FDA Mulls over Lowering Nicotine Levels in Cigarettes

FDA Commissioner Scott Gottlieb2 MD

Separate from the SPECTRUM research cigarettes program, 22nd Century was also chosen to supply the Company's proprietary Very Low Nicotine fine cut tobacco to the FDA for additional research.

"Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year". The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

With 22 Century's propriety technology/plant, they have effectively reduced the levels of nicotine in their cigarettes by 95%. 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 almost $300 billion a year. 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 meant to help smokers quit. He emphasizes that his must be the focus of the FDA's efforts and pursuit for common ground.

"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.

"We want to make sure those products, particularly the e-cigarettes, go through an appropriate set of regulatory dates to make sure they're safe, make sure they are meeting standards", he said.

So the plan is to reduce nicotine levels in cigarettes, while leaving it in other products, like aids to quit smoking and e-cigarettes.

Gottlieb also held out the possibility that premium cigars would be exempted from FDA oversight, but the overall outlook for traditional tobacco products appeared grim.

It's not the nicotine in cigarettes that causes lung cancer and lung disease, but rather the other chemicals released from burning tobacco, he said. The manufacturers are expected to continue marketing the products while the reviewing of the application is done by the FDA.

E-cigarettes, which come in various flavors, may or may not contain nicotine, is an immediate substitute for cigarettes.

Richmond, Va. -based Altria Group Inc. called the FDA's move "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".



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