Posts Tagged ‘tobacco’

FDA To Require Substantial Equivalence Reviews For New Tobacco Products

In National News on January 7, 2011 at 12:24 pm

The U.S. Food and Drug Administration announced this week that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.  

“Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health. This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. The law requires FDA to carefully examine the impact those products may have on the public health,” said Lawrence R. Deyton, M.S.P.H., M.D., director of the agency’s Center for Tobacco Products. “Products that are equivalent to those which were on the market on February 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health.”

“This piece of the Tobacco Control Act protects the health of all Americans,” said Health and Human Services Secretary Kathleen Sebelius. “It does this by setting a clear deadline for tobacco companies to provide important product information to the FDA so the agency can then begin evaluating tobacco products for any potential new risks to public health.”

The Family Smoking Prevention and Tobacco Control Act, which became law June 22, 2009, granted the FDA regulatory authority over tobacco products. Generally, the law allows the FDA to deny applications for new products if marketing the product poses a harm to public health.

FDA may deny applications for substantial equivalence if the marketing of that modified product would raise different questions of public health. An example would be a product that poses an increased health risk to users of the product or to nonusers by causing more of them to start smoking.

In general, in order to continue to market these products, manufacturers of tobacco products that were introduced or changed after Feb. 15, 2007, which include cigarettes, roll-your-own tobacco and all smokeless products must apply for equivalency by Mar. 22, 2011. Manufacturers intending to introduce new products into the market after that date must submit an application for the new product and obtain a marketing order from the FDA before introducing the product to market.

“No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such” said Deyton. “One of the FDA’s missions required by this new law is to ensure new products do not pose an increased threat to the American public. These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products.”

FDA also intends to issue guidance on materials the agency believes would show that a tobacco product was on the market on Feb. 15, 2007, as well as hold a Webinar Series in order to provide more assistance to manufacturers.
Information on the Webinar Series (available soon) and application process details and answers to questions can be found here.

The FDA welcomes public comment on this issue. Go to and insert docket number FDA-2010-N-0646 into the “search” box and follow the prompts.


New Surgeon General’s Report Shows Immediate Need for Strong Tobacco Control Programs

In Local News on December 10, 2010 at 12:04 pm

WASHINGTON, Ind. – Local health advocates say a new U.S. Surgeon General’s Report released Thursday provides a stark reminder of how lethal and addictive smoking is for everyone. This report underscores the importance of actions to prevent kids from starting to smoke, help smokers quit and protect everyone’s right to breathe clean air-free.

“Exposure to tobacco smoke causes immediate damage to your body.  The next cigarette you smoke can be the cigarette that is the trigger for a deadly heart or asthma attack, or damage your DNA which can lead to cancer,” says Sally Petty, coordinator of the Tobacco Prevention and Cessation coalitions in Daviess and Pike counties.

The local tobacco prevention coalitions in Daviess and Pike counties have been working hard over the past several years to protect children and adults from the hazards of tobacco smoke. Their accomplishments include:

  • Working with North Daviess, Washington Community and Pike Central schools to strengthen their tobacco policies and make their entire campuses tobacco-free.
  • Providing Tobacco Education Group, an evidence-based intervention program with a high success rate in helping teens quit using tobacco, as a positive alternative to fines and school suspension for juveniles caught using tobacco in Daviess and Pike counties.
  • Assisting major employers, community organizations, and more than a dozen healthcare clinics in providing cessation support for their employees, clients, and patients.
  • Supporting several local employers in enacting smoke-free workplace policies.
  • Educating adults about available cessation resources, and children about why they should not start using tobacco.

The new report shows biological evidence that suggests each cigarette is doing immediate damage and the sooner the smoker quits, the better. The message is clear; it is important to act now to reduce adult smoking in Indiana.

The report also finds that today’s cigarettes are designed to deliver nicotine more efficiently to the brain, addicting children more quickly and making it harder for smokers to quit. Today’s tobacco products are designed for addiction.

“This report stresses the need for a strong tobacco prevention and cessation program like we have had for the last 10 years in Indiana. Reducing tobacco use is one of the most effective ways to protect our state’s health and prevent deadly and costly diseases such as cancer and heart attacks by preventing kids from starting and helping adults quit,” added Petty.

