CLA-2:OT:RR:CTF:TCM H253927 ERB
Port Director
John F. Kennedy International Airport
U.S. Customs and Border Protection
Building #77
Jamaica, NY 11430
Attn: Amy Berkitt, Import Specialist
RE: Application for Further Review of Protest No. 4701-13-100387; Tariff Classification of Ergocalciferol Capsules
Dear Port Director:
This is in response to the Application for Further Review (AFR) of Protest Number 4701-13-100387, timely filed by Swiss Caps AG (Swiss Caps) on December 13, 2013. This protest involves eleven (11) entries made between 2012 and 2013 of Ergocalciferol Capsules, under the Harmonized Tariff Schedule of the United States (HTSUS). Our response follows.
FACTS:
The Ergocalciferol capsules at issue are a mixture of Ergocalciferol, soybean oil, gelatin, glycerol, water, and coloring. They are imported in bulk in 1.25mg doses, or 50,000 international units (IU).
Swiss Caps originally entered the subject merchandise under heading 2936, HTSUS, which provides for pro-vitamins, but it was later rate advanced by the Port of John F. Kennedy International Airport, and reclassified under heading 2106, HTSUS, which provides for food preparations. Swiss Caps filed this Protest arguing that Ergocalciferol capsules in 50,000 IU strength are not a food supplement of heading 2106, HTSUS, but rather are a medicament of heading 3004, HTSUS, because they are available by prescription only and must be administered under the supervision of a medical doctor.
ISSUE:
Whether the subject Ergocalciferol capsules, imported in bulk in 1.25mg doses (50,000 IU) are classified under heading 2106, HTSUS, which provides for food preparations, or in heading 3004, HTSUS, as a medicament.
LAW AND ANALYSIS:
Initially, we note that the 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 for entries made on or after December 18, 2004. (Miscellaneous Trade and Technical Corrections Act of 2004, Pub. L. 108-429, §2103(2)(B)(codified as amended at 19 U.S.C. §1514(c)(3)(2006)).
Further Review of Protest Number 4701-13-100387 is properly accorded to the Protestant pursuant to 19 C.F.R. §174.24(b), because the decision against which the protest was filed is alleged to involve questions of law or fact which have not been ruled upon by the Commissioner or Customs or his designee or by Customs Courts. Specifically, Protestant argues that the subject merchandise is a prescription medication and not a food supplement, and should be classified as such.
Classification under the 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:
2106 Food preparations not elsewhere specified or included:
2106.90 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 the form of packings for retail sale:
3004.50 Other medicaments containing vitamins or other products of heading 2936:
3004.50.40 Containing vitamins synthesized wholly or in part from aromatic or modified aromatic industrial organic compounds
3004.50.50 Other:
3004.90 Other:
3004.90.91 Other
Chapter 30 covers pharmaceutical products. Note 1(a) to Chapter 30 states:
This chapter does not cover:
Food or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters (section IV).
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 EN 30.04 provides 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…, capsules, cachets, drops or pastilles, … ready for taking as single doses for therapeutic or prophylactic use.
We note that heading 3004, HTSUS, which includes pharmaceutical products, excludes food supplements containing vitamins or mineral salts which are put up for the purpose of maintaining health or well-being, but which have no indication as to use for the prevention of treatment of any disease or ailment. See Headquarters Ruling (HQ) H08300, dated September 19, 1990.
Ergocalciferol is vitamin D. The recommended daily allowance of vitamin D is around 600 IU. This is well below the 50,000 IU, per capsule, being imported here. A search of the U.S. Food and Drug Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations online query of prescription drugs verifies that Ergocalciferol capsules with an application number identical to the subject merchandise, A040833, is listed as a prescription and approved as of May 20, 2009. Ergocalciferol capsules in doses of 50,000 IU are available by prescription only for the treatment of a vitamin D deficiency, osteomalacia or rickets. It is, therefore, classified as a medicament, of heading 3004, HTSUS, distinguishable from food supplements of heading 2106, HTSUS, by dose, method of administration, and use in the treatment of disease. Specifically, the subject merchandise is a medicament containing vitamin D, a vitamin product of heading 2936, HTSUS. It is thus described by the terms of subheading 3004.50, HTSUS, as “containing vitamins” of that heading. As such, it cannot be classified in the basket provision, subheading 3004.90, HTSUS.
At the eight digit level, Ergocalciferol is not an aromatic product, nor is it synthesized from aromatic or modified aromatic sources described by Additional U.S. Note 2 to Section VI. Thus it is not described by the terms of subheading 3004.50.40, HTSUS, and falls instead in subheading 3004.50.50, HTSUS.
HOLDING:
By application of GRI 1, the subject Ergocalciferol capsules are specifically provided for in subheading 3004.50.50, HTSUS, which provides for, “Medicaments… 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 of packings for retail sale: Other medicaments containing vitamins or other products of heading 2936: Other.” You are instructed to GRANT the protest.
In accordance with Sections IV and VI of the CBP/Protest Petition Processing Handbook, you are to mail this decision, together with the CBP Form 19, to the protestant no later than 60 days from the date of the 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 Regulations and Rulings of the Office of International Trade 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