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FDA takes ‘pivotal step’ to reduce smoking rates, deaths
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Today, the FDA issued an advanced notice of proposed rulemaking to lower nicotine in combustible cigarettes to minimally or nonaddictive levels.
This fundamental action advances the FDA’s comprehensive plan on tobacco and nicotine regulation to develop a nicotine product standard, make addiction to cigarettes harder to create or sustain and prevent millions of tobacco-related deaths in the United States, according to an FDA statement.
“Despite years of aggressive efforts to tackle the leading cause of preventable disease and death in the United States, tobacco use — largely cigarette smoking — still kills more than 480,000 Americans every single year,” Scott Gottlieb, MD, commissioner of the FDA, said in the statement. “Tobacco use also costs nearly $300 billion a year in direct health care and lost productivity. In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users.”
The advanced notice of proposed rulemaking includes an extensive review of how nicotine affects the creation or sustainment of cigarette addiction, according to the statement. The FDA is seeking public comment and input on the appropriate potential maximum nicotine level, how to implement a product standard (at once or gradually) and what unintended consequences may ensue from lowering nicotine levels.
An analysis evaluating one possible nicotine product standard included in the notice and also being published in the New England Journal of Medicine suggested that if implemented, approximately 5 million more adults may quit smoking after 1 year and 33 million individuals, mainly youth and young adults, would avoid becoming regular smokers by 2100, according to the statement. Additionally, the current smoking rate of 15% could drop as low as 1.4% and more than 8 million tobacco-related deaths could be avoided through the end of the century, according to the statement.
Gottlieb noted that although a potential nicotine product standard is at the forefront of the FDA’s approach, the FDA is also moving forward with other aspects of its tobacco and nicotine regulation plan, including better protection for children against the marketing of tobacco products, seeking comment on the role of flavors in the initiation, use and cessation of tobacco products, and modernizing the development of medicinal nicotine replacement products.
“We believe this unprecedented approach to nicotine and tobacco regulation not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain,” Gottlieb said. “As we move forward with these efforts, we have an opportunity to more formally solicit feedback, and we’ll continue to foster a public dialogue to re-shape our country’s relationship with nicotine and seek public input on policies that will guide us toward a healthier future.”
“This milestone places us squarely on the road toward achieving one of the biggest public health victories in modern history and saving millions of lives in the process,” he added.
Perspective
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Harold Farber, MD, MSPH
Protecting Youth from Tobacco and Nicotine: There Is So Much More That Needs to Be Done!
The tobacco industry has a track record of engineering their products to be the most addictive that they can be. Taking steps to make tobacco products less addictive is a good thing. The problem is that by focusing energy on decreasing nicotine in cigarettes, the FDA appears to be neglecting other tobacco products.
The FDA is deferring important actions that they can take now to protect our children. E-cigarettes, “vapes,” and “Juul” (an electronic nicotine delivery system designed to look a flash drive) are becoming amazingly popular with middle and high school students. Fruit and candy flavors attract young people to these products. Many harmful, carcinogenic and toxic ingredients have been identified in their emissions.
Research has repeatedly documented that youth who start on electronic cigarettes or other electronic nicotine delivery systems are more likely to go on using other tobacco products, including combustible tobacco. Cigars, hookah (water pipes) and chewing tobacco (dip) are also popular among youth, with fruit and candy flavors attracting young people to these highly addictive products. Although the FDA has issued a “deeming rule” to bring these products under their regulatory purview, they have yet to take action.
There are simple actions that the FDA can take now that will protect our youth from tobacco and nicotine — actions that have a strong evidence base to support them. First is to ban flavors, including menthol, from tobacco products. Flavors attract youth. Young people who start smoking with menthol cigarettes are more likely to go on to become daily smokers. Tobacco advertising, including media, internet and point of sale advertising, attracts youth to tobacco and should be severely restricted. Graphic warning labels that tell the truth about the sickness and disease caused tobacco should be mandated.
State and local governments can increase taxes on tobacco products and raise the age for sale of tobacco products to 21 — as many have already done. These actions also have been shown to protect youth from tobacco.
Needless to say, the tobacco industry vigorously opposes these actions. By effectively protecting our youth these actions would, over time, severely cut the tobacco industry’s business. The tobacco industry needs to addict young people. Although combustible cigarettes are extremely dangerous — they are not the only dangerous tobacco product. It is long past time for the FDA to step up to the plate and take effective action to protect our youth. What is needed, and can be done, is so much more.
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