Opposition Brief — Thomas Keller, Petitioner v. United States

No. 25-7141

________________________________________________________________

________________________________________________________________

IN THE SUPREME COURT OF THE UNITED STATES

_______________

THOMAS KELLER, PETITIONER

v.

UNITED STATES OF AMERICA

_______________

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

_______________

BRIEF FOR THE UNITED STATES IN OPPOSITION

_______________

D. JOHN SAUER

Solicitor General

Counsel of Record

A. TYSEN DUVA

Assistant Attorney General

TORY D. ROBERTS

Attorney

Department of Justice

Washington, D.C. 20530-0001

SupremeCtBriefs@usdoj.gov

(202) 514-2217

________________________________________________________________

________________________________________________________________

QUESTION PRESENTED

Whether

the

delegation

of

authority

in

the

Controlled

Substances Act to the Attorney General to issue regulations under

21 U.S.C. 821 and 871(b), which the Attorney General has exercised

in 21 C.F.R. 1306.04(a) using language that Congress then included

in the Act, violates the nondelegation doctrine.

(I)

ADDITIONAL RELATED PROCEEDINGS

United States Court of Appeals (9th Cir.):

United States v. Keller, No. 23-656 (June 27, 2025)

United States District Court (N.D. Cal.):

United States v. Keller, No. 18-cr-462 (Apr. 10, 2023)

(II)

IN THE SUPREME COURT OF THE UNITED STATES

_______________

No. 25-7141

THOMAS KELLER, PETITIONER

v.

UNITED STATES OF AMERICA

_______________

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

_______________

BRIEF FOR THE UNITED STATES IN OPPOSITION

_______________

OPINION BELOW

The opinion of the court of appeals (Pet. App. 1a-38a) is

reported at 142 F.4th 645.

JURISDICTION

The judgment of the court of appeals was entered on June 27,

2025.

A petition for rehearing was denied on November 5, 2025

(Pet. App. 39a).

On February 3, 2026, Justice Kagan extended the

time within which to file a petition for a writ of certiorari to

and including March 20, 2026, and the petition was filed on that

date.

The jurisdiction of this Court is invoked under 28 U.S.C.

1254(1).

(1)

2

STATEMENT

Following a jury trial in the United States District Court

for the Northern District of California, petitioner was convicted

of unlawfully distributing oxycodone, carisoprodol, and diazepam,

in violation of 21 U.S.C. 841(a)(1) and (b)(1)(C); unlawfully

distributing diazepam, in violation of 21 U.S.C. 841(a)(1) and

(b)(2); unlawfully distributing oxycodone, in violation of 21

U.S.C.

841(a)(1)

and

(b)(1)(C);

and

unlawfully

distributing

carisoprodol, in violation of 21 U.S.C. 841(a)(1) and (b)(2).

Judgment 1.

He was sentenced to 30 months of imprisonment, to be

followed by three years of supervised release.

court of appeals affirmed.

1.

Beginning

in

Judgment 2-3.

Pet. App. 1a-38a.

2011,

petitioner

worked

as

practitioner physician specializing in pain management.

5a.

The

a

solo

Pet. App.

Petitioner possessed a license from the Drug Enforcement

Administration

(DEA)

allowing

him

to

prescribe

substances pursuant to 21 U.S.C. 829(a) and (b).

controlled

Ibid.

Between

2011 and 2018, petitioner was in the 99th percentile of pain

specialists in terms of the quantity of opioids he was prescribing

per patient per day.

Pet. App. 5a.

practices

caused

eventually

one

Petitioner’s prescription

pharmacy

to

refuse

to

fill

prescriptions written by him and caused another doctor to report

him to the state medical board.

Id. at 5a-6a.

In March 2013, Keller began to treat A.M. for low back pain.

Pet. App. 6a.

Although A.M. presented no physical issues that

3

justified prescribing her large amounts of opiates, petitioner

nevertheless prescribed many.

Ibid.

In December 2013, A.M.

attempted suicide. Ibid. Petitioner briefly stopped his treatment

of A.M. but ultimately resumed treatment and, contrary to accepted

professional practice, continued to prescribe A.M. opiates and

other controlled substances.

petitioner

prescribed

A.M.

Ibid.

Over the next four years,

thousands

of

OxyContin, carisoprodol, and diazepam.

pills

of

Ibid.

oxycodone,

In 2017, A.M.

committed suicide by overdosing on prescription drugs, including

multiple drugs that petitioner had prescribed.

2.

Ibid.

A grand jury in the Northern District of California

charged petitioner with ten counts of unlawfully distributing

controlled

substances,

in

violation

of

21

U.S.C.

841(a)(1),

(b)(1)(C), and (b)(2), and one count of healthcare fraud, in

violation of 18 U.S.C. 1347.

Superseding Indictment 1-6.

The Controlled Substances Act (CSA or Act) criminalizes the

unauthorized

distribution

and

dispensation

of

controlled

substances, “[e]xcept as authorized by this subchapter.” 21 U.S.C.

841.

The

Act’s

distribution

exceptions

include

an

to

the

exception

prohibition

for

against

physicians

drug

who

are

“registered by” the DEA and who prescribe controlled substances

only

“to

the

extent

authorized

by

their

registration

and

in

conformity with the other provisions” of the Act. 21 U.S.C. 822(b);

see 21 U.S.C. 823(f).

The Act accordingly authorizes the Attorney

General, who oversees the DEA, to “promulgate rules and regulations

4

and to charge reasonable fees relating to the registration and

control

of

the

manufacture,

controlled substances.”

In

1971,

the

distribution,

and

dispensing

of

21 U.S.C. 821; see 21 U.S.C. 871(b).

Attorney

General

promulgated

a

regulation

specifying that every prescription for a controlled substance “be

issued

for

a

practitioner

practice.”

language

legitimate

acting

in

medical

the

usual

21 C.F.R. 1306.04(a).

in

the

Act

purpose

itself.

course

of

by

an

his

individual

professional

Congress then adopted similar

For

example,

for

purposes

of

dispensing controlled substances over the internet, 21 U.S.C. 829

defines a “‘valid prescription’” as “a prescription that is issued

for

a

legitimate

medical

purpose

in

the

usual

course

professional practice by” a qualifying practitioner.

829(e)(2)(A);

see,

e.g.,

21

U.S.C.

of

21 U.S.C.

830(b)(3)(A)(ii)

(similar

definition of “valid prescription” applicable to certain reporting

requirements for mail-order prescriptions).

Before trial, petitioner moved to dismiss the distribution

counts, contending inter alia that to the extent his conviction

depended on the language included in 21 C.F.R. 1306.04(a), it

rested on an unconstitutional delegation of Congress’s legislative

authority

to

the

Attorney

General

“without

giving

sufficient

guidance to confine the discretion of the Attorney General in

defining

to

what

standard

physicians

should

be

held

determining whether their prescribing conduct is illegal.”

Doc. 148, at 4 (Oct. 12, 2021).

when

D. Ct.

The district court denied

5

petitioner’s motion and the case proceeded to trial.

D. Ct. Doc.

242 (Nov. 5, 2021).

The jury found petitioner guilty on four counts related to

the distribution of oxycodone, carisoprodol, and diazepam to A.M.

on four occasions in 2016 and 2017.

Indictment 2-5.

Judgment 1; see Superseding

The jury did not reach a verdict on the remaining

distribution counts, which the government then dismissed, and the

district court granted petitioner’s motion for a judgment of

acquittal

on

Judgment 1.

the

healthcare-fraud

count.

Pet.

App.

8a;

see

The court sentenced petitioner to 30 months of

imprisonment, to be followed by three years of supervised release.

Judgment 2-3.

3.

The court of appeals affirmed.

Pet. App. 1a-38a.

Among

other things, the court rejected petitioner’s contention that the

CSA’s delegation of authority to the Attorney General to promulgate

regulations implementing the practitioner exception violates the

nondelegation doctrine.

Citing

this

Id. at 16a-22a.

