FDA moves to lower nicotine in cigarettes


An advance notice of proposed rulemaking (ANPRM) has been issued on Thursday by the U.S. Food and Drug Administration along with a new plan that hopefully will be making cigarettes less compelling or addictive.

Despite widespread efforts by U.S. regulators and the World Health Organization to stem the sale of cigarettes and their devastating public health consequences, smoking kills 480,000 Americans every year.

The proposal on "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes" aims to lower nicotine in cigarettes to minimally or non-addictive levels.

Gottlieb said on Twitter this is a "historic first step".

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.

Samir Soneji, an associate professor of health policy at Dartmouth's Geisel School of Medicine and the paper's lead author, said that advertising e-cigarettes as a means to quit or reduce smoking has done damage, mostly to young people.

But the later report also cited new evidence that subtracting the addictiveness from the cigarette equation would require reducing nicotine even further than the previously-suggested 95 percent cut.

"The announcement today is potentially the most significant public health step the Food and Drug Administration has taken in decades", Matthew Myers of the Campaign for Tobacco-Free Kids said to NPR. The exact methods the FDA will use to limit the nicotine content of cigarettes is not yet known however the overall direction has been made explicit.

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"If this could be implemented, it could be a tremendous boon for public health", Waxman said.

Gottlieb cited new estimates of "one possible policy scenario" that, in its first year of implementation, would boost by roughly 5 million the number of Americans who would quit smoking, and drive the USA smoking rate from its current level of 15 percent to as low as 1.4 percent.

Reduced-nicotine cigarettes - such as Marlboro Ultra Lights, which contain 0.5 milligrams of nicotine apiece - have been on the USA market for years, but they aren't very popular and smoking-cessation groups have been reluctant to endorse them, citing the harmful chemicals generated by any combustible product.

Any nicotine standards would need to be part of a "comprehensive package" that would include steps to encourage the development of less harmful products, the company said.

We all know that nicotine in cigarettes is harmful and keep wondering why the government does not take any action against companies that manufacture cigarettes! It could prevent 33 million people from falling prey to the habit by the end of the century and result in more than 8 million fewer tobacco-related deaths in that period.

"We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort", Gottlieb said.

Young people would benefit hugely from the proposed move, one lung health expert said.

In the coming weeks, Zeller and Gottlieb said, the FDA will launch two additional regulatory initiatives related to tobacco - one on the use of menthol and other flavorings, and another related to premium cigars.