The opinion
Slip Op. 23-170
UNITED STATES COURT OF INTERNATIONAL TRADE
NUTRICIA NORTH AMERICA, INC.,
Plaintiff,
Before: Timothy C. Stanceu, Judge
v.
Court No. 16-00008
UNITED STATES,
Defendant.
OPINION
[Granting defendant’s cross-motion for summary judgment on the tariff
classifications of various nutritional preparations intended for use by patients with
medical conditions]
Dated: December 4, 2023
John B. Brew, Crowell & Moring LLP, of Washington, D.C., for plaintiff. With
him on the briefs was Alexander H. Schaefer. Also on the briefs were Maria T. Vanikiotis
and Alexander T. Rosen, Crowell & Moring LLP, of New York, N.Y.
Luke Mathers, Trial Attorney, Commercial Litigation Branch, Civil Division, U.S.
Department of Justice, of New York, N.Y., for defendant. With him on the briefs were
Brian M. Boynton, Principal Deputy Assistant Attorney General, Patricia M. McCarthy,
Director, Justin R. Miller, Attorney-In-Charge, and Aimee Lee, Assistant Director,
Commercial Litigation Branch. Of counsel on the briefs was Yelena Slepak, Office of the
Assistant Chief Counsel for International Trade Litigation, U.S. Customs and Border
Protection.
Stanceu, Judge: Plaintiff Nutricia North America, Inc. (“Nutricia”), contesting the
denials by U.S. Customs and Border Protection (“Customs” or “CBP”) of its
administrative protests, claims that Customs incorrectly determined the tariff
Court No. 16-00008 Page 2
classification of five imported products it describes as “medical foods.” Before the court
are the parties’ cross-motions for summary judgment. The court awards summary
judgment in favor of defendant United States.
I. BACKGROUND
The merchandise was imported on four entries made in November 2014 at the
ports of Philadelphia, Pennsylvania and Washington-Dulles. Upon CBP’s denial of its
protests of the liquidations of these entries, plaintiff commenced this action. Summons
(Jan. 8, 2016), ECF No. 1.
Plaintiff moved for summary judgment, arguing for tariff classification in either
of two duty-free tariff classifications. Pl.’s Mot. for Summary J. (Aug. 31, 2022), ECF
Nos. 73 (Conf.), 74 (Public); Mem. of Law and Authorities in Supp. of Pl.’s Mot. for
Summary J. (Aug. 31, 2022), ECF Nos. 73 (Conf.), 74 (Public) (“Pl.’s Br.”). Defendant
responded and cross-moved for summary judgment, maintaining that the tariff
classification determined by Customs upon liquidation of the entries was correct. Def.’s
Cross-Mot. for Summary J. and Resp. in Opp’n to Pl.’s Mot. for Summary J. (Oct. 28,
2022), ECF Nos. 80 (Conf.), 81 (Public); Def.’s Mem. in Supp. of its Cross-Mot. for
Summary J. and Resp. in Opp’n to Pl.’s Mot. for Summary J. (Oct. 28, 2022), ECF Nos. 80
(Conf.), 81 (Public) (“Def.’s Br.”).
Court No. 16-00008 Page 3
II. DISCUSSION
A. Jurisdiction and Standard of Review
The court exercises jurisdiction according to Section 201 of the Customs Courts
Act of 1980, 28 U.S.C. § 1581(a)1, which grants the court “exclusive jurisdiction of any
civil action commenced to contest the denial of a protest, in whole or in part, under
section 515” of the Tariff Act of 1930 (“Tariff Act”), as amended, 19 U.S.C. § 1515. The
court adjudicates de novo actions to contest the denial of a protest. 28 U.S.C. § 2640(a)(1)
(“The Court of International Trade shall make its determinations upon the basis of the
record made before the court.”).
The court shall grant summary judgment “if the movant shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a
matter of law.” USCIT R. 56(a). In a tariff classification dispute, summary judgment is
appropriate where “there is no genuine dispute as to the nature of the merchandise and
the classification determination turns on the proper meaning and scope of the relevant
tariff provisions.” Deckers Outdoor Corp. v. United States, 714 F.3d 1363, 1371 (Fed. Cir.
2013) (citations omitted).
1
All citations herein to the United States Code are to the 2012 edition.
Court No. 16-00008 Page 4
B. Description of the Merchandise
The facts stated in this Opinion to describe the imported merchandise are taken
from the submissions of the parties in support of their respective summary judgment
motions and are not in dispute between the parties. From a review of these
submissions, the court concludes that there is no genuine dispute as to the facts material
to the classification of the products at issue.
The five imported products at issue in this case are “MSUD Lophlex® LQ,”
“Periflex® Infant,” “Periflex® Junior,” “Neocate® Junior,” and “Ketocal® Liquid.”
Plaintiff describes the five imported products as “certain Medical Foods, which are a
unique class of products defined and regulated by the Food and Drug Administration
(‘FDA’) under the Orphan Drug Act, 21 U.S.C. § 360ee.” Pl.’s Br. 1. Plaintiff further
describes these products as “Medical Foods that are specially designed, produced and
intended for use by infants or toddlers who suffer from a variety of diseases or
disorders.” Id. (citations omitted). All five products are labeled as having been
manufactured in Liverpool, United Kingdom. Id. at Exs. 20A–20E.
MSUD Lophlex® LQ “is used as nutrition therapy for children who suffer from a
severe, life threatening, and permanent disorder called branched-chain alpha ketoacid
dehydrogenase complex (BCKDC) deficiency, (also called Maple Syrup Urine Disease
or MSUD), an inborn error of the metabolism” that causes “impaired ability to
Court No. 16-00008 Page 5
metabolize three of the twenty essential amino acids: leucine, valine and isoleucine.” Id.
at 6–7 (citations omitted).
Periflex® Infant and Periflex® Junior are produced for use by patients with
Phenylketonuria (PKU), which is an “inborn error of metabolism of phenylalanine” that
is “characterized by inadequate formation of L-tyrosine, elevation of serum
L-phenylalanine, urinary excretion of phenylpyruvic acid and other derivatives, and
accumulation of phenylalanine and its metabolites.” Id. at 8 (citation omitted). The
condition “can produce brain damage resulting in severe mental retardation, often with
seizures, other neurologic abnormalities such as retarded myelination and deficient
melanin formation leading to hypopigmentation of the skin and eczema.” Id. (citation
omitted).
Neocate® Junior is produced for use by patients who suffer from Eosinophilic
Esophagitis (EoE), which is “an immune-mediated disease of the esophagus,” id. at 10
(citation omitted), Short Bowel Syndrome (SBS), which “may occur when those portions
of the small intestine have been removed or when portions of the small intestine are
missing or damaged at birth,” id. at 11 (citation omitted), and other diseases and
disorders, id. at 10 (citations omitted).
Ketocal® Liquid is produced for use by patients who suffer from
Intractable/Refractory Epilepsy, Glucose Transporter Type 1 Deficiency (GLUT 1), and
other diseases and disorders. Id. at 12–13. GLUT 1 “is a lifelong genetic metabolic
Court No. 16-00008 Page 6
disorder that occurs as a result of mutation in the SLC2A1 gene.” Id. at 13 (citation
omitted). “Persons with GLUT 1 demonstrate epilepsy, developmental delays, acquired
microcephaly, cognitive impairment and varying degrees of spasticity, ataxia, and
dystonia.” Id. (citation omitted).
