States Don’t Need to Wait for FDA to Adopt Nicotine Reduction Endgame Strategies: Lessons from Flavored Tobacco Litigation

Andrew J. Twinamatsiko


Tobacco is the leading cause of preventable death, accounting for approximately 480,000 deaths per year in the United States. Nicotine—the identified drug in tobacco—is highly addictive, comparable to cocaine and heroin. Nicotine sustains tobacco use, causing repeated exposure to toxicants and carcinogens. The risk of nicotine addiction depends on the dose of nicotine delivered and how it is delivered. Children and young adults are especially vulnerable to nicotine’s addictiveness because their brains are still developing, and they may not fully appreciate the risks of tobacco use and addiction. For these reasons, policy makers have adopted several measures to prevent tobacco use initiation, such as raising the minimum legal sales age for tobacco products, restricting the sale of kid-friendly flavored tobacco products, and raising the prices of tobacco products. While these measures have helped achieve a great deal of success in the fight against the tobacco epidemic, there is more to be done. Because of nicotine’s addictiveness, it becomes important to seek more robust measures to ensure that these highly addictive products are removed from the market. One such measure is prohibiting the sale of tobacco products whose nicotine levels exceed specified thresholds. In June 2022, the U.S. Food and Drug Administration (FDA) announced its plans to propose a product standard that would establish maximum nicotine levels in cigarettes and other finished tobacco products. It is uncertain when a concrete regulatory measure will materialize from this announcement. But states need not wait for FDA action—they can use their traditional police power to regulate nicotine levels in cigarettes. This will not only minimize death and disease from tobacco products, but it will also create an evidence base for federal action and political momentum for such regulation across the county.  Although reducing the level of nicotine could be considered a tobacco product standard, whose regulation is preserved only for FDA, litigation related to federal preemption of state flavored tobacco laws has shown that states can permissibly restrict the sales of categories of tobacco products, including banning categories of highly addictive tobacco products.