HQ 964882

September 26, 2002

CLA-2 RR:CR:GC 964882ptl

CATEGORY: Classification

TARIFF NO.: 2106.90.9998

Port Director

U.S. Customs Service

11099 S. La Cienega Blvd.

Los Angeles, CA 90045

RE: Protest 2720-00-100769; Homeopathic Products

Dear Port Director:

The following is our decision on Protest 2720-00-100769, filed by
counsel on behalf of Boiron USA, against your classification of various
homeopathic liquid and tablet preparations under the Harmonized Tariff
Schedule of the United States (HTSUS).

**FACTS:**

The 45 entries covering merchandise that are the subject of this 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. Samples
of the products were sent to Customs Laboratories for analysis. Based
upon the results of these tests, the goods were reclassified by Customs
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 Customs in which it
argued that the original classification provided by Boiron was correct
and the entries should be reliquidated as entered.

In preparing this decision, consideration has been given to supplemental
documents provided by protestant in April and May 2002, as well as
information and materials presented to members of my staff during a
teleconference on May 22, 2002.

**ISSUE:**

What is the classification of the Boiron homeopathic products?

**LAW AND ANALYSIS:**

Initially we note that the protest (Customs Form 19) was received by
Customs on November 8, 2000. Using the November 8, 2000, date as the
date of filing of the protest, as to the entries liquidated on July 28,
2000, (see Attachment \"A\"), the protest was untimely filed *i.e*., a
protest must be filed within 90 days after but not before the notice of
liquidation (19 U.S.C. §1514(c)(3)(A); 19 C.F.R. §174.12(e)); the
notices of liquidation were dated July 28, 2000, and the protest was
filed November 8, 2000, 102 days \[3 days in July, 31 in August, 30 in
September, 30 in October, and 8 in November equals 102 days\] after the
notice of liquidation). For an example of the judicial treatment of a
protest filed after the 90-day period for filing a protest, see *Penrod
Drilling Co. v. United States*, 13 CIT 1005, 727 F. Supp. 1463,
*rehearing dismissed*, 14 CIT 281, 740 F. Supp. 858 (1990), *affirmed*,
9 Fed. Cir. (T) 60, 925 F. 2d 406 (1991). The protest must be denied as
to the entries liquidated on July 28, 2000. As to the remaining entries
(see Attachment \"B\"), the protest was timely filed (see above) and the
matter protested is protestable (see 19 U.S.C. §1514(a)(2) and (5)).

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:

3004.90.90 Other

3004.90.9090 Other

We note that In the protest filed, protestant begins by stating that:
\'the imported homeopathic medicines were reclassified by Customs in
either HTS, subheading 1702.19.00.00 \[sic\] as lactose (in the case of
tablets) or under HTS, subheading 2208.90.75.00 \[sic\] as an alcoholic
beverage (in the case of liquid homeopathic medicines).\" Then, on the
next page of the protest, counsel states: \"The Notice of Action
reclassified items 3004.90.9090 and 3003.90.0000 (medicaments), which
are not subject to any duty, to 2106.90.9998 (food preparations),
levying duties of 6.4% for 2000 entries and 7% for 1999 entries.\" As
point of fact, Customs liquidated all entries in subheading
2106.90.9998, HTSUS, as food preparations, not elsewhere specified.

Protestant asserts that because its homeopathic products are marketed
and distributed to treat specific \"ailments\" and \"conditions\", they
should be classified as medicaments in heading 3003 or 3004, HTSUS.

To be classified in headings 3003 and 3004, HTSUS, a product must be
used in the internal or external treatment (therapeutic use) or
prevention (prophylactic use) of human or animal ailments. EN 30.04(a)
requires that products put up in measured doses should be used for the
direct treatment of certain diseases. Paragraph (b) requires that there
be a statement of the disease or condition which the product is intended
to cure or relieve. This paragraph also advises that the mere indication
of pharmaceutical or other degree of purity is not alone sufficient to
justify classification in that heading.

The ENs covering medicaments need to be read in conjunction with each
other. EN (1) to heading 30.03 states that the heading includes \"mixed
medicinal preparations such as those listed in an official
pharmacopoeia.\" But the products must contain active ingredients at
sufficiently high levels to be regarded as having primarily therapeutic
or prophylactic effects. The EN continues: \" However, this should not
be taken to mean that preparations listed in an official pharmacopoeia,
proprietary medicines, etc. are always classified in heading 30.03. For
example, anti-acne preparations which are designed primarily to cleanse
the skin and which do not contain sufficiently high levels of active
ingredients to be regarded as having a primary therapeutic or
prophylactic effect against acne are to be classified in heading
33.04.\" This concept is repeated in the EN to heading 3004 where it
states that \"throat pastilles or cough drops containing substances
having medicinal properties, other than flavouring agents, remain
classified in this heading when put up in measured doses or in forms or
packings for retail sale, [provided that the proportion of those
substances in each pastille or drop is such that they are thereby given
therapeutic or prophylactic uses]{.underline}.\" (Emphasis added)

