Remifemin®; Application for Further Review of Protest 3701-06-100009

HQ W968402 January 8, 2009 CLA-2 OT:RR:CTF:TCM W968402ARM CATEGORY: CLASSIFICATION TARIFF NO.: 2106.90.99 Port Director Port of Milwaukee U.S. Customs and Border Protection P.O. Box 370920Milwaukee, WI 53237 RE: Remifemin®; Application for Further Review of Protest 3701-06-100009 Dear Port Director: The following is our decision regarding the Application for Further Review of Protest 3701-06-100009, timely filed on May 19, 2006, regarding the classification of Remifemen®, under the Harmonized Tariff Schedule of the United States (HTSUS). FACTS: The instant merchandise consists of containers of 40 tablets packaged as “Physician’s samples,” composed of 1.4% black cohosh, 69.8% lactose monohydrate, 23.2% powdered cellulose, 5% potato starch, 0.5% magnesium stearate and natural peppermint flavor, which are marketed as a dietary supplement for relief from hot flashes, night sweats and mood swings under the name “Remifemin®”. The product label includes the following: The natural, safe alternative to hormone replacement therapy (HRT) for menopausal symptoms.* With RemiSureTM Black Cohosh Unique - Exclusive, standardized extract, subject of over 90 scientific papers. Proven to be safe and effective.* Safe - . . . . Effective - Recent clinical study shows 70% reduction in hot flashes, night sweats, mood swings, irritability, and related occasional sleeplessness.* *THIS STATEMENT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE. * * * * * * Supplement Facts Serving Size 1 tablet Amount per tablet Black Cohosh Extract (Root and Rhizome) Equivalent to 20mg** **Daily Value not established. Recommendations: One tablet in the morning and one tablet in the evening, with water. You can expect to notice improvements within a few weeks, with full benefits after using Remifemin twice daily for 4-12 weeks. The disclaimer on the label above that “This product is not intended to diagnose, treat, cure, or prevent any disease,” indicates that the product is marketed in accordance with the Dietary Supplement Health and Education Act of 1994 (21 U.S.C. 301 note) (DSHEA). The Physician’s Desk Reference for Nonprescription Drugs & Dietary Supplements, 2003 edition, states, in pertinent part, under its entry for Remifemin Menopause: Remifemin Menopause is drug free and estrogen free. And it is brought to you from a world-renowned health care company. . . . Remifemin Menopause is a natural herbal supplement, not a drug. It will take time for your body’s cycles to respond to its gentle onset. . . . If you do not find any difference in your well being after 12 weeks, please consult your physician to discuss other options. The protest covers two entries made on July 13, and August 10, 2005, entered under heading 3004, HTSUS, which provides for medicaments . . . consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses . . . .” U.S. Customs and Border Protection (“CBP”) liquidated the merchandise on February 10, 2006, in heading 2106, HTSUS, which provides for “food preparations not elsewhere specified or included . . . .” Protest 3701-06-100009 was timely filed on May 19, 2006. ISSUE: What is the correct classification of Remifemin® tablets under the HTSUS? LAW AND ANALYSIS: 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 first entry for entries made on or after December 18, 2004.  (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. 3701-06-100009 was properly accorded to Protestant pursuant to 19 C.F.R. § 174.24 because the classification of the merchandise at issue is alleged to involve questions of law or fact not previously considered or ruled upon by the commissioner of Customs, his designee or the Customs courts. Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context which requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes. GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. The HTSUS provisions under consideration are the following: 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: 3004.90 Other: 3004.90.91 Other. In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989). EN 21.06 states, in pertinent part, the following: Provided that they are not covered by any other heading of the Nomenclature, this heading covers : (A) Preparations for use, either directly or after processing (such as cooking, dissolving or boiling in water, milk, etc.), for human consumption . . . . . . . . Preparations, often referred to as food supplements, based on extracts from plants, fruit concentrates, honey, fructose, etc. and containing added vitamins and sometimes minute quantities of iron compounds. These preparations are often put up in packagings with indications that they maintain general health or well-being. Similar preparations, however, intended for the prevention or treatment of diseases or ailments are excluded (heading 30.03 or 30.04). EN 30.04 states, in pertinent part, the following: This heading covers medicaments consisting of mixed or unmixed products, provided they are: 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, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use. . . . . The heading applies to such single doses whether in bulk, in packings for retail sale, etc.; or (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. Both headings of the HTSUS under consideration are principal use provisions. Additional U.S. Rule of Interpretation 1(a) requires that "a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use." 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. (citations omitted). “Principal use" is defined as the use "which exceeds any other single use." (citations omitted). 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. (citations omitted). E.M. Chems. v. United States, 20 C.I.T. 382, 387-388 (Ct. Int'l Trade 1996). As stated in United States v. The Carborundum Company, 63 CCPA 98, C.A.D. 1172, 536 F.2nd 373 (1976), certain factors must be looked at to determine whether imported merchandise is of a certain "class or kind" as that expression is used in Additional U.S. Rule of Interpretation 1(a). These factors include: (1) the physical characteristics of the merchandise, (2) the expectation of the ultimate purchases, (3) the channels of trade of the merchandise, (4) the environment of the sale (accompanying accessories, manner of advertisement and display) (5) use in the same manner as merchandise which defines the class, (6) the economic practicality of so using the import, and (7) recognition in the trade of this use. Before applying these factors, we note that in Warner-Lambert Company v. United States, 28 Ct. Intl. Trade 939; 341 F. Supp. 2d 1272; (Ct. Intl. Trade, June 21, 2004), the court examined the nature of medicaments of heading 