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This guidance provides information regarding the required warnings for cigarette packages and advertisements, aimed to help small businesses understand and comply with the regulations.
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How to fill out Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide

01
Review the latest regulations regarding required warnings for cigarette packages and advertisements.
02
Gather necessary materials including cigarette package designs and advertisement copies.
03
Identify the specific warning statements required for your products.
04
Incorporate the required warnings into the designs of cigarette packages according to size and placement guidelines.
05
Ensure that the warnings on advertisements meet all size, font, and visibility requirements.
06
Conduct a final review to make sure all warnings comply with the regulations.
07
Submit any required documentation to the relevant regulatory authorities if needed.

Who needs Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide?

01
Manufacturers of cigarettes.
02
Importers of cigarette products.
03
Retailers who sell cigarette packages.
04
Any entity involved in the advertisement of cigarette products.
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People Also Ask about

The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics.
On January 11, 1964, the U.S. Surgeon General issued a detailed report concluding that cigarette smoking was a health hazard warranting “appropriate remedial action.” In June 1964, the Federal Trade Commission (FTC) announced that beginning January 1, 1965, the tobacco industry would be required to place health warning
Federal Law Requires Cigarette Warning Labels. Congress responded to demands for regulation against the tobacco industry, cigarette manufacturers in particular, by requiring health warning labels on cigarette packages and in tobacco-related advertising.
Federal Law Requires Cigarette Warning Labels. Congress responded to demands for regulation against the tobacco industry, cigarette manufacturers in particular, by requiring health warning labels on cigarette packages and in tobacco-related advertising.
Cigarette Packages For cigarette cartons, the required warnings 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.
In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of
The 11 graphic warnings include depictions of how smoking can cause bladder, head and neck cancer; fatal lung disease; stunted fetal growth during pregnancy; cataracts; and type 2 diabetes. The FDA argued the law gave it the authority to adjust the format, type and text of any of the required labels.

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The Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide is a document that outlines the mandatory health warning requirements that cigarette manufacturers and retailers must follow in order to comply with federal regulations. It provides detailed information on the specific warnings, their formats, and placement on product packaging and advertisements.
Cigarette manufacturers, importers, and retailers, particularly small entities who produce or sell cigarettes, are required to comply with the guidelines set forth in the Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide.
To fill out the Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide, entities must gather the necessary information regarding their product warnings, ensure they meet the format and placement requirements, and submit the documentation as part of their compliance strategy with the relevant authorities.
The purpose of the Required Warnings for Cigarette Packages and Advertisements—Small Entity Compliance Guide is to promote public health by ensuring that consumers are adequately informed about the health risks associated with cigarette use through clear and effective warning statements.
The information that must be reported includes the specific health warnings that must appear on cigarette packages and advertisements, the size and placement of these warnings, and whether any additional statements are required to comply with regulatory standards.
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