FOR PUBLICATION

UNITED STATES COURT OF 

APPEALS

FOR THE NINTH CIRCUIT

UNITED STATES OF AMERICA, 

Plaintiff-Appellee, 

 v. 

RICHARD MARSCHALL, 

Defendant-Appellant.

No. 22-30048 

D.C. No.

3:20-cr-05270-

BHS-1 

OPINION

Appeal from the United States District Court

for the Western District of Washington

Benjamin H. Settle, District Judge, Presiding

Argued and Submitted November 8, 2022

Seattle, Washington

Filed September 20, 2023

Before: Sandra S. Ikuta and Daniel P. Collins, 

Circuit Judges, and Sidney A. Fitzwater,* District 

Judge.

Opinion by Judge Collins

* The Honorable Sidney A. Fitzwater, United States District 

Judge for the Northern District of Texas, sitting by designation.
2 USA V. MARSCHALL

SUMMARY*

Criminal Law

The panel affirmed Richard Marschall’s 

conviction under the Federal Food, Drug, and 

Cosmetic Act (“FDCA”) for shipping misbranded 

drugs in interstate commerce in violation of 21 

U.S.C. §§ 331(a) and 333(a)(2).

Marschall contended that the district court erred 

in concluding that the charged offense did not require 

proof that Marschall knew that the drugs he shipped 

were misbranded.

The panel first held that the text of the various 

provisions of the FDCA at issue does not contain any 

language that imposes a scienter requirement of the 

sort that Marschall advocates.

The panel then addressed whether there are 

convincing reasons to depart from the presumption 

that Congress intended to require a defendant to 

possess a culpable mental state regarding each of the 

statutory elements that criminalize otherwise 

innocent conduct, even when Congress does not 

specify any scienter in the statutory text. The panel 

concluded that such convincing reasons are present 

here. The panel wrote that this is the unusual case in 

which a public welfare offense lacks a scienter 

element even though it is a felony with moderately 

severe potential penalties, given the confluence of 

circumstances: (1) Congress augmented, into a 

felony, a predicate misdemeanor offense that 

* This summary constitutes no part of the opinion of the court. 

It has been prepared by court staff for the convenience of the 

reader.
USA V. MARSCHALL 3

concededly lacks a scienter requirement; (2) it did so 

by adding, not a scienter requirement, but a prior 

conviction requirement; (3) this action contrasts with 

Congress’s explicit addition of a scienter 

requirement in the other clause of § 333(a)(2); and 

(4) the prior conviction requirement, as a functional 

matter, largely serves the same purposes as an 

express scienter requirement.

The panel rejected Marschall’s other challenges 

to his conviction in an accompanying unpublished 

memorandum disposition.

COUNSEL

Mohammad Ali Hamoudi (argued) and Gregory 

Geist, Assistant Federal Public Defenders, Federal 

Public Defender’s Office, Seattle, Washington, for 

Defendant-Appellant.

Jonas B. Lerman (argued), Tania M. Culbertson, 

Michelle Jensen, Nicholas A. Manheim, Teal L. 

Miller, and Brian Werner, Assistant United States 

Attorneys; Nicholas W. Brown, United States 

Attorney; United States Attorney’s Office, Western 

District of Washington, United States Department of 

Justice, Seattle, Washington; for Plaintiff-Appellee.
4 USA V. MARSCHALL

OPINION

COLLINS, Circuit Judge:

Defendant-Appellant Richard Marschall appeals 

from his conviction under the Federal Food, Drug,

and Cosmetic Act (“FDCA”) for shipping 

misbranded drugs in interstate commerce in violation 

of 21 U.S.C. §§ 331(a) and 333(a)(2). Marschall 

raises a number of challenges to his conviction, most 

of which we address and reject in an accompanying 

unpublished memorandum disposition. In this 

opinion, we address only Marschall’s contention that 

the district court erred in concluding that the charged 

offense did not require proof that Marschall knew 

that the drugs he shipped were misbranded. Noting 

that the indictment did not allege any such scienter, 

Marschall moved to dismiss the indictment on this 

ground before trial, and the district court denied that 

motion. We conclude that the district court did not 

err, and we therefore affirm its judgment.

I

A

Marschall was first licensed as a naturopathic 

physician in Washington State in August 1986. As 

described at trial, a naturopathic physician, also 

known as a “naturopathic doctor” or “N.D.,” is a 

licensed professional who works with patients “to 

support the body’s ability to resist and recover from 

illnesses and different conditions through the use of 

mainly natural means.” According to a stipulation 

read to the jury in this case, Marschall was convicted

on October 20, 2017 of “Introduction of Misbranded 

Drugs into Interstate Commerce under 21 U.S.C. 

