Family Smoking Prevention And Tobacco Control Act Research Articles

Kebijakan Luar Negeri Indonesia dalam Sengketa Family Smoking Prevention and Tobacco Control Act: Analisis Two-Level Game Theory

This article explains why the Indonesian government did not retaliate the USA according to the DSB WTO authorization, but rather opted to retaliate in the form of signing a mutually agreed solution/MoU in the case of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). FSPTCA was regarded as a discriminatory act issued by the USA against Indonesia’s clove cigarettes. Indonesia responded by disputing it into the Dispute Settlement Body World Trade Organization (DSB WTO). The USA was found guilty because it violated the WTO principle of non-discrimination and so that it was ordered to comply with the Panel and Appellate Body’s recommendation. Indonesia then requested DSB WTO authorization to carry out retaliation. However, Indonesia did not retaliate according to DSB WTO authorization, but rather opted to sign a mutually agreed solution/MoU (Moratorium of Understanding) to end the FSPTCA trade dispute. Using two-level game theory as its analytical framework, this article argued that Indonesia decision to sign a mutually agreed solution instead of retaliation against the USA was driven by the fact that agreement was considered much more significant and suitable to Indonesia interests.

Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA.

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to all new tobacco products, based on a public health standard, before they can be legally marketed. Yet the law also contains an alternative pathway for market entry-the substantial equivalence (SE) clause-by which novel and altered tobacco products can be marketed by demonstrating their substantial equivalence to existing products. Over 99 percent of tobacco product applications sent to the FDA under the new law have used this mechanism, and loose application of the SE mechanism carries the risk of undoing the FDA's gatekeeping power under the law. We review the statutory and regulatory precedent for SE, examining the FSPTCA itself as well as regulatory precedent from drug and device regulation (from which the term substantial equivalence and much of the associated statutory language was derived). Our review of standards and scientific precedent demonstrates that exacting scrutiny under the public health standard should govern all SE reviews and that clinical data incorporating social scientific evidence should be routinely required for SE claims by tobacco product sponsors.

Tobacco Advertising and Promotional Expenditures in Sports and Sporting Events - United States, 1992-2013.

Smokeless tobacco has been actively promoted by tobacco companies using endorsements by major sport figures, and research indicates that tobacco advertising can lead to youth initiation of tobacco use (1,2). Television and radio advertisements for cigarettes and smokeless tobacco have been prohibited since 1969,* and the 1998 Master Settlement Agreement(†) further prohibited tobacco companies from targeting youths with tobacco product advertisements in specified areas. In 2010, the Food and Drug Administration (FDA), under authority of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), prohibited tobacco-brand sponsorship (i.e., sponsorship of sports and entertainment events or other social or cultural events using the tobacco brand name or anything identifiable with any brand of cigarettes or smokeless tobacco).(§) However, corporate-name tobacco sponsorship (i.e., sponsorship using the name of the corporation that manufactures regulated tobacco products) is still permitted under certain conditions.(¶) To monitor tobacco advertising and promotional activities in sports in the United States, CDC analyzed trends in sports-related marketing expenditures for cigarettes and smokeless tobacco during 1992-2013 using data from the Federal Trade Commission (FTC). During 1992-2013, sports-related marketing expenditures, adjusted by the consumer price index to constant 2013 dollars, decreased significantly for both cigarettes (from $136 million in 1992 to $0 in 2013) and smokeless tobacco (from $34.8 million in 1992 to $2.1 million in 2013). During 2010-2013, after the prohibition of tobacco-brand sponsorship in sports under the FSPTCA, cigarette manufacturers reported no spending (i.e., $0) on sports-related advertising and promotional activities; in contrast, smokeless tobacco manufacturers reported expenditures of $16.3 million on advertising and promoting smokeless tobacco in sports during 2010-2013. These findings indicate that despite prohibitions on brand sponsorship, smokeless tobacco products continue to be marketed in sports in the United States, potentially through other indirect channels such as corporate-name sponsorship. Enhanced measures are warranted to restrict youth-oriented tobacco marketing and promotional activities that could lead to tobacco initiation and use among children and adolescents (2). Reducing tobacco industry promotion through sponsorship of public and private events is an evidence-based strategy for preventing youth initiation of tobacco use (3). In addition, other proven interventions (e.g., tobacco price increases, anti-tobacco mass media campaigns, tobacco-free policies inclusive of smokeless tobacco, and barrier-free access to cessation services), could help reduce smokeless tobacco use in the United States (1).

