FDA Issues Guidance on Free Samples, Cigar Warnings

SILVER SPRING, Md. — The Food and Drug Administration (FDA) has issued guidance materials on two key regulations, cigar warning plans and the free sample ban, to help the tobacco industry navigate the regulatory landscape. 

The deeming rule — which went into effect on Aug. 8 — gave the agency the authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco. Part of that requires companies to submit warning plans for cigars. To that end, the FDA recently issued guidance for the industry to comply with the requirement.

According to the FDA, 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, the agency 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 United States. For advertising, all warning statements must rotate quarterly in an alternating sequence. The required warning statements are:

• 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.

According to the FDA, there are also two options for the reproductive health warning: WARNING: Cigar use while pregnant can harm you and your baby, or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

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, the agency explained. 

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. The cigar warning requirements take effect on May 10, 2018.    

The agency also issued a guidance detailing the ban on free samples.

The document explains, among other things, what activities and which persons are subject to the regulations, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through:

• non-monetary exchanges;
• membership and rewards programs;
• contests and games of chance; and
• business-to-business exchanges.

The agency is seeking public comments regarding its interpretation of the free sample ban detailed in the guidance. To read the guidance, click here.