§§ 331 and 333,” and that conviction became final 
USA V. MARSCHALL 5

“before March 1, 2020.”1 After his 2017 conviction, 

Marschall’s license as an N.D. was suspended. After 

he continued to engage in the unlicensed practice of 

naturopathic medicine during the time that his 

license was suspended, the Washington State 

Department of Health permanently revoked

Marschall’s license in 2018. That revocation was 

embodied in a state court order that “permanently 

enjoined” Marschall from the unlicensed practice of 

medicine as well as from “advertising naturopathic 

medical services and representing himself to be a 

naturopath, including but not limited to advertising 

services on his personal website and physical 

business locations, and from using the title ‘Doctor’, 

‘ND’, ‘naturopath’, or any other similar title” unless 

and until he obtained the necessary license. 

In early March 2020, Marschall published a 

series of posts on his Facebook page claiming that 

two products—“Allimed” and “IAG”—could 

prevent and treat “viral, bacterial, fungal and 

parasitic infections,” that they could “crush[] 30 

different viral infections including those in the 

Corona family like in China, 40 different bacterial 

infections, 25 different fungal infections and 20 

different parasitic infections.” He referred to these 

two products as the “Dynamic Duo,” and his posts 

contained lengthy explanations as to how these 

products would prevent and treat such illnesses. On 

March 15, 2020, Marschall posted a further 

statement on his Facebook page suggesting that 

Allimed, which he described as an “empirically 

proven anti-viral,” would help in proactively 

protecting against “the Corona COVID-19 virus.” 

1 Marschall also had a prior conviction in 2011 for violating 

§§ 331 and 333, but it does not appear that the jury was 

informed of that earlier conviction.
6 USA V. MARSCHALL

This post provided Marschall’s phone number and 

invited anyone who was interested in “being 

proactive” in this way to call him. 

Marschall’s posts attracted the attention of the 

FDA, and on March 30, 2020, FDA special agent 

Julie Ryer, posing as “Julie Richardson,” reached out 

to Marschall at the number listed on his March 15 

Facebook post. She first tried unsuccessfully to call 

him, and she then sent him the following text 

message:

Hi, trying to reach Rick Marschall. I 

called this phone number earlier 

today. I’m just hoping to get info 

about something my friend saw and 

thought I would be interested in. 

Dynamic Duo I think she called it. 

Definitely scared about the corona

virus so I would like to hear about this 

product and maybe order it. Do you 

sell this still? Is there a good way to 

reach you? Thanks!

Marschall called her back that same day, and 

Agent Ryer recorded the call. Marschall introduced 

himself as “Dr. Rick Marschall.” Marschall stated 

that he was “semi . . . retired” and that he “no longer 

ha[s] a license in the state that I live in, in 

Washington state.” But he said that he could still 

“sell plant-based medicines,” because they did not 

require prescriptions, and he said that “that’s legal in 

our state and across the country.” In describing the 

“Dynamic Duo,” Marschall said that the first 

product—which at one point he referred to as 

“Allimed”—contained “allicin,” which he said was a 

“biochemical” extracted from garlic that “kills the 
USA V. MARSCHALL 7

viruses, bacteria, parasites and fungus on contact.” 

He said, however, that allicin “doesn’t boost the 

immune system” but “just kills the virus.” Marschall 

instead explained that the second product provided 

such a boost. It contained a “starch” from the “larch 

tree” that contained “fucose.” The fucose, he said, 

sends “a message to the bone marrow to make more 

stem cells,” which would lead to “more 

reticulocytes,” which in turn would lead to more 

“white blood cells” to “attack viruses and cancer.” 

He then volunteered, “I’m not making claims that, 

you know, that the FDA is—you know, the FDA says 

you know, this is all mumbo jumbo. They don’t 

believe in any of this.” He nonetheless said that, 

while he was not “trying to make claims” for the 

Dynamic Duo, “we do have evidence for it, that it’s 

directly antiviral, antibacterial, antifungal, antiyeast.” He stated that, while the Dynamic Duo was 

“pretty amazing,” it was “pricey,” and that “it costs 

$140 to get the kit.” They then talked briefly about 

the Covid pandemic, and Marschall ultimately said 

that, “because everybody wants this stuff,” he could 

put her on a waiting list. Then, when he had the 

product in hand, he could text her on her cell phone. 

The next day, March 31, Marschall called back 

Agent Ryer, and she again recorded the call. He

again introduced himself as “Dr. Rick Marschall,” 

and he said that he had the Dynamic Duo in stock, 

and he asked her for her credit card information and 

her shipping address. After Agent Ryer provided 

that information, Marschall explained that he would 

include, in the shipment, instructions on how to take 

the Dynamic Duo. He asked how old her children 

were, and after she explained that they were nine and 

eleven and that one of them weighed only 70 pounds, 
8 USA V. MARSCHALL

Marschall told her to “cut the dose in half for these 

guys.” 