Court’s

precedent,

the

court

of

appeals

recognized that Congress may delegate authority to the executive

branch

“so

long

as

Congress

articulates

an

‘intelligible

principle’ by which the actor empowered to exercise delegated

authority can conform.”

Pet. App. 17a (citation omitted).

The

court then explained that the “general policy outlined within the

CSA

is

‘the

‘functions

efficient

under’

that

execution’

statute,”

of

the

which

Attorney

“are

General’s

defined

as

6

‘controlling

controlled

the

manufacture,

substances.’”

distribution,

Id.

at

ellipsis, and emphasis omitted).

19a

and

dispensing

(brackets,

of

citations,

And the court observed that

“[t]his kind of mandate -- limited in terms of the subject area in

which delegated authority may be exercised, yet broad as to how

the

delegated

authority

may

be

exercised

--

is

the

delegation of authority long upheld as permissible.”

type

of

Id. at 20a.

The court of appeals also explained that the CSA’s delegation

of authority to the Attorney General “is both clear and bounded”

because that delegation is limited to “rules and regulations

‘relating to the registration and control of the manufacture,

distribution,

and

dispensing

of

controlled

substances

and

to

listed chemicals,’” and rules “in support of the execution of

[those] functions.”

Pet. App. 20a-21a (citation omitted).

The

court further observed that the challenged regulation, 21 C.F.R.

1306.04, “borrows directly from the CSA in declaring that for ‘a

prescription for a controlled substance to be effective’ it ‘must

be

issued

for

a

legitimate

in

the

medical

usual

purpose

course

of

by

an

his

individual

practitioner

acting

professional

practice.’”

Pet. App. 21a (brackets and citation omitted).

The

court explained that the parallelism “reinforces [its] conclusion

that section 1306.04 operates within the limits of delegated

authority.”

Ibid.

Finally, the court of appeals rejected petitioner’s argument

that

“something

greater

than

an

intelligible

principle”

is

7

required when Congress imposes criminal penalties for violating

executive-branch

regulations,

observing

foreclosed by circuit precedent.

that

the

argument

was

Pet. App. 22a (citing United

States v. Pheasant, 129 F.4th 576, 583 (9th Cir. 2025), petition

for cert. pending, No. 25-6911 (filed Feb. 20, 2026)).

ARGUMENT

Petitioner renews his contention (Pet. 4-18) that 21 U.S.C.

821 and 871(b), and 21 C.F.R. 1306.04(a), together effect an

unconstitutional

executive branch.

delegation

of

legislative

authority

to

the

The court of appeals correctly rejected that

contention, and its decision does not conflict with any decision

of

this

Court

or

another

court

of

appeals.

Petitioner

alternatively requests (Pet. 18-19) that the petition for a writ

of certiorari be held pending the disposition of the pending

petition for a writ of certiorari in Pheasant v. United States,

No. 25-6911 (filed Feb. 20, 2026), which raises a similar issue.

No further review is warranted, and the petition should be denied.

1.

This Court has explained that while the Constitution

“permits no delegation of [legislative] powers” to the executive

branch, Whitman v. American Trucking Associations, 531 U.S. 457,

472 (2001), Congress does not run afoul of the nondelegation

doctrine so long as Congress sets forth “an intelligible principle

to which the person or body authorized to [act] is directed to

conform.”

J.W. Hampton, Jr., & Co. v. United States, 276 U.S.

394, 409 (1928).

8

Under

that

intelligible-principle

test,

Congress

must

delineate “both ‘the general policy’ that the agency must pursue

and

‘the

boundaries

of

its

Consumers’

Research,

606

U.S.

citation omitted).

delegated

656,

authority.’ ”

673

(2025)

FCC

v.

(brackets

and

The assessment is contextual; “the degree of

agency discretion that is acceptable varies according to the scope

of the power congressionally conferred.”

Ibid. (quoting American

Trucking, 531 U.S. at 475); cf., e.g., United States v. Miller,

604 U.S. 518, 533 (2025) (“[T]he words of a statute must be read

in their context and with a view to their place in the overall

statutory scheme.”) (citation omitted).