C. Tariff Classification under the HTSUS
Tariff classification under the Harmonized Tariff Schedule of the United States
(“HTSUS”) is governed by the General Rules of Interpretation (“GRIs”) and, if
applicable, the Additional U.S. Rules of Interpretation (“ARIs”), both of which are
contained in the statutory text of the HTSUS. Dependable Packaging Solutions, Inc. v.
United States, 757 F.3d 1374, 1377 (Fed. Cir. 2014) (citations omitted) (“Along with the
headings and subheadings . . . the HTSUS statute also contains the ‘General Notes,’ the
‘General Rules of Interpretation’ (‘GRI’), the ‘Additional United States Rules of
Interpretation’ (‘ARI’), and various appendices for particular categories of goods.”).
The GRIs are applied in numerical order, with GRI 1 providing, in pertinent part,
that “classification shall be determined according to the terms of the headings and any
relative section or chapter notes.” GRI 1, HTSUS. GRIs 2 through 5 apply “provided
such headings or notes do not otherwise require.” Id.
After determining the correct four-digit heading, the court determines the correct
subheading by applying GRI 6, HTSUS (directing determination of the subheading
Court No. 16-00008 Page 7
“according to the terms of those subheadings and any related subheading notes and,
mutatis mutandis, to the above rules” [GRIs 1 through 5]).
D. Judicial Review in Tariff Classification Disputes
In adjudicating a tariff classification dispute, the court first considers whether
“the government’s classification is correct, both independently and in comparison with
the importer’s alternative.” Jarvis Clark Co. v. United States, 733 F.2d 873, 878 (Fed. Cir.
1984) (“Jarvis Clark”). The plaintiff has the burden of showing that the government’s
classification of the subject merchandise was incorrect. Id., 733 F.2d at 876. Subject to
the plaintiff’s rebuttal, factual determinations by Customs are presumed correct, see
28 U.S.C. § 2639(a)(1), but the presumption of correctness applies to issues of fact and
not questions of law, Goodman Mfg. L.P. v. United States, 69 F.3d 505, 508 (Fed. Cir. 1995).
If the plaintiff satisfies its burden of demonstrating that the government’s classification
was incorrect, the court must ascertain “the correct result, by whatever procedure is best
suited to the case at hand.” Jarvis Clark, 733 F.2d at 878 (footnote omitted).
In determining the correct classification, the court undertakes a two-step
analysis. Faus Grp., Inc. v. United States, 581 F.3d 1369, 1371 (Fed. Cir. 2009). “The first
step addresses the proper meaning of the relevant tariff provisions, which is a question
of law.” Id. (citation omitted). “The second step involves determining whether the
merchandise at issue falls within a particular tariff provision as construed, which, when
disputed, is a question of fact.” Id. at 1371–72 (citation omitted).
Court No. 16-00008 Page 8
“Absent contrary legislative intent, HTSUS terms are to be construed according
to their common and commercial meanings.” La Crosse Tech., Ltd. v. United States, 723
F.3d 1353, 1358 (Fed. Cir. 2013) (quoting Carl Zeiss, Inc. v. United States, 195 F.3d 1375,
1379 (Fed. Cir. 1999)). When interpreting tariff terms in the HTSUS, the court “may
consult lexicographic and scientific authorities, dictionaries, and other reliable
information sources.” Carl Zeiss, 195 F.3d at 1379 (citing Baxter Healthcare Corp. of P.R. v.
United States, 182 F.3d 1333, 1337 (Fed. Cir. 1999)).
The court also consults the Explanatory Notes (“ENs”) for the Harmonized
Commodity Description and Coding System (“Harmonized System” or “HS”)
maintained by the World Customs Organization. Although not legally binding, the
Explanatory Notes “are generally indicative of the proper interpretation of a tariff
provision.” Degussa Corp. v. United States, 508 F.3d 1044, 1047 (Fed. Cir. 2007) (citing
Motorola, Inc. v. United States, 436 F.3d 1357, 1361 (Fed. Cir. 2006)). The HTSUS is
organized according to Harmonized System rules and nomenclature (pursuant to the
“Harmonized System Convention”). The Explanatory Notes are informative as to the
intent of the drafters of the Harmonized System where, as in this case, the dispute
involves a legal determination of the scope of the competing headings as determined
under the GRIs.
Court No. 16-00008 Page 9
E. Claims of the Parties
Upon liquidation, Customs classified Nutricia’s imported products in
subheading 2106.90.9998, HTSUS2 (“Food preparations not elsewhere specified or
included: Other: Other: Other: Other: Other: Other: Other: Other: Other: Other”), subject
to duty at 6.4% ad valorem. Defendant maintains that this classification determination is
correct.
Plaintiff claims classification of the products in subheading 3004.50.5040, HTSUS
(“Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or
unmixed products 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: Other medicaments containing vitamins or other products of
heading 2936: Other: Other: Other”), free of duty.
In the alternative, plaintiff claims classification of the products in a special U.S.
duty-free tariff classification provision within chapter 98, HTSUS, specifically,
subheading 9817.00.96 (“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”).
2
The products at issue were subject to the tariff provisions set forth in the
version of the Harmonized Tariff Schedule of the United States (“HTSUS”) that was in
effect on the dates of entry. References to the HTSUS herein are to the 2014 version.
Court No. 16-00008 Page 10
The court first determines the correct classification of the five products according
to the GRIs and the tariff provisions in chapters 1 through 97, HTSUS. It then addresses
the issue of whether these products qualify for the special classification provision
plaintiff claims in the alternative.
F. Application of GRI 1, HTSUS, to Determine the Appropriate Heading
As required by GRI 1, HTSUS, the court first considers the terms of the headings
and any relative section and chapter notes in ascertaining the correct four-digit heading
for the classification of the imported products. The parties have identified the following
candidate headings:
Heading 2106, HTSUS: “Food preparations not elsewhere specified or
included”
Heading 3004, HTSUS: “Medicaments (excluding goods of heading
3002, 3005 or 3006) consisting of mixed or
unmixed products 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”
The parties have not advocated, and the court has not identified, any other candidate
headings within chapters 1 through 97, HTSUS.
1. Classification under Heading 3004 Is Precluded by Note 1(a) to Chapter 30
The terms of headings 3003 and 3004 are in parallel and similar in description,
except that heading 3003 is limited to mixed products “not put up in measured doses or
in forms or packings for retail sale,” as follows:
Court No. 16-00008 Page 11
Heading 3003, HTSUS: “Medicaments (excluding goods of heading
3002, 3005 or 3006) consisting of two or more
constituents which have been mixed together
for therapeutic or prophylactic uses, not put up
in measured doses or in forms or packings for
retail sale”
Heading 3003, HTSUS (emphasis added). Thus, the products of heading 3004, unless
unmixed, would be classified under heading 3003 if imported in bulk form. Although
the HTSUS does not define the heading term “medicament,” the Explanatory Note to
HS heading 30.03 states, in language equally applicable to heading 30.04, that “[t]his
heading covers medicinal preparations for use in the internal or external treatment or
prevention of human or animal ailments.”3 EN 30.03 (2014) (emphasis added).4
It could be argued that the products under consideration are medicaments
because they are “for use in the internal . . . treatment . . . of human . . . ailments.” Id.
3
Similarly, dictionaries consider the term “medicament” synonymous with terms
such as “medicinal substance” and “medication.” As defendant points out, Webster’s
Third New International Dictionary and the Merriam-Webster Online Dictionary define
“medication” as “a medicinal substance: MEDICAMENT.” Def.’s Mem. in Supp. of its
Cross-Mot. for Summary J. and Resp. in Opp’n to Pl.’s Mot. for Summary J. 14 (Oct. 28,
2022), ECFs No. 80 (Conf.), 81 (Public); Medication, WEBSTER’S THIRD NEW
INTERNATIONAL DICTIONARY UNABRIDGED (2002); Medication, MERRIAM-
WEBSTER, https://www.merriam-webster.com/dictionary/medication (last visited Dec. 4,
2023). The Oxford English Dictionary defines “medicament” as “a substance used for
medical treatment; a medicine, remedy.” Medicament, OXFORD ENGLISH DICTIONARY,
https://www.oed.com/dictionary/medicament_n?tab=meaning_and_use#37536447 (last
visited Dec. 4, 2023) (emphasis added).
Citations to the Explanatory Notes of the Harmonized Commodity Description
4
and Coding System are to the 2014 edition.
Court No. 16-00008 Page 12
To that end, plaintiff maintains that “the subject products were conceived, designed,
produced, marketed, and sold for ‘therapeutic or prophylactic use’ to treat persons with
medical problems, which is the defining characteristic of a medicament.” Pl.’s Br. 20.
Plaintiff adds that “[m]edical professionals refer to the deployment of these products as
‘nutritional therapy,’ thus confirming their therapeutic use and value” and that “as
FDA-regulated ‘medical foods’ the subject products are the ‘medicine’ that doctors will
prescribe or recommend to treat children suffering from the referenced diseases.” Id.
Nutricia argues that in order for defendant to prevail “it must demonstrate that
the subject products are not medicaments” and that “[i]t cannot do so, because the tariff
provisions, coupled with the record evidence, establish that the subject products are
indeed medicaments.” Id. The court does not agree with this analysis. Even if some
definitions of the term “medicaments” were considered broad enough to encompass
what plaintiff describes as “nutritional therapy” or “medical food” products, it would
not follow that chapter 30, HTSUS necessarily includes these products. GRI 1 requires
the court first to determine classification according to “any relative section and chapter
notes,” as well as the terms of the headings when interpreted according to intended
meaning. GRI 1, HTSUS. To rule in favor of plaintiff’s claim for classification under
heading 3004, the court would need to agree with plaintiff’s argument that its preferred
classification under heading 3004 is not precluded by a pertinent chapter note, note 1(a)
to chapter 30, HTSUS. But the court must reject that argument.
Court No. 16-00008 Page 13
Note 1(a) to chapter 30, HTSUS expressly excludes from chapter 30, and
therefore from heading 3004, “[f]oods or beverages (such as dietetic, diabetic or fortified
foods, food supplements, tonic beverages and mineral waters), other than nutritional
preparations for intravenous administration (section IV).” The reference to “section IV”
indicates that the products described in the note, i.e., “foods . . . other than nutritional
preparations for intravenous administration,” are to be classified in section IV of the
HTSUS, which includes chapter 21, rather than in section VI (which includes
chapter 30).
In making an exception to the general exclusion that it applies to chapter 30,
note 1(a) specifically references “nutritional preparations for intravenous
administration.” This term necessarily is interpreted to include nutritional preparations
administered intravenously to treat or manage a medical condition, typically in a
hospital or similar clinical setting. See EN 30.03 (specifying that the heading includes
“[n]utritional preparations for intravenous administration only, i.e., by injection or drip
into a vein.”). The implication of this narrow exception to the general exclusion created
by note 1(a) to chapter 30, HTSUS is that other “nutritional preparations,” e.g., those
formulated to be taken orally by persons with specific medical conditions, possibly are
within that general exclusion.
Because Nutricia’s imported products are not for intravenous administration, the
question is whether these products are “foods or beverages” within the meaning of
Court No. 16-00008 Page 14
those terms as used in note 1(a) to chapter 30, HTSUS. The note identifies “dietetic”
and “diabetic” foods or beverages as an example of goods that are within the exclusion
from chapter 30 created by note 1(a), connoting that even foods specialized for intended
use by persons whose medical condition requires a specialized diet fall within the scope
of that exclusion. In describing the products encompassed by that exclusion, the
chapter note does not distinguish what plaintiff would call “medical foods” from other
foods, except for the narrow class of goods comprised of nutritional preparations for
intravenous administration.
The uncontested facts demonstrate that the note 1(a) exclusion to chapter 30
applies to the products at issue in this litigation. Plaintiff itself describes the five
products as “Medical Foods, which are a unique class of products defined and
regulated by the Food and Drug Administration under the Orphan Drug Act, 21 U.S.C.
§ 360ee.” Pl.’s Br. 1. As plaintiff points out, § 360ee defines the term “Medical Food” as
“[a] food which is formulated to be consumed or administered enterally under the
supervision of a physician and which is intended for the specific dietary management of
a disease or condition for which distinctive nutritional requirements, based on
recognized scientific principles, are established by medical evaluation.” Id. (quoting
21 U.S.C. § 360ee) (emphasis added).
The HS Explanatory Notes, which although not part of U.S. law are indicative of
the intended meaning of heading terms and section and chapter notes, further indicate
Court No. 16-00008 Page 15
that note 1(a) to chapter 30 precludes classification of Nutricia’s products under
heading 3004. The Explanatory Notes for headings 30.03 and 30.04, which are
essentially identical, provide as follows:
The provisions of the heading text 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 appropriate headings. This is essentially the case as regards
food preparations containing only nutritional substances. The major
nutritional substances in food are proteins, carbohydrates and fats.
Vitamins and mineral salts also play a part in nutrition.
Similarly foodstuffs and beverages containing medicinal
substances are excluded from the heading if those substances are added
solely to ensure a better dietetic balance, to increase 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.
Moreover, products consisting of a mixture of plants or parts of
plants or consisting of plants or parts of plants mixed with other
substances, used for making herbal infusions or herbal “teas” (e.g., those
having laxative, purgative, diuretic or carminative properties), and
claimed to offer relief from ailments or contribute to general health and
well-being, are also excluded from this heading (heading 21.06).
Further, this heading excludes food supplements containing
vitamins or mineral salts which are put up for the purpose of maintaining
health or well-being but have no indication as to use for the prevention or
treatment of any disease or ailment. These products which are usually in
liquid form but may also be put up in powder or tablet form, are
generally classified in heading 21.06 or Chapter 22.
On the other hand, the heading covers preparations in which the
foodstuff or the beverage merely serves as a support, vehicle or
sweetening agent for the medicinal substances (e.g., in order to facilitate
ingestion).
