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HQ 966779

January 16, 2004

CLA-2 RR:CR:GC 966779ptl


TARIFF NO.: 2106,90.9500/9700; 2106.90.9998.

Erik D. Smithweiss, Esq.
Joseph M. Spraragen, Esq.
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP 245 Park Avenue
New York, NY 10167-3397

RE: PKU Express and PKU Gel

Dear Mr. Spraragen:

This is in response to your letter, dated September 16, 2003, to the Director, National Commodity Specialist Division (NCSD) New York, on behalf of your client, Transnational Service & Operations LLC, requesting a binding ruling on the classification under the Harmonized Tariff Schedule of the United States (HTSUS), of products identified as PKU Express and PKU Gel. At your request, the ruling request was forwarded to this office by the NCSD.


The products under consideration are identified as PKU Express and PKU Gel. They are said to be phenylalanine-free protein substitutes for use in the dietary management of phenylketonuria. Phenylketonuria, also known as PKU, is a disorder characterized by the body's inability to metabolize phenylalanine, an "essential" amino acid, due to the absence of an enzyme. The inability to metabolize phenylalanine can cause it to accumulate in the blood and body tissues, potentially causing severe damage to the brain.

PKU Express and PKU Gel are powders consisting of the essential and non-essential amino acids, aside from phenylalanine, carbohydrates, minerals, trace elements, and vitamins. The PKU Express will be imported in a box containing 30 individual packets each containing 25g of the powder. The PKU Gel will be imported in a box containing 30 individual packets each containing 20g of powder. To consume either product, an individual is instructed to empty the packet contents into a beaker, add water, shake and drink the mixture. Although both products can be drunk as a beverage, the Gel product can be prepared by using less water and allowing the mixture to stand, producing a gel that can then be eaten with a spoon.

Package labeling states that the product is "A phenylalanine free protein substitute for use in the dietary management of Phenylketonuria ." The product box also states that the product "Must only be consumed by patients with proven phenylketonuria under strict medical supervision. Not for intravenous use." The box also states that the user's "Diet must be supplemented with natural protein, water and other nutrients in prescribed quantities to supply the phenylalanine, fluid and general nutrition requirements of the patient."

Because of an inconsistency in information you submitted to Customs, a laboratory analysis was performed on the PKU Gel product. That report, No. SF20032421, indicates that the PKU Gel Raspberry, Batch Number 2115, contained approximately 30 percent sucrose (sugar from cane or beets), 43 percent protein equivalent, 5 percent ash and starch and maltose [sic] dextrin.

This letter also reflects consideration of matters you raised during oral discussions of the products with Headquarters on January 13, 2004.


Are PKU Express and PKU Gel, special dietary food preparations, classified in Heading 3004, HTSUS, as medicaments, or in Heading 2106, HTSUS, as food preparations?


Merchandise is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) in accordance with the General Rules of Interpretation (GRIs). The systematic detail of the HTSUS is such that most goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule 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 may then be applied in order.

In understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes may be utilized. The Explanatory Notes (ENs), although not dispositive or legally binding, provide a commentary on the scope of each heading of the HTSUS, and are the official interpretation of the Harmonized System at the international level. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The HTSUS subheadings under consideration are as follows:

2106 Food preparations not elsewhere specified or included:

2106.90 Other:
Articles containing over 10 percent by dry weight of sugar described in additional U.S. note 3 to chapter 17:

2106.90.9500 Described in additional U.S. note 8 to chapter 17 and entered pursuant to its provisions

2106.90.9700 Other

2106.90.99 Other

2106.90.9998 Other

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 or in forms or packings for retail sale:

3004.50 Other medicaments containing vitamins or other products of heading 2936:

3004.50.50 Other

3004.50.5030 Combined with minerals or other nutrients

Your position is that because the PKU products have been prepared for and are intended to be consumed by individuals who are under medical treatment for PKU the products should be classified under the subheading for medicaments. In support of your position, you refer to HQ 083000, dated September 19, 1990, which classified a product apparently quite similar to the instant PKU product in subheading 3004.50.50, HTSUS. You also refer to the treatment accorded products such as the PKU products by the U.S. Food and Drug Administration (FDA) as "medical foods."

In reaching its decision in HQ 083000, Customs created a distinction between food preparations that are intended for general health and well-being and food preparations intended for the treatment or prevention of diseases or ailments. However, in 2002, the pertinent Chapter note 1(a) to Chapter 30 was amended to provide as follows:

1.This chapter does not cover:
(a) 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);

The added language: "[o]ther than nutritional preparations for intravenous administration (section IV)" acts to allow those products which are administered intravenously to be classified in chapter 30. The amendment does not expand the scope of the heading to other nutritional preparations. The effect of the amendment to chapter note 1(a) was to revoke HQ 083000, void the analysis contained therein, and exclude any and all nutritional products from chapter 30 unless they are administered intravenously. Pursuant to 19 CFR 177.12 (d), when rulings are revoked by operation of law, such as by an amendment to the HTSUS, publication and issuance of notice requirements are inapplicable.

This exclusion from chapter 30 is reinforced by the ENs to Chapter 30 which require that products classified therein be for therapeutic or prophylactic use. The PKU products do not treat or prevent the disease. They enable the patient's body to function without increasing the risk of accumulating excess phenylanine. The PKU products allow patients with PKU to obtain needed vitamins and minerals. Consuming PKU products will neither cure nor prevent the condition. While the products may be considered medical foods by the FDA, it does not necessarily follow that the products are medicaments for tariff purposes. We note that it is a long established principle of Customs practice that the characterization of imported merchandise by governmental agencies for other than tariff purposes does not determine tariff classification. See United States v. Mercantil Distribuidora et al., 45 C.C.P.A. (Customs) 20, C.A.D. 667 (1957); Marine Products Co. v. United States, 42 Cust. Ct. 154 (C.D. 2080) (1959).

As indicated in the labeling of the product, the PKU Gel and PKU Express are nutritional foods, which are intended to be supplemented with other food products in order to provide the required general nutritional needs of the patient. As such, they are excluded by Chapter note 1(a) from classification in Chapter 30. Accordingly, by application of GRI 1, they are classified in heading 2106, HTSUS, which provides for food preparations, not elsewhere specified or included.


PKU Express is classified in subheading 2106.90.9998, HTSUS, which provides for: Food preparations not elsewhere specified or included, other, , other, other.

PKU Gel, because of its sugar content, is classified in subheading 2106.90.9500, HTSUS, which provides for: Food preparations not elsewhere specified or included, , other, other, Articles containing over 10 percent by dry weight of sugar described in additional U.S. note 3 to chapter 17: Described in additional U.S. note 8 to chapter 17 and entered pursuant to its provisions, or the over-quota subheading 2106.90.9700, HTSUS.


Myles B. Harmon, Director

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