In an effort to reduce the risk of nicotine addiction and prevent disease and death from long-term cigarette smoking, the FDA is looking to cut the level of nicotine found in cigarettes to "non-addictive" levels.
"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 in a statement. It will also explore the role of e-cigarettes and other products in lowering harm from smoking. An Advance Notice of Proposed Rulemaking (ANPRM) is indented to be issued by the agency, through which seeking input on possible benefits on public health as well as any probable negative effects of decreasing the nicotine in cigarettes can be done.
The FDA was bestowed with the power to regulate nicotine levels in 2009 but the agency has not used it thus far.
Cigarette smoking is the leading cause of preventable disease and death in the United States, according to the U.S. Centers for Disease Control and Prevention.
E-cigarettes, which come in various flavors, may or may not contain nicotine, is an immediate substitute for cigarettes.
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For Matthew Myers, who heads Campaign for Tobacco-Free Kids, it was a good overall move but hit the e-cigarettes delay as "a serious error". Approval of the application is expected late in 2017 and sets the stage for BRAND-A to become the first approved tobacco product on the market that complies with the new guidelines.
"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", Myers said. New smokers create an addiction to "low tar" cigarettes as fast and easy as normal cigarettes.
Altria's wholly owned subsidiaries include Philip Morris USA Inc., U.S. Smokeless Tobacco Co. "The FDA's deeming rule still bans any innovation in the market and, without major changes to the agency's premarket review process, could still result in the vast majority of the market being banned in 2022".
In addition, regulations that outline the details on the information the agency expects to be included in the Modified Risk Tobacco Product (MRTP), Premarket Tobacco Applications (PMTAs), and reports to demonstrate Substantial Equivalence (SE) are meant to be released by the agency.