Court No. 16-00008 Page 16
EN 30.03, EN 30.04. These Explanatory Notes indicate that note 1(a) to chapter 30 was
intended to draw a bright line between the medicaments of chapter 30 and the foods,
including specialized foods taken orally by persons with medical needs (including, for
example, diabetics), that are to be classified elsewhere in the HS nomenclature. Under
the guidance provided by these ENs, a preparation in which “nutritional substances”
are present only to support a “medicinal substance” (as described in the last paragraph
quoted above) would be classified under HS heading 30.03 or 30.04. Such a product is
to be distinguished from a product comprised entirely of nutritional substances
(described in the first paragraph quoted above), or in which medicinal substances are
present “solely to ensure a better dietetic balance” or “to increase the energy-giving or
nutritional value of the product,” EN 30.03, EN 30.04 (described in the second
paragraph quoted above), which would not. According to this guidance, it is not
sufficient for classification within heading 3003 or 3004, HTSUS that a preparation be
formulated to treat or manage a medical condition: it must do so by administering a
“medicinal substance.” If, instead, the management of the condition is effected solely
by a combination of “nutritional substances,” the preparation is excluded from heading
3003 and 3004 (and from chapter 30 in the entirety) by note 1(a) to chapter 30, HTSUS.
As shown by the uncontested facts, Nutricia’s products fit that description.
Plaintiff acknowledges that the five products provide “nutritional therapy.” Pl.’s
Br. 28 (emphasis added). All of the ingredients in each of Nutricia’s products
Court No. 16-00008 Page 17
(described below) are “nutritional substances.” Four of the products in question,
“MSUD Lophlex® LQ,” “Periflex® Infant,” “Periflex® Junior,” and “Neocate® Junior,”
treat one or more medical conditions by means of specially-formulated combinations of
multiple amino acids and other ingredients, as described below. Proteins are included
within the scope of the term “nutritional substances.” See, e.g., EN 30.04. Citing an
expert witness report, plaintiff recognizes that “[p]roteins are essential to the growth
and function of all living organisms, and are comprised of varying sequences of twenty
different amino acids.” Pl.’s Br. 5 (citing Plaintiff’s Expert Report of Dr. Jonah Essers at 9
(May 27, 2022), Pl.’s Br. Ex. 1 (“Essers Report”)). Plaintiff adds that “[h]umans source
proteins (amino acids) by ingesting plant or animal-based foods.” Id. The fifth product,
Ketocal® Liquid, also contains amino acids and manages intractable or refractory
epilepsy and Glucose Transporter Type 1 deficiency by providing “a ‘ketogenic’ diet
that is high in fat, low in carbohydrates, and contains controlled proportions of
protein.” Pl.’s Br. 13 (citing Pl.’s Br. Ex. 5E, at 2).
Nutricia does not contend, and the report of its own expert witness would rebut
an assertion that, amino acids are outside of the common and ordinary meaning of the
term “nutritional substances.” See Pl.’s Br. 5 (explaining that humans source amino
acids “by ingesting plant or animal-based foods” and, citing Essers Report at 9, that
“[p]roteins are essential to the growth and function of all living organisms”). The other
Court No. 16-00008 Page 18
ingredients in each of the five products, described below, also are nutritional
substances.
Plaintiff states that MSUD Lophlex® LQ contains a combination of 15 amino
acids that does not include the “branch chain” amino acids (“BCAA”), which are
leucine, valine, and isoleucine. Pl.’s Br. 7. Nutricia explains that BCAA, if present in the
diet in more than minimal amounts, are toxic to children who have branched-chain
alpha ketoacid dehydrogenase complex (BCKDC) deficiency (also called Maple Syrup
Urine Disease or MSUD), an inborn error of the metabolism. Id. at 6–7 (citations
omitted). The product is formulated to “provide the minimal amount of BCAA needed
for life, without providing any excess that elicits toxicity.” Id. at 8 (citing Essers Report
at 10). Plaintiff adds that “[o]ther ingredients provided in the formula include: water,
apple, grape, blackcurrent [sic] and elderberry juice concentrates, which are included to
provide carbohydrates needed for energy and taste.” Id. (citing Essers Report at 18 and
Pl.’s Br. Ex. 7). Packaging for MSUD Lophlex® LQ, in 4.2-fluid-ounce “pouches,” is
labeled as “Mixed Berry Blast” and provides as follows:
A leucine, isoleucine and valine-free, berry flavored ready-to-drink
medical food containing mixed fruit juices from concentrate, amino acids,
vitamins, trace elements, and some minerals. Contains docosahexaenoic
acid (DHA). For the dietary management of proven Maple Syrup Urine
Disease (MSUD) in individuals 4 years and older, including pregnant
women (in conjunction with standard folic acid supplementation).
Court No. 16-00008 Page 19
Pl.’s Br. Ex. 20A. The label also states: “Contains 44% fruit juice from concentrate and
natural flavors.”5 Id.
Plaintiff states that Periflex® Infant and Periflex® Junior are used to treat infants
and children, respectively, who have Phenylketonuria (PKU), “an inborn error of
metabolism,” the “prevailing treatment” for which “is a diet low or absent in foods that
contain phenylalanine, which is a common amino acid, and the inclusion of certain
supplements to provide the minimum amount of phenylalanine required for synthesis
5
The ingredients of MSUD Lophlex® LQ are listed on the label as follows:
Ingredients: Water, apple juice from concentrate (34.1%), grape
juice from concentrate (6.9%), blackcurrant juice from concentrate (2.5%),
L-lysine acetate, L-proline, citric acid, L-tyrosine, L-arginine, glycine,
L-serine, L-aspartic acid, L-alanine, L-threonine, corn syrup solids,
L-cystine, L-phenylalanine, dicalcium phosphate, L-histidine, elderberry
juice from concentrate (0.6%), maltodextrin, magnesium acetate, N-acetyl
L-methionine, L-tryptophan, choline bitartrate, C. cohnii oil*, sugar,
microcrystalline cellulose, natural flavor, fruit concentrate (apple,
blackcurrant, radish), L-ascorbic acid, taurine, guar gum, lecithin, xanthan
gum, M-inositol, potassium sorbate (preservative), artificial sweetener:
sucralose, ferrous lactate, artificial sweetener: acesulfame potassium,
sodium benzoate (preservative), zinc sulfate, L-carnitine, niacinamide,
DL-alpha tocopheryl acetate, calcium D-pantothenate, manganese sulfate,
cupric sulfate, thiamine chloride hydrochloride, pyridoxine
hydrochloride, vitamin A palmitate, riboflavin, folic acid, potassium
iodide, ascorbyl palmitate, mixed tocopherols, sodium molybdate,
D-biotin, sodium selenite, chromium chloride, phylloquinone, vitamin D3,
cyanocobalamin.
*A source of docosahexaenoic acid (DHA)
Mem. of Law & Authorities in Supp. of Pl.’s Mot. for Summary J. Ex. 20A
(Aug. 31, 2022), ECF Nos. 73 (Conf.), 74 (Public) (“Pl.’s Br.”).
Court No. 16-00008 Page 20
of body proteins.” Id. at 8–9 (quoting Pl.’s Br. Ex. 9 and citing Essers Report at 11–12,
19–20, 24).
Periflex® Infant contains a combination of 17 amino acids that does not include
phenylalanine and is not naturally found in foods. Id. at 9 (citing Essers Report at 19 and
Pl.’s Br. Ex. 11). “Other ingredients in Periflex® Infant, include: essential vitamins,
minerals, fats and carbohydrates.”6 Id. at 10 (citing Essers Report at 20 and Pl.’s Br.
