(a) Packages.

1. (1) It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigar product unless the product package bears one of the following required warning statements on the package label:

   1. (i) WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
   2. (ii) WARNING: Cigar smoking can cause lung cancer and heart disease.
   3. (iii) WARNING: Cigars are not a safe alternative to cigarettes.
   4. (iv) WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.

   5. (v)

      1. (A) WARNING: Cigar use while pregnant can harm you and your baby.; or
      2. (B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.
   6. (vi) WARNING: This product contains nicotine. Nicotine is an addictive chemical.

2. (2) Each required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows:

   1. (i) 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. (ii) 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. (iii) 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. (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section; and
   5. (v) 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.

3. (3) No person may manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigar without a required warning statement, except for cigars that are sold individually and not in a product package. For cigars that are sold individually and not in a product package, the required warning statements must be posted at the retailer's point-of-sale in accordance with the following:

   1. (i) All of the warnings in paragraph (a) of this section must be placed on a sign that is a minimum of 8.5 x 11 inches, posted on or within 3 inches of each cash register where payment may be made so that the sign(s) are unobstructed in their entirety and can be read easily by each consumer making a purchase;
   2. (ii) The sign must be clear, legible, and conspicuous and 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 type with appropriate space between the warning statements;
   3. (iii) Be printed in a manner that contrasts by typography, layout, or color, with all other printed material; and
   4. (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section.

4. (4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of this section will not be in violation of this section for packaging that:

   1. (i) Contains a health warning;
   2. (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
   3. (iii) Is not altered by the retailer in a way that is material to the requirements of this section.

(b) Advertisements.

1. (1) It is unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of cigars to advertise or cause to be advertised within the United States any cigar unless each advertisement bears one of the required warning statements specified in paragraph (a)(1) of this section.

2. (2) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Internet Web pages, and electronic mail correspondence), each required warning statement must appear in the upper portion of the area of the advertisement within the trim area as follows:

   1. (i) Occupy at least 20 percent of the area of the advertisement;
   2. (ii) Appear in at least 12-point font size that ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the text required;
   3. (iii) Appear 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 material on the advertisement;
   4. (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section;
   5. (v) Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation; and
   6. (vi) Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 mm or more than 4 mm.
3. (3) This paragraph (b) applies to a retailer only if that retailer is responsible for or directs the warning statements required under the paragraph. However, this paragraph does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a health warning or contains a health warning that has been altered by the retailer in a way that is material to the requirements of this section.

(c) Marketing requirements.

1. (1) Except for cigars sold individually and not in a product package, the warning statements required for packages in paragraph (a)(1) of this section 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 and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the cigar manufacturer, importer, distributor, or retailer to, and approved by, the Food and Drug Administration.
2. (2) The warning statements required for advertisements in paragraph (a)(1) of this section must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar in accordance with a plan submitted by the cigar manufacturer, importer, distributor, or retailer to, and approved by, the Food and Drug Administration.
3. (3) Each person required to randomly display and distribute or rotate warnings in accordance with an FDA-approved plan under this part shall submit a proposed warning plan to FDA no later than either 12 months after May 10, 2016, or 12 months before advertising or commercially marketing a product that is subject to such requirement, whichever is later.