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 fo r summary judgment on the tariff classifications of various nu tritional preparations intend ed 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., fo r 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 In ternational Trade Litigation, U.S. Customs and Border Protection. Stanceu, Judge: Plaintiff Nutricia North Americ a, Inc. (“Nutricia”), contesting the denials by U.S. Customs and Border Pr otection (“Customs” or “CBP”) of its administrative protests, claims that Custo ms incorrectly determined the tariffCourt No. 16-00008 Page 2 classification of five imported products it describes as “med ical foods.” Before the court are the parties’ cross-motions for summar y judgment. The co urt awards summary judgment in favor of defendant United States.
I. B ACKGROUND The merchandise was imported on four entries made in November 2014 at the ports of Philadelphia, Pennsylvania and Washi ngton-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 ju dgment, maintaining that the tariff classification determined by Cus toms upon liquidation of t he 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. D ISCUSSION A. Jurisdiction and Standard of Review The court exercises jurisdi ction according to Sectio n 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 disput e as to the nature of the merchandise and
the classification determination turns on t he 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 St ates Code are to the 2012 edition.Court No. 16-00008 Page 4 B. Description of the Merchandise The facts stated in this Opinion to de scribe the imported me rchandise are taken from the submissions of the parties in supp ort of their respective summary judgment motions and are not in dispute between t he 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 produc ts as “certain Medic al Foods, which are a unique class of products defined and regu lated 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 disord er called branched-chain alpha ketoacid dehydrogenase complex (BCKDC) deficiency, (also called Maple Syrup Urine Disease or MSUD), an inborn error of the metabo lism” that causes “impaired ability toCourt No. 16-00008 Page 5 metabolize three of the twenty essential amin o 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 “inbor n error of metabolism of phenylalanine” that is “characterized by inadequate format ion of L-tyrosine, elevation of serum L-phenylalanine, urinary excretion of phenylpyr uvic acid and other derivatives, and accumulation of phenylalanine and its metabolites.” Id . at 8 (citation omitted). The condition “can produce brain damage resultin g in severe mental retardation, often with seizures, other neurologic abnormalities such as retarded myelination and deficient melanin formation leading to hypopigm entation 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 (S BS), 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 Epilep sy, Glucose Transporter Type 1 Deficiency (GLUT 1), and
other diseases and disorders. Id . at 12–13. GLUT 1 “is a lifelong genetic metabolicCourt 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 demonstr ate epilepsy, developmental delays, acquired microcephaly, cognitive impairment and va rying 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 Interp retation (“GRIs”) and, if applicable, the Additional U.S. Rules of Int erpretation (“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) (citat ions omitted) (“Along with the headings and subheadings . . . the HTSUS st atute also contains the ‘General Notes,’ the ‘General Rules of Interpretation’ (‘GRI’), the ‘Additional United States Rules of Interpretation’ (‘ARI’), and various appendices for particular cate gories of goods.”). The GRIs are applied in numerical order, with GRI 1 providing, in pertinent part,
that “classification shall be determined a ccording to the terms of the headings and any relative section or chapter no tes.” 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 (dir ecting determination of the subheadingCourt 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 subjec t merchandise was incorrect. Id. , 733 F.2d at 876. Subject to the plaintiff’s rebuttal, fact ual determinations by Custo ms are presumed correct, see 28 U.S.C. § 2639(a)(1), but the presumption of co rrectness applies to is sues 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 demons trating that the government’s classification was incorrect, the co urt 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 classificati on, 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 relev ant tariff provisions, which is a question
of law.” Id. (citation omitted). “The second st ep involves determ ining 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, HTSU S 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 Explanator y Notes (“ENs”) for the Harmonized Commodity Description and Coding Sy stem (“Harmonized System” or “HS”) maintained by the World Cust oms 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 Exp lanatory Notes are informative as to the intent of the drafters of the Harmonized Sy stem where, as in this case, the dispute involves a legal determination of the scope of the competing headin gs 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, HTSUS 2 (“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 prop hylactic 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 classifica tion of the products in a special U.S. duty-free tariff classification provisio n within chapter 98, HT SUS, specifically, subheading 9817.00.96 (“Articles specially designed or adapted for the use or benefit of the blind or other ph ysically or mentally handicapped pe rsons; parts and accessories (except parts and accessories of braces and ar tificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: . . . Other”).

