HQ 962323

February 3, 2000

CLA-2 RR:CR:GC 962323ptl

CATEGORY: Classification

TARIFF NO.: 2106.90.9998

Patrick D. Gill, Esq.

Rode & Qualey

295 Madison Avenue

New York, NY 10017

RE: Reconsideration of New York Ruling Letter (NY) D82397; Gingko Biloba
Tablets.

Dear Mr. Gill:

This is in response to your letter, dated October 30, 1998, requesting
reconsideration of NY D82397, dated October 22, 1998, issued to you on
behalf of Warner-Lambert Company, concerning the classification, under
the Harmonized Tariff Schedule of the United States (HTSUS), of Gingko
biloba in tablet form. That ruling held that the product should be
classified in subheading 2106.90.9998, HTSUS, as food preparations not
elsewhere specified or included: other, other, other. You contend that
the product is a medicament and should be classified in heading 3004,
HTSUS.

In preparing this ruling, we have considered the sample and materials
you submitted as well as information presented during a meeting in our
office on

November 16, 1999, and your supplemental submission of November 22,
1999.

**FACTS:**

The product under consideration, "Quanterra Mental Sharpness" is a
Gingko Biloba herbal supplement "extract" in single dose, tablet form,
packaged for retail sale in boxes containing 28 tablets per box.
Recommended dosage is two tablets per day. According to the text printed
on the box, the ingredients are 60 mg. per tablet Gingko biloba (leaves)
dried extract with lactose, microcrystalline cellulose, maize starch,
hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene
glycol, magnesium stearate, silicon dioxide, artificial color, talc,
ferric oxide and dimethicone. According to the label, the Gingko biloba
contains a substance referred to as "EGb 761®" which is identified as a
"unique proprietary extract." Language on the box implies that the EGb
761® "promotes and maintains mental sharpness, concentration and focus",
that it "promotes blood circulation and oxygen supply to the brain and
extremities" and that it "provides antioxidant protection for the brain
and cardiovascular system". EGb 761® is also purported to "increase
alpha activity in the brain which is indicative of improved cognitive
performance." All these claims include the disclaimer required by 21
U.S.C. 343(r)(b) for claims made pursuant to that section, which states:
"These statements have not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease."

**ISSUE:**

What is the classification of Quanterra Gingko biloba herbal
supplement?

**LAW AND ANALYSIS:**

Merchandise is classifiable under the Harmonized Tariff Schedule of the
United States (HTSUS) in accordance with the General Rules of
Interpretation (GRIs). The systematic detail of the HTSUS is such that
virtually all goods are classified by application of GRI 1, that is,
according to the terms of the headings of the tariff schedule and any
relative Section or Chapter Notes. In the event that the goods cannot be
classified solely on the basis of GRI 1, and if the headings and legal
notes do not otherwise require, the remaining GRIs may then be applied
in order.

In understanding the language of the HTSUS, the Harmonized Commodity
Description and Coding System Explanatory Notes may be utilized. The
Explanatory Notes (ENs), although not dispositive or legally binding,
provide a commentary on the scope of each heading of the HTSUS, and are
generally indicative of the proper interpretation of these headings.
[See]{.underline} T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23,
1989).

The HTSUS headings under consideration are as follows:

**2106** Food preparations not elsewhere specified or included:

2106.90 Other:

Other:

Other:

Other:

Other:

2106.90.99 Other:

2106.90.9998 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:

3004.90 Other:

Medicaments primarily affecting the central nervous

system:

3004.9040 Other.

3004.9090 Other.

In support of your contention that the Gingko biloba tablets should be
classified as a medicament, you have provided exhibits of studies and
other documents which indicate that herbal substances are used in health
care and medical remedies in Europe and elsewhere. A study from Germany
has been provided in which researchers argue that Gingko biloba has been
demonstrated to have been helpful in treating some patients suffering
from peripheral arterial insufficiency.

Your submission also referred to several Customs rulings which
classified herbal and vegetable extracts in the statistical subheading
of Chapter 13 which provides for "substances having anesthetic,
prophylactic or therapeutic properties." Among the cases cited is NY
A83392, issued May 13, 1996, which classified a powder extract of Gingko
Biloba, imported in bulk form, in subheading 1302.19.4040, HTSUS, which
provides for vegetable saps and extracts which have anesthetic,
prophylactic or therapeutic properties. It should be noted that there is
no requirement that products of Chapter 13 be used for any particular
purpose. The ENs to Chapter 13 state that "\[T\]he vegetable saps and
extracts of this heading are generally raw materials for various
manufactured products. They are **excluded** from the heading when,
because of the addition of other substances, they have the character of
food preparations, medicaments, etc." This exclusionary language makes
it clear that the addition of foreign substances and further processing
can transform an article of Chapter 13 into an article of any one of
several other Chapters. The product under consideration is a totally
different commercial entity than that considered in NY A83392. The
Gingko biloba tablets are finished products containing "other
substances." It is not Gingko biloba extract raw material. As such, the
cited ruling is not precedential for classification of this product.

