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NY N005780

February 8, 2007



TARIFF NO.: 3004.90.9185

Ms. Alma R. Carillo-Garza
M.J. Carillo Company, Inc.
P.O. Box 1475
Laredo, TX 78042-1475

RE: The tariff classification and country of origin marking of SinuCleanse®, under the North American Free Trade Agreement (NAFTA); Article 509

Dear Ms. Carillo-Garza:

In your letter dated January 19, 2007, on behalf of your client, S.F. Contract Packaging S. de R.L. de C.V. (S.F. Contract Packaging Mexico) of Carretera Internacional Km., you requested a ruling on the tariff classification and country of origin of SinuCleanse®, a medicament consisting of two ingredients, namely: sodium chloride (subheading 2501.00, HTSUS) and sodium bicarbonate (subheading 2836.30, HTSUS). For the record, we note that both ingredients are designated as “active (emphasis added) ingredients.” The product is indicated for use as a nasal wash to eliminate mucus buildup, improve nasal breathing, and obtain relief from sinus conditions.

SinuCleanse® will be imported in granular form put up in sealed packets, each containing 700 mg of sodium bicarbonate and 2300 mg of sodium chloride. The packets, in turn, will be put up packed for retail sale in sealed, paperboard containers that contain either 40 or 60 packets per container. You indicate that, in addition to shipping the sealed, paperboard retail packages to the U.S., your client will also ship the packets in bulk, in cartons containing 2,000 packets per carton, to their U.S. customers, who will then repack these packets in sealed paperboard containers for retail sale.

Subsequent to importation, a purchaser would dissolve the contents of 1-2 packets of SinuCleanse® in a SinuCleanse® “Neti Pot” or SinuCleanse® Squeeze™ bottle containing lukewarm water. The resulting solution would then be used to wash the nasal passages. You have indicated, in a telephone conversation with a member of my staff, on January 30, 2007, that neither the “Neti Pot” nor the Squeeze™ bottle will be imported with the sealed, paperboard retail packages or the packets shipped in bulk (i.e., in master cartons).

The applicable subheading for SinuCleanse®, imported as described above, will be 3004.90.9185, Harmonized Tariff Schedule of the United States (HTSUS), which 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: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other. The general rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.

You indicate in your letter that the sodium chloride ingredient will be of U.S. origin and the sodium bicarbonate ingredient will be either of U.S. or Mexican origin. In Mexico, the two ingredients, in apportioned amounts, will be blended together, with 3 gms of the blended mixture eventually being placed into an individual packet, which (as noted above) is then sealed and exported to the U.S.

You believe, pursuant to §102.18(b)(2) of the Customs Regulations, that the single material that imparts the essential character of the mixture is the sodium chloride. We do not agree. Rather, we find that neither the sodium chloride nor the sodium bicarbonate can be said to impart the essential character to the good. Furthermore, with respect to the instant product, we believe that the ability of the sodium bicarbonate to “assuage discomfort” is clearly therapeutic.

The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134 of the Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.

The country of origin marking requirements for a "good of a NAFTA country" are also determined in accordance with Annex 311 of the North American Free Trade Agreement ("NAFTA"), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102 of the Customs Regulations. The marking requirements of these goods are set forth in Part 134 of the Customs Regulations.

Section 134.45(a)(2) of the Customs Regulations, provides that "a good of a NAFTA country” may be marked with the name of the country of origin in English, French or Spanish. Section 134.1(g) of the regulations, defines a "good of a NAFTA country" as an article for which the country of origin is Canada, Mexico or the United States as determined under the NAFTA Marking Rules.

Applying the NAFTA Marking Rules set forth in Part 102 of the Customs Regulations to the facts of this case, we find that, having failed to satisfy any of the criteria set forth in §102.11(a), (b) or (c), §102.11(d)(3) is the rule which must be applied to the imported good. Under this rule, the country of origin of the imported good is the last country in which the good underwent production, which, in this particular case, is the country in which the blending is performed, namely: Mexico.

This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 C.F.R. 181).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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