Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Other Tobacco Products? Tell FDA

Source: US Food and Drug Administration-1

 

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Have you used an e-cigarette, cigar, cigarette, hookah, smokeless tobacco or other tobacco product that you believe is not working properly or that is causing an unexpected health problem? Does the product have a strange taste or smell; has your vape battery exploded; or is there some other problem or concern?

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) regulates the manufacture and sale of tobacco products. If you have a problem with these products, the FDA wants to hear from you—and has an online tool you can use for reporting a problem.

This online tool is the Safety Reporting Portal (SRP). It gives a standardized way for users—including consumers, health care professionals, manufacturers, and researchers—to tell the FDA about unexpected health or safety issues with various products, including animal foods and animal drugs, dietary supplements, and tobacco products.

As part of its mission to protect public health and reduce harm from tobacco products, the FDA is interested in reports about tobacco products that have caused unexpected health problems as well as reports about products that are damaged, defective, or contaminated.

“There is no known safe tobacco product, but the FDA can play a role in helping prevent certain unexpected health consequences,” explains Iilun Murphy, M.D., director of the Division of Individual Health Science in the Office of Science at CTP. “The FDA wants to prevent certain unexpected health consequences that could result from defective tobacco products, as well as health or safety problems beyond those typically associated with tobacco product use.”

What to Report About Tobacco Products

You can submit reports to the portal about problems with all tobacco products, including:

  • cigarettes
  • tobacco used for roll-your-own cigarettes
  • other smoking tobacco
  • cigars
  • smokeless tobacco
  • electronic cigarettes and other vape products
  • hookah (waterpipe)
  • other products made or derived from tobacco that are intended for human consumption

You also can report problems with components and parts of tobacco products, including problems like a vape battery overheating or exploding.

When answering questions in the portal, you can give information on several potential types of product and health problems.

Examples of unexpected health problems include:

  • burns or other injuries
  • allergic reactions, poisonings, and other toxic events
  • an unusual reaction in a long-time user
  • pregnancy or fertility problems
  • harm to children or non-users, including accidental poisoning

Examples of product problems include:

  • fire caused by tobacco product use
  • tobacco product mix-ups (such as labeling or packaging errors)
  • quality problems, such as unexpected appearance, smell or taste; foreign objects or other contamination in products; or products that are faulty or do not work as intended

You can learn more about which information FDA would like you to report, and see information about the tobacco product problems submitted since January 2017, on the FDA’s website.

How to Report Problems with Tobacco Products

Access the Safety Reporting Portal to submit a report online. The portal has instructions and questions to lead you through each reporting section. You should be able to complete a voluntary report about a tobacco product within 10 minutes.

If you can’t report online, you can contact CTP by phone at 1-877-CTP-1373 or by email at AskCTP@fda.hhs.gov

How to Report About Potential Violations of Tobacco Product Regulations

If you would like to report potential violations of tobacco product regulations, you can use the FDA’s product violation reporting process. (Examples of violations include illegal sales of tobacco products to minors at a retail location and sales of cigarettes in packs of less than 20.)

Visit the FDA’s website to learn how to submit a report online, via phone, or via mail.

How to Report Problems with Smoking Cessation Products

Smoking cessation products are regulated through the FDA’s Center for Drug Evaluation and Research, which ensures that the products are safe and effective and that their benefits outweigh any known associated risks.

These products include both nicotine replacement therapy (nicotine gum, patches, sprays, inhalers, or lozenges used to decrease withdrawal symptoms triggered by stopping smoking or chewing tobacco cessation) and prescription products to help you quit.

If you have a problem or adverse experience with a smoking cessation product, please submit your report to the FDA through MedWatch. (MedWatch is the FDA’s reporting system for medical product concerns.)

How to Report Problems with Other FDA-Regulated Products

If you have problems with other FDA-regulated products—such as food products, other human and veterinary drugs, biological products, medical devices, and products that emit radiation—the agency also would like to hear from you. You can learn more about this topic by reading “How to Report Product Problems and Complaints to the FDA.”

What the FDA Does with Reports—and other Reporting Facts

The FDA reviews all Safety Reporting Portal reports and takes steps, as appropriate, to protect the public health.

You do not need to give your contact information to make a report. But it is helpful, as FDA staff may contact you to request more information about your issue, if needed.

The FDA cannot give individual advice to consumers. If you have an issue that requires medical attention, please contact your health care provider.

Want to view reports made in the past? Know that the Freedom of Information Act gives you the right to request access to federal agency records or information, with some exceptions. You can learn more at www.foia.gov.

Also know that the FDA posts frequently requested adverse experience reports online. You can find these reports in the CTP FOIA Electronic Reading Room. Some information from tobacco product problem reports submitted since January 2017 also is also posted on the FDA’s website. Note: The FDA removes personally identifiable information before posting these records.

U.S. EPA and World Health Organization Partner to Protect Public Health

Source: US Environment Protection Agency

Agreement recognizes the increased environmental and public health risks from the warming global climate and prioritizes environmental justice.

WASHINGTON (Jan. 20, 2021) –This week, the U.S. Environmental Protection Agency (EPA) and World Health Organization (WHO) signed a five-year Memorandum of Understanding (MOU). The agreement continues EPA-WHO collaboration on a wide range of specific and crosscutting environment and health issues, particularly air pollution, water and sanitation, children’s health, and health risks due to climate change.  The updated agreement includes exciting new actions on crosscutting issues including infrastructure and environmental justice.

“I am proud to renew EPA’s commitment to working with the WHO to protect the public from the health risks of pollution,” said EPA Administrator Michael S. Regan. “The United States is committed to working closely with WHO, a global leader in protecting human health for all, with a particular focus on addressing the needs of vulnerable and underserved communities.  As we face new challenges from climate change and the COVID-19 pandemic, this collaboration with the WHO has never been more critical.”

EPA’s mission to protect human health and the environment fully aligns with WHO’s charge to lead global efforts to promote health for everyone, everywhere. The WHO estimates that 24% of all global deaths, and 28% of deaths among children under five, are linked to the environment, and people in low- and middle-income countries bear the greatest disease burden.

“The COVID-19 pandemic has highlighted the intimate links between humans and our environment,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Addressing those links is essential to prevent diseases, including future pandemics, to promote health, drive the global recovery and reduce health risks associated with climate change, especially for the most vulnerable. WHO looks forward to continuing its longstanding collaboration with US EPA, and to tapping EPA’s expertise to advance our mission to support countries in meeting the challenges of environmental health.”

EPA and WHO have a long history of collaboration on the most pressing public health issues of our time. Over three decades, this cooperation has included work on climate change, indoor and outdoor air quality, children’s environmental health, chemicals and toxics, water and sanitation, and quantifying the environmental burden of disease.

Over the next five years, EPA and WHO will focus on addressing the health impacts of climate change. Ongoing efforts will address many environmental determents of health affected by climate change, including clean air and safe drinking water. Collaboration will also continue to focus on protecting children by reducing exposure to toxic substances, in particular lead-based paint.

In this MOU, EPA and WHO have established new areas of cooperation to advance shared priorities around crosscutting issues including addressing the disproportionate impacts of environmental challenges on underserved and vulnerable communities. Protecting these populations and increasing access to decision-making is at the core of Administrator Regan’s vision for the EPA. WHO’s Triple Billion targets outline an ambitious plan for the world to achieve good health for all.  Both EPA and WHO prioritize using science as the basis for policies and programs to address environmental health impacts.

WHO also overseas global coordination efforts to respond to the COVID-19 pandemic. EPA is also contributing to COVID-19 response with efforts to register disinfectants for SARS-CoV-2 and researching into antimicrobial products and studies of ways to disinfect personal protective equipment so that it could be reused. EPA has worked to early warning systems by monitoring wastewater for the presence of SARS-Cov-2. The two agencies will continue to advance biodefence science to respond to the current pandemic and be better prepared for all biothreats in the future.

BACKGROUND
About the World Health Organization (WHO)
Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health. The mandate of WHO’s Health and the Environment programme is to support Member States to improve health outcomes linked to environmental risks such as: Unsafe water and inadequate sanitation; Poor indoor and outdoor air quality; Exposure to toxic or hazardous waste and chemicals.

US EPA Administrator Michael S. Regan signs the memorandum of understanding in his office.
WHO Director-General Dr Tedros Adhanom Ghebreyesus signs the MOU in front of a WHO backdrop.

Florida Study Coordinator Sentenced in Scheme to Falsify Clinical Drug Trial Data

Source: US Food and Drug Administration

U.S. Department of Justice

FOR IMMEDIATE RELEASE
Thursday, January 20, 
2022

A federal judge sentenced a Florida man to 30 months in prison today in connection with his participation in a conspiracy to falsify clinical drug trial data. 

U.S. District Judge Robert N. Scola Jr. of the Southern District of Florida entered the sentence against Duniel Tejeda, 35, of Clewiston. The court also ordered Tejeda to pay $2.1 million in restitution.

According to court documents, Tejeda worked as a project manager and study manager for a clinical research firm based in Miami called Tellus Clinical Research. As part of his plea agreement, Tejeda admitted that he agreed with others to falsify data in medical records in connection with clinical trials intended to evaluate various medical conditions, including opioid dependency, irritable bowel syndrome and diabetic nephropathy. Among other things, Tejeda falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not.

“Clinical trials help ensure that new drugs are safe and effective for the public,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “Falsifying clinical trial data undermines a critical component of the drug approval process. The Department of Justice will continue to work with our partners at the Food and Drug Administration (FDA) to investigate and prosecute anyone who puts personal profit over public health by falsifying clinical trial data.”

“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” said Assistant Commissioner Catherine A. Hermsen for the FDA Office of Criminal Investigations (OCI). “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”

FDA OCI is investigating the case.

Trial Attorneys Lauren M. Elfner, Joshua D. Rothman and Matthew M. Ryan of the Civil Division’s Consumer Protection Branch are prosecuting the case. The U.S. Attorney’s Office for the Southern District of Florida has provided critical assistance.

Topic(s): 
Consumer Protection
Component(s): 
Civil Division
USAO – Florida, Southern
Press Release Number: 
22-44

National Airlines Flight Attendants Vote Overwhelmingly to Join the IAM

Source: US GOIAM Union

National Airlines Flight Attendants are officially joining the largest and most powerful airline union in the world.

The Flight Attendants sought out IAM representation, citing a lack of respect from National Airlines management, poor work rules and sub-standard pay and benefits.

“We could not be more excited to welcome National Airlines Flight Attendants into the IAM,” said Richard Johnsen, IAM Chief of Staff to the International President. “We will use every resource available to ensure they secure a strong first contract that addresses their workplace issues.”

“Our thanks go out to Grand Lodge Representative Joe Stassi for his hard work and determination through this successful campaign, along with the lead organizers in the Flight Attendant group,” said IAM Transportation Coordinator Edison Fraser. “Today, National Airlines Flight Attendants no longer stand alone. They now have the support of 600,000 IAM members from across North America.”

The National Mediation Board mail-ballot election took place between December 16, 2021 and January 20, 2022. The final tally was held on January 20.

The IAM is the largest airline union in North America, representing over 100,000 airline workers.

National Airlines, an Orlando-based carrier, has supported industry and governments, aided military forces and provided subsistence logistics solutions to some of the most remote global locations. National Airlines has grown from a small, regional U.S. cargo airline, to one of the world’s leading air cargo carriers, and ultimately into a passenger airline.

