CLA-2 CO:R:C:G 083000 JGH
Category: Classification
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.
--2--
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)."
--3--
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
--4--
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