O'Neill Institute | March 11, 2019
Documents produced in response to Freedom of Information Act (FOIA) requests show that FDA has abandoned its prior conclusion that certain rolls of tobacco for smoking labeled as “filtered cigars” and “little cigars” were actually cigarettes and therefore subject to more stringent public health restrictions and requirements.
This reversal is surprising given that “filtered/little cigars” are the same basic size and shape of conventional cigarettes, have cigarette filters, are typically sold in packs of 20, just like cigarettes, are perceived to be cigarettes by many consumers, and are actively inhaled just like cigarettes. In addition, allowing cigarettes labeled as “filtered/little cigars” to evade being regulated as cigarettes can cause serious public health harms because cigarettes are currently subject to much stronger and more comprehensive health-directed restrictions and requirements than cigars.
The FOIA documents do not explain why FDA has changed its initial finding that “filtered/little cigars” are actually cigarettes, which was originally presented in warning letters sent to four manufacturers of “filtered/little cigars” during the final weeks of the Obama Administration. The FOIA documents do present the arguments the manufacturers made against FDA’s determination that their “filtered/little cigars” were actually cigarettes and, consequently, were violating the ban on flavored cigarettes in the U.S. Tobacco Control Act. But those manufacturer arguments are not persuasive.
Based on available research, analysis, and other evidence – including a 2019 study by O’Neill Institute Director Eric Lindblom and Prof. Darren Mays at Georgetown University’s Lombardi Cancer Center – it appears that FDA could reach all “filtered/little cigars” currently on the U.S. market under the U.S. Tobacco Control Act’s cigarette definition.
FOIA Prime Time International Distributing
FOIA Southern Cross Tobacco Company
FDA Commissioned Study: Consumer Awareness, Perceptions, Attitudes, Behaviors, and Use of Little Cigars
FDA WARNING LETTERS
Prime Time International Distributing FDA Warning Letter
Southern Cross Tobacco Company FDA Warning Letter
Swisher International FDA Warning Letter
For Additional Information and Analysis, Please See:
- O’Neill Institute Press Release on Related Study: Lindblom Eric N., Mays Darren M., et al., “How and why consumer view “little cigars” as legally-defined cigarettes,” Tobacco Regulatory Science 5(2): 124-34 (March/April 2019).
- Delnevo, Christine D, et al., “Close, but no cigar: certain cigars are pseudo-cigarettes designed to evade regulation,” Tobacco Control 26(3):349-54 (2017).
- Delnevo CD, Hrywna M. “A whole ‘nother smoke” or a cigarette in disguise: how RJ Reynolds reframed the image of little cigars. American Journal of Public Health 97(8):1368-75 (2007).