“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use."
Gottlieb said the agency envisions "a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources."
The new initiative could be good news for the e-cigarette industry, which portrays its electronic cigarettes as nicotine delivery systems that avoid the harmful consequences of smoking tobacco. On Wall Street, shares in Altria and other tobacco companies fell after the announcement.
Nicotine "the core of the problem"
Gottlieb said the FDA will try to "strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."
That may mean adjusting some of the deadlines the agency previously imposed on manufacturers of tobacco-related products, including cigars and e-cigarettes.
Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every year, Gottlieb noted.
"A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes," the FDA said in a news release.
The FDA said it plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit, it said.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Gottlieb.