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HQ 967363

December 6, 2004

CLA-2 RR:CR:GC 967363AM


TARIFF NO.: 3004.90.9190

Ms. Heather C. Litman
Stein, Shostak, Shostak & O'Hara
515 South Figueroa St., Ste 1200
Los Angeles, CA 90071-3329

RE: HQ 964188; Homeopathic Products

Dear Ms. Litman:

This is in reference to Headquarters Ruling Letters (HQ) 964188, dated April 3, 2002, regarding the classification of "Drink Ease" and "No Jet Lag," pursuant to the Harmonized Tariff Schedule of the United States (HTSUS). In reviewing a similar matter, we have reviewed this ruling and find it to be incorrect. 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.


HQ 964188 ruled on Protest 2720-00-100187, filed by counsel on behalf of Global Source. "Drink Ease" and "No Jet Lag" are marketed as homeopathic drugs. Each of the products is packaged for retail sale with 30 tablets in a safety sealed blister strip. The outer package is labeled in accordance with regulations of the Food and Drug Administration (FDA) with active ingredient names and potencies, indications, warnings and dosage information. Both products are compressed tablets made of sorbitol (a non-nutritive sweetening agent commonly used to make tablets), sterilized talc and magnesium stearate (both are inactive ingredients used as lubricants/separators in tablet compression). Equal amounts of five homeopathic active ingredients which have been processed by the manufacturer according to rules established by the Homeopathic Pharmacopoeia of the United States (HPUS) are sprayed onto the tablets. The active ingredients have homeopathic potencies of "30C." "Drink Ease" is marketed for the relief of alcoholic hangovers and contains Avena Sativa (oats), Capsicum Annuum (pepper), Nux Vomica (identified as nutmeg, actually strychnine), Veratrum Album (white hellebore) and Zinc Metallicum (zinc metal). "No Jet Lag" is marketed for relief of tiredness associated with air travel and contains Arnica Montana (leopard's bane), Bellis Perennis (daisy), Chamomilla (wild chamomile), Ipecacuanha (ipecac) and Lycopodium (clubmoss).

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" (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.


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?


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 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:





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:




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.


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 2720-00-100187 was final on both the protestant and CBP. Therefore, this decision has no effect on those entries.


HQ 964188, dated April 3, 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.


Myles B. Harmon, Director

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