CLA-2 RR:CR:GC 964673 AM
Port Director
U.S. Customs Service
P.O. Box 17423
Washington, D.C. 20041
Re: Protest 5401-00-100024; Joint Advantage® tablets
Dear Port Director:
This is our decision on Protest 5401-00-100024, timely filed by counsel on behalf of Doctor’s Preferred, Inc., on September 14, 2000, against your decision in the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Joint Advantage tablets.
FACTS:
Joint Advantage® is a tablet consisting of bovine cartilage, lemon myrtle leaf, wild rosella calyce, aniseed myrtle leaf, mountain pepper leaf, devil’s claw extract, yucca extract, white willow extract, feverfew extract, celery extract, boswellia extract, bromelain and papain extract. It is imported packaged in bottles of 60 tablets put up for retail sale. Copies of the label and catalogue description submitted with the protest (Exhibits A and B), reveal that Joint Advantage® tablets are labeled a “dietary supplement” that will “promote lasting joint health.”
The protest was timely filed against seven entries all liquidated on June 16, 2000. The entries were liquidated under subheading 2106.90.99, the provision for "[F]ood preparations not elsewhere specified or included: [O]ther: [O]ther." Protestant claims classification under subheading 3004.90.90, the provision for "[M]edicaments (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 (con.): [O]ther: [O]ther."
ISSUE:
What is the classification of Joint Advantage® tablets?
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
2106.90.99 Other
* * * * *
3004 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 (con.):
Other:
Other
Both headings of the HTSUS under consideration are principal use provisions. 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."
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."]
E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996 Ct. Intl. Trade). Therefore, the determinative issue is whether Joint Advantage®, as imported in bottles of tablets put up for retail sale, labeled and advertised as a dietary supplement which promotes joint 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, classifiable 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), p. 170; 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., Joint Advantage® packaging would have to contain the legally required disclaimer that "the product is not intended to diagnose, treat, cure or prevent any disease," if any such claims were made.
Applying the Carborundum factors set forth supra, Joint Advantage® tablets are presently used in the U.S. as a food supplement. The merchandise is available over the counter in pharmacies and health food stores and recommended for the maintenance of “joint health.” Nor is it economically practical to sell Joint Advantage® for therapeutic use since the Food and Drug Administration (FDA) has not approved the substance for such use. Rather, economic practicality, standards in the trade, and the sale of the product generally place Joint Advantage® squarely under the tariff provisions for food supplements.
Counsel argues that the terms "medicament," "therapeutic" and "prophylactic" should be interpreted consistently throughout the tariff. We agree. Nevertheless, counsel misconstrues the use of these terms in chapters 12 and 13, HTSUS. For instance, the EN’s to chapter 12, on pg. 88, cited by counsel, serve only to limit the terms "therapeutic or prophylactic" in Chapter 30 to products that are indeed therapeutic or prophylactic as opposed to those products simply "used in pharmacy." The ENs do not, as counsel claims, give rise to any presumption that “targeted products” are therapeutic or prophylactic.
Furthermore, the list of medicinal substances and extracts in the EN’s to chapter 13, pg. 99, cited by counsel, do not establish that Joint Advantage® is a medicament for “prophylactic purposes” because it is not composed of like medicinal substances and extracts. Two of the ingredients in Joint Advantage®, bronelian and papain, are enzymes of heading 3507, HTSUS, and one, bovine cartilage, is an animal product probably too advanced for classification in chapter 4, HTSUS. The remaining ingredients are plant extracts not listed in the ENs or formularies as medicinal in nature.
The EN goes on to state that when medicinal substances are mixed for “therapeutic or prophylactic use” they are excluded from heading 1302, HTUS, and classified in Chapter 30. Two examples of medicinal preparations mixed for therapeutic or prophylactic use are included in the EN: a mixture of extract of capsicum, spirits of turpentine, camphor and methyl salicylate and a mixture of tincture of opium, anise oil, camphor and benzoic acid. The first is a liniment containing “counterirritants” used for relief of pain in rheumatic ailments, sciatica, and lumbago. The United States Dispensatory, 27th Ed., J.B. Lippincott Co., at xiv, 220, 223, 749-50 (Philadelphia, 1973). The formula is found in over the counter preparations such as “Sloan’s Liniment.” The second mixture is a Schedule III controlled anti-diarrheal drug (21 CFR 1308-13) better known as camphorated opium tincture or paregoric. Id. at 806. By contrast, none of the ingredients in the instant product are “medicinal” in nature.
The ultimate question remains: what is meant by “therapeutic or prophylactic use” in heading 3004, HTSUS. 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." The common meaning for prophylactic is "preventative". Webster's Third New International Dictionary defines prophylactic as "(1) guarding from disease: preventing or contributing to the prevention of disease (2) tending to prevent or ward off."
Counsel does not claim that Joint Advantage® tablets possess healing or curative powers or prevent a specific disease. Instead, Joint Advantage® tablets are marketed, used and regulated as a dietary supplement to maintain healthy joints 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.
HOLDING:
The protest is DENIED. Joint Advantage® tablets are classified in subheading 2106.90.99, the provision for "[F]ood preparations not elsewhere specified or included: [O]ther: [O]ther: [O]ther."
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 Durant, Director
Commercial Rulings Division