Tobacco Products Scientific Advisory Committee Research Articles

APF Gold Medal Award for Impact in Psychology: Adam Leventhal.

The APF Gold Medal for Impact in Psychology recognizes Adam Leventhal for his his extraordinarily prolific and impactful contributions. Leventhal has contributed significantly to the body of research on youth tobacco use and vaping, which has led to policy decisions responsive to an urgent social problem in the form of U.S. Food and Drug Administration (FDA) decisions to prohibit sales of flavored e-cigarette products that attract youth. Dr. Leventhal has served as a member of the Tobacco Products Scientific Advisory Committee, which advises the FDA in policy decisions. He also has served on panels of the National Academy of Science, Engineering, and Medicine to guide federal policies directed toward tobacco products and has contributed to U.S. Surgeon General Reports focused on tobacco use. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration

Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions. Methods: We reviewed public documents from the 2010–2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information. Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC. Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA’s regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.

Characteristics of Open Public Hearing Speakers of the Tobacco Products Scientific Advisory Committee meetings.

Characteristics of Open Public Hearing Speakers of the Tobacco Products Scientific Advisory Committee meetings.

Assessment of novel tobacco heating product THP1.0. Part 3: Comprehensive chemical characterisation of harmful and potentially harmful aerosol emissions

For a tobacco heating product (THP), which heats rather than burns tobacco, the emissions of toxicants in the aerosol were compared with those in cigarette smoke under a machine-puffing regimen of puff volume 55 ml, puff duration 2 s and puff interval 30 s. The list of toxicants included those proposed by Health Canada, the World Health Organization Study Group on Tobacco Product Regulation (TobReg), the US Food and Drug Administration and possible thermal breakdown products. In comparison to the University of Kentucky 3R4F reference cigarette the toxicant levels in the THP1.0 emissions were significantly reduced across all chemical classes. For the nine toxicants proposed by TobReg for mandated reduction in cigarette emissions, the mean reductions in THP1.0 aerosol were 90.6–99.9% per consumable with an overall average reduction of 97.1%. For the abbreviated list of harmful and potentially harmful constituents of smoke specified by the US Food and Drug Administration Tobacco Products Scientific Advisory Committee for reporting in cigarette smoke (excluding nicotine), reductions in the aerosol of THP1.0 were 84.6–99.9% per consumable with an overall average reduction of 97.5%.

Rapid detection of toxic compounds in tobacco smoke condensates using high-resolution 1H-nuclear magnetic resonance spectroscopy

In 2012, the FDA Tobacco Products Scientific Advisory Committee published a list of 93 harmful and potentially harmful constituents (HPHCs) of tobacco products and tobacco smoke.

Tobacco documents reveal questionable professional recertification by industry menthol expert

Jonathan Daniel Heck, PhD, a board certified toxicologist, career scientist at Lorillard Tobacco, and industry expert on menthol, served as an industry representative on the Food and Drug Administration (FDA)...

The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses.

As part of the Family Smoking Prevention and Tobacco Control Act, the U.S. Food and Drug Administration charged the Tobacco Products Scientific Advisory Committee with developing a report and recommendations about the effect of menthol in cigarettes on the public health. The purpose of this study was to examine smoking behaviors, biomarkers of exposure, and subjective responses when switching from a novel menthol cigarette to a non-menthol cigarette to isolate the effect of menthol and to approximate the effect a menthol ban might have on smokers. Thirty-two adult smokers completed this 35-day randomized, open-label, laboratory study. After a 5-day baseline period, participants were randomized to the experimental group (n = 22) where they would smoke menthol Camel crush for 15 days followed by 15 days of non-menthol Camel crush, or the control group (n = 10) where they smoked their own brand cigarette across all periods. Participants attended study visits every 5 days and completed measures of smoking rate, smoking topography, biomarkers of exposure, and subjective responses. Although total puff volume tended to increase when the experimental group switched from menthol to non-menthol (P = 0.06), there were no corresponding increases in cigarette consumption or biomarkers of exposure (P > 0.1). Subjective ratings related to taste and smell decreased during the non-menthol period (P < 0.01), compared with the menthol. Results suggest menthol has minimal impact on smoking behaviors, biomarkers of exposure, and subjective ratings. When controlling for all other cigarette design features, menthol in cigarettes had minimal effect on outcome measures.

Abstract 664: Menthol cigarettes in relation to breast cancer incidence in African American women

Abstract The Tobacco Products Scientific Advisory Committee has found that smokers of menthol cigarettes have an earlier age at smoking initiation, less success in smoking cessation, and are more likely to be African American than smokers of non-menthol cigarettes. However, whether menthol cigarettes are associated with higher cancer risk relative to non-menthol cigarettes is unclear. Recent studies of smoking and breast cancer suggest that long-term smoking may associated with a small increase in risk, but no data are available on type of cigarette. We assessed the relative effects of menthol and non-menthol cigarettes on incidence of breast cancer in a large prospective cohort of African American women. The Black Women's Health Study has followed approximately 59,000 women with biennial questionnaires since enrollment in 1995. Beginning in 2003, data has been collected on whether cigarettes smoked were menthol or non-menthol; menthol cigarettes were reported by 64.7% of smokers who provided information. During follow-up from 2003 through 2010, 739 incident breast cancer cases occurred. In proportional hazard models that controlled for age and numerous breast cancer risk factors, hazard ratios (HR) were computed for categories of pack-years of smoking of the two types of cigarettes relative to a reference group of never-smokers who reported no regular exposure to second-hand smoke. The HR for β20 pack-years of smoking non-menthol cigarettes was 1.70 (95% confidence interval (CI) 1.04-2.76); for β20 pack-years of smoking menthol cigarettes, the HR was 1.14 (95% CI, 0.72-1.82). Our findings suggest that, to the extent that higher pack-years of smoking may be associated with breast cancer, smoking menthol cigarettes is not more harmful than smoking non-menthol cigarettes. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 664. doi:1538-7445.AM2012-664

Problems with the Tobacco Products Scientific Advisory Committee (TPSAC) List of Harmful or Potentially Harmful Tobacco and/or Tobacco Smoke Components

Abstract The draft initial list of harmful or potentially harmful tobacco and/or smoke components prepared by the Constituent Subcommittee of the Tobacco Products Scientific Advisory Committee (TPSAC) differs significantly from the similar lists prepared by Hoffmann and colleagues who had over four decades of experience and knowledge in tobacco and/or tobacco smoke components and their chemical and biological properties. The draft list comprises 106 components, 60 of which were included in the recent Hoffmann et al. lists but does not include nine of the Hoffmann-listed components. All of the 106 components appear in a list by Rodgman and Green of 162 tobacco and/or tobacco smoke components, each of which was defined as biologically adverse at one time or another over the previous years by one or more investigators. As with the Hoffmann et al. lists, the list by the TPSAC Constituent Subcommittee contains numerous anomalies. · Three harmful components (dibenz[a, j]acridine, dibenz[a, h]acridine, 7H-dibenzo[c, g]carbazole) first reported in tobacco smoke in the 1960s that were not confirmed over the next forty years by many talented investigators in Japan, Germany, and the USA, including several at the U.S. Department of Agriculture (USDA). · Two harmful components (arsenic, N-nitrosodiethanolamine) the levels of which have decreased significantly because their precursors have not been used in tobacco agronomy for over three decades. · The many water-soluble components that reach the lung at a much reduced level to exert their ciliastasis. · A component (chrysene) that the International Agency for Research on Cancer (IARC) has removed from its tumorigenicity listing, a decision accepted by Hoffmann et al. who removed chrysene from their more recent tobacco/tobacco smoke listings of adverse components. TPSAC gives no indication of the following: · The relationship between the per cigarette delivery of some of the harmful components and their level of permissibility by Occupational Safety &amp; Health Administration (OSHA). · The components on its list that significantly offset the adverse biological activity of several others of its listed components. · Many components in tobacco and/or tobacco smoke not listed by TPSAC have been reported to significantly reduce the adverse biological effect of several components on the TPSAC list plus several others.

Food and Drug Administration Regulation of Tobacco: Integrating Science, Law, Policy, and Advocacy

The Family Smoking Prevention and Tobacco Control Act (hereafter referred to as “the Act”) became law in 2009. One of its key provisions grants the Food and Drug Administration (FDA) authority to regulate tobacco products “for the protection of the public health.”1 Recognizing that the traditional “safe and effective” standard governing drugs and devices was inappropriate for tobacco products, which are inherently lethal, Congress designed the “public health standard … to be a flexible standard that focuses on the overall goal of reducing the number of individuals who die or are harmed by tobacco products.”2 The language is intentionally broad, focusing on protecting the health of the population as a whole. Before the FDA can adopt a tobacco product standard, it must consider the scientific evidence regarding: (1) the risks and benefits of the proposed standard to the entire population, including both users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not currently use tobacco products, most notably youth, will start to use tobacco products.1 To assist the FDA with these determinations, a Tobacco Products Scientific Advisory Committee (TPSAC) was established, comprising individuals with expertise ranging from basic to population science. Congress mandated the TPSAC to issue its first report and set of recommendations to the FDA by March 2011 on the impact of menthol on public health, especially on “children, African-Americans, Hispanics, and other racial and ethnic minorities.” The FDA is empowered to ban or reduce menthol in cigarettes if it determines such action would satisfy the public health standard. Given the likely complex impact of product standards on patterns of tobacco use, a transdisciplinary perspective is needed to fully understand how the population will adapt to changes in the regulatory environment. This editorial explores the meaning of the new standard, and specifically how scientific evidence, including 3 articles in this month's Journal,3–5 can help to inform the FDA's consideration of the menthol question.

