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HQ 089455

January 6,1992

CLA-2 CO:R:C:F 089455 JGH


TARIFF NO.: 2106.90.60

Kenneth H. Keefe, Esq
Sandler, Travis & Rosenberg
5200 Blue Lagoon Drive
Miami, Florida 33126-2022

RE: Nutritional Food Product - Medicament - Fortified Food - Food Supplement.

Dear Mr. Keefe:

Your letter of April 17, 1991, concerns the tariff classification of "Accupep HPF", (Accupep) a product of the Netherlands, under the Harmonized Tariff Schedules of the United States (HTSUS).


Accupep is described as offering the benefits of a nutritionally complete elemental formula with short-chain peptides as the primary protein source, as well as other nutrients, such as calories, fats and carbohydrates. It is prepared in powder form and said to consist of maltodextrin, hydrolyzed lactalbumin, corn oil, and numerous vitamins and minerals. It is to be mixed with water and is suitable for either oral or tube feeding.

The suggested usage is said to be for the nutritional management of patients with short bowel syndrome, Crohn's disease and pancreatic insufficiency, as well as patients and others undergoing radiation therapy in the GI tract.


Whether Accupep is classifiable under the provision for other medicaments for therapeutic or prophylactic uses, containing vitamins, put up in packings for retail sale, in subheading 3004.50.50, HTSUS, or other food preparations not elsewhere specified or included in subheading 2106.90.60, HTSUS.


Merchandise imported into the United States is classified under the HTSUS, with classification being governed by principles set forth in the General Rules of Interpretation (GRIs). GRI 1 requires that classification be determined in the terms of the headings of the HTSUS. In addition, the Explanatory Notes to the HTSUS headings provide an interpretation of the individual headings on the international level.

Chapter 30, HTSUS, covers pharmaceutical products. Note 1(a) to Chapter 30 states that the chapter does not cover food or beverages (such as dietic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters). The Explanatory Notes to heading 3004 state further that the heading does not cover food preparations containing only nutritional substances. Major nutritional substances in food are listed as proteins, carbohydrates and fats; vitamins and mineral salts are also said to play a part in nutrition. In fact, the explanatory notes explicitly state that foodstuffs and beverages containing medicinal substances are excluded from the heading if these substances are added solely to ensure better dietetic balance, to increase energy-giving or nutritional value, always provided that the product retains its character as a foodstuff or a beverage. The explanatory notes go on to state that also excluded are" food supplements containing vitamins and 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 be put up in powder or tablet form, are generally classified in heading 21.06 or Chapter 22."

It is maintained that Accupep is classifiable in heading 3004 because it is used in the treatment of patients with serious digestive ailments. However, Accupep is described as a nutritionally complete elemental formula; it contains the major nutritional substances designed to provide a complete diet for the patient who is disabled by disease and unable to tolerate an ordinary diet. It is not designed to be a medicament and provide therapeutic benefits for a specific disease entity, but rather ensure a better dietetic balance and improve the patient's overall condition, so that additional treatment may be tolerated.

The product at best is a fortified food and, as such, one which under note 1(a) of Chapter 30, HTSUS, is not covered in Chapter 30. As explained to you at the meeting held at this office, it is our position that complete nutritional preparations such as this which are designed "to meet the nutritional needs of patients", are primarily designed to provide basic sustenance so that specific treatment for a disease may be given.


Accupep, a nutritionally complete diet, is classifiable under the provision for other food preparations in item 2106.90.60, HTSUS. The rate of duty is 10 percent ad valorem.


John Durant, Director

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