Agent Ryer received the package from Marschall 

a few days later. The package contained one bottle 

of “Allimax Pro” and one bottle of “IAG,” along with 

specially printed instructions prepared by Marschall 

describing when and how to take them. Affixed to 

the instructions was a yellow post-it note with the 

following handwritten comment: “note: Allimed and 

Allimax Pro are the exact same product, 

manufactured by the same corporation.” Marschall’s 

printed instructions differed from the preprinted 

labeling on the bottles, and his instructions stated that 

the products should be used “For Treatment Only.” 

Marschall’s instructions stated that “10 capsules” of 

the Allimed should be taken “at the VERY FIRST 

SIGN OF flu or cold like symptoms” and that, “[a]t 

the SAME time,” one should also take one 

tablespoon of the IAG “in water, juice, or 

EmergenC.” The instruction sheet claimed that 

“[m]ost people will experience no other symptoms 

after one dose,” and it listed his name at the bottom 

as “Rick Marschall N.D.” The package received by 

Agent Ryer also included two other informational 

sheets that were shown as having been authored by 

“Rick Marschall,” with one of them adding the title 

“N.D.” after his name. The content of these sheets 

largely tracked the wording of Marschall’s early 

March 2020 Facebook posts touting the benefits of 

the Dynamic Duo. 

Chemical analysis of the two substances revealed 

that they “did not contain active pharmaceutical 

ingredients” or “controlled substances.” The 

Allimax product was found to contain, inter alia, 

citrate, an unspecified sugar, and two garlic-related 
USA V. MARSCHALL 9

components. A search of the FDA’s “Electronic 

Drug Registration and Listing System,” which 

contains a list of drugs for sale in the United States

by registered manufacturers, did not reveal any 

listings for the Allimax or IAG products. 

FDA agents also obtained business records 

indicating that, in March 2020, Marschall had sold 

the same Dynamic Duo products to other customers 

in Arizona, Washington, California, and Texas. The 

FDA’s investigation did not uncover evidence of any 

person who had been harmed by taking the products. 

B

In August 2020, Marschall was indicted for one 

count of introducing misbranded drugs into interstate 

commerce after a prior conviction under 21 U.S.C. 

§§ 331 and 333(a) had become final. Specifically, 

the indictment alleged that on or about March 31, 

2020, “after a conviction of him under 21 U.S.C. 

§§ 331 and 333 had become final,” Marschall 

“introduced, delivered for introduction into interstate 

commerce, and caused to be introduced and 

delivered for introduction into interstate commerce, 

from Port Angeles, Washington, to Oakland, 

California, via the U.S. Postal service, drugs . . . 

which were misbranded.” The indictment alleged 

that the “drugs” in question were the “Dynamic Duo” 

of Allimax Pro and IAG. The indictment further 

alleged that these drugs were “misbranded” in that, 

inter alia, (1) their “labeling was false and 

misleading” by suggesting that Marschall “was a 

naturopathic doctor by listing him as ‘Rick Marschall 

N.D.’”; and (2) “the drugs were not included in any 

list of drugs manufactured, prepared, propagated, 

compounded, and processed in a registered 

establishment,” which listing is required by the drug 
10 USA V. MARSCHALL

producer registration requirements of the FDCA. 

See 21 U.S.C. § 360(b), (c), (j); see also id. § 352(o) 

(defining as “misbranded” any drug “not included in 

a list required by section 360(j) of this title”).

Before trial, Marschall filed several motions to 

dismiss the indictment. One of those motions alleged 

that the indictment failed to allege an essential 

element of the crime charged and was therefore 

subject to dismissal for failure to state a claim under 

Federal Rule of Criminal Procedure 12(b)(3)(B)(v). 

Specifically, Marschall asserted that the indictment 

omitted the requisite scienter, inasmuch as it failed to 

allege that “Marschall intentionally and knowingly

introduced, delivered, and caused” to be introduced 

and delivered, into interstate commerce, misbranded 

drugs. The district court denied this motion, as well 

as Marschall’s additional motions to dismiss the 

indictment on other grounds.

The jury returned a verdict of guilty on the sole 

count, specifically finding that the drugs were 

misbranded in that (1) “[t]he labeling of the drugs 

was false or misleading”; and (2) “[t]he drugs were 

not included in any list of drugs manufactured, 

prepared, propagated, compounded, or processed in 

a registered establishment.” Marschall was 

sentenced to eight months’ imprisonment to be 

followed by one year of supervised release. 

Marschall timely appealed, and we have 

jurisdiction under 28 U.S.C. § 1291.

II

On appeal, Marschall renews his contention that 

the indictment was defective because, in his view, it 

failed to allege the requisite scienter. According to 

Marschall, “the indictment should have alleged that 
USA V. MARSCHALL 11

[he] knew that the labeling of the ‘Dynamic Duo’ was 

false and misleading” or that he “was at least reckless

with respect to the alleged mislabeling.” In the 

context of the recidivism-based charge at issue here, 

we reject this contention.

A

We begin by examining the text of the relevant 

provisions to determine whether the language of the 

statute contains the scienter requirement that 

Marschall advocates. It does not.

The FDCA is generally classified to Chapter 9 of 

the unenacted title 21 of the United States Code. See

21 U.S.C. §§ 301 et seq. Several provisions of the 

FDCA are relevant here, and we will refer to each of 

them by their assigned section numbers in title 21, as 

the parties have done throughout these proceedings. 

Section 333(a) imposes criminal penalties on any 

person “who violates a provision of section 331” of 

title 21, and it prescribes enhanced penalties for 

§ 331 violations involving specified aggravating 

circumstances. Id. § 333(a)(1), (2). The underlying 

substantive prohibition in § 331 that Marschall is 

alleged to have violated is contained in subsection 

(a), which prohibits, in relevant part, “[t]he 

introduction or delivery for introduction into 

interstate commerce of any . . . drug . . . that is . . . 

misbranded.” 21 U.S.C. § 331(a). Section 321 

defines a “drug” as, inter alia, any “article[] intended 

for use in the diagnosis, cure, mitigation, treatment, 

or prevention of disease in man or other animals.” Id. 

§ 321(g)(1)(B). Section 352, in turn, specifies that a 

drug “shall be deemed to be misbranded” if, inter 

alia, “its labeling is false or misleading in any 

particular.” Id. § 352(a)(1). “Labeling,” for 

purposes of the FDCA, “means all labels and other 
12 USA V. MARSCHALL

written, printed, or graphic matter (1) upon any 

article or any of its containers or wrappers, or 

(2) accompanying such article.” Id. § 321(m). 

Section 352(o) alternatively provides that a drug is 

“misbranded” “if it was not included in a list required 

by” the FDCA’s drug producer registration 

requirements. Taking these provisions together in 

the context of this case, Marschall was charged with 

having introduced into interstate commerce an article 

that was “intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of disease” and 

that was (1) “accompan[ied]” by “written” or 

“printed” matter that was “false or misleading in any 

particular” and (2) not included on a list of drugs 

required by the FDCA’s registration requirements.

Looking first just at the language of the various 

provisions describing this underlying prohibition, we 

conclude that none of them contains language 

imposing a scienter requirement. By its terms, § 331 

flatly prohibits the “act[]” of “[t]he introduction or 

delivery for introduction into interstate commerce” 

of a “drug” that “is . . . misbranded,” and says 

nothing about whether the person introducing it into 

commerce knows that it is misbranded. 21 U.S.C. 

§ 331(a) (emphasis added). Likewise, the drug is 

“misbranded” if “its labeling is false or misleading,” 

without any requirement that the person know that it 

is false or misleading. Id. § 352(a)(1) (emphasis 

added). Similarly, the drug is alternatively 

“misbranded” if it is “not included in a list required 

by” the drug producer registration requirements, 

without any requirement to show the defendant’s

knowledge of any such lack of listing. Id. § 352(o). 

The omission of any scienter requirement from the 

language of these various provisions is hardly 

surprising, given that these underlying prohibitions 
USA V. MARSCHALL 13

are also enforced through civil proceedings for 

injunctive relief or seizure of misbranded drugs. Id.

§ 332(a) (giving the district courts jurisdiction “to 

restrain violations of section 331”); id. § 334(a) 

(authorizing in rem seizure proceedings against, inter 

alia, any drug “that is adulterated or misbranded”). 

These critical civil provisions would be unable to 

accomplish their goal of promptly removing 

misbranded drugs from commerce if they only 

authorized such measures in cases in which the 

distributor knew that the drugs they were distributing

were misbranded.

