Health spotlight
From the FDA Press release dated 7/ 28/ 17
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”
The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Commissioner Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”
The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors.
In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.
“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”
To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
WASH. DOH: Time for back-to-school immunizations
PRESS RELEASE ISSUED 7/ 28/ 17
OLYMPIA – The Washington State Department of Health is urging parents and guardians to make sure their kids’ immunizations are up to date before heading back to school this fall.
Last school year (2016-2017), 85 percent of kindergartners were completely immunized. This school year’s goal is 95 percent. View a list of the elementary schools that achieved 95 percent last year.
Students could be excluded from school if there’s an outbreak of a disease they are not immunized against. Vaccines are critical protection for children; they also help keep other kids around them safe from many diseases.
See all required vaccinations for kindergarten through 12th grade and child care and preschool.
Besides English, the list of required vaccinations is also available in seven different languages such as Spanish, Chinese, and Somali.
Parents and guardians can check their child’s immunization status or print their Certificate of Immunization Status at wa.MyIR.net.
Vaccines are provided at no cost to all kids through age 18. If a health care provider charges a fee to give the shot, parents or guardians may ask to have it waived if they cannot afford it.
By law, no child can be turned away from getting a recommended vaccine from their regular health care provider because the family cannot pay.
Get help finding a health care provider by calling the Family Health Hotline at 1-800-322-2588 or visiting www.parenthelp123.org
WH: President Donald J. Trump Proclaims July 26, 2017, as a Day in Celebration of the 27th Anniversary of the Americans with Disabilities Act
PRESS RELEASE ISSUED 7/ 25/ 17
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA
A PROCLAMATION
On the anniversary of the Americans with Disabilities Act (ADA), we celebrate the landmark legislation that marks our Nation's commitment to ending discrimination against people with disabilities. The ADA's recognition of the inherent dignity of disabled persons solidified America's status as the world leader in protecting fundamental rights. Today, we pay special respect to the contributions of the more than 56 million Americans living with disabilities, and we look forward to further advancing accessibility for all those who need it.
President George H.W. Bush signed the ADA on July 26, 1990, and for 27 years it has been instrumental in protecting the rights and liberties of people with disabilities and strengthening their access to everyday American life. Disabilities are an unavoidable part of the human experience veterans injured in service to their Nation, survivors of accidents and illnesses, children born with disabilities, and our elderly. Since its inception, the ADA has helped empower people living with disabilities by ensuring they have fair and just access to employment, government services, public accommodations, commercial facilities, and public transportation.
Americans are justifiably proud of the ADA and its accomplishments, but more can be done to protect the rights and dignity of Americans living with disabilities. Disabled Americans in the workforce already contribute substantially to our Nation's productivity and prosperity. We must continue to empower them by breaking down obstacles that prevent their full participation in the public and economic affairs of our Nation. In addition, my Administration will encourage American ingenuity and technological advancements in medicine and science, which will give millions of Americans with disabilities opportunities to work, engage in commerce, and connect with others in ways we could not have imagined 27 years ago.
On the anniversary of the ADA, we reaffirm our commitment to fostering an environment that provides all Americans with the opportunity to pursue their American dream. Let us all take this time to refocus our efforts to support our fellow Americans and help them succeed, no matter the obstacles they may face.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim July 26, 2017, as a day in celebration of the 27th Anniversary of the Americans with Disabilities Act. I call upon all Americans to observe this day with appropriate ceremonies and activities that celebrate the contributions of Americans with disabilities and to renew our commitment to achieving the promise of our freedom for all Americans.
IN WITNESS WHEREOF, I have hereunto set my hand this twenty-fifth day of July, in the year of our Lord two thousand seventeen, and of the Independence of the United States of America the two hundred and forty-second.
DONALD J. TRUMP
Related story from the US CHAMBER OF COMMERCE
Disability Employment Summit Highlights Difference U.S. Can Make
Blog posted by, CARRIE BROOKS Staff Assistant, Communications
SOURCE LINK
On July 26, 1990, the Americans with Disabilities Act (ADA) was signed into law, prohibiting discrimination against individuals with disabilities. To commemorate this milestone, the Chamber joined with the U.S. Business Leadership Network to put on an event aimed at promoting the inclusion of all individuals with different abilities in the workplace.
Legislators, activists, and representatives from major international companies met at the Chamber for the Global Disability Employment Summit.
Chamber President and CEO, Tom Donohue, kicked off the summit, noting that, thanks to the ADA, the U.S. has set the gold standard for the inclusion of people with different abilities:
Globally, there are many people with disabilities who are willing and able to work, but they don’t have the same accommodations that workers based in the United States do...Until other countries ensure that people with disabilities have access and opportunities to work and travel, we will always be limited in our ability to operate globally.
Remarks and panel conversations at the summit covered topics ranging from diversification of supply chains to methods for furthering inclusion both in the U.S. and abroad, each with the goal of promoting hiring globally.
In his keynote remarks, Senator Bob Casey (D-PA) stressed the value of common sense practices in order to increase employment opportunities:
Work experience is the number one variable that predicts success for people with disabilities.
Keynote speaker Representative Cathy McMorris Rodgers (WA-05) described the value of work in different terms:
A job is so much more than a paycheck. It’s what gives you purpose and dignity.
Panelists from various companies reinforced these messages, describing how they have created more inclusive workplaces with commonsense strategies that their organizations have implemented. Among them was making an office that is accessible for people of all different abilities. Additional strategies included holding collaborative discussions, providing proper training for workers, and implementing technology that is accessible for all employees.
The process of crafting these strategies includes working alongside and seeking feedback from agencies and actors who have experience with disability. Panelists noted that the most effective way to enact inclusive practices is to check their egos at the door and seek feedback from those who understand the issues best. Whether it be from employees, disability-owned businesses, or customers, their input informs inclusion.
Bank of America Private Wealth Management Managing Director of U.S. Trust Paula Kelly told the audience:
Everyone in our company needs to feel comfortable coming to work as their whole selves every single day.
Participants from other companies echoed this message, enforcing the ultimate goal of diversity inclusion: that employees feel accommodated and comfortable in their work environments.
Another theme that was pervasive throughout the event was that of cooperation. Nearly every speaker mentioned that he or she relied upon the ideas and practices of other companies to boost his or her organization’s approach to disability inclusion. President and CEO of Bender Consulting Services Joyce Bender commented, “Finding global talent is about collaboration.”
One of the issues in promoting disability inclusion abroad stems from the fact that the definition of “disability” varies from one country to another. Thus, different countries have different regulations when it comes to hiring people with different abilities. Individuals who work for U.S.-based companies with global presences shared that it’s crucial to change the culture surrounding disability in order to boost the number of people with disabilities in the workforce.
IBM Director of Global and Americas Diversity and Inclusion Rosalia Thomas offered role models as a means to influence culture:
If you can present a different reality, norms shift.
Acclaimed disability rights activist Judy Heumann closed out the event, impressing upon attendees the role they can play outside the U.S. She called on them to raise the issue of inclusion with chambers of commerce and embassies, noting that when America does something right, foreign actors recognize it. Heumann said:
U.S. leadership can make a dramatic difference.
The Global Disability Employment Summit was one example of that difference.
Daily Bible verse: “You are the light of the world. A city that is set on a hill cannot be hidden. Let your light so shine before men, that they may see your good works and glorify your Father in heaven.
Matthew 5:14,16 NKJV
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