Source: FDA, 12/28/16

The Food and Drug Administration recently issued Submission of Warning Plans for Cigars, a guidance to assist industry who are required to submit warning plans related to required warning statements on cigar packaging and advertising. Those to whom this applies are required to submit a proposed warning plan to the FDA no later than May 10, 2017 (or 12 months prior to advertising or commercially marketing the cigar, whichever is later).

Among other things, the guidance specifies the information that should be submitted in a warning plan; when, where, and how to submit plans; and an example of a cigar warning plan.

Starting on May 10, 2018, in accordance with the FDA’s final “deeming” rule, cigars will be required to randomly display and distribute warning statements on their packaging and quarterly rotate the warning statements in advertisements. Once this requirement goes into effect, cigar packages must bear one of the following six warning statements:
1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
3. WARNING: Cigar smoking can cause lung cancer and heart disease.
4. WARNING: Cigars are not a safe alternative to cigarettes.
5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
6. WARNING: Cigar use while pregnant can harm you and your baby.

• Alternative to #6: SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.
In order to comply with these provisions, industry is also required to submit a proposed warning plan to the FDA. These warning plans are subject to FDA review and approval. This guidance is intended to assist those who will need to submit these plans.

For more information on this topic, please read the guidance.