To be sure, the definition of “drug” that is at issue 

in this case uses language that arguably could “be 

understood to refer to the state of mind of the 

defendant,” Posters ‘N’ Things, Ltd. v. United States, 

511 U.S. 513, 518 (1994), because it refers to an 

“article[] intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of disease in 

man or other animals,” 21 U.S.C. § 321(g)(1)(B) 

(emphasis added). But that reading is wrong, as 

Posters ‘N’ Things makes clear. There, the Court

construed the comparable language in what is now 

21 U.S.C. § 863(d), which defines “drug 

paraphernalia” as meaning anything “which is 

primarily intended or designed for use” with illegal 

drugs.2 The Court held that the phrase “primarily 

intended . . . for use” must “be understood 

objectively” as “refer[ring] generally to an item’s 

likely use,” and the phrase therefore does not 

“serv[e] as the basis for a subjective scienter 

requirement.” 511 U.S. at 521–22. Similarly here, 

the question whether an article is “intended for use” 

2 At the time that Posters ‘N’ Things was decided, this definition 

was contained in former 21 U.S.C. § 857(d).
14 USA V. MARSCHALL

in diagnosing, curing, mitigating, treating, or 

preventing disease turns solely on an objective

inquiry into the article’s likely use in light of its 

features and any accompanying labeling. Indeed, a 

contrary, subjective, reading of this definition of 

“drug” could substantially hinder the ability to 

remove such drugs from the channels of commerce 

under the previously discussed civil measures—a 

result Congress surely did not intend. 

Having concluded that the provisions describing 

the underlying prohibition do not contain any 

language imposing a scienter requirement, we next 

consider whether the relevant criminal penalties 

provision, 21 U.S.C. § 333(a), contains language 

imposing such a requirement. The text of § 333(a) is 

as follows:

(1) Any person who violates a 

provision of section 331 of this title 

shall be imprisoned for not more than 

one year or fined not more than 

$1,000, or both. 

(2) Notwithstanding the 

provisions of paragraph (1) of this 

section, if any person commits such a 

violation after a conviction of him 

under this section has become final, 

or commits such a violation with the 

intent to defraud or mislead, such 

person shall be imprisoned for not 

more than three years or fined not 

more than $10,000, or both.

21 U.S.C. § 333(a). Marschall was charged under 

the first clause of § 333(a)(2), which subjects a 
USA V. MARSCHALL 15

defendant to up to three years in prison if he 

“commits such a violation after a conviction of him 

under this section has become final.” Id. § 333(a)(2). 

On their face, neither § 333(a)(1) nor the relevant

clause of § 333(a)(2) makes any explicit reference to 

scienter. Section 333(a)(1) merely requires proof 

that a person has “violate[d] a provision of section 

331,” and the first clause of § 333(a)(2) only requires 

proof that the person committed a violation of § 331

“after a conviction of him under this section has 

become final.” Nothing in the relevant language of 

these provisions says anything about scienter.

Accordingly, the text of the various provisions of 

the FDCA at issue here does not contain any 

language that imposes a scienter requirement of the 

sort that Marschall advocates. 

B

As Marschall correctly notes, however, the 

absence of such affirmative scienter language, by 

itself, is not sufficient to establish that no such mens 

rea is required. It is well settled that, “even when 

Congress does not specify any scienter in the 

statutory text,” we must “start from a longstanding 

presumption, traceable to the common law, that 

Congress intends to require a defendant to possess a 

culpable mental state regarding ‘each of the statutory 

elements that criminalize otherwise innocent 

conduct.’” Rehaif v. United States, 139 S. Ct. 2191, 

2195 (2019) (citation omitted). But this presumption 

is rebuttable, and it will not be applied if there are 

“convincing reason[s] to depart” from it. Id. We 

conclude that such convincing reasons are present 

here.
16 USA V. MARSCHALL

1

In particular, two aspects of the relevant statutory 

text work together to strongly confirm that the 

aggravated version of the offense that applies to 

recidivists under the first clause of § 333(a)(2) does 

not require proof of scienter as to the misbranded 

nature of the drugs.

First, it is important to note that § 333(a)(2) 

defines the recidivist version of the aggravated 

offense by reference to a base offense that, under 

controlling precedent, does not require scienter. The 

first clause of § 333(a)(2) states that, 

“[n]otwithstanding the provisions of paragraph (1) of 

this section, if any person commits such a violation 

after a conviction of him under this section has 

become final,” the person is guilty of a felony 

punishable by up to three years in prison. 21 U.S.C. 

§ 333(a)(2) (emphasis added). The referent of the 

phrase “such a violation” is unmistakably the 

violation defined in “paragraph (1) of this section.” 

Id. Thus, the offense defined by the relevant clause 

in § 333(a)(2) simply takes the existing offense in 

§ 333(a)(1) and then adds, as an additional element, 

the requirement that the defendant be shown to have 

previously been convicted of violating “this section,” 

i.e., § 333. Under well-settled law, the referenced 

base offense in § 333(a)(1) does not require proof of 

scienter.

The Supreme Court addressed the question of 

scienter for a prosecution under § 333(a)(1) in United 

States v. Dotterweich, 320 U.S. 277 (1943). 

Dotterweich, the president and general manager of a 

pharmaceutical company, was convicted of three 

violations of § 333(a)(1), two involving “misbranded 

drugs,” and one involving “an adulterated drug.” Id. 
USA V. MARSCHALL 17

at 278. In the course of addressing a separate issue 

about the scope of the statute, the Court stated that 

the “prosecution to which Dotterweich was subjected 

is based on a now familiar type of legislation” that 

“dispenses with the conventional requirement for 

criminal conduct—awareness of some wrongdoing.” 

Id. at 280–81. That is, because the subject of the 

FDCA affects “the lives and health of people” in 

ways that “are largely beyond self-protection,” the 

FDCA “puts the burden of acting at hazard upon a

person otherwise innocent but standing in 

responsible relation to a public danger.” Id. The 

Court acknowledged that “[h]ardship there doubtless 

may be under a statute which thus penalizes the 

transaction though consciousness of wrongdoing be 

totally wanting.” Id. at 284. But given the stakes 

involved with distribution of regulated drugs, the 

Court stated that Congress determined to place the 

onus “upon those who have at least the opportunity 

of informing themselves of the existence of 

conditions imposed for the protection of consumers 

before sharing in illicit commerce, rather than to 

throw the hazard on the innocent public who are 

wholly helpless.” Id. at 285.

As the Supreme Court has acknowledged, 

Dotterweich reflects that there is a “limited” category 

of “public welfare offenses”—“involv[ing] statutes 

that regulate potentially harmful or injurious 

items”—as to which Congress has dispensed with the 

normal requirement of scienter and has instead 

“impose[d] a form of strict criminal liability through 

statutes that do not require the defendant to know the 

facts that make his conduct illegal.” Staples v. 

United States, 511 U.S. 600, 606–07 (1994); see also 

Rehaif, 139 S. Ct. at 2197 (“[W]e have typically 

declined to apply the presumption in favor of scienter 
18 USA V. MARSCHALL

in cases involving statutory provisions that form part 

of a ‘regulatory’ or ‘public welfare’ program and 

carry only minor penalties.”). Section 333(a)(1), 

which makes it a misdemeanor to introduce 

misbranded or adulterated drugs into interstate 

commerce, is such a public welfare offense, and it 

does not require the Government to prove 

“knowledge that the items were misbranded or 

adulterated.” Staples, 511 U.S. at 606; see also

United States v. Watkins, 278 F.3d 961, 964 (9th Cir. 

2002) (“An article may be misbranded pursuant to 

the misdemeanor provision ‘without any conscious 

fraud at all,’ thus creating a form of strict criminal 

liability.” (quoting Dotterweich, 320 U.S. at 281)). 

Indeed, the parties here do not dispute that 

§ 333(a)(1) is a strict liability misdemeanor offense. 

As explained earlier, the recidivist offense 

described in the first clause of § 333(a)(2) begins 

with the offense described in § 333(a)(1)—which 

lacks a scienter requirement—and then adds a 

requirement to show that this scienter-less violation 

of § 333(a)(1) occurred after a final conviction for a 

previous violation of § 333. Nothing about that latter 

element suggests any intent by Congress to add a 

scienter requirement to the borrowed base offense. 

The additional element required by this clause to 

raise the misdemeanor to a felony is simply that the 

defendant committed the violation “after a 

conviction of him under this section has become 

final.” 21 U.S.C. § 333(a)(2). Accordingly, nothing 

in the text of this clause of § 333(a)(2) provides any

basis for inferring that a scienter requirement applies 

to this aggravated version of the offense.

Second, this conclusion is overwhelmingly 

reinforced by contrasting the language of the two 
USA V. MARSCHALL 19

alternative clauses in § 333(a)(2). The two clauses 

of § 333(a)(2) define two different ways in which a 

violation of § 333(a)(1) can become a felony—

namely, (1) by committing such a violation after a 

final conviction under § 333 or (2) by “commit[ting] 

such a violation with the intent to defraud or 

mislead.” 21 U.S.C. § 333(a)(2) (emphasis added). 

The second of these two alternatives thus expressly 

imposes a “mens rea element that is absent from the 

broader-reaching misdemeanor provision.” Watkins, 

278 F.3d at 964. That fact strongly confirms that the 

other alternative—the recidivist provision at issue 

here—does not impose a mens rea requirement. 

“Where Congress includes particular language in one

section of a statute but omits it in another section of 

the same Act, it is generally presumed that Congress 

acts intentionally and purposely in the disparate 

inclusion or exclusion.” Russello v. United States, 

464 U.S. 16, 23 (1983) (simplified).

2

Marschall nonetheless argues that the strong 

presumption in favor of scienter has not been 

rebutted. According to Marschall, Dotterweich rests 

on an exception to that strong presumption for 

“public welfare” offenses, and the Supreme Court 

has subsequently clarified that this exception extends

only to public welfare offenses with “minor 

penalties” and not to felonies such as § 333(a)(2).

