

because “[a]ssuming compliance with ordinary licensing re-

quirements, the possession of a gun can be entirely inno-

cent.” Id., at ___ (slip op., at 6).

Like the statutes at issue in these cases, the statute here

contains a scienter provision. Section 841 states: “Except

as authorized by this subchapter, it shall be unlawful for

any person knowingly or intentionally . . . to manufacture,

distribute, or dispense . . . a controlled substance.” (Em-

phasis added.) Like those three cases, the question here

concerns the mental state that applies to a statutory clause

(“[e]xcept as authorized”) that does not immediately follow

the scienter provision. Like the three cases, the statutory

clause in question plays a critical role in separating a de-

fendant’s wrongful from innocent conduct. And, like the

Court in those cases, we conclude that the statute’s mens

rea applies to that critical clause.

III

We are not convinced by the Government’s arguments to

the contrary. First, the Government correctly points out,

and the concurrence emphasizes, that the statutory lan-

guage at issue in the cases we have just described set forth

elements of the offense. Here, the Government and the con-

currence say, the “except as authorized” clause does not set

forth an element. See, e.g., post, at 4–7 (ALITO, J., concur-

ring in judgment).

The Government and the concurrence point to two ways

10 XIULU RUAN v. UNITED STATES

Opinion of the Court

in which the “except as authorized” clause is unlike an ele-

ment, both of which rely on a different provision of the Con-

trolled Substances Act—§885. Section 885 says that the

Government need not “negative”—i.e., refute—“any exemp-

tion or exception . . . in any complaint, information, indict-

ment, or other pleading.” This means that, in a prosecution

under the Controlled Substances Act, the Government need

not refer to a lack of authorization (or any other exemption

or exception) in the criminal indictment. Cf. United States

v. Resendiz-Ponce, 549 U. S. 102, 108 (2007) (criminal in-

dictment must set forth all elements of the charged crime).

Section 885 also says that the Government need not “nega-

tive any exemption or exception . . . in any trial,” and that

“the burden of going forward with the evidence with respect

to any such exemption or exception shall be upon the person

claiming its benefit,” not upon the prosecution. Cf. Patter-

son v. New York, 432 U. S. 197, 210 (1977) (Government

bears burden of proving all elements of charged offense).

But even assuming that lack of authorization is unlike an

element for the two purposes that §885 sets forth, those two

purposes have little or nothing to do with scienter require-

ments. The first has to do with the indictment. It simply

says that the Government need not set forth in an indict-

ment a lack of authorization, or otherwise allege that a de-

fendant does not fall within the many exceptions and ex-

emptions that the Controlled Substances Act contains. The

Act excepts, for example, licensed professionals such as

dentists, veterinarians, scientific investigators, and phar-

macists from the prohibition on dispensing controlled sub-

stances. See 21 U. S. C. §802(21). The Act also excepts em-

ployees of drug manufacturers, common carriers, and

people with sick family members or pets from the prohibi-

tion on possessing controlled substances. See §§802(27),

822(c). Section 885 merely absolves the Government of hav-

ing to allege, in an indictment, the inapplicability of every

Cite as: 597 U. S. ____ (2022) 11

Opinion of the Court

statutory exception in each Controlled Substances Act pros-

ecution.

Section 885’s second purpose refers only to “the burden of

going forward with the evidence,” i.e., the burden of produc-

tion. See Black’s Law Dictionary, at 244. It says nothing

regarding the distinct issue of the burden of persuasion—

i.e., the burden of proving a lack of authorization. Cf. Di-

rector, Office of Workers’ Compensation Programs v. Green-

wich Collieries, 512 U. S. 267, 274 (1994) (“our opinions con-

sistently distinguis[h] between burden of proof, which we

defined as burden of persuasion, and . . . the burden of pro-

duction or the burden of going forward with the evidence”);

see also Schaffer v. Weast, 546 U. S. 49, 56 (2005). Section

885 can thus be understood as providing a presumptive de-

vice, akin to others we have recognized in the criminal con-

text, which “merely shift[s] the burden of production to the

defendant, following the satisfaction of which the ultimate

burden of persuasion returns to the prosecution.” County

Court of Ulster Cty. v. Allen, 442 U. S. 140, 157–158, n. 16

(1979); see Parker v. Matthews, 567 U. S. 37, 42, n. 1 (2012)

(per curiam). Contrary to the concurrence’s assertion, see

post, at 9–11, the differences between these two burdens

and the use of procedural mechanisms to shift one burden

but not the other are well established. See, e.g., 29 Am. Jur.

