• April 21, 2024

The Bigger Picture

 The Bigger Picture

Photo: Alicia

Photo: Alicia

The FDA is fiddling with menthol and nicotine while undermining some of the most powerful tools in the tobacco harm reduction armory.

By George Gay

Earlier this year, the secretary general of the United Nations, Antonio Guterres, warned that the era of global warming had ended and given way to the era of “global boiling.” In other words, our world is heading for hell in a handcart, a direction of travel partly determined by our failure to see the wood for the—burning—trees. Let me elucidate using an example close to home.

Also this year, the U.S. Food and Drug Administration turned down a marketing application for a menthol vaping product, in part on the grounds that the applicant company had failed to present “sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

I find it incongruous that, at a time of existential crisis, this issue was even partly occupying the time of one of the top scientific agencies charged with protecting public health in the world’s third most populous and, arguably, its most technically advanced state.

Of course, it could be argued that life goes on up to the point of complete environmental breakdown, and, anyway, I cannot blame the FDA, which, I assume, is merely following orders. But the agency must take some responsibility for allowing itself to follow the now well-trodden path that has “advanced” science to the point where it is drowning in its own minutiae to the point where scientists are largely unable to step back and look at the bigger picture inhabited by people—adults who don’t need scientists to tell them whether or not menthol provides them with a benefit.

In fairness, I should say that this phenomenon is by no means restricted to science and scientists. Those in authority are generally wading through the treacle of microeconomics and micropolitics but are seemingly unable to understand life at a street level. They—we—are fiddling while Rhodes burns.

Nevertheless, it is the FDA that I am interested in here because it seems to be fiddling with menthol and nicotine while undermining some of the most powerful tools in the tobacco harm reduction armory and encouraging cigarettes to burn on. 

Menthol

In a news story dated April 28, 2022, the FDA announced it was proposing “product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars.” These actions, the agency wrote, “have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction and increasing the number of smokers … [who] quit.”

On face value, this proposal seems to represent an important step in improving public health, but if it is, you have to ask why it has taken the FDA more than 14 years just to reach the proposal stage. In passing in 2009 the Family Smoking Prevention and Tobacco Control Act (TCA), Congress handed the FDA authority to regulate the manufacturing, marketing and distribution of tobacco products with the aim of protecting public health. The TCA, among other provisions, banned the manufacture, import or sale in the U.S. of cigarettes and roll-your-own tobacco with characterizing flavors, including mint, but it exempted menthol, thereby handing the FDA a logical absurdity—an absurdity that the FDA underlined recently when, in the announcement about its proposed menthol product standards, it described menthol as a “flavor additive with a minty taste and aroma.”

Nevertheless, the menthol exemption wasn’t a free pass, and in 2010, the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) was asked to review the scientific evidence concerning menthol, which it did, concluding the next year that a ban on menthol in cigarettes would benefit public health. Through the courts, the tobacco industry successfully questioned the validity of the TPSAC review, and subsequently, the FDA conducted its own evaluation of menthol cigarettes, which also concluded that such a ban would benefit public health.

On my reading, the case against menthol is flimsy even though the FDA claimed in a summary of its Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes that consistent patterns emerged. “While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults,” the FDA reported. “Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking.”

Leaving aside the question as to whether it is possible to quit smoking unsuccessfully, it is valid to ask whether there is enough evidence here to convict. Clearly, the FDA concedes that the presence of menthol in cigarettes does not increase the risk of smoking, and youth initiation is a policing issue. And what would a jury make of “… adequate data suggest [my emphasis] that menthol use is likely [my emphasis] associated …” and “… data indicate [my emphasis] that menthol in cigarettes is likely [my emphasis] associated ….”

Finally, while a ban on menthol cigarettes and the FDA’s seemingly de facto ban on menthol vapes might seem to be a consistent approach, it is surely counterproductive. Since providing access to advanced vaping products is the most efficient method of getting smokers to quit, it would seem logical to assume that the best way of encouraging the smokers of menthol cigarettes to quit would be to provide them with access to menthol vapes.

Nicotine

Meanwhile, just over a year ago, the FDA issued a press note on reducing the addictiveness of cigarettes in which the agency’s commissioner was quoted as saying that nicotine was “powerfully addictive” and that “[m]aking cigarettes and other combusted tobacco products minimally addictive or nonaddictive would help save lives.”

