Jul 28

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death Agency to pursue lowering nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation


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.


From: fda.gov


Jul 27

1 in 3 dementia cases are potentially preventable, report says


One in three cases of dementia could be prevented by tackling risk factors such as education and depression, a large new international review estimates.

A team of 24 experts in dementia conducted the review on prevention and care.

A recent issue of The Lancet and at this year’s Alzheimer’s Association International Conference in London, researchers model how nine health and lifestyle factors contribute to about 35 per cent of dementia.

For instance, they said that if everyone reaped the brain stimulation and interaction of staying in school until over the age of 15, the total number of dementia cases could be reduced.

Controllable factors they identified as important in midlife are preserving hearing and treating high blood pressure and obesity.

In late life, they said, controlling depression, smoking and social isolation are important.

Maintaining physical activity and controlling diabetes also help. But they said that overall, 65 per cent of the risk isn’t considered potentially modifiable.

Source: The National


How many people in your community know about the connection between smoking and dementia? Here’s a chance to educate your community and engage community members in your efforts. Below you can download a draft news release regarding the connection between smoking and dementia, and encouraging parents to talk with their kids about smoking. 

If you use this news release, please remember that your local media want to see original news. You can fill in the blanks on this news release, and you’ll be almost ready to send it to your news media, but you’ll want to make changes to the news content as well to make it your own.


I Want the News Release
May 26

How Big Tobacco stopped a smoking tax in ‘Marlboro Country’


HELENA, Mont. (AP) – When the Montana Senate voted this spring for what would have been the state’s first tobacco tax increase in 12 years, Big Tobacco lobbyists swarmed the Capitol in Helena.

With a crucial committee hearing about the bill looming in Montana’s House, cigarette retailers and vape shop owners were coached by a lobbying pro on how to oppose it with concise and disciplined testimony. Residents inundated lawmakers with calls and emails mostly railing against the tax. A tobacco lobbyist with deep GOP ties appealed directly to the Republican House speaker.

Within a week the bill was dead, its demise a textbook example of how a well-financed industry can torpedo legislation.

Tobacco and other “sin taxes” perennially surface in many legislative sessions, and cigarette makers are used to fighting back. But Montana lawmakers and lobbyists say the opposition this year was particularly fierce.

“Montana is considered Marlboro Country,” said Kristin Page Nei, a lobbyist for the American Cancer Society that supported the tax. Tobacco’s supporters “know that if a red state like Montana can pass a tax, that other states will follow suit.”

Public records and interviews with a dozen lawmakers and lobbyists reveal that two of the nation’s largest tobacco companies launched an expensive and effective lobbying campaign to kill the Montana bill, which would have raised the state tax on cigarettes by $1.50 a pack and set a 74 percent tax on the wholesale price of vaping products, the state’s first such tax.

Montana has had the same $1.70 tax on each pack of cigarettes since 2005, and the tobacco industry wanted to prevent another increase after it unsuccessfully fought a California voter initiative last November to raise cigarette taxes by $2 a pack.

The bill’s sponsor, Democratic Sen. Mary Caferro of Helena, saw the higher Montana tax as a way to reduce smoking and the rate at which children use vaping products. The measure had rare bipartisan support in the solidly Republican Montana Legislature, thanks in large part to its potential to shore up the cash-strapped state’s budget.

Altria Group, the parent company of Phillip Morris USA, and R.J. Reynolds focused their campaign on Montana’s House, where strong anti-tax sentiment among conservative lawmakers was exacerbated by the recent passage of a state fuel tax increase.

The two companies spent a combined $147,000 on lobbying lawmakers in the first three months of the legislative session, according to disclosure reports filed with state commissioner of political practices.

Most spending came in March, when the tobacco tax bill began moving in the Senate, and the amount actually spent is certain to increase when April’s disclosure reports are filed at the end of May.

