For the first time in its history, the Food and Drug Administration is taking steps to propose a rule that would lower the amount of nicotine in cigarettes, thus making them less addictive. The move is part of a plan announced last summer to reduce tobacco-related disease and death in the U.S.
Under the potential plan, cigarettes would contain minimally addictive or nonaddictive levels of nicotine, with the goal of encouraging current smokers to quit or switch to e-cigarettes and other less harmful products, as well as preventing younger generations from becoming addicted in the first place.
The announcement by the FDA is the initial step in proposing a new rule or regulation. The notice, to be published Friday in the Federal Register, invites comments from the public over the next 90 days.
According to an analysis of one policy scenario presented by the FDA, about 5 million additional adult smokers could quit smoking within a year of implementing a new rule, and smoking rates could drop to 1.4 percent from current levels of 15 percent.
FDA Commissioner Scott Gottlieb Thursday called his agency’s move “historic” and “unprecedented.”
“This framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century,” he said. “Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes.”
The agency is looking for public input on several issues as they craft a potential rule, including what the appropriate maximum level of nicotine should be and whether the rule should be implemented all at once or gradually. Federal officials are also considering unintended consequences of nicotine reduction, including the impact on illicit trade.
Reaction from health groups, tobacco companies
Anti-smoking groups applauded the move, though they cautioned this was just the beginning of a lengthy process.
“It’s a game-changer in tobacco for sure,” said Chris Bostic, deputy director for policy at Action on Smoking and Health. “But I’m not holding my breath. The FDA has moved very, very slowly on all its tobacco efforts.”
Still, he said, “We welcome the effort.”
Tobacco companies also cautioned that the announcement was merely a starting point, but most have signaled a willingness to work with the FDA.
“Today’s advance notice is a request for information, not a proposed rule, and is the first step in a multiyear process that will require the agency to examine and resolve many complex issues,” said Murray Garnick, executive vice president and general counsel of Altria Group, in a statement. Altria is the parent company of Philip Morris USA.
“As FDA has acknowledged, any proposed nicotine standard would need to be part of a comprehensive package, which also includes steps to ‘encourage the innovation of less harmful products.’ Altria has already been preparing for any reasonable potential standard, and we plan to participate in every step of this process,” Garnick continued.
Tobacco kills approximately 480,000 Americans every year and, according to Gottlieb, costs the country nearly $300 billion annually in direct health care and lost productivity. The FDA has the power to regulate tobacco under the the Family Smoking Prevention and Tobacco Control Act, which was passed by Congress and signed into law by President Obama in 2009. The agency cannot, however, ban the product.
In addition to opening the door to a rule on nicotine levels, the FDA intends to make announcements about two other proposed tobacco rules soon: one on the role flavors, including menthol, play on the use of cigarettes, and another on regulating premium cigars.