2 The products at is sue were subject to the tariff provisions set forth in the version of the Harmonized T ariff Schedule of the United St ates (“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 determi nes the correct classification of the five products according to the GRIs and the tariff provisions in chap ters 1 through 97, HTSUS. It then addresses the issue of whether these pr oducts qualify for the spec ial 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 fi rst 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 produc ts. The parties have id entified the following candidate headings: Heading 2106, HTSUS: “Food preparatio ns 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 lim ited to mixed products “ not put up in measured doses or in forms or packings fo r 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 a dded). 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 “medicat ion.” As defendant points out, Webster’s Third New International Dict ionary and the Merriam-Webster Online Dictionary define “medication” as “a medicinal substance: ME DICAMENT.” 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 , M ERRIAM

W EBSTER , https://www.merriam -webster.com/dictionary/medic ation (last visited Dec. 4, 2023). The Oxford English Dictio nary defines “medicament” as “a substance used for medical treatment ; a medicine, remedy.” Medicament , O XFORD E NGLISH D ICTIONARY , https://www.oed.com/dictionary/med icament_n?tab=m eaning_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 fo r ‘therapeutic or prophylactic use’ to treat persons with medical problems, which is the defining charac teristic of a medicament.” Pl.’s Br. 20. Plaintiff adds that “[m]edical professionals refer to the depl oyment of these products as
‘nutritional therapy ,’ thus confirming their therapeutic use and value” and that “as FDA-regulated ‘medical foods’ the subject prod ucts are the ‘medicine ’ that doctors will prescribe or recommend to treat children suffering from the referenced diseases.” Id

. Nutricia argues that in order for defendan t 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 evidenc e, 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” we re considered broad enough to encompass what plaintiff describes as “nutritional t herapy” or “medical food ” products, it would not follow that chapter 30, HTSU S necessarily includes these products. GRI 1 requires
the court first to determine classification ac cording 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 pert inent chapter note, note 1(a) to chapter 30, HTSUS. But the co urt must reject that argument.Court No. 16-00008 Page 13 Note 1(a) to chapter 30, HTSUS expr essly excludes from chapter 30, and therefore from heading 3004, “[f]oods or beverage s (such as dietetic, d iabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (s ection IV).” The refer ence to “section IV” indicates that the products described in t he note, i.e., “foods . . . other than nutritional preparations for intravenous administration,” are to be classified in section IV of the HTSUS, which includes c hapter 21, rather than in section VI (which includes chapter 30). In making an exception to the general ex clusion that it applies to chapter 30, note 1(a) specifically references “ nutritional preparations for intravenous
administration.” This term nec essarily is interpreted to in clude 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 impl ication of this narrow exception to the general exclusion created by note 1(a) to chapter 30, HTSUS is that other “nutritional prep arations,” 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 pr oducts are “foods or beverages” within the meaning ofCourt 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 examp le of goods that are within the exclusion from chapter 30 created by note 1(a), connotin g that even foods specialized for intended use by persons whose medical condition requir es a specialized diet fall within the scope of that exclusion. In describing the prod ucts encompassed by that exclusion, the chapter note does not distin guish what plaintiff would c all “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 iss ue 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 ou t, § 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 sp ecific dietary management of
a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, ar e 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 chapte r notes, further indicateCourt No. 16-00008 Page 15 that note 1(a) to chapter 30 precludes classification of Nutricia’s products under heading 3004. The Explanatory Notes fo r 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 artific ial), 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 ar e 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 ba lance, 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, purgativ e, diuretic or carmin ative 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 pu t up for the purpos e 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 co vers preparations in which the foodstuff or the beverage merely serves as a support, vehicle or sweetening agent for the medicinal subs tances (e.g., in order to facilitate ingestion).Court No. 16-00008 Page 16 EN 30.03, EN 30.04. These Explanatory Notes in dicate 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 pe rsons 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 prep aration in which “nutritional substances” are present only to support a “medicinal subs tance” (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 ab ove), 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 co ndition: it must do so by administering a “medicinal substance.” If, instead, the manag ement 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, Nutric ia’s products fit that description. Plaintiff acknowledges that the five products provide “ nutritional therapy.” Pl.’s Br. 28 (emphasis added). A ll of the ingredients in eac h of Nutricia’s productsCourt No. 16-00008 Page 17 (described below) are “nutrit ional substances.” Four of the products in question, “MSUD Lophlex® LQ,” “Periflex® Infant,” “Per iflex® Junior,” and “Neocate® Junior,” treat one or more medical conditions by mean s 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 ar e 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 in tractable or refractory epilepsy and Glucose Transporter Type 1 de ficiency 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 ani mal-based foods” and, citing Essers Report at 9, that “[p]roteins are essential to the growth and func tion of all living organisms”). The otherCourt 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 “branc h chain” amino acids (“BCAA”), which are leucine, valine, and isoleucine. Pl.’s Br. 7. Nutr icia explains that BCAA, if present in the diet in more than minimal amounts, ar e toxic to children who have branched-chain alpha ketoacid dehydrogenase complex (BCK DC) 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 ex cess that elicits toxicity.” Id . at 8 (citing Essers Report at 10). Plaintiff adds that “[o]ther ingredient s provided in the formula include: water, apple, grape, blackcurrent [ sic ] and elderberry juice concentra tes, 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 Lo phlex® 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 ju ices from concentrate, amino acids, vitamins, trace elements, and some minerals. Contains docosahexaenoic acid (DHA). For the dietary manag ement of proven Maple Syrup Urine Disease (MSUD) in indi viduals 4 years and olde r, including pregnant women (in conjunction with stand ard folic acid supplementation).Court No. 16-00008 Page 19

Pl.’s Br. Ex. 20A. The label also states: “Cont ains 44% fruit juice from concentrate and
natural flavors.” 5 Id

. Plaintiff states that Periflex® Infant and Periflex® Junior are us ed to treat infants and children, respectively, who have Phen ylketonuria (PKU), “an inborn error of metabolism,” the “prevailing treatment” for whic h “is a diet low or absent in foods that contain phenylalanine, which is a common amin o 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%), blackc urrant juice from concentrate (2.5%), L-lysine acetate, L-proline, citric acid, L-tyrosine, L- arginine, glycine, L-serine, L-aspartic ac id, L-alanine, L-threonine, corn syrup solids, L-cystine, L-phenylalanine, dicalcium ph osphate, L-histidine, elderberry juice from concentrate (0.6%), maltod extrin, magnesium acetate, N-acetyl L-methionine, L-tryptophan, choline bitartrate, C. cohnii oil*, sugar, microcrystalline cellulose, natural fl avor, fruit concentrate (apple, blackcurrant, radish), L-ascorbic acid , taurine, guar gum, lecithin, xanthan gum, M-inositol, potassium sorbat e (preservative), artificial sweetener: sucralose, ferrous lactate, artific ial sweetener: acesulfame potassium, sodium benzoate (preservative), zinc sulfate, L-carnitine, niacinamide, DL-alpha tocopheryl acetate, calc ium 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 D 3 , 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 in gredients 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, coconu t), calcium phosphate dibasic, L-arginine L-aspartate, tri-potassium citrate, L- leucine, L-lysine acetate, L-tyrosine, L-glutamine, L-prolin e, L-valine, glycine, L- isoleucine, CAEM (an emu[l]sifier), L-threonine, L-seri ne, 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, calc ium-d-pantothenate, cupric sulfate, manganese sulfate, pyridoxine hydrochloride, riboflavin, vitamin A acetate, thiamine chloride hydrochloride, ascorbyl p almitate, potassium iodide, chromium sulfate, mixed tocopherols, DL-alpha tocopherol, phy lloquinone, sodium molybdate, folic acid, sodium hy drogen selenite, D-biotin, vitamin D 3 , 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 ph enylalanine-free, iron-for tified infant formula containing a balance[d] mixture of othe r essential and non- essential amino acids, carbohydrate, fat, vitamins, mi nerals and trace elements. Periflex Infant also contains DHA and ARA, whic h 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 combinatio n 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 ess ential 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 o il, high oleic safflower oil, L-glutamine, L-prolin e, L-asparagine, L-lysine hydrochloride, tripotassium citrate, L-tyrsoine, L- leucine, disodium hydrogen phosphate, L-valine, L-serine, L-iso leucine, tricalcium citrate, tricalcium phosphate, L-alanine, maltodextrin, L-threon ine, 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 to copheryl acetate, manganese sulfate, niacinamide, calcium D-pa ntothenate, cupric sul fate, thiamine chloride hydrochloride, pyridoxine hydrochlor ide, riboflavin, vitamin A acetate, folic acid, potassium iodide, chromi um chloride, sodium selenite, sodium molybdate, phylloquino ne, D-biotin, vitamin D 3 , cyanocobalamin.
Pl.’s Br. Ex. 20C.Court No. 16-00008 Page 22

