Sixty years ago, the Surgeon General’s report on smoking marked a pivotal moment in public health awareness. The findings linked cigarette smoking to serious health issues, leading to widespread efforts to curb smoking rates and educate the public on the dangers of cigarettes. While significant strides have been made in understanding the dangers of cigarettes, a lingering misconception persists — conflating research on the health-outcomes for cigarette smokers with the health-outcomes for consumers who enjoy premium cigars. This conflation impairs the ability of the U.S. Food & Drug Administration (FDA) and other regulators to address the most pressing population-level health risks presented by tobacco products as mandated by Congress. As Cigar Rights of America (CRA) has long articulated, the scientific evidence surrounding premium cigars demonstrates clear evidence that they should be exempt from regulations designed to address the health outcomes for cigarette smokers.
The Surgeon General’s Report:
In 1964, the Surgeon General’s report formally, definitively, linked smoking cigarettes to lung cancer and other respiratory diseases for the first time. This document served as a catalyst for anti-smoking campaigns, warning labels on cigarette packages, and legislative actions to regulate tobacco use.
Over the next six decades, scientific research advanced and provided an in-depth understanding of the harmful effects of cigarette smoking. Smoking-related diseases, including heart disease, stroke, and various cancers, have been extensively documented in cigarette consumption. In our better understanding of cigarettes, public health initiatives have successfully reduced cigarette smoking rates, and have exposed the truth about the actions of cigarette manufacturers.
Despite advancements in scientific knowledge and understanding of cigarettes, there remains a persistent misperception that premium cigars are consumed in the same manner as cigarettes.
The Danger of Conflation:
Scientifically, premium cigars differ from cigarettes in several key aspects. Premium cigars undergo a different fermentation process, are not chemically altered, nor manipulated, to encourage inhalation, do not contain synthetic chemicals and adulterants, and lastly the method of consumption differs – premium cigar consumers typically enjoy a cigar without inhaling the smoke into their lungs. When addressing the question of addiction, premium cigars are uniquely different from other combustible tobacco products. According to the National Academies of Sciences, Engineering and Medicine (NASEM), “the magnitude of premium cigar dependence appears to be less than that of cigarette smoking and smokeless tobacco use dependence. The extent of addiction is likely to depend on the patterns of use.”
Despite these differences, public perception and regulatory frameworks often treat premium cigars similarly to cigarettes. This conflation can lead to misguided policies that do not appropriately address the unique characteristics and risks associated with each product. Premium cigars do not present a threat to mortality and morbidity at the population risk level and thus aren’t warranted for inclusion in FDA’s regulatory framework.
These issues were raised in a recent decision by U.S. District Judge Amit P. Mehta invalidating all FDA regulations on premium cigars. In his decision, which was based largely on FDA’s non-responsiveness to evidence submitted highlighting the differences in premium cigars, Judge Mehta emphasized the distinct nature of premium cigars and the absence of evidence demonstrating increased health risks, compelling the denial of FDA’s regulatory authority.
Examining health data related to premium cigars reveals significantly more positive outcomes than for cigarette smokers. Various independent third-party studies, including those from the National Cancer Institute and NASEM, indicate that premium handmade cigars are different and their impact on public health differs from other combustible tobacco products, particularly in areas such as inhalation, addiction, and mortality. National studies, including those from the New England Journal of Medicine and the Society for Research on Nicotine and Tobacco, show no statistically significant issues regarding youth access and appeal to premium cigars, a commonly cited problem that regulators use to justify regulation of the entire tobacco industry.
Notably, FDA has categorized premium cigars as the lowest priority for enforcement action, as stated in its January 2020 draft guidance entitled Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.
Unfortunately, all too often scientists and regulators treat tobacco products as a monolith. This not only punishes the premium cigar industry for harms they do not cause, but it also impairs the collection of good research data and harms public policy.
Science is harmed because, in the rare instances where ‘cigars’ are studied, researchers too often batch all premium and machine made cigars together, along with blunts. This, in turn, creates data that treats the use patterns and health outcomes for someone inhaling a blunt mixed with synthetic chemicals and other products with a premium cigar, which is not inhaled and only contains natural tobacco.
Public Policy is also harmed because the generalized findings lead to inaccurate regulations. FDA’s efforts to regulate premium cigars not only waste Agency resources focusing on a risk that they have acknowledged is not significant, but also has cost the tax-payer millions in a legal battle which they have so far lost at every turn.
When considering all of the available evidence and information, a picture emerges that reveals that premium cigars are nothing like a cigarette or other combustible tobacco products and are indeed unique and deserve different treatment than other forms of tobacco.
At a minimum, as NASEM has suggested, a definition of premium cigars should be adopted, and FDA, the National Institutes of Health, and other federal agencies should support research on premium cigars, compared to other large cigars, little cigars, cigarillos, and other combustible tobacco products. If the evidence is thoughtfully examined and considered within the scope of combustible tobacco products and the appropriate evidentiary standards, then premium cigars ought to remain outside the scope of FDA regulation.
A Call for Clarity:
As we reflect on 60 years since the Surgeon General’s report, it is crucial to reassess our understanding of different tobacco products. Acknowledging the distinctions between premium cigars, cigarettes, and other combustible tobacco products is essential for crafting effective public health policies. Mislabeling or regulating premium cigars as equivalent to cigarettes and other tobacco products may result in unintended consequences, including potential harm to an industry that is distinct from the mass-produced tobacco market. As science continues to evolve, our understanding should guide nuanced approaches that address the unique characteristics of premium cigars. It is critical that researchers and policy-makers alike recognize that premium cigars and cigarettes, despite their shared association with tobacco, are fundamentally different entities that warrant distinct research and regulatory efforts.