CLA-2 OT:RR:CTF:TCM H121544 RES
2nd & Chestnut Streets
Philadelphia, PA 19106
ATTN: Desiree Nicholls, Import Specialist
RE: Application for Further Review Protest No. 1101-10-100060; Tariff classification of dietary medical products.
Dear Port Director:
This letter is in reply to the Application for Further Review (“AFR”) of Protest number 1101-10-100060, filed February 25, 2010, on behalf of Nutricia North America, Inc. (”Nutricia”). The Protest is against U.S. Customs and Border Protection’s (“CBP”) classification of dietary medical products under heading 2106 of the Harmonized Tariff Schedule of the United States (“HTSUS”). We have also considered arguments presented by counsel on April 8, 2013, to members of my staff.
The articles at issue in this AFR are described as dietary medical products, which are also called “medical foods.” These items are:
Neocate 1+ (aka Neocate One +): a nutritionally complete powdered amino acid-based food. Prepared for consumption by mixing with water.
Neocate Junior: a nutritionally complete, powdered amino acid-based medical food for children over the age of one for the dietary management of cow milk allergy, multiple food protein intolerance (MFPI) and food-allergy-associated conditions: gastroesophageal reflux disease (GERD), eosinophilic esophagitis (EoE), short bowel syndrome (SBS), and other GI disorders. Prepared for consumption by mixing with water. Comes as unflavored or tropical/chocolate flavored.
Neocate LCP (aka Neocate Infant with DHA and ARA): Neocate Infant DHA and ARA is a hypoallergenic, amino acid-based, nutritionally complete infant formula for the dietary management of cow milk allergy, multiple food protein intolerance (MFPI) and food-allergy-associated conditions: gastroesophageal reflux disease (GERD), eosinophilic esophagitis (EoE), short bowel syndrome (SBS), malabsorption and other GI disorders. Prepared for consumption by mixing with water.
Neocate Infant (aka Neocate Infant Formula): a nutritionally complete powdered amino acid-based infant formula. Prepared for consumption by mixing with water.
Milupa PKU-3: a phenylalanine-free powdered food consisting of vitamins and minerals. In can be ingested by people diagnosed with Phenylketonuria (PKU). Prepared for consumption by mixing with water. Product description states that it is “not suitable as sole source of nutrition.”
Phlexy-10 Bar (aka Phlexy-10 System Bars): a phenylalanine-free amino acid-based food in bar form. It can be ingested by people diagnosed with PKU. Product description states that it is “not suitable as sole source of nutrition.”
Xphen, Tyr Maxamum: a phenylalanine and tyrosine free, unflavoured powdered drink mix for older children and adults, containing a balanced mixture of the other essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. In can be ingested by people diagnosed with tyrosinemia type 2. Prepared for consumption by mixing with water. Product description states that it is “not suitable as sole source of nutrition.”
Xphen, Tyr Maxamaid: a phenylalanine and tyrosine free unflavoured powdered drink mix for toddlers and young children, containing a balanced mixture of the other essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. In can be ingested by people diagnosed with tyrosinemia type 2. Prepared for consumption by mixing with water. Product description states that it is “not suitable as sole source of nutrition.”
Super Soluble Duocal (aka Duocal): a high-calorie, protein-free nutritional supplement in powdered form that you can add to foods and beverages without altering the taste or texture when your child needs more calories in his or her diet.
Essential Amino Acid Mix (aka Essential AA): is an unflavoured powdered blend of the essential amino acids. Prepared for consumption by mixing with water.
These articles are categorized, according to U.S. Food & Drug Administration (“FDA”) regulations (21 CFR), as “medical foods.” See 21 CFR § 101.9(j)(8). Medical foods are defined in 21 U.S.C. 360ee(b)(3) as:
The term “medical food” means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
See § 5(b) of the Orphan Drug Act, Pub. L. 97-414, 96 Stat. 2049, (1983) (amended 1988, Pub. L. 100-290, 102 Stat. 90). According to the FDA, medical foods cannot claim to treat a disease, but must be labeled for the “dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements.”
