CLA-2 RR:CR:GC 964710AM

Port Director
U.S. Customs Service
Bldg. #77 Jamaica, NY 11430

Re: Protest 1001-99-105787; Tri-Sodium L-Ascorbyl-2-Phosphate (SAP)

Dear Port Director:

This is our decision on Protest 1001-99-105787, filed by counsel on behalf of Showa Denko America, Inc., against your decision in the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Tri-Sodium L-Ascorbyl-2-Phosphate (hereinafter “SAP”) a vitamin C derivative used in cosmetics. In preparing this ruling, consideration was given to supplemental submissions filed by counsel dated February 13, 2002, March 1, 2002, and arguments presented in a meeting at Customs Headquarters on February 15, 2002.

FACTS:

SAP is a pure, unmixed chemical compound vitamin C derivative. Its CAS registry number is 66170-10-3. Its molecular formula is expressed as C6H6O9P(Na3.

Customs laboratory report 2-1999-21712, dated August 31, 1999, states, in pertinent part, the following:

The sample, a white powder, is sodium ascorbyl phosphate, a non-aromatic heterocyclic compound with oxygen hetero-atom(s) only (lactone).

The technical literature indicates that the product is a heat stabilizer/antioxidant to extend the shelf-life of red blood cells. Vitamin C (ascorbic acid) plays primary roles in the synthesis of collagen and carnitine, is required for the conversion of folic acid to folinic acid and promotes the intestinal absorption of iron. Its primary therapeutic use is in the treatment of scurvy. See Goodman & Gilman's The Pharmacological Basis of Therapeutics, Ninth Ed., p. 1569.

Protestant states that “SAP is typically used as a vitamin C substitute for a wide range of clinical and nutritional purposes including as ingredients for cosmetic products, food additives and fish feed additives.” We note that protestant’s implication above that the imported merchandise is used as a food additive in the U.S. is erroneous, as the Food and Drug Administration (FDA) has not approved the substance for such use.

The entry pertaining to the subject protest was liquidated on October 8, 1999. The subject protest was timely filed on November 22, 1999. Protestant entered the product under subheading 2936.27.00, 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 C (Ascorbic acid) and its derivatives." The merchandise was liquidated under subheading 2932.29.50, HTSUS, the provision for “[H]eterocyclic compounds with oxygen hetero-atom(s) only: [L]actones: [O]ther lactones: [O]ther.”

ISSUE:

What is the classification of SAP 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).

Additional U.S. Rule of Interpretation 1(a), HTSUS, requires that "a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use".

The HTSUS provisions under consideration are the following:

2932 Heterocyclic compounds with oxygen hetero-atom(s) only: Compounds containing an unfused furan ring (whether or not hydrogenated) in the structure:

* * * * *

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 that "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:

Vitamins are active agents, usually of complex chemical composition, which are obtained from outside sources and are essential for the proper functioning of human or other animal organisms. They cannot be synthesized by the human body and must therefore be obtained in final or nearly final form (provitamins) from outside sources. They are effective in relatively minute amounts and may be regarded as exogenous biocatalysts, their absence or deficiency giving rise to metabolic disturbances or “deficiency diseases”.

This heading includes:

Provitamins and vitamins, whether natural or reproduced by synthesis, and derivatives thereof used primarily as vitamins.

* * * * * * * * * *

(IJ)VITAMIN C AND DERIVATIVES THEREOF USED PRIMARILY AS VITAMINS

Vitamin C is the anti-scorbutic vitamin, and increases resistance to infections. It is soluble in water.

(1) Vitamin C (L- or DL-ascorbic acid (INN)). Ascorbic acid is contained in many foodstuffs of vegetable (fruit and green vegetables, potatoes, etc.) or animal (liver, spleen, adrenal glands, brains, milk, etc.) origin; it can be extracted from lemon juice, green and red peppers, green aniseed leaves, and from residual liquors from the treatment of agave fibres. Nowadays, it is obtained almost exclusively by synthesis. It is a white crystalline powder, fairly stable in dry air, and acts as a strong reducing agent.

(2) Sodium ascorbate.

(3) Calcium ascorbate and magnesium ascorbate.

(4) Strontium (L) ascorbocinchoninate (strontium (L) ascorbo-2-phenylquinoline-4-carboxylate).

(5) Sarcosine ascorbate.

(6) L-Arginine ascorbate.

(7) Ascorbyl palmitate. This liposoluble form of vitamin C is also used as an emulsifier and anti-oxidant for fats and oils.

(8) Calcium hypophosphitoascorbate.

(9) Sodium ascorboglutamate.

Calcium ascorboglutamate.

In accordance with the chapter note quoted above, protestant argues that the imported merchandise is indeed described by both headings and should therefore be classified in heading 2936, the later occurring heading.

We agree that if SAP can be classified in heading 2936, HTSUS, it must be so classified, even though SAP is also classifiable in heading 2932, HTSUS. However, SAP is not described by the terms of heading 2936, HTSUS. By its terms, " . . . derivatives . . . used primarily as vitamins," heading 2936, HTSUS, is a principal use provision. The use of the imported product in the U.S., according to protestant, is as a “Vitamin C substitute ingredient in cosmetics for skin treatment and skin whitening . . . .” These facts are relevant to the determination of whether or not the terms of heading 2936, a principal use provision, describes the merchandise. See Additional U.S. Rule of Interpretation 1(a).

The court in E.M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996) explained the application of principal use provisions thus:

When applying a "principal use" provision, the Court must ascertain the class or kind of goods which are involved and decide whether the subject merchandise is a member of that class. See, supra, Additional US Rule of Interpretation 1 to the HTSUS. In determining the class or kind of goods, the Court examines factors which may include: (1) the general physical characteristics of the merchandise; (2) the expectation of the ultimate purchasers; (3) the channels of trade in which the merchandise moves; (4) the environment of the sale (e.g., the manner in which the merchandise is advertised and displayed); (5) the usage of the merchandise; (6) the economic practicality of so using the import; and (7) the recognition in the trade of this use. United States v. Carborundum Co., 63 C.C.P.A. 98, 102, 536 F.2d 373, 377, cert. denied, 429 U.S. 979, 50 L. Ed. 2d 587, 97 S. Ct. 490 (1976); see also Lenox Coll., 20 C.I.T., Slip Op. 96-30, at page 5.

The ENs provide substantive guidance as to the scope of the heading. Using the items listed in the ENs as a guide to the class or kind of goods to which the imported merchandise must belong to be classified in the heading, we apply the Carborundum factors above, as follows:

The listed compounds are physically derivatives of Vitamin C. The imported merchandise is also a derivative of Vitamin C. We note that EN 2932 (B)(r) lists isoascorbic acid as included in heading 2932, HTSUS.

The ultimate purchaser expects that the listed compounds will perform as does Vitamin C, a nutritional supplement required for the conversion of folic acid to folinic acid, promoting the intestinal absorption of iron and synthesis of adrenal steroids. SAP is an ingredient in cosmetics where it is expected to prevent wrinkles, lighten skin and preserve the other ingredients in the cosmetic formulation.

The listed compounds move through channels of trade which lead to production as a dietary supplement or food additive for human consumption. SAP is typically added to cosmetic preparations or used as a heat stabilizer/antioxidant to extend the life of red blood cells.

The environment of sale of the listed compounds is as a dietary supplement, advertised for their nutritional qualities. SAP, on the other hand, is heavily advertised as the active ingredient in cosmetic applications with claims that it prevents wrinkles and lightens skin.

The listed compounds are used as dietary supplements or as food additives for human or animal consumption. They maintain their vitamin activity. Five of the substances in the EN are listed in the International Cosmetic Ingredient Dictionary and Handbook as antioxidants useable in cosmetics and the ENs note the use of one of the substances, ascorbyl palmitate, as an antioxidant in fats and oils. The instant merchandise also maintains physiological action in its derivative form. However, the general sub-Chapter XI EN does not state that physiological action is dispositive on the classification issue. In fact, the note states that the substances in the sub-Chapter must be “essential for the proper functioning and harmonious development of the animal and vegetable organism.” Here, the merchandise is principally used in cosmetic ingredients with no proof that it performs its physiological action on the body “for the proper functioning and harmonious development of the animal and vegetable organism.”

