Smokeless Tobacco Labeling and Warning Statement Requirements

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Required Warning Statements

Since July 22, 2010, smokeless tobacco product packaging and advertising must bear one of the following required warning label statements, per section 3 of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), as amended by section 204 of the Tobacco Control Act, in accordance with an FDA approved warning plan:

These required warning statements must also meet certain requirements, with respect to font, text, size, placement and formatting of the warning statements on the package labels and advertisements. Each warning statement must be:

Warning Plan

You must randomly display in a 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 an FDA approved plan. You must rotate required warnings on advertisements quarterly, in accordance with a warning plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.

Other Smokeless Tobacco Labeling Requirements

There are other labeling requirements that must appear on tobacco product package labels if the product is manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States. The following statements must appear on smokeless tobacco package labels per Section 903(a)(2) of the Tobacco Control Act: