March 15, 2018
The US Food and Drug Administration (FDA) is taking what it calls a historic first step toward eliminating cigarettes' addictive properties by seeking comments on the impact of lower nicotine levels, how lowering of nicotine levels might be accomplished, and whether doing so might have unintended consequences.
The agency said last July that it would eventually propose nicotine reductions as part of a comprehensive overhaul of its regulation of tobacco products. Today's announcement came in the form of an advance notice of proposed rule making — essentially, a document designed to elicit comments and show what direction the agency might take if it were to require lower nicotine levels.
"Given their combination of toxicity, addictiveness, prevalence, and effect on nonusers, cigarettes are the category of tobacco product that causes the greatest public health harm," said Mitch Zeller, director of the FDA's Center for Tobacco Products, in a briefing.
"Cigarettes are the only legal consumer product that when used as intended will kill half of all long-term users prematurely," he said, adding, "We've known for decades that cigarettes are highly engineered and designed to get users addicted."
In its notice, the FDA said it envisions "the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers."
Making less addictive cigarettes and less harmful nicotine products available could result in a median of 2.4 million fewer new smokers by 2025 and 33 million fewer by 2100. This would reduce the prevalence of smoking in the United States to 1.4% from its current 15%, according to an FDA estimate published online March 15 in the New England Journal of Medicine. More than 8 million smokers' lives would be saved by 2100, said the agency.
Tobacco use — largely cigarette smoking — remains the leading cause of preventable disease and death in the United States. It kills more than 480,000 Americans annually and costs more than $300 billion a year, said FDA Commissioner Scott Gottlieb, MD, in the briefing.
"There are few things as commissioner that can save so many lives, which is why I'm so committed to our comprehensive plan on nicotine and tobacco," said Gottlieb. He noted that the agency will soon be seeking comments on proposals to regulate premium cigars and to address flavorings in tobacco products.
The agency is also starting a project to "reevaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products, such as nicotine gums, patches, and lozenges, that help smokers quit," he said in a statement.
What Are Nonaddictive Levels?
Zeller said that the agency is seeking input on a variety of topics related to setting a new nicotine standard for all combustible tobacco products. One such topic concerns an appropriate maximum nicotine level to protect public health. Studies have indicated that a level of 0.3, 0.4, or 0.5 mg of nicotine per gram of tobacco filler would make a good maximum.
The agency also wants to know the best way to measure nicotine levels, whether a nicotine standard should be implemented all at once or through a gradual step approach, and whether unintended consequences might occur. Such unintended consequences might include illicit trade and efforts by addicted smokers to compensate for the reduced levels of nicotine by increasing how many cigarettes they use.
The FDA is soliciting comments on whether certain groups are more sensitive to nicotine's effects, and also on the technical aspects involved in reducing nicotine levels.
Zeller said evidence shows it's possible. He noted that for years, manufacturers have employed a variety of techniques to lower nicotine levels through plant breeding, chemical extraction, or genetic engineering.
Altria, the leading maker of tobacco products, said in the fall of 2017 that it had been working on developing a reduced-nicotine product for almost a decade. It also said it expected that the FDA's quest to require lower levels would take years to complete and that it could lead to various legal challenges.
If the FDA were to require less nicotine, the main goals would be to help addicted adult smokers quit or switch to less risky products and to prevent future generations from starting, said Zeller.
"Kids will always engage in risky behavior," he said. But in the future, children "would only be able to experiment with a cigarette that wouldn't be capable of creating and sustaining addiction," he said. "Were that to happen, that's where you get the demonstrable public health impact at a population level."
Rapid Action Needed
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said, "It is critical that the FDA move as quickly as possible to turn this plan into reality."
He noted that the agency's announcement was only a first step. "It will only have an impact if the FDA quickly develops and implements a final regulation," said Myers in a statement. "The FDA should issue a hard deadline for doing so."
In a statement, Harold P. Wimmer, national president and CEO of the American Lung Association, also urged the FDA to move quickly. He said the organization was pleased that "FDA's notice includes a robust scientific justification, including estimates that reducing nicotine levels in cigarettes could save almost three million lives by 2060."
Zeller said the agency would take comments on the proposal through mid-June and then decide whether it would proceed with a more formal rule-making process.
In the meantime, said Gottlieb, "we plan to take vigorous enforcement steps to make sure that tobacco products aren't being marketed to kids, including e-cigarettes. No youth should use a tobacco product."