FDA approves sale of reduced-nicotine cigarettes

Giving up cigarettes is easier when they contain less nicotine, a chemical stimulant that's highly addictive. That's the logic behind two new tobacco products now cleared for sale by the U.S. Food and Drug Administration.

Made by 22nd Century Group, Moonlight and Moonlight Menthol are combusted, filtered cigarettes that contain 0.2 to 0.7 milligrams of nicotine each, or 95% less than standard cigarettes, the FDA said Tuesday in a news release. 

The company expects to begin limited distribution of the cigarettes in the second quarter of 2020, a spokesperson for 22nd Century emailed.

Kenneth Warner, a tobacco expert at the University of Michigan's school of public health, called the idea "good in concept," but said he would be "astonished if there's much of a market for this."

Reduced-nicotine cigarettes have been around for decades, mostly for research, according to the FDA, while previous efforts to sell low-nicotine products have fallen flat. Philip Morris experimented with selling a line in the late 1980s, with limited success. 

Last year, the agency established rules for regulating nicotine in cigarettes so they are minimally addictive. But the agency has made little progress in outlining how or when it would begin imposing nicotine restrictions. And tobacco companies have signaled their opposition.

The FDA's clearance of the products is a "major milestone in our efforts to drive meaningful change in the tobacco industry," Michael Zercher, president and COO of 22nd Century, said in a statement.

Shares of the plant biotechnology company jumped 20 cents, or 24%, to $1.02, after the FDA's announcement.

Generally speaking, smokers of reduced nicotine cigarettes do not smoke more or inhale more deeply to make up for the lost nicotine, noted the FDA, citing its own scientific review. While data are limited, the agency does not expect non-smokers to start using the reduced nicotine products, and those who do are unlikely to develop nicotine dependence, the agency stated. 

Those scenarios were at times the case with "light" and "low tar" cigarettes from decades past. Those products have since been banned as misleading.

Still, while the FDA's move means the new products can now legally be sold in the U.S., it does not mean they are safe. While presumably less addictive, the reduced nicotine products still have similar health risks as regular cigarettes. Said the FDA: "There are no safe tobacco products, and those who do not use tobacco products should not start."

The U.S. smoking rate has fallen to an all-time low of 14% of adults, or roughly 34 million Americans. But smoking remains the leading cause of preventable disease and death in the U.S., responsible for some 480,000 deaths annually. 

Smoking causes most lung cancers, which kill more people than any other type of cancer, according to the U.S. Centers for Disease Control and Prevention. Nearly 143,000 Americans die each year from lung cancer, said the American Cancer Society.

The Associated Press contributed to this report.