HQ 966771

September 15, 2004

CLA-2 RR:CR:GC 966771ptl

CATEGORY: Classification

TARIFF No.: 2106.90.9998

Ms. Gretchen M. Brunner

Logistics Manager, North America

Novogen, Inc.

One Landmark Square

2^nd^ Floor

Stamford, CT 06901

RE: Reconsideration of NY C80284, \"Promensil,\" Red Clover.

Dear Ms. Brunner:

This is in response to your letter to the Director, National Commodity
Specialist Division, dated September 17, 2003, in which you requested
reconsideration of New York Ruling (NY) C80284, dated October 27, 1997,
which classified \"Promensil\" tablets in subheading 2106.90.9998 of the
Harmonized Tariff Schedule of the United States (HTSUS), which provides
for food preparations not elsewhere specified or included ... other ...
other ... other.

**FACTS:**

The product in question is identified as \"Promensil.\" It is marketed
in the form of 500 milligram tablets. According to manufacturer\'s
product literature provided with your request for reconsideration:

> \"Each tablet of Promensil contains a standardised 40 mg of the four
> principle isoflavones in their aglycone (sugarless) and highly
> bioavailable form -- biochanin A, formononetin, genistein and
> daidzein.
>
> The final product is a blend of extracts from three different red
> clover varieties selected for their high isoflavone content and
> proportions of different isoflavones. The ratio of isoflavones is
> optimized for women\'s health during menopause (Figure 11).
>
> In addition to the red clover extract Promensil tablets contain the
> following excipients:
>
> ● Calcium hydrogen phosphate
>
> ● Microcrystalline cellulose
>
> ● Silica-colloidal anhydrous
>
> ● Magnesium stearate
>
> ● Natural vitamin E (Mixed tocopherols)
>
> ● Titanium dioxind
>
> Promensil is free of sugar, yeast, milk derivitives, wheat,
> cornstarch, gluten, preservatives, artificial colours and flavours.\"
> (Paragraph 3.1, Clinical Monograph, \"The Role of Red Clover
> Isoflavones in Women\'s Health,\" Novogen)

The literature provides information regarding dosage recommendations for
peri-menopausal (women approaching menopause and those who have early
symptoms) and menopausal women, and instructs that Promensil should be
taken with a meal and at approximately the same time each day. Elsewhere
in the literature, the manufacturer states: \"Promensil™ and Rimostil™
(Novogen Ltd) are dietary supplements which contain extracts of red
clover (*Trifolium pratense*), a rich source of all four major active
isoflavones biochanin A, formononetin, genistein and daidzein.\"
(Paragraph 2.6.2, Novogen Monograph)

The Novogen website provides additional information about the product.
After describing Promensil as being a dietary supplement and listing
symptoms for which the product is taken and other benefits attributed to
the product, the website contains language which complies with the Food
and Drug Administration (FDA) mandate that all nutrition supplements
disclose that \"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.\"
([www.promensil.com](http://www.promensil.com/))

This request for reconsideration of the classification of Promensil
contained in

NY C80284, is based upon peer review publications of clinical trials
which \"clearly demonstrate its remedial properties.\" These materials
were presented to Canadian Customs and the product was \"re-assigned a
HTS of 3004.90.00(79). Which is the equivalent to the USA HTS of
3004.90.9190.\" When the materials were presented to Netherlands
Customs, that authority \"reclassified Promensil as a medicament under
heading 1211.90.98, which is the equivalent to the USA HTS
2111.90.9031.\"

Copies of documents from both administrations were provided with your
submission (The Netherlands document untranslated from the original
Dutch). Additionally, you provided literature on clinical studies on the
efficacy of isoflavones on a variety of women\'s health concerns.

**ISSUE:**

What is the classification of \"Promensil\" dietary supplement tablets?

**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
most 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
the official interpretation of the Harmonized System at the
international level. [See]{.underline} T.D. 89-80, 54 Fed. Reg. 35127,
35128 (August 23, 1989).

