Every single year over 480,000 people die from cigarette-related illnesses, according to the CDC. And for every death, 30 people live with cancer, heart disease, lung disease and other smoking-related sicknesses. Thus, on the whole, 16 million people live with an illness caused by cigarettes, leading to $300 billion in total yearly costs. Because of these wide-reaching effects, many are thrilled with the FDA’s recent statement announcing an as-yet indeterminate plan to cut back on nicotine levels in order to tackle what the agency sees as the baseline problem: addiction. As of right now, it isn’t clear whether the FDA will order an all-at-once drop in nicotine or if the agency will phase in the changes over time. Some fear that if the plan is executed piecemeal, then consumers will just adapt and increase their daily intake. Even more worrisome is the FDA’s decision to extend regulatory compliance deadlines for e-cigarette manufacturers.
In announcing his grand plan, FDA Commissioner Scott Gottlieb said the following: “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.” The other half of his vision? An extension on compliance dates for newly regulated manufacturers in order to make a “more efficient” regulatory process.
According to the press release, the agency plans to take stock of its current scientific and regulatory resources. The FDA says it wishes to begin fulfilling the goals laid bare in the Family Smoking Prevention And Tobacco Control Act, a law that allows the FDA to lower nicotine levels. Additionally, with regard to the 2016 “deeming rule” – which extended the jurisdiction of the FDA over various tobacco products (including e-cigarettes) – the federal agency has decided to ease-up on some of the regulation’s scheduling. Specifically, the FDA has given extensions to tobacco companies that have recently become regulated to allow more time “to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.” Ultimately, the FDA wants to create a review process that is “more efficient, predictable, and transparent for manufacturers” (my emphasis).
Additionally, the agency will release an Advance Notice of Proposed Rulemaking (ANPRM) in order to open up the question to the public. The FDA hopes to gather data regarding the positive and negative outcomes of lowering nicotine levels. Mainly, Gottlieb and his cohorts seem concerned with youth addiction, as 90 percent of smokers had their first cigarette when they were below the age of 18 – a fact highlighted in the press release. Specifically, the FDA wishes to collect perspectives on the appeal of flavored vape-cigarettes. To that end, the agency wishes to answer the following questions: how many kids are turned on to smoking due to sweet, youth-oriented flavors? And conversely, how many adults are attracted by these flavors to the (purportedly) less harmful practice of smoking e-cigarettes?
Researchers Speak Up
The Huffington Post recently interviewed eight researchers to glean from them the potential impact of the FDA’s guidance. On the whole, the researchers seemed impressed with the basic idea, but maintained healthy skepticism due to the lack of an implementation plan and a lack of data supporting the underlying claims. To that end, Lynn Kozlowski, of the University at Buffalo School of Public Health and Health Professions, said the following: “We need to have more experience in the marketplace with optional trace-nicotine cigarettes […] When marketed years ago, they were a commercial failure, despite heavy promotion.”
In a larger context – one that includes a major push toward deregulation – it is difficult not to be skeptical of these measures, especially since there is no real plan regarding the reduction in nicotine levels. After all, the FDA’s guidance pushes compliance deadlines for e-cigarette manufacturers from 2018 to 2022. And just last year, those same companies lobbied to prevent the 2016 “deeming rule” from taking effect. Thus, until there is proof otherwise, the FDA’s announcement appears as a boon to large corporations, without any tangible effects for the greater public.