Nutricia North America, Inc. v. United States

United States Court of Appeals
for the Federal Circuit
______________________
NUTRICIA NORTH AMERICA, INC.,
Plaintiff-Appellant
v.
UNITED STATES,
Defendant-Appellee
______________________
2024-1436
______________________
Appeal from the United States Court of International
Trade in No. 1:16-cv-00008-TCS, Senior Judge Timothy C.
Stanceu.
______________________
Decided: November 17, 2025
______________________
AMANDA SHAFER BERMAN, Crowell & Moring, LLP,
Washington, DC, argued for plaintiff-appellant. Also rep-
resented by J OHN B OWERS BREW , ALEXANDER SCHAEFER .
L UKE MATHERS , Commercial Litigation Branch, Civil
Division, United States Department of Justice, New York,
NY, argued for defendant-appellee. Also represented by
G UY EDDON, AIMEE L EE , P ATRICIA M. MC C ARTHY , J USTIN
REINHART M ILLER, BRETT SHUMATE; YELENA SLEPAK, Office
of the Assistant Chief Counsel, Bureau of Customs and
Border Protection, United States Department of Homeland
Security, New York, NY.
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NUTRICIA NORTH AMERICA, INC. v. US 2
______________________
Before P ROST , T ARANTO, and STARK, Circuit Judges.
T ARANTO, Circuit Judge.
Nutricia North America, Inc. imported into the United
States, from the United Kingdom, five products classified
by the United States Food and Drug Administration (FDA)
as “medical foods” under the Federal Food, Drug, and Cos-
metics Act (FDCA). The United States Customs and Bor-
der Protection (Customs) classified the medical foods under
chapter 21 (“Miscellaneous Edible Preparations”) of the
Harmonized Tariff Schedule of the United States
(HTSUS)—specifically, under subheading 2106.90.99,
which applies a non-zero duty to “[f]ood preparations not
elsewhere specified.” Nutricia protested, contending prin-
cipally that its medical foods should instead be classified
within HTSUS chapter 30 (“Pharmaceutical Products”) un-
der heading 3004, which, as relevant here, applies a zero
duty to “[m]edicaments . . . consisting of mixed or unmixed
products for therapeutic or prophylactic uses, put up in
measured doses . . . or in forms or packings for retail
sale[.]” Nutricia also proposed another duty-free classifica-
tion as a backup—chapter 98’s subheading 9817.00.96.
Customs rejected Nutricia’s positions, and Nutricia
then filed an action in the Court of International Trade
(CIT). The CIT granted summary judgment, adopting the
Customs-adopted classification under chapter 21’s sub-
heading 2106.90.99 and rejecting Nutricia’s two alterna-
tives. Nutricia North America, Inc. v. United States, 666 F.
Supp. 3d 1363 (Ct. Int’l Trade 2023) (CIT Decision). On
Nutricia’s appeal, we now reverse, concluding that Nutri-
cia’s “medical foods” properly come within chapter 30’s
heading 3004 of the HTSUS, so we do not reach Nutricia’s
backup proposal within chapter 98.
I
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NUTRICIA NORTH AMERICA, INC. v. US 3
A
There is no dispute about the material facts or the pro-
priety of resolving the case by summary judgment, one way
or another, to give the same answer for all five Nutricia
products without distinguishing among them. Five Nutri-
cia products are at issue:
(1) MSUD Lophlex® LQ. This product is used as a
nutrition therapy for children with branched-chain
alpha ketoacid dehydrogenase complex (BCKDC)
deficiency. The disorder is a permanent inborn
metabolic condition, resulting in an impaired abil-
ity to metabolize certain essential amino acids,
that cannot be managed through a diet of simply
avoiding certain foods.
(2) Periflex® Infant and (3) Periflex® Junior. Both
products are used to treat individuals with phenyl-
ketonuria, which, like BCKDC deficiency, is a per-
manent inborn metabolic condition. These
products exclude phenylalanine, a common amino
acid, and provide certain supplements that are nec-
essary for protein synthesis. Management of phe-
nylketonuria through use of these products as
foods can prevent the buildup of toxic metabolites
that can lead to developmental delay, seizures, or
death.
