CLA-2 CO:R:C:G 086942 RFC
TARIFF No.: 2106.90.6099
District Director of Customs
U.S. Customs Service
300 South Ferry Street, Terminal Island
San Pedro, California 90731
RE: Decision on Application for Further Review of Protest No.
2704-89-003735, on the classification of a food preparation
known by the brand name Lipovitan
Dear Sir:
This is a decision on application for further review of a
protest timely filed on behalf of Taisho Pharmaceutical Co.,
Ltd., on November 21, 1989, against your decision in the
classification of a food preparation known by the brand name
Lipovitan, which was entered under entry number 986-1168447-7 on
May 9, 1989 and liquidated on August 23, 1989.
FACTS:
The product is identified as "Lipovitan." The information
submitted with the instant protest shows the goods to contain 20
milligrams of niacin (niacinamide), 5 milligrams of vitamin B-1
(thiamine), 5 milligrams of vitamin-2 (riboflavin), and 5
milligrams of vitamin B-6 (pyridoxine). The U.S. recommended
daily allowance (U.S. RDA) for these vitamins is 20 milligrams
for niacin, 1.5 milligrams for vitamin B-1, 1.7 milligrams for
vitamin B-2, and 2 milligrams for vitamin B-6. See 21 CFR 101.9.
The other ingredients are set forth in unspecified amounts:
water, sucrose, sorbitol, citric acid, arginine, phosphoric acid,
royal jelly, artificial flavors, sodium benzoate, and sodium
citrate. (It is stated in an August 20, 1990 correspondence from
the importer that the product originally contained taurine and
not royal jelly or arginine, and for a brief marketing period
contained neither taurine, royal jelly or arginine).
The product is sold, marketed, and distributed in 3.3 fluid
ounce (100 ml) bottles. On the label found on each bottle, the
product is described as a "healthful vitamin drink [intended]
for [the] prevention of deficiencies of niacin, vitamin B-1,
vitamin B-2, and vitamin B-6." On each label there is also
stated: "Suggested use: Drink entire bottleful, one time daily."
Similar descriptions and statements can be found on the cartons
in which the bottles are packaged.
In a document from the importer entitled "Attachment to
Request for Further Review," the product is described as a
"vitamin supplement or tonic beverage" and as a "health drink."
In this document, it is stated that "[t]he product is marketed
and sold exclusively as a health drink" and that "Lipovitan is a
vitamin supplement or tonic beverage used to promote a better
dietetic balance and to supplement nutritional value." It is
further stated that "[p]ursuant to discussions with FDA
officials, Lipovitan...[is]...required to be...[labeled] as a
vitamin supplement in compliance with 21 CFR Part 101," and that
"Lipovitan falls squarely within the definition for a vitamin
supplement or tonic beverage...."
In a letter from the importer dated June 14, 1989 and
referenced as "Response to Proposed Rate Advance/Notice of
Action," the instant product is again discussed and descriptions
and statements are provided that are similar to those discussed
above: "[Lipovitan] is a vitamin supplement or tonic beverage
used to promote a better dietetic balance or to supplement
nutritional value, and is so recognized by the Food and Drug
Administration (FDA)" and "Lipovitan...[is]...required to be
[labeled] as a food/vitamin supplement in compliance with 21 CFR
Part 101." Finally, in a letter from the importer dated August
20, 1990, it is stated that "the intended use of Lipovitan is for
the replenishment of bodily fluids and essential substances."
(This letter, however, fails to identify exactly what "bodily
fluids and essential substances" are sought to be replenished and
what ingredients in the product are intended to replenish the
"bodily fluids and essential substances.")
Customs classified the instant goods under heading 3004.
This heading provides for medicaments consisting of mixed or
unmixed products for therapeutic or prophylactic uses, put up in
measured doses or in forms or packings for retail sale. The
importer contests this classification. It contends that the
goods are properly classified under heading 2202. This heading
provides for waters, including mineral waters and aerated waters,
containing added sugar or other sweetening matter or flavored,
and other non-alcoholic beverages, not including fruit or
vegetable juices.
