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HQ 083000


Sept 19, 1990

CLA-2 CO:R:C:G 083000 JGH

Category: CLASSIFICATION

TARIFF NO.: 3004.50.50, HTSUS

Donald J. Unger, Esq
Barnes, Richardson & Colburn
200 East Randolph Drive
Chicago, Illinois 60601

RE: Tariff Classification of Analog XP, Maxamaid XP, Maxamum XP

Dear Mr. Unger:

This is in reference to your submission on the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of phenylalanine-free dietary preparations.

FACTS:

The products are powdered dietary formulations specifically formulated to satisfy the dietary restrictions for a patient suffering from phenylketonuria (PKU). PKU is a metabolic disorder characterized by an inability to convert phenylalanine, an essential amino acid which can not be synthesized by the body and is necessary for survival, into tryosine, an amino acid essential for the PKU patient.
If the phenylalanine is not converted into tryosine, it and its metabolites accumulate in the blood and may be the cause of severe mental retardation.

These diets are designed as special protein diets, low in phenylalanine or phenylalanine free, but supplemented with natural protein to satisfy estimated daily phenylalanine requirements. The diets are physician controlled and designed to ensure that the patient receives only the amount of phenylalanine necessary for normal growth and development. They are a balanced mixture of arnino acids, carbohydrates, minerals and vitamins, specifically formulated to treat PKU and prevent hyperphenylalanine and,ultimately, mental retardation.

A typical product was said to contain:

Sucrose, amino acids( l-lysine glutamate, l-leucine, l-tyrosine, l-arginine, l-proline, l-aspartic acid, l-valine, glycine, l-isoleucine, l-threonine, l-histidine, l-serine, l-alanine, l-cystine, l-tryotophan, l-methionine, l-glutamine, l-glutamic acid); minerals ( calcium phosphate dibasic, sodium citrate, magnesium phosphate dibasic, potassium citrate, potassium chloride, calcium citrate, calcium phosphate tribasic, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium molybdate); vitamins (cholinebitartrate, ascorbic acid, m-inositol, niacinamide, alphatocopheryl acetate, vitamin D-3, calcium pantothentate, vitamin A acetate, thiamine chloride hydrochloride, pyridoxine hydrochloride, riboflavin, folic acid, biotin, cyanocobalamin)

ISSUE:

Whether dietary preparations of this type are classifiable as a food preparation not elsewhere specified or included, in heading 2106, HTSUS, or other medicaments consisting of mixed or unmixed products for therapeutic or prophylatic uses, put up in measured doses or in forms or packings for retail sale containing vitamins in subheading 3004.50.50, HTSUS.

LAW AND ANALYSIS:

Classification under the HTSUS is governed by the General Rules of Interpretation (GRI's). GRI 1 provides that classification is determined first in accordance with the terms of the headings and any relative Section or Chapter notes. The Explanatory Notes constitute the official guide to the HTSUS at the international level.

Heading 3004, HTSUS, provides for medicaments (excluding goods of heading 3002,3005, or 3006) consisting of mixed or unmixed products for therapeutic or prophylatic uses, put up in measured doses or in forms or packings for retail sale. Note l(a) to Chapter 30, HTSUS, states that the chapter does not cover "food or beverages (such as dietetic, diabetic, or fortified foods, food supplements, tonic beverages and mineral waters)."

The Explanatory Notes to heading 3004 provide that the heading does not apply to foodstuffs or beverages such as dietetic,diabetic, or fortified foods, tonic beverages or mineral waters, which are classified under their own appropriate headings. Food preparations containing only nutritional substances are among those foodstuffs or beverages. The Notes further state that the major nutritional substances in food are proteins, carbohydrates and fats, and that vitamins and mineral salts also play a part in nutrition. The heading excludes food supplements containing vitamins or mineral salts which are put up for the purpose of maintaining health or well-being, but which have no indication as to use for the prevention or treatment of any disease or ailment.

Heading 2106, HTSUS, provides for food preparations not elsewhere specified or included. Note l(f) to Chapter 21 states that th~ chapter does not cover products of heading 3003 or 3004. Explanatory Note (B) (16) to heading 2106, states that the heading covers preparations referred to as food supplements which are "based on extracts from plants, fruit concentrates, honey, fructose, etc.", and which contain vitamins. The note further states that these preparations are often put up in packaging with indications that they maintain general health or well-being. Excluded from this heading are similar preparations intended for the prevention or treatment of diseases or ailments.

Here, the labels for the products state that they must be given only to patients with proven phenylketonuria who are under strict medical supervision, and must be supplemented with natural protein, fluid and other nutrients in prescribed quantities to supply the phenylalanine, fluid and general nutritional requirements of the patient. In other
words these preparations are intended to treat a specific condition and not to provide food for general well being and health. As stated in the Explanatory Notes, food supplements put up for the purpose of maintaining health or well being and not to be used for the prevention or treatment of a disease or ailment are excluded from Chapter 30. The labels of the products under consideration make it clear that they are intended to specifically treat patients with PKU, and are not intended for general sustenance, health, or well being.

HOLDING:

Dietary preparations of the type described are classifiable in subheading 3004.50.50,HTSUS. The rate of duty is 3.1 percent.

Sincerely,

,,,' , j-., .7

John Durant, Director
Commerical Rulings Division

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