(4) Neocate® Junior. This product is used as a nu-
trition therapy for individuals with eosinophilic
esophagitis (an allergic response to certain proteins
or peptides that can damage the esophagus wall)
and short bowel syndrome (a condition that may re-
sult after part of the bowel is removed), among
other conditions. This product contains a compre-
hensive array of essential individual amino acids
rather than the whole proteins prevalent in ordi-
nary foods.
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NUTRICIA NORTH AMERICA, INC. v. US 4
(5) Ketocal® Liquid. This product food is a nutri-
tion therapy used to treat children with Glucose
Transporter Type 1 Deficiency (GLUT 1) and in-
tractable (or refractory) epilepsy, among other con-
ditions. The product helps mitigate the risk of
certain seizures by providing a ketogenic diet,
which reduces carbohydrates. Naturally occurring
food cannot match the unique proportion of fat cal-
ories to the non-fat protein and carbohydrate calo-
ries in this product.
See CIT Decision, at 1367–68, 1374–77 & nn.5–9 (describ-
ing and listing ingredients of the five products).
The products have common characteristics: They are
administered enterally (introduced into the intestines or
gastrointestinal tract)—rather than, e.g., intravenously—
and they contain no active pharmacological ingredients.
See CIT Decision, at 1372; J.A. 4441. The products are for-
mulated to omit certain ingredients that are standard in
ordinary foods (such as particular amino acids or carbohy-
drates) yet are composed of particular nutritional sub-
stances (such as particular amino acids, vitamins, or
mineral salts) so that the combination provides a nutri-
tional therapy for individuals with particular health condi-
tions. See CIT Decision, at 1373–74; J.A. 537. Still more
specifically, the parties agree on appeal that the five prod-
ucts may be considered without differentiating them for
classifications purposes and are “medical foods” under the
FDCA, 21 U.S.C. § 360ee(b)(3), and an FDA implementing
regulation, 21 C.F.R. § 101.9(j)(8). CIT Decision, at 1372,
1382; J.A. 4436 (Customs decision).
Congress defined a “medical food” as
a food which is formulated to be consumed or ad-
ministered enterally under the supervision of a
physician and which is intended for the specific di-
etary management of a disease or condition for
which distinctive nutritional requirements, based
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NUTRICIA NORTH AMERICA, INC. v. US 5
on recognized scientific principles, are established
by medical evaluation.
21 U.S.C. § 360ee(b)(3). The FDA supplemented the statu-
tory definition in its nutritional labeling requirements for
foods, explaining that a “medical food” must possess the fol-
lowing characteristics:
(i) It is a specially formulated and processed prod-
uct (as opposed to a naturally occurring foodstuff
used in its natural state) for the partial or exclusive
feeding of a patient by means of oral intake or en-
teral feeding by tube;
(ii) It is intended for the dietary management of a
patient who, because of therapeutic or chronic med-
ical needs, has limited or impaired capacity to in-
gest, digest, absorb, or metabolize ordinary
foodstuffs or certain nutrients, or who has other
special medically determined nutrient require-
ments, the dietary management of which cannot be
achieved by the modification of the normal diet
alone;
(iii) It provides nutritional support specifically
modified for the management of the unique nutri-
ent needs that result from the specific disease or
condition, as determined by medical evaluation;
(iv) It is intended to be used under medical super-
vision; and
(v) It is intended only for a patient receiving active
and ongoing medical supervision wherein the pa-
tient requires medical care on a recurring basis for,
among other things, instructions on the use of the
medical food.
21 C.F.R. § 101.9(j)(8).
Medical foods, which are subject to their own special
regulatory treatment under the FDCA, are “distinguished
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NUTRICIA NORTH AMERICA, INC. v. US 6
from the broader category of foods for special dietary use
. . . by the requirement that [they] are to be used under
medical supervision.” U.S. Food and Drug Administration,
No. 7321.002, Compliance Program Guidance Manual at 1
(2008) (FDA Manual). By this distinction, the FDA differ-
entiates medical foods from dietary foods “such as meal re-
placements or diet shakes, or products for the management
of diseases, such as diabetes, that can be managed through
modification of the normal diet alone.” Is It Really ‘FDA
Approved’?, U.S. F OOD & D RUG ADMINISTRATION (May 10,
2022), https://www.fda.gov/consumers/consumer-up-
dates/it-really-fda-approved. The distinction reflects the
FDA’s recognition of “specially formulated and processed”
medical foods as a “major treatment modality” for patients.
FDA Manual, at 1.
B
Between November 13 and 26 of 2014, Nutricia im-
ported the five medical foods at issue here. J.A. 4699, 4715,
4909. The 2014 edition of the HTSUS is applicable, see CIT
Decision, at 1369 n.2—specifically, Revision 1, which went
into effect in July 2014—so all our references to the HTSUS
are to that version. In 2015, Customs classified Nutricia’s
products within HTSUS chapter 21 (“Miscellaneous Edible
Preparations”) under subheading 2106.90.99 as “[f]ood
preparations not elsewhere specified or included.”1 See
J.A. 4699. That classification resulted in a 6.4 percent
duty. See HTSUS subheading 2106.90.99; CIT Decision, at
1369. In contrast, and most important here, the medical
foods would have entered duty free if they were classified
as a “medicament” under heading 3004 of chapter 30, as
Nutricia has principally argued they should be. See
1 Subheading 2106.90.99 reads: “Food preparations
not elsewhere specified or included: Other: Other: Other:
Other: Other: Other.”
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NUTRICIA NORTH AMERICA, INC. v. US 7
HTSUS heading 3004; CIT Decision, at 1369. Heading
3004 gives the following scope description:
Medicaments (excluding goods of heading 3002,
3005 or 3006) consisting of mixed or unmixed prod-
ucts for therapeutic or prophylactic uses, put up in
measured doses (including those in the form of
transdermal administration systems) or in forms or
packings for retail sale[.]
That description must be read in conjunction with note 1(a)
to chapter 30 (which contains heading 3004). That note
says:
1. This chapter does not cover: (a) Foods or bever-
ages (such as dietetic, diabetic or fortified foods,
food supplements, tonic beverages and mineral wa-
ters), other than nutritional preparations for intra-
venous administration (section IV)[.]
The referred-to “section IV” of the HTSUS includes chap-
ters 16 through 24.
In 2015, Nutricia protested under 19 U.S.C. § 1514,
primarily arguing for classification of its medical foods as
a “medicament” under heading 3004—specifically, sub-
heading 3004.50.5040.2 See CIT Decision, at 1369; J.A.
4700. Nutricia also argued, as a backup, that its products
are classifiable under chapter 98’s subheading 9817.00.96
as “[a]rticles specially designed or adapted for the use or
benefit of . . . handicapped persons,” which may enter the
2 Subheading 3004.50.5040 reads: “Other medica-
ments containing vitamins or other products of heading
2936: Other: Other.” The referred-to heading 2936 covers,
in relevant part, “provitamins” and “vitamins.” See
HTSUS heading 2936. No dispute before us turns on the
choice of subheading within heading 3004 if heading 3004
applies.
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NUTRICIA NORTH AMERICA, INC. v. US 8
country duty free.3 See HTSUS subheading 9817.00.96;
CIT Decision, at 1369–70. Customs denied Nutricia’s two
protests, choosing heading 2106 as the proper classifica-
tion.
On September 1, 2016, Nutricia filed a complaint in the
CIT under 19 U.S.C. § 1515 and 28 U.S.C. § 1581(a), chal-
lenging the protest denials as resting on an incorrect clas-
sification of its products. See CIT Decision, at 1366–67;
J.A. 42. In 2022, after a record was developed, Nutricia
and the government each moved for summary judgment in
its favor. CIT Decision, at 1366–67. The parties disagreed
about the proper interpretation and applicability of head-
ing 3004 and subheading 9817.00.96 (the backup classifi-
cation urged by Nutricia) and of subheading 2106.90.99
(adopted and defended by Customs). CIT Decision, at
1369–70.
On December 4, 2023, the CIT ruled in favor of the gov-
ernment. CIT Decision, at 1382. The CIT concluded that
heading 3004 did not apply. Specifically, based decisively
on the exclusionary provision in chapter 30 note 1(a), with
support from the chapter 30 explanatory notes, the CIT
ruled that Nutricia’s medical foods are not “medicaments.”
CIT Decision, at 1370–80.
The CIT reasoned that “[e]ven if some definitions of the
term ‘medicaments’ were considered broad enough to en-
compass what [Nutricia] describes as . . . ‘medical food’
products, it would not follow that chapter 30, HTSUS
3 Subheading 9817.00.96 reads: “Articles specially
designed or adapted for the use or benefit of the blind or
other physically or mentally handicapped persons; parts
and accessories (except parts and accessories of braces and
artificial limb prosthetics) that are specially designed or
adapted for use in the foregoing articles: Other.”
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NUTRICIA NORTH AMERICA, INC. v. US 9
necessarily includes these products” because of the exclu-
sion in note 1(a). CIT Decision, at 1371. Note 1(a) states:
This chapter [i.e., chapter 30, which contains head-
ing 3004] does not cover: (a) Foods or beverages
(such as dietetic, diabetic or fortified foods, food
supplements, tonic beverages and mineral waters),
other than nutritional preparations for intrave-
nous administration (section IV)[.]
The CIT concluded that chapter note 1(a) created a “gen-
eral exclusion” applicable to all “orally” consumed “nutri-
tional preparations” that are “‘foods or beverages’ within
the meaning of those terms as used in note 1(a).” Id. at
1371–72. The CIT stated specifically that note 1(a) “iden-
tifies ‘dietetic’ and ‘diabetic’ foods . . . as an example of
goods that are within the exclusion . . ., connoting that even
foods specialized for intended use by persons whose medi-
cal condition requires a specialized diet fall within the
scope of that exclusion.” Id. at 1372. The CIT concluded
that note 1(a) does not “distinguish . . . ‘medical foods’ from
other [excluded] foods[.]” Id.
Having held heading 3004 inapplicable, the CIT also
rejected Nutricia’s argument that its medical foods may be
classified as an “[a]rticle[ ]” that is “designed or adapted for
the use or benefit of . . . handicapped persons” under sub-
heading 9817.00.96. Id. at 1380–81. It is undisputed that,
if neither heading 3004 nor subheading 9817.00.96 applies
to the products at issue here, the catch-all heading 2106
applies. The CIT adopted that heading as the proper clas-
sification here. CIT Decision, at 1379–82.
The CIT entered final judgment on December 4, 2023.
Nutricia timely appealed. ECF No. 1. We have jurisdiction
under 28 U.S.C. § 1295(a)(5).
II
No material facts are disputed here. In particular, it is
undisputed that all five products are medical foods under
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NUTRICIA NORTH AMERICA, INC. v. US 10
the FDCA and should be treated together for classification
purposes. In this situation, our classification inquiry “col-
lapses into a determination of the proper meaning and
scope of the HTSUS terms” and that determination, “as a
matter of statutory construction, is a question of law,” so
we review the CIT’s decision de novo. Len-Ron Manufac-
turing Co. v. United States, 334 F.3d 1304, 1308 (Fed. Cir.
2003) (internal quotation marks and citations omitted).
We conclude that heading 3004 applies. It is undisputed
before us that, if we conclude that the medical foods at is-
sue come within heading 3004 (as we do), we need not de-
cide any other issue. Chapter 21 does not apply if heading
3004 does, see HTSUS chapter 21, note 1(f) (“This chapter
does not cover . . . a medicament or other products of head-
ing . . . 3004[.]”), and there is no articulated need, given the
duty-free treatment provided by heading 3004, to consider
applicability of subheading 9817.00.96, another alleged ba-
sis for duty-free treatment. We therefore limit our opinion
to the issue of heading 3004’s coverage of Nutricia’s medi-
cal foods.
A
The HTSUS comprises three binding sources of classi-
fication: (1) headings that specify general categories of
products, (2) subheadings that segregate products within
each category, and (3) chapter notes. See Shamrock Build-
ing Materials, Inc. v. United States, 119 F.4th 1346, 1352
(Fed. Cir. 2024). Congress has provided General Rules of
Interpretation (GRI) to govern the interpretive process.
Id.; Schlumberger Technology Corp. v. United States, 845
F.3d 1158, 1163 (Fed. Cir. 2017). As relevant here, GRI 1
requires “classification [to] be determined according to the
terms of the [HTSUS] headings and any relative section or
chapter notes.” Schlumberger, 845 F.3d at 1163 (citing
GRI1) (alteration in original) (internal quotation marks
and emphasis removed). We have explained that the chap-
ter notes are “an integral part of the HTSUS, and have the
same legal force as the text of the headings.” Roche
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NUTRICIA NORTH AMERICA, INC. v. US 11
Vitamins, Inc. v. United States, 772 F.3d 728, 731 (Fed. Cir.
