Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. This volume, contained in the new print eighth edition, emanates from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of implementation procedures for the Pennsylvania Plain Language Act. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel Uni-versity and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the com-mittees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials.
Tobacco Products Regulationby Roseann B. Termini, Esq.
Did you know that According to the Centers for Disease Control and Prevention, over 443,000 deaths every year are attributed to tobacco use in the United States? Over 8.6 million Americans have chronic illnesses linked to smoking. Approximately 4,000 youth start smoking and 1,000 youth become daily smokers. The rise of teen smoking
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Tobacco Products Regulation
Did you know that According to the Centers for Disease Control and Prevention, over 443,000 deaths every year are attributed to tobacco use in the United States? Over 8.6 million Americans have chronic illnesses linked to smoking. Approximately 4,000 youth start smoking and 1,000 youth become daily smokers. The rise of teen smoking and the long-term effects of nicotine addiction prompted a change.
Smoking has plagued the United States for generations; however, it was not until the past several years that this issue received more serious scrutiny. According to the American Cancer Society, lung cancer in the United States included a diagnosis of approximately 228,190 new cases of lung cancer (118,080 male and 110,110 female) as well as an estimated 159,480 deaths from lung cancer (87,260 male and 72,220 female) in 2013. Further, according to the World Health Organization, tobacco use is the most significant risk factor for cancer. Worldwide this accounts for 71% of global lung cancer deaths.
To that end, on June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA). This historic legislation conferred authority to FDA to regulate tobacco products. This law amended the FDCA and other federal laws by permitting FDA regulatory authority over the manufacture, marketing, and distribution of all tobacco products. This includes all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. For example, The FSPTCA requires large graphic warnings are required on cigarette cartons that describe the health consequences of smoking; however, this has met with resistance based on Constitutional principles.
The impetus for the FSPTCA was due to the United States Supreme Court decision of FDA v. Brown and Williamson Tobacco Corp. The Supreme Court, in Brown, held that FDA lacked the authority to regulate tobacco products. FDA asserted jurisdiction over tobacco products based on the FDCA definitions of “drug” and “device.” Nearly ten years after this United States Supreme Court decision, Congress provided FDA with explicit legal authority or jurisdiction to regulate tobacco products. This volume includes the Brown decision, First Amendment challenges, enforcement and e-cigarettes. Most intriguing are e-cigarettes and the jurisdiction of FDA to regulate these products. E-cigarettes are touted as a safe alternative; however, it is too soon to accurately predict the safety of e-cigarettes.
How does the regulation of tobacco products fit in the scheme of FDA regulation? The Center for Tobacco Products (CTP) within FDA regulates tobacco products. Since its existence, the CTP has maintained a critical focus of prevention of youth smoking. FDA releases a media blitz aimed at youth about the dangers of smoking. Interestingly, CVS Caremark announced plans to phase out the sale of cigarettes and tobacco products. Will other similar retail establishments follow the CVS Caremark lead?
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