Ex. 11). Sample packaging in a 14-ounce canister is labeled as a powdered infant
formula, as follows:
6
The ingredients of Periflex® Infant are listed on the label as follows:
Ingredients: Corn syrup solids, refined vegetable oil (high oleic
sunflower, soy, coconut), calcium phosphate dibasic, L-arginine
L-aspartate, tri-potassium citrate, L-leucine, L-lysine acetate, L-tyrosine,
L-glutamine, L-proline, L-valine, glycine, L-isoleucine, CAEM (an
emu[l]sifier), L-threonine, L-serine, L-histidine, L-alanine, sodium
chloride, l-cystine, L-tryptophan, L-methionine, magnesium acetate,
magnesium L-aspartate, potassium chloride, M. alpina oil*, choline
bitartrate, M-inositol, C. cohnii oil**, L-ascorbic acid, ferrous sulfate, zinc
sulfate, taurine, L-carnitine, niacinamide, sunflower oil, DL-alpha
tocopherol acetate, calcium-d-pantothenate, cupric sulfate, manganese
sulfate, pyridoxine hydrochloride, riboflavin, vitamin A acetate, thiamine
chloride hydrochloride, ascorbyl palmitate, potassium iodide, chromium
sulfate, mixed tocopherols, DL-alpha tocopherol, phylloquinone, sodium
molybdate, folic acid, sodium hydrogen selenite, D-biotin, vitamin D3,
cyanocobalamin.
* A source of arachidonic acid(ARA)
** A source of docosahexaenoic acid (DHA)
Pl.’s Br. Ex. 20B.
Court No. 16-00008 Page 21
Periflex Infant is a phenylalanine-free, iron-fortified infant formula
containing a balance[d] mixture of other essential and non-essential amino
acids, carbohydrate, fat, vitamins, minerals and trace elements. Periflex
Infant also contains DHA and ARA, which are found in breast milk and
are important for infant brain and eye development.
Id. at Ex. 20B. “Directions for Preparation and Use” instruct the consumer to “add five
level scoops” to 5 fluid ounces of “warm or cool sterile water.” Id.
Periflex® Junior contains a combination of 18 amino acids and also “essential
vitamins, minerals, fats and carbohydrates.”7 Id. at 10 (citing Essers Report at 20–21 and
Pl.’s Br. Ex. 14). Sample packaging in a 16-ounce canister is labeled as follows:
Periflex Junior is a phenylalanine-free powder containing a
balanced mixture of the other essential and non-essential amino acids,
carbohydrate, fat, vitamins, minerals and trace elements. For the dietary
management of phenylketonuria in toddlers and young children.
7
The ingredients of Periflex® Junior are listed on the label as follows:
Ingredients: Corn syrup solids, canola oil, high oleic safflower oil,
L-glutamine, L-proline, L-asparagine, L-lysine hydrochloride,
tripotassium citrate, L-tyrsoine, L-leucine, disodium hydrogen phosphate,
L-valine, L-serine, L-isoleucine, tricalcium citrate, tricalcium phosphate,
L-alanine, maltodextrin, L-threonine, sugar, magnesium hydrogen
phosphate, L-citrulline, L-arginine, L-cystine, choline bitartrate, taurine,
fractionated coconut oil, CAEM (an emulsifier), L-histidine,
L-methoionine, L-tryptophan, L-ascorbic acid, M-inositol, ferrous sulfate,
zinc sulfate, L-carnitine, DL-alpha tocopheryl acetate, manganese sulfate,
niacinamide, calcium D-pantothenate, cupric sulfate, thiamine chloride
hydrochloride, pyridoxine hydrochloride, riboflavin, vitamin A acetate,
folic acid, potassium iodide, chromium chloride, sodium selenite, sodium
molybdate, phylloquinone, D-biotin, vitamin D3, cyanocobalamin.
Pl.’s Br. Ex. 20C.
Court No. 16-00008 Page 22
Id. at Ex. 20C. The “Directions for Preparation and Use” inform the consumer that
“[i]ntake is to be determined by a healthcare professional” and instruct the consumer to
“add the prescribed amount of powder” according to specified dilution guidelines. Id.
Plaintiff’s motion describes Neocate® Junior as a product “used to treat patients
who suffer from: (1) Eosinophilic Esophagitis (EoE), (2) Short Bowel Syndrome (SBS),
. . . as well as other diseases and disorders.” Id. at 10 (citing Essers Report at 25–29). It
contains a combination of 19 amino acids, “targeting the unique biology of a specific
disease state.” Id. at 12 (citing Essers Report at 20–21 and Pl.’s Br. Ex. 16). “Other
ingredients in the formula include: essential vitamins, minerals, fats and
carbohydrates.”8 Id. (citing Essers Report at 21 and Pl.’s Br. Ex. 16).
8 The ingredients of Neocate® Junior are listed on the label as follows:
Ingredients: Corn syrup solids (52%), refined vegetable oil (palm
kernel and/or coconut oil (8%), canola oil (8%), high oleic safflower oil
(8%)), L-arginine (2.4%), L-glutamine (2.3%), L-lysine L-aspartate (2%),
and less than 2% of each of the following: tripotassium citrate, calcium
phosphate dibasic, L-leucine, L-phenylalanine, L-proline, silicon dioxide,
L-valine, glycine, L-isoleucine, N-acetyl-L-methionine, L-threonine, mono
and diglycerides, sodium chloride, L-histidine, L-serine, L-alanine,
magnesium acetate, calcium phosphate tribasic, choline bitartrate,
L-tryptophan, L-tyrosine, diacetyl tartaric acid esters of mono &
diglycerides, M-inositol, L-ascorbic acid, L-cystine, propylene glycol
alginate, taurine, ferrous sulfate, L-carnitine, zinc sulfate, DL-alpha
tocopheryl acetate, niacinamide, calcium D-pantothenate, magnesium
sulfate, cupric sulfate, riboflavin, thiamine chloride hydrochloride,
pyridoxine hydrochloride, vitamin A acetate, folic acid, potassium iodide,
(continued…)
Court No. 16-00008 Page 23
A Neocate® Junior package, a 14.1-ounce canister, is labeled as follows:
Neocate Junior provides complete or supplemental nutritional
support for children with gastrointestinal impairment due to cow milk
allergy or other medical conditions of the gastrointestinal tract.
Id. at Ex. 20D. The label also states:
Amino Acid-Based Nutritionally Complete Powdered Formula
Hypoallergenic
For the dietary management of cow and soy milk allergy, multiple
food protein intolerance, eosinophilic esophagitis, short bowel syndrome,
and conditions of gastrointestinal tract impairment and malabsorption
requiring an elemental diet
A Medical Food
Unflavored
Powder – Add Water
Id. The “Directions for Preparation and Use” inform the consumer: “Suggested intake
to be determined by a healthcare professional” and instruct the consumer to “add the
prescribed amount of Neocate Junior” according to specified dilution guidelines. Id.
