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

50 Years Post-Controlled Substances Act: The War on Drugs Rages on with Opioids at the Forefront[1]

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3432531

Ohio Northern University Law Review 46 Ohio N. U. L. Rev.1 (2020) Lead Article.

Roseann B. Termini** and Rachel-Malloy Good*

ABSTRACT

Introduction: Crisis Overview

It is not a hyperbole or a mistaken use of words to state that the United States is in the midst of an Opioid Crisis.[2]  Nearly 200 people die each day from a drug overdose, with nearly 70% of those dying from an opioid-related overdose.[3]  Roughly two million Americans have a “substance use disorder [(SUD)] related to prescription opioid pain medication.”[4]  An estimated eight million children live with at least one parent with a substance use disorder.[5]  Over 35% of children who entered the foster care system in 2016 were removed from their parents due to parental substance abuse.[6]  Between 1999 and 2016, nearly 9,000 children died as a result of opioid poisoning; approximately 81% of those were classified as “unintentional deaths,” 5% were the result of suicide, and 2% were due to homicide.[7]  When broken down further by age group, nearly one quarter of all children under the age of five who died of opioid poisoning died as a result of homicide.[8]  Undoubtedly, there is a crisis and undoubtedly, there is no quick fix.

When a person dies from an overdose, practitioners do not use universal classifications or definitions to determine and record the cause of death[9]; however, according to the Centers for Disease Control and Prevention (CDC), nearly 40% of all opioid overdose deaths in the United States in 2017 involved a prescription opioid, and roughly one third were due to heroin overdose.[10]  Over 47,000 of the roughly 70,000 overdose deaths in 2017 were related to opioids.[11]  As a point of reference, opioid related deaths exceeded the number of individuals killed in car accidents for the first time in 2017.[12]  Opioids have been touted as a gateway drug and, by way of illustration, among those who initially started using heroin between 2000 and 2013, nearly 75% reported having misused prescription opioids prior to starting heroin; this is compared to the 1960s when 80% of heroin users in treatment reported starting heroin prior to using any prescription opioids.[13]  As a result of the staggering statistics linking prescription opioids directly to overdose deaths and heroin addiction, this article focuses on how prescription opioids created the quagmire our nation is mired in today.


c. 2019 Roseann B. Termini and Rachel Malloy-Good. All rights reserved.

[1]. Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, tit. II, §101, 84 Stat. 1242 (1970), codified at 21 U.S.C. sec. 801 et seq.

Authors Note: The authors dedicate this article to all of those who have, and are, suffering due to opioids—to the families who have lost their loved ones; and to the people battling addiction; to the people struggling with chronic pain. This article is also dedicated to all of the individuals who are working each and every day to bring closure to this crisis.  The authors thank Ms. JanetLindenmuth, M.S., research law librarian at Delaware Law School who provided valuable research for this article.  The authors also thank Jeffrey Williams Editor-in-Chief of the Ohio Northern University Law Review and the Editorial Board.

* Rachel Malloy-Good, B.A magna cum laude, M.A academic distinction, Delaware Law School Dean’s list (J.D. expected May 2020). Ms. Malloy-Good has spent her career in an urban school district supporting students with special needs.  It was in seeing opioids impact her students, addiction that has impacted her friends, and watching family members suffer from chronic pain that she became interested in researching this topic. Ms. Malloy-Good would like to thank her daughter, family, friends and gifted Professor Roseann B. Termini for support in working on this article. Author contact: r.malloygood@gmail.com

** Roseann B. Termini, B.S. magna cum laude, M.Ed. Fellow, J.D., a food and drug law attorney, is the author of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products www.fortipublications.com (2019). She teaches several Food and Drug Law courses at Delaware Law School, Widener University School of Law. Ms. Termini dedicates this article to the memory of her parents who instilled values that fostered the determination to write this article, her children and non-lawyer friends for reading many drafts to comport with plain language considering this complicated issue. Finally, Ms. Termini thanks her co-author Ms. Rachel Malloy-Good for her dedication to this topic. Author contact: rbtermini@widener.edu

            [2].   Opioid Crisis Fast Facts, CNN Health (Oct. 5, 2019, 9:14 AM), https://www.cnn.com/ 2017/09/18/health/opioid-crisis-fast-facts/index.html.

            [3].   Drug Overdose Deaths, Centers for Disease Control and Prevention (June 27, 2019), https://www.cdc.gov/drugoverdose/data/statedeaths.html.

            [4].   Nearly One in Three People Know Someone Addicted to Opioids, American Psychiatric Association (May 7, 2018), https://www.psychiatry.org/newsroom/news-releases/nearly-one-in-three-people-know-someone-addicted-to-opioids-more-than-half-of-millennials-believe-it-is-easy-to-get-illegal-opioids.

            [5].   April Dirks, The Opioid Epidemic: Impact on Children and Families, 2 J. Psychiatry and Psychiatric Disorders 9, 10 (2018).

            [6].   Child Welfare and Treatment Statistics, National Center on Substance Abuse and Child Welfare (last visited Oct. 14, 2019), https://ncsacw.samhsa.gov/resources/child-welfare-and-treatment-statistics.aspx.

            [7].   Julie R. Gaither et al.U.S. National Trends in Pediatric Deaths from Prescription and Illicit Opioids, JAMA Network, Pediatrics (Dec. 28, 2018), https://jamanetwork.com/journals/jamanetwork open/fullarticle/2719580.

            [8].   Id.

            [9].   Bruce Goldberger et al.Uniform Standards and Case Definitions for Classifying Opioid-Related Deaths: Recommendations by a Samhsa Consensus Panel, 32 J. Addict Disease 231, 232 (2013).

          [10].   Lawrence Scholl et al.Drug and Opioid-Involved Overdose Deaths – United States, 2013–2017, 67 Morbidity and Mortality Weekly Report 1419, 1420, 1422 (2019).

          [11].   Id. at 1420.

          [12].   National Safety Council, Preventable Deaths – Odds of Dying, National Safety Council Injury Facts (last visited Oct. 14, 2019), https://injuryfacts.nsc.org/all-injuries/preventable-death-overview/odds-of-dying/.

          [13].   National Institute on Drug Abuse, Prescription Opioids and Heroin 6 (2018) [hereinafter Prescription opioids and Heroin].

The Latest ‘Federal Movement’ in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition

Indiana Health Law Review, Vol. 16, Issue 1, November 2018

Abstract and link:https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3239582

Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial.

This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?

Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

FDA CONFERENCE “ALL MATTERS FDA”
Opioids, Whistleblower Actions, Medical Device Safety, Food Defense, Personal Care Products Regulation, Dietary Supplement Regulation,Top Notables, and Other Matters FDA

April 4, 2018 12:30–5:00 p.m.

“All Matters FDA” promises to be informative, focusing on the Food and Drug Administration’s top accomplishments across the food and drug law spectrum. Find out about “hot topics” and hear the latest from seasoned professionals.

Hear the Latest from these Experienced Invited Speakers:

Robert J. Durkin, Esq., M.S., R.Ph.—Deputy Director Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA)

Charlene Fullmer, Esq.—Deputy Chief for Affirmative Litigation, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania

Kevin Spradlin—Intelligence Analyst, FBI, Washington D.C.

Matthew R. Noonan, Esq.—Compliance Officer, FDA Human & Animal Food Division

Stanley R. Milstein, Ph.D.—Former Acting Deputy Director (retired),, FDA Office of Cosmetics and Colors

 Hooman Noorchashm, M.D.—Cardiac Surgeon, Phila., Pennsylvania

Roseann B. Termini, Esq.—Food and Drug Law Legal Scholar; National Speaker, Online FDA Law Courses, Widener University, Delaware Law Schoo

Registration fee: $75;
Students with valid school ID: Free

Registration form available at delawarelaw.widener.edu/fdacle

For questions or for accessibility or special needs requests,
contact Carol Perrupato at DelawareLawCLE@widener.edu or 302-477-2178.
Food and Drug Law Association of Widener University Delaware Law School Wednesday,
Check-in begins at 12:00 p.m.
Widener University Delaware Law School
Ruby R. Vale Moot Courtroom
4 CLE Credits available in DE and PA (including one ethics credit)
NJ attorneys can self-report with our Certificate of Attendance
Course materials will be distributed electronically.

Registration Form

Name _________________________________________________________________________ Firm, Company or Organization ____________________________________________________ Attorney ID # (if applicable): Delaware _______________ Pennsylvania ______________ Address _______________________________________________________________________ City __________________________ State _____ Zip _________ Phone ___________________ Email address for confirmation purposes: ____________________________________________ Registration Fee: $75.00 _____

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Please fax or mail this registration form to: Carol Perrupato, Widener University Delaware Law School, 4601 Concord Pike, Wilmington, DE 19803-0406 – fax number 302-477-2282. Questions or inquiries, please contact Carol Perrupato at 302-477-2178 or via email at caperrupato@widener.edu.