The US Food and Drug Administration commissioner, Scott Gottlieb, M.D., yesterday issued a statement on what he said was the agency’s commitment to improving the efficiency and transparency of the tobacco-product application-review process.
The statement coincided with the FDA’s two-day (October 22 and 23) public meeting to discuss the policies and processes for such reviews.
‘When we first unveiled our comprehensive plan on tobacco and nicotine regulation, we set out to tackle the leading cause of preventable death in the US by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the risks associated with lighting tobacco on fire,’ the statement said.
‘As we continue to advance these policies to significantly reduce tobacco-related disease and death, including a particular emphasis on protecting kids from the dangers of nicotine, it’s critical that we have an efficient regulatory process that puts novel products like e-cigarettes through an appropriate series of regulatory gates to fully evaluate their risks and their potential benefits. Such products still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes. And those risks require closer scrutiny. We must also take a closer look at how these products impact youth use of nicotine and tobacco, and how they may promote adult cessation of combustible cigarettes.
‘As part of this ongoing work, this week we’re holding a two-day public meeting to discuss the policies and processes for tobacco product application review. The discussion on the tobacco product review process is important because the regulatory review of individual products gives the FDA the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users. ‘For e-cigarettes, for example, under the most likely path for marketing authorization, manufacturers of these products must show that marketing the product is appropriate for protecting the public health, taking into account their risks and benefits to the population as a whole. This includes evaluating whether these products get kids addicted to nicotine – a grave concern that we’re addressing through a variety of tools such as cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.’
The full statement is here.
FDA holds public meeting