Id . at Ex. 20C. The “Directions for Preparat ion 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 spec ified dilution guidelines. Id

. Plaintiff’s motion describes Neocate® Juni or as a product “used to treat patients who suffer from: (1) Eosinophilic Esophagiti s (EoE), (2) Short Bowel Syndrome (SBS),
. . . as well as other di seases and disorders.” Id . at 10 (citing Essers Report at 25–29). It contains a combination of 19 amino acids, “tar geting 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: es sential 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 follo wing: tripotassium citrate, calcium phosphate dibasic, L-leucine, L-phen ylalanine, L-proline, silicon dioxide, L-valine, glycine, L-isoleuc ine, N-acetyl-L-methion ine, L-threonine, mono and diglycerides, sodium chlorid e, L-histidine, L-serine, L-alanine, magnesium acetate, calcium phosp hate tribasic, choline bitartrate, L-tryptophan, L-tyrosine, diacetyl ta rtaric acid esters of mono & diglycerides, M-inositol, L-ascorbic acid, L-cystine, propylene glycol alginate, taurine, ferrous sulfate, L-ca rnitine, zinc sulfate, DL-alpha tocopheryl acetate, niacinamide, calcium D-pantothenate, magnesium sulfate, cupric sulfate, riboflavin, thiamine chloride hydrochloride, pyridoxine hydrochloride, vitamin A ac etate, folic acid, potassium iodide, (continued...)Court No. 16-00008 Page 23 A Neocate® Junior package, a 14.1-oun ce 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 Prepar ation and Use” inform the co nsumer: “Suggested intake to be determined by a healthcare professio nal” 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 suff er from: (1) Intractable/Refractory Epilepsy, [or] (2) Glucose Transporter Type 1 Defi ciency (GLUT 1)” who require a “‘ketogenic’ diet that is high in fat, low in carbohyd rates, and contains controlled proportions of

chromium chloride, sodium molybd ate, sodium selenite, phylloquinone, biotin, vitamin D 3 , 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 so y 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 Keto cal® 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 pr otein concentrate (milk), soy fiber, corn starch, inulin, CAEM (an emul sifier), artificial f lavor, dipotassium phosphate, gum arabic, calcium chlo ride, m. alpina oil*, magnesium acetate, potassium chloride, c. cohn ii oil**, microcrystalline cellulose, sugar, fructooligosaccharide, L-asco rbic acid, calcium phosphate monobasic, mono and diglycerides, trisodium citrate, sodium hydroxide, choline chloride, L-cystine, calcium phos phate 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-pantothen ate, manganese sul fate, ascorbyl palmitate, cupric sulfate, thiamine chloride hydrochloride, pyridoxine hydrochloride, riboflavin, vitamin A ac etate, mixed tocopherols, DL-alpha tocopherol, folic acid, potassium iodide, chromi um chloride, sodium selenite, sodium molybdate, phy lloquinone, D-biotin, vitamin D 3 , cyanocobalamin. *A source of Arachidonic Acid (ARA) ** A source of docosahexaenoic acid (DHA) Pl.’s Br. Ex. 20E. A package of unflavor ed Ketocal® Liquid is also illustrated. Id

