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.

United States Announces $40 Million in Additional Humanitarian Assistance for Vulnerable People Affected by the Crisis in Lebanon

Source: USAID

The U.S. Agency for International Development (USAID) is providing $40 million in additional humanitarian assistance to vulnerable people in Lebanon as they continue to confront the impacts of the ongoing economic and financial crisis, the COVID-19 pandemic, and continued displacement resulting from the Syrian civil war. 

With this funding, USAID is partnering with the UN World Food Program to provide emergency food assistance to nearly 740,000 people for four months, including vulnerable Syrian refugees and Lebanese populations. This latest USAID contribution comes as food prices continue to rise in Lebanon due to the collapsing currency and the overlapping crises that exacerbate food insecurity and diminish people’s ability to purchase basic necessities.

As the largest donor of humanitarian assistance in Lebanon, the United States has now contributed more than $440 million since October 2020, during which time the economic and financial crisis in Lebanon has worsened. The United States remains deeply concerned about the rising humanitarian needs in Lebanon and continues to urge other donors to increase their contributions for this response.

For the latest updates on U.S. humanitarian assistance in Lebanon, visit here.

Administrator Power’s Meeting with High Representative for Bosnia and Herzegovina Christian Schmidt

Source: USAID

Readout

The below is attributable to Spokesperson Rebecca Chalif:‎

On January 14, 2021, Administrator Power met with High Representative Christian Schmidt in advance of her visit to Bosnia and Herzegovina (BiH). They discussed the current political crisis in the country, the importance of efforts at de-escalation and reconciliation, and the need to empower those who are fighting corruption and creating economic opportunities for young people. The Administrator reaffirmed U.S. support for the High Representative and his ability to exercise all necessary authorities, including the Bonn Powers, until the 5+2 Agenda is complete and BiH has met the criteria for graduation from international supervision. They agreed that a prosperous future for BiH depends on political leaders and citizens working together to advance the reforms necessary to achieve BiH’s democratic and economic aspirations.

The Administrator and High Representative agreed to remain in close contact regarding the current political situation and in working to fully implement the 5 + 2 Agenda.

Last updated: January 17, 2022

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Deputy Administrator Paloma Adams-Allen at the ATscale: Mobilizing for Assistive Technology Event

Source: USAID

DEPUTY ADMINISTRATOR ADAMS-ALLEN: Hello, everyone, and good morning from Washington, D.C.! What an honor it is to speak to you all, colleagues and partners, leaders and activists on the front lines making inclusive development a reality.

Last month, we celebrated the 29th International Day of Persons with Disabilities since it was established by the United Nations in 1992. We take an opportunity annually to unite around advancing equity and fairness for the disability community and lift up the extraordinary contributions of persons with disabilities around the world.

And, we have cause to celebrate decades of remarkable progress. The Americans with Disabilities Act of 1990, according to one disability lawyer and rights advocate, was “a lightning rod across the world, igniting people with disabilities to seek equality in their own countries.” Indeed, in 2006, the international community adopted the United Nations Convention on the Rights of Persons with Disabilities, a major step toward confirming disability as a human rights issue, and protecting persons with disabilities against discrimination in all areas of life.

These were vital milestones, to be sure. But much like other civil rights movements globally, the disability rights movement was born with a long view, recognizing it would take more than words to realize a world free of prejudice. We acknowledge that despite remarkable progress, many barriers, old and new, persist in our laws, our cultures, our attitudes and our landscapes.

Some of the most widely confronted barriers in the disability community include functions that are often taken for granted—things like sight, sound, and mobility. I find, for example, that I haven’t always appreciated how critical it’s been throughout my life to have access to prescription eyeglasses, without which I could not drive or work or move about the world safely.

But, as you know, there are more than a billion people in need of some form of assistive technology, 90 percent of whom do not have access to the support or products they need. And many of you fighting for greater access to assistive technology are leading the way; building political will and mobilizing needed investments.

At USAID—through ATscale and across our development work globally—we are listening to and empowering assistive technology users to chart their own course.

What we hear is overwhelming support for a vision of inclusive development—one that gives persons with disabilities, and all persons in need of assistive technology, every opportunity at full participation at home, at school, in the economy, and in public life.

Unfortunately, the COVID-19 pandemic has only magnified an already-uneven playing field.