The Surgeon General’s report details the serious health effects of even brief exposure to tobacco smoke. It concludes that:

  • Tobacco smoke contains more than 7,000 chemicals, including hundreds that are toxic and at least 70 that cause cancer.
  • Every exposure to the cancer-causing chemicals in tobacco smoke can damage DNA in a way that leads to cancer.
  • Exposure to secondhand smoke has an immediate adverse impact on the cardiovascular system, damaging blood vessels, making blood more likely to clot and increasing risks for heart attack and stroke.
  • Smoking makes it harder for women to get pregnant and can cause miscarriage, premature birth and low birth weight.  It also harms male fertility.

According to Surgeon General Regina Benjamin, “There is no safe level of exposure to tobacco smoke.  Every inhalation of tobacco smoke exposes our children, our families, and our loved ones to dangerous chemicals that can damage their bodies and result in life-threatening diseases such as cancer and heart disease.”

It is imperative for Indiana to continue its progress; in 2009, smoking rates declined to an historic low rate of 23.1 percent representing a highly significant downward trend in adult smoking between 2001-2009 (down from 27.4% in 2001 to 23.1% in 2009). Indiana now has 208,000 fewer smokers than just 10 years ago, but nevertheless Indiana still ranks below nearly every other state in the country (Indiana ranks 45 in smoking rate). There are still more than one million smokers in Indiana and the costs continue to mount up.

  • Each year there are 9,700 deaths in Indiana due to tobacco use.
  • There are over 194,000 Hoosiers living with serious tobacco-related illness.
  • The tobacco use burden to the Indiana economy is $7.7 billion in annual costs.
  • Indiana spends a total of $487 million each year on Medicaid payments caused by tobacco use.

The report and related materials can be found at

The Daviess and Pike tobacco prevention coalitions are funded by tobacco master settlement funds through Indiana Tobacco Prevention and Cessation. Their mission is to reduce tobacco-related death and disease by preventing youth from starting, helping tobacco users quit, and reducing public exposure to secondhand smoke. For more information about tobacco-free policies, contact Petty at 812-698-0232 or

Closing The Gateway To Alcohol And Drug Use

In State News on April 21, 2010 at 11:41 am

Smoking is not just a bad habit that can lead to premature death, but it also can lead to an increased use of certain drugs. An Indiana University study has found that increased smoking is strongly associated with increased use of alcohol, smokeless tobacco and other illicit drugs.

“The empirical data provides evidence that tobacco still serves as a gateway drug. Furthermore, there is a dose response relationship with regard to monthly use of cigarettes and other substances across all grades surveyed,” said Mohammad Torabi, Chancellor’s Professor in the School of Health, Physical Education and Recreation and study co-author. “Tobacco is everyone’s common enemy.”

The study, published in the American Journal of Health Education, reiterates the findings of Torabi’s 1993 study that tobacco is a significant gateway drug.

“In our current study, increased smoking was strongly associated with increased use of alcohol, smokeless tobacco, and five other drugs. This is a significant public health problem,” Torabi said. “Probably one way to prevent other drug use is concentrating on tobacco prevention and cessation. That is not to say there is cause and effect relationship between tobacco use and other drugs.”

Every year tobacco is responsible for nearly 450,000 deaths in the United States. Its use affects the health and well-being of smokers and nonsmokers alike and it contributes significantly to skyrocketing health care costs. According to the study, tobacco has not only impacted the health but also the wealth of every member of our society.

“As is known, a great majority of smokers start prior to the age of 25. That is why most of the marketing of tobacco is targeted toward younger people. If they are ‘hooked’ to this deadly product, they are almost always ‘hooked’ for life,” Torabi said.

The younger a person begins smoking, the greater the likelihood of addiction and disease. This study reveals that Indiana eighth graders used cigarettes, alcohol and marijuana at a much higher rate than the national average. Similar results were also found in other grade levels. According to the study, “the heavier the level of smoking, the greater the predicted probability of alcohol use.”

Parents constitute the most important ingredient in preventing youth tobacco use. The study makes the following recommendations:

  • School involvement. Schools need to employ smoking bans, to adopt evidence-based tobacco prevention curricula and to offer and promote smoking cessation programs.
  • Community involvement. Evidence-based community strategies include increasing taxes on cigarettes, interventions to reduce youth access to tobacco in combination with mobilization efforts, and counter-marketing campaigns. Communities as well as schools should increase stigmatization of smoking.
  • Adult involvement. Every parent, teacher and person who works with youth should recognize the powerful predictive relationship between cigarette smoking and the use of alcohol and other drugs and be able to have an open dialogue with the said youth.