.Court No. 16-00008 Page 25 An 8-ounce package of the product is lab eled 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 labelin g 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 subs tances” and “medicinal substances”). Note 1(a) to chapter 30, HT SUS, 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, head ing 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 t he most specific description shall be preferred to headings prov iding a more general description.”). By elevating GRI 3(a) over GRI 1, which takes pr ecedence, 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 headin g 2106) “products of heading 3003 or 3004.” According to Nutricia’s argument, “[t]h e 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 exclus ive chapter notes, the prod uct must be classified according to the terms of the headings, GR I 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 beca use Note 1(f) to chapter 21 excludes goods classified under heading 3004 from chapter 21.”). According to plaintiff, “when there ar e mutually exclusive chapter notes
classification is first determ ined 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 a pplying the rule of specificity . . . would yield the somewhat arbitrary result that t he subject merchandise could be classified under different chap ters based solely on which chapter the analysis began.”).Court No. 16-00008 Page 27 Plaintiff’s “relative spec ificity” argument is misguided in failing to give effect to GRI 1, which directs the inquiry to the term s of the headings and the relative section and chapter notes, with the section or chap ter 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, no te 1(f) to chapter 21, HTSUS, which states that chapter 21 “does not cover: . . . Yeast pu t up as a medicament or other products of heading 3003 or 3004,” excludes by name one clas s 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 co nsider the scope of heading 3004 as interpreted according to note 1(a) to chapter 30 as well as co nsidering the effect, if any, of note 1(f) to chapter 21. When it do es 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 co nsidering heading 3004 as a candidate headingCourt No. 16-00008 Page 28 for Nutricia’s products, GRI 1 eliminates heading 3004 from co nsideration, and the issue of relative specificity of the competing headin gs, which is the subject of GRI 3(a), does
not arise. The choice between head ing 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 su bject merchandise could be classified under different chapters based solely on which chapter t he analysis began,” 393 F.3d at 1252 n.6, is not presented by this case. The court has begun its analysis by firs t considering heading 3004, which is plaintiff’s preferred alternative to the government’s classification. But
the same result would obtain were the co urt 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 pr oducts 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. Th e court, therefore, must reject the premise of plaintiff’s argument, under which note 1(a) to chapter 30, HT SUS essentially is disregarded. In support of its argument in favor of classification under heading 3004, plaintiff also argues that heading 3004 is a “use” provis ion (or “principal use” provision) and that the court, in determining the classification of the go ods at issue, therefore mustCourt No. 16-00008 Page 29 apply additional U.S. rule of interpreta tion 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 good s belong, and the controlling use is the principal use.”). Pl.’s Br. 29 (citations om itted). Plaintiff argues that “[e]ach of the products is used as nutrition therapy to treat young children with specific and dangerous medical conditions or di sorders” and “have no other use.” Id . at 30 (citation omitted). According to Nutricia’s argument, t he products at issue ar e of the same class or kind as medicaments and, a ccordingly, 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 im plicating use but
is based on an eo nomine tariff term, “Medicaments . . . .” In any event, plaintiff’s argument overlooks that in th is 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”) be cause heading 3004 is precluded from consideration by GRI 1. GRI 1 requires t he court to apply note 1(a) to chapter 30 to exclude Nutricia’s imported products fro m chapter 30, HTSUS and , therefore, from heading 3004, HTSUS regardless of whether heading 3004 possibl y 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 is sue in this case, being specially-formulated combinations of nutritional substances, ar e “food preparations.” The next question, then, is whether any tariff provision excludes the produc ts at issue from chapter 21, HTSUS, or specifically, from heading 2106, HTSUS. The court concludes there is not. Note 1 to chapter 21 (“Miscellaneous ed ible 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 additi on, the Explanatory Note to HS heading 21.06 lists various classes or kinds of products co vered 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 prepar ations 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 pr eparations” could be read broadly to describe the products at issue in this case . Plaintiff argues t hat the court shouldCourt No. 16-00008 Page 31 interpret the third sentence to apply to its medical food products, resulting in
classification under headin g 3004 rather than heading 2106, HT SUS. 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 chap ter 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 su bstances” 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 “a dded solely to ensure a better dietetic balance, to increase the energy-g iving or nutritional value of the product or to improve its flavour.” EN 30.03, EN 30.04. As shown by the ingredient statements (pre sented 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 im plied premise of the argument Nutricia makes in reliance on EN 21.06 is that its import ed products should not be considered toCourt No. 16-00008 Page 32 be “foods” or “food supplements” within the meaning of note 1(a) to chapter 30, HTSUS. But the facts plaint iff itself puts forth in supp ort of its summary judgment motion, discussed at length above, demonstrat e 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 is sue are “food preparations” and are not “medicaments” of heading 3004, HTSUS. Bec ause 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 uncont ested facts do not demonstrate that they are described by any of the eig ht-digit subheadings between 2106.90.03 and 2106.90.95, HTSUS, inclusive. Therefore, t he correct eight-digit subheading is subheading 2106.90.99, HTSUS (“Food preparat ions not elsewhere specified or
included: Other: Other: Other: Other: Ot her: Other), subject to duty at 6.4% ad valorem

