(a) Required warnings. A required warning must include the following:

(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. Each required warning, comprising a combination of a textual warning label statement and its accompanying color graphic, must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020,” which is incorporated by reference at § 1141.5.

(c) Packages. It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes unless the package of which bears a required warning in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part.

(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. It is unlawful for any manufacturer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless each advertisement bears a required warning in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part.

(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. The required warnings must be indelibly printed on or permanently affixed to the package or advertisement. These 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.

(f) Sale or distribution. No person may manufacture, package, sell, offer for sale, distribute, or import for sale or distribution within the United States cigarettes whose packages or advertisements are not in compliance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part, except as provided by § 1141.1(c) and (d).

(g) Marketing requirements—(1) Random display. The required warnings for packages specified in paragraph (a) of this section must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, distributor, or retailer to, and approved by, the Food and Drug Administration.

(2) Rotation. The required warnings for advertisements specified in paragraph (a) of this section must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan submitted by the tobacco product manufacturer, distributer, retailer to, and approved by, the Food and Drug Administration.

(3) Review. The Food and Drug Administration will review each plan submitted under this section and approve it if the plan:

(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. Each tobacco product manufacturer required to randomly and equally display and distribute warnings on packaging or rotate warnings in advertisements in accordance with an FDA-approved plan under section 4 of the Federal Cigarette Labeling and Advertising Act and this part must maintain a copy of such FDA-approved plan and make it available for inspection and copying by officers or employees duly designated by the Secretary of Health and Human Services. The FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.

(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.