We agree that the severity of the penalty applicable 

under § 333(a)(2)—viz., up to three years in prison—

is a consideration that, all other things being equal, 

weighs in favor of imposing a scienter requirement. 

See Staples, 511 U.S. at 616 (“Historically, the 

penalty imposed under a statute has been a 

significant consideration in determining whether the 
20 USA V. MARSCHALL

statute should be construed as dispensing with mens 

rea.”). But we nonetheless conclude that this 

consideration is not controlling in the unique 

circumstances presented by the recidivist offense in 

§ 333(a)(2). 

In Staples, the Supreme Court confronted a 

similar contention that the “public welfare”

exception to the presumption in favor of scienter 

should be limited to crimes involving modest 

penalties and therefore could not be applied to 

felonies. See 511 U.S. at 616–19. The question in 

Staples was whether, in a prosecution for unlawful 

possession of an unregistered machinegun, “the 

Government should have been required to prove 

beyond a reasonable doubt that [the defendant] knew 

the weapon he possessed had the characteristics that 

brought it within the statutory definition of a 

machinegun.” Id. at 602. In the course of answering 

that question in the affirmative, the Court 

emphasized a number of considerations, one of 

which was “[t]he potentially harsh penalty” for such 

a violation, which was “up to 10 years’ 

imprisonment.” Id. at 616. In discussing the 

significance of the potentially severe penalties, the 

Court distinguished its prior cases involving public 

welfare offenses, noting that they have “almost 

uniformly involved statutes that provided for only 

light penalties such as fines or short jail sentences, 

not imprisonment in the state penitentiary.” Id. 

Indeed, the Staples Court suggested that there was 

some force to the view—similar to what Marschall 

argues here—that, “absent a clear statement from 

Congress that mens rea is not required, [the courts] 

should not apply the public welfare offense rationale 

to interpret any statute defining a felony offense as 

dispensing with mens rea.” Id. at 618. However, the 
USA V. MARSCHALL 21

Court noted that such a rule would directly contradict

its unanimous decision in United States v. Balint, 258 

U.S. 250 (1922),3 and Staples ultimately found it 

unnecessary to “adopt such a definitive rule of 

construction.” 511 U.S. at 618. Instead, the Court 

held “only that where, as here, dispensing with mens 

rea would require the defendant to have knowledge 

only of traditionally lawful conduct, a severe penalty 

is a further factor tending to suggest that Congress 

did not intend to eliminate a mens rea requirement.” 

Id. (emphasis added).

Our construction of the relevant clause of 

§ 333(a)(2) is consistent with Staples’ narrow 

3 Balint involved a prosecution under § 2 of the Narcotic Act of 

1914, 38 Stat. 785, 786, which, as described by the Court, 

prohibited the charged conduct of “unlawfully selling to 

another a certain amount of a derivative of opium and a certain 

amount of a derivative of coca leaves, not in pursuance of any 

written order on a form issued in blank for that purpose by the 

Commissioner of Internal Revenue.” 258 U.S. at 251. The 

Court held that, given the importance of “securing a close 

supervision of the business of dealing in these dangerous drugs 

by the taxing officers of the Government,” Congress had 

decided, in effect, “to require every person dealing in drugs to 

ascertain at his peril whether that which he sells comes within 

the inhibition of the statute, and if he sells the inhibited drug in 

ignorance of its character, to penalize him.” Id. at 254. The 

Court therefore concluded that Congress had permissibly 

determined, “in order to stimulate proper care, [to] require the 

punishment of the negligent person though he be ignorant of the 

noxious character of what he sells.” Id. at 253. As described in 

Staples, the holding of Balint was that the statute “required 

proof only that the defendant knew that he was selling drugs, 

not that he knew the specific items he had sold were ‘narcotics’ 

within the ambit of the statute.” 511 U.S. at 606. Notably, 

Balint held that this form of scienter was not required, even 

though the offense involved was a felony punishable by up to 

five years in prison. See Narcotic Act of 1914, § 9, 38 Stat. at 

789.
22 USA V. MARSCHALL

description of the public welfare exception. Unlike 

in Staples, we are not presented with a situation in 

which “dispensing with mens rea would require the 

defendant to have knowledge only of traditionally 

lawful conduct.” 511 U.S. at 618. On the contrary, 

by requiring proof that the defendant violated 

§ 333(a)(1) after having been finally convicted of an 

earlier violation of § 333, the first clause of 

§ 333(a)(2) ensures that this prohibition will be 

applied only to those who are directly familiar with 

the requirements of the FDCA. That is, having 

previously been made personally aware of the 

strictures of § 333, a defendant covered by the first 

clause of § 333(a)(2) is plainly not someone who, 

when he later engages in delivery of misbranded 

drugs, was merely engaging in what would 

reasonably be thought to be “traditionally lawful 

conduct.” In this way, a prior criminal conviction 

under § 333 effectively serves as a functional 

substitute for a scienter requirement: although the 

Government need not show that the defendant knew 

that the current drugs at issue were “misbranded,” 

