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HQ 963199

October 18, 2000

CLA-2 RR:CR:GC 963199ptl


TARIFF NO.: 3305.10.00

Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Avenue, 39th Floor
New York, NY 10017

RE.: Nizoral® A-D (ketoconazole) 1% Shampoo.

Dear Mr. Leo:

This is in response to your letter of August 23, 1999, on behalf of McNeil Consumer Products Company, a division of McNeil-PPC, Inc., to the Director, Customs National Commodity Specialist Division, New York, requesting the classification of a product identified as Nizoral® A-D (ketoconazole) 1% Shampoo under the Harmonized Tariff Schedule of the United States (HTSUS).

Your letter was forwarded to this office for response. We regret the delay.


The merchandise, identified as "Nizoral® A-D (ketoconazole) 1% Shampoo", is a shampoo. Ketoconazole is a broad spectrum synthetic antifungal drug which, when added to shampoo, is said to reduce scaling due to dandruff. In your letter, you suggest that the proper classification of the product is subheading 3004.90.90, HTSUS, which provides for Medicaments put up in measured doses or in forms or packings for retail sale: other.


What is the classification of Nizoral® A-D (ketoconazole) 1% Shampoo?


Merchandise is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) in accordance with the General Rules of Interpretation (GRIs). The systematic detail of the HTSUS is such that virtually all goods are classified by application of GRI 1, that is, 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 in order.

In understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes may be utilized. The Explanatory Notes (ENs), although not dispositive or legally binding, provide a commentary on the scope of each heading of the HTSUS, and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The HTSUS headings under consideration are as follows:

3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale:

3004.90 Other:

3004.90.90 Other


3305 Preparations for use on the hair:

3305.10.00 Shampoos

You contend that the "Nizoral® A-D (ketoconazole) 1% Shampoo" should be classified in heading 3004, HTSUS. In support of that position, you have included a letter, dated December 4, 1996, which you state was written by the European Union's Ministry of Finance, Department of Customs and Excise. That letter classified Nizoral shampoo "under entry 30.04" [sic]. You also refer to New York Ruling B83221, dated March 31, 1997, which classified Nizoral (ketoconazole) 2% as a medicament under subheading 3004.90.90, HTSUS.

The Chapter Notes to Chapter 30 provide, in pertinent part, as follows:

1. This chapter does not cover:
(d) Preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties.

Therefore, we must determine whether "Nizoral® A-D (ketoconazole) 1% Shampoo" is a preparation of headings 3303 to 3307. If it is, the product cannot be classified in heading 3004, HTSUS.

Chapter Note 3 to Chapter 33 states:
"(3) Headings 3303 to 3307 apply inter alia, to products, whether or not mixed (other than aqueous distillates and aqueous solutions of essential oils), suitable for use as goods of these headings and put up in packings of a kind sold by retail for such use."

Heading 3305, HTSUS, covers preparations for use on the hair and subheading 3305.10.0, HTSUS, covers shampoos. The ENs to heading 33.05 state that: "This heading covers:
(1) Shampoos, containing soap or other organic surface-active agents (see Note 1 (c) to Chapter 34 [which excludes such products from coverage in that Chapter]), and other shampoos. All these shampoos may contain subsidiary pharmaceutical or disinfectant constituents, even if they have therapeutic or prophylactic properties (see Note 1(d) to Chapter 30 [discussed above]).

The ENs make it clear that all products which are presented as shampoos, whether or not they contain any "special" or subsidiary
constituents, are to be classified in subheading 3305.10 which specifically covers shampoos.

Nizoral® A-D (ketoconazole) 1% Shampoo clearly falls within the description of products contemplated by the ENs of heading 3305. It also falls within the scope of the relevant chapter notes. Accordingly, pursuant to GRI 1, Note 1(d) to Chapter 30 and Note 3 to Chapter 33, Nizoral® A-D (ketoconazole) 1% Shampoo is classified in subheading 3305.10.00, HTSUS.

This classification is consistent with a May 1999 decision of the Harmonized System Committee (HSC) which decided by 23 votes to 8 to classify "Nizoral" shampoo in heading 33.05 (Annex IJ/2 to HSC Document NC0090E1, May 1999). According to the regulations of the EC, this vote of the HSC effectively revokes the Ministry of Finance letter written in 1996. Additionally, Customs has reviewed NY B83221, and has determined that it is in error. In accordance with 19 U.S.C. 1625(c), Customs issued HQ 963707, on October 17, 2000, revoking that ruling.


Nizoral® A-D (ketoconazole) 1% Shampoo, is classified in subheading 3305.10.00, HTSUS, which provides for [p]reparations for use on the hair: [s]hampoos.


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