The products involved in this AFR are listed on one entry dated February 11, 2009, and were all classified by the importer under subheading 3004.50.50, HTSUS, as “[m]edicaments (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: [o]ther medicaments containing vitamins or other products of heading 2936: [o]ther: [o]ther: [o]ther” CBP liquated the entry on September 11, 2009, with all the articles classified under subheading 2106.90.99, HTSUS, as “[f]ood preparations not elsewhere specified or included: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther.” Nutricia filed its Protest on February 25, 2010, asserting that the dietary medical products are properly classified as medicaments under heading 3004, HTSUS, or in the alternative as products specially designed for the use of handicapped persons under subheading heading 9817.00.96, HTSUS
Whether the dietary medical products are classified as food preparations under heading 2106, HTSUS, or as medicaments under heading 3004, HTSUS, or as products specially designed for the use of handicapped persons under subheading 9817.00.96, HTSUS?
LAW AND ANALYSIS:
Initially, CBP notes that the Protest was timely filed on February 25, 2010, which is within 180 days after the liquidation date of September 11, 2009. See 19 U.S.C. § 1514(c)(3). Additionally, CBP’s classification of the merchandise is a protestable matter under 19 U.S.C. § 1514(a)(2).
Further Review of Protest No. 1101-10-100060 is properly accorded to Protestant pursuant to 19 C.F.R. § 174.24(a), (b), and (c). The Protestant alleges that CBP’s classification of the articles is inconsistent with CBP rulings, which concern the same or substantively similar merchandise, namely Headquarters Ruling Letter “HQ” 083000, dated Sept. 19, 1990; NY N005717, dated Jan. 26, 2007; NY N006048, dated Feb. 6, 2007, and NY N006049, dated Feb. 6, 2007. In addition, the Protestant alleges that the Protest involves questions of law and facts that have not been ruled upon by CBP or the courts and that there are facts and legal arguments presented in the Protest that were not fully presented and considered at the time of the original ruling.
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRI). GRI 1 provides that the classification of goods shall be “determined according to the terms of the headings and any relative section or chapter notes.” In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may be applied in order.
The following HTSUS provisions are under consideration:
2106 Food preparations not elsewhere specified or included:
3004 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.
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:
Legal Note 1(f) to Chapter 21, HTSUS, excludes from classification under Chapter 21 “[y]east put up as a medicament or other products of heading 3003 or 3004.”
Legal Note 1(a) to Chapter 30, HTSUS, excludes from classification under Chapter 30 the following:
Foods 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)
U.S. Note 4 to Chapter 98, HTSUSA, provides in pertinent part the following:
For purposes of subheading 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
Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover –
articles for acute or transient disability;
spectacles, dentures, and cosmetic articles for individuals not substantially disabled;
therapeutic and diagnostic articles; or
medicine or drugs.
In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System, which constitute the official interpretation of the Harmonized System at the international level, may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
The ENs to 21.06 provide in pertinent part:
Provided that they are not covered by any other heading of the Nomenclature, this heading covers:
(A) Preparations for use, either directly or after processing (such as cooking, dissolving or boiling in water, milk, etc.), for human consumption.
(B) Preparations consisting wholly or partly of foodstuffs, used in making of beverages or food preparations for human consumption. The heading includes preparations consisting of mixtures of chemicals (organic acids, calcium salts, etc.) with foodstuffs (flour, sugar, milk, powder, etc.), for incorporation in food preparations either as ingredients or to improve some of their characteristics (appearance, keeping qualities, etc.) (see the General Explanatory Note to Chapter 38).
* * * * *
The heading includes, inter alia:
(14) * * *
The heading excludes products where an infusion constitutes a therapeutic or prophylactic dose of an active ingredient specific to a particular ailment (heading 30.03 or 30.04).
* * *
(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).
