Many lifelong cigarette smokers and their doctors have pushed smoking cessation to the bottom of the problem list and thus never get to discuss it again. A recent announcement from the FDA may give you a second chance to continue that conversation.
By now most adult cigarette smokers, and their doctors, have heard about ZYN. On June 30, the FDA granted Modified Risk Tobacco Product (MRTP) authorization for several ZYN nicotine pouch products. The agency authorized the company to state in its marketing materials: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
Two important clarifications are in order. The reduction in risk occurs only when cigarettes are completely replaced by an authorized ZYN product. In addition, the FDA’s modified-risk authorization applies only to the specific ZYN products included in its decision; it does not extend to other nicotine pouch brands or to other ZYN products. This article reviews some essential points to prepare you for any conversation about tobacco harm reduction.
Has your patient tried evidence-based treatment?
Although the majority of adult cigarette smokers have tried to quit, only 38.3 percent used medications or counseling in their last quit attempt. Most quit attempts using medication do not include counseling, which would double the effectiveness of any treatment. The medication used most frequently is nicotine replacement, rather than the most effective drug varenicline. Few patients are referred to comprehensive tobacco treatment programs which are available at most medical centers. These programs coordinate multiple medication strategies with long-term counseling.
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A careful review of previous quit attempts often reveals opportunities for improvement. For a quick review of ways to improve tobacco treatment in your practice.
Many patients who believe they have “tried everything” have, in fact, received only fragments of recommended care. Most former smokers required multiple quit attempts over many years before achieving long-term abstinence. Some patients who say they are not ready to quit can respond to a trial of quitting using varenicline or nicotine replacement. There is an emerging literature that suggests that “Medication sampling, giving cigarette smokers a product that reduces craving, allows them to learn that they can alter their smoking behavior.”
Several recent studies, including a Cochrane Review, have shown that electronic cigarettes, when used with counseling, can be part of an effective treatment program for cigarette smokers. England’s National Health Service public guidance on quitting smoking states that “Nicotine vaping is less harmful than smoking and is one of the effective tools to help people stop smoking, though it is not risk-free.” The FDA has not reviewed any vapes or nicotine products as treatment for tobacco use.
When should harm reduction enter the conversation?
A purist might say that tobacco harm reduction should be viewed as an option only after a clear failure of evidence-based treatment. Yet some patients reject the idea of making another quit attempt. Others may be eager to hear your thoughts on the topic of harm reduction. I believe that your patients are eager to have you raise the topic.
Are pouches (ZYN) and vaping less harmful than smoking cigarettes?
The short answer is yes, but it’s complicated. Public discussions often portray tobacco and nicotine products as either safe or dangerous, but the reality is more nuanced. Nicotine products exist on a continuum of risk. The diseases caused by smoking result from inhaling the toxic products generated when tobacco burns, and not from the nicotine.
As shown in the image below, the highest risk is shown on the right. Combustible cigarettes are responsible for nearly half a million deaths annually in the United States. Moving away from combustion generally reduces exposure to harmful chemicals. Heated tobacco products, electronic cigarettes, smokeless tobacco products, and nicotine pouches all occupy lower positions on the risk continuum. None of these products are risk-free, and none should be considered harmless. However, most experts agree that products that eliminate combustion expose users to substantially fewer toxic substances than conventional cigarettes.
Show this graph to your patients. People who want to reduce their risk of tobacco-related disease should move as far to the left as possible. It is important to emphasize that the health benefits only occur if the switch to a lower-risk product is complete. Twenty percent of people who use e-cigarettes also smoke cigarettes some of the time and may be fooling themselves about their healthier choice.
The most popular choice appears to be vaping, which has been adopted by over six million cigarette smokers in the U.S. The Centers for Disease Control and Prevention (CDC) says that vaping is less harmful than smoking, but it is not completely safe. There are over ten thousand different types of vapes sold in the U.S., all based on a device that heats a liquid containing nicotine, flavorings, glycerin, propylene glycol, and water to produce a vapor that can be inhaled. Heating these chemicals also creates formaldehyde, acetaldehyde, acrolein, and small amounts of volatile organic compounds such as toluene. Sometimes metals such as chromium and lead are found. The concentrations of these toxic chemicals are significantly lower than what is found in combusted cigarettes.
Nicotine pouches are much simpler. Most pouches contain cellulose fibers or microcrystalline cellulose derived from wood pulp or other plant materials. The pouches contain nicotine, flavorings, and sweeteners (such as xylitol or sucralose). The nicotine is absorbed through the gums, and the pouch is discarded after use. With even fewer toxic chemicals, pouches appear less harmful than vapes, but no nicotine-containing product is safe. ZYN is a brand of nicotine pouch which has attained FDA authorization that allows marketing as a modified-risk product. This authorization is limited to ten flavors at the 3 mg and 6 mg doses. Higher doses such as Ultra, 11 mg, are not authorized.
FDA authorization for sale of nicotine products can be confusing
The FDA has the authority to review all tobacco products available in the United States. FDA authorization should not be confused with FDA approval, a term reserved for medications shown to be safe and effective. The FDA does not say that these nicotine products are safe, but they are less harmful than cigarettes. FDA review includes chemical and toxicology data as well as evidence regarding the attractiveness of a product to young people as well as people who do not smoke. The full list of products authorized for sale by the FDA is here. Many of the thousands of nicotine products have been rejected because of their attractiveness to young people. Most often this is due to the presence of flavors which are thought to be especially attractive to children. We are not told the reasons for rejection of nicotine products by the FDA so they may contain or generate unknown chemicals with unknown effects.
