Court Opinion

ID: 9840918
Source: CourtListenerOpinion
Date Created: 2023-09-20 17:01:06.50123+00
Date Added: 2024-06-11T08:29:58.083046
License: Public Domain

FOR PUBLICATION

          UNITED STATES COURT OF
                  APPEALS
           FOR THE NINTH CIRCUIT

UNITED STATES OF AMERICA,                             No. 22-30048

                  Plaintiff-Appellee,                   D.C. No.
                                                     3:20-cr-05270-
    v.                                                   BHS-1

RICHARD MARSCHALL,
                                                        OPINION
                  Defendant-Appellant.

      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, anti-
yeast.” 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.