407 F.3d 1207 (Fed. Cir. 2005), 04-1489, Warner-Lambert Co. v. United States

Docket Nº:04-1489.
Citation:407 F.3d 1207
Party Name:WARNER-LAMBERT COMPANY, Plaintiff-Appellant, v. UNITED STATES, Defendant-Appellee.
Case Date:May 11, 2005
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1207

407 F.3d 1207 (Fed. Cir. 2005)

WARNER-LAMBERT COMPANY, Plaintiff-Appellant,


UNITED STATES, Defendant-Appellee.

No. 04-1489.

United States Court of Appeals, Federal Circuit

May 11, 2005

Page 1208

Patrick D. Gill, Rode & Qualey, of New York, New York, argued for plaintiff-appellant. Of counsel on the brief were John S. Rode and Eleanore Kelly-Kobayashi.

Bruce N. Stratvert, Attorney, International Trade Field Office, Commercial Litigation Branch, Civil Division, United States Department of Justice, of New York, New York, argued for defendant-appellee. With him on the brief were Peter D. Keisler, Assistant Attorney General, David M. Cohen, Director, and Barbara S. Williams, Attorney in Charge. Of counsel on the brief was Chi S. Choy, Office of Assistant Chief Counsel, United States Customs and Border Protection, of New York, New York.

Before RADER, SCHALL, and BRYSON, Circuit Judges.

RADER, Circuit Judge.

The United States Court of International Trade sustained the United States Customs Service determination to classify Warner-Lambert's imported Certs TM "Powerful Mints" under Harmonized Tariff Schedule of the United States (HTSUS) subheading 2106.90.99, as a "food preparation not elsewhere specified or included." Customs had proposed this classification if the Court of International Trade found, as a matter of fact, that the mints are sugar-free. Warner-Lambert instead sought classification under HTSUS subheading 3306.90.00, "Preparations for oral or dental hygiene ... Other," which would be free of duty. Because Customs' classification of Warner-Lambert's Certs TM Powerful Mints within subheading 2106.90.99 of the Harmonized Tariff Schedules of the United States (HTSUS) does not persuade under the appropriate standard, this court reverses.


Warner-Lambert markets Certs TM Powerful Mints as a product to freshen the breath, and in particular to eliminate oral malodor. The product contains sorbitol, maltodextrin, aspartame, magnesium stearate, "Retsyn TM," and blue food coloring. Retsyn TM contains flavoring, partially hydrogenated cottonseed oil, and copper gluconate. Warner-Lambert presented expert evidence that Certs TM is "an effective breath freshening product" because it stimulates salivary flow, which controls malodor by purging. Further testimony indicated that the product contains flavors that mask malodor and copper gluconate that breaks down odor-producing volatile compounds. Finally, the product contains cottonseed oil to absorb odor-producing volatile compounds.

Customs presented expert evidence that the product does not contain ingredients considered by professionals to remove bacteria and bacterial products contributing to oral diseases. Accordingly, Customs argues that the product "does not promote oral hygiene." Customs' expert did note, however, that saliva is an effective cleansing solution that dissolves malodorous compounds and helps to mechanically remove bacteria and volatile compounds from the mouth.

The Court of International Trade considered a monograph entitled "Over-the-Counter Oral Health Care and Discomfort Drugs: Establishment of a Monograph," 47 Fed.Reg. 22,760 (May 25, 1982), published by the Food and Drug Administration

Page 1209

(FDA). This monograph summarized the conclusions of a professional panel of the FDA that evaluated ingredients in oral health care preparations sold without prescription. The monograph stated that "hygienic measures" to control malodor included "various cosmetic preparations, such as odoriferous mouthwashes and gargles, and lozenges. Some of the products employed contain antimicrobial and other active ingredients for which therapeutic claims are made in addition to cosmetic claims." Id. at 22,842. The monograph also stated that malodor may be controlled by purging, masking, chemical neutralization, or bacterial inhibition. Id. at 22,843-44.

The Court of International Trade weighed this evidence and consulted definitions for "preparations" and "hygiene" from medical and general dictionaries. The trial court concluded that, because "hygiene" "relates to the presence of health," preparations for oral hygiene are "medicines made ready for the practice of preserving the health of the mouth or oral cavity." Warner-Lambert Co. v. United States, 343 F.Supp.2d 1315, 1320 (Ct. Int'l Trade 2004). Therefore, the court concluded that cosmetic products "must reach an antimicrobial result to be...

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