CLA-2 CO:R:C:G 081662 JGH

David I. Wilson, Esq.
Baker & Hostetler
Attorneys at Law
Washington Square, Suite 1100
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036

Re: Classification of Certain Sugar Pellets

Dear Mr. Wilson:

This is in reference to your submission of January 15, 1988, and subsequent meetings and submissions, concerning the classification of certain sugar pellets produced in France, shipped to the United States in 30 kilogram containers, and used in the production of homeophathic medicines and remedies.

FACTS:

You state that your client imports 3,000 kilograms annually of these sugar pellets, and that subsequent to importation the sugar pellets, which consist of 85 percent sucrose and 15 percent lactose, are treated with one of about 1500 homeophathic medicines by a saturation process to make a finished homeophathic remedy. The pellets are said to have an imported cost of $2.37 per pound, and are small spheres of about 2 mm in size and with a mass of about 50 mg. You note that they have been classified under the provision for other polysaccharides in item 493.68, and that the classification was changed to that for mixtures in item 432.28, with the rate of duty for item 493.68. In December 1987, a ruling received from the port of New York in which the pellets were classified under the provision for other edible preparations, n.s.p.f., in item 183.05, TSUS, and since the pellets contain 85 percent sucrose and were not imported in consumer retail packages, they were subject to the quota provision in item 958.15, TSUS, which prevents the products from entering the country.

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ISSUE:

Whether the sugar pellets are classifiable under the provision for other edible preparations in item 183.05, TSUS, or whether they are classifiable as mixtures in item 432.28, TSUS, or as a drug or an entirety.

LAW AND ANALYSIS:

Subsequent to importation the sugar pellets are used to produce homeophathic remedies by means of saturation process. It is stated that the pellets are used with some 1500 different remedies. Since the pellets are used to administer the remedies it is contended that the pellets cannot be considered foods substances within the meaning of Headnote 3, Part 15(B), Schedule 1, TSUS. In this headnote the term "edible preparations" is defined as substances chiefly used as food or as a food substance. In view of use of the pellets, it is argued that the pellets are not a food substance. Rather, it is urged that they be regarded as a drug, since they are used with medicinal substances. In support of this contention definitions of drugs from other agencies and various court cases are cited. While Customs may consider definitions of terms used by other agencies, where the tariff contains a definition, it is that definition which applies. Headnote 2, Part 3, Schedule 4, TSUS, defines the term "drugs" as a substance which has therapeutic or medicinal properties. Also relied on was the court's decision in Austin Chemical v. United States, Slip Op. 87-21, where the court concluded that an isomer of a certain acid, which it admitted had no therapeutic or medicinal properties, was nevertheless classifiable as a drug since the chemical of which it was an isomer was listed in the TSUS as a drug. However, sugar pellets in and of themselves are not a drug under any definition of the term and they are not essential to the administration of the remedies.

Another argument advanced is that the pellets should be considered classifiable as a drug under the doctrine of entireties. The pellets are shipped in bulk and are to be used with any one of 1500 remedies. As a general proposition, articles are to be regarded as entireties for tariff purposes where there is a natural affinity in composition, particularly where the identity of each article is merged into that of the resulting combination. Here the sugar pellets are finished products, capable of any number of uses. The dutiable condition of the imported articles must be ascertained by an examination of them in their condition as imported. The pellets are not intended for or subordinated to any one use but, as imported, are common carriers capable of any of the many uses for sugar in this form.

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It is also urged that the special construction of the pellets removes them from the category of the ordinary sugar tablets or pellets under the "more than" doctrine. The pellets complex and expensive method of production, requiring 16 days of processing, it is contended, is necesssary to provide pellets of uniform porosity, to ensure the homogeneous absorption of the active ingredient. They are manufactured specifically to be used with the homeophathic remedies. In this regard it is interesting to note that in one of the patent descriptions provided for the machinery used, the drying installation is said to be designed for drying objects of sugar, whether coated candies or globules for homeopathic medicines. In other words the pellets whether for candy or intended as a medicinal carrier were no more than a form of merely sugar. As mentioned previously, Headnote 3, Part 15(B), Schedule 1, defines the term "edible preparation" as substances chiefly used as human food or as an ingredient in such foods. General Headnote 10(e)(i) defines use as referring to the use in the United States of articles or a class or kind to which the imported articles belong, and the chief use is the use which exceeds all other uses combined. It is not the use of a particular shipment but rather the use of a class or type of goods involved which determines the chief use. Regardless of the complexity and expense of manufacture the sugar pellets in question are of a class of product which is chiefly used for food purposes, and under Headnote 3, mixtures of food or food ingredients are to be included in the definition of edible preparations, thus making it a more specific provision for classification purposes. Sugar pellets manufactured in this country, as mentioned in your latest submission, are intended to be used as a base for confectionary or medicinal use. In this latter use they provide flavor as well as act as a carrier.

Even if it is conceded that the complex method of manufacture of these sugar pellets is necessary to ensure the homogeneous absorption of the active ingredients, the purpose of using sugar is also for its sweetening qualities. It is noted that the pellets have a sweet taste when just one of the sample pellets is placed on the tongue. As stated in one of the cases cited by the importer, Nutrilab, Inc. v. Schweiker, 713 F 2d. 335, food includes articles used by people primarily for taste, aroma, or nutritive value. In the technical literature submitted, the globules or pellets are described as being of solid consistency, obtained by the successive addition of sucrose and lactose to particles of sucrose or lactose or to a mixture of both. It is further stated that they are intended for oral or sublingual administration. The pellets characteristics are described as "near spherical white pellets, sweet tasting, easily soluble in water." In the advertising literature submitted, in discussing the various

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dosages to be administered, it is apparent that usually a single pellet is not prescribed; rather dilutions of the active ingredient involved require a "multi-dose" with an average dose of 3 to 5 pellets or unit dose which contains "200 spherical sucrose pellets" (and) "the entire contents should be placed under the tongue." If a single pellet is found to be sweet, it would be difficult to conclude that 200 pellets placed underneath the tongue were not intended to have a saccharide effect and that sweetness was not a quality that was considered when the pellets were developed, especially where bitter tasting medicines are concerned.

HOLDING:

While it is acknowledged that these pellets are specially constructed for a specific purpose, they are entirely of sugar, and ultimately serve the same function as other sugar pellets or tablets: they provide a carrier for the administration of a medicine or for a confectionary coating and in addition contain a desired sweetness which is a quality of food. Therefore, they are properly classifiable under the provision for other edible preparations in item 183.05 and subject to the quota restriction in item 958.15, TSUS.

Under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) scheduled to replace the TSUS on January 1, 1989, the sugar pellets are classifiable under the provision for food preparations not elsewhere specified or included: Other, in subheading 2106.90.60, HTSUSA. The rate of duty is 10 percent ad valorem. In addition the pellets would be subject to a quota restriction in subheading 9904.50.40, HTSUSA, similar to the one they were subject to in the TSUS.

Sincerely,

John Durant, Director
Commercial Rulings Division