Could your future cigarette purchase come with a little less nicotine? It’s possible, as the FDA revealed today a new multi-year roadmap intended to protect kids and reduce tobacco-related disease and death.
The FDA announced today a comprehensive regulatory plan that moves the issues of addiction and its relation to nicotine to the forefront of the agency’s efforts to implement the Family Smoking Prevention and Tobacco Control Act.
“Congress gave FDA powerful tools to help reduce the harms caused by tobacco use when it passed the Family Smoking Prevention and Tobacco Control Act in 2009,” FDA Commissioner Scott Gottlieb said today. “And it sent a strong signal by calling it the Family Smoking Prevention and Tobacco Control Act. To put it simply: it’s all about kids and families. Congress made that clear in the law. And we take that responsibility very seriously.”
To this end, the agency says it will use its rule-making authority and seek input on public health issues in determining how it should move forward with the regulation of nicotine.
According to the FDA, tobacco use remains the leading cause of preventable disease and death in the U.S., with more than 480,000 deaths occurring each year.
To reduce this number, the FDA plans to create a greater awareness that nicotine is addictive.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” Gottlieb said.
Gottlieb claimed that unless the FDA does something, 5.6 million young people could die prematurely later in life from tobacco use.
“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 – and we believe it’s vital that we pursue this common ground,” he added.
One step the FDA plans to pursue in order to reduce the prevalence of nicotine addiction is reducing the amount of nicotine found in cigarettes.
“Nicotine is astonishingly addictive,” Gottlieb said. “And when nicotine is attached to cigarette smoke particles, it’s not only highly addictive, but an addictive chemical mix of disease and death. So we need to take a fresh look at nicotine itself, and how the addiction that it causes relates to the potential harm of its delivery mechanism.”
The agency says it plans to begin a public dialogue about lowering the permissible nicotine levels in combustible cigarettes to non-addictive levels. This would involve reducing the amount of nicotine in cigarettes through product standards.
FDA intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.
By lowering the level of nicotine in cigarettes, the FDA believes it can decrease the likelihood that future generations become addicted to cigarettes, while also assisting those currently addicted to kick the habit.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” Gottlieb said. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products. To be successful all of these steps must be done in concert and not in isolation.”
Looking To Other Options
In addition to exploring a decrease in nicotine found in cigarettes, the FDA says it is committed to finding other innovative ways to influence public health changes.
The agency said today that it intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016.
This action, the FDA said, will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.
For example, the FDA intends to develop product standards to protect against known public health risks such as e-cigarette battery issues and concerns about children’s exposure to liquid nicotine.
Additionally, the expanded timeframe will allow manufacturers to develop higher quality, more complete applications informed by additional guidance from the agency, the agency said.
Under expected revised timelines, applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products like e-cigarettes would be submitted by Aug. 8, 2022.
The FDA says that it also plans to seek public input on other ways it can help protect public health related to new tobacco products.
This, the agency says, will insult looking for input on approaches to regulating kid-appealing flavors in e-cigarettes and cigars.
By seeking public input on the issues, the FDA says it will ensure that it has proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.
“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said.