Slip Op. 23-170

UNITED STATES COURT OF INTERNATIONAL TRADE 

NUTRICIA NORTH AMERICA, INC., 

Plaintiff, 

 v. 

UNITED STATES, 

Defendant. 

Before: Timothy C. Stanceu, Judge 

Court No. 16-00008 

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, MERRIAMWEBSTER, 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). 

4 Citations to the Explanatory Notes of the Harmonized Commodity Description 

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.