Tobacco Products

Required Warning Label Statement on Packages

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1. Nicotine Addictiveness Warning Label Statement for Cigarette Tobacco, RYO Tobacco, and Covered Tobacco Products (Except Cigars)

For cigarette tobacco, RYO tobacco, and covered tobacco products other than cigars, the Deeming Rule requires that the tobacco product package bear the following required warning label statement on packages: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

This required warning statement must appear on all cigarette tobacco, RYO tobacco, and covered tobacco product package labels. It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States these products without the required warning label statement on the tobacco product package (§ 1143.3(a)(1)).

Section 1143.3(a)(2) provides that the required warning statement on package labels must also appear directly on the package, and be clearly visible underneath any cellophane or other clear wrapping as follows:

  • Be displayed in a conspicuous and prominent place on the two principal display panels of the package;
  • Comprise at least 30 percent of each of the principal display panels (warning label area);
  • Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
  • Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts 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;
  • Be capitalized and punctuated as indicated in § 1143.3(a)(1); and
  • Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.

A special provision in § 1143.3(d) applies to packages that are too small to display the required warning statement. A covered tobacco product that is too small or otherwise unable to accommodate a label must contain the information and specifications required under § 1143.3(a)(1) and (2) on one of the following:

  • The covered tobacco product carton;
  • The outer container or wrapper that provides sufficient space to bear the information; or
  • On a tag firmly and permanently affixed to the tobacco product package.

The carton, outer container, wrapper, or tag will serve as the location of the principal display panels.


2. Minimum Required Warning Label Statements for Cigar Packages

For cigars, § 1143.5(a)(1) of the Deeming Rule requires that the tobacco product package bear one of the following required warning statements on the package label:

  • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  • WARNING: Cigar smoking can cause lung cancer and heart disease.
  • WARNING: Cigars are not a safe alternative to cigarettes.
  • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  • WARNING: Cigar use while pregnant can harm you and your baby.

or

  • SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.

These required warning statements must appear on all cigar package labels if the cigar product is manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States (§ 1143.5(a)(1)).

These required warning statements must also meet the same requirements that apply to cigarette tobacco, RYO tobacco, and other covered tobacco products, with respect to font, text, size, placement and formatting of the package labels (§ 1143.5(a)(2)).

An exception exists for cigars that are sold individually, and not in a product package. In this circumstance, the retailer must display all six of the required warning statements on a sign posted at the point-of-sale (§ 1143.5(a)(3)).

The sign must meet the following requirements, as described in § 1143.5(a)(3):

  • The sign must be at least be 8.5 × 11 inches in size;
  • The sign must be clear, legible, and conspicuous;
  • The sign must be printed in black Helvetica bold or Arial bold type or other similar sans serif fonts against a solid white background, in at least 17-point font size with appropriate spacing between the warning statements;
  • The required warning statements must be printed in a manner that contrasts by typography, layout, or color, with all other printed material; and
  • The required warning statements must be capitalized and punctuated as indicated in § 1143.5(a)(1).

The sign must be posted according to the following requirements stated in § 1143.5(a)(3):

  • The sign must be posted on or within 3 inches of each cash register where payment may be made; and
  • The sign(s) must be unobstructed in its entirety and can be read easily by each consumer making a purchase.

Section 1143.5(c)(1) provides that except for cigars sold individually and not in a product package, the six required warning statements must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging. The six warning statements must also be randomly distributed in all areas of the United States where the product is marketed, in accordance with a plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to, and approved by, FDA.

 

 

 

Page Last Updated: 12/15/2016
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