the defendant’s prior conviction puts him amply on 

notice that he is operating in a heavily regulated area 

that involves potentially dangerous substances and as 

to which he must proactively exercise care. Such 

recidivists are, in other words, the paradigmatic 

example of the sorts of persons who may be expected 

to “inform[] themselves of the existence of 

conditions imposed for the protection of consumers 

before sharing in illicit commerce.” Dotterweich, 

320 U.S. at 285; see also Posters ‘N’ Things, 511 

U.S. at 522 (stating that the public welfare exception 

to the presumption in favor of scienter generally 

applies only where there is “proof that the defendant 

had knowledge of sufficient facts to alert him to the 
USA V. MARSCHALL 23

probability of regulation of his potentially dangerous 

conduct”).

3

Marschall argues that, at the very least, a scienter 

requirement must be read into the recidivist 

provision of § 333(a)(2) in order to avoid a serious 

concern that the statute would violate the 

constitutional guarantee of due process. We reject 

this contention.

Even assuming that the Due Process Clause 

imposes an outer limit on Congress’s power to define 

strict liability offenses, compare United States v. 

Wulff, 758 F.2d 1121, 1125 (6th Cir. 1985) (holding 

that it would violate due process to subject “a person 

acting with a completely innocent state of mind . . . 

to a severe penalty and grave damage to his 

reputation”) with United States v. Engler, 806 F.2d 

425, 433 (3d Cir. 1986) (“We are persuaded that the 

Sixth Circuit in Wulff . . . ignored a formidable line 

of cases imposing strict liability in felony cases 

without proof of scienter.”), the recidivist clause of 

§ 333(a)(2) is well within any such constitutional 

limits. As the Supreme Court explained in United 

States v. International Minerals & Chemical Corp,, 

402 U.S. 558 (1971), there may be certain “type[s] of 

products” where imposing criminal penalties on 

those dealing in them “might raise substantial due 

process questions if Congress did not require . . .

‘mens rea’ as to each ingredient of the offense.” Id. 

at 564–65. But such due process notice concerns are 

inapplicable where, as here, the statute permits a 

conviction only upon a showing that the defendant 

committed a second violation of § 333 after having

already been finally convicted of a prior violation of 

that same statute. Such a defendant has personally 
24 USA V. MARSCHALL

received ample notice “of sufficient facts to alert him 

to the probability of regulation of his potentially 

dangerous conduct.” Posters ‘N’ Things, 511 U.S. at 

522. Put another way, a person such as Marschall 

cannot be heard to complain that he was not given 

notice that he was engaging in something other than 

“traditionally lawful conduct.” Staples, 511 U.S. at 

618.

4

* * *

In view of these considerations, and the strong 

textual evidence noted earlier, we conclude that this 

is the unusual case in which a public welfare offense 

lacks a scienter element even though it is a felony 

with moderately severe potential penalties. In short, 

(1) Congress augmented, into a felony, a predicate

misdemeanor offense that concededly lacks a 

scienter requirement; (2) it did so by adding, not a 

scienter requirement, but a prior conviction 

requirement; (3) this action contrasts with 

Congress’s explicit addition of a scienter 

requirement in the other clause of § 333(a)(2); and 

(4) the prior conviction requirement, as a functional 

matter, largely serves the same purposes as an 

express scienter requirement. Under this confluence 

of circumstances, we conclude that the first clause of 

§ 333(a)(2) does not require the Government to 

prove that the defendant knew that the drugs were 

4 We reject Marschall’s argument that the requisite notice has 

been afforded only if the same drugs are at issue in each 

successive prosecution under § 333. A prior prosecution and 

conviction under § 333 provides more than enough notice of the 

scope of the regulatory regime that is enforced by § 333 and to 

alert the defendant of the need “to ascertain at his peril” whether 

another drug that he thereafter “sells comes within the 

inhibition of the statute.” United States v. Freed, 401 U.S. 601, 

609 (1971) (quoting Balint, 258 U.S. at 254).
USA V. MARSCHALL 25

misbranded. Accordingly, the indictment here did 

not need to allege that Marschall knew that the 

labeling of the “Dynamic Duo” rendered those 

products misbranded in the respects described in the 

indictment. The district court therefore properly 

denied Marschall’s motion to dismiss the indictment.

AFFIRMED.