CLA-2 OT:RR:CTF:TCM H243587 TNA
Port Director, Service Port- New York/Newark
U.S. Customs and Border Protection
1100 Raymond Boulevard
Newark, NJ 07102
Attn: Amy Berkitt, Senior Import Specialist
Re: Application for Further Review of Protest No. 4601-13-100263; Tariff Classification of Rescue Remedy Gum
Dear Port Director:
The following is our decision regarding the Application for Further Review (“AFR”) of Protest No. 4601-13-100263, timely filed on February 22, 2013, on behalf of Nelson Bach USA, Ltd. (“Nelson Bach” or “Protestant”). The AFR concerns the classification of Rescue Remedy Gum under the Harmonized Tariff Schedule of the United States (“HTSUS”).
FACTS:
The subject merchandise consists of Nelsons Bach’s “Rescue Remedy Gum.” It is a liquid-filled chewing gum that contains artificial sweeteners and is designed to be chewed so as to ingest the liquid inside. The artificial sweeteners contained in the gum are: Isomalt, Sorbital, Maltitol, Mannitol, and Xylitol. The gum is imported packaged and sold for retail sale. Each retail package of the subject merchandise contains 17 pieces of gum, and each piece contains one dose of the liquid inside.
Rescue Remedy is the brand name of a homeopathic drug that is delivered in many forms, including the subject chewing gum. The liquid inside the Rescue Remedy gum contains the active ingredients for natural stress relief, each in a 5x dilution: Helianthemum nummularium, Clematis vitalba, Impatiens glandulfera, Prunus cerasifera, and Ornithogalum umellatum. The product’s dosage instructions direct users to chew one piece of gum as needed for stress relief.
The subject merchandise was entered on April 22, 2012 under subheading 3004.90.91, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other.” CBP liquidated the entry on September 14, 2012 in subheading 2106.90.99, HTSUS, as “Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other.” The importer filed this protest and AFR on February 22, 2013, claiming classification as entered.
ISSUE:
Whether the subject rescue remedy gum is classified as confectionary of heading 1704, HTSUS, as a food preparation not elsewhere specified or included of heading 2106, HTSUS, or as a drug of heading 3004, HTSUS?
LAW AND ANALYSIS:
Initially, we note that the matter protested is protestable under 19 U.S.C. §1514(a)(2) as a decision on classification. The protest was timely filed within 180 days of liquidation of the entries. (Miscellaneous Trade and Technical Corrections Act of 2004, Pub.L. 108-429, § 2103(2)(B)(ii), (iii) (codified as amended at 19 U.S.C. § 1514(c)(3) (2006)).
Further Review of Protest No. 4601-13-100263 is properly accorded to Protestant pursuant to 19 C.F.R. § 174.24(a), (b), (c), and (d) because the decision against which the protest was filed is alleged to be inconsistent with prior CBP rulings. Specifically, the Protestant argues that the liquidation of the subject merchandise in heading 2106, HTSUS, is inconsistent with the classification of homeopathic remedies as drugs of heading 3004, HTSUS, in HQ H145541, dated April 4, 2012. Protestant also alleges that the subject merchandise was not addressed in either HQ H145541 or HQ H086082, dated October 15, 2010, the Request for Internal Advice that was revoked by HQ H145541.
Classification under the Harmonized Tariff Schedule of the United States (HTSUS) is made in accordance with the General Rules of Interpretation (GRI). GRI 1 provides that the classification of goods shall be determined 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.
The HTSUS provisions under consideration are as follows:
1704 Sugar confectionery (including white chocolate), not containing cocoa:
2106 Food preparations not elsewhere specified or included:
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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale:
The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The EN to heading 17.04 states, in pertinent part, the following:
This heading covers most of the sugar preparations which are marketed in a solid or semi-solid form, generally suitable for immediate consumption and collectively referred to as sweetmeats, confectionery or candies.
It includes, inter alia:
Gums containing sugar (including sweetened chewing gum
and the like)…
The heading excludes:…
(d) Sweets, gums and the like (for diabetics, in particular) containing synthetic sweetening agents (e.g., sorbitol) instead of sugar; pastes based on sugar, containing added fat in a relatively large proportion and, sometimes, milk or nuts, not suitable for transformation directly into sugar confectionery (heading 21.06).
