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NY C87468




May 20, 1998

CLA-2-30:RR:NC:2:238 C87468

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0090

Mr. Gary M. Moore
Western Nutriceuticals, Inc.
P.O. Box 6296, Building 500 - 2nd Floor North 12100 East Colfax Avenue
Aurora, CO 80045-0296

RE: The tariff classification of heme-iron polypeptide (HIP) from Japan

Dear Mr. Moore:

In your letter dated May 1, 1998, you requested a tariff classification ruling.

According to your letter, the subject product, designated as "heme-iron polypeptide (HIP)", is obtained as follows: Hog's blood, collected at the time of slaughter, is centrifuged to separate the red blood cells from the plasma. The red blood cells are washed with a saline solution, and then hemolytically ruptured by the addition of distilled water. The cell membranes of the ruptured red blood cells are then removed, and the remaining solution of hemoglobin digested with proteolytic enzymes. Cleaved amino acids and short peptides, not attached to the iron-containing heme ring, are then removed by ultrafiltration. The remaining iron-enriched peptide fraction (i.e., the subject product) is then concentrated, sterilized, dried, and milled into a fine powder.

You state in your letter that the subject product will initially be used in a clinical study to evaluate its efficacy as a treatment for iron-deficiency anemia in hemodialysis patients, and that, if the clinical trials are successful, your firm intends to market it as a "'Medical Food.'"

The applicable subheading for the subject product will be 3002.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for: "Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other." The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number (301) 443-6553.

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 212-466-5770.

Sincerely,

Robert B. Swierupski

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