2d Evidence §207, p. 246 (2019) (“due process does not pro-

hibit the use of a . . . procedural device that shifts to a de-

fendant the burden of producing some evidence contesting

a fact that may otherwise be inferred, provided the prose-

cution retains the ultimate burden of proof ”); 1 W. LaFave,

Substantive Criminal Law §1.8(a), p. 102 (3d ed. 2018) (sim-

ilar). In a §841 prosecution, then, once the defendant sat-

isfies the initial burden of production by producing evidence

of authorization, the burden of proving a lack of authoriza-

tion shifts back to the Government. And, as with §885’s

indictment-related purpose, §885’s burden-related purpose

simply relieves the Government from having to disprove, at

12 XIULU RUAN v. UNITED STATES

Opinion of the Court

the outset of every Controlled Substances Act prosecution,

every exception in the statutory scheme.

Section 885 thus does not provide a basis for inferring

that Congress intended to do away with, or weaken, ordi-

nary and longstanding scienter requirements. At the same

time, the language of §841 (which explicitly includes a

“knowingly or intentionally” provision); the crucial role au-

thorization (or lack thereof ) plays in distinguishing morally

blameworthy conduct from socially necessary conduct; the

serious nature of the crime and its penalties; and the vague,

highly general language of the regulation defining the

bounds of prescribing authority all support applying nor-

mal scienter principles to the “except as authorized” clause.

That statutory requirement, while differing from an ele-

ment in some respects, is sufficiently like an element in re-

spect to the matter at issue here as to warrant similar legal

treatment.

And the Government does not deny that, once a defend-

ant claims that he or she falls within the authorization ex-

ception and the burden shifts back to the Government, the

Government must prove a lack of authorization by satisfy-

ing the ordinary criminal law burden of proof—beyond a

reasonable doubt. See Brief for United States 26; Tr. of

Oral Arg. 50–51; see also id., at 62–65. But see post, at 10–

11 (concurrence suggesting, contrary to the position ad-

vanced by all parties to these cases, that the Government

need only prove lack of authorization by a preponderance of

the evidence). Once the defendant meets his or her burden

of production, then, the Government must prove lack of au-

thorization beyond a reasonable doubt.

Resisting the “knowingly or intentionally” standard, the

Government instead offers a substitute mens rea standard.

The Government says that rather than simply apply the

statute’s “knowingly or intentionally” language to the au-

thorization clause, we should read the statute as implicitly

containing an “objectively reasonable good-faith effort” or

Cite as: 597 U. S. ____ (2022) 13

Opinion of the Court

“objective honest-effort standard.” Brief for United States

16–17; cf. post, at 13 (concurrence arguing that doctors can

defend against a §841 prosecution by proving that they

have “act[ed] in subjective good faith in prescribing drugs”).

That is to say, once a defendant meets his or her burden of

production, the Government can convict “by proving beyond

a reasonable doubt that [the defendant] did not even make

an objectively reasonable attempt to ascertain and act

within the bounds of professional medicine.” Brief for

United States 16.

We are not convinced. For one thing, §841, like many

criminal statutes, uses the familiar mens rea words “know-

ingly or intentionally.” It nowhere uses words such as “good

faith,” “objectively,” “reasonable,” or “honest effort.”

For another, the Government’s standard would turn a de-

fendant’s criminal liability on the mental state of a hypo-

thetical “reasonable” doctor, not on the mental state of the

defendant himself or herself. Cf. id., at 24 (Government ar-

guing that “a physician can violate Section 841(a) when he

makes no objectively reasonable attempt to conform his

conduct to something that his fellow doctors would view as

medical care” (emphasis added)).

We have rejected analogous suggestions in other criminal

contexts. In Elonis, for example, we considered the mental

state applicable to a statute that criminalized threatening

communications but contained no explicit mens rea require-

ment. 575 U. S., at 732. The Government argued that the

statute required proof that a reasonable person would find

the communications threatening. Id., at 738–739. But, we

said, “[h]aving liability turn on whether a ‘reasonable per-

son’ regards the communication as a threat—regardless of

what the defendant thinks—reduces culpability on the all-

important element of the crime to negligence.” Id., at 738

(some internal quotation marks omitted). “[A]nd,” we em-

phasized, “we ‘have long been reluctant to infer that a neg-

ligence standard was intended in criminal statutes.’ ” Ibid.

14 XIULU RUAN v. UNITED STATES

Opinion of the Court

(quoting Rogers v. United States, 422 U. S. 35, 47 (1975)

(Marshall, J., concurring)). We believe the same of the Gov-

ernment’s proposed standard here.