The EN to heading 21.06 states, in pertinent part, the following:
Provided that they are not covered by any other heading of the Nomenclature, this heading covers:
Preparations for use, either directly or after processing (such as cooking, dissolving or boiling in water, milk, etc.), for human consumption….
The heading includes, inter alia:…
(9) Sweets, gums and the like (for diabetics, in particular) containing synthetic sweetening agents (e.g., sorbitol) instead of sugar.
The EN to heading 30.04 states, in pertinent part, the following:
This heading covers medicaments consisting of mixed or unmixed products, provided they are:
(a) Put up in measured doses or in forms such as tablets, ampoules (for example, re-distilled water, in ampoules of 1.25 to 10 cm3, for use either for the direct treatment of certain diseases, e.g., alcoholism, diabetic coma or as a solvent for the preparation of injectible medicinal solutions), capsules, cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use…
(b) In packings for retail sale for therapeutic or prophylactic use. This refers to products (for example, sodium bicarbonate and tamarind powder) which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.
These indications (in any language) may be given by label, literature or otherwise. However, the mere indication of pharmaceutical or other degree of purity is not alone sufficient to justify classification in this heading…
This heading includes pastilles, tablets, drops, etc., of a kind suitable only for medicinal purposes, such as those based on sulphur, charcoal, sodium tetraborate, sodium benzoate, potassium chlorate or magnesia…
The heading also excludes:
(f) Preparations, such as tablets, chewing gum or patches (transdermal systems), intended to assist smokers to stop smoking (heading 21.06 or 38.24).
The subject merchandise is imported in the form of a chewing gum. Such gum has long been recognized as a type of candy or confectionary. See, e.g., www.oed.com (defining gum as “a mixture, of which gelatine is a main ingredient, from which a hard sweetmeat is made in a mould; a sweetmeat made of this.”) CBP has long classified chewing gums as sugar confectionary of heading 1704, HTSUS, and in subheading 1704.10.00, HTSUS, in particular, which provides for chewing gum eo nomine. See, e.g., HQ 958150, dated April 7, 1998; HQ 963670, dated April 12, 2002; NY A85048, dated July 3, 1996; NY A84164, dated June 25, 1996; and NY 806794, dated February 15, 1995; among many others.
However, heading 1704, HTSUS, provides for merchandise that is made of sugar. The gums that are provided for in this heading eo nomine must contain sugar; this category includes sweetened chewing gum and similar products. See EN 17.04. Heading 1704, HTSUS, specifically excludes gums that are made with artificial sweeteners, such as those for diabetics. See EN 17.04. In the present case, the subject Rescue Remedy gum is made with the artificial sweeteners Isomalt, Sorbitol, Maltitol, Mannitol, and Xylitol. See http://www.bachflower.com/rescue-gum/. As such, it contains no natural sugar. Thus, it is precluded from classification in heading 1704, HTSUS. See, e.g., Warner-Lambert Company v. United States, 407 F.3d 1207; 2005 U.S. App. LEXIS 8227; 27 Int'l Trade Rep. (BNA) 1038 (Fed. Cir. 2005) (declining to classify breath mints made of sorbitol, maltodextrin, aspartame, magnesium stearate, flavoring, partially hydrogenated cottonseed oil, copper gluconate and blue food coloring in heading 1704, HTSUS, because it lacked sugar). As a result, we examine alternate headings.
In EN 17.04, the exclusion of gums made of artificial sweeteners directs classification of this merchandise into heading 2106, HTSUS, as other food preparations. Protestant, in requesting AFR, argues for classification as a drug of heading 3004, HTSUS. In HQ 967075 and HQ 967363, both dated December 6, 2004, we reasoned that headings 2106 and 3004, HTSUS, 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, 839 F. Supp. 866, 867 (1993). “Principal use” is defined as the use “which exceeds any other single use.” Minnetonka Brands v. United States, 24 C.I.T. 645; 110 F. Supp. 2d 1020; 2000 Ct. Intl. Trade LEXIS 87; Slip Op. 2000-86. “The fact that the merchandise may have numerous significant uses does not prevent… classif[ication of] the merchandise according to the principal use of the class or kind to which the merchandise belongs.” Lenox Coll. v. United States, 20 C.I.T. 194; 18 Int’l Trade Rep. (BNA) 1181; 1996 Ct. Intl. Trade LEXIS 38; SLIP OP. 96-30 (Ct. Int’l Trade 1996).
