CLA-2 RR:CR:GC 962323ptl
Patrick D. Gill, Esq.
Rode & Qualey
295 Madison Avenue
New York, NY 10017
RE: Reconsideration of New York Ruling Letter (NY) D82397; Gingko Biloba Tablets.
Dear Mr. Gill:
This is in response to your letter, dated October 30, 1998, requesting reconsideration of NY D82397, dated October 22, 1998, issued to you on behalf of Warner-Lambert Company, concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Gingko biloba in tablet form. That ruling held that the product should be classified in subheading 2106.90.9998, HTSUS, as food preparations not elsewhere specified or included: other, other, other. You contend that the product is a medicament and should be classified in heading 3004, HTSUS.
In preparing this ruling, we have considered the sample and materials you submitted as well as information presented during a meeting in our office on
November 16, 1999, and your supplemental submission of November 22, 1999.
FACTS:
The product under consideration, “Quanterra? Mental Sharpness” is a Gingko Biloba herbal supplement “extract” in single dose, tablet form, packaged for retail sale in boxes containing 28 tablets per box. Recommended dosage is two tablets per day. According to the text printed on the box, the ingredients are 60 mg. per tablet Gingko biloba (leaves) dried extract with lactose, microcrystalline cellulose, maize starch, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, magnesium stearate, silicon dioxide, artificial color, talc, ferric oxide and dimethicone. According to the label, the Gingko biloba contains a substance referred to as “EGb 761®” which is identified as a “unique proprietary extract.” Language on the box implies that the EGb 761® “promotes and maintains mental sharpness, concentration and focus”, that it “promotes blood circulation and oxygen supply to the brain and extremities” and that it “provides antioxidant protection for the brain and cardiovascular system”. EGb 761® is also purported to “increase alpha activity in the brain which is indicative of improved cognitive performance.” All these claims include the disclaimer required by 21 U.S.C. 343(r)(b) for claims made pursuant to that section, which states: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
ISSUE:
What is the classification of Quanterra? Gingko biloba herbal supplement?
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 generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The HTSUS headings 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:
Medicaments primarily affecting the central nervous
system:
3004.9040 Other.
3004.9090 Other.
In support of your contention that the Gingko biloba tablets should be classified as a medicament, you have provided exhibits of studies and other documents which indicate that herbal substances are used in health care and medical remedies in Europe and elsewhere. A study from Germany has been provided in which researchers argue that Gingko biloba has been demonstrated to have been helpful in treating some patients suffering from peripheral arterial insufficiency.
Your submission also referred to several Customs rulings which classified herbal and vegetable extracts in the statistical subheading of Chapter 13 which provides for “substances having anesthetic, prophylactic or therapeutic properties.” Among the cases cited is NY A83392, issued May 13, 1996, which classified a powder extract of Gingko Biloba, imported in bulk form, in subheading 1302.19.4040, HTSUS, which provides for vegetable saps and extracts which have anesthetic, prophylactic or therapeutic properties. It should be noted that there is no requirement that products of Chapter 13 be used for any particular purpose. The ENs to Chapter 13 state that “[T]he 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.” This exclusionary language makes it clear that the addition of foreign substances and further processing can transform an article of Chapter 13 into an article of any one of several other Chapters. The product under consideration is a totally different commercial entity than that considered in NY A83392. The Gingko biloba tablets are finished products containing “other substances.” It is not Gingko biloba extract raw material. As such, the cited ruling is not precedential for classification of this product.
Since we have determined that the Gingko biloba tablets are not products of Chapter 13, we must determine whether they are food preparations of heading 2106 or medicaments of heading 3004.
When articles are imported into the US, their classification is governed not only by the GRIs, as stated above, but also by the Additional U.S. Rules of Interpretation. Additional U.S. Rule 1(a) provides:
1. In the absence of special language or context which otherwise requires
(a) 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; ... .
Heading 3004, HTSUS, which you suggest is the proper heading for your client’s product is a use heading. This is clear from the language of both the legal text of the tariff (“... products for therapeutic or prophylactic uses...”) and the language contained in the ENs.
On page 468, EN 30.04 states:
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, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use. (Emphasis added)
However, EN 30.04 (b) on page 469, also states, in part, “… the mere indication of pharmaceutical or other degree of purity in not alone sufficient to justify classification in this heading.”
On page 470, EN 30.04 further states:
Moreover, products consisting of a mixture of plants or parts of plants or consisting of plants or parts of plants mixed with other substances, used for making herbal infusions or herbal “ teas ” (e.g., those having laxative, purgative, diuretic or carminative properties), and claimed to offer relief from ailments or contribute to general health and well-being, are also excluded from this heading (heading 21.06).
Referring to The Random House Dictionary of the English Language, unabridged Edition, 1973, on page 890, we find “medicament” defined as “a healing substance; medicine; remedy.” “Therapeutic” is defined, on page 1472, as “of or pertaining to the treating or curing of disease; curative.” “Prophylactic” is defined, on page 1153, as “defending or protecting from disease, as a drug.” “Disease” is defined, on page 411, as “a condition of an organ, part, structure or system of the body in which there is incorrect function resulting from the effect of heredity, infection, diet, or environment; illness; sickness; ailment.”
