FDA Issues Guidance for Submission of Warning Plans for Cigars
The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco.
What is a warning plan?
A warning plan details how a company plans to achieve random distribution of the required warning statements on cigar packages and advertisements. For each brand of a cigar product, FDA requires that all statements be displayed on packaging an equal number of times within a 12-month period. All statements must be randomly distributed in all areas that the product is marketed in the US. For advertising, all warning statements must rotate quarterly in an alternating sequence. There are six required warning statements:
- WARNING: This product contains nicotine. Nicotine is an addictive chemical.
- 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.
- There are two options for the reproductive health warning: 1) WARNING: Cigar use while pregnant can harm you and your baby, or 2) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight
Who submits the cigar warning plans?
A cigar product manufacturer, distributor, importer, or retailer should submit the warning plan. In most circumstances, FDA believes that manufacturers are most capable of creating a sufficient warning plan for packaging.
What is the compliance deadline?
Warning plans for cigars should be submitted to FDA by May 10, 2017 or 12 months before advertising and marketing begin, whichever date is later. FDA expects that a large volume of plans will be submitted near this deadline and thus suggests they be submitted as soon as possible to ensure they are reviewed in time to comply with the warning requirements that take effect on May 10, 2018. FDA has deemed it unlawful for cigar products to be produced, manufactured, or distributed in the United States without the packaging containing one of the required statements once the warning requirements take effect.
FDA encourages cigar product manufacturers, distributors, importers, and retailers to submit warning plans electronically, with all content in Portable Document Format (PDF) format. Electronic submissions must be submitted through FDA’s Electronic Submissions Gateway.
Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations. Registrar Corp can help tobacco product manufacturers determine how FDA’s guidance apply to their particular products. Additionally, Registrar Corp can also review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations. For more information, contact Registrar Corp at
+1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp