Nicotine takes Center stage

Altria on Friday described the US Food and Drug Administration’s Comprehensive Plan for Tobacco and Nicotine Regulation as an important evolution in the Agency’s approach to regulating tobacco products and a meaningful step forward in developing a comprehensive regulatory policy that acknowledges the continuum of risk.

‘We supported FDA regulation because, among other things, it created a framework for communication about reduced harm products,’ the company said in a note posted on its website. ‘Reconsideration of the rules and timelines for newly deemed products is an important and timely step in this effort.

‘The process outlined by the [FDA] commissioner today will allow all stakeholders the opportunity to participate in a science and evidence based regulatory framework which is “transparent, predictable, and sustainable”.

‘It’s important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable. Establishing a standard of any sort is a deliberative process, with multiple opportunities for interested parties to provide perspectives. We intend to be fully engaged throughout this process.’

In announcing its plan, the FDA said it would serve as a multi-year roadmap to better protect young people and significantly reduce tobacco-related disease and death.

The approach placed nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts, the FDA’s Center for Tobacco Products (CTP) said in a press note. The goal was to ensure that the FDA had the proper scientific and regulatory foundation efficiently and effectively to implement the Family Smoking Prevention and Tobacco Control Act.’

“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,” said FDA Commissioner Dr. Scott Gottlieb.

Among other aspects of the comprehensive approach, the FDA plans 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. This will help begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.’
• ‘Extend timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of Aug. 8, 2016. This will allow the agency to further examine how existing regulatory science can encourage innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. Under the expected revised timeline, the application deadlines for newly-regulated products would be as follows: combustible products, such as cigars and hookah tobacco, Aug. 8, 2021; non-combustible products, such as ENDS or e-cigarettes, Aug. 8, 2022.’
• ‘Further explore how best to protect public health in the evolving tobacco marketplace by issuing two ANPRMs to seek input from the public on a variety of significant topics, including: ‘The role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery’; and ‘The patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule’.

The FDA’s announcement was generally positively received, though it was acknowledged that some devils could lie lurking in the details.

The R Street Institute welcome the FDA announcement saying it would postpone a regulation, previously set to take effect this fall, that would have forced manufacturers to get agency approval for tobacco and nicotine products introduced to the market after February 2007. This costly process would, in practice, have resulted in the near-complete elimination of harm-reduction tools such as electronic cigarettes from the market.

R Street’s harm reduction policy director Carrie Wade said the FDA’s plans should be considered an important first step to reorient FDA regulation of tobacco products from a process designed to protect the sales and profits of the major cigarette makers to one designed to reduce tobacco-related addiction, illness and death.

“R Street has been one of the leading proponents of a harm-reduction approach to cigarette addiction, so to read today’s [Friday’s] announcement feels like vindication that someone is listening,” Wade said. “It’s taken a little while, but it seems the FDA is beginning to realize something the scientific community woke up to years ago: policies aimed at destroying the e-cigarette market actually would result in the unintended consequence of more smokers sticking with traditional combustible cigarettes.”

Jeff Stier, the director of the Risk Analysis Division of the National Center for Public Policy Research, said he applauded Gottlieb and the CTP for making sweeping changes to the Obama-era approach to tobacco regulation that would have effectively banned almost all e-cigarettes on the market today.

“The most significant change is that the FDA’s regulatory approach will now seek to implement a ‘tobacco harm reduction’ approach, recognizing that there’s a continuum of risk among different nicotine products,” he said.

“In other words, it will not impose onerous deadlines and ill-defined requirements for so-called pre-market tobacco applications.

“The FDA will first develop clear, science-based product standards before manufacturers would be required to submit applications.

“The FDA will now begin to develop new rules which will recognize that non-combustible lower-risk products such as e-cigarettes and next generation ‘heat not burn’ products should no longer be treated solely as public health threats. The FDA will instead embark on a rule-making process whereby the products will be regulated based on their risk profile. This approach, if implemented properly, will foster a robust market offering a range of options to smokers who wish to reduce the risk from smoking.”

Alex Clark, the CEO of the Consumer Advocates for Smoke-free Alternatives Association (CASAA) described the FDA plan as a positive step forward in preserving consumer access to low-risk vapor products. Most importantly, it said, the forthcoming guidance from the FDA would play a vital role in reducing harm for millions of Americans who continued to smoke and would benefit from honest information about low-risk alternatives to combustible tobacco.

“Delaying the deadline for pre-market tobacco applications from vapor product manufacturers is an important first-step.” said Alex Clark, CASAA’s CEO.

“CASAA and our membership have been asking for this delay since March as it allows science, genuine public health, and consumer needs – rather than ideology – to contribute to developing reasonable and achievable regulation of low-risk nicotine products.

“Too much of the current legislative and regulatory efforts are born out of fear and misinformation. As a result, policymakers and regulators are losing sight of the most important goal – reducing the harm from traditional combustible tobacco products.”

The Vapor Technology Association focused on the FDA’s granting of a four-year extension of the deadline for Premarket Tobacco Applications for electronic nicotine delivery systems (ENDS) until August 8, 2022. “This decision is a victory for science-based regulation and for public health,” said Tony Abboud, VTA’s executive director.

“By recognizing that US policies need to evolve to the current state of science which demonstrates that ENDS products are at least 95 percent safer than combustible cigarettes, FDA is taking a big step forward in protecting public health by acknowledging for the first time that ENDS are a harm reduction product and need to be regulated as such.

“By delaying the deadline for compliance for electronic nicotine delivery systems, FDA has also recognized that the current regulations have halted the kind of technological innovation that is key to ending this country’s reliance on combustible cigarettes, and that we need to implement clear and meaningful regulations that strike the right balance between consumer protection and fostering innovation.”

But not everyone agreed. Matthew L. Myers, resident of the Campaign for Tobacco-Free Kids, said the sweeping tobacco regulatory agenda proposed by Gottlieb represented a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and the death and disease it caused in the US. “Critical to his vision is his recognition that the components of his proposal need to work together as ‘a package deal – ‘it is really all or nothing,’ as he put it,” Myers said in a statement.

“At the same time, it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products.

“This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight. There is no reason to allow these products to stay on the market while developing and implementing the comprehensive strategy Dr. Gottlieb outlined today [Friday].”