CLA-2 RR:CR:GC 964807AM
Port Director
U.S. Customs Service
Building # 77
Jamaica, N.Y. 11430
Re: Protest 1001-00-103455; Pantethine, CAS #16816-67-4
Dear Port Director:
This is our decision on Protest 1001-00-103455, filed by Pharmline, Inc. against your decision in the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Pantethine, a dietary supplement for proper fat and cholesterol breakdown.
FACTS:
Pantethine is formed by oxidation of Pantetheine, which is "a naturally occurring amide of pantothenic acid (aka Vitamin B5) and b-mercaptoethanolamine (aka Cysteamine); it is an intermediate in the biosythesis of Coenzyme A, a growth factor for Lactobacillus bulgaricus and certain other bacteria, and a cofactor in certain enzyme complexes (e.g., in fatty acid or polypeptide synthesis). Two molecules of Pantetheine combine to form one molecule of Pantethine, which results in a stable disulfate dimer. Thus, Pantethine is also referred to as the disulfide dimer of pantetheine.
The B vitamins, of which pantothenic acid is one, function as coenzymes that catalyze many of the anabolic and catabolic reactions of living organisms necessary for the production of energy; the synthesis of tissue components, hormones, and chemical regulators; and the detoxification and degradation of waste products and toxins.
Protestant entered the product under subheading 2936.24.00, HTSUS, the provision for "[P]rovitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent; [V]itamin B3 and B5 and its derivatives." In accordance with New York Ruling 818369, dated February 8, 1996, the entries pertaining to the subject protest were liquidated under subheading 2930.90.90, HTSUS, the provision for "[O]rgano-sulfur compounds: [O]ther: [O]ther,” on June 2 and 16, 2000. The subject protest was timely filed on August 8, 2000.
ISSUE:
What is the classification of Pantethine under the HTSUS?
LAW AND ANALYSIS:
Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context, which requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in their appropriate order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and, mutatis mutandis, to the GRIs.
In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See, T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
The HTSUS provisions under consideration are the following:
2930 Organo-sulfur compounds:
* * * * *
2936 Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent:
Chapter Note 3 to Chapter 29, HTSUS, states, in pertinent part, "goods which could be included in two or more of the headings of this chapter are to be classified in that one of the headings which occurs last in numerical order.”
EN 29.36 states, in pertinent part, the following:
This heading includes:
Provitamins and vitamins, whether natural or reproduced by synthesis, and derivatives thereof used primarily as vitamins.
* * * * * * * * * *
(E) D- OR DL-PANTOTHENIC ACID (ALSO KNOWN AS
VITAMIN B3 OR VITAMIN B5)AND DERIVATIVES THEREOF USED PRIMARILY AS VITAMINS
These compounds play a part in preventing grey hair, in the development of skin, and in fat and carbohydrate metabolism. They are essential for the activity of the glands and liver, and of the gastro-intestinal and respiratory tracts. They are soluble in water.
(1)D- or DL- Pantothenic acid (N-( 1, 1-dihydroxy- ß, ß-dimethylbutyryl)- ß-alanine). This vitamin, also known as vitamin B3 or vitamin B5, is found in all living cells and tissues (e.g., in the liver and kidneys of mammals, in the pericarp of rice, in brewers ’ yeast, milk, crude molasses, etc.). It is generally obtained by synthesis. Yellow viscous oil; slowly soluble in water and most organic solvents.
(2)Sodium D- and DL-pantothenate.
(3)Calcium D- and DL-pantothenate. This white powder, soluble in water, is the most common form of vitamin B3.
(4)Pantothenyl alcohol or pantothenol (D- and DL-) ( 1, 1-dihydroxy-N-3-hydroxypropyl- ß, ß-dimethylbutyramide). Viscous liquid, soluble in water.
(5)D-pantothenol ethyl ether (D- 1, 1-dihydroxy-N-3-ethoxypropyl- ß, ß-dimethylbutyramide). Viscous liquid, water-miscible and readily soluble in organic solvents.
The ENs to Sub-Chapter XI, Chapter 29, state, in pertinent part, the following: "[I]n this Sub-Chapter, the term "derivatives" refers to chemical compounds which could be obtained from a starting compound of the heading concerned and which retain the essential characteristics of the parent compound, including its basic chemical structure."
In accordance with Chapter 29, Note 3, HTSUS, merchandise classifiable in heading 2936, HTSUS, can not be classified in heading 2930, HTSUS, the earlier occurring heading. However, Pantethine is not described by the terms of heading 2936, HTSUS, because it is not a derivative of Pantothenic acid. Van Nostrand's Scientific Encyclopedia, 5th Edition, defines "derivative" as "[A] term used in organic chemistry to express the relation between certain known or hypothetical substances and the compound formed from them by simple chemical processes in which the nucleus or skeleton of the parent substance exists. Id. at 764. (emphasis added). This accords with the definition cited above in the ENs.
Pantethine does not retain the carboxylic acid functionality found in pantothenic acid. Rather, the hydroxyl group on the carboxylic acid is substituted with Cysteamine forming an internal amide. Thus, Pantethine does not retain the skeleton or the basic structure of Pantothenic acid in its structure as do Sodium D- and DL-pantothenate and Calcium D- and DL-pantothenate. ENs p. 464. Neither is Pantethine a provitamin (a substance that produces vitamins by a natural reaction) as are pantothenyl alcohol and D-pantothenol ethyl ether. ld. because Pantethine is not metabolized to panthothenic acid.
HOLDING:
Pantethine is classified in subheading 2930.90.90, HTSUS, the provision for "[O]rgano-sulfur compounds: [O]ther: [O]ther.” NY 818369 is affirmed with regards to the classification of Pantethine under the HTSUS. The protest is DENIED.
In accordance with Section 3A(11)(b) of Customs Directive 099 3550 065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
John A. Durant, Director
Commercial Rulings Division