The records made public so far show the two companies spent more money lobbying Montana lawmakers this session than they have over the last decade. Altria’s $120,000 topped all lobbyist spending during the first three months.

Vape shop owners were coached on how to present compelling testimony before the House Taxation Committee. Extra tobacco industry lobbyists were hired so they could reach out to state legislators not courted routinely by the sector.

Altria spent $31,000 on advertising and communications in March, according to the disclosure reports. Posters and handbills appeared in convenience stores, gas stations and vape shops – urging tobacco buyers to reach to their legislators and complain about the tax increase.

“The legislators were getting hammered with emails and phone calls around this issue,” said Amanda Cahill, a lobbyist for the American Heart Association, which also supported the bill.

R.J. Reynolds lobbyist E.J. Redding reported spending $1,960 on entertainment in March, including a $207 tab for a dinner attended by House Speaker Austin Knudsen and freshman lawmakers.

Redding and Altria lobbyist Mark Baker, who is a well-connected former executive director of the state GOP and has worked on the staff of a former U.S. senator and a representative, met privately with Knudsen to urge him to oppose the bill.

“Yes, there were attempts by the tobacco lobbyists to influence all of the members of the House, I imagine,” Knudsen said. “They did not influence our decision.”

Eleven of the 13 Republican bill co-sponsors changed their minds and bailed. Several insisted lobbying didn’t affect them, saying they did research that convinced them to agree with the lobbyists’ opposition talking points.

Six days after the Senate passed the bill, the House Taxation Committee held a hearing in which dozens of people testified for and against the measure.

The next day, the committee killed the bill with a rarely used measure called an “adverse committee report” that makes it nearly impossible for bills to be voted on by the House.

That same committee also approved a new estimate forecasting Montana would take in an additional $100 million in revenue over the next two years – essentially eliminating financial justification for the tobacco tax increase.

Rep. Zach Brown, a Bozeman Democrat and a taxation committee member, said he opposed the bill because it would have hit poor smokers the hardest.

But he believes the adverse committee report was a strategy hatched by tobacco lobbyists.

“They put the death nail in it, for sure,” Brown said.

An increase in cigarette taxes would be used to fund public health services under a bill heard by the Revenue Committee March 17.

<a href=’http://news.legislature.ne.gov/dist09′ target=’_blank’ title=’Link to the website of Sen. Sara Howard’>Sen. Sara Howard</a>
Sen. Sara Howard
LB438, introduced by Omaha Sen. Sara Howard, would raise taxes on a pack of 20 cigarettes from 64 cents to $2.14 beginning July 1, 2017. Cigarette tax revenue credited to the state’s general funds would increase from 49 cents per pack to $1.24. The bill also would increase the tax on other tobacco products — excluding snuff — from 20 percent of the purchase price to 65 percent.

Howard said more than 150,000 teens start smoking in the U.S. each year. If current tobacco use patterns continue, she said, approximately 38,000 youths under age 18 who continue to smoke into adulthood will die prematurely from smoking-related illnesses.

“Raising the tax on tobacco products may not only deter abuse by youths but provide much-needed revenue for our state during a time of severe economic shortfalls,” Howard said.

The Legislative Fiscal Office and the state Department of Revenue estimate the bill would increase general funds by approximately $50 million.

Additionally, LB438 would increase the annual transfer of cigarette tax revenue to the Nebraska Health Care Cash Fund from $1.25 million to approximately $60 million. The programs funded would include local public health departments, community health centers and a tobacco prevention and control program. The bill also would create a fund intended to help reimburse behavioral health service provider rates.

Mar 20

Bill would more than triple Nebraska’s cigarette tax


Supporters of a bill that would more than triple Nebraska’s tax on cigarettes argued Friday it would discourage teenagers from smoking, but retailers contend a higher tax would cause customers to buy tobacco in other states.
A measure sponsored by Sen. Sara Howard of Omaha would increase the state’s cigarette tax from 64 cents on a 20-cigarette pack to $2.14. Revenue from the extra $1.50 in tax would be split between the state’s general fund and funds used for behavioral health services.
More at: Lincoln Journal Star

Mar 17

AHA Poll: Majority of Nebraska Voters Support an Increase in the Tobacco Tax


A strong majority of Nebraska voters support a $1.50 increase in the cigarette tax and an equivalent increase for other tobacco products to help address the budget shortfall and fund health programs. The results show a resounding 71 percent of Nebraska voters support increasing the tobacco tax, while 28 percent oppose it.


The poll of 500 Nebraska registered voters was conducted by Public Opinion Strategies from March 4-7.  The poll’s margin of error is +/- 4.38 percent.


 Source: The American Heart Association & American Stroke Association:

The American Heart Association is devoted to saving people from heart disease and stroke –  the two leading causes of death in the world. We team with millions of volunteers to fund innovative research, fight for stronger public health policies, and provide lifesaving tools and information to prevent and treat these diseases. The Dallas-based association is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. To learn more or to get involved, call 1-800-AHA-USA1, visit heart.org or call any of our offices around the country.  Follow us on Facebook and Twitter.

Mar 16

Students rally in Lincoln to combat tobacco use



LINCOLN, Neb. — No Limits, Nebraska’s youth-led tobacco prevention movement, held its No Limits Kick Butts Day Rally March in Lincoln on Wednesday.

The event was open to Nebraska youth ages 12-18, in grades 7-12.

The No Limits Kick Butts Day event included a march from downtown Lincoln to the rally site on the steps of the Nebraska State Capitol.

The theme for this year’s Kick Butts Day Rally was “Same ol’ dog. Same ol’ tricks.”

Participants also meet with state senators prior to the march to discuss how tobacco is impacting Nebraska teens.

No Limits Youth Board Co-Chair Kamrin Edmonds says the opportunity to meet with lawmakers is a valuable experience.

“I never imagined myself talking to our local state senators. When we get to speak with them or their staff, we know they are really hearing our message,” Edmonds said. “The senators are the decision makers, and we are letting them know the opinions of youth in their districts.”

Molly Kincaid, No Limits project coordinator, says the event helps participants learn leadership skills while pursuing a cause they are passionate about.

“No Limits empowers youth to take a stand against Big Tobacco and the marketing tactics the industry uses to peddle their products to young people,” Kincaid said.

Kick Butts Day is a nationwide event promoted by the Campaign for Tobacco-Free Kids to encourage youth to stand out, speak up and seize control in the fight against Big Tobacco.

Additional information about tobacco use, including state-by-state statistics, can be found here.

Source: 10/11 News

Mar 16

Tobacco Tax LB438 Hearing: Watch Live Here


LB438 will be heard today by the Revenue Committee.

The bill, introduced by Sen. Sara Howard of Omaha, would increase the tax in cigarettes from 64 cents per pack to $2.14 per pack. It also would increase the tax on tobacco products other than snuff from 20 percent of wholesale to 65 percent of wholesale.

At the same time, it also would set the Nebraska Health Care Cash Fund as the receiving and distribution fund for all cigarette tax revenues. The receiving and distribution fund for revenues from the taxation of other tax products would remain the Tobacco Products Administration Cash Fund.

Other actions proscribed by the bill include designating a variety of health and safety initiatives and organizations as recipients of cigarette tax revenues. Recipients include public health departments ($6 million), the College of Public Health at the University of Nebraska Medical Center ($4 million), and $2.4 million for the Tobacco Prevention and Control Program.

The bill also would create the Behavioral Health Provider Rate Stabilization Fund for reimbursement of behavioral health services providers. It would provide that the Nebraska Health Care Cash Fund issue a portion of cigarette taxes ($8 million) as funding for the Behavioral Health Provider Rate Stabilization Fund.

The hearing starts at 1:30 p.m. Friday, March 17, and is second on the agenda. At that time, you can watch the hearing here.