The US Food and Drug Administration (FDA) has announced a new comprehensive plan for tobacco and nicotine regulation to combat nicotine addiction.
The FDA said its plan would “serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death”.
The news sent shares of most of the major listed cigarette companies sliding, although there is a lot of lobbying to be done yet before the plan becomes concrete.
The tobacco lobby has proved itself formidable in the past at convincingly arguing that black is white, but these days few seriously contest that smoking cigarettes is a massive and potentially fatal health risk.
The FDA reckons 480,000 death in the US are caused by tobacco each year.
“In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year,” the FDA's announcement said.
“A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes,” it added.
The regulatory body said its new approach would place nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.
The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some time-lines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
“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,” said FDA Commissioner Scott Gottlieb, MD.
“Unless we change course, 5.6 million young people alive today will 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.”
Meanwhile, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.
Under expected revised time-lines, applications for non-combustible products such as ENDS or e-cigarettes would need to be submitted by Aug. 8, 2022, compared to its previous deadline of 2018.
Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
It looks as if the FDA is keen to shift nicotine addicts away from cigarettes or, to paraphrase the comedian Rob Newhart, shoving a load of leaves in their mouth and setting fire to them, on to e-cigarettes.
On the other hand, it did express concern at some of the flavors used in e-cigarettes that might be expected to appeal to adolescents.
The FDA intends to issue Advance Notices of Proposed Rulemaking (ANPRMs) to: seek public comment on 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 solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule.
Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.