When applying a “principal use” provision, CBP must ascertain the class or kind of goods which are involved and decide whether the subject merchandise is a member of that class. See 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. See 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. 194; E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (Ct. Intl. Trade 1996). Therefore, the determinative issue in HQ 967075 and HQ 967363 was whether the homeopathic products classified therein belonged to the class or kind of good that was principally prepared for therapeutic or prophylactic use or whether they belonged to the class or kind of good that was principally used as a dietary supplement.
Medicaments principally prepared for therapeutic or prophylactic use in the U.S. are packaged for oral, parenteral, or dermatological administration. The ultimate purchaser expects that the substance will cure their condition or reduce its symptoms. They are 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. They are also 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 that need only be prepared for human consumption. As such, they are simply packaged for oral ingestion as a capsule, tablet, powder or liquid. They are put up in packaging with indications that they maintain general health or well-being, and are often used daily without a strict dosage schedule or time limit recommended. See HQ 967075; HQ 967363; HQ H145541, dated April 4, 2012.
The web page of the Homeopathic Pharmacopeia of the United States (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.
See http://www.hpus.com/whatishomeopathy.php.
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.
Whereas prior CBP rulings once held that the relevant standard in classifying homeopathic products was the ability to detect the presence of the active ingredient, HQ 967075 and HQ 967363 specifically overruled that approach to find that homeopathic products are medicaments within the meaning of heading 3004, HTSUS. Such products must comply with the standards listed in the HPUS. Furthermore, these products 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 also marketed and sold in relation to a disease, condition, or ailment which they purport to treat, and sometimes only by prescription. As a result, HQ 967075 and HQ 967363 found 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.
This reasoning also applies to the homeopathic gum at issue in the present case. It contains specific dosage instructions. It also contains statements regarding the ailments or symptoms they treat, and the concentration of active substances the product contains. It is also sold in relation to the ailment that it is purported to treat. Furthermore, gum is increasingly becoming a form in which to deliver medicaments. For example, motion sickness medications in the form of a gum are being explored because slow release formulations have been found to increase the efficacy of the medication and decrease unwanted side effects. See, e.g., http://www.ncbi.nlm.nih. gov/pubmed/12189776; http://www.medicalnewstoday.com/articles/251638.php. In addition, recent studies show that medicated chewing gum provides advantages over conventional drug delivery, such as high bioavailability, how quickly the medication works when delivered in this form, higher patient compliance because of easy and discreet administration without water, and the pleasant taste of the medication. See, e.g., http://www.slideshare.net/HealthinGum/ medical-uses-of-chewing-gum. Thus, for certain substances that are safe at low and constant dosing, such as motion sickness medication, gum can be a useful delivery method. Homeopathic remedies are exactly this type of medicament, as prior CBP rulings explain. See, e.g., HQ 967075; HQ 967363; HQ H145541. As a result, the subject homeopathic remedies are medicaments, even though gum is not a listed method of delivery in the ENs.
Furthermore, where, as here, the homeopathic remedies in other forms would be classified in heading 3004, HTSUS, their form as a gum does not preclude such classification. This finding is consistent with EN 30.04, which excludes nicotine gums from classification in heading 3004, HTSUS, because nicotine is not a substance which treats a disease or ailment. Therefore, the subject Rescue Remedy Gum, which contains an active ingredient or ingredients officially included in the HPUS, and is 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, is classified in subheading 3004.90.91, 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.” This conclusion is consistent with prior CBP rulings. See, e.g., HQ 967075; HQ 967363; HQ H145541.
HOLDING:
By application of GRI 1, the subject Rescue Remedy Gum is classified in heading 3004, HTSUS, and specifically in subheading 3004.90.91, 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.” The column one, general rate of duty is 6.4% ad valorem.
You are instructed to ALLOW the protest.
In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP 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 International Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division