“Obviously, this study demonstrated that tobacco use is one of the most critical public health problems,” Torabi said. “If we make an investment in prevention and cessation, it not only saves premature death and suffering, but it saves taxpayers’ resources in the long term and will reduce our skyrocketing health care costs.”

Torabi, chair of the School of HPER’s Department of Applied Health Science, can be reached at 812-855-4808 or

No To Tobacco But Yes To Marijuana?

In National News on March 25, 2010 at 11:34 am

The state of California is a leader in tobacco control but is now looking into legalizing marijuana. This seems like a double standard since the CDC has found numerous negative health effect associated with marijuana use, some similar to the negative effects of tobacco use.

Among the known or suspected chronic effects of marijuana are:

  • short-term memory impairment and slowness of learning.
  • impaired lung function similar to that found in cigarette smokers. Indications are that more serious effects, such as cancer and other lung disease, follow extended use.
  • decreased sperm count and sperm motility.
  • interference with ovulation and pre-natal development.
  • impaired immune response.
  • possible adverse effects on heart function.
  • by-products of marijuana remaining in body fat for several weeks, with unknown consequences. The storage of these by-products increases the possiblilties for chronic, as well as residual, effects on performance, even after the acute reaction to the drug has worn off. Of special concern are the long-term developmental effects in children and adolescents

Check out this news story:

Indiana Cigarette Consumption Down by 36%

In State News on March 22, 2010 at 8:17 am

Since 2000, cigarette consumption has declined by 36% in Indiana. Cigarette consumption is calculated based on per-pack sales and provides an estimate of “how” much Hoosiers are smoking. Indiana has long had one of the highest smoking consumption rates in the country. The decrease of consumption, particularly in the last 2 years, is a strong indicator that Hoosiers are changing their smoking behavior.

Tobacco Will Kill 6 Million People Next Year

In National News on October 30, 2009 at 8:44 am

Fact for Life #261: Tobacco use will kill 6 million people next year from cancer, heart disease, emphysema and a range of other illnesses, and will cost the global economy $500 billion a year in direct medical expenses.

Source: The Tobacco Atlas, Third Edition:

“Facts for Life,” providing statistics on the toll of tobacco on Hoosiers and the State of Indiana, is presented by Indiana Tobacco Prevention and Cessation.

For more information on Indiana Tobacco Prevention and Cessation, visit,, or

Smoking Causes Brain Damage

In National News on October 9, 2009 at 8:47 am

Fact for Life #260: Research suggests there is a direct link between smoking and brain damage. NNK, a compound in tobacco, changes to a cancer-causing chemical once it has been metabolized, triggering white blood cells in the brain’s immune system to attack healthy brain cells.

Source: Ghosh, D et al. Tobacco carcinogen induces microglial activation and subsequent neuronal damage. Journal of Neurochemistry 2009, 110(3); 1070-1081.

“Facts for Life,” which provides statistics on the toll of tobacco on Hoosiers and the State of Indiana, is presented by Indiana Tobacco Prevention and Cessation. For more information on Indiana Tobacco Prevention and Cessation, visit,, or

Lance Armstrong On Tobacco

In National News on September 8, 2009 at 8:26 am

Lance Armstrong spoke out about tobacco in a recent USA Today article:

As we were wrapping up our session at the Global Cancer Summit, I received an interesting question from the Indian delegate: “If you had to choose one thing to focus on to reduce cancer rates, what would it be?” That’s easy: tobacco. It’s the only product that, if used as directed, will kill you. One third of all cancer deaths are attributed to this drug.

I joined my good friend Dr. John Seffrin from the American Cancer Society along with the world’s leading tobacco control experts to roll out the third edition of the “Tobacco Atlas.” The Atlas chronicles the prevalence of tobacco use, health risks, economic costs, marketing and legislation of tobacco worldwide. One hundred million people were killed by tobacco in the 20th century and if we do nothing, another 1 billion lives will be lost in the 21st.

At LIVESTRONG, we talk a lot about bridging the gap between what we know and what we do. We know that tobacco kills. We need to bridge this gap by educating people around the globe about the dangers of tobacco and do all we can to stop the use of the products.

