Tobacco Products

Smokeless Tobacco Labeling and Warning Statement Requirements

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:

  • WARNING: This product can cause mouth cancer.
  • WARNING: This product can cause gum disease and tooth loss.
  • WARNING: This product is not a safe alternative to cigarettes.
  • WARNING: Smokeless tobacco is addictive.

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:

  • located on the 2 "principal display panels" of the package, and each label statement shall comprise at least 30 percent of each such display panel; and
  • in 17-point conspicuous and legible type and in black text on a white background, or white text on a black background, in a manner that contrasts by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the warning plan, except that if the text of a label statement would occupy more than 70 percent of the area specified above, such text may appear in a smaller type size, so long as at least 60 percent of such warning area is occupied by the label statement.

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:

  • the name and place of business of the tobacco product manufacturer, packer, or distributor;
  • an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
  • an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
  • the statement: "Sale only allowed in the United States" on labels, packaging, and shipping containers of tobacco products

Page Last Updated: 11/01/2016
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