Tobacco Products

Cigar Labeling and Warning Statement Requirements


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Required Warning Statements

The United States District Court for the District of Columbia recently issued an order enjoining FDA from enforcing the health warnings requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 until 60 days after final disposition of the plaintiffs’ appeal of the court’s order on the health warnings requirements. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018). The compliance date for the health warnings requirements in 21 CFR part 1143 is August 10, 2018. FDA intends to comply with the court’s order in Cigar Association of America. In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a)(1) for cigars and pipe tobacco while the injunction is in effect so that firms may make these required label changes at one time. See 81 Fed. Reg. at 29,006 (noting that compliance date for the 903(a)(2) and 920(a)(1) requirements is intended to match date for health warnings). We note that cigar and pipe tobacco firms may choose to voluntarily comply with 21 CFR §§ 1143.3 and 1143.5 and sections 903(a)(2) and 920(a)(1) while the injunction is in effect. Below we are describing certain provisions relating to the health warning requirements for cigars as set forth in the deeming rule. This description is intended to assist firms with voluntary compliance since, as noted, the health warning requirements for cigars will not be enforced while the injunction is in effect.  For more information, see new guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco.

The deeming regulation requires that 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.

Cigar box with warning label

50-Count Cigar Box

Cigar box with front and back view of packaging

5-Count Cigar Box

These images are intended to serve as examples and alternative approaches may suffice.

*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 this requirement 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 in 21 CFR § 1143.5(a)(1); 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.

A cigar retailer will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this section.


Cigars in Small Packages

The FDA issued Guidance: Compliance Policy for Required Warning Statements on Small-Packaged Cigars. This guidance document is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in 21 CFR § 1143 for product packaging.

Single cigar in packaging

These images are intended to serve as examples and alternative approaches may suffice.


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 the aforementioned plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to, and approved by, FDA.


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 in 21 CFR § 1143.5(a)(1).

Other Cigar Labeling Requirements

There are other labeling requirements. For example, tobacco products deemed under the deeming final rule to be subject to FDA’s authority, if in package form, must bear a label containing—

  • 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 required under section 920(a)…(section 903(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)).

Section 920(a) of the FD&C Act provides that the label, packaging, and shipping containers of tobacco products shall bear the statement “Sale only allowed in the United States”.

In the draft guidance, entitled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops”, which is currently available for public comment, FDA indicated that it does not intend to enforce section 903(a)(2)(C) of the FD&C Act for those products that are made or derived from tobacco. When the draft guidance is finalized it will represent FDA’s current thinking on the issues contained therein.

Page Last Updated: 08/13/2018
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