The US Food and Drug Administration says that its release of an advance notice of proposed rulemaking (ANPRM) in respect of nicotine is a major step on the path to changing ‘dramatically’ the future of smoking in the US and saving millions of lives.
The ANPRM, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, is seeking public comment for consideration in developing a potential nicotine product standard.
The FDA believes that lowering nicotine to a minimally- or non-addictive level ‘could potentially save millions of lives, both in the near and long-terms’.
‘The ANPRM includes newly published estimates of one possible policy scenario for a nicotine product standard, including that approximately five million additional adult smokers could quit smoking within one year of implementation, compared to the baseline scenario,’ the FDA said in a note issued through its Center for Tobacco Products.
‘However, an even greater impact could be felt over time: by the year 2100, its estimated more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. This could result in more than eight million fewer tobacco-caused deaths through the end of the century.
‘In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced a new comprehensive plan that places nicotine – and the issue of addiction – at the center of the agency’s tobacco regulation efforts. As the cornerstone of the plan, the release of today’s [March 15] ANPRM is a major step on the path to dramatically changing the future of smoking in the United States and saving millions of lives.’
Meanwhile, Gottlieb said in a statement that the ANPRM provided a wide-ranging review of the current scientific understanding about the role nicotine played in creating or sustaining addiction to cigarettes. It sought comments on key areas, as well as additional research and data for public review, as the FDA continued its consideration of developing a nicotine product standard.
‘We’re interested in public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health?,’ the statement said. ‘Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result? As we explore this novel approach to reducing the death and disease from combustible cigarettes, it’s critical that our policies reflect the latest science and is informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment.’
Gottlieb said also that the FDA’s plan demonstrated a greater awareness that nicotine, while highly addictive, was delivered through products on a continuum of risk, and that in order to address cigarette addiction successfully, it had to make it possible for current adult smokers who still sought nicotine to get it from alternative and less harmful sources.
‘To that end, the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms,’ Gottlieb said. ‘This will be achieved through our ongoing regulatory work to develop several foundational rules, guidances, product standards and other regulations.’
Gottlieb said also that the FDA planned shortly to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – played in initiation, use and cessation of tobacco products. ‘A second ANPRM will solicit additional comments and data related to the regulation of premium cigars.
‘At the same time we’re also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches and lozenges that help smokers quit. This is a pivotal part of our overall public health approach.’
Gottlieb’s statement is at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601039.htm.