HQ 964673

February 4, 2002

CLA-2 RR:CR:GC 964673 AM

**CATEGORY:** CLASSIFICATION

**TARIFF NO.:** 2106.90.99

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:

2106. Food preparations not elsewhere specified or included:

      90. 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.):

90. Other:

    60. 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.
> \[Hereinafter cited as \"Ca*rborundum* factors.\"\]

*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 Ca*rborundum* 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*, 27^th^ 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](http://www.customs.ustreas.gov/), by means of the
Freedom of Information Act, and other methods of public distribution.

Sincerely,

John Durant, Director

Commercial Rulings Division