The FDA has an additional category of authorization called Modified Risk Tobacco Products (MRTP), which must demonstrate that the product will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users, and benefit the health of the population as a whole. In addition to twenty types of ZYN products, the following products have authorization as MRTP: General Snus, IQOS heated tobacco system, VLN King and Menthol King, and Copenhagen Classic Snuff. As a result of the FDA announcement regarding ZYN, availability of and interest in these products is likely to increase.
Like ZYN, the FDA does not say these MRTP products are safe. The FDA announcements for these products do not encourage nonsmokers to begin using nicotine. They do not claim that nicotine use promotes health. Rather, the FDA recognizes that switching completely from cigarettes to a specific noncombustible nicotine product may reduce the risk of major smoking-related diseases.
The FDA also regulates Non-Tobacco Nicotine Products (NTN) which may be chemically similar to nicotine but do not contain extracts found in tobacco plants. These products were developed to bypass FDA authority over tobacco products but as of a recent update are under FDA review. NTNs are addictive and no NTN products of this type have been authorized for sale.
Are there harms associated with tobacco harm reduction?
According to the FDA, all nicotine products have some risk, and not all the risks are fully understood. The FDA requires a warning label, “WARNING: This product contains nicotine. Nicotine is an addictive chemical,” as well as limiting the health claims that can be made by the various nicotine products. There is no mention of the need to switch completely to reduce the harm of smoking cigarettes. There is no requirement to list all ingredients or the chemicals created when heated. There is no mention that the long-term effects of these chemicals are not yet known.
The risk of each of the products in a category may be similar, but there may be significant differences between seemingly similar products which cannot be discerned from product websites. Some degree of additional risk occurs in using products still under FDA review and not yet authorized for sale.
Although all nicotine products are required to have a warning about the risk of addiction, many of the more recent products provide higher doses of nicotine. Thus, more people are likely to experience palpitations, increased heart rate and blood pressure, nausea, and other symptoms. Higher doses of nicotine would make quitting more difficult. The effects of nicotine products on pregnant women are the same as smoking: low birth weight, prematurity, and impaired brain development of the fetus.
Another important omission from discussion of tobacco harm reduction is cost. Many cigarette smokers spend thousands of dollars a year on their nicotine habits. Some clinicians use future expenses on tobacco products as an added motivator to help people stop smoking. Vaping and nicotine pouches may be less costly in the short run, but they still create a lifetime expense.
One unintended consequence of the current debate about tobacco harm reduction is the effect on young people. Although sale of all tobacco products to people under the age of 21 is prohibited, increased use by adults may prompt more young people to try tobacco products and become addicted.
In conclusion
There are over 56 million people in the United States who have quit smoking cigarettes. There is no reason to believe that your patient is different from all those former smokers. Yet, tobacco users are being repeatedly told that they are addicted and the only way to reduce their risk of tobacco-related disease is to use vaping or nicotine pouches. A conversation about tobacco harm reduction becomes a way to reiterate a clear message about cessation of all nicotine products. As an alternative, a recommendation to use a tobacco harm reduction product may be warranted.
Quitting cigarettes completely is the best form of harm reduction
- Be sure to include a recommendation for free counseling at 1-800-QUIT-NOW.
- Help your patient make a plan.
If your patient elects to use a nicotine product to help them quit smoking
- Be sure to include a recommendation for free counseling at 1-800-QUIT-NOW.
- Help your patient make a plan.
If your patient seeks a tobacco harm reduction approach
- Quit smoking completely (otherwise there is no benefit).
- Select an FDA-authorized product, preferably a Modified Risk Tobacco Product (MRTP).
Many of the sources of information on tobacco harm reduction have conflicts of interest; some are clearly selling their product, some not-for-profit groups are funded by the tobacco industry, and some are adhering to international guidelines that focus on the future health of young people rather than adults who smoke cigarettes. The role of nicotine products in tobacco harm reduction is rapidly evolving and is being debated worldwide. Here are a few highlights: Nicotine Counseling and Harm Reduction Information for Physicians, The Anselm Nicotine Prescription. Amid this ongoing controversy I endeavor to provide useful information to adults who smoke cigarettes and their clinicians. I welcome your feedback. You can reach me at [email protected].
Edward Anselm is a board-certified internist with a long-standing focus on public health, tobacco control, and preventive care. He earned his medical degree from the Chicago Medical School at Rosalind Franklin University and completed his internal medicine residency at Montefiore Medical Center in New York. Over the past three decades, Dr. Anselm has served in senior leadership roles across clinical, corporate, and managed-care settings, including chief medical officer positions at HIP Health Plan of New York, FidelisCare, and Health Republic Insurance of New York.
Recently retired from his role as medical director at Aetna, Dr. Anselm continues to teach at the Icahn School of Medicine at Mount Sinai as a clinical assistant professor. His current work focuses on strengthening reimbursement pathways for tobacco cessation and preventive services, helping clinicians integrate evidence-based care that improves patient outcomes while supporting practice sustainability. His research has been published in the American Journal of Accountable Care, the American Journal of Preventive Medicine, AJPM Focus, and Health Affairs Forefront, including articles on tobacco control in accountable care, underbilling of cessation services, and the financial and quality benefits of treating tobacco use as a clinical priority.
Dr. Anselm’s educational and policy work is shared through EdwardAnselmMD.com and The Anselm Nicotine Prescription, with professional updates available on LinkedIn.
