CLA-2: OT: RR: CTF: TCM: ERB
Ms. Lisa Crosby
Sidley Austin, LLP
1501 K Street, NW
Washington DC 20005
RE: Revocation of N209720 dated April 9, 2012; BOTOX® Cosmetic
Dear Ms. Crosby:
This letter is in response to Allergan Inc.’s (Allergan) request for reconsideration, dated July 2, 2012, made on Allergan’s behalf by you as Allergan’s counsel referencing New York Ruling Letter (NY) N209720, dated April 9, 2012, concerning the tariff classification of BOTOX® Cosmetic (onabotulinumtoxinA). We have reviewed NY 209720 and found it to be incorrect. Accordingly for the reasons set forth below, we are revoking that ruling.
Pursuant to section 625(c), Tariff Act of 1930 (19 U.S.C. 1625(c)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), this notice advises interested parties that Customs and Border Protection (CBP) is revoking a ruling concerning the classification of BOTOX® Cosmetic, under the Harmonized Tariff Schedule of the United States (HTSUS). Similarly, CBP is revoking any treatment previously accorded by CBP to substantially identical transactions. Notice of the proposed revocation was published on April 30, 2014 in Volume 48, Number 17, of the Customs Bulletin. No comments were received in response to the proposed notice.
BOTOX® (onabotulinumtoxinA) Purified Neurotoxin Complex, is approved by the Food and Drug Administration (FDA) and marketed for the treatment of cervical dystonia (a neurological disorder that causes neck spasms), strabismus (eyes do not face the same direction), blepharospasm associated with dystonia (a disorder which causes involuntary eye spasms), overactive bladder due to incontinence, and to prevent headaches in adults with chronic migraines, among other ailments.
BOTOX® Cosmetic (onabotulinumtoxinA) is an identical compound approved by the FDA to be injected into facial muscles to temporarily improve the look of moderate to severe frown lines between the eyebrows. Both products are prescription drugs, diluted for administration by a doctor, via injection, which is described in the FDA-approved prescribing and packaging information that accompanies the products. The contents of the vials and the dosage amounts are the same for both products. The only difference between the two products is the FDA labeling requirements.
Currently, BOTOX® is classified in 3002.90.51, HTSUS, which provides for “Human blood; …; vaccines, toxins, cultures, micro-organisms (excluding yeasts) and similar products: Other; Other: Other. BOTOX® Cosmetic is classified in 3304.99.50, HTSUS, which provides for Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations.
FACTS:
Each vial of BOTOX® contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative. Each vial of BOTOX® Cosmetic contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; or 100 units of Clostridium botulinum type A neurotoxin, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride n a sterile, vacuum-dried form without a preservative.
Both products are intramuscular injections of a form of botulinum toxin type A, (onabutulinumtoxinA) designed to harness the deleterious effect of the toxin to reduce muscle activity upon absorption by the muscles. This reduction in muscle activity will reduce the appearance of lines and wrinkles when injected between the eyebrows but it will also, for example, reduce or dull migraine headache symptoms when injected around the head and neck, or calm neck shoulder twitches caused by certain neurological disorders, when injected into the shoulders.
ISSUE:
Whether BOTOX® Cosmetic, an identical chemical compound to BOTOX®, but marketed under different names for different uses should be classified under heading 3002, HTSUS, as a toxin or under heading 3304, HTSUS, as a beauty or make-up preparation or preparation for the care of the skin?
LAW AND ANALYSIS:
Classification of goods under the HTSSU 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 GRI may then be applied. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs 1 through 5.
The HTSUS provisions under consideration are as follows:
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: [Emphasis added]
3304 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations:
Proper classification requires analysis as to whether any Section or chapter Notes exclude the product from heading 3002. Note 1 to chapter 30, HTSUS, states, in pertinent part:
This chapter does not cover:
(e) Preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties; …
The Harmonized Commodity Description and Coding System Explanatory Note (ENs) constitute the official interpretation of the Harmonized System. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127 (Aug. 23, 1989).
The EN to heading 30.02 states, in pertinent part:
This heading covers:
(D) Vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products. [Emphasis added]
These products include:
(2) Toxins (poisons), toxoids, crypto-toxins and anti-toxins.[Emphasis added]
The EN to heading 33.04 stats, in pertinent part:
Beauty or make-up preparations and preparations for the care of the skin, including sunscreen or sun tan preparations.
This part covers:
(3) Other beauty or makeup preparations and preparations for the care of the skin (other than medicaments), such as: face powders (whether or not compressed), baby powders (including talcum powder, not mixed, not perfumed, put up for retail sale), other powders and grease paints; beauty creams, cold creams, make-up creams, cleaning creams, skin foods (including those containing bees’ royal jelly) and ski tonics or body lotions; petroleum jelly, put up in packages of a kind sold by retail for the care of the skin; barrier creams to give protection against kin irritants; injectable intracutaneous gels for wrinkle elimination and lip enhancement (including those containing hyaluronic acid); anti-acne preparations (other than soaps of heading 34.01) which are designed primarily to cleanse the skin and which do not contain sufficiently high levels of active ingredients to be regarded as having a primary therapeutic or prophylactic effect against acne; toilet vinegars which are mixtures of vinegars or acetic acid and perfumed alcohol.
Thus, we begin our analysis determining whether BOTOX® Cosmetic is prima facie classified under heading 3304, HTSUS.
BOTOX® Cosmetic, as well as its identical sister-product BOTOX®, contain botulinum type A neurotoxin complex, albumin human, and sodium chloride. In layman’s terms, that is a mixture comprised of a toxin with small amounts of a protein and salt. At the outset, we must determine if the subject mixture is also a “preparation” as it is understood by the HTSUS.
The term “preparation” is not defined in the HTSUS, but “To assist…in ascertaining the common meaning of a tariff term, the court may rely upon its own understanding of the terms used, and it may consult lexicographic and scientific authorities, dictionaries, and other reliable information sources.” Brookside Veneers, Ltd. v. United States, 847 F.2d 786, 789, 6 Fed. Cir. 121, 125 (Fed. Cir) cert. denied, 488 U.S. 943 (1988). CBP has previously done exactly that with the term “preparation” and have determined that the relevant definition of “preparation,” found in the Oxford English Dictionary, 2281 (compact ed. 1987), is “6. A substance specially prepared or made up for its appropriate use or application, e.g., as food or medicine, or in the arts or sciences.” Further, Webster’s Third New International Dictionary, 1790 (unabridged 1986), states: “5. Something that I prepared: something made, equipped, or compounded for a specific purpose.” In the Random House Unabridged Dictionary 2d ed. (1993) “preparation” is, in pertinent part: “5. Something prepared, manufactured or compounded: a special preparation for sunbathers.” Taking these definitions and usages together, it is clear that each specifically indicate that a “preparation” is something prepared for a designated purpose or items put up together for a specific use. Thus, under the common meaning of the term, the subject merchandise is something created for a specific purpose and is a “preparation” as it is understood by the HTSUS.
That said the terms of heading 3304, HTSUS, provide for beauty and make-up preparations, and preparations for the care of the skin. Goods of this heading must be substances made for the specific purpose of beautifying or caring for the user’s skin, understood to be the natural outer layer or tissue on the human body. So our analysis next turns to whether the subject merchandise is a beauty preparation or a make-up preparation or a preparation for the care of the skin.
The exemplars in (A)(3) to heading 33.04, HTSUS, are all products used to enhance, clean, change, or improve the outer appearance, texture or appeal of the user’s skin. “Beauty” and “make-up” or cosmetics are not defined in the HTSUS. However, Merriam-Webster defines these concepts as: (1) of, relating to, or making for beauty especially of the complexion; (2) done or made for the sake of appearance: as (a) correcting defects especially of the face. Without getting into whether wrinkles are beautiful in the eye of the beholder, BOTOX® Cosmetic is not a “beauty product” because it does not necessarily “beautify” the user by enhancing or reacting with the user’s skin. Neither is it “make-up” as it is understood by the exemplars of EN (A)(3), as the powders, creams, lotions or jellies listed are applied topically to enhance, augment, improve or change the user’s skin so as to create a different outward appearance. BOTOX® Cosmetic is not applied topically to the skin at all. It is not created for or marketed for the care of the skin. It does not have a direct effect on the skin itself. The product is injected intramuscularly, or into the muscles, where the toxic effects are experienced upon absorption. In the case of BOTOX® Cosmetic, those effects include the softening of the muscles which may give the appearance that wrinkles in the skin are lessened. As such, the subject merchandise is not a beauty or make-up preparation or preparation for the care of the skin, as is described by EN (A)(3) and heading 33.04, HTSUS.
Furthermore, CBP has already distinguished between similar products that are instructive in the instant case. In NY R04609, dated September 5, 2006, CBP determined that Juvéderm™ Dermal Filler, a sterile gel implant put up in pre-filled syringe containing a viscoelastic, transparent hyaluronic acid gel, designed and meant to be injected into the skin, is a skin care preparation indicated for use in the correction of facial wrinkles, acne scars and other soft issue contour deformities, and it is classified under heading 3304, HTSUS. It is also specifically provided for in EN (A)(3) as an “injectable intracutaneous gel for wrinkle elimination and lip enhancement (including those containing hyaluronic acid).” Contrast that item with the subject merchandise in NY N111260, dated July 6, 2010, where CBP classified Xeomin® a highly purified botulinum neurotoxin type A, intended for intramuscular injection for the treatment of cervical dystonia and blepharospasms in adults, under heading 3002, HTSUS. The subject merchandise in NY N111260 contains the same type of toxin as BOTOX® Cosmetic.
Thus, BOTOX® Cosmetic is not prima facie “beauty or make-up preparation, or a preparation for the care of the skin.” Pursuant to GRI 1, it is not classifiable in heading 3304, HTSUS, and thus is not excluded from heading 3002, HTSUS by Note 1 to that chapter. BOTOX® Cosmetic is an intramuscular injection of a toxin and is properly classified in heading 3002, HTSUS.
HOLDING:
Under the authority of GRI 1 via Note 1 to Chapter 30, HTSUS, and EN 30.02 and EN 33.04 the subject BOTOX® Cosmetic is a toxin and properly classifiable under subheading 3002.90.51, HTSUS. The duty rate is free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the internet at www.usitc.gov/tata/hts/.
EFFECT ON OTHER RULINGS:
NY 209720, dated April 9, 2012, is REVOKED.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division