The HTSUS subheadings under consideration are as follows:

**1211** Plants and parts of plants (including seeds and fruits), of a
kind used primarily in perfumery, in pharmacy or for insecticidal,
fungicidal or similar purposes, fresh or dried, whether or not cut,
crushed or powdered:

1211.90 Other:

1211.90.90 Other

> Substances having anesthetic, prophylactic or therapeutic properties
> and principally used as medicaments or as ingredients in medicaments:

1211.90.9031 Other

**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 (including those in the form of
transdermal administration systems) or in forms or packings for retail
sale:

3004.90 Other:

3004.90.91 Other

3004.90.9190 Other

CPB has previously considered products which contain extracts and other
ingredients which in addition to being marketed as nutrition
supplements, are also said to provide some particular health benefit. We
will address the classification considerations in the various competing
headings.

The ENs to heading 1211 provide, in relevant part, as follows:

> \"This heading covers vegetable products of a kind used primarily in
> perfumery, in pharmacy or medicine, or for insecticidal, fungicidal,
> parasiticidal or similar purposes. They may be in the form of whole
> plants, mosses or lichens, or of parts (such as wood, bark, roots,
> stems, leaves, flowers, petals, fruits and seeds (**other than**
> oleaginous fruits and oil seeds classified in **headings 12.01 to
> 12.07**)), or in the form of waste resulting, in the main, from
> mechanical treatment. They remain in the heading whether fresh or
> dried, whole, cut, crushed, ground or powdered or (where appropriate)
> grated or hulled. Products of this heading impregnated with alcohol
> remain classified here.\"

The EN continues to provide, as follows:

> \"However, the heading **excludes** such products consisting of plants
> or parts of plants (including seeds or fruits) of different species
> (whether or not incorporating plants or plant parts of other headings)
> or consisting of plants or parts of plants of a single or of different
> species mixed with other substances, such as one or more plant
> extracts (**heading 21.06**).\"

The Promensil tablets are not in the form of whole plants, or parts of
plants. The Promensil tablets contain some parts of plants, but those
parts have been mixed with other substances to make them suitable for
use as nutrition supplements. Accordingly, they are excluded from
classification in heading 1211, HTSUS.

Since we have determined that the Promensil tablets are not products of
Chapter 12, 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
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 571, 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** (Emphasis added) 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, medicaments in the form of transdermal
> administration systems, or small quantities of powder, ready for
> taking as single doses **for therapeutic or prophylactic use**
> (Emphasis added).\"
>
> However, EN 30.04 (b) 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 572, 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, CBP can look to the packaging and
labeling of the product. In this instance, the Promensil literature
states, among other claims, that the product is proven to "promote
emotional well-being" and manage the symptoms of menopause naturally.
The literature further states that "A healthy diet and exercise are also
an important part of managing menopause." 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 solely for its therapeutic or prophylactic
properties. Paragraph (16) to EN 21.06, page 183, 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
not be classified in heading 3004.

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 962323,
issued February 3, 2000, 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 CBP classification disputes,
because of Additional U.S. Rule 1(a), CBP 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.

Promensil 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
Promensil 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, CBP 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 CBP can reach the same conclusion regarding the
character and use of the product.

Based on the above discussion, we cannot agree with the classifications
of Promensil provided by either the decision of the Canadian
Administration or that of the Netherlands which you have provided.

Accordingly, Promensil tablets which are dietary supplements are
properly classified in heading 2106, HTSUS, as food preparations not
elsewhere specified or included.

**HOLDING:**

\"Promensil\" 500 milligram tablets are dietary supplements and are
classified in subheading 2106.90.9998, HTSUS, which provides for food
preparations not elsewhere specified or included: other: other: other:
other: other: other other. The 2004 rate of duty is 6.4% *ad valorem*.

Duty rates are provided for your convenience and are subject to change.
The text of the most recent HTSUS and the accompanying duty rates are
provided on the World Wide Web at
[www.usitc.gov](http://www.usitc.gov/).

NY C80284, dated October 27, 1997, is affirmed.

Sincerely,

Myles B. Harmon, Director

Commercial Rulings Division