Abstract IA13: Connecting science to law: Understanding the policymaking process

Abstract Tobacco use remains the leading cause of preventable death in the U.S., killing 480,000 Americans a year. To address the death and disease caused by tobacco use, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, granting the U.S. Food and Drug Administration (FDA) broad authority to regulate the manufacture, marketing, and sale of tobacco products. In order to help build the science base for tobacco regulation, the FDA has invested heavily in “tobacco regulatory science.” In partnership with the National Institutes of Health (NIH), it is investing $273 million over five years in the Tobacco Centers of Regulatory Science (TCORS) initiative. The TCORS program funds 14 centers at academic institutions (including Ohio State) that conduct research relevant to the FDA's regulation of tobacco. This initiative is a unique partnership between a regulatory agency and researchers, developed with the explicit expectation that the research will directly inform the FDA's regulatory actions. To conduct research that will assist the FDA in fulfilling its regulatory mission, researchers must venture outside of their comfort zone and consider the relevant legal and policy environment. More specifically, scientists engaged in tobacco regulatory science must consider at least four different questions: (1) what FDA regulatory action(s) might my research inform?; (2) what types of evidence would the FDA need to consider in order to take such actions?; and (3) if such a regulation were reviewed in court, what questions would the courts ask about the available evidence? Failure to consider these questions may lead to research that, while scientifically valid, does not advance the FDA's ability to fulfill its regulatory mission. Thus, in order for the TCORS program to succeed, there must be a productive and ongoing dialogue between scientists and attorneys familiar with the regulatory landscape. This presentation will discuss the need for better coordination between scientists and attorneys, particularly in the context of tobacco regulatory research. It will also discuss how law acts as a social determinant of health that has a significant impact (both positive and negative) on health disparities. Citation Format: Micah L. Berman. Connecting science to law: Understanding the policymaking process. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr IA13.

State Level Point-of-Sale Policy Priority as a Result of the FSPTCA.

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) give the U.S. Food and Drug Administration (FDA) unprecedented power to regulate tobacco products. One of the most significant provisions of the law allows state and local governments to adopt and enforce tobacco control legislation restricting the time, place, and manner (but not the content) of tobacco advertising. However, there is still reluctance among states and localities for mass adoption of laws due to challenges associated with legal feasibility and lack of U.S.-based evidence in effectiveness. The Center for Public Health Systems Science conducted interviews with key tobacco control contacts in 48 states at two time points (2012 and 2014) since the passage of the FSPTCA to assess the influence of the law on point-of-sale policy development in their state tobacco programs. Logistic regression results show that point-of-sale policy importance is growing post-FSPTCA, and that key influencers of this importance are states' tobacco control histories and environments, including that related to excise taxes and smoke free air policies. The adoption of smokefree and tax policies has become commonplace across the U.S., and the quality and extent of these laws and prevailing political will increasingly impact the ability of states to work in emerging tobacco control policy areas including those directed at the point of sale.

Enhancing youth tobacco surveillance to inform tobacco product regulation: findings from the 2012 National Youth Tobacco Survey.

Decreasing youth tobacco use is a significant public health priority. In the U.S., nearly one in 15 middle school students and one in four high school students were current tobacco users in 2012,1 and 5.6 million youth aged under 18 years today are projected to die prematurely from smoking-related disease.2 The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed into law on June 22, 2009, amended the Federal Food Drug and Cosmetic Act (FD&C Act) to provide the U.S. Food and Drug Administration (FDA) with the authority to regulate the manufacturing, distribution, and marketing of tobacco products to protect public health.

Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?

BackgroundUnder the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey...

Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey

BackgroundOn June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA.MethodBetween November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC) United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA.ResultsMost smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form.ConclusionMost smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

