CLA-2 OT:RR:CTF:TCM H095405 CkG
TARIFF NO: 1302.19.40
Port Director
U.S. Customs and Border Protection
3150 Tchulahoma Road
Suite 1 Memphis, TN 38118
Re: Application for Further Review of Protest No. 2006-09-100916; Devil’s claw
PE 5%
Dear Port Director:
This is our decision regarding the Application for Further Review (“AFR”) of Protest No. 2006-09-100916, filed on behalf of Naturex, Inc. (“Protestant”) on April 4, 2009, against U.S. Customs and Border Protection’s (CBP’s) classification of Devil’s claw PE 5% under the Harmonized Tariff Schedule of the United States (HTSUS).
The entries subject to the protest were entered between March 18, 2009, and June 02, 2009, in subheading 1302.19.91, HTSUS. The entries were liquidated between May 08, 2009, and July 10, 2009, in subheading 1302.19.40, HTSUS.
FACTS:
Devil’s claw PE 5% is an extract of the root of the Devil’s claw plant, harpagophytum procumbens. The main active ingredients in Devil’s claw are Beta Sitosterol and Harpagoside, which studies have shown have anti-inflammatory properties. See e.g., http://www.nlm.nih.gov/medlineplus/print/druginfo/natural/patient-devilsclaw.html. The instant preparation is standardized to 1.5-2.5% Harpagoside. Devil’s claw PE 5% belongs to the NATpharma line of products by Naturex, Inc., which is described in the NATpharma brochure as a line of herbal extracts that covers a broad range of pharmaceutical product applications.
ISSUE:
Whether the instant merchandise is classified in subheading 1302.19.40, HTSUS, as a vegetable extract having anesthetic, prophylactic or therapeutic properties, or in subheading 1302.19.91, HTSUS, as an “other” vegetable extract.
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 and on the rate and amount of duties chargeable. 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) (2007)).
The Port of Memphis properly approved the Application for Further Review of Protest No. 3901-08-100169, because the decision against which the protest was filed involves specific factual and legal questions that have not been the subject of a Headquarters ruling or court decision.
Merchandise is classifiable under the HTSUS in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that classification shall be determined according to the terms of the headings 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 or notes do not require otherwise, the remaining GRIs 2 through 6 may be applied.
The HTSUS provisions under consideration are as follows:
1302: Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products: Vegetable saps and extracts:
1302.19: Other:
Ginseng; substances having anesthetic, prophylactic or therapeutic properties:
1302.19.40: Other…
1302.19.91: Other…
* * * * *
The Explanatory Notes (ENs) to the Harmonized Commodity Description and Coding System represent the official interpretation of the tariff 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).
EN 13.02 provides, in pertinent part, as follows:
The heading covers saps and extracts (vegetable products usually obtained by natural exudation or by incision, or extracted by solvents), provided that they are not specified or included in more specific headings of the Nomenclature…The vegetable saps and extracts of this heading are generally raw materials for various manufactured products. They are excluded from the heading when, because of the addition of other substances, they have the character of food preparations, medicaments, etc.
* * * * *
At GRI 1, there is no dispute that the instant merchandise is described by
and is thus classifiable in heading 1302, HTSUS, as a vegetable extract. At issue is the proper eight-digit classification, which requires the application of GRI 6. GRI 6 requires that the GRI's be applied at the subheading level on the understanding that only subheadings at the same level are comparable.
At the eight-digit subheading level, protestant requests classification of the instant merchandise in subheading 1302.19.91, HTSUS, as an “other” vegetable sap or extract. Protestant claims that the merchandise was incorrectly liquidated by the Port in subheading 1302.19.40, HTSUS, because Naturex’s devil’s claw extract is used only as a dietary ingredient and is not marketed or known to prevent or cure any disease.
Subheading 1302.19.40, HTSUS, provides for, inter alia, substances having anesthetic, prophylactic or therapeutic properties. EN 13.02 further notes that “The vegetable saps and extracts of this heading are generally raw materials for various manufactured products.” Extracts of heading 1302, HTSUS, can therefore be used in a variety of applications. There is no requirement that they have a pre-determined or principal use. Subheading 1302.19.40, HTSUS, is thus an eo nomine, not a principal use provision, which means that for Devil’s claw to be classified in subheading 1302.19.40, HTSUS, it must possess anesthetic, prophylactic or therapeutic properties, but it need not be principally used for these properties. There is thus no requirement that devil’s claw be used to treat any specific condition or illness, nor is it necessary that the importer or anyone else make any such claim. The issue presented is whether devil’s claw possesses such properties.
