The agency is seeking to determine a level of nicotine in cigarettes and other tobacco products that would be minimally addictive or nonaddictive, according to a draft proposal.
Gottlieb, the commissioner of the FDA, said the announcement was "a significant step in our efforts to confront nicotine addiction in combustible cigarettes".
In addition, the FDA plans to issue a series of foundational rules and guidance documents that will delineate key requirements of the regulatory process, such as the demonstration of substantial equivalence and the submission of applications for new tobacco products. For context, most regular cigarettes contain about 10 to 14 mg of nicotine. The FDA also has to consider how quickly any rules could be implemented, and it will seek information on the costs, including costs to tobacco farmers.
Tobacco industry representatives, many of whom are seeking FDA approval for new "modified risk" tobacco products, cautiously applauded the focus on making smoking less unsafe. Gottlieb outlined a plan "to explore a product standard" applicable to all cigarettes that would lower nicotine content to levels below those likely to induce dependence.
The FDA is opening a 90-day public comment period on the proposed rule-making, and officials said they would evaluate the input and determine what steps to take next.
Although the overall rate of Americans who smoke is declining, public health gains are not evenly spread. This research was pivotal to establishing that smokers won't compensate by smoking more cigarettes or inhaling more deeply if nicotine levels are low enough.
So could these cigarettes actually work to reduce nicotine addiction and prevent tobacco-related deaths? Gottlieb said in the statement.
The Food and Drug Administration floated the proposallast summer, but provided new details in a government filing on the potential impact of drastically cutting nicotine from cigarettes, by as much as 80 percent. But more than 15 percent of USA adults remain addicted and tobacco-caused diseases still kill 480,000 Americans every year.
"To achieve its intended goal, we strongly believe that any future regulation must apply the nicotine reduction plan to ALL combustible tobacco products including cigars, little cigars, cigarillos and loose tobacco that can be used in roll-your-own cigarettes", according to Robin Koval, CEO and President of Truth Initiative.
Waxman spoke with the Los Angeles Times about the significance of the proposed regulations, how they might improve public health, and why he's not in favor of banning nicotine altogether. 'A ban on menthol, nicotine reduction; these can have an huge impact because menthol cigarettes are easier to pick up but harder to put down because they mask the harshness. "This is a clinical and public health action that will help them".
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