FDA ponders lower nicotine levels to make cigarettes less addictive, easier to quit

Cigarettes of the future could have less nicotine, making them less addictive and making it easier for smokers to quit.

The White House on June 21 published plans for future regulatory actions that include the U.S. Food and Drug Administration’s (FDA) plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes.

“The goal of the potential rule would be to reduce youth use, addiction and death,” said the FDA announcement about the plans.

“Nicotine is powerfully addictive,” FDA Commissioner Robert M. Califf, MD, said in the agency’s news release. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives.

“The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age,” Califf said. “Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.”

The announcement did not include an exact date or schedule for proposed new rules on nicotine levels.

Nicotine addiction

Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Additionally, tobacco use costs nearly $300 billion a year in direct health care and lost productivity, according to FDA.

“While nicotine is not what makes smoking cigarettes so toxic, it’s the ingredient that makes it very hard to quit smoking,” the FDA announcement said. “Addiction to nicotine in combusted products is the main driver of sustained use of these products.”

Each year, more than half of adult cigarette smokers make a serious quit attempt, defined as quitting for at least a day, but most do not succeed due to the addictive nature of cigarettes, according to FDA.

A new nicotine product standard would make those products minimally addictive, possibly nonaddictive. That would help prevent experimenters, who mainly are youths, from starting and becoming regular smokers, said the notice posted by the president’s Office of Information and Regulatory Affairs.

The lower levels of nicotine also would advance health equity by addressing disparities associated with cigarette smoking, dependence, and cessation, according to the federal notice.

Smoking regulation

The action is the second major regulatory step by FDA this year affecting tobacco products, and another regulatory step could be coming.

In April, FDA proposed banning menthol cigarettes and flavored cigars to prevent youths from starting smoking and reduce tobacco-related disease and death. Menthol adds a minty taste and aroma to cigarettes, while adding flavors such as strawberry, grape, cocoa and fruit punch appeal to youths and young adults and make cigars easier to use, according to FDA.

The FDA action deals with manufacturers, distributors, wholesalers, importers and retailers who make, distribute or sell the products. FDA “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars,” the agency announcement said.

FDA is in a public comment period that lasts until July 5 for that ban.

On June 22, the Wall Street Journal, citing people familiar with the matter, reported the FDA is preparing to announce its order to Juul Labs Inc. to take its e-cigarettes off the U.S. market.