Therapeutic is defined as "having healing or curative powers." See Lonza, Inc. v. U.S., 46 F. 3d 1098 (Fed.Cir. 1995). The common meaning for prophylactic is "preventative". Webster's Third New International Dictionary defines prophylactic as "(1) guarding from disease: preventing or contributing to the prevention of disease (2) tending to prevent or ward off." Devil’s claw is widely acknowledged as an alternative remedy for joint or back pain due to the claimed anti-inflammatory properties of its active ingredients, Beta Sitosterol and Harpagoside. The instant preparation is standardized to Harpagoside. Several studies have examined the effectiveness of Devil’s claw for a wide variety of uses, including joint pain due to osteoarthritis, back pain, cancer, and as an appetite stimulant. The best evidence was found for its effectiveness in treating osteoarthritis and lower back pain. See e.g., http://www.nlm.nih.gov/medlineplus/print/druginfo/natural/patient-devilsclaw.html; http://www.naturalpedia.com/devils_claw.html; and http://en.wikipedia.org/wiki/ Harpagophytum#cite_note-5. In addition, Devil’s Claw is listed in the Physician’s Desk Reference for herbal medicines, which states that “the medicinal parts are the dried tubular secondary roots and the thick lateral tubers.” It indicates that the “anti-inflammatory, analgesic (and thus anti-arthritic) effect has been shown in animal experiments.”
Protestant acknowledges that “the use of devil’s claw as a traditional remedy is well documented but limited to specific forms, dosages and routes of administration, and does not preclude its use as a non medicinal ingredient.” Protestant cites Warner-Lambert Co. v. United States 341 F. Supp. 2d 1272 (C.I.T. 2004) in support of this argument. However, this case considered only classification in heading 3004, HTSUS, which provides for “medicaments…for therapeutic or prophylactic uses, put up in measured doses…or in forms or packings for retail sale.” Heading 3004, HTSUS, is a principal use provision, and subheading 1302.19.40, HTSUS, is not. Moreover, as the CIT noted in Warner-Lambert, medicaments of heading 3004, HTSUS, must be put up in measured doses and/or have indications as to their use. Classification in subheading 1302.19.40, HTSUS, however, does not require evidence of principle use, suggested dosage, or indications as to use.
Yet, while subheading 1302.19.40, HTSUS, is not a principal use provision, use can nevertheless be taken into consideration as a factor when determining classification in an eo nomine provision. See Myers v. United States, 969 F. Supp. 66, 72-73 (C.I.T. 1997). In the instant case, the NATpharma brochure claims that the NATPharma line of products are designed for pharmaceutical application. The brochure further lists the application of its Devil’s claw extract as treatment of articular pain or digestive disorders. Furthermore, in addition to its popularity for use in humans as an alternative to anti-inflammatory drugs such as Vioxx, Devil’s claw is also commonly used as an anti-inflammatory and analgesic for providing pain relief to horses. See e.g., http://www.equi-therapy.net/equi-therapy/herbal/ devils-claw.shtml; http://www.vetherb.com/library/DevilsClawindepth .html; http://www.smartpakequine.com/health_and_nutrition/diseases_and_conditions /Osteoarthritis.aspx.
There is thus sufficient technical evidence of the therapeutic properties of Devil’s claw extract, as well as evidence of common use of Devil’s claw extract for its therapeutic properties, to classify Devil’s claw PE 5% in subheading 1302.19.40, HTSUS.
HOLDING:
By application of GRIs 1 and 6, Devil’s claw PE 5% is classified in heading
1302, HTSUS, specifically subheading 1302.19.40, HTSUS, which provides for
“Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-
agar and other mucilages and thickeners, whether or not modified, derived from
vegetable products: Vegetable saps and extracts: Other: Ginseng; substances
having anesthetic, prophylactic or therapeutic properties.” The 2009 general,
column one rate of duty is 1%.
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 Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision the Office of 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