FDA’s Nicotine Regulation Efforts

By: Mike Copperman, Executive Director of Cigar Rights of America

The U.S. Food & Drug Administration’s (FDA) Center for Tobacco Products (CTP) recently issued a quarterly update on its activities, along with an outlook for the Agency’s future regulatory actions. Among a number of other actions, CTP is now working to complete a proposal that would set limits on the amount of nicotine allowed in tobacco products. Such a rule could fundamentally reshape the entire tobacco industry, as the FDA has previously stated that their goal is to lower nicotine to “non-addictive levels.”

If applied to premium cigars, a nicotine limit could amount to a de facto ban on the premium cigar industry. As a result of the CRA-led court victory last summer, FDA rulemaking does not currently apply to premium cigar products, however, we continue to monitor this troubling action closely. Continued monitoring and engagement on this topic is critical, as FDA is currently appealing Judge Mehta’s decision, and, regardless of the outcome of the appeal the court case only struck down the FDA’s prior attempt and does not bar future re-regulation. 

While nicotine is not generally considered to be a carcinogen, there is no doubt that it is addictive. But not all nicotine containing products are created equal. In fact, every tobacco product will deliver nicotine in different ways, with different impacts on the body. CRA insists that any regulations meant to decrease nicotine levels must take those scientific differences into account, rather than imposing a one-size-fits-all solution.

Cigarettes and many vaping products are specifically designed to rapidly diffuse large quantities of nicotine into a smoker’s bloodstream through the lungs. Nicotine concentration in the body spikes rapidly in a manner that promotes addiction. Both product categories show patterns of use consistent with addiction, including a tendency to smoke or vape multiple times per day and difficulty abstaining from use. 

Premium cigars, on the other hand, are entirely different in use and therefore nicotine absorption. While premium cigars certainly contain nicotine, their smoke is not typically inhaled, as it has a higher pH than other tobacco products. Absorption of nicotine, then, is not primarily through the lungs, as it is with cigarettes and vaping products. This means that 99.97% of the surface area which cigarette and vape smokers expose to nicotine is avoided by people who enjoy premium cigars without inhalation.

Additionally, data from the Center for Disease Control on how premium cigars are used supports the understanding that premium cigars are significantly less addictive. A review of data on consumption patterns for premium cigars reveals that an average premium cigar user enjoys 1-2 cigars per month, rather than multiple cigars throughout the day. Further, a full scientific review by the National Academies of Science, Engineering, and Medicine looked at all the available literature on the premium cigar category and found no conclusive evidence that premium cigar use is linked to addiction. 

For years, CRA has been a vocal advocate for nuanced and evidence-based tobacco regulation. We have led the industry in asserting that premium cigars should be evaluated as a category separate from mass-market tobacco products and cigarettes and that our mortality, morbidity, and lack of youth usage and access concerns warrant exemption from FDA regulation. We see the FDA’s forthcoming treatment of nicotine products as a potential example of the FDA treating all tobacco and tobacco-related products as a monolith. 

As proven by our victory in federal court last August and established by the Reagan-Udall Foundation’s report in December of 2022, the FDA needs to be more deliberative in its efforts to adhere to its Congressional mandate of prioritizing the most significant threats to public health. A critical part of that is making decisions based on sound evidence and diligent research, a duty the FDA continues to shirk, a key finding of the Reagan-Udall Foundation’s report last year. 

While CRA generally does not take a position on policies surrounding nicotine salts, vapes, and pouches, we monitor the tobacco-regulation space diligently and want to share the FDA’s aggressive approach to nicotine regulation with our constituents to help articulate the manifold ways that the FDA’s approach to regulation needs to be improved. 

As the FDA considers rules that target products that contain nicotine in tobacco products, it is imperative that the Agency avoid overly simplistic metrics and superficially drafted policies that may not account for the nuanced differences between various nicotine delivery methods. Ultimately, the FDA’s goal remains the same: protecting public health. However, it is equally vital for the Agency to ensure that regulatory actions are rooted in a thorough understanding of the potential risks and benefits associated with each product so that the FDA’s resources are allocated in a manner that does the most good.

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