Since we have determined that the Gingko biloba tablets are not products
of Chapter 13, we must determine whether they are food preparations of
heading 2106 or medicaments of heading 3004.

When articles are imported into the US, their classification is governed
not only by the GRIs, as stated above, but also by the Additional U.S.
Rules of Interpretation. Additional U.S. Rule 1(a) provides:

> 1\. In the absence of special language or context which otherwise
> requires‑‑
>
> \(a\) 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; \... .

Heading 3004, HTSUS, which you suggest is the proper heading for your
client's product is a use heading. This is clear from the language of
both the legal text of the tariff ("\... products for therapeutic or
prophylactic **uses**\...") and the language contained in the ENs.

On page 468, EN 30.04 states:

This heading covers medicaments consisting of mixed or unmixed products,
provided they are:

> \(a\) Put up in measured doses or in forms such as tablets, ampoules
> (for example, re‑distilled water, in ampoules of 1.25 to 10 cm³, **for
> use** either for the direct treatment of certain diseases, e.g.,
> alcoholism, diabetic coma or as a solvent for the preparation of
> injectible medicinal solutions), capsules, cachets, drops or
> pastilles, or small quantities of powder, ready for taking as single
> doses **for therapeutic or prophylactic use.** (Emphasis added)

However, EN 30.04 (b) on page 469, also states, in part, "... the mere
indication of pharmaceutical or other degree of purity in not alone
sufficient to justify classification in this heading."

On page 470, EN 30.04 further states:

Moreover, products consisting of a mixture of plants or parts of plants
or consisting of plants or parts of plants mixed with other substances,
used for making herbal infusions or herbal  " teas  " (e.g., those
having laxative, purgative, diuretic or carminative properties), and
claimed to offer relief from ailments or contribute to general health
and well-being, are also excluded from this heading (heading 21.06).

Referring to *The Random House Dictionary of the English Language*,
unabridged Edition, 1973, on page 890, we find "medicament" defined as
"a healing substance; medicine; remedy." "Therapeutic" is defined, on
page 1472, as "of or pertaining to the treating or curing of disease;
curative." "Prophylactic" is defined, on page 1153, as "defending or
protecting from disease, as a drug." "Disease" is defined, on page 411,
as "a condition of an organ, part, structure or system of the body in
which there is incorrect function resulting from the effect of heredity,
infection, diet, or environment; illness; sickness; ailment."

If the products are to be classified in heading 3004, they must, as
indicated by the EN, be used for therapeutic or prophylactic purposes.
In determining how a product is used, Customs can look to the packaging
and labeling of the product. In this instance, the Gingko biloba
packaging states that the product "is designed to work with your body so
that you can feel and perform at your best." The package further states
that the product "Promotes and maintains mental sharpness." These
statements, especially when read together with another statement which
also appears on the package, "This product is not intended to diagnose,
treat, cure, or prevent any disease" indicate that the product is being
marketed principally as something to promote general health and
well-being and not as a product to be used for its therapeutic or
prophylactic properties. Paragraph (16) to EN 21.06, page 172, directs
that when goods based on extracts from plants are put up in packagings
with indications that they maintain general health or well-being, they
should be classified in heading 2106.

Further evidence that these products are not medicaments intended for
therapeutic or prophylactic use is provided by the fact there is no
recommended duration after which the consumer should stop taking the
product and seek medical attention, as there is with medicaments. The
implication is that these products can be taken indefinitely by the
consumer. The product does not attempt to cure or prevent a particular
disease or ailment.

Because the product contains parts of plants mixed with other substances
and is used to promote general health and well-being, in accordance with
the language of EN 30.04, it is not a medicament of heading 3004, HTSUS,
but rather a food supplement of heading 2106, HTSUS.

In earlier rulings, Customs has classified herbal supplements which were
marketed as nutritional supplements in Chapter 21, HTSUS. In HQ 953679,
issued February 1, 1994, HQ 085492, issued October 20, 1989, and HQ
960607, issued July 31, 1998, Customs classified a variety of herbal
supplement products containing herb and plant extracts (and also
containing added excipients and/or other substances, as do the instant
articles) which had been put up for retail sale in heading 2106, HTSUS.

The language of Additional U.S. Rule 1(a) provides that goods are to be
classified as they are to be used in the U.S. In the U.S., the
introduction into commerce, labeling and use of foods, drugs and
medicaments is governed by the Food, Drug and Cosmetic Act (FD&C Act)
(21 U.S.C.A. 301 *et seq.*). Although it is well established that while
statutes, regulations and administrative interpretations not related to
tariff purposes are not determinative of Customs classification
disputes, because of Additional U.S. Rule 1(a), Customs may refer to
them to assist in determining the use of goods in the U.S.