* * * * *
(Emphases in original).
The ENs to 30.04 provide in pertinent part:
* * * * *
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).
* * * * *
(Emphases in original).
The competing headings at issue here are headings 2106, 3004, and 9817, HTSUS. If the articles are considered “foods’ for classification purposes, then they are excluded from heading 3004 by Legal Note 1(a) to Chapter 30. The importer asserts that the articles are “medicaments” under the premise that they are used for therapeutic or prophylactic uses. The threshold issue is whether a “medical food” is considered a “food” for classification purposes or whether a “medical food” is a medicament.
“Medical food” is not defined or listed anywhere in the HTSUS. A common definition of “medical food” is that they are “foods specially formulated and intended for the dietary management of disease that has distinctive nutritional needs that cannot be met by normal diet alone.” This common definition is identical to the FDA’s definition of “medical food” in 21 U.S.C. 360ee(b)(3) listed supra. Furthermore, medical foods can, depending upon their composition, be considered to be part of an “elemental diet.”
The tariff term “food” is not specifically defined in the HTSUS. “When a tariff term is not defined in either the HTSUS or its legislative history, the term's correct meaning is presumed to be its common meaning in the absence of evidence to the contrary." Timber Prods. Co. v. United States, 515 F.3d 1213, 1219 (Fed. Cir. 2008). In discerning this common meaning, dictionaries, encyclopedias, scientific authorities, and other reliable information sources may be consulted to construe the meaning of a statute’s words. See Len-Ron Mfg. Co. v. United States, 334 F.3d 1304, 1309 (Fed. Cir. 2003).
The Merriam-Webster online dictionary defines “food” as:
1 a: material consisting essentially of protein, carbohydrate, and fat used in the body of an organism to sustain growth, repair, and vital processes and to furnish energy; also: such food together with supplementary substances (as minerals, vitamins, and condiments) b: inorganic substances absorbed by plants in gaseous form or in water solution
2: nutriment in solid form
See http://www.merriam-webster.com/dictionary/food (last visited July 12, 2012). In Webster’s New World College Dictionary, “food” is defined as “any substance taken into and assimilated by a plant or animal to keep it alive and enable it to grow and repair tissue; nourishment; nutriment . . . anything that nourishes or stimulates . . .” See Webster’s New World College Dictionary 550 (fourth ed. 2007). Other online sources define “food” similarly as “any nourishing substance that is eaten, drunk, or otherwise taken into the body to sustain life, provide energy, promote growth, etc” or as “[m]aterial, usually of plant or animal origin, that contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals, and is ingested and assimilated by an organism to produce energy, stimulate growth, and maintain life.”
Thus, based on the common definition of food and EN(A) 21.06, “food”, for tariff purposes is defined as any nourishing substance containing essential nutrients that is ingested and assimilated by a person to produce energy, stimulate growth, and maintain life. There is nothing that limits the definition of food to conventional food articles. For tariff purposes, food can encompass natural, processed, and highly formulated substances used for nourishment, which includes medical foods and substances that are part of an elemental diet.
Furthermore, the tariff term “medicament” is not specifically defined in the HTSUS. Webster’s dictionary defines medicament as a “medication”, which is “as medicine; substance for curing or healing, or for relieving pain.” See Webster’s New World College Dictionary 894 (fourth ed. 2007). A medicament is also defined in more general terms as “a substance used in therapy.” The CIT, in citing several reference sources, noted that the definition of “therapeutic” is “of or relating to the treatment of disease or disorders by remedial agents or methods: curative, medicinal” and “prophylactic” as meaning “preventive; preventing disease . . . an agent that acts to prevent a disease.” Warner-Lambert Co. v. United States, 28 C.I.T. 939, 946 (2004) aff’d 425 F.3d 1381 (Fed. Cir. 2005). “Medicinal” is defined as something that is “of or relating to, or being medicine: tending or used to cure disease or relieve pain.”