The Government asserts that we held to the contrary,

and “effectively endorsed” its honest-effort standard, in

United States v. Moore, 423 U. S. 122 (1975). Brief for

United States 26. But the question in Moore was whether

doctors could ever be held criminally liable under §841. 423

U. S., at 124. Moore did not directly address the issue be-

fore us here regarding the mens rea required to convict un-

der the statute.

Further, the Government, citing Yermian, notes that the

authorization clause precedes the words “knowingly or in-

tentionally.” And, the Government argues, grammatically

speaking, that fact prevents the latter mens rea provision

from modifying the former clause. See Brief for United

States 24–25. But Yermian based its holding on the fact

that the clause preceding the mens rea provision set forth a

jurisdictional criteria, which is typically not subject to a sci-

enter requirement. 468 U. S., at 68–69; see also Rehaif, 588

U. S., at ___ (slip op., at 4). Yermian did not base its holding

on the grammatical positioning of the statutory language.

Finally, the Government argues that requiring it to prove

that a doctor knowingly or intentionally acted not as au-

thorized will allow bad-apple doctors to escape liability by

claiming idiosyncratic views about their prescribing au-

thority. See, e.g., Brief for United States 33. This kind of

argument, however, can be made in many cases imposing

scienter requirements, and we have often rejected it on ba-

ses similar to those we have set forth in Part II of this opin-

ion. See, e.g., Rehaif, 588 U. S., at ___ (slip op., at 8); Lipa-

rota, 471 U. S., at 433–434.

We do the same here. The Government, of course, can

prove knowledge of a lack of authorization through circum-

stantial evidence. See ibid. And the regulation defining the

scope of a doctor’s prescribing authority does so by reference

Cite as: 597 U. S. ____ (2022) 15

Opinion of the Court

to objective criteria such as “legitimate medical purpose”

and “usual course” of “professional practice.” 21 CFR

§1306.04(a); see Gonzales, 546 U. S., at 285 (Scalia, J., dis-

senting) (“The use of the word ‘legitimate’ connotes an ob-

jective standard of ‘medicine’ ”); Moore, 423 U. S., at 141–

142 (describing Congress’ intent “to confine authorized

medical practice within accepted limits” (emphasis added)).

As we have said before, “the more unreasonable” a defend-

ant’s “asserted beliefs or misunderstandings are,” espe-

cially as measured against objective criteria, “the more

likely the jury . . . will find that the Government has carried

its burden of proving knowledge.” Cheek v. United States,

498 U. S. 192, 203–204 (1991). But the Government must

still carry this burden. And for purposes of a criminal con-

viction under §841, this requires proving that a defendant

knew or intended that his or her conduct was unauthorized.

IV

The Government argues that we should affirm Ruan’s

and Kahn’s convictions because the jury instructions at

their trials conveyed the requisite mens rea. Alternatively,

the Government argues that any instructional error was

harmless. But the Court of Appeals in both cases evaluated

the jury instructions under an incorrect understanding of

§841’s scienter requirements. We decline to decide in the

first instance whether the instructions complied with the

standard we have set forth today. Cf. Rehaif, 588 U. S., at

___ (slip op., at 11). We leave that and any harmlessness

questions for the courts to address on remand.

* * *

We conclude that §841’s “knowingly or intentionally”

mens rea applies to the “except as authorized” clause. This

means that in a §841 prosecution in which a defendant

meets his burden of production under §885, the Govern-

16 XIULU RUAN v. UNITED STATES

Opinion of the Court

ment must prove beyond a reasonable doubt that the de-

fendant knowingly or intentionally acted in an unauthor-

ized manner. We vacate the judgments of the Courts of Ap-

peals below and remand the cases for further proceedings

consistent with this opinion.

It is so ordered.

Cite as: 597 U. S. ____ (2022) 1

ALITO,AJ., , J., concurring

concurring

LITO in judgment

SUPREME COURT OF THE UNITED STATES

_________________

Nos. 20–1410 and 21–5261

_________________

XIULU RUAN, PETITIONER

20–1410 v.

UNITED STATES

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE ELEVENTH CIRCUIT

SHAKEEL KAHN, PETITIONER

21–5261 v.

UNITED STATES

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE TENTH CIRCUIT

[June 27, 2022]

JUSTICE ALITO, with whom JUSTICE THOMAS joins, and

with whom JUSTICE BARRETT joins as to Parts I–A, I–B, and

II, concurring in the judgment.

