Lever-Rule Protection Request; 19 CFR § 133.2(e); Trademarks for Toothpaste Products: (1) COLGATE word mark (U.S. Trademark Registration No. 0, 227, 647/CBP Recordation No. TMK 88-00297) and (2) COLGATE word & design mark (U.S. Trademark Registration No.

October 10, 2008 HQ H020757 ENF-4-02-OT:RR:BSTC:IPR H020757 RFC CATEGORY: Trademark James D. Weinberger, Esquire Fross, Zelnick, Lehrman & Zissu 866 United Nations Plaza At First Avenue & 48th Street New York, NY 10017 RE: Lever-Rule Protection Request; 19 CFR § 133.2(e); Trademarks for Toothpaste Products: (1) COLGATE word mark (U.S. Trademark Registration No. 0, 227, 647/CBP Recordation No. TMK 88-00297) and (2) COLGATE word & design mark (U.S. Trademark Registration No. 1,290,656/CBP Recordation No. TMK 04-01107) Dear Mr. Weinberger: This letter is in response to your May 19, 2008, revised requests, on behalf of your client Colgate-Palmolive Company, for Lever-rule protection, pursuant to 19 CFR § 133.2(e), against the importation of certain gray market toothpaste products bearing the above-referenced COLGATE trademarks. The products (and country of origin) against with Lever-rule protection is sought are set forth below: COLGATE Cavity Protection (South Africa, China, Canada, Mexico, India) COLGATE Gel (South Africa) COLGATE Triple Action (South Africa, Mexico, China) COLGATE Fresh Confidence (South Africa, Canada, Mexico) COLGATE Total (South Africa, Canada, Mexico, China, India) COLGATE Herbal (Brazil, China, India) COLGATE Tartar Control (Canada) COLGATE Max Fresh (Canada, Mexico, China, India) FACTS In your submissions, your contend that the above-referenced toothpaste products while authorized by the Colgate-Palmolive Company to bear the above-referenced U.S. trademarks are not authorized for importation into the United States. You further contend that each of the products is physically and materially different from the products authorized to use the trademarks for sale in the United States. The specific products not authorized for sale in the United States and how they are physically and materially different from the products authorized for sale in the United States, as set forth and described in your submissions, are discussed below (including with respect to certain U.S. Food & Drug Administration (FDA) requirements). BRAZIL Product manufactured in Brazil but not authorized for sale in the United States.
COLGATE Herbal   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Packaging of unauthorized products does not present product information in the form and manner required by FDA’s “DRUG FACTS” labeling requirements: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. B. Other physical and material differences: 1. Product is a Colgate “Herbal” brand, which have no corresponding U.S.-authorized products and which contain ingredients not found in U.S. products. 2. Measurement of net contents in unauthorized products is always in milliliters (ml) or centimeters cubed (cm3), sometimes followed by grams (g) in parenthesis. Authorized products usually set forth net contents in ounces (oz.) and grams (g). 3. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022,” although the distributor is usually another Colgate entity (e.g., Colgate-Palmolive S.A. de C.V.). CANADA Products manufactured in Canada but not authorized for sale in the United States.
COLGATE Cavity Protection (Regular)  
COLGATE Fresh Confidence  
COLGATE Max Fresh  
COLGATE Tartar Control  
COLGATE Total   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Packaging of unauthorized products has extremely limited information about the product, and, in any event, does not present product information in form and manner required by FDA’s “DRUG FACTS” labeling requirements. All identified unauthorized products do not list ingredients: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. B. Other physical and material differences: 1. Measurement of net contents in unauthorized products is always in milliliters (ml) or centimeters cubed (cm3), sometimes followed by grams (g) in parenthesis. Authorized products usually set forth net contents in ounces (oz.) and grams (g). 2. Unauthorized products are certified by foreign dental associations, and not, as is the case with certain authorized products, by the American Dental Association. These are easily identified by crests appearing on the back of the packaging and toothpaste tubes. 3. Unauthorized products are labeled in French and English on alternating sides of the packaging and bilingually on tubes. 4. Unauthorized products manufactured for sale in Canada all have DIN or NPN numbers on the front of the package. 5. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022,” although the distributor is usually another Colgate entity (e.g., Colgate-Palmolive S.A. de C.V.). CHINA Products manufactured in China but not authorized for sale in the United States.