3004, HTSUS, by examining the connection between a dose and therapeutic or prophylactic properties. The court stated “A measured dose is not merely a certain amount; it should contemplate an effect there from. Hence, the dose must be viewed as a way to link the properties of a substance with that effect.” Id. at 949, 1280. Based on this reasoning, the court found that the mere fact of a lozenge containing a certain amount of vitamin C did not make the lozenge a medicament of heading 3004, HTSUS. We apply the Carborundum factors as follows: (1) The general physical characteristics of the merchandise: The instant merchandise consists of tablets put up in bottles. The tablets contain extract of black cohosh standardized to be 20 mg per tablet, as well as other ingredients. Both medicaments and dietary supplements physically consist of tablets containing an active standardized ingredient and excipients. The evidence pertaining to this factor is inconclusive as between headings 2106 and 3004, HTSUS. (2) The expectation of the ultimate purchasers: The product is used as an alternative to hormone replacement therapy. The labeling claims that it is not a drug or hormone in itself. [T]he labeling of a product as a dietary supplement is not determinative of its tariff classification. . . . (quoting Inabata Specialty Chemicals v. United States, 29 Ct. Int'l Trade, 366 F. Supp. 2d 1358, 1363-64 (2005) (citations omitted) . . . . However, to say that FDA labeling requirements are not controlling is not to say that they are irrelevant. For example, labeling a product as a "dietary supplement" certainly has an effect on consumers' expectations of that merchandise. Maxcell Bioscience, Inc. v. United States, 533 F. Supp. 2d 1261, 1270 (Ct. Int'l Trade 2007). The ultimate purchaser expects relief from menopausal symptoms such as “hot flashes, night sweats, mood swings, irritability and related occasional sleeplessness” eliminating the need for hormone replacement therapy. But the ultimate purchaser’s expectation of these results would be mediated by the disclaimer that “this product is not intended to diagnose, treat, cure, or prevent any disease,” and that the statement of safety, efficacy, and ability to decrease any menopausal symptoms “ . . . has not been evaluated by the Food and Drug Administration.” Hormone replacement tablets, that contain actual hormones, are classified in heading 3004. Likewise, a homeopathic liquid preparation for menopausal symptom relief using a specific concentration of active ingredient and packaged in accordance with The Federal Food Drug and Cosmetic Act ("FFDCA")(21 U.S.C. §§301 et seq) as a drug recognized in the official Homoeopathic Pharmacopoeia of the United States was classified in heading 3004 (see HQ 964494, dated August 28, 2002). However, dietary supplements for the relief of peri-menopausal symptoms are classified in heading 2106 (see HQ 966771, dated September 15, 2004). While protestant notes that the general health and well-being claims on that product are not repeated on the packaging of Remifemin, both products contain the disclaimer language on the prevention of disease. Coupled with claims to reduce mood swings and irritability, the message in toto is that the product will contribute to general well-being amongst women of a certain age. (3 & 4) The channels of trade in which the merchandise moves and environment of sale: The instant merchandise is distributed by Enzymatic Therapy, Inc., a “world-renowned health care company” which sells, dietary supplement capsules and tablets such as CoQ10, flax oil, DHEA, vitamin B12, all of which have been classified under heading 2106 (see HQ N007593, dated March 2, 2007, NY L80521, dated November 8, 2004, NY I88871, dated December 9, 2002, and NY L81778, dated January 20, 2005). The merchandise is sold over the counter in the dietary supplement section of grocery stores and pharmacies. Furthermore, “health care” companies specifically do not produce or sell pharmaceuticals or medicaments. Rather, pharmaceutical companies produce and sell these products. Accordingly, the evidence pertaining to this factor indicates that the merchandise should be classified in heading 2106, HTSUS. (5) The usage of the merchandise: The merchandise is used as an alternative to hormone replacement therapy. However, while the black cohosh extract is standardized, the daily recommended dosage is not established (see label). Remifemin® is listed in Physicians’ Desk Reference (PDR) for Nonprescription Drugs and Dietary Supplements™. Here, the tablets contain a certain amount of black cohosh, but the dosing is not established and does not constitute a “measured dose” under Warner-Lambert. The suggested use of the merchandise is one pill twice a day. This type of dosing instruction is commonly seen on dietary supplement packaging. In fact, the PDR monograph states that because the product is not a drug, it will take time for your body’s cycles to respond to its “gentle onset” and that if there is no difference in “well being” to consult a physician to discuss other options. The evidence regarding this factor weighs toward classification in heading 2106, HTSUS. (6) The economic practicality of so using the import: We do not have sufficient information to evaluate this factor. (7) The recognition in the trade of use: The products contains food products such as lactose monohydrate, powdered cellulose, and potato starch as well as the active ingredient black cohosh. It is recognized and used in the trade as an alternative to hormone replacement therapy, and is specifically referred to as a dietary supplement or herbal supplement. (See, eg. www.enzy.com, www.remifemin.com). On the balance, we find that the merchandise belongs to the class or kind of goods known as dietary supplements which are classified as food preparations of heading 2106, HTSUS. Specifically, Remifemin® tablets are classified in subheading 2106.90.99, HTSUS, the provision for "Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other." HOLDING: On application of GRI 1, Remifemin® tablets are classified in heading 2106, HTSUS. Specifically, the merchandise is classified in subheading 2106.90.99, HTSUS, the provision for: "Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other." The 2006 column one, “General” duty rate is 6.4% ad valorem. Duty rates are provided for the protestant’s convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov. Since the rate of duty is the same as the liquidated rate, you are instructed to deny the protest in full. 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.  Sixty days from the date of this letter, the Office of International Trade will make this letter 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