Read in context, the

statute must provide “sufficient standards to enable both ‘the

courts and the public to ascertain whether the agency’ has followed

the law.”

Consumers’ Research, 606 U.S. at 673 (brackets and

citation omitted).

The court of appeals correctly determined that the delegation

in this case did not violate nondelegation principles.

As this

Court has recognized, “[t]he CSA gives the Attorney General limited

powers, to be exercised in specific ways.”

Gonzales v. Oregon,

546 U.S. 243, 259 (2006). Congress set forth “‘the general policy’

that the agency must pursue,” Consumers’ Research, 606 U.S. at 673

(citation omitted) -- namely, the “registration and control of the

manufacture,

distribution,

and

dispensing

of

controlled

substances.”

21 U.S.C. 821; see 21 U.S.C. 871(b) (directing the

Attorney General to promulgate rules “for the efficient execution

9

of his functions under” the CSA).

Congress likewise defined “the

boundaries of [the] delegated authority.”

606 U.S. at 673 (citation omitted).

Consumers’ Research,

As this Court has observed,

by limiting the Attorney General’s rulemaking authority to the

items listed above, “Congress did not delegate to the Attorney

General authority to carry out or effect all provisions of the

CSA.

Rather,

he

can

promulgate

rules

relating

only

to

‘registration’ and ‘control,’ and ‘for the efficient execution of

his functions’ under the statute.”

Oregon, 546 U.S. at 259

(citation omitted).

The CSA also limits the Attorney General’s discretion to

regulate

on

those

topics.

To

deny,

revoke,

or

suspend

a

physician’s registration to dispense controlled substances, the

Attorney General must make factual findings based on specific

factors listed in the CSA.

21 U.S.C. 823(f), 824(a).

Similarly,

to exercise the delegated authority to add or remove a controlled

substance from the schedules established by the CSA, the Attorney

General must follow specific procedures and consider a list of

eight enumerated factors.

21 U.S.C. 811, 812.

This Court has

found that those provisions “painstakingly described the Attorney

General’s limited authority” under the CSA, and has relied on them

to reject a claim of authority for the Attorney General simply “to

decide whether a physician's actions are inconsistent with the

‘public interest.’”

Oregon, 546 U.S. at 262.

10

2.

Petitioner no longer contends that the CSA’s delegation

to the Attorney General to promulgate regulations, standing alone,

fails to satisfy the intelligible-principle test.

Instead, he

contends (Pet. 5) that the delegation is problematic to the extent

it allows the Attorney General to “defin[e] the elements of a

federal crime.”

But as the court of appeals recognized (Pet. App.

21a), it was Congress -- not the Attorney General -- that made it

a federal crime to “knowingly or intentionally

* * *

CSA].”

* * *

distribute

a controlled substance” in a manner not “authorized by [the

21 U.S.C. 841(a)(1).

Indeed, in United States v. Moore, 423 U.S. 122 (1975), this

Court focused on the statutory provisions in the CSA itself in

holding that a registered physician was appropriately convicted

under 21 U.S.C. 841 for prescribing controlled substances outside

“the bounds of ‘professional practice.’”

Id. at 142 (citation

omitted); see id. at 138-143; see also id. at 137 n.13 (observing,

in context of possible prosecution under a different statute, that

the

regulatory

language

that

today

is

located

in

21

C.F.R.

1306.04(a) made “explicit” the “medical purpose requirement” that

was both implicit and explicit in other relevant provisions of the

CSA).

In any event, this Court has made clear that “[t]here is no

absolute rule

* * *

against Congress’ delegation of authority to

define criminal punishments.”

748, 768 (1996).

Loving v. United States, 517 U.S.

Such delegations are appropriate so long as the

11

“agency defines by regulation what conduct will be criminal, * * *

Congress makes the violation of regulations a criminal offense and

fixes the punishment, and the regulations ‘confine themselves

within the field covered by the statute.’ ”

Ibid. (brackets

omitted) (quoting United States v. Grimaud, 220 U.S. 506, 518

(1911)).