In criminal law, the distinction between the elements of

an offense and an affirmative defense is well-known and

important. In these cases, however, the Court recognizes a

new hybrid that has some characteristics of an element and

some characteristics of an affirmative defense. The conse-

quences of this innovation are hard to foresee, but the result

may well be confusion and disruption. That risk is entirely

unnecessary.

We granted certiorari in these cases to decide whether a

physician may be convicted of dispensing or distributing

drugs by prescription under a provision of the Controlled

Substances Act of 1970 (CSA), 21 U. S. C. §841(a), if he or

she believed in good faith that the prescription was within

the course of professional practice. In my view, there is a

2 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

straightforward answer to this question. The CSA contains

an exception for prescriptions issued in the course of profes-

sional practice, and this exception is a carry-over from the

CSA’s predecessor, the Harrison Narcotics Act of 1914, 38

Stat. 785. In interpreting the Harrison Act, this Court held

that a registered physician acts “in the course of his profes-

sional practice” when the physician writes prescriptions “in

good faith.” Linder v. United States, 268 U. S. 5, 17–18

(1925). I would hold that this rule applies under the CSA

and would therefore vacate the judgments below and re-

mand for further proceedings.

The Court declines to adopt this approach and instead

takes a radical new course. It holds that the mental state

expressed by the terms “knowingly or intentionally” in

§841(a) applies to the provision’s “[e]xcept as authorized”

proviso. It bases this conclusion not on anything in the lan-

guage of the CSA, but instead on the “presumption, tracea-

ble to the common law, that Congress intends to require a

defendant to possess a culpable mental state.” Rehaif v.

United States, 588 U. S. ___, ___ (2019) (slip op., at 3).

The Court’s analysis rests on an obvious conceptual mis-

take. A culpable mental state—or, to use the traditional

Latin term, “mens rea”—is the mental state an accused

must have in relation to the elements of an offense. But the

authorizations in the CSA that excuse acts that are other-

wise unlawful under §841(a) are not elements of the of-

fenses created by that provision. They are affirmative

defenses. The presumption that elements must be accom-

panied by a culpable mental state—which I will call “the

mens rea canon”—provides no guidance on what a defend-

ant must prove to establish an affirmative defense. And for

that reason, that canon does not help to decide whether

there is a good-faith defense in §841(a) prosecutions of phy-

sicians.

The Court does not claim that the “[e]xcept as authorized”

Cite as: 597 U. S. ____ (2022) 3

ALITO,AJ., , J., concurring

concurring

LITO in judgment

proviso actually constitutes an element of dispensing or dis-

tributing a controlled substance. But it concludes, based on

a vague four-part test, that the proviso is “sufficiently like

an element in respect to the matter at issue here as to war-

rant similar treatment.” Ante, at 12. How many other af-

firmative defenses might warrant similar treatment, the

Court does not say. It leaves prosecutors, defense attor-

neys, and the lower courts in the dark. I cannot accept this

cavalier treatment of an important question.

Nor can I accept the Court’s conclusion that once a de-

fendant produces evidence that his or her conduct was “au-

thorized,” “the Government must prove beyond a reasona-

ble doubt that the defendant knowingly or intentionally

acted in an unauthorized manner.” Ante, at 5. We did not

grant certiorari on the question of the burden of proof ap-

plicable to authorizations to dispense or distribute con-

trolled substances. No party has briefed this issue, and its

resolution is not essential to our decision in these cases. In

keeping with our normal practice, I would not address this

question. But because the Court volunteers its own answer,

I will offer one as well. As I see it, the text of the CSA does

not show that Congress intended to deviate from the common-

law rule that the burden of proving “affirmative defenses—

indeed, ‘all . . . circumstances of justification, excuse or al-

leviation’—rest[s] on the defendant.” Patterson v. New

York, 432 U. S. 197, 202 (1977) (quoting 4 W. Blackstone

Commentaries *201). And absolutely nothing in the text of

the statute indicates that Congress intended to impose a

burden on the Government to disprove all assertions of au-

thorization beyond a reasonable doubt.

I

A

As relevant here, §841(a)(1) provides that “except as au-

thorized by this subchapter, it shall be unlawful for any per-

4 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

son knowingly or intentionally . . . to manufacture, distrib-

ute, or dispense, or possess with intent to manufacture, dis-

tribute, or dispense, . . . a controlled substance.” According

to the Court’s reasoning, the terms “knowingly or intention-

ally” in §841(a)(1) apply to the “except as authorized” pro-

viso at the beginning of the provision. But it is hard to see

how this could be true.

As a matter of elementary syntax, the adverbs “know-

ingly” and “intentionally” are most naturally understood to

modify the verbs that follow, i.e., “manufacture,” “distrib-

ute,” etc., and not the introductory phrase “except as au-

thorized.” That phrase, in turn, clearly modifies the term

“unlawful.”