The adjective “medicinal” is used throughout EN 30.03 to describe articles classified under this heading, i.e., “medicinal compound vegetable extracts”; “medicinal mixtures of plants”; “medicinal salts”; “medicinal baths”; “. . . used for medicinal purposes”; and “. . . consisting of a medicinal component . . . .” The ENs to heading 3004 (and heading 3003) instruct that medicaments does not cover “food preparations containing only nutritional substances,” i.e., substances that are proteins, carbohydrates, fats, vitamins, and minerals. The CIT has stated that heading 3004 requires substances to have some recognizable “medicinal” impact. Warner-Lambert, 28 C.I.T. at 949. While heading 3004, HTSUS, is a principal use provision, see Warner-Lambert, 425 F.3d at 1384 (finding that, although vitamin C has therapeutic and prophylactic properties in the treatment of scurvy, that is not the principal use it is put up to), the first question under Warner-Lambert is whether there is any ingredient containing medicinal value at all.
Here, Nutricia’s medical food preparations do not contain any active ingredients in them that treat or act upon the underlying pathology of any disease or disorder. Instead, the preparations merely lack the substances that trigger the symptoms of a particular disease. None of the importer’s products mitigate or repress the symptoms if they are triggered. None of the products have an active ingredient that would prevent the symptoms from flaring up in the presence of a triggering substance. None of the products provide the recipients with the ability to process or metabolize substances that a person is unable to process because of his/her disorder. Instead, the preparations’ sole purposes are to provide nutrition.
For example, the Milupa PKU-3 product does not give the person with Phenylketonuria the ability to metabolize phenylalanine nor does it act to actively reduce it, keep it from building up, or remove it from the blood stream. Rather, the composition of this product simply lacks the phenylalanine amino acid but also provides the essential amino acids as an elemental protein source (and other nutrients) needed to “sustain life, provide energy, promote growth” that one would get from conventional food sources. Similarly, the Xphen metabolic products do not bestow upon a person with Tyrosinemia the ability to break down tyrosine, or actively reduce the tyrosine by removing the built up tyrosine from a person’s blood stream or mitigate the toxicity caused by the inability to fully metabolize tyrosine (such as what the drug Nitisinone does). What the Xphen provides is the needed proteins and other nutrients for normal growth and development of persons with Tyrosinemia. Likewise, the Essential Amino Acid Mix for use with people with Urea Cycle Disorder does not actively reduce the ammonia in the blood as drugs like sodium benzoate and sodium phenylbutyrate would. Rather this mix provides the amino acid supplementation (an elemental protein source), which one would normally get from the break down of larger protein compounds, as building blocks used for normal growth and tissue repair.
In fact, all of Nutricia’s preparations are used in the dietary management of those with metabolic disorders, which is a part of the overall treatment regimen. The preparations are used as part of the diet for their nutritional value that maintains the health and well being of those with metabolic diseases and severe food allergies and intolerances. Thus, Nutricia’s dietary medical products are not medicaments as they do not contain any active ingredient which performs some preventive, therapeutic (treatment), or curative function on a disease or condition by effectuating a chemical or biological change. See Lonza, Inc. v. United States, 18 C.I.T. 230 (1994). Accordingly, they are not classifiable in heading 3004.
Nevertheless, in regard to Nutricia’s PKU products, the importer cites Headquarters ruling (HQ) 083000, dated September 19, 1990, New York rulings (NY) N005717, dated January 26, 2007, NY N006048 and NY N006049, both dated February 6, 2007 classifying substantially similar merchandise under heading 3004, HTSUS.
With respect to HQ 083000, we note that the ruling was issued prior to the adoption of Note 1(a) to Chapter 30 which provides that only nutritional preparations administered intravenously are classified under Chapter 30. As a result, HQ 083000 was revoked by operation of law and is no longer a valid precedent for the classification of nutritional foods for PKU products under heading 3004, HTSUS.
