It used to be that we castigated the tobacco companies for lying to or misleading the public. Now, apparently, we think that it's appalling that a tobacco company be allowed to tell the truth.
Years ago, I testified in the Engle case, a class action suit brought by Florida smokers against Big Tobacco that resulted in a $145 billion punitive damage verdict against the companies. The basis of the lawsuit was that for years, the tobacco companies lied about the health effects of their products and were liable for damages based on their fraudulent behavior. And in a more recent lawsuit, the tobacco companies were forced to put corrective statements on cigarette packs in order to atone for deceptive statements they had made in the past. Clearly, a major problem for which we held tobacco companies responsible was lying to the public about the health effects of their products.
Today, for some reason, the tables have turned. Instead of demanding that tobacco companies tell the truth about the health effects of their products, the American Lung Association is appalled that the FDA is allowing them to tell the truth.
Earlier this week, the FDA authorized Swedish Match - the manufacturer of Zyn nicotine pouches - to tell consumers that: "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." This decision was based on what is called an MRTP [modified risk tobacco product] application, which required Swedish Match to provide solid scientific documentation that the product is in fact safer than cigarettes and poses a lower risk of heart disease, stroke, mouth cancer, lung cancer, and chronic obstructive pulmonary disease.
The FDA's authorization of this modified risk claim was based on its conclusion that: "as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco
products and persons who do not currently use tobacco products."
According to an NBC News article, the American Lung Association responded to the FDA's action by calling it "appalling" and demanding that the agency reverse this decision: "Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, called the move “appalling.” “The Lung Association calls on the FDA to reverse this action,” Seilback said in an emailed statement. “We must protect our children from a lifelong addiction to nicotine.”"
The Rest of the Story
What's actually appalling is that the American Lung Association would prefer that Swedish Match not be allowed to tell consumers that nicotine pouches are much safer than cigarette smoking because they pose a lower risk of lung cancer and COPD. You would think that an organization devoted to preventing lung disease would want smokers to know that if they quit by switching to nicotine pouches, they will lower their risk for lung cancer and chronic lung disease. But for some reason, the American Lung Association is actually lobbying to get the FDA to forbid Swedish Match from telling consumers the truth.
Why the American Lung Association would want smokers to incorrectly think that switching from cigarettes to Zyn pouches would have no impact on their health is beyond me. This is a great public disservice. It could potentially result in deaths that could otherwise have been prevented. After all, if reversing this FDA decision results in smokers not believing there is any health advantage to switching to nicotine pouches, then why should they bother switching? Might as well get the full enjoyment of your Marlboro's if the tobacco-free, combustion-free, alternative is no safer.
Here is just one of the many testimonials that the FDA received from smokers who basically saved their lives by switching to Zyn:
"I was a smoker for ten years and a smokeless tobacco user (snuff) since 1983. I found myself unable to quit tobacco for more than a few weeks at best. I switched to Zyn a year ago, and it has been game changing. To be blunt, I still get my nicotine, but not the cancer. It's fairly ludicrous to point at the risk of teenagers "getting hooked" on Zyn as a risk factor. Literally throwing out a valuable baby with the proverbial bathwater. This product is absolutely life-changer for the long-term nicotine junkie like myself."
The reason given by the American Lung Association for demanding that the FDA prohibit Swedish Match from telling the consumers the truth is that "we must protect our children from a lifelong addiction to nicotine." I agree with that goal. But we should do this by lying to them? And by lying to adult smokers as well?
In public health, we have a code of ethics. And that code makes it clear that honesty and transparency are important core values. The first principle of health communication should be to tell the truth. The ends do not justify the means: it is not ethical for us to achieve a public health aim by lying to the public.
The New Jersey Policy Institute summarized it well in its comment to the FDA, stating that: "many consumers lack a clear understanding of the differences in risk across nicotine products. When adults are not provided with clear, evidence-based information, they often assume that all nicotine products carry comparable harms. That misperception can discourage individuals who are actively trying to choose products that expose them to fewer toxicants than cigarettes."
I would argue that the authorized modified risk statement is actually understated because there is no evidence that Zyn causes lung cancer or chronic lung disease in the first place. But clearly, merely claiming that Zyn use is safer than smoking, which involves the direct inhalation of tens of thousands of chemicals including 60 proven carcinogens, is a no-brainer based on scientific evidence.
The FDA concluded that Zyn poses no significant risk of lung cancer, while "the risk of dying from lung cancer is 25 times higher among adults who smoke combusted cigarettes than those who do not smoke." Similarly, the FDA concluded that Zyn poses no significant risk of chronic obstructive lung disease, while "combusted cigarette smoking is associated with 22-25 times the risk of dying from COPD as having never smoked." You can see that the approved statement is actually an understatement because it merely suggests that Zyn reduces the risk of lung cancer and lung disease but does not provide any quantitative information so that consumers can appreciate the magnitude of these risk differences.
Furthermore, the authorized statement explicitly refers to quitting smoking by switching to Zyn. It starts: "Using Zyn instead of cigarettes... ." Why would public health groups object to a statement that essentially notes that the purpose of Zyn is to aid in smoking cessation? Ironically, by asking FDA to take away the only honest way that Swedish Match can market Zyn (i.e., telling smokers that switching to Zyn reduces health risks), the American Lung Association and other tobacco control groups that are also "appalled" are leaving the company no marketing path other than making nicotine pouch use look glamorous or appealing. The MRTP process is actually an effective way for FDA to control the marketing of these products. At the same time, it provides a pathway for companies to tell the truth about the purpose of these products, rather than having to mislead people into thinking that the purpose of these products is to make them look cool and appealing.
Tobacco control groups should consider the comments of Dr. Karl Fagerstrom, perhaps the world expert on nicotine addiction:
"In my experience, most people who smoke do not view their dependence as a condition requiring medical intervention, and many cannot afford the time or cost associated with obtaining prescriptions or counseling. As a result, most smokers quit either unaided or with the help of alternative nicotine products such as e-cigarettes, nicotine pouches, snus, or heated tobacco. In Sweden and Norway, snus has become the most widely used nicotine product and has historically been the most frequently used aid to quit smoking. Today, nicotine pouches increasingly play this role and are on the verge of becoming the most commonly used nicotine product category in Sweden. In the United States, early data suggest that nicotine pouches are displacing traditional smokeless tobacco products. Researchers have described a “market disruption in the oral tobacco and nicotine category,” with notable declines in smokeless tobacco sales between 2018 and 2024 coinciding with the rapid growth of nicotine pouches. Importantly, this transition has occurred with very limited uptake among youth. With appropriate communication—including clear messaging that nicotine pouches present substantially lower health risks than smoking—these products could help reduce harm not only for users of smokeless tobacco but also for people who smoke. Authorizing nicotine pouches with modified risk claims could also help correct widespread misperceptions about the relative risks of different tobacco and nicotine products in the United States."
In closing, I find it appalling that the American Lung Association finds it appalling that the FDA is allowing Swedish Match to tell consumers the truth about the relative health risks of Zyn compared to combustible cigarettes. Reversing this decision would essentially force the company to lie to the public (a lie of omission) and to hide the single most important fact about the product that consumers need to know. Why in the world would we want Swedish Match to market Zyn as just another dangerous tobacco product for recreational use rather than encourage smokers to switch to Zyn to save their lives?
