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HQ 966568

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February 4, 2003

CLA-2 RR:CR:GC 966568 DSS

CATEGORY: CLASSIFICATION

TARIFF NO.: 9001.30.00

Mr. Robert Tanda
Fashionwear Services
Four Eyez Warehouse
Beechings Way
Alford, Lincolnshire
LN13 9JE, England, UK

RE: Four Eyez fashion contact lenses; NY J83159 Affirmed

Dear Mr. Tanda:

In a letter dated June 3, 2003, you request reconsideration of New York Ruling Letter (NY) J83159, which the Director, National Commodity Specialist Division, New York, issued to you on April 30, 2003. The issue is the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of certain Four Eyez “fashion lenses.” A sample package, containing the lenses in their retail packaging (containing (1) two lenses, each in a glass vial, (2) a bottle of soft lens disinfectant and storage solution, (3) instructions, and (4) a plastic lens case), was submitted. We have reviewed NY J83159 and determined that the classification is correct for the reasons set forth below.

FACTS:

In NY J83159, we classified the goods under subheading 9001.30.00, HTSUS, which provides for contact lenses. We described the lenses as follows:

The Four Eyez fashion lenses are decorative soft contact lenses. The lenses are plano lenses. They are colored and patterned and are used to change the appearance of the wearer’s eyes. Various colors such as aqua, violet and green, and various patterns such as star, cat eyes, spirals and swirls, are available. The lenses are sold in a blister package that includes the decorative lenses in glass vials, a lens case, a bottle of cleaning solution, and instructions. The instruction booklet gives information on how to insert the lenses in the eye, how to clean, rinse, disinfect and store the lenses, and lists precautions and warnings. The packaging indicates that the lenses will last for 30 days after the vials containing the lenses are opened. The decorative lenses will be sold in retail stores such as Spencer Gifts, Inc.

You state in your letter that you believe the Four Eyez fashion lenses are cosmetics. The decorative contact lenses are not classified as cosmetics. Heading 3304, Harmonized Tariff Schedule of the United States, provides for products used in the care and maintenance of the skin. The Encyclopedia Britannica defines the word cosmetic as "any of several preparations (excluding soap) that are applied to the human body for beautifying, preserving, or altering the appearance or for cleansing, coloring, conditioning, or protecting the skin, hair, nails, lips, eyes, or teeth." Decorative contact lenses are not classified as cosmetics in the Harmonized Tariff Schedule of the United States. The decorative lenses, the lens case and the cleaning solution are packaged together for retail sale and are considered a set for tariff classification purposes. The essential character of the set is imparted by the decorative contact lenses.

You argue that these lenses are classifiable under subheading 3304.20.00, HTSUS, as eye make-up preparations. You argue that the lenses are decorative in nature and are used to change the eye color of the wearer. You argue that the Food and Drug Administration (FDA) has determined that plano (i.e., non-corrective) contact lenses meant to change eye color, such as these, are to be regulated as a cosmetic rather than as a device. You argue that the more specific provision for these lenses is heading 3304 rather than heading 9001, which provides in relevant part for contact lenses.

ISSUES:

(1) Whether the instant fashion lenses are classified as make-up preparations under heading 3304, HTSUS, or as contact lenses under heading 9001, HTSUS.

(2) Whether the instant articles are classified as a set.

LAW AND ANALYSIS:

Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs may then be applied. GRI 3(b) provides, “Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable.”

The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding, the ENs provide a commentary on the scope of each heading of the HTSUS and are thus useful in ascertaining the classification of merchandise under the System. The Bureau of Customs and Border Protection (Customs) believes the ENs should always be consulted. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The HTSUS provisions under consideration are as follows:

Beauty or make-up preparation and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations: 3304.20.00 Eye make-up preparations

9001 Optical fibers and optical fiber bundles; optical fiber cables other than those of heading 8544; sheets and plates of polarizing material; lenses (including contact lenses), prisms, mirrors and other optical elements, of any material, unmounted, other than such elements of glass not optically worked: 9001.30.00 Contact lenses