2014). We generally give tariff terms their “common and
commercial meanings, which are presumed to be the
same,” Carl Zeiss, Inc. v. United States, 195 F.3d 1375,
1379 (Fed. Cir. 1999), and we may also consult the non-
binding explanatory notes to “help resolve an interpretive
dispute” about the meaning of headings and relevant sec-
tion or chapter notes. Shamrock, 119 F.4th at 1352 (citing
Kahrs International, Inc. v. United States, 713 F.3d 640,
644–45 (Fed. Cir. 2013)).
B
The two binding sources for determining whether the
medical foods here are covered by heading 3004 are 3004’s
language and chapter 30 note 1(a)’s language. The CIT did
not rely on the former to find medical foods to be outside
heading 3004, and the government here makes essentially
no argument for such a conclusion based on the language
of 3004. The dispositive issue, then, is what to make of
chapter 30 note 1(a). Before turning to that issue, how-
ever, we recite the compelling reasons that Nutricia’s prod-
ucts come within 3004’s language, as confirmed by the
absence of a contrary analysis from the CIT or the govern-
ment.
1
It is undisputed that Nutricia’s products are “medical
foods,” as defined under the FDCA. They are “formulated”
to be used “under the supervision of a physician” for “the
specific dietary management of a disease or condition for
which distinctive nutritional requirements . . . are estab-
lished by medical evaluation.” 21 U.S.C. § 360ee(b)(3).
They are “specially formulated and processed product[s]
(as opposed to a naturally occurring foodstuff used in its
natural state)” for “feeding of a patient by means of oral
intake or enteral feeding by tube”; are intended for a pa-
tient with “therapeutic or chronic medical needs” linked to
impaired intake or processing capacities or other “special
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NUTRICIA NORTH AMERICA, INC. v. US 12
medically determined nutrient requirements” that cannot
be managed “by the modification of the normal diet alone”;
“provide[ ] nutritional support specifically modified for the
management of the unique nutrient needs that result from
the specific disease or condition, as determined by medical
evaluation”; and are “intended to be used under medical
supervision” and “only for a patient receiving active and
ongoing medical supervision wherein the patient requires
medical care on a recurring basis for, among other things,
instructions on the use of the medical food.” 21 C.F.R.
§ 101.9(j)(8).
Those characteristics bring the products at issue
within heading 3004’s language of “medicament.” The
term has standard, broad definitions that embrace a sub-
stance designed for medically defined therapy for (i.e.,
treatment of) a medically identified condition. See, e.g.,
CIT Decision, at 1370–71 & n.3; J.A. 4873–74. Its scope is
not defined by what is regulated as a “drug” under the
FDCA, 21 U.S.C. § 321(g)(1), and Congress, in head-
ing 3004, did not use the term “drug,” whereas it used that
term repeatedly in chapter 29 of the HTSUS. Nothing
about the broad term “medicament” excludes therapeutic
substances formulated to prevent or to moderate outbreaks
of symptoms of medical conditions, such as those which are
incurable.
Nutricia’s products meet the requirements of head-
ing 3004 that the covered “medicaments” “consist[ ] of
mixed or unmixed products for therapeutic or prophylactic
uses, put up in measured doses . . . or in forms or packings
for retail sale.” Nutricia’s medical foods are mixed prod-
ucts that are consumed in measured dosages and are avail-
able through retail sale (which does not imply mass-market
general consumer marketing). J.A. 861, 4897. And they
are made, prescribed, and marketed for “therapeutic and
prophylactic uses” (which might be inherent in the very
term “medicament”), as the government recognizes. See
Appellee’s Br. at 16–17, 28 (“[T]here is no dispute that the
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NUTRICIA NORTH AMERICA, INC. v. US 13
medical foods are used in nutritional therapy to treat even
drug-resistant conditions like intractable epilepsy. . . .
That Nutricia’s medical foods do not ‘cure’ thus does not
render them non-therapeutic[.]”). Indeed, as the CIT ob-
served when discussing the chapter 98 ground, which in-
volves the term “therapeutic,” the parties effectively agree
that Nutricia’s medical foods are “‘indicated for use in the
treatment of a variety of diseases, predominantly in very
young children,’ [and] that ‘in some instances they are the
only, or primary, available treatment to ameliorate these
severe and sometimes fatal conditions’ and that ‘[m]edical
professionals refer to the deployment of these products as
‘nutritional therapy,’ thus confirming their therapeutic use
and value.” CIT Decision, at 1381 (alteration in original).
We have held that heading 3004 is a “use” provision,
meaning that it “limits the category [of products] to those
[ ] for specified uses,” and “the controlling use is the princi-
pal use.” Warner-Lambert Co. v. United States, 425 F.3d
1381, 1384 (Fed. Cir. 2005) (internal quotation marks omit-
ted); Rule 1(a), HTSUS Additional U.S. Rules of Interpre-
tation. Here, the definitions of “medical foods” under the
FDCA make clear that the medical foods at issue are prin-
cipally used therapeutically or prophylactically for specific
medical conditions under medical supervision. And other
evidence confirms the point, including the report submitted
by Nutricia’s expert, see, e.g., J.A. 169–70, Nutricia’s prod-
uct labels, J.A. 2638–81, and Nutricia’s marketing materi-
als directed to medical providers, who are responsible for
recommending the product to patients, J.A. 97–98, 183.
See Warner-Lambert, 425 F.3d at 1383 (treating such ma-
terial as relevant to use analysis).
For those reasons, if the language of heading 3004 were
the only binding provision, Nutricia would easily be correct
that the provision covers its products at issue here.
2
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NUTRICIA NORTH AMERICA, INC. v. US 14
But there is an additional binding provision. Note 1(a)
of chapter 30 states that chapter 30 does not cover “[f]oods
. . . (such as dietetic, diabetic or fortified foods, [and] food
supplements, . . .), other than nutritional preparations for
intravenous administration (section IV)[.]” The govern-
ment contends, and the CIT concluded, that note 1(a)—spe-
cifically, its listing of “dietetic . . . foods”—embraces
medical foods, thus excluding them from heading 3004 and
all the rest of chapter 30. CIT Decision, at 1371; Appellee’s
Br. at 13–20. We treat note 1(a) as “an integral part of the
HTSUS” and give it “the same legal force as the text of the
headings.” Roche Vitamins, 772 F.3d at 731 (citation omit-
ted); see also Magid Glove & Safety Manufacturing Co. LLC
v. United States, 87 F.4th 1352, 1358 (Fed. Cir. 2023) (“As
part of the legal text of the HTSUS, section and chapter
notes have the force of statutory law.”).
We proceed in accordance with the government’s own
formulation of the proper approach—that GRI 1 “provides
for the holistic consideration of the terms of the headings
‘and any relative section or chapter notes.’” Appellee’s Br.
at 17. That approach, which is consistent with the HTSUS-
specific General and Additional Rules of Interpretation, re-
flects a general legal principle that one statutory provision
should be interpreted in the light of other related provi-
sions, especially (but not only) provisions of the same stat-
ute, to achieve coherence where reasonable. See, e.g., Food
and Drug Administration v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 132–33 (2000); Teva Branded Pharma-
ceutical Products R&D, Inc. v. Amneal Pharmaceuticals of
New York, LLC, 124 F.4th 898, 917 (Fed. Cir. 2024);
ANTONIN S CALIA & BRYAN A. G ARNER , R EADING L AW : T HE
I NTERPRETATION OF L EGAL T EXTS at 180 (2012) (stating
that “[t]he provisions of a text should be interpreted in a
way that renders them compatible, not contradictory,” and
that “there can be no justification for needlessly rendering
provisions in conflict if they can be interpreted harmoni-
ously”). Of course, two provisions of a law can make clear,
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NUTRICIA NORTH AMERICA, INC. v. US 15
e.g., through an explicit “provided, however” or similar
clause, that one has primacy over the other. But neither
heading 3004 nor note 1(a) contains such primacy-estab-
lishing language. In this circumstance, we look to see if
note 1(a) warrants an interpretation that renders it con-
sistent with the clear meaning of heading 3004 in the re-
spect at issue. We conclude that note 1(a) should not be
read to embrace Nutricia’s medical foods—or, therefore, to
exclude them from heading 3004.
The dispute over the meaning of note 1(a) comes down
to the following. The government argues, as the CIT essen-
tially concluded, that note 1(a)—in its coverage of foods
“such as . . . dietetic . . . foods”—embraces any product used
for dietary reasons, as long as it “contain[s] only nutritional
substances,” even if it qualifies as a “medical food” under
the FDCA, it is not generally marketed to consumers, its
only meaningful use is as a medically supervised therapy
for specific medical conditions, and it is not a mere modifi-
cation of a generally available food item that retains the
item’s basic commercial character (e.g., fat-free milk, glu-
ten-free bread, or sugar-free soda) but a preparation made
out of chemical-level substances (such as specific amino ac-
ids, proteins, vitamins, etc.) for specific medical conditions.