The next paragraph had it that “[a] paper published by the FDA in the New England Journal of Medicine in 2018 projected that by year 2100, a potential nicotine product standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4 percent and more than 8 million fewer people dying from tobacco-related illnesses.”

Sounds impressive? Perhaps, though “… potential nicotine product standard could …” sounds less than convincing to me, and the above should have read, I hope, “… 33 million people, who otherwise would have, not becoming regular smokers ….” But the important question you need to ask is would the number of smoking-related premature deaths fall in the period up to 2100? Let me explain.

The second paragraph of the press note opens with the statement that has become almost de rigueur in the case of FDA communications: “Each year, 480,000 people die prematurely from a smoking-attributed disease ….” Now, 480,000, that is the same number of people who were said to have died prematurely from smoking-attributed diseases annually between 2005 and 2009.

In 2009, the year the TCA was signed into law, the U.S. population was about 306 million, and the adult smoking rate was about 21 percent, meaning there were about 64 million smokers in the country. Currently, the population is about 334 million, and the smoking rate is about 12 percent, meaning there are about 40 million smokers. What this seems to mean is that the FDA has managed to hold the annual premature death toll from smoking-attributed diseases at 480,000 during a period when the number of smokers has fallen by more than 37 percent. That gives a whole new meaning to the word “control” in the Tobacco Control Act.

Even if these figures are not quite as they seem to be, the question must be asked whether the FDA is on the right track. I think there are a number of reasons to suggest that it is not, but the most important is that the agency seems to favor the speculative over the obvious. For instance, if you follow one of the links from the press note, you will come to a passage titled “Where do e-cigarettes fall on the continuum of risk,” which includes a statement saying, “many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes,” a statement qualified by “[t]hough more research on both individual and population health effects is needed.”

This is obfuscation—a two-way bet. You’ll notice the statement doesn’t spell out why this extra research is needed. And, typically, it gives no indication of how long is needed for such research. Of course scientists say more research is needed. I believe more stories are needed.

E-cigarettes and noncombustibles clearly provide a fast-track route for many people out of smoking, and relatively harmless recreational drugs for nonsmokers, but the FDA seems intent on holding up the development of such products and their launch onto the market and even seeks to remove them from the market, especially if they even whisper the word menthol.

Contrast this obstructive attitude to e-cigarettes with the FDA’s promotion of low-nicotine cigarettes, the consumption of which will keep smokers inhaling tar, which the agency sees as the dangerous component of tobacco smoke. Such promotion has been allowed even though the “science” of low-nicotine cigarettes and addiction seems little understood by the FDA. The press note was titled “FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products.” Plans for proposed rule? That is one mighty qualification. It brings to mind the strapline to the movie O Brother, Where Art Thou?: “They had a plan but not a clue.”

The heading uses the term “addictiveness,” implying there are levels of addictiveness, an idea I have always found odd. Surely, addiction implies a compulsion to do or consume something that causes harm, and there can be no degrees of compulsion. Smoking might be considered addictive, but vaping cannot because vaping does good, not harm, in allowing a smoker to quit. But the press note speaks of nicotine as being powerfully addictive even though the FDA concedes elsewhere that nicotine is not harmful while at the same time saying tobacco products are potentially minimally addictive even though the agency believes the tar from cigarettes is harmful.

To me, the language used and the thinking behind the low-nicotine project are all over the place, and this seems to indicate that the FDA does not truly consider how its words will be received and how its plans will play out in the real world.

Menthol and Nicotine

Of course, those people who, in the U.S., enjoy cigarettes, menthol or not, need not be concerned that their favorite products are going to disappear from the shelves anytime soon. A June 29 news piece by the director of the FDA’s Center for Tobacco Products (CTP), Brian King, pointed out that the CTP was “in the process of finalizing [my emphasis] rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed [my emphasis] rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.”

And the CTP has other things on its mind. It is responding to the evaluation of certain of its tobacco program operations by an independent expert panel, including by developing a new strategic plan due to be announced by the end of this year.

To my way of thinking, the CTP needs to replot its direction of travel. It seems to have been panicked by the panel’s evaluation so that it is now doubling down on the minutiae of its operations, as if it were building a space vehicle set for a billion-light-year journey. What it should be doing, or what another agency should be doing, is thinking for itself, loosening up and adding a little common sense to the mix. It is not dealing with a space vehicle. It is supposed to be dealing with consumer products used by ordinary people as they go about their often messy lives, stressed and spooked by the idea that their world is boiling ….