Heading 9001, HTSUS, provides for "[o]ptical fibers and optical fiber bundles . . . lenses (including contact lenses) . . . ." The term “contact lenses” is not defined in the HTSUS. To determine the proper meaning of tariff terms as contained in the statute, the terms are "construed in accordance with their common and popular meaning, in the absence of contrary legislative intent." E.M. Chemicals v. United States, 920 F.2d 910, 913 (Fed. Cir. 1990). "To assist it in ascertaining the common meaning of a tariff term, the court may rely upon its own understanding of the terms used, and it may consult lexicographic and scientific authorities, dictionaries, and other reliable information sources." Brookside Veneers, Ltd. v. United States, 847 F.2d 786, 789, 6 Fed. Cir. (T) 121, 125 (Fed. Cir.) cert. denied, 488 U.S. 943 (1988).

A contact lens is described as, “A thin, bowl shaped lens worn on the surface of the eye,” (www.vsp.com/source/html/glossary.htm), as a “lens made of glass or plastic designed to maintain contact on the surface of the cornea; usually used to correct refractive error,” (www.usaeyes.org/glossary/bc.html), and as “a thin lens designed to fit over the cornea usu. worn to correct defects in vision.” Merriam-Webster’s Collegiate Dictionary, 10th ed. (2002).

The instant articles fall under these descriptions, in that they are thin, plastic lenses that are worn on the eye. The instant lenses are not designed to correct vision or to deliver medication. However, they are sold as fashion lenses and the sample package included: two glass vials, each containing one lens; a bottle of soft lens disinfectant and storage solution; and a plastic lens case, which is how contact lenses are typically sold and packaged. The packing also indicates that the lenses must be removed and disinfected after each wearing, or serious eye damage can develop rapidly and lead to loss of vision; prescription contact lenses carry similar warnings. Moreover, the FDA and the American Academy of Ophthalmology, among others, recognize plano, or non-corrective, and decorative contact lenses as contact lenses. See www.fda.gov and www.aao.org.

Heading 9001, HTSUS, is an eo nomine provision. An eo nomine provision is one that describes a commodity by a specific name, as opposed to use. Absent limiting language or indicia of contrary legislative intent, an eo nomine provision covers all forms of the article. See National Advanced Sys. v. United States, 26 F.3d 1107, 1111 (Fed. Cir. 1994). An eo nomine provision may be limited by use, but such use limitation should not be read into an eo nomine provision unless the name itself inherently suggests a type of use. See United States v. Quon Quon Co., 46 C.C.P.A. 70, 72-73 (1959), cited by Carl Zeiss, Inc. v. United States, 195 F.3d 1375, 1379 (Fed. Cir. 1999).

There is no such limiting language in the text of heading 9001. The language itself indicates that the lenses are used when in contact with the eye. Moreover, EN 90.01 states in relevant part that the heading includes: “(3) Ophthalmic lenses. These lenses may be aspherical, spherical, sphero-cylindrical, uni-focal, bi-focal or multi-focal. They also include contact lenses.” (emphasis in original.)

Heading 3304, HTSUS, is also an eo nomine provision. The term “preparations" is not defined in the HTSUS; however, there have been several Customs rulings that have addressed the issue. See HQ 965857, dated December 20, 2002, and HQ 965977, dated December 19, 2002. These rulings indicate that “preparations” are mixtures, compounds, or other substances for the specific purpose of making one up. Moreover, the exemplars listed in EN 33.04 are preparations for the care or beautification of the skin or other external features (i.e., mascara beautifies the eye lashes, which are external). These exemplars include lipstick, foundation, blush and eye shadow. Decorative contact lenses do not fall under heading 3304 because they are not preparations and they do not care for or beautify the skin.

With regard to FDA regulation of decorative contact lenses as cosmetics, we note that it is a long established principle of Customs practice that the characterization of imported merchandise by governmental agencies for other than tariff purposes does not determine tariff classification. See United States v. Mercantil Distribuidora et al., 45 C.C.P.A. 20, C.A.D. 667 (1957); Marine Products Co. v. United States, 42 Cust. Ct. 154 (C.D. 2080) (1959).

