Category: Youth Smoking

#FDA DENIES AUTHORIZATION to Market-Juul Products

Currently Marketed #JUUL Products Must Be Removed from US Market

For Immediate Release:June 23, 2022 Press Release

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products. 

After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications. 

BACKGROUND

FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health

https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence

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

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

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 >

all-matters-fda-2022Download PDF

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

all-matters-fda-2022-save-the-date

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/

COVID-19, CBD, VAPING, PET PRODUCTS SAFETY, OPIOID EPIDEMIC

This week, on Wednesday October 21, from 1-4pm, the FDLA, Delaware Law will be virtually hosting its “All Matters FDA” Symposium which will host a variety of speakers from professors, to judges, to other professionals in the field to discuss a range of topics such as: opioids and pharmaceuticals, COVID-19, vaping, cannabis law, and pet products. Just follow the link below to register. Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

https://epay.widener.edu/C21798_ustores/web/store_main.jsp?STOREID=34&SINGLESTORE=true

The Symposium will be hosted over zoom, and a link will be sent out beforehand.

Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

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