The tariff classification of Blautix Capsules (Blautia hydrogenotrophica) in dosage form

N295684 April 27, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9260 Mr. Robert Shapiro Thompson Coburn LLP 1909 K Street, NW Washington, D.C. 20006 RE: The tariff classification of Blautix Capsules (Blautia hydrogenotrophica) in dosage form Dear Mr. Shapiro: In your letter dated March 30, 2018, on behalf of 4D Pharma PLC, you requested a tariff classification ruling. The subject product, Blautix, is a medicinal preparation in capsule form containing Blautia hydrogenotrophica, a live bacteria, as the active ingredient. In a follow-up email to this office, you indicated Blautix capsules will be imported in their finished form, ready for administration in clinical trials for the treatment of irritable bowel syndromes (IBS). The applicable subheading for Blautix Capsules (Blautia hydrogenotrophica) in dosage form will be 3004.90.9260, 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 digestive system: Other.” 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 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 merchandise may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address [email protected]. 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division