Tobacco Asia

Tobacco Asia 33 SPONSORED CONTENT e-cigarettes, which reduce consumers' exposure to HPHCs in cigarette smoke. Such products are intentionally excluded from the proposal; a concrete example of risk-proportionate tobacco regulation at the highest level in the US; one that, surely, will help signal to consumers the salient reality that not all tobacco/ nicotine products are created equal and that some are much, much riskier than others. Is harm reduction finally having its day in America? It certainly deserves it. Though it remains the leading cause of preventable disease and death in the US, the prevalence of cigarette smoking is now at its lowest rate since record-keep- ing began. This decline has accelerated as uptake of reduced risk products (RRPs) has increased. Data from the National Youth Tobacco Survey suggests that 'youth smoking has nearly ceased to exist'. Youth vaping rates, which caused such alarm in the late 2010s have declined dramatically since 2019 too. If the rule is implemented; if large proportions of adult smokers quit or switch to safer alternatives this would likely be the public health victory FDA frames this as. But the 'ifs' are doing some legwork there. There can be little doubt that people who smoke prefer cigarettes with the current levels of nicotine: The only combustible product cur- rently compliant with the proposed standard has yet to gain a significant share of the US market. Problematically, regulated products (combustible or otherwise) will not be the only choices consumers will have. Both history and economic theory concur that regulations that restrict consumer access to popular, all-be- it stigmatized, products stimulate illicit markets. True, the most prevalent form of illicit tobacco in the US typically leverages tax-gradients between states to ship products from a low tax state to a high tax state; since the proposed rule will be implemented at the federal level it will not provide ad- ditional incentives for inter-state smuggling. True, the proposed rule would not ban cigarettes, but merely a (defining) charac- teristic of them. And true, safer alternative nicotine products, exempt from the proposed rule, could cater to those who are dependent on (or merely enjoy) nicotine. The availability of saf- er nicotine products will likely attenuate what might otherwise have been an overwhelming demand surge to illicit spaces. And substitutions to safer alternatives will accelerate the proposal's intended outcome: smoking cessation. Dr. King made all these points in the FDA press interview, and while we agree with these points, the reality might be somewhat more complicated. The dominant modality of illicit tobacco trade in the US could easily shift to international smuggling. Illicit vendors, or consumers for that matter, could add nicotine to otherwise compliant products. Formal prohibitions are not a necessary condition for stimulating illicit markets; the removal of desir- able product categories or characteristics is more than sufficient. And which agencies will enforce against illicit trade resulting from the VLNC rule, and with what resources? FDA's Office of Criminal Investigations (OCI) is responsible for criminal investigations into illegal activities involving FDA-regulated products but with 200 'special agents' to cover all 50 states and Puerto Rico, OCI seems ill equipped to tackle even a modest surge in illicit tobacco and would have to rely on other agen- cies including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and Immigration and Customs Enforcement (ICE) as well as local law enforcement to detect and prosecute violations. Those agencies, however, have other priorities. AFT, for example, dedicates only a tiny fraction of its special agents to illicit tobacco and ICE, along with state and local law enforce- ment agencies, may be expected to prioritize other violations, not least narcotics. If illicit tobacco markets did become a more pressing priority for law enforcement, there would be significant social justice implications; a concern raised by, among others, the ACLU in the context of FDA's proposed menthol ban. Given that smoking is concentrated in historically disad- vantaged communities, it is at least plausible that post-limit il- licit tobacco markets would be too. In that scenario, community police interactions could also be expected to be concentrated in those communities. Understandably, one of the motivations behind the nicotine cap is to protect against youth smoking. But unlike regulated markets, illicit spaces provide no opportunities to age-gate sales; those selling illicit tobacco have no incentive to ID their patrons. By undercutting the tax-inclusive prices of reg- ulated products, illicit tobacco reduces the price incentive that may otherwise curb demand, especially among price-sensitive groups including young people. FDA judges that the benefits of the proposed rule outweigh any harms flowing from resulting illicit trade, but Dr. King accepts that there may be some illicit market growth in response to the enacted rule. How to keep that to a minimum will take careful consideration. Transitions to safer alternative nicotine products may at- tenuate the demand shift to illicit cigarettes following enactment of the proposed rule. However, an overwhelming majority of the reduced-risk products that consumers use are still, techni- cally, illegal. Recent estimates suggest that PMTA-approved e- cigarettes represent less than 2% of the products that current frequent adult consumers use. Still, cigarettes are so dangerous, and alternatives may be less harmful, that substitutions from regulated combustibles to yet-to-be approved RRP is likely to be a net positive in terms of individual risk exposure. But re- placing combustible cigarettes with regulated RRP would be far better, providing all the benefits of quality control and product standards. If FDA expects safer alternatives to serve as a safety- valve against an illicit market response, it needs to approve more e-cigarette, heated tobacco, and oral nicotine products – includ- ing the kinds of products that consumers actually-enjoy. Just one day after the announcement of the proposed VLNC rule, FDA announced marketing authorizations for 20 varieties of Zyn nicotine pouches, concluding after extensive review that these products meet the 'appropriate for public health' (APPH) standard enshrined in the 2009 Tobacco Con- trol Act. Swedish Match waited almost five years for marketing authorization, including four amendments (one in response to a deficiency letter). Yet, this is the first time FDA has autho- rized marketing of oral nicotine products and the first time it has authorized any RRPs with flavors other than tobacco or mint/menthol. The latest announcement warrants cautious optimism that FDA may approve other nicotine pouch products; may finally approve other flavored RRP, too, provided they can satisfy the APPH standard; and may, perhaps, encourage additional manu- facturers to pursue the PMTA pathway. Time will tell if, under the incoming administration, FDA can build on this progress. A period of public comment for the proposed rule runs through September 15, 2025.

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