Indianapolis Star Editorial

In State News on July 20, 2009 at 9:13 am

Check out this recent editorial in the Indianapolis Star:

Snuffing out youth puffing

If physical health is inseparable from economic well-being — and it is — then one might argue that Indiana can’t stand prosperity.

Cigarettes kill roughly 10,000 Hoosiers a year and cost the state an estimated $3.5 billion in hospitalization, lost work time and other damage. It would make good fiscal sense for Indiana, one of the nation’s heaviest-smoking states, to kick the habit.

And we’re headed that way, according to a recent survey by Indiana Tobacco Prevention and Cessation. The anti-smoking organization found that puffing by high school students has dropped 42 percent since the start of the decade, while the vice has declined 58 percent among middle-schoolers.

The good news would be even better if it did not follow an Indiana General Assembly session in which a proposed statewide smoking ban succumbed to special-interest politics and funding for anti-tobacco education and assistance for aspiring quitters was slashed.

We have seen this penny wisdom and pound foolishness before. About a decade ago, when the state was devoting the bulk of its share of the nationwide tobacco lawsuit settlement to anti-smoking efforts, youth smoking plummeted. When our leaders commenced to siphon off most of the windfall for other, unrelated budgetary needs, youth smoking shot up again.

The decline in recent years has been attributed, reasonably enough, to the proliferation of local anti-smoking ordinances and the 44-cent cigarette tax increase enacted in 2007, along with the work of Indiana Tobacco Prevention and Cessation. Clearly, a statewide ban and a lighter hit on the organization’s finances would have been timely investments in money and political capital, given the benefits.

As it turned out, a funding cut that was expected to be about 10 percent widened to 33 percent during the special session, leaving the program with just under $11 million compared to the $32 million a year it originally commanded from the settlement.

Hard times make for hard choices; bringing better times requires tougher decisions than lawmakers and the Daniels administration were willing to make this year when it came to the health of the younger generation.

At the same time, indications are that the status of smoking among adolescents has deteriorated despite seductive advertising and media glamorization. Education, taxation, ordinances and restrictions have been essential to that change of consciousness, and the heat must be kept on.

FDA To Regulate Tobacco Products

In National News on June 16, 2009 at 11:51 am

Below is a great news release from our partners at Campaign For Tobacco Free Kids:

The U.S. Congress has delivered a truly historic victory for America’s children and health by approving legislation granting the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products.  President Obama supports the legislation and is expected to sign it into law in the near future.

On June 11, 2009, the U.S. Senate voted 79 to 17 to approve the bill, H.R. 1256/S. 982, known as the Family Smoking Prevention and Tobacco Control Act.

On June 12, 2009, the U.S. House of Representatives voted 307 to 97 to approve the identical bill.

The bill is sponsored by Senator Edward Kennedy (D-MA) and U.S. Reps. Henry Waxman (D-CA) and Todd Platts (R-PA).

Members of Congress and public health organizations have worked for more than a decade to grant the FDA authority to regulate the manufacturing, marketing and sale of tobacco products.  This bill will end the special protection the tobacco industry has enjoyed for far too long and protect our nation’s children and health instead.  It represents the strongest action Congress has ever taken to reduce tobacco use, the leading preventable cause of death in the United States.

Tobacco use kills more than 400,000 Americans and costs the nation $96 billion in health care bills each year. Every day, another 1,200 lives are lost and more than 1,000 kids become new regular smokers.

Yet, until now, tobacco products have escaped the FDA’s common-sense regulations that apply to other consumer products, such as food, drugs and even lipstick. This legislation will:

Crack down on tobacco marketing and sales to kids.

Require larger, more effective health warnings on tobacco products.

Require tobacco companies to disclose the contents of tobacco products, as well as changes in products and research about their health effects.

Ban terms such as “light” and “low-tar” that mislead consumers into believing that certain cigarettes are safer.

Strictly regulate all health-related claims about tobacco products to ensure they are scientifically proven and do not discourage current tobacco users from quitting or encourage new users to start.

Empower the FDA authority to require changes in tobacco products, such as the removal or reduction of harmful ingredients.

This legislation has been endorsed by more than 1,000 public health, faith and other organizations across the country. And it is supported by 70 percent of American voters.