COLGATE Maximum Cavity Protection  

COLGATE Total  
COLGATE Herbal  
COLGATE Max Fresh  

COLGATE Triple Action  
COLGATE Cavity Protection   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Unauthorized products contain no labeling information whatsoever, which means that product information is not presented in the form and manner required by FDA’s “DRUG FACTS” labeling requirements.: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. B. Other physical and material differences: 1. Authorized products usually set forth net contents in ounces (oz.) and grams (g). Measurement of contents in unauthorized products is in grams (g) only, in milliliters (ml) followed by grams (g), or in a measurement expressed in foreign-language characters, i.e., Chinese or Russian characters. 2. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022,” or by do not identify a distributor. INDIA Products manufactured in India but not authorized for sale in the United States.
COLGATE Strong Teeth  
COLGATE Herbal  
COLGATE Total  
COLGATE Max Fresh   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Packaging of unauthorized products does not present product information in form and manner required by FDA’s “DRUG FACTS” labeling requirements: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. B. Other physical and material differences: 1. Authorized products usually set forth net contents in ounces (oz.) and grams (g). Measurement of net contents in unauthorized products is always in grams (g) only. 2. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022.” 3. Unauthorized products do not display a complete list of ingredients, as do authorized products in the United States. Rather, the packaging of unauthorized products displays only a very limited list of “key ingredients.” MEXICO Products manufactured in Mexico but not authorized for sale in the United States.
COLGATE Maxima Proteccion Anticaries  
COLGATE Triple Acción  
COLGATE Frescura Confiable  
COLGATE Max Fresh  
COLGATE Total   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Packaging of unauthorized products do not present product information in form and manner required by FDA’s “DRUG FACTS” labeling requirements: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. 3. Other than COLGATE brand name and product name, e.g., MAX FRESH or descriptor, e.g., “whitening,” labeling is entirely in Spanish: 21 C.F.R. § 201.15(c)(1) requires all labeling to appear in English, other than for products directed specifically to Puerto Rico or other territories where another language is predominantly spoken. Certain listed ingredients identified on unauthorized products appear to be in English, but the statement of identity of the product and how it works is always in Spanish. B. Other physical and material differences: 1. Measurement of net contents in unauthorized products is always in milliliters (ml) or centimeters cubed (cm3), sometimes followed by grams (g) in parenthesis. Authorized products usually set forth net contents in ounces (oz.) and grams (g). 2. Unauthorized products are certified by foreign dental associations and not, as is the case with certain authorized products by the American Dental Association. These are easily identified by crests appearing on the back of the packaging and toothpaste tubes. 3. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022,” although the distributor is usually another Colgate entity (e.g., Colgate-Palmolive S.A. de C.V.). SOUTH AFRICA Products manufactured in South Africa but not authorized for sale in the United States.
COLGATE Maximum Cavity Protection  
COLGATE Gel  
COLGATE Triple Action  
COLGATE Fresh Confidence  
COLGATE Total   Physical and Material Differences A. Failure to comply with FDA requirements: 1. Unauthorized products are not registered with the FDA pursuant to 21 C.F.R. § 207 et seq. 2. Packaging of unauthorized products do not present product information in form and manner required by FDA’s “DRUG FACTS” labeling requirements: 21 C.F.R. § 201.66 requires authorized products to include information under the “Drug Facts” heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. B. Other physical and material differences: 1. Measurement of net contents in unauthorized products is always in milliliters (ml) or centimeters cubed (cm3), sometimes followed by grams (g) in parenthesis. Authorized products usually set forth net contents in ounces (oz.) and grams (g). 2. Unauthorized products are distributed by an entity other than “Colgate-Palmolive Company New York, NY 10022,” although the distributor is usually another Colgate entity (e.g., Colgate-Palmolive S.A. de C.V.). LAW AND ANALYSIS Gray market goods are imported goods bearing a U.S. trademark (1) that have been produced by the owner of the U.S. trademark or with the owner’s consent (i.e., the U.S. trademark owner authorized the use of its mark on the goods under consideration) and (2) that not have been authorized for sale in the United States by the owner of the U.S. trademark. See Gamut Trading Co. v. Int'l Trade Comm'n, 200 F.3d 775, 777 (Fed. Cir. 1999). CBP does not consider gray market goods to be restricted goods (and subject to seizure) unless the marks on the goods have gray market protection. See 19 CFR § 133.23. A trademark that is recorded with CBP may receive gray market protection when it is applied under the authority of a foreign trademark owner other than the U.S. owner, a parent or subsidiary of the U.S. owner, or a party subject to common ownership or control with the U.S. owner, from whom the U.S. owner acquired the domestic title, or to whom the U.S. owner sold the foreign title. See 19 CFR §133.23(a)(2). Under the so-called "affiliate exception," CBP has interpreted section 133.23(a)(2) to mean, among other things, that where the U.S. trademark owner owns the subject trademark in a foreign country or where a parent, subsidiary or party subject to common ownership or control with the U.S. owner owns the subject trademark in a foreign country, the trademark is not entitled to gray market protection from CBP. See, e.g., HQ 469076 (November 19, 2001). Neither of the two above-referenced CBP recorded COLGATE trademarks has been accorded gray market protection by CBP. See TMK 88-00297 & TMK 04-01107, Intellectual Property Rights Search (IPRS) System on www.cbp.gov. Nonetheless, under CBP’s “Lever-rule” regulations, those marks might still qualify for certain gray market protection: Gray market goods that would not otherwise be restricted under the CBP regulations may be, among other things, refused entry into the United States when it is established to the satisfaction of CBP that such goods are physically and materially different from goods produced for the U.S. market under authority of the U.S. trademark owner. See 19 CFR §§ 133.2,133.23(3). See also, Lever Bros. Co. v. United States, 981 F. 2d 1330 (D.C. Cir.1993). Even in “affiliate exception” cases, upon application and a finding that specific gray market goods are physically and materially different from goods authorized by the U.S. trademark owner for importation into the United States, CBP will restrict the importation of the gray market goods. Id. In such a case, the good will only be permitted entry into the United States if the labeling requirements set forth in 19 CFR §133.23(b) have been satisfied. When applying for Lever-rule protection for specific products, a trademark owner (1) must state the basis for this claim with particularity; (2) support the claim by competent evidence; and (3) provide CBP with summaries of the alleged physical and material differences that exist between the articles authorized for sale in the United States and those intended for other markets. 19 CFR §133.2(e). When reviewing an application for Lever-rule protection for specific products, CBP may consider, among other things, the following information and factors: specific composition of both the authorized and gray market product(s), (including chemical composition); formulation, product construction, structure, or composite product components, of both the authorized and gray market products; performance and/or operational characteristics of both the authorized and gray market product; differences resulting from legal or regulatory requirements, certification, etc.; or other distinguishing and explicitly defined factors that would likely result in consumer deception or confusion as proscribed under applicable law. (Emphasis added.) Id. Several court decisions have addressed the issue of physical and material differences involving gray market goods vis-á-vis those authorized for sale in the United States. In a landmark gray market decision, the court in Societe Des Produits Nestle, S.A. v. Casa Helvetia, Inc., 982 F.2d 633 (1st Cir. 1992) held that: [A]n unauthorized importation may well turn an otherwise “genuine” product into a “counterfeit” one. In other words, the unauthorized importation and sale of materially different merchandise violates Lanham Act section 32 because a difference in products bearing the same name confuses consumers and impinges on the local trademark holder’s goodwill…[It] boils down to whether material differences exist between the...[authorized imported product and the unauthorized imported product]…sufficient to create a likelihood of consumer confusion, mistake, or deception. (Emphasis added.) o o o There is no mechanical way to determine the point at which a difference [between goods authorized for sale in the United States and those authorized for sale other than the United States] becomes “material”…[but] we can confidently say that the threshold of materiality is always quite low in such cases. Id. at 638, 641. The court in Societe Des Produits Nestle, S.A. went on to hold that differences in presentation (packaging), composition (ingredients) and price of the products under consideration to be material. Id. at 643-4. Other court decisions have also articulated (1) the principle that material differences revolve around those that will affect a consumer’s decision to purchase a product bearing a trademark and (2) the low level for the threshold of materiality in gray market cases. See, e.g., In Davidoff & CIE v. PLD Int’l Corp., 263 F. 3d 1297,1302 (11th Cir. 2001) (A material difference is one that consumers consider relevant to a decision about whether to purchase a product, and the threshold of materiality must be kept low to include even subtle differences between products.). ALLEGED DIFFERENCES BETWEEN AUTHORIZED & UNAUTHORIZED PRODUCTS As discussed above, you have made several allegations with respect to numerous products made in numerous countries as concerns possible differences in the products that are authorized and that are not authorized for sale in the United States (but you have not submitted or offered any arguments as to why a consumer would consider any of the alleged differences to be relevant when deciding whether to purchase a particular product). Whether any of these alleged differences constitutes a material difference for purposes of Lever-rule protection will depend on whether (1) they create a likelihood of consumer confusion, mistake or deception or (2) they are ones that a consumer would consider relevant when deciding to purchase a particular product. See Societe Des Produits Nestle, S.A. v. Casa Helvetia, Inc., supra, at 638 and In Davidoff & CIE v. PLD Int’l Corp., supra, at 1302. The alleged differences set forth and described in your submissions are addressed below. Products Are Not Registered With the FDA With respect to all products, you allege that none of the products not authorized for sale in the United States are “registered” with the FDA. Upon review of the applicable regulations, it appears that such products are not required to be registered but rather to be “listed” with the FDA when the producers of the products register them with the FDA. See 21 CFR § 207. Upon review, we cannot conclude with a satisfactory degree of certainty that a consumer‘s purchasing decision would not be affected by whether or not the above-referenced requirement (whether involving a listing or registration of the products) has been satisfied or not. That is, we find it relatively likely that a consumer would not be aware at the time of purchase of such a product whether that requirement had been satisfied, or even existed (as there would be no indications with respect to this requirement on the product packaging). Therefore, this information would likely not be before a consumer when deciding whether to purchase the product (and thus would not affect the consumer’s decision on whether to purchase the product). Thus, in our view, this would not constitute a material difference for purposes of Lever-rule protection. Packaging Not Presented As Required With FDA’s “Drug Facts” Labeling Requirements With respect to all products, you allege that none of the packaging for the products not authorized for sale in the United States contains product information in the form and manner required by the FDA’s “Drug Facts” labeling requirements: You indicated that 21 CFR § 201.66 requires authorized products to include information under the Drug Facts heading (either in a set-off text box or other clear presentation) on all over-the-counter FDA-registered products, such as toothpaste. Upon review, we conclude that a product featuring non-conforming or incomplete information normally featured in conformance with FDA labeling requirements could affect a consumer’s decision to purchase the product. That is, as such FDA labeling is generally found on drugs and food sold throughout the United States, its absence on a product could create a likelihood of confusion or mistake on the part of the consumer, and consequently negatively affect the consumer’s decision to purchase the product. Id. For example, a consumer might wonder if the product is safe for use without the labeling. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Measurement of Net Contents Differs With respect to all products, you allege that the “net contents” information is set forth in standards of measurement on the packaging for the products not authorized for sale in the United States that differs from that on the packaging for the products authorized for sale in the United States. Upon review, we conclude that such differences in standards of measurement could affect a consumer’s decision to purchase the product. If consumers in the United States are accustomed to buying Colgate toothpaste products in one standard(s) of measurement, toothpaste products bearing the Colgate trademark but listing a different standard(s) of measurement could affect a consumer’s decision on whether to purchase the product. That is, unfamiliar standards of measure could create a likelihood of confusion or mistake on the part of the consumer. Id. For example, if the consumer were not familiar with the different standards of measurement, he or she might not purchase the product. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Products Distributed By an Entity Other Than Colgate-Palmolive Company in New York With respect to all products, you allege that the products not authorized for sale in the United States are distributed by an entity other than the Colgate-Palmolive Company in New York and, in some instances, the products do not identify a distributor (as apparently found on the packaging for these products). Upon review, we conclude that the listing on the packaging for a product of a distributor located outside of the United States (or no distributor listed at all) could affect a consumer’s decision on whether to purchase the product. If consumers in the United States are accustomed to buying Colgate toothpaste products that identify the same distributor with the U.S. address, toothpaste products bearing the Colgate trademark but listing a different distributor (particularly with a foreign or non-U.S. address) or not listing a distributor could affect a consumer’s decision on whether to buy the product. That is, the (1) listing on the product packaging of a distributor other than the Colgate-Palmolive Company in New York (2) or not listing any distributor could create a likelihood of confusion or mistake on the part of the consumer, and negatively affect the consumer’s decision to purchase the product. Id. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Products Certified By Foreign Dental Associations and Not By ADA You allege that some of the products not authorized for sale in the United States are certified on the product packaging by a foreign dental association and not by the American Dental Association (ADA). Upon review, we conclude that products that are certified on the product packaging by a foreign dental association rather than a U.S. dental association could affect a consumer’s decision to purchase the product. If consumers in the United States are accustomed to purchasing Colgate toothpaste products that are certified by the American Dental Association, toothpaste products bearing the Colgate trademark but certified by a foreign dental association could affect a consumer’s decision on whether to purchase the product. That is, the certification by a foreign dental association rather than the American Dental Association could create a likelihood of confusion or mistake on the part of the consumer. Id. For example, a consumer may have doubts about the quality or safety of toothpaste certified by a foreign dental association and decide not to purchase it (and perhaps affect its decision to purchase Colgate toothpaste products in the future). Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Product Packaging Does Not Display Complete List of Ingredients You allege that some of the products not authorized for sale in the United States do not contain a complete list of ingredients on the packaging (but rather just list “key” ingredients) whereas the products authorized for sale in the United States contain a complete list of ingredients. Upon review, we conclude that products that do not contain a complete list of ingredients as discussed above could affect a consumer’s decision to purchase the product. That is, if consumers in the United States are accustomed to buying Colgate toothpaste products with a complete list of ingredients, toothpaste products bearing the Colgate trademark that do not contain such a complete list could create a likelihood of confusion or mistake on the part of the consumer, and consequently negatively affect the consumer’s decision to purchase the product. Id. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Products Are Labeled In or Contain a Foreign Language You allege that some of the products not authorized for sale in the United States are labeled in or contain a foreign language (e.g., French and English on alternating sides of the packaging and bilingually on tubes for products from Canada and measurements expressed in foreign-language characters) on the product packaging. Upon review, we conclude that products that are labeled in or contain a foreign language text on the product packaging could affect a consumer’s decision to purchase the product. That is, foreign language on the product packaging could create a likelihood of confusion or mistake on the part of the consumer (who may not understand the foreign language text), and consequently negatively affect the consumer’s decision to purchase the product. Id. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Product Packaging Has Additional Designations You allege that some of the products not authorized for sale in the United States contain certain additional designations on the packaging (e.g., DIN or NPN numbers on the front of the package for products from Canada) that are not found on the products authorized for sale in the United States. Upon review, we conclude that products that contain new and additional designations as discussed above could affect a consumer’s decision to purchase the product. That is, if one is used to or accustomed to purchasing a product with particular designations on the product packaging, and product packaging now appears with new and additional designations, this could cause one to pause and wonder if it were the same product or same quality of product that he or she purchased in the past. In the instant case, if consumers in the United States are used to or accustomed to buying Colgate toothpaste products without these new and additional designations now encounter toothpaste products bearing the Colgate trademark with these designations, this could create a likelihood of confusion or mistake on the part of the consumer with respect to whether these products are the same products that they have purchased in the past. Consequently, these new and additional designations could negatively affect the consumer’s decision to purchase the toothpaste products bearing the Colgate trademark. Id. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. Products Have Ingredients Not Found in U.S. Authorized Products You allege that some of the products not authorized for sale in the United States contain ingredients that are not found in the products authorized for sale in the United States (e.g., herbal products from Brazil). Upon review, we conclude that products that contain different ingredients from those products authorized for sale in the United States could affect a consumer’s decision to purchase the product. For example, toothpaste having a different taste or color than that authorized for sale in the United States could create a likelihood of confusion or mistake on the part of the consumer, and consequently negatively affect the consumer’s decision to purchase the product. Id. Thus, in our view, this constitutes a material difference for purposes of Lever-rule protection. CONCLUSION In light of the foregoing, Colgate-Palmolive Corporation’s applications for Lever-rule protection against the importation of the above-referenced gray market toothpaste products from Brazil, Canada, China, India, Mexico and South Africa are granted for the reasons discussed above. Sincerely, George Frederick McCray, Chief, Intellectual Property Rights Branch