Section 321 of the FD&C Act (21 U.S.C.A. 321) contains definitions of
terms used in that Act. Section 321(g) defines the term "drug" for
purposes of the FD&C Act and states:

> (g)(1) The term "drug" means (A) articles recognized in the official
> United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the
> United States, or official National Formulary, or any supplement to
> any of them; and (B) articles intended for use in the diagnosis, cure,
> mitigation, treatment, or prevention of disease in man or other
> animals; and (C) articles (other than food) intended to affect the
> structure or any function of the body of man or other animals; and (D)
> articles intended for use as a component of any article specified in
> clauses (A), (B), or (C) of this paragraph. A food or dietary
> supplement for which a claim, subject to sections 343(r)(1)(B) and 343
> (r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this
> title, is made in accordance with the requirements of section 343(r)
> of this title is not a drug solely because the label or labeling
> contain such a claim. A food, dietary ingredient, or dietary
> supplement for which a truthful and not misleading statement is made
> in accordance with section 343(r)(6) of this title is not a drug under
> clause (C) solely because the label or the labeling contains such a
> statement.

Section 321(ff) defines the term "dietary supplement." The term "dietary
supplement" means, among other things, a product (other than tobacco)
intended to supplement the diet that contains one or more of certain
dietary ingredients, such as a vitamin, a mineral, an herb or other
botanical, an amino acid, a dietary substance for use by man to
supplement the diet by increasing the total dietary intake, or a
concentrate, metabolite, constituent, extract, or combination of the
preceding ingredients. Section 321(ff) further limits the term dietary
supplement to mean products that are intended for ingestion in a form
described in 21 U.S.C. 350(c)(1)(B)(I) (i.e., tablet, capsule, powder,
softgel, gelcap, and liquid), that are not represented as conventional
food, or as the sole item of a meal or of the diet, and that are labeled
as dietary supplements.

Section 321 further states that: "Except for purposes of paragraph (g)
\[of 21 U.S.C. 321\], a dietary supplement shall be deemed to be a food
within the meaning of th\[e\] \[act\]." 21 U.S.C. 321(ff). Therefore,
the language of the FD&C Act clearly states that dietary supplements are
foods.

Ginkgo biloba tablets are clearly dietary supplements within the meaning
of the FD&C Act. First, the product contains ingredients defined in 21
U.S.C. 321(ff) and is labeled as a dietary supplement in accordance with
21 U.S.C. 321(ff)(2)(C) and 21 CFR 101.3(g). Second, the label bears
nutrition labeling in accordance with the mandatory dietary supplement
requirements in 21 CFR 101.36. Third, the label bears claims made
pursuant to 21 U.S.C. 343(r)(6), including the mandatory disclaimer
required for claims made under the authority of that section. Only
dietary supplements are eligible to bear claims on their label under the
authority of 21 U.S.C. 343(r)(6). Fourth, the label bears no claims that
evidence that the product is intended for use as a drug within the
meaning of 21 U.S.C. 321(g). Because these tablets are dietary
supplements under the FD&C Act, they are also foods under the FD&C Act.
Congress, in enacting the Dietary Supplement Health and Education Act of
1994 (21 U.S.C. 301 note) (DSHEA), established that articles such as the
Gingko biloba tablets are to be regulated by the FDA as foods and not as
drug products.

While classifying products based solely upon labeling in compliance with
FDA regulations would be an abuse of discretion, Customs cannot
arbitrarily ignore the actions and intent of Congress embodied in the
DSHEA. When the DSHEA and EN 30.04 are read together, it is clear that
both are referring to the same product. By independently applying the
DSHEA and the HTSUS, the FDA and Customs can reach the same conclusion
regarding the character and use of the product.

Counsel has cited other rulings in which Customs relied, in part, upon
scientific studies when it classified products in heading 3004, HTSUS.
However, the products classified in those rulings were expressly
designed and prepared to be used to treat or prevent specific conditions
or ailments. The Gingko biloba tablets under consideration claim to have
been formulated to address the consumer's overall mental and physical
well being and not to cure or heal any particular disease or ailment.

For the above reasons, the Gingko biloba herbal supplements were
properly classified by NY D82397 in heading 2106, HTSUS, as food
preparations not elsewhere specified or included: other, other, other,
other, other, other, other.

**HOLDING:**

"Quanterra Mental Sharpness," a Gingko biloba herbal supplement
"extract" in single dose, tablet form, packaged for retail sale is
classified in subheading 2106.90.9998, HTSUS, which provides for food
preparations not elsewhere specified or included: other, other, other,
other, other, other, other.

NY D82397, issued October 22, 1998, is affirmed.

Sincerely,

John Durant, Director

Commercial Rulings Division