Lance's Corner

FDA and DOJ Launch Joint Action Against Illegal E-Cigarettes

Jun 10, 2024

Per the notice below, the United States Department of Justice (DOJ) and the United States Food and Drug Administration (FDA) have jointly launched action against illegal electronic cigarettes (e-cigarettes).

US Food and Drug Administration

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes

The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.  Along with the FDA and the Justice Department, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth.  Additional agencies may join the task force in the coming weeks and months. 

“Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans – particularly children and adolescents – across the country,” said Acting Associate Attorney General Benjamin C. Mizer.  “This interagency Task Force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority.”

“The Justice Department is committed to enforcing the laws that prevent the sale and distribution of unlawful e-cigarettes,” said Principal Deputy Assistant Attorney General Brian Boynton, head of DOJ’s Civil Division.  “We will work closely with our Task Force partners to address this crisis with all of the enforcement tools available to us.”

“Curbing the widespread availability of illegal ENDS products is a top priority of the Justice Department’s consumer protection efforts,” said Deputy Assistant Attorney General Arun G. Rao of the Civil Division’s Consumer Protection Branch.  “Together with our law enforcement partners, we look forward to advancing aggressive and innovative solutions to the unique and constantly evolving problem of illegal vaping products.”

“Enforcement against illegal e-cigarettes is a multi-pronged issue that necessitates a multi-pronged response,” said Dr. Brian King, director of the FDA’s Center for Tobacco Products.  “This ‘All Government’ approach – including the creation of this new Task Force - will bring the collective resources and experience of the federal government to bear on this pressing public health issue.”

The 2023 National Youth Tobacco Survey found that about 2.1 million youths reported currently using e-cigarettes, which reflects a considerable decline from 5.3 million youth in 2019.  However, 10 percent of high school students and almost five percent of middle school students reported currently using e-cigarettes, and more than one in four of those e-cigarette users reported daily e-cigarette use.  Manufacturers, distributors and retailers market a wide range of products that appeal directly to school-age users, such as candy and fruit flavors, some of which come in devices designed to be easily concealed.  Youth use of tobacco products in any form – including e-cigarettes – is unsafe.  According to the CDC, nicotine poses unique dangers to young people.  In addition to being highly addictive, nicotine can harm the developing adolescent brain, which continues to develop until about age 25.  Young people who use nicotine may also be at risk for addiction to other drugs.  To date, the FDA has authorized the sale of 23 specific tobacco-flavored e-cigarette products and devices.  These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States.  To date, the FDA has issued more than 1,100 warning letters to manufacturers, importers, distributors and retailers for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes, and has filed civil money penalty complaints against more than 55 manufacturers and 140 retailers for the manufacture and/or sale of unauthorized tobacco products.  In addition, the FDA and the Justice Department have obtained injunctions against six manufacturers to stop them from manufacturing and selling unauthorized e-cigarette products.  The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the PACT Act; the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA); and other authorities.  Violations of these statutes can result in felony convictions and significant criminal fines and civil monetary penalties.  They can also result in seizures of unauthorized products, which can help to make illegal e-cigarettes less accessible, including to young people.  Through their participation in the task force, USMS will help the FDA and the Department effectuate seizures of unauthorized e-cigarettes within the United States.

“The U.S. Marshals Service Asset Forfeiture Division stands ready to work with our Task Force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald L. Davis, director of the U.S. Marshals Service.

The Justice Department is also collaborating with ATF and USPIS on potential criminal and civil enforcement actions under the Prevent All Cigarette Trafficking Act of 2009 (PACT Act).  The PACT Act requires online sellers of ENDS products to register with ATF and to verify the age of purchasers both at the point of sale and the point of delivery, as well as to comply with tax collection provisions and state and local laws.  The task force announced today will support these actions and coordinate enforcement strategies the FDA and the Justice Department are working on with multiple agency partners.

“The PACT Act is an important tool for preventing the unlawful sale of e-cigarettes to minors online.  ATF looks forward to working with other components of the Department of Justice and USPIS to enforce the law,” said ATF Director Steven M. Dettelbach.

“The U.S. Postal Inspection Service is committed to working with the Task Force to investigate violations of the PACT Act and other statutes that govern the distribution of e-cigarettes through the mails,” said Chief Postal Inspector Gary R. Barksdale.

Finally, the Federal Trade Commission (FTC), which releases reports about cigarette, smokeless tobacco and e-cigarette marketing, and enforces various statutory and regulatory prohibitions on false and misleading advertising, will support the activities of the task force, including by sharing its knowledge about the marketplace for vaping products.

“We look forward to sharing our experience with this rapidly changing, multi-billion dollar market through this important Task Force,” said Samuel A.A. Levine, director of the FTC’s Bureau of Consumer Protection.

For more information on e-cigarette regulation, including legal compliance and enforcement efforts, see the FDA’s website at https://www.fda.gov/tobacco-products and the ATF’s website at https://www.atf.gov/alcohol-tobacco/vapes-and-e-cigarettes.

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc