(a) Packages. (1) It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes the package of which fails to bear, in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part, one of the required warnings on the front and the rear panels.

(2) The required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings.”

(3) The required warning shall appear directly on the package and shall be clearly visible underneath the cellophane or other clear wrapping.

(4) The required warning shall be located in the upper portion of the front and rear panels of the package and shall comprise at least the top 50 percent of these panels; Provided, however, that on cigarette cartons, the required warning shall be located on the left side of the front and rear panels of the carton and shall comprise at least the left 50 percent of these panels.

(5) The required warning shall be positioned such that the text of the required warning and the other information on that panel of the package have the same orientation.

(b) Advertisements. (1) It shall be unlawful for any manufacturer, importer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless its advertising bears, in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part, one of the required warnings.

(2) The text in each required warning shall be in the English language, except that:

(i) In the case of an advertisement that appears in a non-English publication, the text in the required warning shall appear in the predominant language of the publication whether or not the advertisement is in English; and

(ii) In the case of an advertisement that appears in an English language publication but that is not in English, the text in the required warning shall appear in the same language as that principally used in the advertisement.

(3) For English-language and Spanish-language warnings, each required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings.”

(4) For foreign-language warnings, except for Spanish-language warnings, each required warning shall be obtained from the electronic images contained in “Cigarette Required Warnings,” which is incorporated by reference at § 1141.12, and accurately reproduced as specified in “Cigarette Required Warnings,” including the insertion of a true and accurate translation of the textual warning. The inserted textual warning must comply with the requirements of section 4(b)(2) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(b)(2)).

(5) The required warning shall occupy at least 20 percent of the area of each advertisement, and shall be placed in accordance with the requirements in the Federal Cigarette Labeling and Advertising Act.

(c) Irremovable or permanent warnings. The required warnings shall be indelibly printed on or permanently affixed to the package or advertisement. Such warnings, for example, must not be printed or placed on a label affixed to a clear outer wrapper that is likely to be removed to access the product within the package.

“Cigarette Required Warnings” Edition 1.0 (June 2011), consisting of electronic files, U.S. Food and Drug Administration, referred to at § 1141.3, § 1141.10(a) and (b), and § 1141.16(a), is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, FDA must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Also, you may obtain a copy of the material by contacting the Center for Tobacco Products, Food and Drug Administration, Office of Health Communication and Education, ATTN: Cigarette Warning File Requests, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-CTP-1373, or cigarettewarningfiles@fda.hhs.gov. You may also obtain the material at http://www.fda.gov/cigarettewarningfiles.

(a) A cigarette shall be deemed to be misbranded under section 903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part. A cigarette shall be deemed to be misbranded under section 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act if its advertising does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part.

(b) A cigarette advertisement or package will be deemed to include a brief statement of relevant warnings for the purposes of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act if it bears one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part. A cigarette distributed or offered for sale in any State shall be deemed to be misbranded under section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the manufacturer, packer, or distributor includes in all advertisements and packages issued or caused to be issued by the manufacturer, packer, or distributor with respect to the cigarette one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part.