Appellee’s Br. at 12; see also id. at 12–20. Nutricia argues
that note 1(a) should be read as limited to foods generally
marketed to consumers and used by many people outside
the above-noted context of therapy for specific conditions
under medical supervision, thus excluding all “medical
foods” or at least those specially formulated out of chemi-
cal-level substances rather than a mere modification of an
existing food item. Appellant’s Opening Br. at 52–57. In
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our view, Nutricia’s position is, on the whole, the better one
for several reasons taken together.4
One dictionary definition of “dietetic” on which the gov-
ernment relies is this: “adapted for use in special diets.”
Appellee’s Br. at 13 (emphasis added) (internal citations
omitted) (quoting Merriam-Webster Online Dictionary).
As applied to “foods,” that proposed definition does not
clearly help the government. An ordinary meaning of
“adapt” is to “adjust or modify” something preexisting,
RANDOM HOUSE D ICTIONARY OF THE ENGLISH L ANGUAGE 15
(College Edition 1968), and to “modify” is generally to alter
only “moderately or in minor fashion,” as the Supreme
Court explained in MCI Telecommunications Corp.
v. American Telephone & Telegraph Co., 512 U.S. 218, 225
(1994) (citations omitted). That definition tends to favor
Nutricia’s position more than the government’s, given the
character of the medical-food products as specially formu-
lated preparations made from chemical-level substances
for individuals with specific disorders, as the result is not
a mere modification of, nor resembles, a preexisting food
item. See Oral Arg. 4:58–6:11; 12:28–13:11, https://www.
cafc.uscourts.gov/oral-arguments/24-1436_10082025.mp3;
21 C.F.R. § 101.9(j)(8).
Congress’s overall drafting of note 1(a) also runs coun-
ter to the government’s position that the note covers all
foods that contain only nutritional substances (“other than
4 It appears at present that the best bottom-line stat-
utory interpretation, for substantive and practical reasons,
is that heading 3004 does—because note 1(a) does not—en-
compass anything that qualifies as a “medical food” under
the FDCA. We need not squarely adopt that categorical
rule in this case, however, as Nutricia’s products have
characteristics (e.g., concerning composition) that might go
beyond what is necessary to qualify as “medicaments” and
provide additional reason that they are outside note 1(a).
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nutritional preparations for intravenous administration”).5
Had Congress meant what the government urges, it had
other choices of phrasing—perhaps simply saying “foods or
beverages, other than . . . .” Instead, Congress included a
specific listing: “Foods or beverages (such as dietetic, dia-
betic or fortified foods, food supplements, tonic beverages
and mineral waters), other than . . . .” That choice itself
indicates adoption of a narrower scope for the note (to foods
or beverages “such as” the listed items) than the govern-
ment urges. Indeed, the government’s position runs coun-
ter to the surplusage canon of construction, which prefers
interpretations that “give[ ] effect to every clause and
word” of a provision. Marx v. General Revenue Corp., 568
U.S. 371, 385 (2013) (citation omitted and internal quota-
tion marks omitted); see ClearCorrect Operating, LLC v. In-
ternational Trade Commission, 810 F.3d 1283, 1294 (Fed.
Cir. 2015) (citing TRW Inc. v. Andrews, 534 U.S. 19, 31
(2001)). Indeed, the government’s broad view even as to
“dietetic” runs counter to the surplusage canon, as it would
make at least the separate mention of “diabetic” (perhaps
other items as well) “superfluous, void, or insignificant.”
ClearCorrect, 810 F.3d at 1294 (quoting TRW, 534 U.S. at
19); Jarecki v. G. D. Searle & Co., 367 U.S. 303, 307 (1961).
An additional canon of construction further indicates
that “dietetic” (and note 1(a) overall) should not be given
the broad meaning the government urges when it goes be-
yond the notion of a moderate alteration of an existing food
or beverage. The noscitur a sociis canon (the association of
5 We omit mention of the parenthetical “(section IV)”
in note 1(a). Although the CIT placed some reliance on that
parenthetical to support its ruling about the scope of
note 1(a), CIT Decision, at 1371, Nutricia explained why
that parenthetical does not support the CIT’s view, Appel-
lant’s Opening Br. at 57–60, and the government here
places no reliance on the parenthetical.
