Running head: TOBACCO CONTROL ACT

The Family Smoking Prevention and Tobacco Control Act of 2009

Yukiko Griffin MBA 6310 XA

The Tobacco Control Act TABLE OF CONTENTS

Abstract...2 The Family Smoking Prevention and Tobacco Control Act of 2009. 3 Literature Review....5 Tobacco Control Act5 The Impact of the Act on Tobacco Use...5 R.J. Reynolds Tobacco et al v. FDA....6 What the Tobacco Control Act Does...7 Background.7 Warning Labels...7 Authorities..8 To protect the citizens or rule the cigarette companies..8 Prevention of Tobacco Use v Freedom of Speech...9 Background.9 The Courts ruling...9 Options for the Act10 Conclusion.11 References..12

The Tobacco Control Act Abstract The purpose of this paper is to examine the purpose of The Family Smoking Prevention and Tobacco Control Act of 2009, and examine the legal case, R.J. Reynolds Tobacco et al v. FDA which is related to the Act. The paper explains what for the Act became law, how the Act has influenced the society, and why the cigarette companies were against the Act. The paper then discusses the options for the Act. It concludes the main purpose of the act was to protect citizen, not to regulate cigarette companies, and since the federal judges ruled that cigarette companies win a freedom of speech challenge against the Act, the government needs to consider other options such as more strict taxation on cigarettes or try a regulation in another country.

The Tobacco Control Act The Family Smoking Prevention and Tobacco Control Act of 2009 The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and the

Drug Administration (FDA) authority for the first time to regulate tobacco products. A provision directed the agency to require larger, graphic warning labels covering the top half of the front and back of cigarette packs by Sept. 22, 2012, as well as 20 percent of print advertising for cigarettes. The photos the FDA selected for the labels are similar to some on cigarette packaging in Canada (Strom, 2012). On August 24, 2012, The United States Court of Appeals for the District of Columbia said that the Act violated corporate free speech rights. Judge Janice Rogers Brown of the District of Columbia Circuit wrote This case raises novel questions about the scope of the government's authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest -- in this case, by making 'every single pack of cigarettes in the country a mini billboard' for the government's antismoking message (Reuters, 2012). Rep. Henry A. Waxman, the author and champion of the Food and Drug Administrationtobacco bill, said that the FDA is the only agency equipped to limit and reduce the damage that tobacco use does to the nations health, and stem the recruitment of new smokers among the nations youth (Healy, 2009). Thus, the FDA should have powers to influence tobacco use by the Act. This paper examines whether the main purpose of this Act is to preserve the well-being of U.S. citizens, or rule the cigarette companies, how the package labels influence tobacco use, and if the Act violated Freedom of Speech of cigarette companies, then what the Act can do anything effective to prevent youth smokers except package warnings.

The Tobacco Control Act

These are important questions because now that the court ruled the regulation which had been success to influence on youth smokers, the U.S. government needs to find another effective way to prevent youth smokers as soon as possible.

The Tobacco Control Act Literature Review Tobacco Control Act According to the FDA, The Family Smoking Prevention and Tobacco Control Act became law on June 22, 2009. It gives the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health (Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer fact Sheet, 2012). Melissa Healy (2012) overstated that the Act stipulates that the FDAs regulation would be underwritten by user fees

levied on the tobacco companies and regulating tobacco became a tricky job for the FDA given a task of protecting the nations health. The Impact of the Act on Tobacco Use According to the American Academy of Pediatrics, warning labels which were required by The Family Smoking Prevention and Tobacco Control Act of 2009 played a critical role in educating children, teens, and parents about the harmful effects of tobacco. Dr. Block said With the average pack-a-day smoker encountering cigarette warning labels more than 7,000 times a year, the FDAs effort to improve warning labels would be a significant step forward in the effort to reduce the death and disease caused by tobacco use, especially in young people (American Academy of Pediatrics [AAP], 2012). David Hammond, Ph.D., School of Public Health and Health Systems, evaluated the perceived efficacy of the 36 proposed FDA warnings. The result from the evaluation provided evidence that pictorial health warnings on tobacco packages are a cost-effective means to increase public awareness about the danger of tobacco use (Hammond, 2011). The U.S. Surgeon General issued the first report on youth smoking since 1994. Surgeon General Regina Benjamin calls tobacco use a "pediatric epidemic." She suggested the Act needs

The Tobacco Control Act to focus on teenagers and young adults. That means doing a lot more to counter the billions of dollars the tobacco industry still spends on advertising and marketing (Burnham, 2012). R.J. Reynolds Tobacco et al v. FDA Floyd Abrams, a New York attorney for the plaintiffs and prominent First Amendment scholar of the Tobacco Act, said that The government, as the court said, is free to speak for itself, but it may not, except in the rarest circumstance, require others to mouth its position." Christopher W. Hansen of the Cancer Action Network, on the other hand, stated that: "today's ruling ignores the overwhelming, decades-long need for strong cigarette warning labels and

allows Big Tobacco to proceed 'business as usual,' continuing to promote its highly addictive and deadly products (Federal Judge Blocks Imposition of Graphic Anti-Smoking Pictures on Tobacco Products, 2012). Gary Sanford (2012) suggested that if the governments aim is to protect society from the consequences of unhealthy behaviors, the Act should have been The American Family Protection Act and includes other preventable health risk behaviors such as obesity or alcohol. The Act should not be attacking only cigarette companies. AAP president Robert W. Block said Smoking is 100 percent preventable. Todays decision ensures that the American public, particularly children, teens and adolescents so easily influenced and frequently targeted by tobacco product advertising, will be educated about the dangers of tobacco use. Hopefully, this means fewer children will start to smoke in the first place, and more lives will be saved (AAP, 2012).

The Tobacco Control Act What the Tobacco Control Act Does Background In June 2009, the Family Smoking Prevention and Tobacco Control Act is signed into law

The Tobacco Act allows the Food and Drug Administration not only to forbid advertising geared toward children but also to lower the amount of nicotine in tobacco products, ban sweetened cigarettes that appeal to young taste buds and prohibit labels like ''light'' and ''low tar"(ZELENY, 2009). The FDA chose nine graphic images of corpses, cancer-ridden lungs and a guy exhaling smoke through a tracheotomy hole in his neck stub out cigarette consumption to be placed prominently on cigarette packs sold in the USA after September 2012 in June, 2011. The FDAs goal was to slash consumption among the nation's 43 million smokers and prevent millions more, especially teens, from ever starting (Strauss, 2012). Warning Labels The Act specifically packaging and advertisements for cigarettes and smokeless tobacco must have revised warning labels with a larger font size. Font colors are limited to white on a black background or black on a white background. Sec. 201 and 204. Cigarette package health warnings will be required to cover the top 50 percent of both the front and rear panels of the package and the nine specific warning messages must be equally and randomly displayed and distributed in all areas of the United States. These messages must be accompanied by color graphics showing the negative health consequences of smoking cigarettes. Sec. 201. Smokeless tobacco package warnings must cover 30 percent of the two principal display panels, and the four specific required messages must be equally and randomly displayed and distributed in all areas of the United States. Sec. 204(The U.S. Food and Drug Administration [FDA], 2012).

The Tobacco Control Act Requiring warning labels was a key part of tobacco control policy because tobacco advertising plays an important part in encouraging non-smokers to become smokers. In 2010, Hammond, Reid, Driezen, and Boudreau (2012) conducted Web-based surveys to evaluate the perceived efficacy of the 36 proposed FDA warnings. They concluded seven of the nine health warnings selected by the FDA for implementation were among the proposed warnings rated as most

effective. However, the warnings added for comparison were rated higher than the FDA-selected warning for five of the nine sets, suggesting some warnings could be improved for greater impact such as full color (vs. black and white), featured real people (vs. comic book style), contained graphic images (vs. nongraphic), and included a telephone quit line number or personal information. Authorities The Act Gives the FDA authority over registration and inspection of tobacco companies, Standards for tobacco products, Premarket Review of new tobacco products, Modified risk products, and Enforcement action plan for advertising and promotion restrictions. There are limits on the FDAs authority. The FDA cannot ban certain specified classes of tobacco products require the reduction of nicotine yields to zero, require prescriptions to purchase tobacco products, or ban face-to-face tobacco sales in any particular category of retail outlet (FDA, 2012) To protect the citizens or rule the cigarette companies The main purpose of the Act was to protect citizens, especially young generations. Since Research studies have found that kids are three times as sensitive to tobacco advertising than adults and are more likely to be influenced to smoke by cigarette marketing than by peer pressure; and that a third of underage experimentation with smoking is attributable to tobacco

The Tobacco Control Act company advertising and promotion, regulating the cigarette companies could be the minimum requirement for the Act (Guilfoyle, 2012). Prevention of Tobacco Use v Freedom of Speech Background

