Tobacco Products Regulation

Tobacco Products Regulation

by Roseann B. Termini, Esq.
Tobacco Products Regulation

Tobacco Products Regulation

by Roseann B. Termini, Esq.



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Tobacco Products Regulation
Admittedly, smoking has plagued the United States for generations; however, it was not until the past several years that this issue received more serious scrutiny. FDA determined that over 1,300 people die each day in the United States due to smoking and over 8.6 million Americans have chronic illnesses linked to smoking. According to the CDC in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, including more than 41,000 deaths resulting from secondhand smoke exposure. Based on CDC statistics, every day about 2000 youth start smoking their first cigarette and 300 youth become day-to-day smokers.* This means that using current rates, of smoking among youth, 5.6 million Americans younger than 18 years of age are expected to die prematurely from a smoking-related illness. This denotes about one in every 13 Americans aged 17 years or younger who are alive today. FDA regulates tobacco products by utilization of a public health standard. The Center for Tobacco Products (CTP) within FDA regulates tobacco products with a single focused mission; that is, to diminish tobacco related deaths and diseases. Since its existence, the CTP has maintained a critical focus of prevention of youth smoking.
The United States Supreme Court decision of FDA v. Brown and Williamson Tobacco Corp. spurred the impetus for the Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Control Act). 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 the United States v. Brown decision, Congress provided FDA with explicit legal authority or jurisdiction to regulate tobacco products. To that end, on June 22, 2009, Former President Obama signed the FSPTCA or Tobacco Control Act. 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. Initially, this included cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. In 2016, FDA issued what are known as "deeming regulations" to include regulation of e-cigarettes, as well as other covered tobacco products such as cigars. Covered tobacco product means any tobacco product deemed subject to the Federal Food, Drug, and Cosmetic Act pursuant to § 1100.2. The FSPTCA requires large graphic warnings on cigarette cartons that describe the health consequences of smoking; however, this was met with resistance. However, FDA was ordered in 2018 to redraft the graphic warnings which were finalized March 202 and industry lawsuits ensued. A further crackdown by initiating age restricted sales and online heightened age verification of electronic nicotine delivery system
The tobacco industry spends billions of dollars on cigarette and smokeless tobacco advertising. Back in 2016, approximately $26 million daily was spent on marketing of cigarettes and smokeless tobacco. The the economic costs are astounding with over $300,000 billion a year with a breakdown of nearly $170,000 billion in medical care and $156 billion in lost productivity.
Previously, according to the 50 years of Progress Report issued in 2014, 3,200 youth started smoking their initial cigarette and 2,100 youth become day-to-day smokers. See: The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General.

Product Details

BN ID: 2940160939896
Publisher: Forti Publications
Publication date: 01/06/2022
Series: Food and Drug Law , #11
Sold by: Barnes & Noble
Format: eBook
File size: 780 KB

About the Author

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 vaping, e-cigarettes, opioid epidemic, 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. In 2018, Ms. Termini was admitted to the United States Supreme Court.
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