The Court does not suggest otherwise. It does not claim

that “knowingly or “intentionally” modifies the introductory

proviso in a grammatical sense. (If it did, the introductory

phrase would clearly be an element, and for reasons that I

will explain, infra, at 5–6, 21 U. S. C. §885 unmistakably

rules that out.) Instead, the Court pointedly uses different

terminology. It repeatedly says that the phrase “knowingly

or intentionally” “applies” to the introductory phrase, ante,

at 2, 4, 6, 9, 15 (emphasis added). And it reaches this con-

clusion based on grounds that have nothing to do with

grammar or syntax.

Specifically, the Court relies on a substantive canon of in-

terpretation—the mens rea canon. Under this canon, the

Court interprets criminal statutes to require a mens rea for

each element of an offense “even where ‘the most grammat-

ical reading of the statute’ does not support” that interpre-

tation. Rehaif, 588 U. S., at ___ (slip op., at 6) (quoting

United States v. X-Citement Video, Inc., 513 U. S. 64, 70

(1994)).* But until today, this canon has been applied only

——————

*Why we have held that the mens rea canon allows courts to ignore

obvious textual evidence of congressional intent is not obvious. In our

constitutional system, it is Congress that has the power to define the

elements of criminal offenses, not the federal courts. Liparota v. United

Cite as: 597 U. S. ____ (2022) 5

ALITO,AJ., , J., concurring

concurring

LITO in judgment

to elements, and the “except as authorized” introductory

phrase in §841(a)(1) is plainly not an element.

“The definition of the elements of a criminal offense is en-

trusted to the legislature, particularly in the case of federal

crimes, which are solely creatures of statute.” Liparota v.

United States, 471 U. S. 419, 424 (1985). See also Dixon v.

United States, 548 U. S. 1, 7 (2006). But authorization to

dispense or distribute a controlled substance lacks the most

basic features of an element of an offense. For one thing, it

is black-letter law that an indictment must allege “the ele-

ments of the offense charged.” Hamling v. United States,

418 U. S. 87, 117 (1974). So if lack of authorization were an

element, it would be necessary to allege that in every

§841(a)(1) indictment. But §885 says that it is not “neces-

sary for the United States to negative any exemption or ex-

ception set forth in [the relevant subchapter] in any . . . in-

dictment.” Beyond that, the prosecution bears the burden

of producing evidence with respect to every element of a

crime. Patterson, 432 U. S., at 215. But §885(a)(1) also pro-

vides that “the burden of going forward with the evidence

with respect to any such exemption or exception shall be

upon the person claiming its benefit.” It could hardly be

——————

States, 471 U. S. 419, 424 (1985); see also United States v. Davis, 588

U. S. ___, ___ (2019) (slip op., at 5) (“Only the people’s elected represent-

atives in the legislature are authorized to ‘make an act a crime’ ” (quoting

United States v. Hudson, 7 Cranch 32, 34 (1812))). The mens rea canon

is legitimate when it is used to determine what elements Congress in-

tended to include in the definition of an offense. See, e.g., Staples v.

United States, 511 U. S. 600, 605 (1994) (explaining that the canon is

founded on an inference of congressional intent). But applying that

canon to override the intentions of Congress would be inconsistent with

the Constitution’s separation of powers. Federal courts have no consti-

tutional authority to re-write the statutes Congress has passed based on

judicial views about what constitutes “sound” or “just” criminal law. Cf.

X-Citement Video, 513 U. S., at 80–82 (Scalia, J., dissenting) (criticizing

our mens rea canon precedents for “convert[ing a] rule of interpretation

into a rule of law” binding on Congress).

6 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

more obvious that Congress did not cast the “except as au-

thorized” introductory proviso as an element of distributing

or dispensing a controlled substance.

Instead, that proviso clearly creates an affirmative de-

fense—that is, a “justification or excuse which is a bar to

the imposition of criminal liability” on conduct that satisfies

the elements of an offense. 1 W. LaFave, Substantive Crim-

inal Law §1.8(c) (3d ed. 2018). Section 841(a)(1) has two

main parts: a principal clause generally prohibiting “know-

ingly or intentionally” doing certain things with respect to

controlled substances (i.e., manufacturing them, distrib-

uting them, etc.), and a proviso indicating that these acts

are unlawful “except as authorized” by other statutory pro-

visions. As we have long held, the default rule for inter-

preting provisions with this structure is that “ ‘an exception

made by a proviso or other distinct clause’ ” designates an

affirmative defense that the Government has no duty to

“ ‘negative.’ ” Dixon, 548 U. S., at 13 (quoting McKelvey v.

