The FDA Moves Forward on Efforts to Reduce Nicotine Levels In Cigarettes


FDA Commissioner Gottlieb Wants to Lower Nicotine Levels In Cigarettes to Reduce Smoking Rates


In a historic move, the Food and Drug Administration has announced their plans to reduce nicotine levels in tobacco cigarettes in an effort to reduce smoking rates.

FDA Commissioner Scott Gottlieb said that the FDA has issued an advance notice of proposed rulemaking (ANPRM) which described their plans for a policy that would set the limit of nicotine in cigarettes to non-addictive amounts, a regulatory step that Gottlieb believes could help avoid millions of smoking related deaths across America. 

“As part of our comprehensive plan on tobacco and nicotine regulation announced last summer, we’re issuing an advance notice of proposed rulemaking to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels,” Gottlieb said in a statement. Read the full statement here.

Although some concerns have been raised by anti-tobacco and anti-smoking groups who say that lowering nicotine levels will only encourage smokers to consume more cigarettes in order to get their nicotine fix, possibly increasing their exposure to carcinogens released from the burning tobacco.

“The FDA concedes that a ban on today’s cigarettes could have significant unintended consequence, leading to compensatory smoking, where smokers inhale more dangerous chemicals in an effort to get the nicotine they crave.” Stated by Jeff Stier, a senior fellow with the advocacy group Consumer Choice Center. 

Gottlieb had also stated that the question about compensatory smoking is one of the issues being reviewed as a part of their ANPRM. 

“It’s critical that our policies reflect the latest science and are informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment.” 

Through a recently published study by the New England Journal of Medicine, the FDA predicts that over 5 million adult smokers could quit smoking within a year of implementation of nicotine reduction in cigarettes, which is about 12% of the 40 million adults in the US who currently smoke.

“(Adult) smoking rates could drop from the current 15% to as low as 1.4%,” Gottlieb stated. “…this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century—an undeniable public health benefit.”


But where do vapor products fit in this new policy?


The growing popularity of e-cigarettes and vapor products have refocused the health debate in the position of nicotine as what keeps smokers from quitting. Vapor devices deliver nicotine without the carcinogens from burning tobacco cigarettes but also produce the satiety of the nicotine “buzz”.

“We see a historic opportunity here to potentially more rapidly migrate cigarette users into products that are modified-risk,” Gottlieb stated, but added that “the jury’s still out” on if vaping presents a benefit to the public’s health.

The director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that the FDA’s proposed regulations on tobacco would focus primarily on traditional tobacco products, which he had referred to as the most dangerous device for nicotine delivery due to the carcinogens from the burning tobacco.

Dr. Michael Fiore, a tobacco researcher from the University of Wisconsin, called the FDA’s new initiative “a potential game-changer.”

“When we talk to smokers, almost all rue the day they ever began smoking and became addicted,” Fiore said. “They dread the cost, the health impacts, what they’re modeling for their children. And 50% to 60% try to quit every year.

When asked if smokers would rally in protest against the FDA’s new policy, Fiore said that they are more likely to welcome a chance to be free of the chains of their addiction. 

They’re letting us know they don’t want to smoke. This is a clinical and public health action that will help them.”