My column last month discussed one of the “endgame” approaches to finally end tobacco smoking. This approach is the “birthdate-based phaseout” of tobacco use whereby people born after a certain date would never be able to legally buy tobacco their entire lives. Over time, this would produce a total phaseout of legal tobacco sales and use.
Here’s another endgame approach: The reduction of nicotine in combustible tobacco, either progressively or abruptly, to non-addictive or minimally addictive amounts.
Combustible tobacco is the most toxic of tobacco products. According to the U.S. Food and Drug Administration this endgame strategy could result in 13 million smokers quitting over five years; it could prevent 33 million youth and young adults from becoming regular smokers and 8 million tobacco-caused deaths by the end of this century.
In 2009, Congress gave authority to the FDA to comprehensively regulate tobacco and nicotine products including limitation (but not to zero) of the amount of nicotine, the addictive component in tobacco. Although nicotine is not the direct cause of smoking-related diseases, it is integral in causation because nicotine addiction sustains the smoking behavior. Cigarette smoking usually begins in youth and nicotine addiction is important in the transition of adolescent experimentation to a lifetime of smoking.
In 2018, the FDA initiated a regulatory plan to investigate the reduction of nicotine in cigarettes with consideration of the risks and benefits to the entire population, both smokers and non-smokers.
According to Havard public-health professor Howard Koh, the tobacco industry has long contended that combustible tobacco use is about choice, not addiction. On one would think, then, that the industry would support reducing tobacco’s nicotine content. This isn’t the case.
A big question is whether to reduce nicotine to minimal levels abruptly or gradually. It seems counterintuitive, but smokers in a 2018 Journal of the American Medical Association study tolerated an abrupt change well. Abrupt reduction was also associated with greater reductions in smoking, dependence, and increased cessation.
Intuitively, one would also think that smokers who switch to very low nicotine cigarettes would smoke more and inhale more deeply to obtain their needed nicotine fix, thus actually increasing their exposure to tobacco’s toxins and carcinogens. However, the FDA notes studies demonstrating that smokers using minimal-dose nicotine cigarettes had difficulty discriminating between typical-cigarette nicotine levels and minimally-addicting levels, reducing their consumption.
For this strategy to work, it would be necessary to reduce nicotine in all combustible tobacco products, not just cigarettes, to prevent product switching. Exclusion of vaping products in the regulation should be considered. Although long-term studies of vapes are lacking, they are still thought to be less toxic than combustible tobacco. It would be important to have non-combustible nicotine products available, possibly including vapes, for those needing transitional nicotine supplementation.
The tobacco industry has been very adept in manipulating the design and composition of cigarettes to maximize addictiveness. Caution must be paid to the industry’s response to circumvent the nicotine limitation and undermine its effectiveness.
A recent article in the New England Journal of Medicine outlines these potential actions by Big Tobacco: physical and chemical redesign of filters; nicotine-loaded wrappers; tobacco additives to enhance nicotine delivery, bioavailability, or attachment of nicotine to brain nicotine receptors; addition of addictive nicotine derivatives without increasing actual nicotine; and addition of substances that would inhibit the metabolism of nicotine or of the reward neurotransmitter, dopamine, that nicotine ignites.
How this endgame strategy unfolds will be fascinating.
Richard D. Feldman, M.D. is an Indianapolis family physician and former Indiana State Health Commissioner who served in the administration of Governor Frank O’Bannon.
This is telling the story of 22nd Century Groups VLN products development along side of studies with the FDA. Big Tobacco has claimed that 22nd Group holds all the patents for the pathway to the development of a low nicotine plant, blocking their development. 22nd has developed plants at commercial scale and offered Big Tobacco access. Big Tobacco claims that it would take them a decade or more to come up with such a product. 22nd has offered them access through royalties.
Further, 22nd Century has a menthol product, that along with conventional VLN that would be a readily available off-ramp for current menthol cigarette smokers. The subject of an exemption for the menthol VLN, with the proposed menthol ban was broached in regulatory talks. VLN is in a unique category compared to all other MRTP authorized products in that it doesn’t support initiation or continued addiction to nicotine. Breaking the bond of addiction gives back choice to abstain from nicotine use.
There is only one combustible product that has been awarded an MRTP by the FDA. It is unique in that it has been shown by studies to greatly lessen the number of cigarettes consumed. It is also the only product in the catagory that does not initiate or maintain the nicotine addiction, as do all Big Tobacco products. With a menthol ban, the approved menthol VLN product would serve well as an off-ramp for menthol cigarette user. This possible exemption has been breached in regulatory discussions.