HealthDay News — For Black adults who smoke, adaptation to varenicline and/or bupropion plus nicotine patch (NP) does not improve abstinence rates compared with NP monotherapy, according to a study published online June 20 in JAMA Network Open.

Nicole L. Nollen, PhD, from the University of Kansas School of Medicine in Kansas City, and colleagues examined the efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily in a randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC). Both groups received 18 weeks of pharmacotherapy with follow-up through week 26. The ADT group included 196 individuals who received an NP and up to two pharmacotherapy adaptations (varenicline at week 2 and bupropion at week 6 if needed), while the UC group included 196 individuals who received NP throughout.

The researchers observed no significant difference in verified 7-day abstinence by treatment group at 12, 18, or 26 weeks. Of the 71.8% of the ADT participants who received pharmacotherapy adaptations, 8.1% were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had carbon monoxide-verified abstinence at week 2 had significantly increased odds of being abstinent at week 12 compared to those who did not respond to treatment (28.7 vs 7.8%; odds ratio, 4.6).

“Findings highlight the continued need to identify effective treatment, particularly for those at high risk for cessation failure and those disproportionately impacted by tobacco-related disease,” the authors write.

Several authors disclosed financial ties to industry.

Abstract/Full Text

HealthDay News — The heavily criticized US Food and Drug Administration tobacco program promised changes on Friday, including a 5-year strategic plan to better outline priorities.

“As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle,” FDA Commissioner Robert Califf, MD, said in a statement. “Our ability to keep pace with these changes will depend on immediate, short-term, and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products.”

The agency has faced criticism from antitobacco advocates, the industry, and lawmakers for its past work in cigarette and vaping regulation, the Associated Press reported. An external review commissioned last summer released a report in December that called the FDA “reactive and overwhelmed.” Its workforce was struggling to manage tobacco and largely unauthorized e-cigarettes, the report stated.

The new FDA strategic plan is expected to outline efforts on e-cigarettes, as well as to be more transparent about FDA decisions, such as mass rejection of applications from e-cigarette makers.

Regulators would like to “better communicate” with companies about how the FDA makes decisions, said Brian King, tobacco chief for the agency. “Some things will take longer than others, but we’re committed to getting everything done that we’ve outlined as expeditiously as possible,” King told the AP. The FDA will also meet with the US Department of Justice on efforts to crack down on the fruit- and candy-flavored e-cigarettes that appeal to teens, King added.

Hundreds of warning letters to vaping retailers and e-cigarette manufacturers are sometimes ignored, the FDA noted. King said the FDA relies on the Justice Department on when to bring on lawsuits. The two agencies have announced lawsuits and fines in recent months. “Those are the first of their kind, and I hope they’re a wake-up call to industry that if you are violating the law we are going to use the full portfolio of our enforcement activities to ensure that you comply,” King told the AP.

Associated Press Article

This is the second lawsuit that the plaintiffs, the African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association, have filed against the US Food and Drug Administration over delays in banning menthol cigarettes.

The first lawsuit, filed in 2020, demanded that the FDA add menthol to its list of prohibited flavors for public health reasons. Once the agency began to take action on the issue, that lawsuit was dismissed.

In the latest lawsuit, the groups claim the agency missed a March deadline for issuing a final rule on a menthol ban. Menthol cigarettes are particularly popular in the Black community.

“Because of defendants’ inaction, tobacco companies have continued to use menthol cigarettes to target youth, women and the Black community, all to the detriment of public health,” the lawsuit stated.

“As African American physicians, we are deeply disturbed at the continuing delays in FDA’s finalizing of the ban on menthol cigarettes,” Dr Yolanda Lawson, president of the National Medical Association, said in a news release announcing the lawsuit. “Our patients, more than any other group, become disabled and die prematurely due to the continued use of these cigarettes.”

All flavored cigarettes except menthols were first banned in 2009. The FDA has been considering a menthol ban for more than a decade, CNN reported.

“We’re extremely disappointed to be forced to file this second lawsuit against the FDA in support of protecting Americans from menthol cigarettes,” Laurent Huber, executive director of Action on Smoking and Health, said in the news release. “The FDA’s own research confirms that a menthol ban would save lives; there is no scientific reason to delay finalizing this rule.”

The FDA told CNN that it does not comment on pending litigation, but “remains committed to issuing the tobacco product standards for menthol in cigarettes and characterizing flavors in cigars as expeditiously as possible; these rules have been submitted to [the Office of Management and Budget] for review, which is the final step in the rule-making process.”

But the plaintiffs said the time for action is long past due.