Although no clear criteria is provided in either the tariff text or the
ENs to differentiate products which are medicinal preparations from
those which are designed to maintain general health and well-being,
there is a definite distinction made between them. The only exact
criterion provided is in Chapter 17, Additional U.S. note 11, which
provides that : \" \'cough drops\' must contain a minimum of 5 mg per
dose of menthol, of eucalyptol, or a combination of menthol and
eucalyptol.\" This U.S. note is based on a Food and Drug Administration
(FDA) opinion that a 5 mg or larger dose of menthol is therapeutic. This
treatment is supported by language of EN 30.04 which provides, in
relevant part, as follows:

> \"However, preparations put up as throat pastilles or cough drops,
> consisting essentially of sugars (whether or not with other foodstuffs
> such as gelatin, starch or flour) and flavouring agents (including
> substances having medicinal properties, such as benzyl alcohol,
> menthol, eucalyptol and tolu balsam) fall in heading 17.04. Throat
> pastilles or cough drops containing substances having medicinal
> properties, other than flavouring agents, remain classified in this
> heading when put up in measured doses or in forms or packings for
> retail sale, provided that the proportion of those substances in each
> pastille or drop is such that they are thereby given therapeutic or
> prophylactic uses.\"

Protestant concedes that its products are not intended to be used for
prophylactic purposes, but contends that because they are marketed as
homeopathic products, they are used by persons for therapeutic purposes
and should therefore be classified as medicaments in heading 3004,
HTSUS.

According to the internet web page of the Homeopathic Pharmacopoeia of
the United States, \"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.\" The particularized
remedy is designed to address the symptoms exhibited by the afflicted
patient. Further, \"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. Potentization,
or dynamization, is the sequential dilution of a substance to release
its immaterial and spiritual powers. The process is called attenuation
when it refers to liquids and trituration when it refers to solid
preparations. 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 ration 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. These
preparations are referred to as submolecular. It is the contention of
protestant that it is the overall preparation, and not any particular
element of it, that is the \"active\" component of a homeopathic drug.

Basic laws of chemistry place a limit on the dilutions that can be made
without losing the original substance altogether. Once this limit,
called Avogadro\'s Number (6.023 x 10^23^ -- the number of molecules in
1 mole of substance) is reached, the original substance is totally
undetectable. The sequential dilutions used to prepare homeopathic
preparations create products in which the \"active\" ingredients are
virtually indectable. Current scientific instruments can detect
compounds which have been diluted to the 16X/8C level.

Customs has been consistent in its treatment between products which
contain \"sufficient\" or \"efficacious\" levels of active ingredients
for medical purposes and those which have only low levels of active
ingredients. See HQ 957394, dated February 5, 1998, on Fisherman\'s
Friend mentholated lozenges, HQ 961061, dated August 24, 1998, on
Hall\'s Sugar Free Cough Drops, HQ 958150, dated April 7, 1998, on
Hall\'s Vitamin C Drops, HQ 963764, dated January 11, 2002, on Certs
Mints, and HQ 964188, dated April 3, 2002, and HQ 964494, dated August
28, 2002, on homeopathic products.

To support the proposition that the products should be classified in
heading 3004, HTSUS, protestant points out that according to the
definitions contained in section 321(g)(1) of the Food, Drug and
Cosmetic Act (FDCA) (21 USC 301 et seq.), the term \"drug\" includes
\"articles recognized in the official United States Pharmacopoeia,
official Homeopathic Pharmacopoeia, or official National Formulary, or
any supplement to them; ....\" Protestant also points out that this
definition requires the U.S. Food and Drug Administration (FDA) to
oversee homeopathic products. This oversight is accomplished by means of
regulations and Compliance Policy Guides issued by the FDA which govern
the labeling and marketing of homeopathic products. However, under this
regulatory scheme, much greater leeway is accorded homeopathic products
than mainstream drugs. Among some of the more significant differences is
that homeopathic drug manufacturers are exempt from expiration dating
their products, and laboratory determination of the identity and
strength of each active ingredient. Additionally, homeopathic drug
manufacturers are exempt from the requirements that they register a new
product for an Investigational New Drug (IND) number at early stages of
development and they are not required to submit new drug applications,
nor do they have to prove the safety and efficacy of their products
before marketing them.

We have previously noted that the introduction to the Homeopathic
Pharmacopoeia of the United States provides, in part, that \"\[a\]ny
substance may be considered a homeopathic medicine ... \[if it\] is
manufactured according to the specifications of the Homeopathic
Pharmacopoeia of the United States (HPUS).\" Since the FDA is required
by law to accept as drugs articles claimed by their manufacturers to be
homeopathic products because they are included HPUS, essentially any
substance can, through this process, be considered a drug.

While we recognize the treatment which the FDA law requires that agency
to accord protestant\'s products, Customs does not believe that products
which do not contain sufficient active medicinal ingredients satisfy the
tariff requirements for classification as medicaments. We note that it
is a long established principle of Customs practice that the
characterization of imported merchandise by governmental agencies for
other than tariff purposes does not determine tariff classification. See
*United States v. Mercantil Distribuidora et al*., 45 C.C.P.A. (Customs)
20, C.A.D. 667 (1957); *Marine Products Co. v. United States*, 42 Cust.
Ct. 154 (C.D. 2080) (1959). We also note that the courts have also held
that inclusion in the United States Pharmacopoeia or National Formulary
does not automatically establish that classification \[by the FDA\] of
such article as a \"drug\" is reasonable. *National Nutritional Foods
Ass\'n. v. Matthews*, 557 F.2d 325 (1977).

Protestant has referred to several New York rulings dating from 1994,
which classified some homeopathic products in heading 3004, HTSUS, and
states that these rulings should be a basis for similar treatment of his
product. Unfortunately, none of the rulings cited by protestant provide
a detailed composition for any of the products classified and all
records relating to those rulings have been lost as a result of the
destruction of the Customs offices at the World Trade Center in New York
on September 11, 2001. We note that the language of the ENs 3003 states
that although components of a product are listed in an official
pharmacopoeia that \"this should not be taken to mean that preparations
listed in an official pharmacopoeia, proprietary medicines, etc. are
always classified in heading 30.03 \[and, by extension heading 3004\].\"
Since we do not have full details of those rulings, we will not base
classification of protestant\'s products on an incomplete record.

While they are not treated as dispositive, decisions of the Harmonized
Systems Committee (HSC) of the World Customs Organization can provide
guidance in the interpretation of tariff construction. Over several
years, the HSC considered the classification of products identified as
\"Bach Flower\" preparations and \"Original Schwedenbitter.\" In 1994,
in Annex G/4 to Doc 38.960, the HSC determined that the Bach Flower
remedies were not classifiable in heading 3004 since no active
therapeutic or prophylactic ingredients had been detected by the various
Customs Laboratories. Similarly, the Schwedenbitter was not classifiable
in heading 3004 because the product was not a medicament. Because of
their substantial ethanol content, the HSC decided to classify both
products in heading 2208.

Based on the above analysis and discussion of the language of the HTSUS,
the ENs and relevant Customs rulings, we 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.\" While we realize the
homeopath contends that the entire dilution or succintion is the
\"active ingredient,\" for classification purposes, \"active
ingredient\" will be taken to mean that herb or element identified on
the label as the item which supposedly distinguishes one product from
another similarly diluted product. 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.

Customs has taken samples of over 50 of the products which are under
protest. In no instance, do the results of the laboratory analysis
indicate that any of the products contain delectable amounts of active
ingredients, let alone quantities which can be considered sufficient for
therapeutic or prophylactic purposes of chapter 30.

Since the subject merchandise is precluded from classification in
chapter 30, classification must be based on the detectable components of
the products. The products are in the form of edible articles for human
consumption (tablets, liquids and syrups). Accordingly, they are
classified in heading 2106, HTSUS, as food products not elsewhere
specified or included.

**HOLDING:**

Accordingly, based on the above discussion the homeopathic products
which are the subject of this protest do not contain significant
detectable amounts of active ingredients which have therapeutic or
prophylactic uses. Because they are intended to be consumed by humans,
they are classified in subheading 2106.90.9998, HTSUS, which provides
for food preparations not elsewhere specified or included, other, ...
other.

The protest should be DENIED. 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,

Myles B. Harmon, Acting Director

Commercial Rulings Division

ATTACHMENT A

Entries Liquidated on July 28, 2000:

112-xxxx2612

112-xxxx6678

112-xxxx4666

112-xxxx5450

112-xxxx7546

112-xxxx1060

112-xxxx9435

112-xxxx7571

112-xxxx0598

112-xxxx6436

112-xxxx7742

112-xxxx9043

112-xxxx7105

112-xxxx0282

112-xxxx7920

112-xxxx8488

112-xxxx0474

112-xxxx1734

112-xxxx0231

112-xxxx8394

112-xxxx0138

112-xxxx6436

112-xxxx9068

112-xxxx5500

112-xxxx5471

112-xxxx0197

112-xxxx9876

112-xxxx3079

ATTACHMENT B

Entries Liquidated on August 11, 2000:

112-xxxx2642

112-xxxx1406

Entries Liquidated on August 25, 2000:

112-xxxx9209

112-xxxx0811

112-xxxx0329

112-xxxx0843

112-xxxx5337

112-xxxx4783

112-xxxx6121

112-xxxx5611

112-xxxx8916

112-xxxx1506

Entry Liquidated September 1, 2000:

112-xxxx0380

Entry Liquidated September 8, 2000:

112-xxxx2469

Entries Liquidated September 15, 2000:

112-xxxx1927

112-xxxx4468

Entry Liquidated September 22, 2000:

112-xxxx0640