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Pivotal public health step to dramatically reduce smoking rates

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601039.htm

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

When I returned to the U.S. Food and Drug Administration last year, it was immediately clear that tackling tobacco use – and cigarette smoking in particular – would be one of the most important actions I could take to advance public health. With that in mind, we’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products. As part of our comprehensive plan on tobacco and nicotine regulation announced last summer, we’re issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels. This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country.

Despite years of aggressive efforts to tackle the leading cause of preventable disease and death in the United States, tobacco use – largely cigarette smoking – still kills more than 480,000 Americans every single year. Tobacco use also costs nearly $300 billion a year in direct health care and lost productivity. In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it’s clear that to maximize the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes.

The ANPRM being issued today provides a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard. We’re interested in public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health?

Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result? As we explore this novel approach to reducing the death and disease from combustible cigarettes, it’s critical that our policies reflect the latest science and is informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment.

We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort. Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard. If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation. And with this scenario, an even greater impact could be felt over time: by the year 2100, the analysis estimates that more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. And smoking rates could drop from the current 15 percent to as low as 1.4 percent. All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century – an undeniable public health benefit.

No statistical model can truly capture the full impact of this effort – including the joy from years of quality life gained with a loved one, or how much pain and suffering would be avoided for millions of families across the country. But what we’re learning about the significant public health promise of this approach leaves me encouraged and optimistic. Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes. And this unprecedented public health opportunity, contrasted against the cost of doing nothing, weighs heavily on me.

We’re at a crossroads when it comes to addressing nicotine addiction and smoking in this country – with important new tools to address this devastating public health burden. And although a potential nicotine product standard for cigarettes is the cornerstone of our approach, we also continue to push forward on additional pieces of the FDA’s multi-year plan designed to work in concert to better protect kids and significantly reduce tobacco-related disease and death. We said from the outset that ours was a comprehensive approach that requires us to pursue all of its parts in tandem.

For example, our plan demonstrates a greater awareness that nicotine, while highly addictive, is delivered through products on a continuum of risk, and that in order to successfully address cigarette addiction, we must make it possible for current adult smokers who still seek nicotine to get it from alternative and less harmful sources. To that end, the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms. This will be achieved through our ongoing regulatory work to develop several foundational rules, guidances, product standards and other regulations. At the same time, we plan to take vigorous enforcement steps to make sure that tobacco products aren’t being marketed to kids, including e-cigarettes. No youth should use a tobacco product.

In addition, as we advance our framework to protect public health in the evolving tobacco marketplace, the FDA also plans shortly to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use and cessation of tobacco products. A second ANPRM will solicit additional comments and data related to the regulation of premium cigars. At the same time we’re also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches and lozenges that help smokers quit. This is a pivotal part of our overall public health approach.

Finally, we also plan to take new steps to make sure that our policies and processes for the regulation of tobacco products are efficient and predictable, and consistent with the mandate Congress gave us under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We’re committed to making sure that we have transparent regulatory policies and best practices in place to maximize our public health impact. To these ends, we plan to issue a series of foundational rules and guidance documents that will delineate key requirements of the regulatory process, such as the demonstration of substantial equivalence and the submission of applications for new tobacco products. We also plan to release soon a framework for how we’ll address the so-called provisional substantial equivalence applications. These are for products that entered the market during a grace period set up in the law and for which companies submitted reports to demonstrate that the new product has the same characteristics as a predicate product, or has different characteristics, but such differences do not cause the new product to raise different questions of public health. These “provisional” products can remain on the market unless the FDA finds them not substantially equivalent. Our new framework aims to provide more clarity by delineating between individual provisional applications which the FDA intends to continue to review to reach a final determination on whether they can remain on the market and those provisional applications that the agency does not intend to review further and which can continue being sold.

All of these efforts complement our ongoing work to educate kids about the dangers of all nicotine-containing products, limit youth access and encourage adults to quit smoking cigarettes.

We believe this unprecedented approach to nicotine and tobacco regulation not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain. As we move forward with these efforts, we have an opportunity to more formally solicit feedback, and we’ll continue to foster a public dialogue to re-shape our country’s relationship with nicotine and seek public input on policies that will guide us toward a healthier future.

Today’s ANPRM is a significant step in our efforts to confront nicotine addiction in combustible cigarettes. This milestone places us squarely on the road toward achieving one of the biggest public health victories in modern history and saving millions of lives in the process.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by 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.

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As Part Of ‘Tobacco Nation,’ Indiana Has A Smoking Rate On Par With Developing Countries

A group of 12 contiguous U.S. states in the Midwest and South has the highest rate of adult tobacco use in the nation. If taken as a country, this group would rank among those with the highest smoking rates in the world.

https://www.wfyi.org/news/articles/as-part-of-tobacco-nation-indiana-has-a-smoking-rate-on-par-with-developing-countries

According to a report released by Truth Initiative last week, Indiana is one of these 12 states, along with neighboring Ohio, Michigan, West Virginia, Kentucky, Tennessee, Alabama, Mississippi, Louisiana, Arkansas, Oklahoma and Missouri.

The Washington-based tobacco control nonprofit has termed this group, “tobacco nation.”

Three non-contiguous states ‒ South Carolina, Maine and North Dakota ‒ have also have high adult tobacco use.

According to the report, if these 12 contiguous states made up a “nation,” it would rank fifth among the countries with the highest smoking rates, behind Indonesia, Ukraine, China and the Philippines ‒ “countries with a fraction of our financial, scientific and healthcare resources,” said Truth Initiative CEO Robin Koval.

For instance, in the Philippines, 23 percent of adults use tobacco. In the “tobacco nation,” 22 percent of adults do. The U.S. national average is 15 percent.

In Indiana, smoking is still the leading cause of preventable death, causing a host of illnesses including cancer, heart disease and stroke. The Centers for Disease Control and Prevention ranks Indiana’s adult smoking rate the 10th highest in the country.

Richard M. Fairbanks School of Public Health Dean Paul Halverson was not surprised to see Indiana highlighted in the report.

“We are horrible when it comes to funding public health,” he said. “We’re ranked 49th in 50 states in our per capita investment in public health.”

Furthermore, while the CDC recommends a state the size of Indiana should spend $70 million a year in tobacco control and prevention. Halverson said Indiana only invests $7 million annually.

Beside their proclivity for smoking, the twelve states have other characteristics in common, too.

One is poverty. Compared with the other 38 states, “tobacco nation” earns nearly 21 percent less per year, the report said.

Additionally, this region has weak smoke-free laws and tobacco control policies.

In April, Indiana lawmakers proposed increasing the tax levied on a pack of cigarettes, but it failed to pass. The state’s cigarette tax is around a dollar, one of the lowest in the county, and well below the national average, $1.71.

Indiana also has a preemptive law, common in the other “tobacco nation” states, that restricts tobacco control efforts at a local level.

For instance, even if local governments wanted to raise the minimum age for purchasing cigarettes to 21, the preemptive law would prevent them from passing policies more stringent than state law.

While the U.S. smoking rate has declined in recent years, it remains high in rural communities.

“In fact, in some of our areas, it has actually increased,” said Alana Knudson, co-director of the Walsh Center for Rural Health Analysis.

“Many of the counties in ‘tobacco nation’ are rural, and when you look at the public health infrastructure in our rural communities, it has greatly diminished,” Knudson said.

She said not enough federal funding flows into smaller communities.

“We already know 70 percent of smokers want to quit,” said Corinne Graffunder, director of CDC’s Office on Smoking and Health.

However, she said those who live below the poverty line have the hardest time quitting.

Dr. Kasisomayajula Viswanath, who teaches behavioral sciences at Harvard’s T.H Chan School of Public Health, said it’s important to study tobacco use within “the context of class, place and race.”

While the data show high rates of poverty in this region, Viswanath said researchers should take into context what compels people to smoke.

In many of these states the manufacturing industry has disappeared, said Viswanath. The threat of losing work demoralizes residents.

“It is a challenge of micro-humiliations where they’re constantly under stress,” he said “One part of it is mental health, but the other part is just not mental. It’s the stress associated with navigating and maneuvering through life.”

This story was produced by Side Effects Public Media, a reporting collaborative focused on public health.

Public smoking in Santa Monica

Yuri was visiting Santa Monica recently and took a stroll down the Third Street Promenade. He paused for a moment to light up a cigarette, and exhaled a plume of smoke.

http://smdp.com/public-smoking-in-santa-monica/162863

Yuri was startled when another pedestrian tapped him on the shoulder and pointed at a nearby “No Smoking” sign.

He hastily put out his cigarette and carried the butt to a nearby trash can.

Yuri was surprised that he couldn’t smoke outside, but he wanted to obey the law and avoid bothering other visitors.
Yuri had just gotten a crash course in Santa Monica’s smoking law.

Santa Monica has long been on the forefront of protecting residents and visitors from secondhand smoke. Twenty years ago it was the first city to prosecute bars for allowing patrons to smoke.

Now, both smoking and vaping (e-cigarettes) are prohibited not only on the Third Street Promenade, but in most public places:

parks

beaches

the Santa Monica Pier

outdoor dining areas

farmer’s markets

Outdoor Service Areas (bus stops, ATMs, and anywhere else people wait for services)

It’s also unlawful to smoke or vape within 20 feet of doors or open windows of buildings that are open to the public. (This includes all businesses and basically all places other than private residences.)

Smoking in these public areas is a criminal infraction, punishable by a $100 base fine plus penalties for the first offense; $200 base fine for the second offense within one year; and $500 base fine for all subsequent violations within one year.

Santa Monica also prohibits smoking in common areas of all multi-unit housing (both apartments and condos), and inside units for all residents who moved in after November 22, 2012.

While marijuana is now legal in California, it’s still unlawful to smoke it in public, or anywhere else that tobacco is prohibited.

Smoking marijuana in public is punishable by a $100 base fine, or a $250 base fine if it’s a place where tobacco smoking is forbidden.

There are additional penalties for smoking pot within 1,000 feet of schools, daycare centers and youth centers while children are present, unless it’s in a private residence.

So where is it OK to smoke? There are still plenty of areas where smoking is allowed. These include sidewalks and other public places where it isn’t expressly prohibited – so long as it’s not within 20 feet of doors or open windows.

It’s also allowed in single-family homes, and inside apartments or condos that were occupied before November 22, 2012 (unless the unit was designated as non-smoking).

If you have questions or need information about smoking laws in Santa Monica, please call the City Attorney’s Office at (310) 458-8336 or visit smconsumer.org.

The Consumer Protection Division of the City Attorney’s Office enforces the law and educates the public about tenants’ rights, fair housing, consumer protection and other issues. They can be reached at 310-458-8336 or smconsumer.org.

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