“The relentless and racist tobacco industry targeting has killed too many members of the Black community,” Carol McGruder, co-chair of the African American Tobacco Control Leadership Council, said in the news release. “If Black lives truly matter, then we must end the sale of menthol cigarettes and do it now!”

Studies on the benefits of a menthol ban are plentiful.

Over a 20-year period, it could lower health care costs among all adult smokers by about $1.62 billion, a recent study found. It would also save up to 654,000 lives within 40 years, including 255,000 Black lives, a 2022 study found.

Meanwhile, a 2020 study showed that while 43% of all adult smokers smoked menthols, more than 83% of Black smokers did. But within five years, the elimination of menthol cigarettes could close the gap in lung cancer deaths, another report found.

“The administration continues to miss the opportunity to leave a significant, lasting public health legacy, save lives and reach their Cancer Moonshot goals by not finalizing these rules,” Dr Karen Knudsen, CEO of the American Cancer Society and the Cancer Action Network, said in a news release supporting the move.

The American Lung Association (ALA) is also not part of the lawsuit, but expressed its support.

“The FDA’s findings show that menthol cigarettes are not appropriate for the protection of public health. It is frustrating that the continued delay of the menthol rules compelled our partners to go back to court,” ALA President and CEO Harold Wimmer said in a news release.

The FDA will likely have about two months to respond to the lawsuit in court, the groups’ attorney, Christopher Leung, told CNN.

The White House did not respond to a request for comment on the lawsuit, CNN reported.

More information

The American Lung Association has more on menthol cigarettes.

SOURCES: African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association, news release, April 1, 2024; CNN

HealthDay News — During April 2022 to March 2023, the number of reported US electronic cigarette (e-cigarette) poisoning exposure cases increased, according to research published in the June 23 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Nicole A. Tashakkori, MPH, from the US Food and Drug Administration in Silver Spring, Maryland, and colleagues examined the number and characteristics of e-cigarette exposed cases in the US by analyzing data from the National Poison Data System for April 1, 2022, to March 31, 2023.

The researchers found that 7043 e-cigarette exposure cases were reported during April 1, 2022, to March 31, 2023, representing a 32% increase from 476 to 630. Overall, 87.8% of exposures occurred among children aged 5 years or greater. The most common exposure routes were inhalation or nasal (61.0%) and ingestion or oral (40.0%). Hospital admission occurred in 0.6% of e-cigarette exposure cases, and 8.3% of exposures required treatment at a health care facility. In 0.2 and 1.9% of exposure cases, respectively, a major and moderate effect were experienced. One reported case resulted in death. About one-half of reported cases resulted in a minor effect or no reported effect (27.2 and 19.1%, respectively). Of the 342 cases with brand information, Elf Bar was the most commonly reported brand (60.8%).

“Health care providers; the public health community; e-cigarette manufacturers, distributors, sellers, and marketers; and the public should be aware that e-cigarettes have the potential to cause poisoning exposure and are a continuing public health concern,” the authors write.

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Blake Thomson, DPhil, and Farhad Islami, MD, PhD, from the American Cancer Society in Atlanta, examined the association between years since quitting smoking and mortality. Self-reported current and never smokers were compared to former smokers who had quit 1 to 9, 10 to 19, 20 to 29, and 30 or more years before recruitment for cardiovascular, cancer, and respiratory deaths at ages 25 to 89 years.

The researchers identified 11,860 cardiovascular, 10,935 cancer, and 2060 respiratory deaths during 5.0 million person-years of follow-up in the 438,015 included adults. The current versus never smoker rate ratios were 2.30, 3.38, and 13.31 for cardiovascular, cancer, and respiratory mortality, respectively. Former smokers avoided an estimated 64, 53, and 57% of excess cardiovascular, cancer, and respiratory mortality associated with current smoking within the first decade after quitting, respectively, with further benefits accruing over time. Little to no excess cardiovascular mortality was seen at 20 to 29 years after quitting among former smokers. Former smokers avoided an estimated 100, 93, and 97% of the excess cardiovascular, cancer, and respiratory mortality associated with continued smoking after 30 or more years of smoking cessation, respectively.

“These findings emphasize that with sustained cessation, cause-specific mortality rates among former smokers may eventually approximate those of never smokers,” the authors write.

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Fabienne Baur, MD, from University Hospital Basel in Switzerland, and colleagues investigated gender differences in weight change after dulaglutide-assisted smoking cessation. The analysis included 255 adults who smoked daily (155 women and 100 men) who were randomly assigned to weekly dulaglutide (1.5mg) or placebo (0.9% sodium chloride) in addition to standardized smoking cessation care (varenicline 2mg/day plus behavioral counseling) for 12 weeks.