The Threat of Menthol Cigarettes to U.S. Public Health

In March, after conducting a thorough review of menthol cigarettes' effects, the Tobacco Products Scientific Advisory Committee submitted a report to the Food and Drug Administration concluding that removing these cigarettes from the market would benefit public health.

A Lost Opportunity for Public Health — The FDA Advisory Committee Report on Menthol

The recent report of the FDA's Tobacco Products Scientific Advisory Committee represents a huge victory for Lorillard, the manufacturer of the leading brand of menthol cigarettes — and a disappointing setback for the health of black Americans.

FDA Finding May Curb Mentholated Cigarette Availability

T he availability of menthol cigarettes increases the likelihood that youths and African Americans will become habitual smokers, making menthols a greater public-health hazard than regular brands, the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) said at its mid-March meeting. “The availability of menthol cigarettes has an adverse impact on public health by increasing the number of smokers and increasing the number of avoidable deaths and premature mortality,” said committee member Mark Stuart Clanton, M.D., chief medical officer of the American Cancer Society’s High Plains Division. However, the committee found insuffi cient evidence to conclude that smoking menthols increases the likelihood of addiction among all adults. Nor did evidence indicate that mentholated brands are more dangerous than regular cigarettes, which increase lung and other cancers, heart disease, emphysema, and other chronic conditions. The TPSAC’s conclusions came after a year-long review of epidemiological and physiological studies of menthol smokers in the past decade. The committee’s fi ndings could lead to stepped-up FDA regulation of mentholated brands, which could go as far as a ban. The FDA has until mid-June to issue its fi nal review of the evidence. Agency officials were noncommittal about what actions they might take in response to the TPSAC report. “We do recognize the strong interest in this issue,” said Lawrence Deyton, M.D., director of the Center for Tobacco Products at FDA. “Now it’s up to us to do our job.” The 2009 Tobacco Control Act, which created TPSAC and gave the FDA the authority to regulate tobacco, targeted menthol cigarettes as the fi rst product for heightened scrutiny because of mounting evidence that mentholated brands ultimately lead to lifelong smoking by youths and minorities. The consensus statement of the eight-member panel (three industry representatives on the committee were not allowed to vote on the fi nal recommendations) said the evidence was suffi cient to reach that conclusion. The committee found that menthol brands increase experimentation and regular smoking, as well as increase the likelihood of addiction in young smokers and African-Americans, 80% of whom prefer menthols. It also found that smoking menthols makes the success of smokingcessation programs less likely. “Youths who initiate with menthol cigarettes are more likely to become daily, regular smokers than those who initiate with nonmenthol cigarettes, [and] adolescent menthol smokers have a higher prevalence of addiction than those who smoke nonmenthol cigarettes,” Clanton said. Also, “the availability of menthol cigarettes results in lower likelihood of smoking cessation in AfricanAmericans [than that for] nonmenthol cigarettes.”

Introduction: Mentholated cigarettes and public health

The Food and Drug Administration’s Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act, H.R. 1256. Among its many provisions, section 907(a) of the Tobacco Control Act banned the use of characterizing flavors, specifically excluding only tobacco and menthol flavors from the ban. According to section 907(e)(2), “[n]ot later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to [menthol],” which, according to section 907(e)(1), is “the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.” The inaugural meeting of the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) was held March 30–31, 2010 in Washington, DC. In preparation for this meeting, CTP reviewed peer-reviewed literature on menthol and tobacco as indentified by the National Cancer Institute’s “Bibliography of literature on menthol and tobacco”, and seven scientific presentations were made, including the use of menthol cigarettes (epidemiology), smoking topography and sensations associated with menthol cigarettes, marketing of menthol cigarettes, menthol cigarettes and initiation of smoking behavior, menthol cigarettes and nicotine dependence, menthol cigarettes and cessation of tobacco use, and the health effects of menthol cigarettes as compared to non-menthol cigarettes. Following this initial presentation, additional information was collected through FDA investigation, as well as recommendations from the public, research community and tobacco industry, resulting in comprehensive reviews. Thus, this supplement brings together the extant peer-reviewed information on these seven topics.