On June 21, the U.S. Food and Drug Administration announced its plans to introduce regulations on the nicotine levels in cigarettes for the first time in history. The proposed regulations would put a cap on the amount of nicotine in combustible tobacco products in an effort to reduce the addictiveness of these products.
"While nicotine is not what makes smoking cigarettes so toxic, it's the ingredient that makes it very hard to quit smoking," the FDA wrote in its announcement. "A product standard, if proposed and then finalized after a thorough process, would make those products minimally- or non-addictive."
The fact that nicotine is addictive has been well-known for decades, but it still has never been regulated by the FDA. Already, tobacco companies have come out to say that any regulations on nicotine by the FDA would be unlawful and government overreach.
Along with aggressive lobbying and political action from tobacco companies, part of the reason why nicotine is still less regulated than both makeup and pet food, according to NPR, is a Supreme Court ruling from 2000 that blocked the agency from regulating with nicotine without express Congressional approval. In 2009, Congress finally gave the FDA that permission, but it has so far been either unwilling or unable to get regulation approved.
While traditional smoking is declining in the U.S., tobacco use is still the leading cause of preventable death and disease in the country, leading to 480,000 premature deaths each year, according to the FDA. In addition to the loss of life, nicotine-related medical problems cost around $300 billion each year in medical costs and reduced productivity.
"Nicotine is powerfully addictive. Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives," FDA Commissioner Robert M. Califf, M.D., is quoted in the agency announcement. "Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit."
The new regulations from the FDA are set to be introduced on May 2023, but details on the nicotine cap have not yet been released. If the regulations come into effect, the U.S. will be the second country, behind New Zealand, to take such a significant step to cut tobacco use.
"This one rule could have the greatest impact on public health in the history of public health," said former-FDA tobacco center director Mitch Zeller. "That's the scope and the magnitude we're talking about here because tobacco use remains the leading cause of preventable disease and death."