If the products are to be classified in heading 3004, they must, as indicated by the EN, be used for therapeutic or prophylactic purposes. In determining how a product is used, Customs can look to the packaging and labeling of the product. In this instance, the Gingko biloba packaging states that the product “is designed to work with your body so that you can feel and perform at your best.” The package further states that the product “Promotes and maintains mental sharpness.” These statements, especially when read together with another statement which also appears on the package, “This product is not intended to diagnose, treat, cure, or prevent any disease” indicate that the product is being marketed principally as something to promote general health and well-being and not as a product to be used for its therapeutic or prophylactic properties. Paragraph (16) to EN 21.06, page 172, directs that when goods based on extracts from plants are put up in packagings with indications that they maintain general health or well-being, they should be classified in heading 2106.
Further evidence that these products are not medicaments intended for therapeutic or prophylactic use is provided by the fact there is no recommended duration after which the consumer should stop taking the product and seek medical attention, as there is with medicaments. The implication is that these products can be taken indefinitely by the consumer. The product does not attempt to cure or prevent a particular disease or ailment.
Because the product contains parts of plants mixed with other substances and is used to promote general health and well-being, in accordance with the language of EN 30.04, it is not a medicament of heading 3004, HTSUS, but rather a food supplement of heading 2106, HTSUS.
In earlier rulings, Customs has classified herbal supplements which were marketed as nutritional supplements in Chapter 21, HTSUS. In HQ 953679, issued February 1, 1994, HQ 085492, issued October 20, 1989, and HQ 960607, issued July 31, 1998, Customs classified a variety of herbal supplement products containing herb and plant extracts (and also containing added excipients and/or other substances, as do the instant articles) which had been put up for retail sale in heading 2106, HTSUS.
The language of Additional U.S. Rule 1(a) provides that goods are to be classified as they are to be used in the U.S. In the U.S., the introduction into commerce, labeling and use of foods, drugs and medicaments is governed by the Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C.A. 301 et seq.). Although it is well established that while statutes, regulations and administrative interpretations not related to tariff purposes are not determinative of Customs classification disputes, because of Additional U.S. Rule 1(a), Customs may refer to them to assist in determining the use of goods in the U.S.
Section 321 of the FD&C Act (21 U.S.C.A. 321) contains definitions of terms used in that Act. Section 321(g) defines the term “drug” for purposes of the FD&C Act and states:
(g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph. A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343 (r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or labeling contain such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
Section 321(ff) defines the term “dietary supplement.” The term “dietary supplement” means, among other things, a product (other than tobacco) intended to supplement the diet that contains one or more of certain dietary ingredients, such as a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of the preceding ingredients. Section 321(ff) further limits the term dietary supplement to mean products that are intended for ingestion in a form described in 21 U.S.C. 350(c)(1)(B)(I) (i.e., tablet, capsule, powder, softgel, gelcap, and liquid), that are not represented as conventional food, or as the sole item of a meal or of the diet, and that are labeled as dietary supplements.
Section 321 further states that: “Except for purposes of paragraph (g) [of 21 U.S.C. 321], a dietary supplement shall be deemed to be a food within the meaning of th[e] [act].” 21 U.S.C. 321(ff). Therefore, the language of the FD&C Act clearly states that dietary supplements are foods.
Ginkgo biloba tablets are clearly dietary supplements within the meaning of the FD&C Act. First, the product contains ingredients defined in 21 U.S.C. 321(ff) and is labeled as a dietary supplement in accordance with 21 U.S.C. 321(ff)(2)(C) and 21 CFR 101.3(g). Second, the label bears nutrition labeling in accordance with the mandatory dietary supplement requirements in 21 CFR 101.36. Third, the label bears claims made pursuant to 21 U.S.C. 343(r)(6), including the mandatory disclaimer required for claims made under the authority of that section. Only dietary supplements are eligible to bear claims on their label under the authority of 21 U.S.C. 343(r)(6). Fourth, the label bears no claims that evidence that the product is intended for use as a drug within the meaning of 21 U.S.C. 321(g). Because these tablets are dietary supplements under the FD&C Act, they are also foods under the FD&C Act. Congress, in enacting the Dietary Supplement Health and Education Act of 1994 (21 U.S.C. 301 note) (DSHEA), established that articles such as the Gingko biloba tablets are to be regulated by the FDA as foods and not as drug products.
While classifying products based solely upon labeling in compliance with FDA regulations would be an abuse of discretion, Customs cannot arbitrarily ignore the actions and intent of Congress embodied in the DSHEA. When the DSHEA and EN 30.04 are read together, it is clear that both are referring to the same product. By independently applying the DSHEA and the HTSUS, the FDA and Customs can reach the same conclusion regarding the character and use of the product.
Counsel has cited other rulings in which Customs relied, in part, upon scientific studies when it classified products in heading 3004, HTSUS. However, the products classified in those rulings were expressly designed and prepared to be used to treat or prevent specific conditions or ailments. The Gingko biloba tablets under consideration claim to have been formulated to address the consumer’s overall mental and physical well being and not to cure or heal any particular disease or ailment.
For the above reasons, the Gingko biloba herbal supplements were properly classified by NY D82397 in heading 2106, HTSUS, as food preparations not elsewhere specified or included: other, other, other, other, other, other, other.
HOLDING:
“Quanterra? Mental Sharpness,” a Gingko biloba herbal supplement “extract” in single dose, tablet form, packaged for retail sale is classified in subheading 2106.90.9998, HTSUS, which provides for food preparations not elsewhere specified or included: other, other, other, other, other, other, other.
NY D82397, issued October 22, 1998, is affirmed.
Sincerely,
John Durant, Director
Commercial Rulings Division