HQ 967075

December 6, 2004

CLA-2 RR:CR:GC 967075AM

CATEGORY: Classification

TARIFF NO.: 3004.90.9190

Mr. Daniel E. Waltz

Patton Boggs LLP

2550 M Street, NW

Washington, DC 20037-1350

RE: HQ 964882 Homeopathic Products

Dear Mr. Waltz:

This is in reference to Headquarters Ruling Letter (HQ) HQ 964882, dated
September 26, 2002, regarding the classification of various homeopathic
liquid and tablet preparations, pursuant to the Harmonized Tariff
Schedule of the United States (HTSUS). We have reviewed this ruling and
find it to be incorrect. Accordingly, we are revoking it.

Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C.
1625(c)(1)), as amended by section 623 of Title VI, Customs published a
notice in the October 27, 2004, *Customs Bulletin*, Volume 38, Number
44, proposing to revoke Headquarters Ruling Letters (HQ) 964882, dated
September 26, 2002, and 964188, dated April 3, 2002, and to revoke any
treatment accorded to substantially identical merchandise. Twenty-two
comments were received in support of this notice.

**FACTS:**

HQ 964882 ruled on Protest 2720-00-100769, filed by counsel on behalf of
Boiron USA. The 45 entries covering merchandise that were the subject of
that protest were made between May 26, 1999 and May 30, 2000. In these
entries, the various products at issue, identified as homeopathic
medicines by Boiron, were classified as medicaments in heading 3004,
HTSUS.

The Federal Food Drug and Cosmetic Act (\"FFDCA\")(21 U.S.C. §§301 *et
seq*), states, in pertinent part, that \"the term 'drug' means (A)
articles recognized in the official United States Pharmacopoeia,
official Homoeopathic 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 clause (A), (B), or (C) (21 U.S.C.
§321(g)(1)).

In 1988, FDA issued a compliance policy guide (\"CPG\"), entitled
\"[Conditions under Which Homeopathic Drugs May be
Marketed]{.underline}\" (Sec. 400.400 CPG 7132.25), describing FDA\'s
regulatory approach toward homeopathic medicines. The CPG explains that
Homeopathic products must meet the standards for strength, quality, and
purity set forth in the Homeopathic Pharmacopeia (21 U.S.C. 351).
Additionally, product labeling must comply with the labeling provisions
of Sections 502 and 503 of the FFDCA and Part 201 (21 CFR 201). Each
product must bear the name and place of business of the manufacturer,
adequate directions for use, a statement of the quantity and amount of
ingredients in the product expressed in homeopathic terms, indications
for use, and warnings as described in 21 CFR 201 *et seq.* The CPG
explains that homeopathic products are subject to FDA enforcement if
they are misbranded, or violate any FDA adulteration or promotional
restrictions. Furthermore, Section 503(b) of the FFDCA mandates that
homeopathic products offered for conditions not amenable to
over-the-counter use must be marketed as prescription products. Lastly,
the FDA does not regulate these products under the Dietary Supplement
Health and Education Act of 1994, (21 U.S.C. 301 *et seq.*), which
amended the FFDCA by adding provisions to regulate dietary supplements
as it does food.

Samples of the merchandise show that the outer package is labeled in
accordance with regulations of the FFDCA as a homeopathic drug, with
active ingredient names and potencies, indications, warnings and dosage
information. Furthermore, the active ingredients have been processed in
accordance with the Homeopathic Pharmacopoeia of the United States
(HPUS).

These samples were sent to the CBP Office of Laboratories and Scientific
Services for analysis. Based upon the results of these tests, the goods
were reclassified by CBP in subheading 2106.90.9998, HTSUS, which
provides for food preparations not elsewhere specified or included, ...
other. The entries liquidated between July 28, 2000 and September 22,
2000. On November 8, 2000, counsel filed a protest with CBP in which it
argued that the original classification provided by Boiron was correct
and the entries should be reliquidated as entered.

**ISSUE:**

What is the classification of homeopathic products containing an active
ingredient or ingredients officially included in the HPUS, packaged with
statements of: (1) the specific diseases, ailments or their symptoms for
which the product is to be used; (2) the concentration of active
substance or substances contained therein; (3) dosage; and (4) mode of
application in accordance with the requirements of the FFDCA?

**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
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 provisions under consideration are as follows:

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

2106.90 Other:

> Other:
>
> Other:
>
> Other:
>
> 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:

\* \* \* \* \* \*

3004.90 Other:

3004.90.91 Other:

Other:

3004.90.9190 Other

Both headings of the HTSUS under consideration are principal use
provisions.

> The principal use of the class or kind of goods to which an import
> belongs is controlling, not the principal use of the specific import.
> *Group Italglass U.S.A., Inc. v. United States*, 17 C.I.T. 1177, 1177,
> 839 F. Supp. 866, 867 (1993). \"Principal use\" is defined as the use
> \"which exceeds any other single use.\" *Conversion of the Tariff
> Schedules of the United States Annotated Into the Nomenclature
> Structure of the Harmonized System*: Submitting Report at 34-35 (USITC
> Pub. No. 1400) (June 1983). As a result, \"the fact that the
> merchandise may have numerous significant uses does not prevent the
> Court from classifying the merchandise according to the principal use
> of the class or kind to which the merchandise belongs.\" *Lenox
> Coll.*, 20 C.I.T., Slip Op. 96-30.
>
> 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
> US 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.

*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
these homeopathic products, which are regulated as drugs under the
FFDCA, belong to the class or kind of good that is principally prepared
for therapeutic or prophylactic use or whether they belong to the class
or kind of good that is principally used as a dietary supplement.

Medicaments principally prepared for therapeutic or prophylactic use in
the U.S. are packaged for oral, parenteral (by injection), or
dermatological administration. The ultimate purchaser expects that the
substance will cure their condition or reduce its symptoms. The
merchandise is regulated by the FDA as a drug and 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.

By contrast, food supplements encompass a much more expansive group of
items. They simply must be prepared for human consumption. 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.

The internet web page of the HPUS, states, in pertinent part, the
following:

> Homeopathy is the art and science of healing the sick by using
> substances capable of causing the same symptoms, syndromes and
> conditions when administered to healthy people. . . . Any substance
> may be considered a homeopathic medicine if it has known \'homeopathic
> provings\' and/or known effects which mimic the symptoms, syndromes or
> conditions which it is administered to treat, and is manufactured
> according to the specifications of the Homeopathic Pharmacopoeia of
> the United States.

One of the principal concepts of Homeopathy is the \"Law of
Infinitesimals.\" This principal holds that the smaller the dose of the
substance, the more powerful will be its healing effects. For example,
the starting substance is first mixed in alcohol to obtain a tincture.
One drop of the tincture is mixed with 99 drops of alcohol (to achieve a
ratio of 1:100) and the mixture is strongly shaken. This shaking process
is known as succussion. This bottle is labeled as \"1C\" or \"2X.\" One
drop of this 1C is then mixed with 100 drops of alcohol and the process
is repeated to make 2C. By the time 3C (6X) is reached, the dilution is
1 part in 1 million.

In HQ 964882 we stated the following:

> . . . \[w\]e are of the opinion that even though homeopathic products
> are marketed and labeled in a manner approved by the FDA indicating
> that they are intended to be used by purchasers for therapeutic
> purposes that unless such products contain a significantly detectable
> amount of that particular element or compound that is claimed to be an
> \'active ingredient,\' such products are similar to placeboes and
> should not be classified in chapter 30, HTSUS, as medicaments. We have
> determined that products which contain dilutions of active ingredients
> less than or equal to 16X or 8C may be classified in chapter 30,
> HTSUS, provided that Customs is able to detect significant levels of
> the \'active ingredient.\' . . . If the identifying component can be
> detected in quantities that can be considered effective, and that
> component is included in the HPUS, and the product is labeled in
> accordance with FDA guidelines, then Customs will concede
> classification in heading 3004, HTSUS.

However, upon further consideration, we no longer are of the view that
the relevant standard in classifying homeopathic products is our ability
to detect the presence of the active ingredient. Homeopathic products
are considered to be drugs by the FDA. They all must comply with the
standards listed in the HPUS. They all must be packaged with statements
of the specific diseases, ailments or their symptoms for which the
product is to be used, the concentration of active substance or
substances contained therein, the recommended dosage and the mode of
application. They are all marketed and sold in relation to a disease,
condition, or ailment which they purport to treat. If the condition is a
very serious one, e.g. cancer, they are sold only by prescription.
Hence, we find that in the context of homeopathic products, the outcome
of the principal use test described above should not be based on the
degree of dilution of the active ingredient in the homeopathic product.
Therefore, we no longer believe that classifying homeopathic products
according to the dilution of the active ingredient is correct.

**HOLDING:**

Accordingly, homeopathic products, which are considered by the FDA as
drugs because they contain an active ingredient or ingredients
officially included in the HPUS, and are packaged with statements of the
specific diseases, ailments or their symptoms for which the product is
to be used, the concentration of active substance or substances
contained therein, the recommended dosage and the mode of application,
are classified in subheading 3004.90.9190, HTSUSA, 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: Other.\"

Under *San Francisco Newspaper Printing Co. v. United States*, 9 CIT
517, 620 F. Supp. 738 (1985), the liquidation of the entries covering
the merchandise which was the subject of Protest 2720-00-100769 was
final on both the protestant and CBP. Therefore, this decision has no
effect on those entries.

However, in a comment, dated November 23, 2004, you requested, on behalf
of Boiron, USA, that the decision be made effective immediately upon
publication of the final decision. Pursuant to 19 CFR §177.12(e)(2)(ii),
this ruling is effective upon the date of its publication in the
*Customs Bulletin*.

**EFFECT ON OTHER RULINGS:**

HQ 964882, dated September 26, 2002, is revoked. Furthermore, to the
extent that HQ 964494, dated August 28, 2002, issued to Bioforce AG, or
any other ruling, contradicts in *dicta*, or otherwise, the analysis set
forth above with regard to the classification of homeopathic products,
that analysis no longer represents the position of CBP.

Sincerely,

Myles B. Harmon, Director

Commercial Rulings Division