CLA-2-30:OT:RR:E:NC:2:238

Mr. Siegfried Gursche
Alpha Health Products Ltd.
7434 Fraser Park Drive
Burnaby, British Columbia
Canada V5J 5B9

RE: The tariff classification of the TOXIKATOR skin pH tester from Germany

Dear Mr. Gursche:

In your letter dated August 22, 2008, you requested a tariff classification ruling.

The TOXIKATOR pH tester is designed for self-testing of the body’s acid-base balance by indicating the pH of the skin. It is a chemical preparation containing a number of waxes, preservatives and inorganic and organic colorants. The preparation is put up in a container that resembles a lipstick tube. The product is applied to the inside crook of the elbow and leaves a visible blue stain on the skin. The initial blue stain changes to pink over time. The length of time required to change color indicates how acidic the body is.

You suggest that classification may be in subheading 3822.00.1090. We respectfully disagree. While the reagent preparation is similar to those products covered by heading 3822 (i.e., it is used in the evaluation of a physical processes and states in the human body, and its function is based upon an observable change in the chemical substances constituting the reagent), it is designed to be applied to the body. The products of heading 3822 are exclusively for in vitro use.

The applicable subheading for the TOXIKATOR skin pH tester will be 3006.30.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4 to this chapter: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient: 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 http://www.usitc.gov/tata/hts/.

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 Harvey Kuperstein at (646) 733-3033.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division