Update in Chronic Obstructive Pulmonary Disease in 2010

The year 2010 marked several milestones for chronic obstructive pulmonary disease (COPD). Unfortunately, COPD moved from fourth leading cause of death in the United States to third. On the other hand, the United States also celebrated the 1-year anniversary of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which led to increased regulation of tobacco marketing, and the implementation of public health strategies to reduce tobacco-related morbidity and mortality (1). Also in 2010, the editorial team of the Journal published an article entitled “What the Journal Would Like to Publish on Chronic Obstructive Pulmonary Disease” (2). This article challenged the scientific community to focus on issues such as understanding disease susceptibility, the mechanism of inflammation persistence after smoking exposure is withdrawn, and the multicomponent nature of the disease. The review that follows is an overview of key publications on COPD in the last year. So I invite you to be the judge: Have we risen to the challenge? The obstacles we face in understanding and treating COPD are great, but not unique. The year 2010 also marked the 5-year anniversary for the Bill & Melinda Gates Foundation Grand Challenges in Global Health initiative. In reviewing the past 5 years, Bill Gates reflected, “We were naive when we began.” The rate of discovery in medical research may seem slow relative to the exponential pace of advance in fields such as computing. Yet we are making progress. The articles that follow demonstrate progress in our understanding of host susceptibility and the inflammatory response in COPD, and also the mechanisms of currently available therapies and how biomarkers may help us better target therapies in the future.

Tobacco and nicotine product testing.

Tobacco product testing is a critical component of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which grants the Food and Drug Administration the authority to regulate tobacco products. The availability of methods and measures that can provide accurate data on the relative health risks across types of tobacco products, brands, and subbrands of tobacco products on the validity of any health claims associated with a product, and on how consumers perceive information on products toxicity or risks is crucial for making decisions on the product's potential impact on public health. These tools are also necessary for making assessments of the impact of new indications for medicinal products (other than cessation) but more importantly of tobacco products that may in the future be marketed as cessation tools. To identify research opportunities to develop empirically based and comprehensive methods and measures for testing tobacco and other nicotine-containing products so that the best science is available when decisions are made about products or policies. Literature was reviewed to address sections of the FSPTCA relevant to tobacco product evaluation; research questions were generated and then reviewed by a committee of research experts. A research agenda was developed for tobacco product evaluation in the general areas of toxicity and health risks, abuse liability, consumer perception, and population effects. A cohesive, systematic, and comprehensive assessment of tobacco products is important and will require building consensus and addressing some crucial research questions.

Family Smoking Prevention and Tobacco Control Act: Banning Outdoor Tobacco Advertising Near Schools and Playgrounds

The tobacco industry has challenged new FDA rules restricting outdoor tobacco advertising near schools and playgrounds on First Amendment grounds, arguing that they would lead to a near complete ban on tobacco advertising in dense urban areas. To examine how the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA) rules banning outdoor tobacco advertising near schools and playgrounds would affect tobacco retailers. GIS spatial analyses of two different states (Missouri, New York), along with more detailed analyses of two urban areas within those states (St. Louis, New York City), were conducted in 2010. The percentage of tobacco retailers falling within 350-, 500-, and 1000-foot buffer zones was then calculated. 22% of retailers in Missouri and 51% in New York fall within 1000-foot buffers around schools. In urban settings, more retailers are affected, 29% in St. Louis and 79% in New York City. Sensitivity analyses demonstrate that smaller buffers decrease the proportion of affected retailers. That is, 350-foot buffers affect only 6.7% of retailers in St. Louis and 29% in New York City. The effects of new outdoor tobacco advertising restrictions vary by location and population density. In Missouri and New York, outdoor tobacco advertising would still be permitted in many locations if such advertising was prohibited in a 1000-foot buffer zone around schools and playgrounds. Much smaller buffer zones of 350 feet may result in almost no reduction of outdoor advertising in many parts of the country.

Nicotine reduction revisited: science and future directions

Regulation of nicotine levels in cigarettes and other tobacco products is now possible with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, giving the US Food and Drug Administration (FDA) authority to regulate tobacco products, and with Articles 9-11 of the WHO Framework Convention on Tobacco Control. Both regulatory approaches allow establishing product standards for tobacco constituents, including nicotine. The FSPTCA does not allow nicotine levels to be decreased to zero, although the FDA has the authority to reduce nicotine yields to very low, presumably non-addicting levels. The proposal to reduce levels of nicotine to a level that is non-addicting was originally suggested in 1994. Reduction of nicotine in tobacco products could potentially have a profound impact on reducing tobacco-related morbidity and mortality. To examine this issue, two meetings were convened in the US with non-tobacco-industry scientists of varied disciplines, tobacco control policymakers and representatives of government agencies. This article provides an overview of the current science in the area of reduced nicotine content cigarettes and key conclusions and recommendations for research and policy that emerged from the deliberations of the meeting members.