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NUTRICIA NORTH AMERICA, INC. v. US 18
words canon) counsels that a term in a series like this one
be given a meaning consistent with its neighboring terms.
See Schlumberger, 845 F.3d at 1165 (invoking the canon in
a HTSUS matter); see also United States v. Williams, 553
U.S. 285, 294 (2008); Ali v. Federal Bureau of Prisons, 552
U.S. 214, 225–26 (2008); Veterans4You LLC v. United
States, 985 F.3d 850, 862 (Fed. Cir. 2021). All the terms
other than “dietetic” fit Nutricia’s narrower understanding
of note 1(a)’s scope; “dietetic” should be understood the
same way.6
We consider, finally, the Explanatory Notes “main-
tained by the World Customs Organization,” which are “not
legally binding” but are “generally indicative of the proper
interpretation of a tariff provision.” CIT Decision, at 1369
(internal quotation marks and citations omitted). The ex-
planatory notes here do not alter our conclusion as to the
medical foods at issue.
The explanatory note to chapter 30 heading 3004
(which is, relevantly, identical to the note for head-
ing 3003) states that the heading’s “provisions . . . do not
apply to foodstuffs or beverages such as dietetic, diabetic or
fortified foods, tonic beverages or mineral waters (natural
or artificial), which fall to be classified under their own ap-
propriate headings,” J.A. 4836 (emphasis removed), and it
immediately adds: “This is essentially the case as regards
food preparations containing only nutritional substances,”
id.; see CIT Decision, at 1372. The first sentence does not
answer the question whether medical foods are dietetic
(the relevant term), and the second sentence states a gen-
eralization by its terms not absolute and not yet addressing
6 If “dietetic” appeared in the phrase as a catch-all,
such a narrowing would be supported by the closely related
ejusdem generis canon. See, e.g., Ali, 552 U.S. at 223–25;
Sports Graphics, Inc. v. United States, 24 F.3d 1390, 1392
(Fed. Cir. 1994).
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the situation of “medicinal” substances, i.e., substances for
therapy. When the note then addresses “foodstuffs and
beverages containing medicinal substances,” it says that
they are excluded from heading 3004 “if those substances
are added solely to ensure a better dietetic balance, to in-
crease the energy-giving or nutritional value of the product
or to improve its flavour, always provided that the product
retains its character of a foodstuff or a beverage,” J.A. 4836
(emphasis added), and in a similar vein, it says that also
excluded are “food supplements containing vitamins or
mineral salts which are put up for the purpose of maintain-
ing health or well-being but have no indication as to use for
the prevention or treatment of any disease or ailment,” id.
(emphasis added). See CIT Decision, at 1372–73. None of
this directly deals with medical foods or with the charac-
teristics we have discussed, including the specific formula-
tion and marketing for medically supervised use for specific
medical conditions. And the language offers some support,
if only by possible negative implication, for Nutricia’s posi-
tion that note 1(a) is inapplicable to its medical foods, given
their key characteristics.
An explanatory note for chapter 21—Explanatory Note
21.06 ¶ 16—supports Nutricia’s position. It states that
food preparations classifiable under heading 2106 “often”
have indications on the packaging that “they maintain gen-
eral health or well-being” but “[s]imilar preparations . . .
intended for the prevention or treatment of diseases or ail-
ments are excluded (heading 30.03 or 30.04).” J.A. 4438
(emphasis added). That statement positively suggests cov-
erage by heading 3004 for the medical foods here.
In sum, the applicability of heading 3004’s language to
medical foods is clear and not even meaningfully contested.
In contrast, there are substantial difficulties with conclud-
ing that Nutricia’s medical foods come within chapter
note 1(a) even when the note is considered alone, and the
nonbinding explanatory notes do not resolve those difficul-
ties in the government’s favor. In this circumstance, the
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narrow view of note 1(a) is also supported by the principle
favoring an interpretation that achieves consistency with
the clearly applicable language of heading 3004.
III
We reverse the CIT’s classification of the medical foods
under HTSUS chapter 21 and hold that the proper classifi-
cation is heading 3004. We remand for the CIT to decide
the proper subheading, which may not be in dispute.
The parties shall bear their own costs.
REVERSED and REMANDED
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