The researchers observed no gender differences in absolute or relative weight change for either dulaglutide or placebo treatment. In the placebo group, substantial weight gain (>6% increase) was almost five times more frequent in women than men (24% vs 5%). On dulaglutide, female participants were less likely to have substantial weight gain versus those treated with placebo (1% vs 24%). This dulaglutide effect was less pronounced in men (0% vs 5%).

“Our results underline the efficacy of dulaglutide in preventing post-cessation weight gain in both genders and particularly in women who appear to be more prone to substantial weight gain than men,” the authors write.

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HealthDay News — For younger adults, the prevalence of electronic cigarette (e-cigarette) use increased from 2019 to 2021, especially among those who never smoked cigarettes, according to a study published online April 18 in the American Journal of Preventive Medicine.

Priti Bandi, PhD, from the American Cancer Society in Atlanta, and colleagues estimated current e-cigarette use prevalence using data from cross-sectional, nationally representative National Health Interview Surveys in 2019, 2020, and 2021 by age group (younger, 18 to 29 years; middle age, 30 to 44 and 45 to 59 years; and older, 60 years and older) and by cigarette smoking status.

The researchers found that between 2019 and 2021, there was an increase in the prevalence of e-cigarette use among younger adults (8.8 to 10.2%; adjusted prevalence difference, 1.7%), mainly due to an increase among never smokers (4.9 to 6.4%; adjusted prevalence difference, 1.7%). Of the younger adults who used e-cigarettes in 2021, people who never smoked cigarettes constituted 53%. The prevalence was similar in 2019 and 2021 among middle-age and older adults, regardless of cigarette smoking status; the largest proportion of people who used e-cigarettes in 2021 was made up of those who formerly smoked cigarettes (51.8, 51.6, and 47.5% among those aged 30 to 44, 45 to 59, and 60 years and older, respectively).

“We must address the rise in e-cigarette use among younger adults who never smoked cigarettes and, at the same time, help those who may have switched from cigarettes to e-cigarettes to stop using these devices completely,” Bandi said in a statement.

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HealthDay News — Electronic cigarettes and the medicines cytisine and varenicline appear to help the most people to quit smoking, according to a review published online September 12 in the Cochrane Library.

Nicola Lindson, PhD, from University of Oxford in the United Kingdom, and colleagues investigated the comparative benefits, harms, and tolerability of different smoking cessation pharmacotherapies and e-cigarettes to help people stop smoking tobacco.

Based on 319 randomized controlled trials (157,179 participants), the researchers found with high-certainty evidence that nicotine e-cigarettes (odds ratio, 2.37; 16 trials), varenicline (odds ratio, 2.33; 67 trials), and cytisine (odds ratio, 2.21; 7 trials) were associated with higher quit rates than control, each yielding an additional 7 or 8 quitters per 100. The combination of nicotine replacement therapy (patch plus a fast-acting form) was also effective (odds ratio, 1.93). Overall, the rates of serious adverse events were low (average, 3%) for treatments, excluding nortriptyline and non-nicotine e-cigarettes. Removing the 104 studies at high risk for bias did not alter the results.

“More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these,” the authors write. “Future work should unify data from behavioral and pharmacological interventions to inform approaches to combined support for smoking cessation.”

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Hao-Xing Lin, Dr PH, from Peking University in Beijing, and colleagues conducted a randomized clinical trial at seven sites involving participants who were smoking at least 10 cigarettes per day and were motivated to quit. A cartridge-based EC, varenicline, and 2 or 4mg nicotine chewing gum were provided for 12 weeks and accompanied by minimal behavioral support. Sustained abstinence from smoking at 6 months was the primary outcome. A total of 1068 participants were included and randomly assigned to the EC, varenicline, and NRT arms (409, 409, and 250, respectively).

The researchers found that in the EC, varenicline, and NRT arms, the 6-month biochemically validated abstinence rates were 15.7, 14.2, and 8.8%, respectively. The quit rate was noninferior in the EC vs the varenicline arm (absolute risk reduction, 1.47%; 95% confidence interval, −1.41 to 4.34%) and was higher in the EC versus the NRT arm (odds ratio, 1.92; 95% CI, 1.15 to 3.21). During the initial three months, treatment adherence was similar in all study arms; 62.8% of participants in the EC arm were still using ECs at 6 months, while in the other arms, interventions were no longer used.

“As 63% of participants in the EC arm still used their products at 6 months, further studies are needed to assess whether such use is beneficial or harmful,” the authors write.