United States, 260 U. S. 353, 357 (1922)); see also United

States v. Dickson, 15 Pet. 141, 165 (1841) (calling this “the

general rule of law which has always prevailed”). When

this rule applies, it is “ ‘incumbent on one who relies on such

an exception to set it up and establish it.’ ” Dixon, 548 U. S.,

at 13 (quoting McKelvey, 260 U. S., at 357).

The CSA explicitly incorporates this default rule. As

noted, §885(a)(1) provides that the prosecution need not

“negative any exemption or exception set forth in this sub-

chapter in any complaint, information, indictment, or other

pleading or in any trial, hearing, or other proceeding.” (Em-

phasis added.) Short of using the words “affirmative de-

fense,” there is no clearer way of indicating that authoriza-

tion constitutes an affirmative defense.

On the most natural reading, then, §841(a)(1) creates an

offense that has as its elements (1) knowingly or intention-

ally (2) distributing or dispensing (3) a controlled sub-

stance. The “[e]xcept as authorized” proviso recognizes an

Cite as: 597 U. S. ____ (2022) 7

ALITO,AJ., , J., concurring

concurring

LITO in judgment

affirmative defense that excuses or justifies conduct that

otherwise would fall within §841(a)(1)’s general prohibition.

The mens rea canon does not speak to the constituents of

that defense.

B

While the Court does not claim that the “[e]xcept as au-

thorized” proviso is an element of a §841(a)(1) offense, the

Court argues that the proviso is “sufficiently like an ele-

ment in respect to the matter at issue here” for the mens

rea canon to apply, ante, at 12. The Court provides four

reasons for this conclusion: “[T]he language of §841 (which

explicitly includes a ‘knowingly or intentionally’ provision);

the crucial role authorization (or lack thereof ) plays in dis-

tinguishing morally blameworthy conduct from socially

necessary conduct; the serious nature of the crime and its

penalties; and the vague, highly general language of the

regulation defining the bounds of prescribing authority.”

Ibid. Not one of these reasons withstands scrutiny.

“[T]he language of §841.” The Court notes that this pro-

vision expressly sets out a mens rea that applies to the ele-

ments of the offense, ante, at 13, but the vast majority of

criminal statutes share this characteristic. Therefore, this

feature does not set §841 apart.

“[T]he crucial role authorization (or lack thereof ) plays in

distinguishing morally blameworthy conduct from socially

necessary conduct.” The Court claims that authorization

separates out morally blameworthy innocent conduct; but

something very similar may be said about most, if not all,

affirmative defenses. Take the common-law defense of du-

ress. Duress “excuse[s] criminal conduct where the actor

was under an unlawful threat of imminent death or serious

bodily injury” and the “threat caused the actor to engage in

conduct violating the literal terms of the criminal law.”

United States v. Bailey, 444 U. S. 394, 409 (1980). But a

8 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

person who acts under duress is not “morally blamewor-

thy”—that is part of what it means to say that duress ex-

cuses otherwise-criminal conduct. Similarly, individuals

who kill or wound another person in self-defense to prevent

their own death or serious injury are not considered morally

blameworthy. No one supposes that these defenses are hy-

brids, or that the mens rea canon is a guide to their content.

It is unclear why the Court thinks that §841(a)’s affirma-

tive defense is different. There are hints in the Court’s

opinion that it has crafted a special rule for doctors—for ex-

ample, the Court describes their conduct in writing pre-

scriptions as not just “innocent,” but “socially beneficial”

and “socially necessary.” Ante, at 6, 12. But §841(a) is not

a doctor-specific provision. Section 841(a)’s proviso presum-

ably applies in the same way for all §841(a) defendants—

whether they are drug dealers accused of selling heroin or

are physicians charged with abusing their authority to pre-

scribe painkillers.

“[T]he serious nature of the crime and its penalties.” The

Court also suggests that authorization is “like an element”

because dispensing or distributing a controlled substance is

a felony that carries a substantial sentence. But would all

felonies qualify? If not, where would the Court draw the

line? The Court provides no answers.

“[T]he vague, highly general language of the regulation

defining prescribing authority.” As the Court explains, the

regulation defining the authority of physicians to prescribe

controlled substances allows them to issue a prescription

“for a legitimate medical purpose . . . in the usual course of

. . . professional practice.” 21 CFR §1306.04(a) (2021). But

§841(a) applies to many other types of violations and many

other categories of defendants. Is the proviso a hybrid ele-

ment/defense only for doctors? Would its status change if

the regulation were reframed in more specific terms? How

can the status of a phrase in a statute depend upon an im-

plementing regulation? The Court provides no answer to

Cite as: 597 U. S. ____ (2022) 9

ALITO,AJ., , J., concurring

concurring

LITO in judgment

these or any other questions naturally raised by its ipse

dixit that the exception in §841(a) is “sufficiently like” an

element to require that it be treated as such in some re-

spects but not others.

C

The Court also errs in holding that, if a §841(a)(1) defend-

ant “meets the burden of producing evidence that his or her

conduct was ‘authorized,’ ” the Government has the burden

to “prove beyond a reasonable doubt that the defendant

knowingly or intentionally acted in an unauthorized man-

ner,” ante, at 5. As noted, the common-law rule was that

the defendant had the burden of production and persuasion

on any affirmative defense. And the Court has held that

when Congress does not address the burden of proof in the

text of a statute, “we presume that Congress intended to

preserve the common-law rule.” Smith v. United States,

568 U. S. 106, 112 (2013); see also Dixon, 548 U. S., at 13–

14.

The Court identifies one and only one reason for deviat-

ing from this background rule—the fact that §885(a)(1)

states that “the burden of going forward with the evidence

with respect to any . . . exemption or exception shall be upon

the person claiming its benefit.” Because this provision

does not say expressly that a defendant also has the burden

of persuasion, the Court infers that Congress meant to al-

locate that burden to the prosecution. That inference is un-

warranted. Section 885(a)(1) explicitly relieves the Govern-

ment of the burden of “negativ[ing]” exceptions “in any

trial.” And it is hard to see how the Government does not

have the burden to “negative” exceptions if it must affirma-

tively disprove a prima facie case of authorization any time

a defendant satisfies the initial burden of production.

But even if one credits the majority’s assumption that the

CSA partly deviates from the common-law rule by shifting

the burden of persuasion to the Government, the majority’s

10 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

further holding that the Government must carry that bur-

den with proof “beyond a reasonable doubt” comes out of

thin air. The usual rule is that affirmative defenses must

be proved “by a preponderance of the evidence.” Id., at 17.

But the majority does not identify a single word in

§§841(a)(1), 885(a)(1), or any other provision of the CSA

that even suggests that the statute imposes a burden of dis-

proving authorization defenses beyond a reasonable doubt.

The only thing that could conceivably justify reading a

reasonable-doubt requirement into a statute that says

nothing on the subject is the principle that an ambiguous

statute must be interpreted, when possible, to avoid uncon-

stitutionality. See A. Scalia & B. Garner, Reading Law: The

Interpretation of Legal Texts 247–251 (2012). But the

Court does not claim that it would be unconstitutional for

Congress to require the Government to prove lack of au-

thorization by only a preponderance of the evidence. In-

deed, the Court does not even claim that it would be uncon-

stitutional to shift the burden of persuasion to the

defendant. Nor could it. Our precedents establish that gov-

ernments are “foreclosed from shifting the burden of proof

to the defendant only ‘when an affirmative defense . . . ne-

gate[s] an element of the crime.’ ” Smith, 568 U. S., at 110

(quoting Martin v. Ohio, 480 U. S. 228, 237 (1987) (Powell,

J., dissenting)). And we have held that when an affirmative

defense instead justifies or “ ‘excuse[s] conduct that would

otherwise be punishable,’ ” the “Government has no consti-

tutional duty to overcome the defense beyond a reasonable

doubt.” 568 U. S., at 110 (quoting Dixon, 548 U. S., at 6).

The authorization defense made available to prescribing

physicians by the CSA plainly does not negate any of the

defining elements of dispensing or distributing a controlled

substance in violation of §841(a)(1). As a result, the Court

has no basis for reading a requirement to disprove authori-

zation into the CSA. And at a minimum, even if the Gov-

ernment must bear the ultimate burden of persuasion once

Cite as: 597 U. S. ____ (2022) 11

ALITO,AJ., , J., concurring

concurring

LITO in judgment

the burden of production is satisfied, the CSA should be

read to preserve a traditional preponderance-of-the-

evidence standard for authorization defenses.

II

My analysis thus far establishes that authorization is an

affirmative defense to liability under §841(a)(1), and the

constituents of that defense cannot be identified through

brute-force application of a canon designed to identify the

elements of an offense. In my view, the contours of that

defense can be elucidated only by examining the text, struc-

ture, and history of the provisions of the CSA that define it.

I turn to that task now.

