All Matters FDA March 31 Virtual Symposium

Food and Drug Law books  published 2022 new editions —Full Print and 12 Subject specific E-Books and a full print E-Book.  Please pass on to colleagues and anyone  you think would benefit.
https://fortipublications.com print and subject specific E-book links

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace. 

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

REGISTRATION NOW OPEN! All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Registration NOW OPEN >

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

UPDATE! All Matters FDA March 31 Virtual

UPDATE!

Save the Date March 31, 2022

1pm-5pm Virtual

Pre Registration: https://bit.ly/all-matters-fda-2022

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

  Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

  Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas     Ethics and Professional Conduct

  Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.     Food Law Cases

  Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration     Enforcement

  George D. Lapsley  —   Food Safety Expert    Court Appointed Expert – Miller’s Organic Farm 

  Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration    
COVID-19 Vaccines    and    Alzheimer’s Aduhelm® Approval

  Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance     Enforcement

  Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY      Pet Product Safety

  Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School    
Symposium Director     Year in Review

  Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration     FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration


Further Info. Roseann Termini: rbtermini@widener.edu

FDA Matters Symposium Virtual March 24

https://delawarelaw.widener.edu/about/news-events/events/event/3681/

TOBACCO CONTROL ACT AND THE PRESENT-DAY IMPACT ON “OVERLOOKED AND BELATED ISSUES”—ENDS, YOUTH EPIDEMIC, GRAPHIC WARNINGS

Abstract

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3311583

Although smoking has plagued the United States for generations, it was not until the past several years that smoking received more serious scrutiny. Yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to human health as evidenced by the Surgeon General’s report explaining that smoking causes cancer.  

Fast forward to current times, the Centers for Disease Control (“CDC”) has determined that over 1,300 people in the United States die each day due to smoking and over sixteen million Americans have a disease attributed to smoking. The CDC concluded that in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.  

These statistics do not just cover the older generations that many associate with smoking. Over the years, the numbers in teen smoking statistics have escalated since the 1990s. Based on CDC statistics, about 2,000 youth start smoking their initial 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 eighteen years of age are expected to die prematurely from a smoking-related illness. This denotes about 1 in every 13 Americans aged seventeen years or younger who are alive today. The Center for Tobacco Products (“CTP”) within the United States Food and Drug Administration (“FDA”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases. Since its creation, the CTP has maintained a critical mission on educating youth about the dangers of smoking. Yet, teen use of tobacco related products has increased.  

The Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Act) became law on June 22, 2009. This legislation conferred authority to the FDA to regulate tobacco products. The FSPTCA amended the Food, Drug, and Cosmetic Act (FDCA) and other federal laws by permitting FDA regulatory authority over of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Yet, the FSPTCA, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (ENDS) and were eventually “deeming” as part of the FSPTCA. 

There are a myriad of matters concerning tobacco products regulation. However, this article highlights critical issues important to the public health in the United States. This article provides an overview of tobacco products regulation, including the FSPTCA. Yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements. Further, the FSPTCA was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco and ENDS including e-cigarettes. To overcome the lack of inclusion in the FSPTCA, deeming regulations were enacted. Despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated. Finally, this article discusses the FDA’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. 

Keywords: Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking

A Look Back Evolution of the Family Smoking Prevention and Tobacco Control Act —Present-Day Impact on ‘Overlooked and Belated Issues’ — Electronic Nicotine Delivery Systems and the Youth Epidemic, Menthol, Graphic Warnings and Corrective Statements

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3311583

Although smoking has plagued the United States for generations, it was not until the past several years that smoking received more serious scrutiny. Yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to human health as evidenced by the Surgeon General’s report explaining that smoking causes cancer.  

Fast forward to current times, the Centers for Disease Control (“CDC”) has determined that over 1,300 people in the United States die each day due to smoking and over sixteen million Americans have a disease attributed to smoking. The CDC concluded that in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.  

These statistics do not just cover the older generations that many associate with smoking. Over the years, the numbers in teen smoking statistics have escalated since the 1990s. Based on CDC statistics, about 2,000 youth start smoking their initial 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 eighteen years of age are expected to die prematurely from a smoking-related illness. This denotes about 1 in every 13 Americans aged seventeen years or younger who are alive today. The Center for Tobacco Products (“CTP”) within the United States Food and Drug Administration (“FDA”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases. Since its creation, the CTP has maintained a critical mission on educating youth about the dangers of smoking. Yet, teen use of tobacco related products has increased.  
The Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Act) became law on June 22, 2009. This legislation conferred authority to the FDA to regulate tobacco products. The FSPTCA amended the Food, Drug, and Cosmetic Act (FDCA) and other federal laws by permitting FDA regulatory authority over of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Yet, the FSPTCA, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (ENDS) and were eventually “deeming” as part of the FSPTCA. 

There are a myriad of matters concerning tobacco products regulation. However, this article highlights critical issues important to the public health in the United States. This article provides an overview of tobacco products regulation, including the FSPTCA. Yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements. Further, the FSPTCA was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco and ENDS including e-cigarettes. To overcome the lack of inclusion in the FSPTCA, deeming regulations were enacted. Despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated. Finally, this article discusses the FDA’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. 

Keywords: Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking