The White House unveiled its 2022 Unified Regulatory Agenda and Regulatory Plan in January. Among the many proposals for lawmaking were details of potential Food and Drug Administration actions on tackling tobacco, most notably prohibiting the sale of menthol cigarettes and an enforced maximum limit of nicotine allowed in combustible tobacco.
One would need a time machine to gauge if these tobacco control ideas are to be successful.
Jain Gaurav, a Barclays analyst, noted in the Winston-Salem (N.C.) Journal that rules on a menthol ban in cigarettes and flavored cigars have moved to the “final rule stage,” as has the proposal to ban characterizing flavors in cigars. The nicotine cap proposed standard development is expected to be debated in May.
However, a key consideration for these plans is the time it would take to implement them. And, in the case of the nicotine cap, if the move will happen at all. Gaurav observed, “We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long 9-step process at the FDA, the inevitable litigation, and then the one year given to retailers to get rid of the excess inventory.”
Gaurav expects the menthol ban rule to be published by August 2023, remarking that “we expect a two- to three-year cycle from the day FDA passes any rule to the time such rule survives the inevitable court challenges.” He estimated that he didn’t expect to see “a menthol cigarette ban from the FDA implemented (if it were to pass) at least until 2026.”
Considering that 480,000 Americans die yearly in the United States of smoking, one must wonder how serious President Biden’s “cancer moonshot” aspiration is. By the time the FDA’s much-criticized nicotine cap idea is in place, nearly 5 million citizens who smoke will no longer be with us.
The nicotine cap revolves around cigarettes that have been scientifically developed to provide a negligible level of nicotine. Logic dictates that it will be easier to quit or help adults smoke less. The policy is an unprecedented gamble by the government (taxpayers), which has reportedly funded trials of these products at the cost of $100 million. Even with this massive amount of taxpayer money, it is debatable whether human behavior will match the highly optimistic predictions of the FDA. Likewise, there is no guarantee that menthol smokers will not simply switch to non-menthol cigarettes.
Instead of gazing into a crystal ball about what could happen in 2026 or in the next decade, it would be far better if the White House could focus more on doing something significant in the present.
Punting on measures that are, so far, only potentially useful in spreadsheets and computer models is just delaying take-off on the cancer moonshot when the president could instead instruct the FDA to better regulate reduced-risk nicotine alternatives to smoking that have proven in other countries to greatly assist in transitioning the market away from lethal combustibles.
It only takes a presidential order demanding the FDA stop acting on ideology rather than public health, and there could be a sensible regulatory plan for e-cigarettes and other lower-risk, non-combustible products in place in a matter of months.
A notification system for novel nicotine products, such as that employed by the United Kingdom and the European Union, should replace the FDA’s slow, expensive and heavily bureaucratic premarket authorization process. This would remove miles of red tape and help the United States enjoy the same astounding declines in smoking prevalence, and the subsequent improvements in public health, as in nations with a liberal approach to tobacco harm reduction.
Coupled with accurate communication of relative-risk messages to people who smoke cigarettes, approval of far more alternatives and encouraging risk-proportionate regulation could start immediately, and in any event, are prerequisites if a cap on nicotine levels in cigarettes is to be successful.
Instead, the White House document offers grandiose and experimental ideas that can begin only far in the future and only distract from the FDA’s failure to regulate in a manner that could drastically reduce smoking rates right now.