ISSUE:
What is the proper classification under the Harmonized
Tariff Schedule of the United States Annotated (HTSUSA) of a
product containing 20 milligrams of niacin (niacinamide), 5
milligrams of vitamin B-1 (thiamine), 5 milligrams of vitamin
B-2 (riboflavin), 5 milligrams of vitamin B-6 (pyridoxine);
unspecified amounts of water, sucrose, sorbitol, citric acid,
arginine, phosphoric acid, royal jelly, artificial flavors,
sodium benzoate, and sodium citrate; sold, marketed, and
distributed in 3.3 fluid ounce (100 ml) bottles; described on
the product label as a "healthful vitamin drink [intended] for
[the] prevention of deficiencies of niacin, vitamin B-1, vitamin
B-2, and vitamin B-6"; and with a recommended dosage of one
entire bottle once a day?
LAW AND ANALYSIS:
Classification of merchandise under the HTSUSA is governed
by the General Rules of Interpretation (GRIs). GRI 1 requires
that classification be determined first according to the terms of
the headings of the tariff and any relative section or chapter
notes and, unless otherwise required, then according to the
remaining GRIs, taken in order.
A review of the chapters in the HTSUSA reveals that the
instant goods may be potentially classified in three chapters:
chapter 30, chapter 22, and chapter 21. Chapter 30 covers
pharmaceutical products. As the instant goods are promoted as a
healthful drink for the prevention of certain vitamin
deficiencies, a proper heading under which to classify them in
chapter 30 may be heading 3004. This heading provides for
medicaments consisting of mixed or unmixed products for
therapeutic or prophylactic uses, put up in measured doses or in
forms or packings for retail sale. Guidance concerning what
constitutes "medicaments" for purposes of classification under
heading 3004 can be found in the Explanatory Notes to this
heading. Instructive on this point is the following note found
in the Explanatory Notes to heading 3004:
[T]his heading excludes food supplements containing
vitamins or 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 also be put up in powder or tablet form, are
generally classified in heading 2106 or Chapter 22.
There exists no indication that the instant goods are used for
the prevention or treatment of any disease or aliment.
Therefore, pursuant to the above note, the goods are not properly
classified under heading 3004. Accordingly, the instant goods
are not classified in chapter 30 as there exists no other
heading in this chapter under which they could be classified.
The second possible chapter within which the goods may be
classified is chapter 22. This chapter provides for beverages,
spirits and vinegar. The general notes to the Explanatory Notes
to chapter 22 state that:
The products of this Chapter constitute a group quite
distinct from the foodstuffs covered by the preceding
Chapters of the Nomenclature[, and]...[the products] fall
into four main groups: (A) [w]ater and other non-alcoholic
beverages and ice[;] (B) [f]ermented alcoholic beverages
(beer, wine, cider, etc.)[;] (C) [d]istilled alcoholic
liquids and beverages (liqueurs, spirits, etc.), compound
alcoholic preparations therefor and ethyl alcohol[; and] (D)
[v]inegar and substitutes for vinegar.
In view of these notes, then, it is clear that the scope of this
chapter is something less than all consumable liquids.
With respect to the statement in the Explanatory Notes to
heading 3004 that food supplements are generally classified in
heading 2106 or chapter 22, there exists no terms in any heading
in chapter 22 that specifically provide for such supplements and
the Explanatory Notes to this chapter only provide for such
supplements in headings 2205 and 2206. The Explanatory Notes to
each of these headings state that some of the goods provided for
under these headings may contain added vitamins or iron
compounds, are sometimes referred to as "food supplements," and
are designed to maintain general health or well-being. The
instant goods, however, do not fit the heading descriptions of
"vermouth and other wine of fresh grapes [flavored] with plants
or aromatic substances" for heading 2205 or of "other fermented
beverages (for example, cider, perry, mead)" for heading 2206.
Thus, neither of these headings is appropriate for classification
of the instant goods.
The only other heading in chapter 22 that merits
consideration in the instant classification analysis is heading
2202. This heading provides for "waters, including mineral
waters and aerated waters, containing added sugar or other
sweetening matter or [flavored], and other non-alcoholic
beverages, not including fruit or vegetable juices of heading
[2009]." As the instant goods are not merely a water, including
mineral water or aerated water containing added sugar or other
sweetening matter or flavored, then pursuant to GRI 1, the
instant product must fit the description of an "other non-
alcoholic beverage" or be classified elsewhere in the schedule.
The Explanatory Notes to heading 2202 make no provision for
products containing added vitamins or iron compounds, referred to
as food supplements, and designed to maintain general health or
well-being as do the Explanatory Notes to headings 2205 and 2206.
Rather, the Explanatory Notes to heading 2202 provide for a very
different product:
This heading covers non-alcoholic beverages...not classified
under other headings, particularly heading [2009] [{which
provides for "fruit juices (including grape must) and
vegetable juices, unfermented and not containing added
spirit, whether or not containing added sugar or other
sweetening matter")] or [2210] [(which provides for "waters,
including natural or artificial mineral waters and aerated
waters, not containing added sugar or other sweetening
matter nor [flavored]; ice and snow)"]. It includes, inter
alia[,] [the following "other non-alcoholic
beverages":]...[b]everages such as lemonade, orangeade,
cola...[,] ...[t]amarind nectar rendered ready for
consumption as a beverage by the addition of water and sugar
and straining...[,] ...[and] [c]ertain other beverages ready
for consumption, such as those with a basis of milk and
cocoa.
A careful and thoughtful review of the above-listed terms of
heading 2202 and the Explanatory Notes thereto, shows that this
heading contemplates and encompasses as "other non-alcoholic
beverages" a product that is to be consumed primarily for
pleasure in generally unlimited or unrestricted quantities and
not a product that is to be consumed for an exceedingly high
vitamin content in limited or restricted quantities. In point
of fact, there exists no authority to support a contrary
conclusion.
The instant product is clearly not within the contemplation
or coverage of the terms of heading 2202 as its exceedingly high,
multi-vitamin ingredients (with each vitamin ingredient equal to
or exceeding by over 200 percent the U.S. RDA) makes it a
product that is to be consumed as a food or vitamin supplement
(which is the description provided for the product by the
importer) in limited or restricted quantities. Given its
exceedingly high, multi-vitamin ingredients, this product would
not be purchased solely for its taste or for consumption in
unlimited, unrestricted, or even large quantities.
In addition to the above-mentioned descriptions and
statements set forth in written submissions by the importer and
the exceedingly high, multi-vitamin ingredients contained in the
product, additional evidence exists of the use of the product as
a food or vitamin supplement and not as a conventional beverage
contemplated by heading 2202. This evidence can be found (1) in
the non-conventional-size bottles (3.3 ounces) in which the
instant product is sold; (2) in the product's description
labeling as a healthful vitamin drink for the prevention of
certain vitamin deficiencies; (3) and in the recommended dosage
of the product (i.e., drink one entire bottle once a day). In
light of the above, one can only conclude that pursuant to GRI 1
the instant product is not properly classified under heading 2202
as "other non-alcoholic beverages."
The final chapter in which the instant product may be
potentially classified is chapter 21. This chapter covers
miscellaneous edible preparations. As the instant product is a
food preparation and has not been found to be specified or
included elsewhere in the schedule, a heading in chapter 21
providing for such a product would need to be given serious and
thoughtful consideration as a potential heading for
classification of the product. Within chapter 21, just such a
heading exists: heading 2106 provides for "food preparations not
elsewhere specified or included" in the schedule. Guidance
concerning what constitutes a "food preparation" for purposes of
classification under heading 2106 can be found in the Explanatory
Notes to this heading. As concerns products included under
heading 2106, note (16) to the Explanatory Notes to this heading
identifies "[p]reparations, often referred to as food
supplements, based on extracts from plants, fruit concentrates,
honey, fructose, etc. [(which is merely an illustrative and not
exhaustive list)] and containing added vitamins and sometimes
minute quantities of iron compounds...[which]...are often put up
in packagings with indications that they maintain general health
or well-being" as a type of "food preparation" properly
classified under heading 2106. In fact, this note is consistent
with the previously discussed note found in the Explanatory Notes
to heading 3004, wherein heading 2106 is specifically identified
as a potential heading for classification of vitamin-fortified,
liquid food supplements. In the instant case, the product is
based on extracts similar to those listed above (e.g., sucrose,
sorbitol, arginine, royal jelly), contains multiple vitamins, and
is put up in packagings with indications that its use maintains
general health or well-being (i.e., prevents certain vitamin
deficiencies). In view thereof, we must conclude that the
instant goods are properly classified under heading 2106.
HOLDING:
The above-identified product is properly classified under
subheading 2106.90.6099, HTSUSA, which provides for food
preparations not elsewhere specified or included, other, other,
other, other, other. The rate of duty for goods entered under
this subheading is 10 percent ad valorem.
As the rate of duty under the classification indicated above
is more than the liquidated rate, you are instructed to deny the
protest in full. A copy of this decision should be furnished to
the protestant with the form 19 notice of action.
Sincerely,
John Durant, Director
Commercial Rulings Division