Clearing the Smoke—What’s Really Behind FDA’s Proposed Flavor Rule

In a country where consumers have to be 21 years or older to even purchase tobacco, how do activists justify more government intervention?  The standard measure has always been the 30-day youth tobacco consumption rate. This rate has been in steady decline for decades, which is an inconvenient truth when your job requires a public health crisis to be relevant. Activist organizations pushing this product standard to the FDA have a clear incentive to keep moving the goalposts, irrespective of the actual facts. 

Youth Access and Adult Choice Limits

On December 20, 2019 a new national minimum age policy for tobacco (T-21) took effect.    Choosing to consume tobacco now requires more maturity than voting, joining the military, or owning a firearm.  This bold policy was even celebrated by some in the tobacco industry as a regulation to end future regulations.  Hardly the case . . . 

In reality, it meant the prohibitionists needed to move efforts to limit consumer choice more quickly.  With youth tobacco consumption having dropped 81.83% in the past twenty years (2001 to 2021)[1][2] anti-tobacco activism is losing relevance fast.  The solution – convince the Biden Administration to target minorities – identify the products that are popular in BIPOC and LBGTQ+ communities and ban them.  

Small Business & International Impact

In addition to the millions of adult consumers affected, no consideration has been given to the livelihood of retail managers and owners, who are often active members of the community.  Nor has any consideration been given to the impact the rule will have on the cultivators and processors in Central America. This proposed regulation will result in significant economic losses of jobs and small businesses, both domestically and abroad. That is why the Premium Cigar Association has called upon the FDA to conduct a more thorough economic and international analysis. 

FDA Needs Cigar Smokers to Inhale

This is the foundation of the health argument against flavored cigars.  Without this, the leap to equating cigar enthusiasts with cigarette smoking is simply too far.  And without conflating cigarette and cigar data, there is no public health crisis of which to speak. FDA makes this clear:

“Through cigar smoke, nicotine can be absorbed by inhalation (like cigarettes) or through the oral mucosa (like smokeless tobacco). Multiple studies found that cigar smokers inhale.”[3]

 “Studies demonstrate that not only is cigar smoking causally associated with many of the same diseases as cigarette smoking, but cigar smoking risks can also exceed those causally associated with cigarette use depending on the number of cigars smoked and the depth of smoke inhalation.”[4]

“The overall mortality rates for cigar smokers who inhale generally approach the same mortality rates observed for cigarette smokers.”[5]

To the casual observer, it’s a compelling argument.  If only cigar smokers were inhaling. Instead, their own clear scientific evidence is ignored: cigar smokers don’t inhale.  

FDA Knows the Reality

FDA’s most recent commissioned study by the National Academies of Science, Engineering and Medicine (“NASEM report”) reviewed all available research on the topic of cigar smoking.  Published in March 2022, among its conclusions were that cigar smokers are unlikely to inhale.[6] The review committee at NASEM even went further in explaining that most of the cigar inhalation data results from former and current cigarette smokers who also smoke cigars.  Even the National Cancer Institutes has conceded that typical use for cigars and cigarettes is not the same.

“While almost all cigarette smokers inhale, the majority of cigar smokers do not.”  [7]

“. . . non-inhaling cigar smokers have lower rates of coronary heart disease, COPD and lung cancer . . .”[8]

For its own credibility, FDA should at least rely on current data and be transparent when they are merely speculating. After all, the FDA is a sponsor of the Population Assessment of Tobacco and Health study, the U.S. government’s longitudinal survey on the matter.  Yet, when the facts muddy the anti-tobacco talking points, they slip back to the comforting habit of blending cigarette data with cigar data and referring to “smoking” as a catch-all generality to justify taking another bite out of the industry.

The Crux of the Effort

It’s never been a secret that activists are seeking a tobacco free society.  With an almost religious zeal. Moving the goalposts from cigarettes to flavored cigars is just a business decision.  This is no longer about public health, it’s about relevance for organizations with budgets rivaling major corporations to maintain operational significance. It is an unholy alliance between anti-tobacco advocacy groups and a regulator seeking a new power grab that runs counter to Congressional intent. 

Government has failed in its duty to consider the community impact and failed in considering the impact on our trade partners in Central America.  FDA made no effort to examine how this proposed rule will harm the very communities they are espousing to protect.  They have but a single motive, “this proposed rule, if finalized, would (…) increase cessation among current users.” [9]    

The premise of a “product standard” is a laughable charade. This is a ban on a product type without economic or health justifications for adult consumers. After all, it’s hard to choose to purchase a product that has been banned from sale.


Gomez, Yessica, MeLisa Creamer, Katrina F. Trivers, Gabriella Anic, Aura Lee Morse, Chad Reissig, and Israel Agaku. “Patterns of tobacco use and nicotine dependence among youth, United States, 2017-18.” Preventive Medicine 141 (2020): 1-6. Accessed May 12, 2022.

National Academies of Sciences, Engineering, and Medicine. 2022. Premium Cigars: Patterns of Use, Marketing, and Health Effects. Washington, DC: The National Academies Press.

National Cancer Institute. Cigars: Health Effects and Trends. Bethesda: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, 1998. Accessed May 12, 2022.

Wang, Yingning, Hai-Yen Sung, Tingting Yao, James Lightwood, and Wendy Max. “Health Care Utilization and Expenditures Attributable to Cigar Smoking Among US Adults, 2000-2015.” Public Health Reports 133, no. 3 (2018): 329-337. Accessed May 12, 2022.

“Youth and Tobacco Use.” Centers for Disease Control and Prevention. Centers for Disease

Control and Prevention, March 10, 2022.

“Youth and Tobacco Use.” Centers for Disease Control and Prevention. Centers for Disease

Control and Prevention, March 10, 2022.

“Youth Tobacco Surveillance — United States, 2001–2002.” Centers for Disease Control and

Prevention. Centers for Disease Control and Prevention. Accessed May 24, 2022.

[1] CDC, 2021 Youth Tobacco Use

[2] CDC, 2001 Youth Tobacco Use

[3] FDA, Proposed Flavor Rule (cigars)., 67

[4] FDA, Proposed Flavor Rule (cigars)., 71

[5] FDA, Proposed Flavor Rule (cigars)., 72

[6] National Academies of Sciences, Engineering, and Medicine. 2022.

[7] National Cancer Institute, ii

[8] National Cancer Institute, 5  

[9] FDA, Proposed Flavor Rule (cigars)., 84