Accordingly, the Department of Homeland Security does not

“defin[e] the elements of a federal crime” (Pet. 5) when it

designates ports of entry at which aliens may lawfully enter the

United States -- even though its designation affects the scope of

criminal liability.

See 8 U.S.C. 1325(a)(1) (prescribing criminal

punishment for any alien who “enters or attempts to enter the

United States at any time or place other than as designated by

immigration officers”); see also United States v. Melgar-Diaz,

2 F.4th 1263, 1266-1269 (9th Cir. 2021), cert. denied, 142 S. Ct.

813 (2022).

Nor does the Secretary of Agriculture create a crime

when he promulgates regulations prohibiting the grazing of sheep

without a license in a public forest preserve under his statutory

authority “to regulate the occupancy and use and to preserve the

forests

from

destruction,”

even

though

regulations carries criminal penalties.

violation

of

those

United States v. Grimaud,

220 U.S. 506, 522 (1911) (citation omitted).

The same principle applies to the CSA, where Congress made

the unauthorized dispensation of Schedule II drugs without a valid

prescription “a criminal offense and fixe[d] the punishment,”

12

Loving, 517 U.S. at 768.

Indeed, in Touby v. United States, 500

U.S. 160 (1991), this Court rejected a nondelegation challenge to

a CSA provision authorizing the Attorney General to temporarily

schedule a controlled substance, 21 U.S.C. 811(h), even though

such scheduling could result in criminal penalties for violators.

Touby, 500 U.S. at 164-169; see 21 U.S.C. 811(a)(1) and (2),

841(a).

That precedent, which petitioner does not seek to overrule,

applies a fortiori here.

The challenged delegation does not

(unlike in Touby) authorize the Attorney General to temporarily

render unlawful the distribution of a previously lawful substance.

It instead simply authorizes the Attorney General to clarify when

a concededly unlawful substance may nevertheless be distributed by

a

practitioner

under

an

exception

to

the

general

statutory

prohibition against distributing controlled substances.

Indeed, in doing so, the challenged regulation barely says

more than what the statute says (as exemplified by the conviction

in Moore).

The CSA allows for the prescription of controlled

substances only if they have a “currently accepted medical use,”

21 U.S.C. 812(b); defines a “valid prescription” in the context of

online or mail-order dispensing as one “that is issued for a

legitimate medical purpose in the usual course of professional

practice,” 21 U.S.C. 829(e)(2)(A); and defines a “practitioner” to

include a physician authorized to dispense a controlled substance

“in the course of professional practice,” 21 U.S.C. 802(21).

By

13

announcing that a prescription for a controlled substance “must be

issued

for

a

practitioner

legitimate

acting

in

the

medical

usual

purpose

course

by

of

an

his

individual

professional

practice” in order to be “effective,” 21 C.F.R. 1306.04(a), the

regulation “does little more than restate the terms of the statute

itself,” Oregon, 546 U.S. at 257.

And that Congress expressly

incorporated the regulation’s language when amending the CSA to

address online and mail-order dispensing underscores that the

regulation falls well within the bounds of permissible regulatory

action by the DEA.

3.

See Loving, 517 U.S. at 768.

Petitioner does not contend that the decision below

conflicts with any decision of this Court or another court of

appeals. Instead, he suggests (Pet. 8-17) that courts should apply

some standard stricter than the intelligible-principle test when

addressing

congressional

delegations

to

issue

regulations

violation of which might trigger criminal penalties.

the

Although

this Court stated in Touby that it is “not entirely clear as to

whether more specific guidance is in fact required” when Congress

delegates authority “to promulgate regulations that contemplate

criminal sanctions,” 500 U.S. at 165-166, the Court has never

adopted any such higher standard.

As illustrated by Grimaud and Loving v. United States (among

other examples), this Court has, in substance, “routinely applied

the ‘intelligible principle’ test even when the challenged statute

authorized regulations backed by criminal penalties.”

United

14

States v. Pheasant, 129 F.4th 576, 583 (9th Cir. 2025), petition

for cert. pending, No. 25-6911 (filed Feb. 20, 2026); see, e.g.,

Grimaud, 220 U.S. at 521; Loving, 517 U.S. at 771-772.

And because

Congress has adopted the regulatory language in the statute itself,

this would be a particularly inappropriate case for considering

whether some heightened standard should apply.

Courts of appeals

likewise

the

have

“decline[d]

to

abandon

well-settled

‘intelligible principle’ standard” when reviewing “a statute with

criminal consequences.”

United States v. Nichols, 775 F.3d 1225,

1232 (10th Cir. 2014), rev’d on other grounds, 578 U.S. 104 (2016);

accord Pheasant, 129 F.4th at 582-583; United States v. Cooper,

750 F.3d 263, 270-271 (3d Cir.), cert. denied, 574 U.S. 866 (2014).

Petitioner attempts to bolster his nondelegation challenge

(Pet. 12-14) by claiming ambiguity or vagueness regarding the

dividing

line

between

authorized

conduct under 21 U.S.C. 841.

and

unauthorized

prescribing

But any ambiguity or vagueness would

implicate the CSA itself, which employs near-identical terminology

to define a valid prescription in the context of online or mailorder dispensing.

And in any event, petitioner’s own words belie

his claim that he was unaware that his prescribing conduct exceeded

the bounds of accepted medical practice and therefore violated the

plain text of 21 U.S.C. 841.

Petitioner’s writings show that he

viewed himself as a “legal drug dealer” treating “stupid” “highlevel addicts”; dropped his malpractice insurance “because the

druggies are stupid and just want drugs,” and thus “won’t sue me”;

15

and callously celebrated the suicide of A.M:

“Psycho bitch girl

high-level addict killed herself Thursday.

Her second suicide

attempt and successful.

Adios motherfucker.”

Trial Tr. 1857-

1858, 1880; see Moore, 423 U.S. at 140-142 (rejecting a similar

vagueness challenge).

4.

This case also is an especially unsuitable vehicle for

addressing whether a heightened standard applies to delegations

implicating criminal penalties.

First, there is no sound basis

for concluding that petitioner’s conviction actually rests on the

regulation that he challenges.

The operative indictment cites

only the CSA statutory provisions; it does not even mention the

regulation.

See Superseding Indictment 1-5.

And the portion of

the jury instructions that echoes the regulatory language (without

citing the regulation) was proposed by petitioner himself. Compare

Trial Tr. 1838 (“outside the usual course of professional practice,

and, without a legitimate medical purpose”), with D. Ct. Doc. 208,

at 59 (Oct. 22, 2021) (“outside the usual course of professional

practice and without legitimate medical purpose”).

If this Court

wishes to consider whether a heightened standard applies to a

delegation that implicates criminal penalties, it should do so in

a case where the exercise of delegated authority clearly forms the

basis for the defendant’s criminal liability -- not a case (like

this one) where the defendant was convicted directly under the

statute, and the regulatory and statutory language parrot each

other.

Cf. Oregon, 546 U.S. at 257 (explaining that 21 C.F.R.

16

1306.04

“just

repeats

two

statutory

phrases”

and

its

interpretation thus presents a question of “the meaning of the

statute”).

Second, this case presents a highly unusual nondelegation

claim because the challenged delegation concerns the scope of an

exception to a generally applicable criminal prohibition.

If the

delegated authority to define the scope of that exception were

held unconstitutional, that would at most require severing the

exception;

the

statutory

remain enforceable.

prohibition

would

be

unaffected

and

Cf. Barr v. American Association of Political

Consultants,

591

U.S.

610,

630

was]

the

(2020)

(severing

“exception,

[which

provision”).

Such a holding would hardly inure to petitioner’s

constitutionally

a

statutory

offending

benefit.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

D. JOHN SAUER

Solicitor General

A. TYSEN DUVA

Assistant Attorney General

TORY D. ROBERTS

Attorney

JULY 2026