CLA-2 RR:CR:GC 966527 AM
Port Director
U.S. Customs and Border Protection
4341 International Parkway Suite 600 Atlanta, GA 30354
Re: Protest 1704-03-100047; SAM-e tablets
Dear Port Director:
This is our decision on Protest 1704-03-100047, timely filed by counsel on behalf of AHD International, on January 17, 2003, against your decision in the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of SAM-e tablets. We have also considered the arguments counsel made in a supplemental submission, dated October 9, 2003, and in a telephone conference on October 9, 2003.
FACTS:
The instant merchandise, SAM-e tablets, consist of S-adenosyl-l-methionine tosylate disulfate, CAS 97540-22-2, methacrylic acid copolymer, mannitol, glyceryl behenate, silicon dioxide, triethyl citrate, titanium dioxide, talc, magnesium stearate, sodium starch glycolate, cellulose gel, and FD&C yellow 5. Customs Laboratory Report, SV 20020751, states, in pertinent part, that the samples are “yellow colored tablets containing s-adenosyl-l-methionine tosylate.” The tablets are imported packaged in bottles of 200mg or 400mg tablets put up for retail sale. Counsel’s submission states that because SAM-e is not approved by the FDA (Food and Drug Administration), its retail packaging contains a required FDA disclaimer. This disclaimer states that “the product is not intended to diagnose, treat, cure or prevent any disease.” An advertisement depicting the packaging also states: "mood plus," and "mood support, joint pain relief, liver health."
SAM-e tablets can also be manufactured from a different salt of s-adenosyl-l methionine, namely S-adenosylmethionine 1,4-butanedisulfonate, CAS No. 101020-79-5. New York Ruling E84438, dated July 23, 1999, classified SAM-e tablets of the 1,4-butanedisulfonate formulation in subheading 2106.90.99, the provision for "Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other."
The protest was timely filed against thirty three entries, from July 7, 2001, to September 29, 2002, all liquidated between October 25, 2002, and December 27, 2002. All but one of the entries were liquidated under subheading 2106.90.99, HTSUS. One entry was liquidated under subheading 2934.99.39, the provision for "Nucleic acids and their salts whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI." Protestant claims classification under subheading 3004.90.91, HTSUS, the provision for "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other."
ISSUE:
Are SAM-e tablets medicaments for therapeutic or prophylactic uses?
LAW AND ANALYSIS:
Merchandise imported into the U.S. 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 that 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.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any related section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in 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 interpreting 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 HTSUSA. See T.D. 89 80, 54 Fed. Reg. 35127 (August 23, 1989).
The following HTSUS provisions are relevant to the classification of this product:
Food preparations not elsewhere specified or included:
Other:
Other:
Other:
Other:
Other:
2106.90.99 Other
* * * * *
Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale:
Other:
3004.90.91 Other
In New York Ruling (NY) E84438, dated July 23, 1999, we classified SAM-e dietary supplement tablets that contain SAM-e 1, 4-butanedisulfonate and other ingredients in subheading 2106.90.99, HTSUS. Protestant claims that the tosylate disulfate form of SAM-e tablets should not be classified in the same HTSUS provision as the 1, 4 butanedisulfonate form. We disagree. Regardless of the chemicals used to create the salt of the S-Adenosyl Methionine in the tablets, both forms are marketed and used as dietary supplements as explained below.
EN 21.06 provides that the products covered by the heading are preparations for use for human consumption. Heading 3004, HTSUS, requires that the product be for therapeutic or prophylactic uses. Both of these headings are therefore principal use provisions. (See HQs 964673, dated February 4, 2002, 963197, dated December 11, 2000, 962323, dated February 3, 2000). Additional U.S. Rule of Interpretation 1(a) 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 Court in E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996 Ct. Intl. Trade), stated, in pertinent part, the following:
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 U.S. 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. [Hereinafter cited as "Carborundum factors."]
Therefore, the determinative issue is whether SAM-e, as imported in bottles of tablets put up for retail sale, labeled and advertised as a dietary supplement which promotes joint and emotional health, is of the class or kind of good that is principally prepared for therapeutic or prophylactic use or whether it is of the class or kind of good that is principally used as a dietary supplement.
Medicaments principally prepared for therapeutic or prophylactic use, of heading 3004, HTSUS, are packaged for oral, parenteral (by injection), or dermatological administration. See EN 30.04, p. 468-9. The ultimate purchaser expects that the substance will cure their condition or reduce its symptoms. The merchandise is typically sold in pharmacies, over the counter or by prescription only, or administered by health care personnel in hospitals or clinics. The merchandise is used according to a strict dosage schedule usually with a time limit on the recommended use. See HQ 963197, dated December 11, 2000.
By contrast, food supplements, classified in heading 2106, HTSUS, encompass a much more expansive group of items. They simply must be prepared for human consumption. See EN 21.06(A); HQs 962923, dated October 26, 2000, and 962921, dated December 11, 2000. As such, they are packaged for oral ingestion only as a capsule, tablet, powder or liquid. They are put up in packaging with indications that they maintain general health or well-being. The merchandise is often used daily without a strict dosage schedule or time limit recommended. In compliance with the Dietary Supplement Health and Education Act of 1994, P.L. 103-417, 21 U.S.C. 301, et seq., its packaging contains the legally required disclaimer that "the product is not intended to diagnose, treat, cure or prevent any disease."
Applying the Carborundum factors set forth supra, (1) SAM-e are physically in the form of tablets. (2) According to the label, purchasers can expect the product to provide "mood support, joint pain relief and liver health" but not to "prevent, cure or treat any disease." A meta-analysis on the product published by the U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, concludes that the data supports the effectiveness of SAMe in the treatment of depression, osteoarthritis (OA), and cholestasis, although there may be problems of publication bias. Furthermore, it states that "Additional studies are needed to assess fully the efficacy and safety of SAMe for the treatment of depression, OA and cholestasis. These studies should include review studies, those elucidating the pharmacology of SAMe, and clinical trials." (3) The merchandise is processed by neutraceutical companies, and is available over the counter in drug stores and health food stores, and on the internet. It is not currently available in hospitals or other clinical settings where medicaments are available. We note counsel's claim that the Veteran's Administration is currently reviewing a proposal from the importer to supply the product in its hospitals for use in liver disease. (4) The merchandise is advertised as a mood enhancer and for joint and liver health. It is sold in the dietary supplement section of stores. (5) By law, the product is used as a dietary supplement. (6) It is not economically practical to sell SAM-e tablets for therapeutic use since the FDA has not approved the substance for such use. (7) The trade recognizes SAM-e as a dietary supplement. The first of the 7 factors above is inconclusive. The conclusions in the meta-analysis outlined in factor 2 probably would not sway a reasonable purchaser to use SAM-e to treat a specific disease given the claims made on the label. Otherwise, the factors all place SAM-e tablets squarely under the tariff provisions for food supplements.
Counsel does not claim that SAM-e tablets possess healing or curative powers or prevent a specific disease. Instead, SAM-e tablets are marketed, used and regulated as a dietary supplement to maintain healthy joints and emotional well being not unlike the purposes provided by any nutrient. See H. Reisman Corp. v. U.S., 17 CIT 1260 (1993) (Vitamin B-12 “is not used in a therapeutic or prophylactic manner beyond the purposes provided by any nutrient, including ordinary grain feed or food of any kind.”) See also HQs 962323, 962324 and 962335 dated February 3, 2000, and 963749 dated April 20, 2000.
In HQ 966382, dated July 3, 2003, we found that S-adenosyl-l-methionine tosylate disulfate (SAM-e), CAS 97540-22-2, is entitled to duty free status under General Note 13, HTSUS, which provides "[W]henever a rate of duty of “Free” followed by the symbol “K” in parentheses appears in the “Special” subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision . . . shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule." We found that SAM-e was so included.
It does not follow, however, that any tablet made with SAM-e as an ingredient is automatically considered a medicament. Rather, General Note 13 simply provides a method by which pharmaceutical ingredients are given duty free status. The analysis for classification of a tablet containing a pharmaceutical ingredient under the principal use provisions must proceed as outlined above.
For the reasons stated above, SAM-e tablets are classified in subheading 2106.90.99, the provision for "Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other."
HOLDING:
SAM-e tablets are classified in subheading 2106.90.99, the provision for "Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other."
You are instructed to DENY the protest.
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.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial Rulings Division