CLA-2 RR:CR:GC 964188ptl
Port Director
U.S. Customs Service
11099 S. La Cienega Blvd.
Los Angeles, CA 90045
RE: Protest 2720-00-100187, "Drink Ease" and "No Jet Lag" Homeopathic Products
Dear Port Director:
The following is our decision on Protest 2720-00-100187, filed by counsel on behalf of Global Source, against your classification of products identified as "Drink Ease" and "No Jet Lag" under the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
According to information supplied by protestant, "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 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 products were entered from March through November 1999, under subheading 3004.90.9090, 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 … other. All protested entries were liquidated on January 28, 2000, and the products were classified in subheading 2106.90.9998, HTSUS, which provides for: Food preparations not elsewhere specified or included: other, other, other, other, other, other, other. A timely protest was filed on April 14, 2000.
ISSUE:
What is the classification of the homeopathic products "Drink Ease" and "No Jet Lag"?
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:
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 or in forms or packings for retail sale:
* * *
3004.90 Other:
3004.90.90 Other
3004.90.9090 Other
Protestant asserts that because its homeopathic products, "Drink Ease" and "No Jet Lag" are marketed and distributed to treat specific "ailments" (if a hangover or jet lag can properly be considered an "ailment") they should be classified as medicaments in heading 3003 or 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." 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. The final bottle is labeled as "1C." 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 is reached, the dilution is 1 part in 1 million.
In the instant products, we have potencies of "30C" which is 1x10-60. Basic laws of chemistry place a limit on the dilutions that can be made without losing the original substance altogether. This limit, called Avogadro's Number (6.023 x 1023 – the number of molecules in 1 mole of substance), is reached with homeopathic potencies of 12C or 24X. After that, any trace of the original substance is totally undetectable.
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 in the United States is in Chapter 17, Additional U.S. note 11: "'cough drops' must contain a minimum of 5 mg per dose of menthol, of eucalyptol, or a combination of menthol and eucalyptol." Thus U.S. note is based on 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:
"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."
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, and HQ 963764, dated January 11, 2002.
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 Schwedendbitter 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.
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 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. 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 not required to submit new drug applications, nor do they have to prove the safety and efficacy of their products before marketing them.
In spite of the treatment which the FDA law requires that agency to accord protestant's products, Customs does not believe that either product contains sufficient active ingredient medicaments to 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 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. All records relating to those rulings have been lost as a result of the incident in New York on September 11, 2001. We note that one of the rulings cited by protestant ( NY A82970) was revoked by HQ 963794, dated April 20, 2000, which reclassified valerian herbal tablets from heading 3004, HTSUS, to heading 2106, HTSUS. We also 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.
Neither product under consideration contains an identifiable amount of a product which contains a therapeutic or prophylactic property with respect to any identifiable illness or disease.
HOLDING:
Accordingly, based on the above discussion and the composition of the products, "Drink Ease" and "No Jet Lag," 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 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,
John Durant, Director
Commercial Rulings Division