The fifth product, Ketocal® Liquid, “is unique in that it provides a 4:1 ratio of fat
calories to ‘non-fat’ protein and carbohydrate calories.” Id. at 13 (citing Essers Report
at 21). It “is used to treat patients who suffer from: (1) Intractable/Refractory Epilepsy,
[or] (2) Glucose Transporter Type 1 Deficiency (GLUT 1)” who require a “‘ketogenic’
diet that is high in fat, low in carbohydrates, and contains controlled proportions of
chromium chloride, sodium molybdate, sodium selenite, phylloquinone,
biotin, vitamin D3, cyanocobalamin.
Pl.’s Br. Ex. 20D.
Court No. 16-00008 Page 24
protein.” Id. at 12–13 (citing Pl.’s Br. Ex. 5E, at 1–3). Plaintiff states that “[t]he fats in
Ketocal® are: Refined vegetable oil (high oleic sunflower, soy, palm), alpina oil,
C. Cohnii oil, mono and diglycerides, and soy lecithin” and that “[c]arnitine and taurine
are added to further optimize digestion and metabolism.” Id. at 13 (citing Essers Report
at 21). “Other ingredients are: water, proteins, minimal carbohydrates, vitamins,
minerals and fiber.”9 Id. at 14 (citing Pl.’s Br. Ex. 18).
9
The ingredients of vanilla-flavored Ketocal® Liquid are listed on the label of
outer packaging (containing 27 8-ounce individual containers) as follows:
Ingredients: water, refined vegetable oil (high oleic sunflower, soy,
palm), sodium caseinate (milk), whey protein concentrate (milk), soy fiber,
corn starch, inulin, CAEM (an emulsifier), artificial flavor, dipotassium
phosphate, gum arabic, calcium chloride, m. alpina oil*, magnesium
acetate, potassium chloride, c. cohnii oil**, microcrystalline cellulose,
sugar, fructooligosaccharide, L-ascorbic acid, calcium phosphate
monobasic, mono and diglycerides, trisodium citrate, sodium hydroxide,
choline chloride, L-cystine, calcium phosphate dibasic, artificial sweetener:
sucralose, propylene glycol alginate, ferrous lactate, L-carnitine, taurine,
M-inositol, L-tryptophan, zinc sulfate, DL-alpha tocopheryl, soy lecithin,
niacinamide, calcium D-pantothenate, manganese sulfate, ascorbyl
palmitate, cupric sulfate, thiamine chloride hydrochloride, pyridoxine
hydrochloride, riboflavin, vitamin A acetate, mixed tocopherols, DL-alpha
tocopherol, folic acid, potassium iodide, chromium chloride, sodium
selenite, sodium molybdate, phylloquinone, D-biotin, vitamin D3,
cyanocobalamin.
*A source of Arachidonic Acid (ARA)
** A source of docosahexaenoic acid (DHA)
Pl.’s Br. Ex. 20E. A package of unflavored Ketocal® Liquid is also illustrated. Id.
Court No. 16-00008 Page 25
An 8-ounce package of the product is labeled as Ketocal® 4:1 LQ Multi Fiber and
states: “A ready-to-feed 4:1 ratio ketogenic formula, for the dietary management of
intractable epilepsy.” Id. at Ex. 20E.
The descriptions and labeling of Nutricia’s products demonstrate that each of
these five products is comprised entirely of “nutritional substances.” See EN 30.03,
EN 30.04 (distinguishing between “nutritional substances” and “medicinal
substances”). Note 1(a) to chapter 30, HTSUS, by plain meaning and as interpreted
according to EN 30.03 and EN 30.04, excludes from chapter 30 all such products. GRI 1
requires the court to give effect to note 1(a) to chapter 30 and thereby exclude Nutricia’s
products from the scope of heading 3004, HTSUS.
Nutricia argues that note 1(a) to chapter 30, HTSUS does not defeat its claim for
classification under heading 3004, essentially on the premise that this case presents a
special situation under which chapter note 1(a) to chapter 30 must be disregarded.
According to plaintiff’s argument, the court should compare the heading the
government advocates, heading 2106, HTSUS, with its preferred heading, heading 3004,
HTSUS, and choose the latter based on the “relative specificity” of the two headings
according to GRI 3(a), HTSUS (“The heading which provides the most specific
description shall be preferred to headings providing a more general description.”). By
elevating GRI 3(a) over GRI 1, which takes precedence, this argument misinterprets the
GRIs.
Court No. 16-00008 Page 26
Plaintiff bases its argument on note 1(f) to chapter 21, HTSUS, which excludes
from chapter 21 (and therefore from heading 2106) “products of heading 3003 or 3004.”
According to Nutricia’s argument, “[t]he chapter 21 and 30 notes are mutually
exclusive” and “[t]he [Court of Appeals for the] Federal Circuit has held that when
there are two mutually exclusive chapter notes, the product must be classified
according to the terms of the headings, GRI 1 and GRI 3(a), and the most specific
provision prevails.” Pl.’s Br. 37 (citing Bauer Nike Hockey USA, Inc. v. United States, 393
F.3d 1246, 1252–53 (Fed. Cir. 2004) (citing Sharp Microelectronics Tech., Inc. v. United
States, 122 F.3d 1446, 1450–51 (Fed. Cir. 1997))). See also Pl.’s Resp. to Def.’s Cross-Mot.
for Summary J. and Reply to Def.’s Resp. to Pl.’s Mot. for Summary J. 17 (Dec. 2, 2022),
ECF Nos. 86 (Conf.), 83 (Public) (“Pl.’s Resp.”) (“Note 1(a) cannot be used to exclude
products from chapter 30 in this case because Note 1(f) to chapter 21 excludes goods
classified under heading 3004 from chapter 21.”).
According to plaintiff, “when there are mutually exclusive chapter notes
classification is first determined according to the relative specificity of the competing
headings’ text.” Id. (quoting Bauer Nike Hockey USA, Inc., 393 F.3d at 1252 n.6)
(“Resorting to the exclusionary note before applying the rule of specificity . . . would
yield the somewhat arbitrary result that the subject merchandise could be classified
under different chapters based solely on which chapter the analysis began.”).
Court No. 16-00008 Page 27
Plaintiff’s “relative specificity” argument is misguided in failing to give effect to
GRI 1, which directs the inquiry to the terms of the headings and the relative section
and chapter notes, with the section or chapter notes and the heading terms given equal
consideration. A critical flaw in plaintiff’s argument is that note 1(a) to chapter 30,
which limits the scope of heading 3004 so as to exclude plaintiff’s goods, and note 1(f) to
chapter 21, which limits the scope of heading 2106, are not “mutually exclusive.”
