CLA-2-35:OT:RR:NC:2:236

Joseph F. Walter
Livingston International Professional Services, Inc.
670 Young Street
Tonawanda, NY 14150

RE: The tariff classification and country of origin of “Immunocal” from the United States and applicability of subheading 9801.00.10, Harmonized Tariff Schedule of the United States, (HTSUS); The tariff classification and country of origin of “Immunocal Platinum” from Canada; Article 509

Dear Mr. Walter:

In your ruling request received June 9, 2015, on behalf of your client, Immunotec Inc., you requested a tariff classification, country of origin, and applicability of subheading 9801.00.10, HTSUS, ruling on “Immunocal” and a tariff classification and country of origin ruling on “Immunocal Platinum.”

You describe “Immunocal” as a dietary supplement for human consumption composed entirely of 90% or greater whey protein isolate powder, which is produced in the United States. You explain that the whey protein isolate powder will be shipped in bulk form to Canada, where your client will package it as “Immunocal” in 10 gram pouches and ship it back to the United States for sale.

The applicable subheading for “Immunocal” will be 3504.00.1000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: Protein isolates. The general rate of duty will be 5 percent ad valorem.

Based on the above described scenario, where whey protein isolate powder is made in the United States, exported to Canada to be repackaged, not advanced in value or improved in condition by any process of manufacturer or other means while aboard, and returned to the United States, the country of origin for U.S. Customs entry purposes will be the United States and “Immunocal” will be eligible for duty-free treatment under 9801.00.10, HTSUS, provided all of the subheading requirements are met.

You describe “Immunocal Platinum” as a dietary supplement for human consumption that is composed of 10 grams (80 percent) of whey protein isolate powder (more than 90% protein), produced in the United States, combined with 2.5 grams (20 percent) of a mineral complex. The mineral complex, produced in Canada, is said to contain 500 mg sodium citrate, 400 mg magnesium citrate, 400 mg potassium citrate, 300 mg calcium citrate, 400 mg creatine monohydrate, and 500 mg citric acid. The “Immunocal Platinum” is blended in Canada. The product is stated to be used as an electrolyte and mineral supplement for the maintenance of good health. The product will be sold in pouches containing 12.5 grams, net weight.

Your suggested classification of 3504.00.1000, HTSUS, for “Immunocal Platinum,” which provides for peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included ... protein isolates. We disagree. Based on the ingredients composition, it will be classified elsewhere.

The applicable subheading for the “Immunocal Platinum” will be 2106.10.0000, HTSUS, which provides for food preparations not elsewhere specified or included . . . protein concentrates and textured protein substances. The general rate of duty will be 6.4 percent ad valorem.

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, CBP Regulations (19 C.F.R. 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 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 CBP Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102, CBP Regulations. The marking requirements of these goods are set forth in Part 134, CBP Regulations.

Section 134.1(b) of the regulations, defines "country of origin" as:

the country of manufacture, production, or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within this Part; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin.

Section 134.1(j) of the regulations, provides that the "NAFTA Marking Rules" are the rules promulgated for purposes of determining whether a good is a good of a NAFTA country. 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. Section 134.45(a)(2) of the 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.

Part 102 of the regulations, sets forth the "NAFTA Marking Rules" for purposes of determining whether a good is a good of a NAFTA country for marking purposes. Section 102.11 of the regulations, sets forth the required hierarchy for determining country of origin for marking purposes.

Applying the NAFTA Marking Rules set forth in Part 102 of the regulations to the facts of this case, we find that the country of origin of the “Immunocal Platinum” for marking purposes is Canada.

This merchandise may be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is administered by the Food and Drug Administration (FDA). Information concerning FDA import requirements and regulations can be obtained by contacting the FDA at: Food and Drug Administration, Division of Import Operations and Policy, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (888) 463-6332. Information on the Bioterrorism Act can be obtained by calling FDA at (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.

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 on “Immunocal,” contact National Import Specialist Nuccio Fera at [email protected] or if you have any questions regarding the ruling on “Immunocal Platinum,” contact National Import Specialist Bruce Hadley at [email protected].


Sincerely,

Gwenn Klein Kirschner
Director
National Commodity Specialist Division