HQ 089455
January 6,1992
CLA-2 CO:R:C:F 089455 JGH
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).
FACTS:
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.
ISSUE:
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.
- 2 -
LAW AND ANALYSIS:
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.
- 3 -
HOLDING:
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.
Sincerely,
John Durant, Director
Commercial Rulings Division