The FDA's New Mission to Lower Nicotine in Cigarettes

The FDA's New Mission to Lower Nicotine in Cigarettes

The U.S. Food and Drug Administration announced a plan on Friday to reduce tobacco-related disease and death by increasing regulations on tobacco and nicotine products. According to the FDA, manufacturers of combustible products (i.e. cigars and pipe and hookah tobacco) would have until August 2021 to submit applications for revised products while makers of non-combustible products like e-cigarettes would have until August 2022. British American Tobacco's stock fell as much as 11 percent.

The Tobacco Vapor Electronic Cigarette Association posted the commissioner's remarks on its website.

"These include proposals to reduce nicotine levels in cigarettes to nonaddictive levels; to regulate the use of flavors in tobacco products, including prohibiting the use of menthol in cigarettes; and to develop more effective tobacco cessation treatments in order to help more smokers quit".

"The risk is that he is never permitted to go forward with the bold components created to reduce cigarette use, while e-cigarettes and cigars remain on the market", Myers added.

For the first time, the federal government is proposing cutting the nicotine level in cigarettes so they aren't so addictive. Reynolds American, a division of British American Tobacco, said it was encouraged by the move and that the FDA had recognised "tobacco harm-reduction policies and the continuum of risk for tobacco products".

The product-approval requirement for e-cigarettes and cigars was part of the so-called "deeming rule", in which the agency decided that e-cigarettes would be subject to the same rules as conventional cigarettes.

Unsurprisingly, the big losers in this announcement were tobacco companies, which lost about $26 billion in market value after the announcement.

"Here's an opportunity to reframe the debate [about e-cigarettes]", Mitch Zeller, the FDA's director of the Center for Tobacco Products, said during Friday's news conference.

Scientists have been pushing the FDA to limit nicotine levels in cigarettes for more than 20 years. It will also not affect future deadlines for other provisions of the deeming rule.

The FDA wants to start a public conversation around the idea of lowering nicotine levels in conventional cigarettes to non-addictive levels and to determine potential public health benefits - or possible adverse effects - of doing so. The FDA "must also recognise potential for innovation to lead to less harmful products", Gottlieb said.

The FDA gained oversight of tobacco products in 2009 through the Family Smoking Prevention and Tobacco Control Act.

The FDA also delayed its regulation of additional tobacco products, such as e-cigarettes and flavoured vaping liquids, because it said it needs more time to set a comprehensive framework for regulation. Smoking is responsible for nearly half a million deaths per year, as well as half of all long-term smokers.

The FDA explained its focus on nicotine by pointing out the enormous impact of addiction.

"Philip Morris, many years ago, did try to market a low-nicotine cigarette, and there was no commercial market for it", Dr. Benowitz said.

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