CLA-2 RR:CR:GC 964494ptl
Port Director
Port of New York
c/o Liquidation and Protest Branch
U. S. Customs Service
Building 77, JFK Int'l Airport
Jamaica, NY 11430
RE: Protest 1001-00-103114; Homeopathic Liquid and Tablet Preparations.
Dear Port Director:
The following is our decision on Protest 1001-00-103114, filed by counsel on behalf of Bioforce AG, against your classification of various homeopathic liquid and tablet preparations under the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
The goods subject to this protest were entered as part of nine separate entries made between April 12, 1999 and December 8, 1999. The entries contained both herbal dietary supplements and homeopathic medicines. Only the classification of the homeopathic medicines is under protest. At entry, the homeopathic medicines were classified in subheading 3004, HTSUS, as medicaments. Four of the entries were liquidated on April 28, 2000, and the others on May 19, 2000, and the homeopathic medicines were reclassified by Customs depending on whether the product was in solid or liquid form, in either subheading 1702.19.00, HTSUS, which provides for lactose or subheading 2208.90.75, HTSUS, which provides for alcohol products. A timely protest was filed on July 17, 2000, in which protestant asserts the original classification is correct.
In preparing this decision, consideration has been given to supplemental documents provided by protestant in April 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 homeopathic products.
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 T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The HTSUS provisions under consideration are as follows:
1702 Other sugars, including chemically pure lactose, maltose, glucose and fructose, in solid form; sugar syrups not containing added flavoring or coloring matter; artificial honey, whether or not mixed with natural honey; caramel:
Lactose and lactose syrup:
1702.11.0000 Containing by weight 99 percent or more lactose, expressed as anhydrous lactose, calculated on the dry matter
1702.19.0000 Other
2208 Undenatured ethyl alcohol of an alcoholic strength by volume of less than 80 percent vol.; spirits, liqueurs and other spirituous beverages:
* * *
2208.90 Other:
* * *
2208.90.7500 Other
3003 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale:
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
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." (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 1023 – 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, 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 terrorist incident 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 scientifically detectable amount of that particular element or compound that is claimed to be an "active ingredient," such products 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.
We note that each of the products under protest for which packaging has been submitted by protestant contain "active" ingredients in concentrations which have not undergone the multiple dilutions which characterize traditional homeopathic products. Indeed, many of the products are said to contain active ingredients which have only been diluted to the 1X level, which is a far greater concentration than that found in traditional homeopathic drugs.
HOLDING:
Accordingly, based on the above discussion and information provided by protestant regarding the composition, marketing, labeling and use of the products, the following homeopathic products which contain concentrations of selected active ingredients greater than or equal to 16X/8C, are classified in subheading 3004.90.90, HTSUS, which provides 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.
All of the following products are marketed under the "A. Vogel Homeopathic" label:
Allergy Relief, Pollinosan, tablet – Ammi visnaga 1X
Allergy Relief, Pollinosan, liquid – Ammi visnaga 1X
Arthritis Relief, liquid – Symphytum officinale 4X
Arthritis Relief, tablet -- Symphytum officinale 4X
Asthma Relief, tablet – Ammi visnaga 1X
Bladder Irritation, liquid – Solidago virgaurea 1X
Bladder Irritation, tablet – Solidago virgaurea 1X
Cold Relief, liquid – Hydrastis canadensis 4X
Cold & Flu Relief, liquid – Echinacea purpuea 1X
Cold & Flu Relief, tablet -- Echinacea purpuea 1X
Cough Relief, liquid – Ammi visnaga 1X
Headache Relief, liquid – Ammi visnaga 1X
Headache Relief, tablet – Ammi visnaga 1X
Insomnia Stress Relief, liquid – Avena sativa 2X
Insomnia Stress Relief, tablet – Avena sativa 2X
Menopause Relief, liquid – Agnus castus 2X
Menopause Relief, tablet – Agnus castus 2X
PMS Relief, tablet – Potentille anserina 1X
Sinus Relief, tablet – Lemna minor 4X
The protest should be GRANTED for the above listed products. 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