The tariff classification and country of origin marking of a dietary supplement; Article 509

N211157 April 25, 2012 CLA-2-21:OT:RR:NC:N2:228 CATEGORY: Classification TARIFF NO.: 2106.90.9998 Ms. Deanna M. Jones Banner Pharmacaps Inc. 4125 Premier Drive High Point, NC 27265 RE: The tariff classification and country of origin marking of a dietary supplement; Article 509 Dear Ms. Jones: In your letter dated March 21, 2012, you requested a tariff classification and country of origin marking ruling. A bill of material[s], manufacturing flow chart, and sample were provided with your letter. The sample was examined and disposed of. Simply Right™ Co Q-10 (Item No. BCP-59) is a human dietary supplement composed of red-colored gelatin capsules filled with soybean oil, coenzyme Q-10, yellow beeswax, and lecithin (soy), packed for retail sale in a sealed plastic bottle containing 60 capsules. The gelatin capsules consist of gelatin, glycerin, water, FD&C red #40 and titanium dioxide. The gelatin is a product of Canada. The soybean oil, beeswax, lecithin, FD&C red #40, water and glycerin are products of the United States. The coenzyme may be a product of China or Japan. The titanium dioxide is a product of Italy. In the United States, the product is produced by mixing the ingredients to form a gelatin mass and filling material, encapsulated, dried and packaged. The applicable subheading for the Co Q-10 will be 2106.90.9998, Harmonized Tariff Schedule of the United States (HTSUS), which provides for food preparations not elsewhere specified or included … other … other … other. The rate of duty will be 6.4 percent ad valorem. 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 the World Wide Web at http://www.usitc.gov/tata/hts/. 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, 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, Customs Regulations. The marking requirements of these goods are set forth in Part 134, Customs 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. (Emphasis added). 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 Co Q-10 is a product of the United States. Products of the United States are not subject to the country of origin marking requirements of 19 U.S.C. 1304. Whether an article may be marked with the phrase "Made in the USA" or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you direct any questions on this issue to the FTC. This merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). 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, contact National Import Specialist Bruce N. Hadley, Jr. at (646) 733-3029. Sincerely, Thomas J. Russo Director National Commodity Specialist Division