The tariff classification of Vascepa™ from France and the Netherlands

N298125 July 11, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9220 Ms. Natasha E. Nelson-Ling Amarin Pharma, Inc. 1430 U.S. Route 206 Bedminster, NJ 07921 RE: The tariff classification of Vascepa™ from France and the Netherlands Dear Ms. Nelson-Ling: In your letter dated June 20, 2018, you requested a tariff classification ruling. The subject product, Vascepa, is a lipid-regulating agent containing 1 gram of Icosapent ethyl in capsule form, as the active ingredient. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). Vascepa is available by prescription only and it is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with very severe hypertriglyceridemia. The applicable subheading for Vascepa imported in dosage form will be 3004.90.9220, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Cardiovascular medicaments." The 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 the World Wide Web at https://hts.usitc.gov/current. 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. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division