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  1. Labeling and Warning Statements for 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 vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.

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.
    SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.*
  • WARNING warning: This product contains nicotine. Nicotine is an addictive chemical.
CTP - 50 count cigar box resized

50-Count Cigar Box

front and back of 5 cigar box

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 guidance entitled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops” 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.

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