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US Proposed Cuts in Cigarette Nicotine Levels

07 August 2017
US Proposed Cuts in Cigarette Nicotine Levels

It aims at ensuring that the FDA has a scientific, as well as regulatory, foundation for the effective and proficient implementation of the Family Smoking Prevention and Tobacco Control Act.

Gottlieb, a cancer survivor and physician who was confirmed as FDA Commissioner on May 9, was expected to be friendly toward the e-cigarette industry since he previously held a financial interest in a so-called "vape" shop called Kure. In fact, based on the FDA's proposed approach to potentially mandate non-addictive levels of nicotine in tobacco cigarettes, 22nd Century Group might be the only company that can deliver such a product. It causes over 480,000 deaths per year. Tobacco is also blamed for nearly $300 billion a year in direct health care and lost productivity costs.

University of Pittsburgh researcher Eric Donny and his team found in their study that significant nicotine reduction, or by a good 90 percent, translated to smokers depending less on cigarettes as well as smoking fewer sticks.

The Food and Drug Administration is the federal agency that regulates cigarettes, and it has been working to limit how companies can advertise cigarettes to children and require labels that state upfront how unsafe the products can be.

A serious effort should be made to reduce the level of nicotine in combustible products.

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.

The agency plans to issue this guidance describing a new enforcement policy shortly.

Jamie Hartmann-Boyce, an expert at Britain's Oxford University and at the Cochrane Tobacco Addiction Group who was not involved in the BMJ research, said the findings suggested e-cigarettes may prove a useful tool in bringing tobacco use down.

Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

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

Friday's announcement will not affect other requirements, such as mandatory age and photo-ID checks to prevent illegal sales to minors. Future deadlines for other provisions of the rule, which includes needed cautioning statements, the listing of ingredients, required warning statements etc. will also not be affected.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA's proposal "represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and death". It also seeks to create rules balancing safety and e-cigarettes' role in smoking cessation, Gottlieb added.