Note 1(a) to chapter 30, HTSUS excludes from that chapter a defined class or
kind of goods: “[f]oods or beverages . . . other than nutritional preparations for
intravenous administration.” In contrast, note 1(f) to chapter 21, HTSUS, which states
that chapter 21 “does not cover: . . . Yeast put up as a medicament or other products of
heading 3003 or 3004,” excludes by name one class or kind of goods (yeast put up as a
medicament) but, as is pertinent here, also excludes the “products of heading 3003 or
3004” (emphasis added). In doing so, note 1(f) to chapter 21, HTSUS requires a
classification determination to be made before it can be decided whether the exclusion in
note 1(f) to chapter 21 applies. Therefore, the court must consider the scope of heading
3004 as interpreted according to note 1(a) to chapter 30 as well as considering the effect,
if any, of note 1(f) to chapter 21. When it does so, it must conclude that there is no
occasion to apply note 1(f) to chapter 21 where, as here, a good is excluded from
heading 3004 by operation of note 1(a) to chapter 30. In other words, because note 1(a)
to chapter 30 precludes the court from considering heading 3004 as a candidate heading
Court No. 16-00008 Page 28
for Nutricia’s products, GRI 1 eliminates heading 3004 from consideration, and the issue
of relative specificity of the competing headings, which is the subject of GRI 3(a), does
not arise. The choice between heading 3004 and heading 2106 is determined
conclusively by GRI 1, not GRI 3(a).
The problem addressed in Bauer Nike Hockey USA, Inc., under which the
“arbitrary result that the subject merchandise could be classified under different
chapters based solely on which chapter the analysis began,” 393 F.3d at 1252 n.6, is not
presented by this case. The court has begun its analysis by first considering heading
3004, which is plaintiff’s preferred alternative to the government’s classification. But
the same result would obtain were the court to consider heading 2106 in the first
instance. Note 1(f) to chapter 21, HTSUS would require the court, in doing so, to decide
whether Nutricia’s products actually are products of heading 3004. The court must
apply GRI 1 in making this determination, which entails giving effect to note 1(a) to
chapter 30, under which heading 3004 is eliminated from consideration and there is no
occasion to apply note 1(f) to chapter 21. The court, therefore, must reject the premise of
plaintiff’s argument, under which note 1(a) to chapter 30, HTSUS essentially is
disregarded.
In support of its argument in favor of classification under heading 3004, plaintiff
also argues that heading 3004 is a “use” provision (or “principal use” provision) and
that the court, in determining the classification of the goods at issue, therefore must
Court No. 16-00008 Page 29
apply additional U.S. rule of interpretation 1(a), HTSUS (“a tariff classification
controlled by use (other than actual use) is to be determined in accordance with the use
in the United States at, or immediately prior to, the date of importation, of goods of that
class or kind to which the imported goods belong, and the controlling use is the
principal use.”). Pl.’s Br. 29 (citations omitted). Plaintiff argues that “[e]ach of the
products is used as nutrition therapy to treat young children with specific and
dangerous medical conditions or disorders” and “have no other use.” Id. at 30 (citation
omitted). According to Nutricia’s argument, the products at issue are of the same class
or kind as medicaments and, accordingly, must be classified by operation of additional
U.S. rule of interpretation 1(a) as medicaments under heading 3004, HTSUS. Id.
(citations omitted).
Heading 3004 (like heading 3003) arguably contains language implicating use but
is based on an eo nomine tariff term, “Medicaments . . . .” In any event, plaintiff’s
argument overlooks that in this instance there is no occasion to apply additional U.S.
note of interpretation 1(a) (which applies only “[i]n the absence of special language or
context which otherwise requires”) because heading 3004 is precluded from
consideration by GRI 1. GRI 1 requires the court to apply note 1(a) to chapter 30 to
exclude Nutricia’s imported products from chapter 30, HTSUS and, therefore, from
heading 3004, HTSUS regardless of whether heading 3004 possibly could be considered
to be a use provision.
Court No. 16-00008 Page 30
2. Heading 2106 Is the Correct Heading for Nutricia’s Products
Based on the uncontested facts as taken from the submissions of the parties in
support of their cross-motions for summary judgment, there can be no genuine dispute
over whether the five “medical foods” at issue in this case, being specially-formulated
combinations of nutritional substances, are “food preparations.” The next question,
then, is whether any tariff provision excludes the products at issue from chapter 21,
HTSUS, or specifically, from heading 2106, HTSUS. The court concludes there is not.
Note 1 to chapter 21 (“Miscellaneous edible preparations”) excludes from the
chapter certain foods and food preparations but does not exclude “medical foods” such
as those at issue in this case. In addition, the Explanatory Note to HS heading 21.06 lists
various classes or kinds of products covered by the heading and distinguishes from
them some that are not covered. The EN provides as follows:
Provided that they are not covered by any other heading of the
Nomenclature, this heading covers:
* * *
(16) Preparations, often referred to as food supplements, based on
extracts from plants, fruit concentrates, honey, fructose, etc. and
containing added vitamins and sometimes minute quantities of iron
compounds. These preparations are often put up in packagings with
indications that they maintain general health or well-being. Similar
preparations, however, intended for the prevention or treatment of diseases or
ailments are excluded (heading 30.03 or 30.04).
EN 21.06 ¶ 16 (emphasis added). The issue presented by this EN is whether the
reference in the third sentence to “[s]imilar preparations” could be read broadly to
describe the products at issue in this case. Plaintiff argues that the court should
Court No. 16-00008 Page 31
interpret the third sentence to apply to its medical food products, resulting in
classification under heading 3004 rather than heading 2106, HTSUS. Pl.’s Br. 39. The
court disagrees.
The paragraph quoted above from EN 21.06 addresses “food supplements” and
“[s]imilar preparations.” It must be read in context with HS note 1(a) to chapter 30
(and, accordingly, with note 1(a) to chapter 30, HTSUS), which expressly excludes all
“food supplements” from chapter 30. Thus, food supplements fall within chapter 21,
while certain products that are “similar” to food supplements (but are to be
distinguished from food supplements) and are intended to treat a specific disease or
ailment are “medicaments” or “medicinal substances” within the intended scope of
HS heading 30.03 or 30.04. A food or beverage intended to treat a specific disease or
ailment is not within that scope, unless it is based on a “medicinal substance” that, as
instructed by EN 30.03 and EN 30.04, is not “added solely to ensure a better dietetic
balance, to increase the energy-giving or nutritional value of the product or to improve
its flavour.” EN 30.03, EN 30.04.
As shown by the ingredient statements (presented above), each of the products at
issue in this litigation is formulated from a large number of different nutritional
substances but is not based on a “medicinal substance” as required for classification
within heading 3003 or 3004, HTSUS. The implied premise of the argument Nutricia
makes in reliance on EN 21.06 is that its imported products should not be considered to
Court No. 16-00008 Page 32
be “foods” or “food supplements” within the meaning of note 1(a) to chapter 30,
HTSUS. But the facts plaintiff itself puts forth in support of its summary judgment
motion, discussed at length above, demonstrate that these are food products, comprised
of nutritional substances, that note 1(a) to chapter 30, HTSUS excludes from that
chapter.
In summary, the five products at issue are “food preparations” and are not
“medicaments” of heading 3004, HTSUS. Because no other heading within chapters 1
to 97 of the HTSUS specifies or includes these food preparations, heading 2106 (“Other
food preparations, not elsewhere specified or included”) is the correct heading by
operation of GRI 1.
G. Application of GRI 6, HTSUS to Determine the Correct Subheading
The products at issue are not “[p]rotein concentrates or textured protein
substances” of subheading 2106.10, HTSUS and thus are classified in six-digit
subheading 2106.90, HTSUS (“Other:”). The uncontested facts do not demonstrate that
they are described by any of the eight-digit subheadings between 2106.90.03 and
2106.90.95, HTSUS, inclusive. Therefore, the correct eight-digit subheading is
subheading 2106.90.99, HTSUS (“Food preparations not elsewhere specified or
included: Other: Other: Other: Other: Other: Other), subject to duty at 6.4% ad valorem.
