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FDA In Brief: FDA provides guidance related to health warning statements required for cigars such as little filtered cigars and cigarillos as part of the agency’s oversight of tobacco products

For Immediate Release: Sept. 22, 2017

Media Inquiries

  Michael Felberbaum
  240-402-9548

"In order to meaningfully shift the trajectory of tobacco-related disease and death, we must continue to implement the provisions of the Tobacco Control Act and fulfill its mandate to ensure the public is aware of the potential harms associated with the tobacco products the FDA oversees. This includes making certain that required health warning statements are appropriately displayed on packages of cigars, including ones like cigarillos and flavored cigars that are particularly appealing to adolescents,” said FDA Commissioner Scott Gottlieb, M.D. “This guidance aims to provide clarity to cigar manufacturers and importers on the requirement that health warnings be prominently displayed on packages, in a way that accounts for both risk and how these products are being sold." 

The U.S. Food and Drug Administration issued a final guidance related to health warning statements that are required on cigar packaging following the 2016 final rule that extended the FDA’s regulatory authority to cigars, among other tobacco products. Beginning on Aug. 10, 2018, it will be unlawful for anyone to manufacture, package, sell, import or distribute any cigar within the United States unless the product packaging bears one of the following 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.
  • 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.

Under a compliance policy outlined in the guidance, the FDA does not currently intend to take enforcement action with respect to cigars in packaging that is too small or otherwise unable to accommodate a label with the required warning statement if the warning statements appear either: on the carton or other outer container or wrapper of the carton if the wrapper has sufficient space to bear the information; or on a tag otherwise firmly and permanently affixed to the package. Additionally, as outlined in the guidance and the 2016 final rule, cigars that are sold individually without any packaging, which could include what are often referred to as premium cigars, may satisfy the requirements with warning statements posted at the point of sale.

In July, the FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. As part of this effort, the FDA plans to issue foundational rules to make the regulatory process more efficient, predictable, and transparent for manufacturers and importers, while upholding the agency’s public health mission. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

For More Information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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