Commissioner Margaret Hamburg called the rule “a historic moment for the FDA.” During a press briefing Wednesday, she noted that the proposal lays the foundation for further control of e cigarettes as well as cigars, another currently unregulated tobacco product that also would be covered by the rule.

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And Health and Human Services Secretary Kathleen Sebelius said in a statement that it is “the latest step in our efforts to make the next generation tobacco free.” Recent federal data show that e cigarette use among middle and high school students has more than doubled since 2011.

Over the past several months, frustrated public health groups and lawmakers have sent dozens of letters to the Obama administration and pushed legislation at both the state and federal level. In the absence of federal regulation, 32 states have passed bans on the sale of e cigarettes to minors. FDA regulation would not pre empt those state efforts.

It s inexcusable that it has taken the FDA and the administration more than three years to issue the deeming regulation,” said Vince Willmore, vice president of communications for the Campaign for Tobacco Free Kids. “It can t take another three years before this is finalized.”

“The regulator will finally be doing its job,” Mitch Zeller, director of FDA s Center for Tobacco Products, acknowledged at the briefing. With no regulation, he said, it s been “the wild, wild west.”

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With U.S. sales now estimated at $1.5 billion annually, e cigarette companies say they welcome federal regulation. Many have supported bans on sales of their products to minors and say they would like to see the same at the federal level.

“NuMark supports FDA extending the appropriate regulation over all tobacco products, including those containing tobacco derived nicotine,” said David Sutton, a spokesman for Altria Inc., whose subsidiary NuMark manufactures e cigarettes. “We think that this comprehensive regulatory framework can contribute to resolving many of the complex issues” surrounding e cigarettes.

The proposed rule would give FDA authority over e cigarettes, cigars, pipe tobacco, nicotine gels, hookah and dissolvables. FDA currently can regulate only cigarettes, cigarette tobacco, roll your own tobacco and smokeless tobacco. A public comment period on the draft language will follow for the next 75 days. There is no set schedule for issuance of a final rule.

Sen. Tom Harkin (D Iowa), who has long pressed both FDA and the Federal Trade Commission to pursue the industry s marketing tactics targeting children, said Thursday that he would examine the new proposal closely. “It s past time for FDA to take action on e cigarettes and to treat these products as what they are addictive tobacco products,” Harkin said in a statement.

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FDA would include e cigarettes, cigars and the additional items in several provisions that apply to regulated tobacco products, including age and identification requirements to restrict sales to youth under 18 and prohibitions on free samples and vending machine sales. These provisions would go into effect 30 days after the final rule is released.

Further restrictions, such as required health warning labels, would go into effect two years after the final rule is released. Cigars would bear five warnings, including one about the addictiveness of their nicotine content, Zeller said. E cigarettes would also come with an addiction warning.

Manufacturers would be required to register with FDA and report their products ingredients. Marketing of new products and marketing that makes health claims would require FDA approval.

The proposed rule is likely to be controversial for failing to limit online sales or television advertising. Nor would FDA categorically ban flavoring. Cigars and e cigarettes come in fruity flavors like peach and cherry that public health advocates say are especially appealing to minors.

Such additional restrictions would require separate rule making, Hamburg said. In the meantime, the agency is funding research about the potential health risks and benefits of the products, as well as who is using them and how. The jury is still out on the safety of e cigarettes, which contain liquid nicotine that is inhaled as a vapor. Some people argue they are a helpful tool for individuals trying to quit smoking traditional cigarettes. Others point to research that suggests they re no less carcinogenic.

The continuation of online sales is sure to draw public health groups ire. Enforcement of restrictions on online sales to minors will be a “huge challenge,” Hamburg said.

Manufacturers of the newly deemed tobacco products will have two years after the final rule is released to submit an application to keep their products on the market. During that period, even as an application is pending, they can continue to sell their products. But after two years, new products must be approved by FDA before going to market.