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Governor of Washington Issues Green Crab Infestation Proclamation

Source: US National Invasive Species Information Center

Story 

Gov. Jay Inslee today issued an emergency order to address the exponential increase in the European green crab population within the Lummi Nation’s Sea Pond and outer coast areas. The European green crab is a globally-damaging invasive species that, if they become permanently established, will particularly harm endangered species, impact resources that are part of the cultural identity of the tribes and native peoples, and affect small businesses.

The emergency order directs the Department of Fish and Wildlife (WDFW) to begin implementation of emergency measures, as necessary, to effect the eradication of or to prevent the permanent establishment and expansion of the European green crab. The order also directs the Department of Ecology to, and requests that the Department of Natural Resources and the State Parks and Recreation Commission, identify European green crab management as a high priority on their respective state-owned aquatic lands and to facilitate implementing emergency measures. Finally, the order urges the Legislature to provide additional emergency funding as requested by the WDFW as soon as possible.

The order is effective immediately and will remain in effect until rescinded.

Proclamation 22-02.

IAM Urges U.S. Labor Department to Protect Maine Loggers

Source: US GOIAM Union

IAM International President Robert Martinez Jr. wrote a letter to U.S. Department of Labor Secretary Marty Walsh seeking his immediate assistance to obtain actual enforcement on the use of Canadian loggers under the I-l2A immigration system.

The letter details how the IAM has been working with Maine’s hard-working and highly-skilled loggers for years to help them bargain collectively and stop depressing wages in the industry. The situation is so dire that it has forced U.S. workers to give up altogether and leave the logging industry in the region.

“When we started this campaign three years ago, we were faced with a large group of workers that had been turned into independent contractors while still being completely directed at every step of the day by landowners,” wrote Martinez. “Since that time, we have moved on to another concern; one that I thought would be very easy to accomplish but has proven to be a much more difficult task: the illegal use of H2A drivers in the logging industry. As you know, H2A workers are only supposed to be utilized if they do not affect the wages or working conditions of U.S. workers. Our national union representatives and Maine Senate President Troy Jackson have met with hundreds of workers and have been out in the harvesting areas of northern Maine to witness firsthand the abuse of these workers. All of this is the result of violations of federal cabotage laws or point-to-point hauling in the United States.”

“The IAM urges the Department of Labor to enforce the law and protect the U.S. workers in Maine’s logging industry,” said IAM Eastern Territory General Vice President Brian Bryant. “The IAM Eastern Territory remains committed to providing every resource possible to protect Maine loggers. We hope this matter is reviewed swiftly and puts the proper enforcement in place. The IAM will fight to ensure justice is served.”

Read the full letter here.

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Register Now for the 2022 Midwest Territory Kourpias K-9 Classic Motorcycle Ride

Source: US GOIAM Union

Join fellow riders and Guide Dogs of America/Tender Loving Canines supporters from July 17-19, 2022 for the approximately 750-mile motorcycle ride in Deadwood, SD. The three-day event will be hosted by the IAM Midwest Territory.

The fundraiser benefits Guide Dogs of America/Tender Loving Canines, whose mission is to transform lives through partnerships with service dogs.

Register for the ride today.

As a shift from previous years, this year’s Kourpias ride will consist of day trips which will start and end at the Cadillac Jacks Gaming Resort in Deadwood each day. Riders can elect to do each day’s ride or one or more days of the ride. Routes include runs through Devil’s Tower, Badlands National Park, Needles Highway, Iron Mountain Road, and more.  

If you don’t ride a motorcycle, ATV and jeep rentals are also available. See rental rates here.

If you aren’t riding and still want to support the 2022 Kourpias K-9 Classic, you can sponsor a person for each mile they ride, donate to your favorite rider, or simply donate to the cause.

Sponsor a rider, or donate to the cause

“Guide Dogs of America/Tender Loving Canines has always been the IAM’s favorite charity and this year the Midwest Territory has the honor of hosting the annual Kourpias Classic motorcycle ride,” said IAM Midwest Territory General Vice President Steve Galloway. “The fundraiser is named after the late IAM International President George Kourpias, a native of Sioux City, Iowa, who initiated into then-IAM Local 1637 here in the Midwest Territory. So we’re especially excited to make this year’s event unique and special. I encourage all Machinists to contribute in any way they can so we can continue to make a difference to those in need.”

