PART 1141—REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 387i; Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776. Source: 85 FR 15708, Mar. 18, 2020, unless otherwise noted. Subpart A—General Provisions § 1141.1 Scope. (a) This part sets forth the requirements for the display of required warnings on cigarette packages and in advertisements for cigarettes. (b) The requirements of this part do not apply to manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or distribution within the United States. (c) A cigarette retailer will not be in violation of § 1141.10 for packaging that: (1) Contains a warning; (2) Is supplied to the retailer by a license- or permit-holding tobacco product manufacturer, or distributor; and (3) Is not altered by the retailer in a way that is material to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) or this part. (d) Section 1141.10(d) applies to a cigarette retailer only if that retailer is responsible for or directs the warnings required under § 1141.10 for advertising. However, this paragraph (d) does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a warning or has been altered by the retailer in a way that is material to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act or this part. § 1141.3 Definitions. For purposes of this part: Cigarette (1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco; and (2) Any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (1) of this definition. Commerce (1) Commerce between any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof; (2) Commerce between points in any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any place outside thereof; or (3) Commerce wholly within the District of Columbia, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman Reef, or Johnston Island. Distributor Front panel rear panel Manufacturer Package packaging Person Retailer United States, § 1141.5 Incorporation by reference. (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at U.S. Food and Drug Administration, Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the source listed in paragraph (b) of this section. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected] www.archives.gov/federal-register/cfr/ibr-locations.html. (b) Center for Tobacco Products, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993; 1-888-463-6332. You may also obtain the material at https://www.fda.gov/cigarette-warning-files. (1) “Required Cigarette Health Warnings, 2020”, IBR approved for § 1141.10. (2) [Reserved] Subpart B—Required Warnings for Cigarette Packages and Advertisements § 1141.10 Required warnings. (a) Required warnings. (1) One of the following textual warning label statements: (i) WARNING: Tobacco smoke can harm your children. (ii) WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. (iii) WARNING: Smoking causes type 2 diabetes, which raises blood sugar. (iv) WARNING: Smoking reduces blood flow to the limbs, which can require amputation. (v) WARNING: Smoking causes cataracts, which can lead to blindness. (vi) WARNING: Smoking causes bladder cancer, which can lead to bloody urine. (vii) WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. (viii) WARNING: Smoking causes head and neck cancer. (ix) WARNING: Smoking can cause heart disease and strokes by clogging arteries. (x) WARNING: Smoking during pregnancy stunts fetal growth. (xi) WARNING: Smoking causes COPD, a lung disease that can be fatal. (2) A color graphic to accompany the textual warning label statement. (b) Accurately reproduced. (c) Packages. (1) The required warning must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping. (2) The required warning must comprise at least the top 50 percent of the front and rear panels; provided, however, that on cigarette cartons, the required warning must be located on the left side of the front and rear panels of the carton and must comprise at least the left 50 percent of these panels. (3) The required warning must be positioned such that the text of the required warning and the other information on that panel of the package have the same orientation. (d) Advertisements. (1) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, retail displays, internet web pages, digital platforms, mobile applications, and email correspondence), the required warning must appear directly on the advertisement. (2) The required warning must comprise at least 20 percent of the area of the advertisement in a conspicuous and prominent format and location at the top of each advertisement within the trim area, if any. (3) The text in each required warning must be in the English language, except as follows: (i) In the case of an advertisement that appears in a non-English medium, the text in the required warning must appear in the predominant language of the medium whether or not the advertisement is in English; and (ii) In the case of an advertisement that appears in an English language medium but that is not in English, the text in the required warning must appear in the same language as that principally used in the advertisement. (4) For English-language and Spanish-language warnings, each required warning must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020,” which is incorporated by reference at § 1141.5. (5) For non-English-language warnings, other than Spanish-language warnings, each required warning must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020,” which is incorporated by reference at § 1141.5, including the substitution and insertion of a true and accurate translation of the textual warning label statement in place of the English language version. The inserted textual warning label statement must comply with the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act, including area and other formatting requirements, and this part. (e) Irremovable or permanent warnings. (f) Sale or distribution. (g) Marketing requirements Random display. (2) Rotation. (3) Review. (i) Will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and (ii) Assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, distributor, or retailer at the same time. (4) Record retention. § 1141.12 Misbranding of cigarettes. (a) A cigarette will 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 and this part. A cigarette will 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 and this part. (b) A cigarette advertisement and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor 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 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 other descriptive printed matter 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 and this part.