This is the tariff classification Customs determined upon the liquidation of the entries
Court No. 16-00008 Page 33
and the tariff classification defendant advocates in support of its cross-motion for
summary judgment.
H. Subheading 9817.00.96, HTSUS Does Not Apply to Nutricia’s Products
Plaintiff claims, in the alternative, that even if its products are not
“medicaments” of heading 3004, HTSUS, they still would qualify for duty-free
treatment under a special tariff provision, subheading 9817.00.96, HTSUS, which
applies to “[a]rticles 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.”
In support of its argument that the persons for whom its medical foods are
produced are “physically or mentally handicapped persons,” Nutricia directs the
court’s attention to U.S. note 4(a) to subchapter XVII, chapter 98, HTSUS, which defines
the term “physically or mentally handicapped persons” as follows:
For purposes of subheadings 9817.00.92, 9817.00.94 and 9817.00.96,
the term “blind or other physically or mentally handicapped persons”
includes any person suffering from a permanent or chronic physical or
mental impairment which substantially limits one or more major life
activities, such as caring for one’s self, performing manual tasks, walking,
seeing, hearing, speaking, breathing, learning, or working.
The court finds no merit in plaintiff’s alternate classification claim. U.S. note 4(b)
to subchapter XVII, chapter 98, HTSUS provides that subheading 9817.00.96 does not
cover “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic
Court No. 16-00008 Page 34
articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or (iv) medicine or drugs.” Plaintiff bases its argument on the premise that the
persons for whom its medical foods are produced are “physically or mentally
handicapped persons” and that these food products, even if not considered “medicine
or drugs,” nevertheless are not “therapeutic . . . articles” within the meaning of U.S.
note 4(b)(iii) to subchapter XVII, chapter 98, HTSUS.
Defendant argues that the medical foods are “therapeutic” within the meaning of
the note. Def.’s Br. 31. The undisputed facts provide some support for that argument.
Plaintiff informs the court—and it is not contested—that the five products are
“indicated for use in the treatment of a variety of diseases, predominantly in very
young children,” 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.” Pl.’s Br. 20.
Nevertheless, plaintiff urges the court to give the word “therapeutic” a different,
and narrower, meaning when construing U.S. note 4(b)(iii) to subchapter XVII,
chapter 98, HTSUS. According to Nutricia’s argument, the word “therapeutic” as it
appears in U.S. note 4(b) to subchapter XVII, chapter 98, HTSUS is confined to those
articles that heal or cure a disability rather than treat or manage it. Pl.’s Resp. 34.
Plaintiff argues that “U.S. note 4(a) and subheading 9817.00.96 were implemented as
Court No. 16-00008 Page 35
part of the Educational, Scientific, and Cultural Materials Importation Act of 1982,
which implemented the Nairobi Protocol” and that “[t]hese provisions were intended to
liberally and broadly encourage the importation of articles for hand[ica]pped persons.”
Id. (citations omitted).
In support of its argument, Nutricia quotes Richards Medical Co. v. United States,
910 F.2d 828, 831 (Fed. Cir. 1990) (“Congress intended to encourage the importation of
that merchandise which is designed to compensate for, or help adapt to, the
handicapped condition. At the same time, Congress did not want to allow duty-free
importation of merchandise which is used to heal or cure the condition causing the
handicap.”). Pl.’s Resp. 35. The facts of the case (decided under the previous Tariff
Schedule of the United States but involving an antecedent provision to subheading
9817.00.96, HTSUS) are inapposite. The Court of Appeals for the Federal Circuit
(“Court of Appeals”) was considering whether the duty-free provision at issue applied
to an imported hip prosthesis. The court recognized that the term “‘therapeutic’ has
many different meanings and is subject to both broad and narrow interpretations.”
Richards Medical Co., 910 F.2d at 830. Reading the term narrowly in light of the intent of
the provision, the Court of Appeals affirmed a factual finding of the Court of
International Trade in the decision being appealed, under which the prosthetic hip
allowed a patient to “better compensate for the handicap” but did not cure the patient
of an underlying condition, such as arthritis. Based on that finding, the Court of
Court No. 16-00008 Page 36
Appeals concluded that the imported article was not “therapeutic” so as to preclude
classification within the duty-free provision.
The flaw in plaintiff’s alternate classification claim does not turn on whether the
medical foods are other than “therapeutic,” in the narrow sense of that term as urged
upon the court by Nutricia. Instead, the error in plaintiff’s classification analysis is its
overly broad construction of the terms of the duty-free provision, considered on the
whole. Read in conjunction with U.S. note 4(a) to subchapter XVII, chapter 98, HTSUS,
the duty-free provision in subheading 9817.00.96 is limited to “[a]rticles specially
designed or adapted for the use or benefit” of a “handicapped” person, i.e., “a person
suffering from a permanent or chronic physical or mental impairment which
substantially limits one or more major life activities, such as caring for one’s self,
performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or
working.” Plaintiff interprets the terms “handicapped” and “physical or mental
impairment” so broadly as to include virtually any serious medical condition, despite
the words of limitation used to delineate the scope of the provision. Moreover, plaintiff
interprets the term “[a]rticles specially designed or adapted for . . .” so broadly as to
include “foods” or “beverages” designed to treat or manage (but not cure) such medical
condition, provided they are not “medicines or drugs.” The weakness in plaintiff’s
argument lies in its tortured interpretation of each of these terms, considered together
and in context. Nothing in the terms of subheading 9817.00.96, HTSUS provides or
Court No. 16-00008 Page 37
even connotes that Congress, addressing the needs of “the blind or other mentally or
physically handicapped persons” for “articles specially designed or adapted” for their
“use or benefit,” intended the scope of the subheading to be so broad as to cover foods,
food supplements, or nutritional substances or ingredients of any type.10 The court,
therefore, rejects plaintiff’s alternate claim for classification of the five products in
subheading 9817.00.96, HTSUS.
III. CONCLUSION
The court concludes that there is no genuine dispute as to any material fact and
that plaintiff has not demonstrated that “the government’s classification is incorrect.”
Jarvis Clark, 733 F.2d at 876. Therefore, defendant is entitled to judgment as a matter of
law. Accordingly, the court will deny plaintiff’s motion for summary judgment, grant
defendant’s cross-motion, and enter summary judgment in favor of defendant.
/s/ Timothy C. Stanceu
Timothy C. Stanceu
Judge
Dated: December 4, 2023
New York, New York
10
Illustrative of the limited scope of the provision is the formulation of the
related subheadings 9817.00.92 and 9817.00.96, HTSUS (which share the same general
article description with subheading 9817.00.98) and are limited to physical articles
(“Books, music, and pamphlets, in raised print” and “Braille tablets, cubarithms, and
special apparatus, machines, presses, and types”) as opposed to substances (e.g., liquids
or powders) or foods. Under plaintiff’s interpretation, for example, a food or food
supplement specially designed to manage (but not cure) a severe visual impairment
would qualify under the provision even though subheadings 9817.00.92 and 9817.00.96,
HTSUS would not describe it.