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Editorial (subscription or payment may be required)

Kyung-Yeon Lee, from Seoul National University Hospital in South Korea, and colleagues used data from 400,493 adults (aged 40 to 69 years) participating in the UK Biobank.

The researchers found that 21% of participants reported being exposed to SHS in the previous year, with an average exposure of 2.2 hours per week. During a median follow-up of 12.5 years, AF developed in 6% of participants. Even when adjusting for age, sex, ethnicity, body mass index, daily alcohol consumption, moderate-to-vigorous physical activity, diabetes, high blood pressure, high blood lipids, and socioeconomic status, a 6% higher risk for AF persisted among those exposed to SHS. Every increase in the duration of weekly passive smoking was associated with further heightened risk for AF (e.g., 7.8 hours of passive smoking per week was associated with an 11% higher likelihood of AF vs no passive smoking).

“The dangers of secondhand smoke were significant regardless of whether individuals were at home, outdoors, or at work, indicating that exposure universally elevates the risk of atrial fibrillation,” Lee said in a statement. “We should all make every effort to avoid spending time in smoky environments.”

Press Release

More Information

The Food and Drug Administration (FDA) has issued marketing denial orders for 2 menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.

The marketed products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Under these orders, the Company may not market or distribute these products in the US without risking FDA enforcement.

The Agency denied the Company’s premarket tobacco product applications (PMTA) because the application lacked sufficient evidence to show that permitting the marketing of these products would provide a benefit to adult smokers that would outweigh the potential appeal to youth. Because of the increased risk of youth initiation, applicants must provide robust evidence showing that use of menthol flavored e-cigarette products would result in a complete switch or a significant reduction in the use of combustible cigarettes in adult smokers beyond that observed with tobacco-flavored e-cigarettes.

“Today’s decision pertains to the specific application submitted for review by FDA,” said Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

Only 23 tobacco-flavored e-cigarette products and devices are currently authorized by the FDA for sale in the US.

Reference

FDA denies marketing of two vuse menthol e-cigarette products following determination they do not meet public health standard. News release. US Food and Drug Administration. Accessed January 24, 2023. https://www.prnewswire.com/news-releases/fda-denies-marketing-of-two-vuse-menthol-e-cigarette-products-following-determination-they-do-not-meet-public-health-standard-301729373.html.

HealthDay News — A proposed rule from federal regulators that would ban menthol cigarettes and flavored cigars has been sent to the White House Office of Management and Budget for final review.

The U.S. Food and Drug Administration first announced the proposed rule in April. The agency said then that the rule had “the potential to significantly reduce disease and death,” reduce “youth experimentation and addiction,” and increase the numbers of smokers who quit.

“Once finalized, rules to end the sale of menthol cigarettes and flavored cigars rule will be the most significant actions that the FDA’s Center for Tobacco Products has taken in its 14-year history. The American Lung Association [ALA] is eager for these lifesaving rules to be implemented and urges the White House to finalize these rules before the end of the year,” ALA President and CEO Harold Wimmer said in a statement. “The science and data are clear. Ending the sale of menthol cigarettes and flavored cigars will save lives. It will also help reduce the unjust disparities in tobacco use caused by the tobacco companies targeting certain communities with menthol cigarettes.”

While the numbers of smokers have dropped, the numbers of those who smoke menthols have increased, according to the US Centers for Disease Control and Prevention. The menthol flavor is appealing to new smokers, making cigarettes more addictive, according to scientists. It has also been blamed for health disparities in smoking. About 43% of all adult smokers smoked menthols, but more than 83% of Black smokers did so, according to a 2020 study. Only 30% of White smokers smoke menthols.

States have been enacting their own menthol bans, specifically Massachusetts in 2020 and California in 2022, CNN reported. Meanwhile, tobacco companies have already created a potential workaround to any menthol ban, formulating a synthetic menthol-like cooling agent and then marketing those products to menthol smokers. A study published last week revealed that some of these brands are providing even more cooling than actual menthol.

Still, the final rule may incorporate language that addresses that issue, also. “It’s a big deal for them because it is how they attract and sustain people’s addiction,” Erika Sward, assistant vice president of national advocacy with the ALA, told CNN. “So if this stands, they will have lost a major tool that they’ve used to addict and sustain an addiction for millions of people.”

CNN Article

The product designs could appeal to young people and help them conceal e-cigarettes from adults, FDA officials believe. They also might be confused with an everyday object by young children and accidentally ingested.

The warning letters cover unauthorized products that are designed to imitate youth-appealing drinks like milk cartons, soda bottles, convenience store slushies, and children’s sippy cups. Others are designed to look like dice, phones, and action figures.

The FDA noted that retailers receiving these warning letters are selling or distributing e-cigarettes that lack the agency’s authorization. The 7 retailers have been given 15 working days to respond with steps they will take to correct the violations and prevent future violations. Failure to respond could result in injunctions, seizures, and civil money penalties.

As of this month, the FDA has issued about 630 warning letters related to manufacturing or distributing vaping products and devices and more than 400 warning letters to retailers selling unauthorized e-cigarettes. Civil money penalty complaints have been filed against 35 manufacturers and 42 retailers over unauthorized vaping products, the FDA said. The agency also has worked with the Department of Justice to seek injunctions against six manufacturers.

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HealthDay News — One in 7 dual users of electronic nicotine delivery systems (ENDS) and cigarettes continues using both products during 6 years of follow-up, according to a study published online December 13 in Tobacco Control.

Nandita Krishnan, from the George Washington University Milken Institute School of Public Health in Washington, DC, and colleagues assessed the longitudinal trajectories of ENDS and cigarette use among dual users. The analysis included data from 545 adult dual users across waves 1 to 5 (2013 to 2019) of the Population Assessment of Tobacco and Health study.

The researchers report that in wave 1, 2 ENDS trajectories (early quitters, 66.0%; stable users, 34.0%) and 3 cigarette trajectories (stable users, 55.2%; gradual quitters, 27.3%; early quitters, 17.5%) were identified. When analyzing joint trajectories, the researchers found 41.6% of participants were early ENDS quitters and stable cigarette users, 14.8% early ENDS quitters and gradual cigarette quitters, 14.6% stable ENDS users and stable cigarette users, 11.2% stable ENDS users and gradual cigarette quitters, 10.3% early ENDS quitters and early cigarette quitters, and 7.4% stable ENDS users and early cigarette quitters. Trajectory group membership was predicted by cigarette and ENDS use frequency, nicotine dependence, cannabis use, and other noncombusted tobacco product use.

“Before 2019, ENDS use did not contribute to substantial smoking cessation at the population level,” the authors write.

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Michael E. Johansen, MD, from OhioHealth in Columbus, and colleagues sought to determine the amount of care for LE8 that is performed by primary care, given its role in access, screening, and prevention. The analysis included data from 68,062 participants (older than 17 years) in the Medical Expenditure Panel Survey (2017 to 2019).

The researchers found that rates of meeting the LE8 measures varied from 3.8% for tobacco treatment to 52.9% for those who received a medical checkup. Across all LE8 measures, primary care alone was the most involved in LE8-related care, ranging from 43.1% of people with tobacco use to 69.2% of people who received tobacco treatment. The combination of cardiology and primary care together cared for 4.5% with tobacco use (the lowest measure) to up to 19.2% of statin users. Cardiology alone was associated with care of 1.3% of tobacco users to 3.9% of statin users. Many people saw neither primary care nor cardiology (51.1% of tobacco users).

“Supporting primary care in their core functions of preventive care and chronic management will be key to achieving cardiovascular health,” the authors write.

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HealthDay News — Overall, 18.7% of US adults reported currently using any tobacco product in 2021, with most reporting combustible tobacco product use, according to research published in the May 5 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Monica E. Cornelius, PhD, from the CDC in Atlanta, and colleagues examined recent national estimates of commercial tobacco use among US persons aged 18 years and older using 2021 National Health Interview Survey data.

The researchers found an estimated 46 million US adults (18.7%) reported currently using any tobacco product in 2021, including 11.5, 4.5, 3.5, 2.1, and 0.9%, respectively, using cigarettes, e-cigarettes, cigars, smokeless tobacco, and pipes (including hookah). Overall, 77.5% of those who used tobacco products reported using combustible products (cigarettes, cigars, or pipes) and 18.1% used two or more tobacco products. Increased prevalence of any tobacco product use was seen in the following populations: men; persons aged younger than 65 years; persons of non-Hispanic other races; non-Hispanic Whites; residents of rural (nonmetropolitan) areas; financially disadvantaged individuals; lesbian, gay, or bisexual persons; those uninsured or on Medicaid; those whose highest level of education was a general education development certificate; those with a disability; and those with serious psychological distress.

“In 2021, approximately one in nine (11.5%) US adults aged 18 years or older currently smoked cigarettes,” the authors write. “Although this finding represents the lowest smoking prevalence recorded since 1965, nearly one in five adults continue to use tobacco products.”

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