CLA-2 RR:CR:GC 965055 RFA
Port Director
U.S. Customs Service
BLDG #77 Jamaica, NY 11430
RE: Protest 1001-01-100376; ENADA- NADH; Tablets put up in Blister Form; Vitamins and their Derivatives; Other Medicaments; Food Preparations Not Elsewhere Specified or Included
Dear Port Director:
The following is our decision regarding Protest 1001-01-100376, which concerns the classification of ENADA- NADH put up in tablet form on blister strips under the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
ENADA, which is a brand name for a substance scientifically known as NADH (“Nicotinamide adenine dinucleotide hydride”) consists of 5 mg tablets, put up in retail sale packages. The package describes the product as an energizing coenzyme dietary supplement that improves cellular energy, elevates mental clarity, improves alertness and concentration. All of these claims are qualified by the disclaimer required by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994 (Pub.L. 103-417) which states on the back of the package: “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.”
The merchandise was entered under subheading 2936.29.50, HTSUS, as vitamins and their derivatives. In the alternative, the protestant claims
classification under subheading 3004.50.50, HTSUS, as other medicaments. The entries were liquidated on October 27, 2000, under subheading 2106.90.99, HTSUS, as food preparations not elsewhere specified or included. The protest was timely filed on January 25, 2001.
The HTSUS subheadings under consideration are as follows:
2106.90.99: Food preparations not elsewhere specified or included: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther. . . .
Goods classifiable under this provision have a general, column one rate of duty of 6.4 percent ad valorem.
2936.29.15 Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives there used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent: [v]itamins and their derivatives, unmixed: [o]ther vitamins and their derivatives: [f]olic acid: [n]iacin and niacinamide. . . .
Goods classifiable under this provision have a general, column one rate of duty of free.
3004.50.50 Medicaments. . . consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: [o]ther medicaments containing vitamins or other products of heading 2936: [o]ther. . . .
Goods classifiable under this provision have a general, column one rate of duty of free.
ISSUE:
Whether the ENADA-NADH is classifiable as vitamins and other derivatives, or as medicaments put up in measured doses or in forms or packings for retail sale, or as other food preparations not elsewhere specified or included under the HTSUS?
LAW AND ANALYSIS:
Classification of merchandise under the HTSUS is in accordance with the General Rules of Interpretation (GRI's). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative section or chapter notes.
Counsel for the protestant claims that the subject merchandise is classifiable in heading 2936, HTSUS, as vitamins and other derivatives. Specifically, counsel states that: “NADH is a substance associated with the normal function, maintenance and efficiency of the human body. Particularly it functions as fuel for cellular energy production and plays a key role in DNA and cell damage repair. NADH is a coenzyme form of a vitamin (Niacinamide) and is used by the body as such.” In support of this position, counsel cites to NY D88971, dated April 4, 1999, in which Customs classified a coenzyme that constitutes the metabolically active form of Vitamin B12 in heading 2936. Based on this ruling, counsel believes that because NADH functions as a coenzyme it should be classified under heading 2936.
However, to be classified within heading 2936, the subject merchandise must not be excluded by any legal note. Legal Note 1(a) to Chapter 29 provides that the headings to this chapter apply only to: “separate chemically defined organic compounds, whether or not containing impurities”. The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the official interpretation of the HTSUS. While not 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 FR 35127, 35128 (August 23, 1989). The General EN (A) to Chapter 29, page 1346, states in pertinent part that: “[s]eparate chemically defined compounds containing other substances deliberately added during or after their manufacture (including purification) are excluded from this Chapter.”
According to the information provided, each ENADA tablet consists of a formulated mixture, containing by weight 10% NADH and the remaining 90% are “inert” ingredients. While NADH may be considered a coenzyme, the ENADA tablet as a whole does not meet the terms of Legal Note 1(a) to Chapter 29, because it has other substances deliberately added during its manufacture. Therefore, classification under heading 2936 is precluded.
In the alternative, counsel claims classification under heading 3004 as a medicament consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale, because of the product’s therapeutic uses. EN 30.04, page 571, states that:
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. (Emphasis added)
However, EN 30.04 (b) on page 571, also states, in pertinent part: “… the mere indication of pharmaceutical or other degree of purity in not alone sufficient to justify classification in this heading.”
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.” See HQ 962364, dated February 3, 2000.
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 package describes the product as an energizing coenzyme dietary supplement that improves cellular energy, elevates mental clarity, improves alertness and concentration. 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.
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. Therefore, we find that the ENADA is not a medicament within the meaning of heading 3004 and is precluded from classification within this heading. Heading 2106 provides for food preparations not elsewhere specified or included. As no other heading describes the ENADA, we find it is classified in Heading 2106.
HOLDING:
For the foregoing reasons, the ENADA is classifiable under subheading 2106.90.99, which provides for: “[f]ood preparations not elsewhere specified or included: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther. . . .” Goods classifiable under this provision have a general, column one rate of duty of 6.4 percent ad valorem.
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,
Myles B. Harmon, Acting Director
Commercial Rulings Division