FDA

New FDA Cigar Labeling and Warning Statement Requirements

Know the New FDA Warning Statement Requirements for Tobacco Products

The FDA finalized its rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (The Deeming Rule).

21 Code of Federal Regulations 1143.3

fda changes

Effective August 10, 2018

The FDA finalized its rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (The Deeming Rule). The Deeming Rule extends FDA’s tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products. In addition to other requirements, The Deeming Rule requires specific warning labels on packages and advertisements.

FDA WARNING LABEL REQUIREMENTS
  • Be displayed in a conspicuous and prominent place on the two principal display panels of the package.
  • The required warning statement must appear directly on the package, and be clearly visible underneath any cellophane or other clear wrapping.
  • Comprise at least 30 percent of each of the principal display panels (warning 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.
  • 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.
  • CIGARS: The package must bear one of the warning statements on the package label, and each 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 manufacturer, importer, distributor, or retailer to, and approved by, FDA.
  • WARNING STATEMENTS:
    • 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.
    • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  • 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.
FDA REQUIRED WARNING SIGNS

If cigars are sold individually, and not in a product package that is able to display a warning label, the retailer must display all six of the required warning statements on a sign posted at the point-of-sale. The sign must meet the following requirements:

  • The sign must be at least 8.5 x 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.
  • The required warning statements must be capitalized and punctuated as indicated.
  • The sign must be posted on or within 3 inches of each cash register where payment may be made.
  • The sign(s) must be unobstructed in its entirety and can be read easily by each consumer making a purchase.
PENALTIES

Any person who violates this provision shall be subject to a civil penalty of up to $15,000 for each violation and up to $1 million for multiple violations ruled on in a single proceeding.

This website and all of its published content is strictly for users age 21 or above. Not all legal requirements related to tobacco products are discussed in the contents of this site. Please remember that it is your responsibility to comply with all applicable provisions of the FD&C Act, and other federal, state, or local requirements that apply to you.
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