For Immediate Release: Mar. 23, 2018
"The FDA took an important step in 2016 to bring additional tobacco products under the agency’s oversight to help better protect Americans from the dangers of tobacco use. This rule provided the FDA with the critical footing necessary to effectively implement our new comprehensive tobacco plan announced last summer, which places nicotine – and the issue of addiction – at the center of our regulatory efforts,” said FDA Commissioner Scott Gottlieb, M.D. “As we continue to move forward with this multi-year roadmap aimed at significantly reducing tobacco-related disease and death, we’re aware of the ongoing interest into how ‘premium’ cigars fit into our policy framework. As such, we’re welcoming stakeholders to share any new and relevant information that could inform the FDA’s regulation of ‘premium’ cigars, and address the question of whether ‘premium’ cigars present different risks or patterns of use when compared to other combustible tobacco products, and therefore merit different consideration by the FDA. We’re committed to reviewing any new data and insights as we continue our important efforts to ensure all tobacco and nicotine-containing products are appropriately regulated."
Today, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) to seek comments and scientific data related to the patterns of use and resulting public health impacts from what are often referred to as “premium” cigars to inform the agency’s regulatory policies. This is one of three ANPRMs previously announced last summer as part of the FDA’s comprehensive plan on nicotine and tobacco regulation.
The agency is specifically requesting comments and information not previously submitted in response to the 2014 initial proposal to extend its authority under the Family Smoking Prevention and Tobacco Control Act to additional tobacco products, which ultimately led to the inclusion of all cigars in the 2016 final rule. That rule extends to additional tobacco products provisions such as mandatory age and photo-ID checks to prevent illegal sales to minors, premarket product review, required warning statements, ingredient reporting, health document submissions, harmful and potentially harmful constituent reporting, and the prohibition on marketing of modified risk products, e.g. those with "light," "low," or "mild," or similar descriptors, without an FDA order in effect.
Through the ANPRM, the agency is requesting new comments, data, research results, or other information on topics including, but not limited to: the definition of “premium” cigars, use patterns of “premium” cigars generally and among youth and young adults specifically, public health considerations associated with “premium” cigars including the health risks, and consumer perceptions of the health risks of “premium” cigars. The FDA will consider all submissions to help inform its regulatory decision making regarding “premium” cigars. The ANPRM will be available for comment for 90 days, beginning Monday, March 26, 2018.
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.