The definition of the term “cosmetic” found in the Federal Food, Drug and Cosmetic Act is specifically limited to that Act. 21 U.S.C. 321(i) (“For the purposes of this Act-¼[t]he term “cosmetic” means¼”). Further, as a general rule, terms defined in non-tariff statutes do not determine the meaning of the term for tariff purposes. Amersham Corp. v. United States, 5 CIT 49, 56, 564 F.Supp. 813 (1983). Other agency decisions are relevant to tariff classification only where the tariff provision is a use provision and the other agency decision limits certain uses of the imported merchandise. Thus, the FDA definition of “cosmetic” is not coterminous with the term as used in Chapter 33 of the HTSUS. Indeed, in a Federal Register notice regarding these lenses, they are referred to as contact lenses. See 68 Fed. Reg. 16520 (Apr. 4, 2003). See also “Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert 86-10): http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0118-gdl0001.pdf; FDA Warns Consumers Against Using Decorative Contact Lenses Obtained Without a Prescription or Professional Fitting: http://www.fda.gov/bbs/topics/NEWS/2002/NEW00846.html; FDA Public Health Web Notification: Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription: http://www.fda.gov/cdrh/safety/declensenorx.html; FDA Issues Warning on Decorative Contact Lenses, FDA Consumer magazine January-February 2003: http://www.fda.gov/fdac/features/2003/103_eyes.html.

Thus, it is irrelevant for tariff classification purposes whether the instant fashion contact lenses are regulated by the FDA as a cosmetic or as a device; what is relevant is that they are commonly and commercially known as contact lenses. Based on the foregoing analysis, the instant lenses are classified under subheading 9001.30.00, HTSUS, as contact lenses.

We are not able to classify all of the items included in the sample package at GRI 1 because the headings of the various components are equally specific in relation to the items. The sample is a set. To determine what is a set, EN Rule 3(b)(X) provides a three-part test:

For the purposes of this Rule, the term ‘goods put up in sets for retail sale’ shall be taken to mean goods which:

(a) consist of at least two different articles which are prima facie, classifiable in different headings . . . ; (b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and (c) are put up in a manner suitable for sale directly to users without repackaging (e.g., in boxes or cases or on boards).

Applying the above GRI 3(b) EN criteria, the instant sample contains different goods classifiable in different headings (i.e., contact lenses, cleaning solution, plastic lens case). Criteria (a). The goods are put up together for the care and use of the contact lenses. Criteria (b). The goods are put up in a manner suitable for sale directly to users without repacking. Criteria (c). In order to determine the classification of the set, we must determine the essential character of the set. EN (VIII) to GRI 3(b) provides:

The factor which determines the essential character will vary as between different kinds of goods. It may, for example, be determined by the nature of the material or component, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods.

The article(s) in this set that impart the essential character are the fashion contact lenses; all the other items are used for the care or maintenance of the lenses. Thus, the set is classified under subheading 9001.30.00, HTSUS.

HOLDING:

Under the authority of GRI 1, the instant fashion lenses are provided for in heading 9001, HTSUS. They are classified under subheading 9001.30.00, HTSUS, which provides for “Optical fibers and optical fiber bundles; optical fiber cables other than those of heading 8544; sheets and plates of polarizing material; lenses (including contact lenses), prisms, mirrors and other optical elements, of any material, unmounted, other than such elements of glass not optically worked: Contact lenses.”

Under the authority of GRI 3(b), the items included in the blister package (including the decorative lenses in glass vials, a lens case, a bottle of cleaning solution, and instructions) are a set, which is classified under subheading 9001.30.00, HTSUS.

EFFECT ON OTHER HOLDINGS:

NY J83159 is AFFIRMED.

Sincerely,

Myles B. Harmon
Director,

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See also:

• Tariff No.: 3304.20.00 - Eye make-up preparations
• Tariff No.: 9001.30.00 - Contact lenses