10

The Family Smoking Prevention and Tobacco Control Act passed in 2009 have required nine written warnings such as "Cigarettes are addictive" and "Tobacco smoke causes harm to children." Also included would have been alternating images of a corpse and smoke-infected lungs. In September 21, 2011, attorneys for five tobacco companies told a federal judge that such radical "rebranding" was unconstitutional and costly, and would cause them irreparable injury. R. J. Reynolds Tobacco Co. attorney Noel J. Francisco said that Government cannot make businesses act as an "unwilling mouthpiece" for its advocacy campaigns and asked U.S. District Judge Richard Leon in the District of Columbia to issue a preliminary injunction to block the FDAs cigarette-packaging rules from going into effect until 15 months after a final judgment on the issue (Wetzstein, 2011). The Courts ruling A federal judge, D.C. District Court Judge Richard Leon ruled that cigarette makers were likely to win a free speech challenge against the proposed labels by the FDA which include images of a simulated cadaver, a cartoon drawing of a baby in a cloud of smoke, and a photo of a blackened lung on November 7, 2011. The judge said the companies would suffer irreparable harm if the provision were enforced before it was fully decided in courts, a process that is likely to take years (Wilson, 2011). On March 1, 2012, Judge Richard J. Leon of the United States District Court in Washington ruled that forcing the companies to use the labels violated their free speech rights under the First

The Tobacco Control Act

11

Amendment. Judge Leon offered alternative ways to convey the health risks of smoking without violating the First Amendment, such as reducing the amount of space taken up by its warning labels and changing the images to convey ''only purely factual and uncontroversial information rather than gruesome images designed to disgust the consumer''(Strom, 2012). The United States Court of Appeals for the District of Columbia, in a 2-to-1 ruling on August 24, 2012, struck down the new warnings on the grounds that they violated the First Amendment rights of the tobacco companies. It ruled that the government failed to provide evidence that the warnings would reduce smoking rates, and therefore could not justify what it called a restraint on corporate free speech(Warning: Smoking Can Kill You, 2012). .Options for the Act Tobacco advertising plays an important part in encouraging non-smokers to begin smoking. The Acts purpose is to protect society from the consequences of unhealthy behaviors. Therefore, the Act requires warning labels because the labels are a key part of tobacco control. However, if the cigarette companies claimed that the Act violate free speech protections to protect them, the government needs to find another effective way to prevent youth smokers. Taxation is another cost-effective way of reducing tobacco consumption, especially populations that youth and young adults, racial and ethnic minorities, and lower income and less educated populations which are considered as the most difficult to reach with other cigarette control efforts. In high-income countries taxation generates significant revenues for governments. It can also cover the costs to society of tobacco use. However, there is some studies indicate that the increasing cigarette prices may lead young people to use marijuana as a substitution for cigarettes because they have lower income and they are very responsive to changes in the prices(Chaloupka, 1998). The tobacco industry also has been undermining the

The Tobacco Control Act anti-smoking effect of tax increases by discounting the price of its product. The result is that

12

state and federal cigarette tax increases are generating more revenue and less smoking reduction than expected (Goozner, 2012). In Australia, The law of new packaging rules was passed in 2011, which requires cigarettes to be sold in olive green packets, with graphic images warning of the consequences of smoking. Authorities have said that plain packaging of cigarettes will help reduce the number of smokers in the country. However, tobacco manufacturers claimed that removing their brand names and company colors from packets will lead to a drastic cut in profits and that the law is unconstitutional and infringes on their intellectual property rights by banning the use of brands and trademarks (Kennedy, 2012). This rule can be an option for the U.S. government. Since smoking is not only a problem in the states, but also a problem in the world, the U.S. government should try the regulations of other countries.

The Tobacco Control Act Conclusion This paper has examined the purpose of The Family Smoking Prevention and Tobacco

13

Control Act of 2009, and the legal case, the violation Freedom of Speech of cigarette companies which is related to the Act. The Family Smoking Prevention and Tobacco Control Act of 2009 became law for protecting society from the consequences of unhealthy behaviors. To protect society, the law regulates the marketing of cigarette companies such as warning labels because regulating the cigarette companies could be the minimum requirement for the Act to reduce smokers. Therefore, the main purpose of the act was just purely to protect citizen. Marketing is very important element of business success and, of course, cigarette companies want to make a profit by using effective marketing plans. If the government violates and regulated their marketing plans, it would be natural that companies are against the government. However, since over a billion people will die prematurely as a result of smoking, their marketing plans should have been considered as a harm which influences people to adopt a deadly habit. Unfortunately, since the federal judge ruled the minimum requirement of the Act to reduce smokers, the government needs to set new regulations such as more strict taxation on cigarettes or try a regulation in another country such as requiring plain packaging of cigarettes like in Australia.