The imported merchandise, SAP, has no economic practicality as a food additive for human consumption or dietary supplement as it is not approved for such use by the Food and Drug Administration (FDA). Although another agency's regulations are not controlling in Customs classification decisions, where Customs must apply a "use" provision to merchandise, the controlling regulatory scheme is indeed relevant.

The trade recognizes the nutritional uses of the listed compounds. SAP is not so recognized. Customs must look at “the principal or predominant use, or the usual and common use. Neither the fugitive use of an article, nor the mere susceptibility or capability of use, is a determinative factor.” HQ 963032, dated July 24, 2000. Although SAP is used for nutritional purposes in fish food in other countries, protestant has submitted no evidence that SAP is not primarily used in the United States as a cosmetic anti-wrinkle, skin whitening and preservative ingredient. Such use is certainly not “essential for the proper functioning of human or other animal organisms.” EN 29.36.

On balance, analysis of the Carborundum factors reveals that SAP does not belong to the class or kind of goods that are “principally used” as vitamins, even though it is undisputedly a derivative of Vitamin C.

Furthermore, protestant claims that Headquarters Ruling (HQ) 953829, dated July 26, 1993, supports the position that “stabilized vitamins used in animal feed are classifiable under HTSUS subheading 2936.90.” HQ 953829 deals with a combined vitamin A and vitamin D3 product solely used for nutrition in animal feed. As such, it is correctly classified in heading 2936, HTSUS, by the terms of the heading, “Provitamins and vitamins. . . .” This ruling has no bearing on the situation where, as here, the product is a vitamin derivative used primarily in cosmetic applications.

Moreover, comparisons to substances classified in Chapter 29, HTSUS, as drugs, or in heading 3004, HTSUS, as medicaments are irrelevant. To be classified as a drug or medicament a substance must be used for its therapeutic properties. The court in Lonza, Inc. v. U.S., 46 F. 3d 1098 (Fed.Cir. 1995) defines “therapeutic” substances as those "having healing or curative powers." Certainly there are topical and other routes of administration acceptable for drugs or medicaments either because the body part to be healed, (conjunctiva of the eye, the skin, or the oral mucosa, etc) can be treated by direct application of the drug, or because the substance is absorbed into the blood stream through the skin. See New York Ruling Letters G84846, dated November 30, 2000, E82841, dated June 7, 1999, and HQs 961177 and 961666, dated April 14, 1998.

Here, the problem is not the route of administration, but the fact that protestant does not claim, and has not shown, that a dermal route of administration of SAP effects the metabolic functioning of the body. Stated another way, while SAP applied to the skin has been shown to build collagen in the skin, thereby preventing wrinkles, application on the skin has not been shown to build collagen in the bones, thereby preventing scurvy. In fact, application of SAP on the skin has not been shown to perform any of the metabolic functions that vitamin C performs in the body, such as converting folic acid to folinic acid and promoting the intestinal absorption of iron. Hence, SAP is simply not used, as are vitamins, for its nutritional content and contribution to the metabolic functions of the body. Rather, in the U.S., SAP is used solely to prevent wrinkles and lighten age spots.

Lastly, protestant submitted, for our consideration, a determination made by another country classifying the substance in subheading 2936.27, under the Harmonized Tariff System. However, such determinations are merely instructive of how others may classify like goods. Customs is not bound to abide by another country's determination, especially, as is the case here, where no rationale is provided for the finding. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).

HOLDING:

SAP is classified in subheading 2932.29.50, HTSUS, the provision for “[H]eterocyclic compounds with oxygen hetero-atom(s) only: [L]actones: [O]ther lactones: [O]ther.” The protest is DENIED.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550065, 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