However, the remaining rulings cited by the Protestant were issued after the adoption of Note 1(a) to Chapter 30. We note that in a document published in the Customs Bulletin dated September 3, 2014, CBP revoked the subject rulings in accordance with 19 U.S.C. 1625. As a result, merchandise covered by that revocation, including Milupa PKU-3 and Phlexy-10 Bar products, entered or withdrawn from warehouse for consumption on or after November 3, 2014, are classifiable in heading 2106.
In light of the fact that the entries of Milupa PKU-3 and Phlexy-10 Bar products which are the subject of this protest were made prior to the effective date of the revocation of those rulings, that merchandise is classifiable under subheading 3004.50.50, HTSUS, as “[m]edicaments (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: [o]ther medicaments containing vitamins or other products of heading 2936: [o]ther: [o]ther.” The rate of duty is free.
The importer argues in the alternative that its products are classifiable under subheading 9817.00.96, HTSUSA, as articles “specifically designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons.”
The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials established duty-free treatment for certain articles for the use or benefit of the handicapped in addition to providing duty-free treatment for articles for the blind. Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 and Presidential Proclamation 5978 provided for the implementation of the Nairobi Protocol by inserting permanent provisions, subheadings 9817.00.92, 9817.00.94, and 9817.00.96 into the HTSUS. These tariff provisions specifically state that “articles specifically designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons” are eligible for duty-free treatment.
U.S. Note 4(a), Chapter 98, HTSUS, states that 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.
U.S. Note 4(b), Chapter 98, HTSUS, states that subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover (i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or (iv) medicine or drugs.
There are no rulings on whether a metabolic disease/disorder or severe food allergies/intolerances are considered a handicap for classification purposes. People with metabolic diseases or disorders and severe food allergies/intolerances certainly are limited in their capacity to digest or metabolize or ingest specific substances found in conventional food (i.e., foodstuff occurring naturally). And these conditions require a person to avoid certain foods or category of foods. However, these disorders do not impair the actual physical act of eating. In all the other CBP rulings regarding classification under heading 9817, the conditions or diseases directly impaired one’s physical ability to perform one or more of the major life activities listed.
Furthermore, even in a recognized disability such as diabetes, CBP has not previously ruled that foods formulated for those with diabetes would be classified under this subheading. Accordingly, CBP finds that medical foods that provide the nutritional support as part of the dietary management of a metabolic disease/disorder or severe food allergy/intolerance are not classifiable under heading 9817, HTSUS.
In light of the foregoing, Nutricia’s dietary medical products are classifiable under heading 2106, HTSUS, as “[f]ood preparations not elsewhere specified or included.”
Pursuant to GRI 1 and Legal Note 1(a) to Chapter 30, the following Nutricia’s medical food products—Neocate 1+, Neocate Junior, Neocate LCP, Neocate Infant, Xphen Tyr Maxamum, Xphen Tyr Maxamaid, Super Soluble Duocal, Essential Amino Acid Mix—are classified under subheading 2106.90.99, HTSUS, as “[f]ood preparations not elsewhere specified or included: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther.” The column one, rate of duty, is 6.4 percent ad valorem.
Pursuant to New York rulings (NY) N005717, dated January 26, 2007, NY N006048 and NY N006049, both dated February 6, 2007 classifying substantially similar merchandise under heading 3004, HTSUS , the Milupa PKU-3 and Phlexy-10 Bar medical food products which are the subject of this protest are classified under subheading 3004.50.50, HTSUS, as “[m]edicaments (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: [o]ther medicaments containing vitamins or other products of heading 2936: [o]ther: [o]ther.” The rate of duty is free.
The Protest should be GRANTED in part and DENIED in part. A copy of this ruling should be attached to the CBP Form 19 and provided to the protestant as part of the notice of action on the protest.
Sixty days from the date of the decision the Office of International Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the U.S. Customs and Border Protection Home Page on theWorld Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Myles B. Harmon, Director
Commercial and Trade Facilitation Division