Summer Reading: Harm Reduction

For beachgoers on vacation looking to have a good time, it can be hard to prioritize health and put the cigarettes away. After all, cravings can be hard to curb and it’s difficult to defy pervasive peer pressure. Fortunately, products such as e-cigarettes offer smokers the sensation of a cigarette without the significant health risks associated with the deadly habit. Vapes are 95 percent safer than cigarettes and offer users a hit of nicotine without the harmful combustion associated with traditional tobacco products. Despite these overwhelming benefits, the Food and Drug Administration (FDA) is determined to regulate harm reduction products out of existence through an onerous pre-market review process. Regulators need to ditch the risk aversion and fear mongering and let beachgoers safely enjoy their vacations.

It is exceedingly difficult to kick the deadly habit of cigarette smoking. Author Earl Chinnici struggled mightily to end his 28-year addiction, lamenting, “I had not been at all fair to myself, or to anyone or anything near me, by keeping my cigarettes right there next to me or in my shirt pocket throughout the years.” In his book Maybe You Should Move Those Away From You, he offers an important insight into ending addiction: “it can help significantly to have some powerful weapons in your arsenal. Knowledge is a remarkably powerful weapon against cigarette addiction.” 

One critical piece of knowledge is the safety and effectiveness of reduced-risk products for weaning adults who smoke off cigarettes. According to a 2018 National Academies of Sciences report, “There is conclusive evidence that completely substituting e-cigarettes for combustible cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” These products are better for these adults who smoke families too because there is “evidence that second‐​hand exposure to nicotine and particulates is lower from e-cigarettes compared with combustible tobacco cigarettes.” Some regulatory agencies have opted to acknowledge the evidence. Public Health England (PHE) famously found in 2015 (and reaffirmed in 2018) that vaping is 95 percent safer than smoking. According to PHE director of health improvement Prof. John Newton, “It would be tragic if thousands of smokers who could quit with the help of an e-cigarette are being put off due to false fears about safety. We need to reassure smokers that switching to an e-cigarette would be much less harmful than smoking.”

Bizarrely, this groundbreaking finding has not resulted in a more permissive regulatory structure on the other side of the Atlantic. The FDA has received tobacco product applications for more than 26 million deemed tobacco products, largely e-cigarette and vapor devices. The agency has claimed to have made determinations on more than 99 percent of those 26 million applications. These decisions have almost all been rejections. The agency recently green-lit the e-cigarette brand Vuse Alto but limited approval to the tobacco flavor of the product. The FDA also approved the e-cigarette brand Njoy in its first authorization for a menthol-flavored e-cigarette product.

While these are welcome first steps, allowing more vibrant flavors such as banana and mango are key to getting smokers to kick their deadly cigarette habit. According to a 2022 peer-reviewed meta-analysis of more than 100 studies published in the journal Nicotine and Tobacco Research, “E-cigarettes may provide a reduced-harm alternative to cigarettes for smokers unwilling/unable to quit or serve as a path for quitting all nicotine products…Higher nicotine concentrations and the availability of a variety of flavors in e-cigarettes might facilitate complete substitution for cigarettes…Regulation of nicotine concentration and flavors aimed at decreasing naïve uptake may inadvertently decrease uptake and complete switching among smokers, reducing the harm reduction potential of e-cigarettes. Evidence-based effects of regulating nicotine concentration and flavors must be considered for the population as a whole, including smokers.”

Instead, the FDA has focused on the supposed risks of flavors for teenagers, who might get “hooked” on fruity vapes. The agency claims it has prioritized “enforcement against unauthorized flavored e-cigarette products that appeal most to kids, including certain candy-, fruit- and mint-flavored products.” Regulators have announced their, “commitment to dramatically limit children’s access to certain flavored e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities.” This commitment has been implicit in the FDA’s many marketing denial orders of reduced-risk products.

In kickstarting this crusade, the agency is ignoring its legal mandate from Congress to focus on the overall public health of the population, including adults and teenagers. According to the plain language of the Tobacco Control Act, the FDA must make regulatory marketing-based decisions on whether a product is “appropriate for the protection of the public health” of the overall population. As Georgetown Law scholar Eric N. Lindblom notes, “When FDA evaluates whether a tobacco control rule or order is appropriate for the protection of the public health, only the overall health impact on the population as a whole is relevant. Health impacts on specific subpopulations are relevant only to the extent they contribute to the overall net public health impact…[There is] equal priority given to reducing youth and adult tobacco use and harms.”

The exact meaning and legal implications of this mandate will soon be litigated by the Supreme Court. In July, Vaping360 reported, “The Supreme Court has agreed to review a lower court decision that found the FDA acted improperly when it denied marketing applications by Texas-based vape manufacturer Triton Distribution. The FDA petitioned the high court to accept the case. The decision to hear the case marks the first time the Supreme Court will consider a challenge to the fairness of the FDA’s vaping regulations… The court will hear oral arguments in the fall from lawyers for Triton and the FDA, and rule on the appeal in 2025. How the court decides will have a profound impact on the future of vaping and nicotine use in the United States.”

The Taxpayers Protection Alliance will fight for the rights of smokers to use reduced-risk products and will submit an amicus brief in support of Triton Distribution. This will not only (hopefully) persuade the Court, but also provide enough summer reading material for the next five years. Stay tuned!