The authorization relied on by the petitioners in these

cases permits physicians registered with the federal Drug

Enforcement Administration to prescribe controlled sub-

stances to patients by prescription. §§822(b), 823(f ), 829(a).

As we have previously interpreted it, this authorization

does not allow physicians to dispense controlled substances

by prescription for any reason they choose; instead, the au-

thorization “is limited to the dispensing and use of drugs ‘in

the course of professional practice or research.’ ” United

States v. Moore, 423 U. S. 122, 141 (1975) (quoting §802(20)

(1970 ed.)).

The notion of action taken “in the course of professional

practice” is not defined in the CSA, but our precedents hold

that when Congress employs a term of art “obviously trans-

planted from another legal source,” it “brings the old soil

with it.” George v. McDonough, 596 U. S. ___, ___ (2022)

(slip op., at 5) (quoting Taggart v. Lorenzen, 587 U. S. ___,

___ (2019) (slip op., at 5); internal quotation marks omit-

ted). And the notion that a prescription is authorized if it

is issued in the course of professional practice is directly

traceable to the Harrison Act, which prohibited “any per-

son” from distributing or dispensing coca leaves or opium

12 XIULU RUAN v. UNITED STATES

ALITO,AJ., , J., concurring

concurring

LITO in judgment

“except in pursuance of a written order” issued by a practi-

tioner “in the course of his professional practice only.” §2,

38 Stat. 786. Arguably, the phrase “in the course of . . . pro-

fessional practice” could have been read to refer only to con-

duct that conforms to the standards of medical practice as

a purely objective matter. But our Harrison Act precedents

interpreted that phrase to refer to “bona fide medical prac-

tice,” which meant that any prescription issued “in good

faith” qualified as an authorized act of dispensing one of the

drugs proscribed by the statute. Linder, 268 U. S., at 17–

18; see also Boyd v. United States, 271 U. S. 104, 107 (1926);

Webb v. United States, 249 U. S. 96, 99 (1919).

Nothing in the CSA suggests that Congress intended to

depart from the preexisting understanding of action “in the

course of professional practice.” We have previously held

that the CSA incorporates settled understandings of “the

exemption given to doctors” to dispense controlled sub-

stances “ ‘in the course of . . . professional practice’ ” under

the Harrison Act. Moore, 423 U. S., at 139–140 (quoting 38

Stat. 786). And the language of the CSA supports the same

conclusions that we previously reached about the Harrison

Act. As our CSA precedents have explained, to act “in the

course of professional practice” is to engage in the practice

of medicine—or, as we have put it, to “act ‘as a physician.’ ”

Moore, 423 U. S., at 141. For a practitioner to “practice

medicine,” he or she must act for a medical purpose—which

means aiming to prevent, cure, or alleviate the symptoms

of a disease or injury—and must believe that the treatment

is a medically legitimate means of treating the relevant dis-

ease or injury.

But acting “as a physician” does not invariably mean act-

ing as a good physician, as an objective understanding of

the “in the course of professional practice” standard would

suggest. A doctor who makes negligent or even reckless

mistakes in prescribing drugs is still “acting as a doctor”—

he or she is simply acting as a bad doctor. The same cannot

Cite as: 597 U. S. ____ (2022) 13

ALITO,AJ., , J., concurring

concurring

LITO in judgment

be said, however, when a doctor knowingly or purposefully

issues a prescription to facilitate “addiction and recrea-

tional abuse,” Gonzales v. Oregon, 546 U. S. 243, 274 (2006).

Objectives of that kind are alien to medical practice, and a

doctor who prescribes drugs for those purposes is not “act-

ing as a physician” in any meaningful sense.

I would thus hold that a doctor who acts in subjective

good faith in prescribing drugs is entitled to invoke the

CSA’s authorization defense. Under the correct under-

standing of that defense, a doctor acts “in the course of pro-

fessional practice” in issuing a prescription under the CSA

if—but only if—he or she believes in good faith that the pre-

scription is a valid means of pursuing a medical purpose. A

doctor who knows that he or she is acting for a purpose for-

eign to medicine—such as facilitating addiction or recrea-

tional drug abuse—is not protected by the CSA’s authoriza-

tion to distribute controlled substances by prescription.

Such doctors may be convicted of unlawfully distributing or

dispensing a controlled substance under §841(a)(1).

Based on this holding, I would vacate the judgments of

the Courts of Appeals below. And like the Court, I would

leave it to those courts to determine on remand whether the

instructions provided in petitioners’ respective trials ade-

quately described the good-faith defense and whether any

errors in the instructions were harmless.