CLA-2 OT:RR:CTF:TCM H240613 RES
Mr. Mark DeFries
Solace Nutrition
46 Kilvert Street
Warwick, RI 02866
RE: Revocation of New York Ruling Letters N006048, dated February 6, 2007, N006049, dated February 6, 2007, and N005717, dated January 26, 2007; classification of medical foods used for dietary management of Phenylketonuria.
Dear Mr. DeFries:
This letter is to inform you that U.S. Customs and Border Protection (“CBP”) has reconsidered New York (“NY”) Ruling letters N006048 and N006049, both dated February 6, 2007, and N005717, dated January 26, 2007, regarding the classification of medical foods used for dietary management of Phenylketonuria (“PKU”), under the Harmonized Tariff Schedule of the United States (“HTSUS”). The merchandise in NY N006048, NY N006049, and NY N005717 were classified as medicaments, under heading 3004, HTSUS. We have determined that NY N006048, NY N006049, and NY N005717 were in error. Accordingly, we are revoking NY N006048, NY N006049, and NY N005717, to reflect the proper classification of the medical foods used for dietary management of PKU.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. § 1625(c)(1)), as amended by section 623 of Title VI, notice of the proposed action was published on April 30, 2014, in Volume 48, Number 17, of the Customs Bulletin. No comments were received in response to this notice.
FACTS:
The following facts were set forth in NY N006048:
The subject product, NeoPhe® LNAA Tablets®, is described as a “medical food,” for use, under medical supervision, for the dietary management of phenylketonuria (PKU). The tablets contain large neutral amino acids (LNAAs) as the active ingredient. Wording on the printed label found on the container in which the tablets are supplied states that the tablets are “[N]ot for the general population of consumers.”
Pursuant to HQ 083000, dated September 19, 1990, the applicable subheading for NeoPhe® LNAA Tablets® will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.
The following facts were set forth in NY N006049:
The subject products, Avonil® AA Tablets and Avonil® AA Powder, are phenylalanine-free nutritional supplements consisting of various amino acids, vitamins and minerals. Both products are specifically intended for the dietary management of phenylketonuria (PKU). The tablets are used by persons with phenylketonuria from 4 years of age, including maternal PKU patients. The powder is for use by children over 4 months of age, and by adults, including maternal PKU patients.
Pursuant to HQ 083000, dated September 19, 1990, the applicable subheading for Avonil® AA Tablets and Avonil® AA Powder will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.
The following facts were set forth in NY N005717:
The subject product, PreKUnil® LNAA Tablets ®, is described as a “medical food,” for use under medical supervision, for the dietary management of Phenylketonuria (PKU). The tablets contain large neutral amino acids (LNAAs) as the active ingredient. Wording on the printed label found on the container in which the tablets are supplied states that the tablets are “[N]ot for the general population of consumers.”
Pursuant to HQ 083000, dated September 19, 1990, the applicable subheading for PreKUnil® LNAA Tablets® will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Other.” The rate duty will be free.
ISSUE:
Whether the subject merchandise are classified under heading 2106, HTSUS as food preparations or under 3004 as medicaments?
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRI), and, in the absence of special language or context which otherwise requires, by the Additional U.S. Rules of Interpretation (ARI). 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:
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)
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 a 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 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 such as nutritional supplements designed specifically for persons with PKU. As such, unless specified elsewhere, the merchandise at issue is described by the term “food preparation” of heading 2106, HTSUS.
The classification of the articles in NY N006048, NY N006049, and NY N005717, as medicaments was predicated upon the classification of similar merchandise in HQ 083000, dated September 19, 1990, which classified nutritional supplements used by persons with PKU as medicaments under heading 3004, HTSUS. However, CBP in HQ 966779, dated January 16, 2004, determined that the effect of the 2002 amendment to Chapter note 1(a) to Chapter 30 was to revoke by operation of law HQ 083000, and the analysis contained within it, and exclude any and all nutritional products from chapter 30 unless they are administered intravenously. Consequently, HQ 083000 was, at the time NY N006048, NY N006049, and NY N005717 were issued, no longer a valid precedent for the classification of nutritional supplements for PKU products under heading 3004, HTSUS. Rather, HQ 966779 classified nutritional foods/supplements designed for use by persons with PKU as food preparations under heading 2106, HTSUS. The analysis set forth in HQ 966779 is incorporated here by reference.
Therefore, upon reconsideration that the classification of the merchandise in NY N006048, NY N006049, and NY N005717 was based upon a revoked HQ ruling, CBP has determined that the classifications in NY N006048, NY N006049, and NY N005717 of the nutritional foods for PKU under heading 3004, HTSUS, are incorrect. Nutritional foods/supplements for persons with PKU are excluded from classification in Chapter 30 and are therefore classified under heading 2106, as “food preparations not elsewhere specified or included.”
HOLDING:
Pursuant to GRI 1, Legal Note 1(a) to Chapter 30, and HQ 966779, the NeoPhe® LNAA Tablets®, Avonil® AA Tablets, Avonil® AA Powder, and PreKUnil® LNAA Tablets® are classified under subheading 2106.90.9998, 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; [o]ther.” The column one, rate of duty, is 6.4 percent ad valorem
EFFECTS ON OTHER RULINGS:
NY N006048 and NY N006049, both dated February 6, 2007, and NY N005717, dated January 26, 2007, are revoked.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division