Smoked out: Smoking cessation products on the rise
Many of the 7,000 chemicals in cigarettes—some absorbed when the tobacco plant grows and others released when cigarettes are manufactured and smoked—are known to cause major health conditions, such as cancer, COPD and cardiovascular diseases. So, why are people still smoking?
The highly addictive chemical compound in tobacco is nicotine. In 2018, 55.1% of adult smokers said they had tried to quit in the past year, while 7.5% of them were successful, according to the Centers for Disease Control and Prevention. In 2016, researchers from the Ontario Tobacco Research Unit, the University of Toronto and Johns Hopkins University published in BMJ Open that many smokers may make at least 30 quit attempts before they stop smoking for good.
While some people quit smoking without using cessation products, the Food and Drug Administration states on its website that “many smokers try to quit ‘cold turkey’ and are not successful.” FDA has approved cessation medications as solutions. Meanwhile, the agency has authorized tobacco companies to market certain products for reducing harm or disease risks. FDA has approved seven smoking cessation medications.
Five fall under the definition of Nicotine Replacement Therapy products: patches, lozenges, gum, oral inhalers and nasal sprays. NRT products contain a low amount of nicotine that is delivered over a longer timespan than via cigarettes. The other two FDA-approved medications are the prescriptions Verenicline and Bupropion SR, which do not contain nicotine.
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Jennifer Folkenroth, national senior director of tobacco programs at the non-profit American Lung Association, said these cessation medications address the physical part of a nicotine addiction, but that psychological and behavioral challenge represent “two other points of the triangle” of addiction.
Folkenroth, a certified tobacco treatment specialist and nicotine dependence specialist with a national certificate in tobacco treatment practice, said behavioral counseling allows quitters to develop a plan in which they can combat psychological and behavioral challenges in addition to physical cravings.
“What are you going to replace? How are you going to overcome those triggers?” Folkenroth said. “How are you going to change up the routine to really avoid the extreme urges that may be experienced—or intensity of urges that are experienced—through just societal, day-to-day cues to smoke, in addition to the psychological component? If we feel as though we are removing something from our lives, many times we can feel deprived.”
NRT options on the market
Dr. Reddy’s Laboratories sells multiple NRT products, including 2-mg and 4-mg nicotine lozenges and transdermal patches with 21-mg, 14-mg and 7-mg nicotine doses. The company sells the products through the Habitrol brand, store brands and the Dr. Reddy’s label, the last of which is available through pharmacies, hospitals, and government channels.
These products alleviate the physiological aspect of nicotine addiction, said Ashish Girotra, senior director and head of marketing, OTC at Dr. Reddy’s.
“In a way, you are avoiding a sharp withdrawal of nicotine to alleviate symptoms by providing some amount of nicotine without having all the bad effects that smoking a cigarette has,” Girotra said.
The patch treatment has three steps. First, apply 21-mg patches for 24-hour periods for four weeks, then 14-mg patches for two weeks, followed by 7-m patches for two weeks, Girotra said. Smokers of more than 10 cigarettes per day should start with the 21-mg patch, while smokers of 10 or fewer cigarettes per day should start with the 14-mg patch.
Dr. Reddy’s entire eight-week, step-down patch treatment contrasts with 10-week programs offered by other companies, Girotra said. Out of customers who use lozenges, those who have their first cigarette within 30 minutes of waking should start with 4 mg, and those who have their first cigarette more than 30 minutes after waking should start with 2 mg.
People can feel the urge to smoke based on multiple triggers, among them stressful or celebratory situations, or substances such as coffee or alcohol, Girotra said. “To that extent, we truly agree that smoking cessation products like NRT addresses only a part of those needs, and there is definite room for complementing these products with additional benefits, services, offerings like counseling, coaching, motivational tips, financial benefits,” he said.
That thought process was behind the development of an app from Dr. Reddy’s. Named AIMI by Habitrol, the app allows people who are quitting smoking to track their journey and their urges to smoke, Girotra said. In its current form, the app is designed for patch users. It calculates how much they save by not purchasing cigarettes, provides reminders about product refills and offers healthy tips for overcoming cravings.