George Kourpias guided the IAM through some of our union’s most challenging times with dignity and grace. He was just as passionate about raising money for Guide Dogs of America. No matter the role, Kourpias always gave everything he had, which is why this ride was created to honor his memory and contribute to one of his favorite charities.

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Does Schrier think Biden’s doing a good job?

Source: US National Republican Congressional Committee

The following text contains opinion that is not, or not necessarily, that of MIL-OSI –


January 20, 2022


Today marks one year of the Biden presidency.

Throughout this year, we’ve seen rising prices, empty grocery shelves, skyrocketing crime, a crisis at the southern border, and a failed COVID response.

Does Kim Schrier think Joe Biden’s first year was a success?


CFTC Chairman Rostin Behnam Announces Executive Staff Appointments

Source: US Commodity Futures Trading Commission

— Commodity Futures Trading Commission Chairman Rostin Behnam today announced the following executive leadership and communications appointments as he begins his chairmanship. This team will work directly with Chairman Behnam to establish the Commission’s agenda and execute the responsibilities in the CFTC governing statute and other issues facing the agency. Today’s announcement follows Chairman Behnam naming Tanisha Cole Edmonds as the CFTC’s first Chief Diversity Officer. Chairman Behnam plans to make additional staff and leadership announcements very soon.

“I have worked with all of these individuals as a Commissioner and as Acting Chairman and have utmost respect for each of them,” said Chairman Behnam. “I am confident in their knowledge, expertise and commitment to public service and the CFTC’s mission to work diligently alongside me, with each other, and the excellent staff at the CFTC on critical priorities confronting the agency.”

David Gillers, Chief of Staff

David Gillers is currently the Chief of Staff and will continue in this role. Mr. Gillers joined the then-Commissioner Behnam’s office in 2019 after a decade as a congressional staff member working on financial services and energy matters, most recently as Democratic Senior Counsel to the Senate Committee on Energy and Natural Resources. He worked extensively on the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act), the Small Business Jobs Act of 2010, and the energy provisions of the Fixing America’s Surface Transportation Act of 2015. Gillers worked as a corporate attorney prior to his time in Congress. He is a graduate of Columbia College and received his JD from Boston College Law School where he was a Weinstein Scholar.  

Laura Gardy, Deputy Chief of Staff

Laura Gardy is the Chairman’s Deputy Chief of Staff and will oversee Commission administrative functions and operations with an emphasis on human capital management. Ms. Gardy previously served as a Special Counsel to Acting Chairman Behnam during his time as Commissioner. She joined his legal team in 2017 from an Associate Director position in the former Division of Swap Dealer and Intermediary Oversight (renamed the Market Participants Division in 2020). She previously worked at the Office of the Comptroller of the Currency, where she was Counsel in the Securities & Corporate Practices Group in the Office of Chief Counsel. Ms. Gardy began her career at the CFTC in 2002 as a trial attorney in the Division of Enforcement and as Counsel to the Director. She later served as Legal Assistant to the late Commissioner Bart Chilton and as Senior Counsel to then-Commissioner Scott D. O’Malia during the Dodd-Frank Act rulemakings. Ms. Gardy holds a B.S. in Natural Resources from Cornell University and a J.D. from Washington and Lee University School of Law. 

John Dunfee, Chief Counsel

John Dunfee will continue to serve as Chief Counsel to Chairman Behnam. Prior to his role as Chief Counsel, he was Special Counsel to then-Commissioner Behnam from 2017 to 2021. Mr. Dunfee joined the CFTC in 2000, and has held numerous important roles at the Commission. From 2011 to 2017, he held a number of positions in the Office of General Counsel, including Acting Deputy General Counsel for Trade Execution and Data. From 2010 to 2011, he served as Counsel to Commissioner Michael Dunn.  From 2003 to 2010, Mr. Dunfee was in the position of Chief Trial Attorney in the Division of Enforcement. He began his CFTC career as a Trial Attorney in the Division of Enforcement. Mr. Dunfee holds a B.A. from the University of Pennsylvania and a J.D. from the University of Michigan Law School.   

Alicia L. Lewis, Special Counsel

Alicia Lewis will continue to serve as Special Counsel to Chairman Behnam managing clearing, LIBOR transition, and international regulatory matters. Ms. Lewis joined the CFTC in 2009. Since 2017, she has served as the Designated Federal Officer for the CFTC’s Market Risk Advisory Committee for which Chairman Behnam is the sponsor. From 2017 to 2019, she was a member of then-Commissioner Behnam’s legal team. Ms. Lewis also has served as Special Counsel in the Office of International Affairs (2020-2021), and in the International and Domestic Clearing Initiatives (2019-2020) and Chief Counsel (2009-2017) Branches of the Division of Clearing and Risk. Before the CFTC, Ms. Lewis was Interim Legal Counsel at the Managed Funds Association where she was responsible for monitoring and commenting on regulatory developments affecting the alternative investment industry at U.S. financial regulatory agencies. Ms. Lewis began her legal career as an associate in the Securities Enforcement and Investment Management practices at K&L Gates where she worked for eight years.  Ms. Lewis is also licensed as a Certified Public Accountant (inactive status) and previously worked on investment company audit engagements at Price Waterhouse LLP. Ms. Lewis holds degrees from the University of Pennsylvania’s Wharton School of Business Undergraduate Division (BS) and William & Mary Law School (JD)

Abigail S. Knauff, Special Counsel

Abigail Knauff joins Chairman Behnam’s office as Special Counsel, where she will serve as the deputy of the CFTC’s Climate Risk Unit, which focuses on the role of derivatives in addressing climate-related risk and fostering product innovation to facilitate the transition to a low-carbon economy. In addition to climate-finance and related risk issues, she will manage matters involving intermediaries and data. Ms. Knauff previously served as Special Counsel in the Clearing Policy Branch of the CFTC’s Division of Clearing and Risk (2018-2021) and the Market Review Branch of the CFTC’s Division of Market Oversight (2012-2018). She also served as the Secretary of the CFTC’s Energy and Environmental Markets Advisory Committee (2019-2021).  Ms. Knauff received a LL.M. in Securities and Financial Regulation from the Georgetown University Law Center, a JD from the University of Baltimore School of Law, and a BBA from The College of William and Mary.

Steven W. Adamske, Public Affairs Director

Steven Adamske rejoins the CFTC as the agency’s Director of Public Affairs. Adamske previously held the role for almost seven years and served as a Senior Policy Advisor to Commissioner Sharon Y. Bowen. Most recently Mr. Adamske was the Vice President and Head of Communications and Public Affairs at FIA. At the CFTC, Adamske implemented the communications strategy and outreach efforts for more than 65 final rules, orders and guidance documents required in the Dodd-Frank Act and the Libor and benchmark manipulation cases to name a few. Prior to joining the CFTC, Mr. Adamske served as Deputy Assistant Secretary for Public Affairs at the U.S. Department of Treasury, where he specialized in Domestic Finance and oversaw communications for the Dodd-Frank Act, the Troubled Asset Relief Program (TARP) and Treasury’s housing programs. Prior to that, Mr. Adamske was a senior staff member and Communications Director for the House Financial Services Committee and for Rep. Barney Frank during a time when the committee passed the Dodd-Frank Act, the auto industry rescue, TARP and the Housing and Economic Recovery Act. He also served in senior press roles for several members of Congress, and he served in the Clinton Administration as a senior advance and scheduling aide to Vice President Al Gore and held communications positions at the Department of Interior and the Federal Communications Commission. Mr. Adamske is a graduate of the University of California, Irvine.