When “normal life” came to a screeching halt, right around this time two years ago, many industries and many in the global workforce had the option to work remotely. When schools and businesses closed their doors, the Internet was a lifeline. People around the world were forced to adapt quickly, due to something outside of their control.

Responses to the pandemic left much to be desired for the disability community, and all those in need of assistive technology. But at such a defining moment for public health—and for global health equity—I sense from this community of leaders and advocates that this is also a moment of great opportunity.

Alongside USAID’s work to build back stronger, more resilient, more equitable health systems in over 100 countries, ATscale is bolstering its efforts to make accessible the products, systems, and services that so many of us take for granted. Because when it comes to inclusive development, we recognize that assistive technology is not simply a “nice to have.” It is imperative, both morally and economically.

Access to assistive tech, whether a prosthetic limb or caption-generating software, can mean the difference between success or failure in the classroom, between a job and unemployment, between freedom and dependency.

And the economic benefits are clear. ATScale’s latest report finds that investment in the provision of just four assistive products—hearing aids, prostheses, eyeglasses, and wheelchairs—can yield a return of nine to one. So, not only do we risk further marginalizing individuals who require these types of aids, but we’re leaving trillions of dollars in economic benefits on the table if we fail to meet the global need for assistive technology.

With a strong mandate from the United States Congress, and invaluable support from champions of disability rights like Senator Patrick Leahy, USAID has already reached more than a quarter of a million people with assistive products in recent decades, but the need continues to grow.

After establishing ATscale in 2018, USAID and many of the partners who are with us today worked to define a clear and compelling strategy to reach 500 million more people with assistive technology by 2030. But as we continue on the path to recovery from the pandemic, we must recommit to the principles of equality and opportunity that brought us together in the first place.

To help us reach this ambitious goal, USAID has committed $25 million to support ATscale over the next five years, and we are grateful to our bilateral and multilateral partners who are sparing no effort to commit their support. But it will take bold action and big investments from all of us.

We must continue to work with partner governments to support the development of national assistive technology programs. We must bring more private sector partners into the fold, like those who are with us today—Ottobock, a leading innovator in prosthetics; and Essilor, the world’s largest manufacturer of ophthalmic lenses—to deliver quality, affordable products to more low- and middle-income countries.

And with our multilateral partners at UNICEF and the World Health Organization, we must ramp up support for national governments seeking to adopt global standards and access critical supply chains.

We at USAID remain committed to a world where all people are afforded equal opportunity and access. It is because of the dedication and ingenuity of this community that we are able to imagine such a world.

I hope you will join us as we continue to improve access to assistive products for the nearly one billion people in need.

I thank you.

You’re Invited – Advancing Diversity and Inclusion Across Financial Services

Source: US Federal Deposit Insurance Corporation FDIC

Who:     Jelena McWilliams, Chairman, Federal Deposit Insurance Corporation
              Robert E. James, II Chairman, National Bankers Association
              Nicole Elam, President and CEO, National Bankers Association
              Nikita Pearson, Deputy to the Chairman for External Affairs and Director of the Office

              of Minority and Women Inclusion, Federal Deposit Insurance Corporation

 

What:   Advancing Diversity and Inclusion Across Financial Services

             View Agenda

 

When:  11:00 a.m. – Noon ET

             Friday, January 21, 2022

 

Where: Register to Join

 

If you have any questions, please contact us at communications@fdic.gov.

 

The FDIC does not send unsolicited e-mail. If this publication has reached you in error, or if you no longer wish to receive this service, please unsubscribe.

One-Year Anniversary of the Global Child Thrive Act

Source: USAID

Throughout the world, children and families confront poverty, disease, conflict, disasters, violence, inadequate access to basic needs, or some odious combination of these circumstances that harms their development. As a nation working to address these wrongs, and facilitate the healthy development of children, we celebrate the one-year anniversary of the Global Child Thrive Act.

Through USAID, and other U.S government child-focused foreign assistance programs, this Act commits the United States to invest in early childhood development and support parents and families as they nurture, love, and protect their children by establishing a coordinated and multifaceted response at the highest levels of government. Because of the grassroots activism and bipartisan support that led to the passage of this Act, children around the world are receiving comprehensive programming in early childhood development, responsive caregiving for social and emotional well-being, and opportunities for early learning, all of which will support their health, nutrition, and safety. On behalf of my USAID colleagues, I thank Congress for its bipartisan commitment to helping children through this Act, particularly Representative Joaquin Castro, Representative Brian Fitzpatrick, Senator Roy Blunt, and Senator Chris Coons, for their leadership on this bill.

As we celebrate the anniversary of this historic law, we should remember that every child deserves the chance to thrive, reach their full potential, and live a healthy life. Long term investments made in early childhood development are vital to help eliminate extreme poverty, promote a peaceful society, and create a better future for all.

USAID Launches the MujerProspera (WomanProsper) Challenge to Support Women in El Salvador, Guatemala, and Honduras

Source: USAID

As part of the Biden-Harris Administration’s efforts to address the root causes of irregular migration, the United States Agency for International Development (USAID) is launching the MujerProspera (WomanProsper) Challenge, a regional challenge to advance gender equity and equality in El Salvador, Guatemala, and Honduras. USAID Administrator Samantha Power first announced this challenge during her trip to El Salvador in June 2021.

Through the MujerProspera Challenge, USAID expects to issue up to 14 awards, each valued between $150,000 and $500,000. USAID welcomes applicants from local organizations in El Salvador, Guatemala, and/or Honduras.

The MujerProspera Challenge seeks holistic and impactful solutions that advance women’s economic security, employment, and/or entrepreneurship. The challenge is seeking new and innovative proposals that:

  • Advance women’s economic security by improving working conditions and labor protections, recruitment, retention, promotion, and the advancement of women in dignified, stable work that results in increased access, productivity, and a fair and stable income in the workforce; and
  • Address harmful gender norms and enable safe work environments through promoting positive gender norms, egalitarian attitudes and behaviors, a holistic safe working environment, and safe transportation to and from work, supportive of women’s economic security and agency.

Applicants are encouraged to incorporate an intersectional approach that addresses the multiple layers of discrimination and inequality faced by women and girls, in all their diversity. Solutions should root out systemic barriers and discrimination, ambitiously pursue equity and equality for all people, and intentionally address the needs of women and girls, particularly those from marginalized and underserved populations including but not limited to Indigenous and African descendant women and girls.

Visit the MujerProspera Challenge’s website to learn more about the challenge and submit your application by February 14, 2022 at 12:00 PM EST.

Administrator Samantha Power’s Meeting with UN World Food Program Executive Director David Beasley

Source: USAID

The below is attributable to Spokesperson Rebecca Chalif:‎

Today, Administrator Samantha Power met with UN World Food Program (WFP) Executive Director David Beasley to discuss worsening food insecurity around the world and shortfalls in funding needed to address urgent humanitarian crises, particularly in Afghanistan and Ethiopia.

During their meeting, Administrator Power thanked Executive Director Beasley for WFP’s efforts to quickly scale up food assistance and expand air bridge operations for humanitarian personnel in Afghanistan as well as its continued efforts to deliver humanitarian aid to Ethiopians in dire need, as up to 900,000 people face famine-like conditions in the north, and the drought deepens across the south.

Administrator Power and Executive Director Beasley also discussed the importance of the ongoing partnership between USAID and WFP in the year ahead. They emphasized the increasing humanitarian needs around the world and the need for other donors to step up in order to enable a swift response to humanitarian crises.

Administrator Samantha Power’s Meeting with Mark Suzman Chief Executive Officer of the Bill and Melinda Gates Foundation

Source: USAID

The below is attributable to Spokesperson Rebecca Chalif:‎

On January 11, 2022, Administrator Samantha Power met with Chief Executive Officer of the Bill and Melinda Gates Foundation (BMGF), Mark Suzman. The two discussed the recently announced whole-of-government effort, the Initiative for Global Vaccine Access (Global VAX), to accelerate vaccine delivery and administration. They also discussed USAID and BMGF’s coordinated work to deliver critical oxygen resources to those in need as well as efforts to encourage donors to support plans to increase oxygen resources.

Administrator Power and Mark Suzman discussed their joint efforts to accelerate action towards U.S. government climate commitments launched at COP26, including a focus on agriculture and adaptation, gender-responsive climate programs, and women and girls’ engagement. Finally, they discussed continued efforts to eradicate polio around the world.