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