The FDA’s proposed ‘very low nicotine’ standard has a very low chance of helping

Rather than nudge smokers toward healthier behaviors, a new rule from the FDA would shove millions of Americans away from the legal market, fueling the development of a black market for traditional cigarettes.

This would threaten the effectiveness of the very regulatory system that health experts and policymakers have relied on to reduce tobacco use, potentially crippling future efforts to reduce the harms associated with smoking.

U.S. smoking rates have reached all-time lows under the current regulatory system. In a 2024 poll, only 11 percent of Americans reported having smoked a cigarette in the last week, down from 20 percent a decade ago and from 40 percent 50 years ago. Cigarette use has declined even more rapidly among young adults, with just 6 percent having smoked one within the last week, compared to over 30 percent 20 years ago.

Despite this progress, smoking remains the leading cause of preventable death in the U.S., and further efforts to reduce smoking have the potential to save hundreds of thousands of American lives. Unfortunately, the FDA’s latest proposal risks unintentionally jeopardizing those efforts.

The new rule, published Jan. 15 in the Federal Register, would reduce the allowable nicotine levels in cigarettes by up to 95 percent, banning nearly all cigarettes currently on the market. Only “very low nicotine cigarettes,” which are far less appealing to consumers due to the limited amount of the addictive substance, would remain legal.

Although very low nicotine cigarettes carry the same health dangers as traditional cigarettes, the agency reasons that if these undesirable cigarettes are the only option available to smokers, then they will have an easier time quitting. Indeed, studies have shown that the reduced nicotine exposure and dependence associated with smoking very low nicotine cigarettes make it easier to quit.

In a vacuum, this scheme could accomplish the agency’s goal of helping individuals quit smoking. Unfortunately, this plan overlooks a crucial reality: Prohibition only makes legally available cigarettes undesirable. The agency has no ability to reduce the nicotine content of illicit cigarettes.

When the Volstead Act of 1919 banned beverages with more than 0.5 percent alcohol, most consumers did not switch to the low-alcohol “near beers” produced by traditional manufacturers such as Anheuser-Busch. Instead, they sought out unregulated manufacturers for stronger alternatives. Similarly, if conventional cigarettes are banned, many consumers will turn to the black market rather than settle for legal very low nicotine cigarettes.

This shifting of sales to the black market would severely reduce policymakers’ abilities to influence the cigarette market, reducing the potency of future smoking reduction efforts. The current regulatory system would be powerless in an underground market, where black-market actors could simply disregard the rules.

Black-market dealers are unlikely to adhere to current cigarette packaging requirements for warning labels reminding consumers of the risks of smoking. They are not likely to comply with the strict retail regulations and identification requirements that prevent minors from purchasing cigarettes. And they won’t pay excise taxes, removing policymakers’ ability to influence the price of cigarettes.

Additionally, the current comprehensive track-and-trace system for cigarettes, which allows the government to monitor cigarette sales and usage, would become obsolete. This detailed data on distribution can be crucial for designing targeted intervention strategies, and its absence would hinder all future campaigns to reduce smoking rates.

This is not to say that the FDA should abandon all attempts to drive down smoking rates. The agency currently has significant regulatory control of the cigarette market, which it could put to better use by enacting harm-reduction strategies that encourage the use of alternative nicotine products. Studies have shown that these alternatives can encourage smoking cessation, even among individuals not actively trying to quit.

Comprehensive bans such as the very low nicotine product standard carry unintended risks that could strip the agency — and the consumer — of all control over cigarette production standards. The FDA would be foolish to adopt this measure.

Logan Calendine is a contributor to Young Voices and a policy analyst for Americans for Prosperity.

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