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HQ 963764

January 11, 2002

CLA-2 RR:CR:GC 963764ptl


TARIFF NO.: 1704.90.3550; 2106.99.9985.

Mr. Patrick D. Gill
Rode & Qualey
295 Madison Avenue
New York, NY 10017

RE: Certs® Cool Mint Drops and Certs® Powerful Mints.

Dear Mr. Gill:

This is in reference to your request, dated February 1, 2000, filed with the Director, National Commodity Specialist Division, New York, on behalf of the Warner-Lambert Company, regarding the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of products referred to as Certs® Cool Mint Drops and Certs® Powerful Mints.

Your letter, and the accompanying product samples, was forwarded to this office for reply. In preparing this response, we have considered the additional information you and your clients presented at a conference on June 28, 2001, as well as your supplemental submission of July 9, 2001. We regret the delay.


You state Certs® is a breath deodorizing product which has been marketed by Warner-Lambert for over 30 years. The packaging identifies the actual products for which you have requested classification as being "Certs® Cool Mint Drops" and "Certs® Powerful Mints." The sample package lists the ingredients of Certs® Cool Mint Drops as: sugar, modified food starch, glucose syrup, artificial and natural flavoring, maltodextrin, gum arabic, rice starch, magnesium stearate, red 40 lake, partially hydrogenated cottonseed oil and copper gluconate. The sample package of Certs® Powerful Mints lists its ingredients as: Sorbitol, Maltodextrin, natural flavoring, aspartame, magnesium stearate, partially hydrogenated cottonseed oil, copper gluconate and blue 1. According to your letter, and in product advertising you provided, "[t]he most important ingredient in the product is the active ingredient Retsyn® which is a combination of partially hydrogenated cottonseed oil, copper gluconate and flavoring." It is stated that it is the ingredient Retsyn® which combats oral malodor, thus enabling the product to function as promoted.

You have provided client sponsored laboratory studies which support the claims that the ingredients of the Certs® products were "clinically efficacious in reducing and/or controlling intrinsic (morning breath) and extrinsic (onion) oral malodor." You submit that because of these studies and product advertising the Certs® products should be classified in heading 3306, HTSUS, as preparations for oral hygiene.


What is the classification of Certs® Cool Mint Drops and Certs® Powerful Mints?


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 the official interpretation of the Harmonized System at the international level. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The HTSUS headings under consideration are as follows:

1704 Sugar confectionery (including white chocolate), not containing cocoa:

1704.90 Other:

1704.90.35 Other

Put up for retail sale:

1704.90.3550 Other

1704.90.90 Other

2106 Food preparations not elsewhere specified or included:

2106.90 Other:

2106.90.99 Other

2106.90.9985 Confectionery (including gum) containing synthetic sweetening agents (e.g., saccharin) instead of sugar

3306 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in individual retail packages:

3306.90.0000 Other

Because the Certs® products combat oral malodor (bad breath) you contend that they should be classified in subheading 3306.90.00, HTSUS, which provides for preparations for oral or dental hygiene. You state that Certs® products are able to function as breath deodorizers because they contain Retsyn®, which, according to studies you submitted that had been prepared for your client, is capable of absorbing the sulfides and mercaptans which are contributors to oral odor. You argue that because the Certs® products act as breath deodorizers by neutralizing substances which cause oral malodor (bad breath) they should be considered "preparations for oral and dental hygiene." You alternatively offer that the Certs® products should be considered an oral perfume, "an antiseptic flavored product used for freshening the breath."

Even the materials you have submitted, do not support the proposition that the articles rise to the level of dental hygiene products. A selection you provided from the Food and Drug Administration (FDA) monograph published in the Federal Register of May 25, 1982, (47 FR 22842 – 22845, May 25, 1982) discusses causes of and treatments for oral malodor. That document states that "The Panel concludes that most mouth odors are not associated with symptoms of pathologic processes requiring the need for medicated oral health care products." It further states that "local" oral malodor is the most common type of oral malodor, and then lists measures which are considered effective in controlling this type of malodor. You have provided company studies which purport to show that Certs® products perform one or more of these measures. On page 22844, the FDA document states: "The Panel considers products intended for elimination or suppression of mouth odor of local origin in healthy persons with healthy mouths to be cosmetics unless they contain antimicrobial or other drug ingredients."

While the FDA Panel did not directly address products with the same physical composition as Certs® products, it does address products which are marketed similarly when it states: "It is the consensus of the Panel that the use of OTC mouthwashes to control oral malodor is simply determined by an individual's need for social acceptance or personal oral gratification and is not mandated by the need to relieve symptoms of a pathologic state." Most of the advertising materials for various Certs® products you supplied emphasize the "fresh," "cool," "frosty mint" taste and feeling of the product. No claim of any hygienic benefit is made for the products.

To be classified in heading 3306, HTSUS, the product must be described by the terms of the heading. The ENs to heading 3306 identify certain types of articles which are covered by that heading. These are: dentifrices, toothpastes, denture cleaners, mouth washes and oral perfumes, denture fixative pastes, powders and tablets, and yarn used to clean between the teeth (dental floss). Breath mints are not included among this listing. They also do not appear among the many articles used in the care of teeth and mouth enumerated in The Handbook of Nonprescription Drugs.

We do not dispute the claim that the Certs® products may help reduce or control bad breath. However, they are packaged, labeled and marketed as mints. Mints do not appear anywhere among the examples of oral health products listed by the ENs. The Random House Dictionary of the English Language offers these definitions of "mint": "3. a soft or hard confection, often shaped like a wafer, that is flavored with peppermint or other flavoring and sometimes served after lunch or dinner" and "4. any of various flavored hard candies packaged as a roll of small round wafers." While the Certs® products are not wafers, they are small round confections, flavored with mint. Mint candies have traditionally been used as confectioneries and breath fresheners.

The Random House Dictionary of the English Language defines "hygiene" as "1. Also, hygienics. the science that deals with the preservation of health. 2. a condition or practice conducive to the preservation of health, as cleanliness." No claim is made that these Certs® products address the cause of the bad breath, as a toothbrush and toothpaste or a dental hygienist would, by improving the overall cleanliness of the mouth. Rather, through their ingredients, they simply absorb the odors and, through the mint, impart a cool sensation to the mouth.

Oral perfumes mask the malodor of the mouth or give a fragrance, such as Binaca spray, mouthwashes, oral rinses and similar products. The Random House Dictionary of the English Language defines "perfume" as "a substance, extract, or preparation for diffusing or imparting an agreeable or attractive smell." The marketing material presented with the Certs® products states that the product has a "lasting freshness" and "Inside, a cool drop of Retsyn® for fresh cool breath". The materials and marketing literature promote "coolness" rather than "clean breath". The Certs® packages do not indicate a use as an oral perfumes or for use in removing bad breath. The products are marketed as mints. Mints are confectioneries that give a cool sensation, which is imparted by the mint flavor. The Certs® mints are sold with other candies at newspaper stands, pharmacies and supermarkets. The products are not sold with dental or oral products, such as toothpaste and toothbrushes. By contrast, Binaca and other breath sprays are sold with mouthwashes and dental preparations. For these reasons, Certs® mints are not classified in heading 3306, HTSUS, as preparations for oral hygiene.

Confections containing sugar are classified in heading 1704, HTSUS, which provides for sugar confectionery (including white chocolate), not containing cocoa. The ENs to heading 17.04 state that "This heading covers most of the sugar preparations which are marketed in a solid or semi-solid form, generally suitable for immediate consumption and collectively referred to as sweetmeats, confectionery or candies." Exemplars of the types of products covered in the heading are described on page 140 of the ENs as follows:

"(v) Preparations put up as throat pastilles or cough drops, consisting essentially of sugars (whether or not with other foodstuffs such as gelatin, starch or flour) and flavouring agents (including substances having medicinal properties, such as benzyl alcohol, menthol, eucalyptol and tolu balsam). However, throat pastilles or cough drops which contain substances having medicinal properties, other than flavouring agents, fall in Chapter 30, provided that the proportion of those substances in each pastille or drop is such that they are thereby given therapeutic or prophylactic uses."

Additional U.S. Note 11 to Chapter 17 states: "For the purposes of subheading 1704.90.25, "cough drops" must contain a minimum of 5 mg per dose of menthol, of eucalyptol, or a combination of menthol and eucalyptol."

You argue that HQ 961061, dated August 24, 1998, which classified Halls® Sugar Free Cough Drops in heading 3004, HTSUS, as a medicament supports your contention that Certs® are oral hygiene products. However, the product classified in HQ 961061 contained 5 to 6 mg of menthol per dose which "acts (1) as an effective cough suppressant and (2) as an effective oral health-care anesthetic for sore throat relief. The FDA has accepted the results of those studies and recognizes the effectiveness of cough drops with 5 to 10 mg per measured dose of menthol in combating specific ailments, namely maladies manifesting themselves in coughing and sore throats. Clearly, then, menthol has “therapeutic” or “prophylactic” uses when present in sufficient amounts in cough drops." The Certs® mints do not fall within the category of Chapter 30 medicaments. The Certs® mints do not contain therapeutic or medicinal properties or substances such as menthol cough suppressants. The previously cited FDA document stated that oral malodor is not symptomatic of a condition which requires medicated oral health care products. The Retsyn® in Certs® may be effective at reducing the oral malodor, but it does not perform a hygienic function.

You also refer to other Headquarters and New York Customs Rulings which you say support your contention that Certs® products should be classified in heading 3306, HTSUS. These rulings are HQ 954198, dated October 22, 1993, NY D83572, dated October 30, 1998,NY C87664, dated May 14, 1998 and NY C87089, dated May 11, 1998. We believe that HQ 954198 is a typographic error for HQ 954918, dated December 22, 1993, for a product containing the sorbitol and mannitol ingredients you mention. In all of these rulings, some sort of breath or mouth product was classified in a heading other than 3306, HTSUS. You point out that none of the rulings covered articles which contained a claim that the product was an oral hygiene product, nor does the record indicate that any of those products contain an "active ingredient" such as the Retsyn® in Certs®. We agree with your analysis of those rulings, but point out that while Retsyn® may be an "active ingredient," for the reasons stated above, its action on oral malodor does not raise it, or the products that contain it, to the status of an oral or dental hygienic product.

The Certs® Cool Mint Drops consist essentially of sugar. They do not meet the ingredient requirements of Additional U.S. Note 11 to Chapter 17 to qualify as cough drops, nor do they have the characteristics of dental hygiene articles of subheading 3306.90.00, HTSUS. Accordingly, they are classified in subheading 1704.90.3550, HTSUS, which provides for sugar confectionery (including white chocolate), not containing cocoa other: confections or sweetmeats ready for consumption other other put up for retail sale.

The Certs® Powerful Mints contain only synthetic sweetening agents and cannot be classified in Chapter 17. Because they contain no medicinal substances, and no claim has been made that they are intended to be used for therapeutic or prophylactic purposes, or that they are designed to treat and specific disease or condition, they are precluded from consideration as medicaments of Chapter 30. As stated above, these mints do not have the characteristics of articles of heading 3306, HTSUS.

The ENs to heading 21.06 state that the heading includes, inter alia, "(8) Edible tablets with a basis of natural or artificial perfumes (e.g., vanillin). (9) Sweets, gums and the like (for diabetics, in particular) containing synthetic sweetening agents (e.g., sorbitol) instead of sugar." These exemplars describe articles akin to the Certs® powerful Mints. Accordingly, in the absence of a more specific provision, the Certs® Powerful Mints are classified in heading 2106.99.9985, HTSUS, which provides for food preparations not elsewhere specified or included other otherconfectionery (including gum) containing synthetic sweetening agents (e.g. saccharin) instead of sugar).


Certs® Powerful Mints are classified in heading 2106.99.9985, HTSUS, which provides for food preparations not elsewhere specified or included other otherconfectionery (including gum) containing synthetic sweetening agents (e.g. saccharin) instead of sugar).

Certs® Cool Mint Drops are classified in subheading 1704.90.3550, HTSUS, which provides for sugar confectionery (including white chocolate), not containing cocoa other: confections or sweetmeats ready for consumption other other put up for retail sale


John Durant, Director

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