The Tobacco Control Act References Zeleny, J. (2009, June 23) Occasional Smoker, 47, Signs Tobacco Bill. The New York Times, p.A15. Reuters. (2012, August 25). Appeals Court Blocks Graphic Warnings on Cigarettes. The New York Times, p.B4.

14

Strom, S. (2012, March 1). U.S. Judge Strikes Down F.D.A. Cigarette Labels. The New York Times, p.B4. Strauss, G (2011, June 22). WARNING In a new, controversial push against smoking, the FDA will require graphic photos on cigarette packs. USA TODAY, p. 1A. Strom, S (2012, March 2). U.S. judge sides with tobacco firms; Free speech is violated by requiring labels with graphic photos, he rules. The International Herald Tribune, p. 23 Warning: Smoking Can Kill You. (2012, August 28). The New York Times, p. A22. American Academy of Pediatrics. (2012, March 19). AAP Commends Court Ruling to Limit Marketing of Tobacco Products to Children: Decision Reflects the Impact of Tobacco Advertising in Enticing Young Smokers. Wetzstein, C. (2011, September 22). Cigarette makers sue to block new graphic warnings. The Washington Times, p.A4 Wilson D. (2011, November 8). Federal Court Blocks the Graphic Warning Labels on Cigarette Packages. The New York Times, p.B2. Healy, M. (2009, June 20). The tobacco law: What the FDA can and cant do. Los-Angeles Times. Retrieved from http://articles.latimes.com/2009/jun/29/health/he-tobacco29 Mears, B. (2012, March 1). Federal judge blocks anti-smoking images required on

The Tobacco Control Act tobacco products. CNN.com. Retrieved from http://www.cnn.com/2012/02/29/us/tobaccowarnings/index.html Pelofsky, J. (2012). Tobacco Health Labels Violate Free Speech, Judge Rules. NBCNews.

15

com. Retrieved from http://www.msnbc.msn.com/id/46577000/ns/health-addictions/t/tobaccohealth-labels-violate-free-speech-judge-rules/ Sanford, G. (2012). Family Smoking Prevention and Tobacco Control Act Rightly Overturned by Court. Retrieved from http://www.policymic.com/articles/4960/familysmoking-prevention-and-tobacco-control-act-rightly-overturned-by-court Know Cancer. (2012). Federal Judge Blocks Imposition of Graphic Anti-Smoking Pictures on Tobacco Products. Retrieved from http://www.knowcancer.com/blog/graphic-antismoking-pictures-on-tobacco-products/ Burnham, T. (2012). Surgeon General Calls Smoking A 'Pediatric Epidemic'. Retrieved from http://www.npr.org/blogs/health/2012/03/08/148237461/surgeon-general-calls-smokinga-pediatric-epidemic Guilfoyle, J. (2012, June 13). Toll of Tobacco in the United States of America. Campaign for Tobacco-Free Kids. Retrieved from http://www.tobaccofreekids.org/research/factsheets/pdf/0072.pdf. Hammond, D., Reid, J., Driezen. P., & Boudreau, C. (2012). Pictorial Health Warnings on Cigarette Packs in the United States: An Experimental Evaluation of the Proposed FDA Warnings. Oxford Journal. doi: 10.1093/ntr/nts094. The Food and Drug Administration. (2012). Overview of the Family Smoking Prevention

The Tobacco Control Act and Tobacco Control Act: Consumer fact Sheet. Retrieved from

16

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.h tm. Chaloupka, F. (1998). How Effective Are Taxes in Reducing Tobacco Consumption? University of Illinois at Chicago. Goozner, M. (2012, July 12). Tobacco Companies Get a Breather from Tax Hikes. The Fiscal Times. Retrieved from http://www.thefiscaltimes.com/Articles/2012/07/12/TobaccoCompanies-Get-a-Breather-from-Tax-Hikes.aspx#page1. Kennedy, D. (2012, August 14). Australia cigarette plain packaging law upheld by court. BBC News. Retrieved from http://www.bbc.co.uk/news/business-19264245