[Read more: Perrigo obtains FDA OK for nicotine coated mint lozenge OTC]
Highlighting the app’s wellness tips, Girotra said: “In our app, a user can record his or her urge, and right when they record their urge to smoke, they get a tip in terms of practicing mindfulness, breathing exercises, some hand-to-mouth fixations, like pop in a chewing gum or any other candy ... or [to] go take a walk or play some small game on the phone.”
Heat-not-burn products and snus
Smokers who do not wish to entirely quit using tobacco have the option of using what the FDA calls Modified Risk Tobacco Products. According to the agency, MRTPs are “tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.”
After gathering research from companies that apply for MRTPs and conducting its own science, the FDA has so far approved a “heat-not-burn” tobacco product, a brand of low-nicotine cigarettes, two brands of snus and one brand of snuff.
The IQOS Tobacco Heating System from Philip Morris International and General Snus from the company Swedish Match, which PMI acquired a majority stake in late 2022, have been authorized by FDA as MRTPs. IQOS is not currently available in the U.S., but PMI will receive commercialization rights from Altria in April 2024. (In 2008, PMI split from Altria, formerly known as Philip Morris Companies.)
FDA authorized the marketing of IQOS, an electronic device that heats tobacco “sticks” rather than burning tobacco. Per FDA, PMI can state in its marketing: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
Corey Henry, director of U.S. communications at PMI, said: “The IQOS system is designed purposefully to replicate as much as possible the experience that a smoker is accustomed to, so the taste, the ritual, the nicotine content.”
FDA authorized Swedish Match to market eight General Snus smokeless tobacco pouch products, which are available in the U.S., with the claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
[Read more: Up in smoke: Which smoking-cessation products really help smokers quit?]
Henry said the MRTP designation lets smokers know that the products have been third-party tested by FDA scientists. “Our perspective is, you’ve got to help smokers find these products because there is a very good chance, then, that more people will stop smoking,” he said. “There’s no such thing as a safe tobacco product,” Henry said. “There can be a better alternative to a cigarette.”
Low-nicotine cigarettes
Plant biotechnology company 22nd Century Group has received MRTP authorization from FDA for its VLN King and VLN Menthol King cigarettes. With 95% less nicotine than other cigarettes on the market, the cigarettes’ name comes from their “very low nicotine” levels.
FDA authorized 22nd Century Group to market the cigarettes’ nicotine content relative to conventional cigarettes, in addition to the claims, “Helps reduce your nicotine consumption” and “Greatly reduces your nicotine consumption.” The agency also required all of the company’s reduced-nicotine exposure claims to include the phrase, “Helps you smoke less.” John Miller, president of 22nd Century Group’s tobacco division, said the company is currently working on education and awareness surrounding VLNs, which were pilot-launched in Illinois and Colorado in 2022 and hit convenience stores in California, Texas and Florida in July.
“In terms of the product efficacy, when people understand the science behind this and what it’s supposed to achieve, they try the product,” Miller said. “It passes all the tests because it is from a tobacco plant, and it does look, feel, smell and taste like your regular cigarette. It just doesn’t have the highly addictive nicotine in it. So, when people understand that they’re like, ‘OK, now I’ve finally found something that is meeting me where I am.’”
Product Picks
Habitrol Nicotine Transdermal System Patch
Habitrol Nicotine Patches can help reduce nicotine withdrawal symptoms such as irritability, anxiety, depression, sleeplessness, and increased appetite and nicotine cravings. Patches come in three decreasing nicotine levels. During the eight-week step-down program, smokers work your their way through the steps, gradually reducing nicotine dependency.
IQOS Philip Morris International
The FDA has authorized the IQOS Tobacco Heating System as a Modified Risk Tobacco Product. IQOS is the first heat-not-burn tobacco product to be authorized as an MRTP. The company will commercialize the product in the U.S. in 2024.
22nd Century Group VLN
22nd Century Group’s VLN King and VLN Menthol King cigarettes are the world’s only combustible cigarettes to receive Modified Risk Tobacco Product authorization from FDA. In granting this designation, the agency established that VLN cigarettes “help reduce exposure to, and consumption of, nicotine for smokers who use them.”