Case Information
*1 OCTOBER TERM, 2021 (Slip Opinion)
Syllаbus 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.,
Syllabus 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 wаs 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 v.
Syllabus
tentionally.” And in §841 prosecutions, authorization plays a “crucial”
role in separating innocent conduct from wrongful conduct.
United
States
v.
X-Citement Video, Inc.
,
(b) Analogous precedent reinforces the Court’s conclusion here. In
Liparota
v.
United States
,
(c) Neither the Government’s nor the concurrence’s contrary argu-
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 sеt 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 tо 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 “gоod 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
,
Syllabus
Court effectively endorsed its honest-effort standard in
United States
v.
Moore
,
B REYER , J. delivered the opinion of the Court, in which R OBERTS , C. J., and S OTOMAYOR , K AGAN , G ORSUCH , and K AVANAUGH , JJ., joined. A , J., filed an opinion concurring in the judgment, in which T HOMAS , J., joined, and in which B ARRETT , J., joined as to Parts I–A, I–B, and II.
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]
J USTICE B REYER 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).
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 Ruаn 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- *7 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
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 cоurse 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. *9 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 conсlusion 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
,
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
,
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
,
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
,
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
,
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
,
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
,
Nor is the “except as authorized” clause a jurisdictional
provision, to which the presumption of scienter would not
apply. Cf.
Rehaif
,
B
Analogous precedent reinforces our conclusion. In
Lipa-
rota
, we interpreted a statute pеnalizing anyone who
“ ‘knowingly uses [food stamps] in any manner not author-
ized by’ ” statute.
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.’ ”
Finally, in Rehaif , we interpreted a statutory sсheme 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 *13 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 (A , J., concur- ring in judgment).
The Government and the concurrence point to two ways *14 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 аuthorization (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 *15 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
,
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 intentiоnally” 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 *17 “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 thе 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.
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.
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 imрosing
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
,
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
*19
to objective criteria such as “legitimate medical purpose”
and “usual course” of “professional practice.” 21 CFR
§1306.04(a); see
Gonzales
,
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- *20 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.
A LITO , J., concurring A LITO , J., concurring 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]
J USTICE A , with whom J USTICE T HOMAS joins, and with whom J USTICE B ARRETT 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 *22 A LITO , J., concurring
A , J., concurring 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 physiсian 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
,
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 сanon”—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” *23 A LITO , J., concurring A , J., concurring 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 questiоn 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- *24 A LITO , J., concurring
A , J., concurring 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 “knоwingly 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” thаt 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 *25 A LITO , J., concurring
A , J., concurring 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
,
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
,
A , J., concurring in judgment more obvious that Congress did not cast the “except as au- thorized” introductory proviso as an element of distributing оr 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
,
The CSA explicitly incorporates this default rule. As noted, §885(a)(1) provides that the prosecution need not “ negative any exemption or еxception 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 *27 A LITO , J., concurring
A , J., concurring 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 cоnduct; 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 *28 A LITO , J., concurring
A , J., concurring 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 lеgitimate 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 *29 A LITO , J., concurring
A , J., concurring 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 burdеn of proof in the
text of a statute, “we presume that Congress intended to
preserve the common-law rule.”
Smith
v.
United States
,
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 *30 A LITO , J., concurring
A , J., concurring 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 defendаnt only ‘when an affirmative defense . . . ne-
gate[s] an element of the crime.’ ”
Smith
,
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 *31 A LITO , J., concurring
A , J., concurring 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
,
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
,
A , J., concurring 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
,
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
,
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 *33 A LITO , J., concurring
A , J., concurring in judgment
be said, however, when a doctor knowingly or purposefully
issues a prescription to facilitate “addiction and recrea-
tional abuse,”
Gonzales
v.
Oregon
,
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.