FDA on Friday announced it intends to propose rules aimed at cutting the level of nicotine in cigarettes to non-addictive levels.
The negative health effects of cigarettes largely stem from tar and other substances inhaled through smoking rather than nicotine, AP reports. However, nicotine is what makes tobacco addictive.
According to FDA, tobacco use causes more than 480,000 deaths each year in the United States, making it the country's leading cause of preventable heart disease, cancer, and death. The monetary toll of "direct health care and lost productivity" stemming from tobacco use "total[s] nearly $300 billion a year," the agency said.
According to AP, FDA initially received authority to regulate nicotine levels in tobacco products in 2009. However, FDA has not yet exercised that authority.
On Friday, FDA Commissioner Scott Gottlieb said the agency plans to release an advance notice of proposed rulemaking to initiate a public conversation about cutting the level of nicotine in combustible cigarettes to non-addictive levels.
According to Gottlieb, FDA's Center for Tobacco Products also will assess whether curbing the level of nicotine in cigarettes could create a black market for products with more nicotine, as well as whether electronic cigarettes (e-cigarettes) and other forms of nicotine delivery could be used to help lower the health risks of smoking.
In addition, FDA also intends to release advance notices of proposed rules to collect public comment on the best way to regulate menthol and flavored tobacco products that critics say appeal to children—including a potential ban on menthol cigarettes.
Further, FDA said it intends to generate product standards designed to make the batteries used in e-cigarettes safer and to childproof packaging for e-liquids. The agency added that it would assess data on how premium cigars are consumed and potentially exempt cigars from the proposed regulations.
FDA also plans to assess how to facilitate access to and use of FDA-approved nicotine products that are designed to help smokers quit the practice, The Hill reports.
FDA delays safety review for e-cigarettes, cigars
Gottlieb also announced that in light of the agency's focus on nicotine regulation, FDA would delay the safety review of previously unregulated tobacco products.
Originally, the manufacturers of such products—including e-cigarettes, cigars, pipe tobacco, and hookah tobacco—had until 2018 to submit their products for review. FDA said it will issue guidance "describing a new enforcement policy shortly," but that it expected manufacturers of combustible products, such cigars, pipe tobacco, and hookah tobacco, would have until Aug. 8, 2021, to submit applications, while manufacturers of non-combustible products, such as e-cigarettes, would have until Aug. 8, 2022.
FDA said other rules governing e-cigarettes would remain in place, including regulations designed to prevent e-cigarette sales to minors. In addition, the agency said the upcoming deadlines on other requirements, such as a rule that manufacturers submit a list of ingredients for tobacco products to FDA, currently remain in place.
Announcing the agency's plans, Gottlieb said, "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."
He continued, "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use," adding, "Envisioning 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, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground."
Separately, Matthew Myers, president of the Campaign for Tobacco Free Kids, in a statement said the agency's plan to regulate nicotine was a "bold and comprehensive vision" that could "accelerate progress in reducing tobacco use and the death and disease it causes in the United States."
However, Myers also said FDA shouldn't delay its safety review deadlines for products already on the market. "This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush, and banana smash, to stay on the market with little public health oversight," he said.
Eric Donney, director of the University of Pittsburgh's Center for the Evaluation of Nicotine in Cigarettes, also praised the announcement, citing his research into how smokers who use cigarettes with 90 percent lower nicotine levels than is standard are less dependent on the products and consume fewer of them. Noting that the research debunks concerns that people would smoke more cigarettes to compensate for less nicotine, Donny said, "If you just reduce it a little, people might smoke more to make up the difference. They need to reduce it [between 95 and 97 percent]."
Tobacco companies say they'll work with FDA
Altria Group—which sells Marlboro cigarettes, as well as other brands—in the United States, said it plans to be "fully engaged" in FDA's rule-making process. "It's important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences, and must be technically achievable," company officials said.
Separately, British American Tobacco, the cigarette manufacturer that produces R.J. Reynolds cigarettes, said it looks forward to "participating in a thorough process to develop a comprehensive plan for tobacco and nicotine regulation."
According to AP, stock for Altria and other tobacco manufactures "plunged" after FDA's announcement (Wheeler, The Hill, 7/28; Swetlitz, STAT News, 7/28; Chappell, "The Two-Way," NPR, 7/28; AP/Los Angeles Times, 7/28; McGinley/Wan, "To Your Health," Washington Post, 7/28; Maloney, Wall Street Journal, 7/28; Kaplan, New York Times, 7/28; FDA release, 7/28).
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