President Biden on March 15 signed into law a massive $1.5 trillion spending bill containing a range of spending priorities. Tucked away in this bill is a small provision that allows the Food and Drug Administration to expand what is considered a “tobacco product” to include synthetic nicotine. This change specifically allows the FDA — under the federal Food, Drug, and Cosmetic Act — to regulate all lab-made nicotine products.
In practice, this means all manufacturers of synthetic nicotine products will now need to first submit an application, and receive approval from the FDA, before they can sell their products. A similar regulation restricting the retail of flavored cartridge-based e-cigarettes went into effect in 2020. That measure has since led to the rejection of more than 5 million vaping products.
Not surprisingly, the revised definition of tobacco is already being hailed as a win for consumers by public health advocates. However, the subtle change in language may have profound consequences for the industry and for those who believe tobacco risk-proportionate legislation is a much more effective, and market friendly, approach to advancing public health.
While it remains to be seen how aggressively the FDA will approach future applications for tobacco products, it seems fair to conclude that the department’s approach will continue to be top down and unlikely to differentiate between the large variation of products and their associated health effects. In practice, this will most likely mean very few new products will receive FDA approval, and many mom-and-pop vape and e-cigarette shops offering safer alternatives will suffer.
Tobacco risk-proportionate legislation offers a viable alternative to this heavy-handed approach to regulation because it recognizes that tobacco products exist along a spectrum and carry different levels of risk. For instance, traditional tobacco products like cigarettes and cigars use combustion and tend to be more harmful. However, other products like e-cigarette or vape pens use e-liquid heating, which tends to reduce the types of negative respiratory issues such as shortness of breath that are common in other tobacco products.
This isn’t to say that tobacco products are as safe as air, but not all are equally harmful, and some have even played a role in smoking cessation treatments. In fact, studies have shown vaping and e-cigarette products are 95 percent safer than ignited tobacco products.
In general, tobacco risk-proportionate legislation works by placing more stringent regulations on the most dangerous tobacco products and relaxing regulations on those that are not. This usually means creating legislative carve-outs. In order to incorporate this approach into the FDA application process, this would mean loosening restrictions for less harmful tobacco products of any kind, including snus, e-cigarettes and vaping.
Tobacco risk-proportionate legislation also avoids many of the common pitfalls of bans and prohibitions. As was true for alcohol in the 1920s, history has proved time and again that prohibitions of any kind are a terrible policy prescription for controlling risky behavior.
Yet in recent years, many state and local governments have chosen to enact bans anyway. For instance, states like Massachusetts, New Jersey and Rhode Island have all recently effectively banned the sale of e-cigarette flavors. In the case of Massachusetts, this has led to a 7.5 percent increase in the sale of more harmful combustible cigarettes, as consumers exchanged e-cigarettes for traditional tobacco. Some evidence suggests that other consumers simply drove across state borders to make their purchase.
Plenty of cities have also experimented with bans, often with similar results. For instance, in 2018 San Francisco passed a ban on flavored tobacco. However, that same year a study by the Yale School of Public Health found that following the ban’s implementation, the odds of local high school students’ smoking more than doubled. Others like Beverly Hills, have gone so far as to ban the sale of all tobacco products. Such stringent measures are shortsighted and unlikely to achieve the outcomes advocates desire. They may even contribute to the overcriminalization of banned substances.
Lawmakers should take lessons from these policy failures and seek to avoid more restrictive measures like those guiding the FDA application process. Instead, lawmakers should support legislation that is risk-proportionate and flexible to the diverse preferences of consumers. This will go a long way toward preventing unintended consequences, improving public health and protecting consumer choice.
