Warning Labels

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As part of the deeming regulations, all cigars sold in the U.S. are required to have warning labels placed on two "principal display panels" of the packaging, like the front and top of the box. These warnings must cover at least 30 percent of each of the panels they are affixed to with black font on a white background.

  • 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.

Seven cigar manufacturers have previously signed a separate agreement with FTC that has required them to use smaller warning labels. FDA believes that using its warning labels will satisfy the FTC requirement. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 371-372) FDA is giving those seven manufacturers the option to use an alternative warning in place of the aforementioned fifth warning regarding pregnancy:

  • SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Warning Plans

FDA requires the five warning messages to be rotated evenly by each manufacturer. So if a manufacturer sells 1,000 boxes of a particular SKU in a given year, they must ensure the five warning labels each appear on 200 boxes.

Beginning in August 2017, cigar makers were required to submit a warning plan, outlining how manufacturers intend on rotating these messages on a quarterly basis. The warning plan must cover not only the cigars themselves but also the warning labels used on advertising.

These warning plans must be submitted on an annual basis outlining how a manufacturer intends to use warning labels.

Cigar retailers are required to have an 8 1/2 x 11 sheet of paper with all five placed three-inches from the register.

The only exception would be if that store did not sell any cigars individually and only sold cigars by the box.

Questions

Cigar boxes might have warning labels for three different reasons.

  1. FTC Consent Decree — In 2000, a variety of companies including Altadis U.S.A., General Cigar Co., Swisher International and Altria voluntarily agreed to place warning labels—smaller than those which are to be required under FDA's deeming regulations—on their products as part of an agreement with the Federal Trade Commission (FTC). Because Swisher owns Drew Estate and Altria owns Nat Sherman, it means a variety of brands are already federally required to have warning labels on their boxes.
  2. California — California's Proposition 65 requires all cigars sold in the state to carry a warning label. Cigar makers have chosen to place the warning label on all boxes, not just the cigars specifically sold in California.
  3. Early Compliance — The decision to delay the warning labels came barely a month before the new warning label rules were set to take effect. As such, some manufacturers—most notably Drew Estate and General Cigar Co.—had already begun applying warning labels to its product. Ultimately, both companies stopped placing warning labels on boxes, but not after tens of thousands of boxes had entered the market.

There are other reasons, including some smaller companies copying larger companies, which explains why companies like Maya Selva have FTC warning labels, even though the company is not a signee to the FTC consent decree.

Yes. And unless they are one of the seven manufacturers to have signed the FTC agreement, it's unlikely warning messages will need to be included.

Yes. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 60)

FDA's position is no, not at the moment. FDA believes that the warning messages that are required to be placed near a retailer's register would satisfy the need to place a warning label on a tube or an individual cigar.

FDA has explored this idea, but has yet to state whether it would be required for shipments. This wouldn't be required for any cigar that is sold with a warning label attached, but the agency has questioned whether this would be necessary for individual cigars that are sold to a customer without an affixed warning label.

Last Updated: May 24, 2019.

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