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M. Zeller
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MS 06 - Regulation of Tobacco Products (ID 24)
- Event: WCLC 2015
- Type: Mini Symposium
- Track: Prevention and Tobacco Control
- Presentations: 1
- Moderators:E. Santos, N. Yamaguchi
- Coordinates: 9/07/2015, 14:15 - 15:45, 201+203
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MS06.03 - FDA Regulation of Tobacco Products in the US (ID 1870)
15:00 - 15:20 | Author(s): M. Zeller
- Abstract
- Presentation
Abstract:
Learning Objectives: • Describe FDA’s authority under the Family Smoking Prevention and Tobacco Control Act and the steps FDA has taken to regulate tobacco products in the 6 years since enactment of the law. • Understand FDA’s Center for Tobacco Products’ (CTP) strategic priorities and CTP’s vision for the regulation of tobacco products to help reduce the death and disease toll caused by tobacco use. • Describe how the CTP Office of Science supports and evaluates research to ensure that CTP has the science base to make regulatory decisions. • Discuss the ways the public health community can engage with FDA to participate in tobacco product regulation. • Identify opportunities to inform FDA action on tobacco to promote public health. Abstract: The landmark Family Smoking Prevention and Tobacco Control Act (TCA) gave the U.S. Food and Drug Administration (FDA) sweeping new authorities to create a healthier future for America’s families by regulating the manufacture, marketing, and distribution of tobacco products. The law, passed by Congress and signed by the President in 2009, gave FDA the authority to establish the Center for Tobacco Products (CTP), which drives powerful change to protect children and families from the dangers of tobacco products. The TCA takes a comprehensive approach—grounded in rigorous, timely science and the law—to improve public health, especially for the next generation. FDA uses its regulatory authority to take action to protect American families, charting a new course for comprehensive change. These actions include: • Developing science-based regulations to safeguard the nation’s health. • Publishing guidance to help the industry comply with regulations for tobacco products. • Conducting retailer inspections to ensure compliance with laws restricting sales of tobacco products to youth, and issuing warning letters and monetary penalties for violations. • Requiring tobacco manufacturers to report the ingredients in their products so FDA can evaluate the harm caused by the ingredients, take steps to reduce the harm, and educate the public about the toxic substances in tobacco products so public health can be improved. • Reviewing proposed modified risk tobacco products before they can be sold. • Restricting the access and attractiveness of cigarettes and smokeless tobacco to young people. • Enforcing the ban on the manufacture and sale of fruit- or candy-flavored cigarettes. • Prohibiting the use of misleading claims such as “low,” “light,” and “mild” that falsely imply that some tobacco products are safer. • Reviewing new tobacco products to determine whether they can be legally marketed. • Launching public information and education campaigns, particularly targeted to youth, about the dangers of regulated tobacco products. • Partnering with other public health agencies to conduct cutting-edge research on a range of topics such as smoking initiation and nicotine addiction. Currently, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. FDA has also published a proposed rule to bring other products that meet the definition of tobacco product under FDA’s regulatory authority, such e-cigarettes, waterpipes, some or all cigars, and pipe tobacco. Despite major progress over the past half-century tobacco use kills more than 480,000 Americans each year, making it the leading cause of preventable death and disease in the United States.[1] Every day in the United States, nearly 2,900 youth under the age of 18 smoke their first cigarette, and more than 700 youth under age 18 become daily smokers.[2] Nationwide, 5.5 percent of high school students currently use smokeless tobacco.[3] Nearly 9 out of 10 daily adult smokers used their first cigarette before the age of 18.1 On a global level, tobacco use causes nearly six million deaths a year and at current rates could kill up to one billion people this century.[4] Tobacco use is the most important risk factor for cancer causing around 20% of global cancer deaths and around 70% of global lung cancer deaths.[5] Tobacco regulators around the globe seek to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke. We share common priorities and face common challenges in the fight to improve global public health. It is imperative that all global stakeholders, including the medical and scientific community, learn from one another’s successes and failures. In the United States, FDA's unique position as a regulatory agency allows for a framework of decisionmaking based on – and within the limits of – both the science and the law. CTP uses a comprehensive approach as the best way to end the negative health effects of tobacco use. This includes defining policy, issuing regulations, conducting research, educating Americans on regulated tobacco products, and making decisions on whether new products and claims can be marketed—including reviewing and evaluating applications and claims before the products are allowed on the market. CTP educates the public about the harms of tobacco products, working to reduce their appeal and keep them out of the hands of America’s youth. CTP is committed to protecting and improving public health by focusing on three top priorities: • Reduce initiation rates and prevent youth from starting to use tobacco • Encourage tobacco users to quit • Decrease the harms of tobacco product use This session will help the global medical, research, and public health communities understand the authority granted to the FDA to regulate tobacco and how science is used to make the most effective regulatory decisions. FDA staff will describe actions taken by the FDA in the first six years of regulating tobacco products and preview future regulatory priorities. Attendees will learn about specific ways in which they can collaborate with and inform FDA’s work. At the conclusion of this session, attendees will be able to describe the FDA's role, its activities to date and priorities for the future. References: 1. US Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. 2. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2012 National Survey on Drug Use and Health, NSDUH: Table 4.10A Past Year Initiation of Substance Use Among Persons Aged 12 or Older Who Initiated Use Prior to the Age of 18, by Gender: Numbers in Thousands, 2012 and 2013. Rockville (MD): US Dept of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2014. 3. Centers for Disease Control and Prevention. Tobacco Product Use Among Middle and High School Students - United States, 2011-2014. Morbidity and Mortality Weekly Report 2015; 64: 381-385. 4. http://www.who.int/mediacentre/factsheets/fs339/en/ 5. http://www.who.int/mediacentre/factsheets/fs297/en/ The U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (TCA). This session will help the medical, research, and public health communities understand the authority granted to FDA to regulate tobacco and how science is used to make the most effective regulatory decisions. Mr. Zeller will describe actions taken by the FDA in the first six years of regulating tobacco products and provide an overview of CTP’s strategic priorities. Attendees will learn about specific ways in which they can collaborate with and inform FDA’s work. At the conclusion of this session, attendees will be able to describe the FDA's role, its activities to date and priorities for the future and understand CTP's strategic priorities and vision for the regulation of tobacco products to help reduce the death and disease toll caused by tobacco use.
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