. This is the tariff classifica tion Customs determined upon the liquidation of the entriesCourt No. 16-00008 Page 33

and the tariff classification defendant advoc ates 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, th ey still would qu alify for duty-free treatment under a special tariff prov ision, subheading 9817.00.96, HTSUS, which applies to “[a]rticles specially designed or adap ted for the use or benefit of the blind or other physically or mentally handicapped pers ons; 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 hand icapped persons,” Nutricia directs the court’s attention to U.S. note 4(a) to subc hapter 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, breat hing, learning, or working.
The court finds no merit in plaintiff’s alternate classifica tion claim. U.S. note 4(b) to subchapter XVII, chapte r 98, HTSUS provides that subheading 9817.00.96 does not cover “(i) articles for acute or transient disabilit y; (ii) spectacles, de ntures, and cosmeticCourt No. 16-00008 Page 34

articles for individu als not substantially disabled; ( iii) therapeutic and diagnostic articles; or (iv) medicine or drugs.” Plaintiff bases its argu ment on the premise that the persons for whom its medical foods are produced are “physically or mentally handicapped persons” and that these food pr oducts, even if not co nsidered “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 un disputed 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 var iety of diseases, pred ominantly 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 therapeu tic use and value.” Pl.’s Br. 20. Nevertheless, plaintiff urges the court to give the word “therapeutic” a different, and narrower, meaning when cons truing U.S. note 4(b)(i ii) 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 asCourt 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 t he 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 in tended 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 t he case (decided under the previous Tariff
Schedule of the United States but involvin g 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 affir med 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 th e handicap” but did not cure the patient of an underlying condition, such as arthriti s. Based on that finding, the Court ofCourt 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 alter nate classification claim do es not turn on whether the
medical foods are other than “therapeutic,” in the narrow s ense of that term as urged upon the court by Nutricia. Instead, the error in plaintiff’s classifica tion 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 ac tivities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” Plaintiff interprets the te rms “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 tr eat 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 in terpretation of each of these terms, considered together and in context. Nothing in the term s of subheading 9817.00.96, HTSUS provides orCourt No. 16-00008 Page 37 even connotes that Congress, addressing t he 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 su bheading to be so broad as to cover foods, food supplements, or nutritional subs tances or ingredients of any type. 10 The court, therefore, rejects plaintiff’s alte rnate claim for clas sification of the five products in subheading 9817.00.96, HTSUS.
III. C ONCLUSION The court concludes that there is no genu ine dispute as to any material fact and that plaintiff has not demonstrated that “t he 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 plain tiff’s motion for summary judgment, grant defendant’s cross-motion, and enter summ ary 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 t he provision is the formulation of the related subheadings 9817.00.92 and 9817.00.96, HTSU S (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 type s”) as opposed to substances (e.g., liquids or powders) or foods. Under plaintiff’s in terpretation, for example, a food or food supplement specially designed to manage (but not cure) a severe visual impairment would qualify under the provision ev en though subheadings 9817.00.92 and 9817.00.96, HTSUS would not describe it.