The tariff classification of BOTOX® Cosmetic from Ireland

N209720 April 9, 2012 CLA-2-33:OT:RR:NC:N2:240 CATEGORY: Classification TARIFF NO.: 3304.99.5000 Ms. Iliana Fuller Allergan 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of BOTOX® Cosmetic from Ireland Dear Ms. Fuller: In your letter dated March 15, 2012, you requested a tariff classification ruling. BOTOX® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations. The principle use in the United States of BOTOX® Cosmetic is a preparation, which is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows. BOTOX® Cosmetic is supplied in a single use vial containing 100 units. The applicable subheading for the BOTOX® Cosmetic will be 3304.99.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations: Other: Other: Other. The rate of duty will be free. Perfumery, cosmetic, and toiletry products are subject to the requirements of the Food, Drug and Cosmetic Act, and the Fair Packaging and Labeling Act (FPLA), which are administered by the U.S. Food and Drug Administration.  Questions regarding FDA requirements may be addressed to the U.S. Food and Drug Administration, Office of Cosmetics and Colors, 5100 Paint Branch Parkway, College Park, MD 20740-3835, telephone number 888-463-6332, or by visiting their website at: www.fda.gov. 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 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 Stephanie Joseph (646) 733-3268. Sincerely, Thomas J. Russo Director National Commodity Specialist Division