The U.S. Food and Drug Administration will focus on reducing nicotine levels in cigarettes to make them less addictive, while also making other nicotine products — including patches and gum — safer, agency officials said Friday.
In addition, the FDA is delaying implementation of last year’s rules on cigars and e-cigarettes currently on the market until 2021 and 2022, respectively. That will allow time to ensure the regulatory standards are appropriate, FDA Commissioner Dr. Scott Gottlieb said at a morning media briefing.
“We want to make sure those products, particularly the e-cigarettes, go through an appropriate set of regulatory dates to make sure they’re safe, make sure they are meeting standards,” he said.
Central to the FDA’s new approach to tobacco control is the belief that products such as e-cigarettes and cigars should not be used by kids. Rules are needed to deal with “kid-appealing” flavors, Gottlieb said.
Patricia Folan, director of Northwell Health’s Center for Tobacco Control in Great Neck, N.Y., applauded the FDA’s attention to teen smoking.
“Addressing the detrimental role of flavors, including menthol, in the initiation of tobacco use will be a very significant step in reducing tobacco use among our youth,” she said. “Not only are flavors attractive to youth, but are also harmful to lung health.”
Cigarette smoking is the leading cause of preventable disease and death in the United States, according to the U.S. Centers for Disease Control and Prevention. Studies have shown that most cigarette smokers start as teens, and the FDA wants to prevent them from getting hooked in the first place, potentially stemming rates of lung disease.
But the American Lung Association believes kids will suffer if the FDA delays implementation of the e-cigarette and cigar rules.
“The Lung Association is concerned,” said Erika Sward, the association’s vice president for national advocacy. “What we are seeing here is that FDA, under the framing of a new approach, is weakening public health protection for e-cigarettes and cigars, and they are punting protection for kids down the road for five years.”
Probably the most significant part of the FDA’s new proposal is “advancing a regulation to reduce nicotine levels in combustible cigarettes to nonaddictive levels,” Gottlieb said.
If cigarettes are no longer addictive, “we can take a more balanced approach to some of the newer innovations that might have the potential to help current combustible cigarette smokers transition off combustible cigarettes and on to products that might be less harmful,” Gottlieb said.
It’s not the nicotine in cigarettes that causes lung cancer and lung disease, but rather the other chemicals released from burning tobacco, he said. Nicotine, however, is the addictive element.
Matt Myers, president of the Campaign for Tobacco-Free Kids, said the FDA’s broad approach is inventive. But he worries it may stall.
“The vision Gottlieb painted in its entirety is the most comprehensive approach to reducing the death and disease from cigarette smoking that we have seen from the FDA,” Myers said.
“The risk is that he is never permitted to go forward with the bold components designed to reduce cigarette use, while e-cigarettes and cigars remain on the market,” Myers added.
Any plan to get the tobacco industry to create lower-nicotine cigarettes will be a lengthy process. It must take into account the problems observed with previous low-nicotine cigarettes, namely that people smoke more and inhale more deeply to get the same nicotine hit.
Gottlieb said other issues may arise, such as a black market in high-nicotine cigarettes.
The FDA thinks exploring safe ways to deliver nicotine in products like e-cigarettes and nicotine gum is essential for their users.
“Here’s an opportunity to reframe the debate [about e-cigarettes],” Mitch Zeller, the FDA’s director of the Center for Tobacco Products, said during Friday’s news conference.
“We need to ask some tough questions about the benefits and potential risks about any new technology. But those questions should be asked through a reframing of what’s it going to take to address the leading cause of disease and death related to tobacco use, which is cigarettes,” he said.
The agency will also review its position on premium cigars, reopening a discussion on special regulations for these cigars, he said.