Tobacco Products

Cigar Labeling and Warning Statement Requirements

Required Warning Statements

As of August 10, 2018, all cigar packages that are manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States must bear one of the following required warning statements, per 21 CFR § 1143.5(a)(1), 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.

*You may choose to display either one of the warning statements regarding reproductive health. FDA expects that providing this optional alternative will benefit entities bound by the Federal Trade Commission (FTC) consent decrees, and the statement is appropriate for the protection of public health.

Each required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows, per 21 CFR § 1143.5(a):

  1. Be located in a conspicuous and prominent place on the two "principal display panels" of the package and the warning area must comprise at least 30 percent of each of the principal display panels;
  2. Appear in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;
  3. 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;
  4. Be capitalized and punctuated as indicated; and
  5. 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 that principal display panel have the same orientation.

Cigar Warning Plans for Packaging

You must submit a proposed warning plan to FDA no later than August 10, 2017, or 12 months before advertising or commercially marketing a cigar product, whichever is later (21 CFR § 1143.5(c)(3)). 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, in accordance with an FDA approved warning plan, per 21 CFR § 1143.5(c)(1).

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.

Cigars in Small Packages

The FDA issued Draft Guidance: Compliance Policy for Required Warning Statements on Small-Packaged Cigars. This draft guidance is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports small-packaged cigars in complying with warning statement requirements. The draft guidance also describes the agency’s compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to display the required warning statements.

Cigars Sold Individually without Packaging

For cigars that are sold individually, and not in a product package, the retailer must display all six of the required warning statements on a sign posted at the point-of-sale, per 21 CFR § 1143.5(a)(3).

The sign at point-of-sale must be:

  • At least 8.5 × 11 inches in size;
  • Clear, legible, and conspicuous;
  • 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;
  • Posted on or within 3 inches of each cash register where payment may be made; and
  • Unobstructed in its entirety and read easily by each consumer making a purchase.
  • The required warning statements on the sign must be:
    • Printed in a manner that contrasts, by typography, layout, or color, with all other printed material; and
    • Capitalized and punctuated as indicated above.

Other Cigar 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 cigar 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: 06/20/2017
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