“By coming forward now with this proposed rule, it starts a process where industry recognizes that regulation is in its future,” Hamburg said. Officials said the agency is confident that should manufacturers pursue litigation, there will be sufficient science based evidence to support the final rule.

FDA is specifically requesting public comment on whether all cigars should be regulated. Zeller said some outside parties have suggested that “premium cigars,” which include cigars made from whole tobacco leaves and those with no added flavors, are used differently and should therefore be exempted.

“It won t be the beginning of the end of the regulatory process,” Gregg Haifley, director of federal relations at the American Cancer Society Cancer Action Network, said of the proposed rule. “It will be the end of the beginning of the regulatory process.”

Hamburg would not give a timeline for finalizing the rule. “What I can tell you is that we seek a sense of urgency to finalize the deeming rule,” she said during a media call Thursday. “We are very very eager to move forward.”

“light” cigarettes and cancer risk – national cancer institute

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  1. What is a so called light cigarette?

    Tobacco manufacturers have been redesigning cigarettes since the 1950s. Certain redesigned cigarettes with the following features were marketed as light cigarettes

    • Cellulose acetate filters (to trap tar).
    • Highly porous cigarette paper (to allow toxic chemicals to escape).
    • Ventilation holes in the filter tip (to dilute smoke with air).
    • Different blends of tobacco.

    When analyzed by a smoking machine, the smoke from a so called light cigarette has a lower yield of tar than the smoke from a regular cigarette. However, a machine cannot predict how much tar a smoker inhales. Also, studies have shown that changes in cigarette design have not lowered the risk of disease caused by cigarettes (1).

    On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which granted the U.S. Food and Drug Administration the authority to regulate tobacco products. One provision of the new law bans tobacco manufacturers from using the terms light, low, and mild in product labeling and advertisements. This provision went into effect on June 22, 2010. However, some tobacco manufacturers are using color coded packaging (such as gold or silver packaging) on previously marketed products and selling them to consumers who may continue to believe that these cigarettes are not as harmful as other cigarettes (2 4).

  2. Are light cigarettes less hazardous than regular cigarettes?

    No. Many smokers chose so called low tar, mild, light, or ultralight cigarettes because they thought these cigarettes would expose them to less tar and would be less harmful to their health than regular or full flavor cigarettes. However, light cigarettes are no safer than regular cigarettes. Tar exposure from a light cigarette can be just as high as that from a regular cigarette if the smoker takes long, deep, or frequent puffs. The bottom line is that light cigarettes do not reduce the health risks of smoking.

    Moreover, there is no such thing as a safe cigarette. The only guaranteed way to reduce the risk to your health, as well as the risk to others, is to stop smoking completely.

    Because all tobacco products are harmful and cause cancer, the use of these products is strongly discouraged. There is no safe level of tobacco use. People who use any type of tobacco product should quit. For help with quitting, refer to the National Cancer Institute (NCI) fact sheet Where To Get Help When You Decide To Quit Smoking, which is available at on the Internet.

  3. Do light cigarettes cause cancer?

    Yes. People who smoke any kind of cigarette are at much greater risk of lung cancer than people who do not smoke (5). Smoking harms nearly every organ of the body and diminishes a person s overall health.

    People who switched to light cigarettes from regular cigarettes are likely to have inhaled the same amount of toxic chemicals, and they remain at high risk of developing smoking related cancers and other disease (1). Smoking causes cancers of the lung, esophagus, larynx (voice box), mouth, throat, kidney, bladder, pancreas, stomach, and cervix, as well as acute myeloid leukemia (6).

    Regardless of their age, smokers can substantially reduce their risk of disease, including cancer, by quitting.

  4. What were the tar yield ratings used by the tobacco industry for light cigarettes?

    Although no Federal agency formally defined the range of tar yield for light or ultralight cigarettes, the tobacco industry used the ranges shown in the table below (5, 7).

    Industry Terms on PackagesMachine measured Tar Yield (in milligrams)Ultralight or Ultralow tarUsually 7 or lessLight or Low tarUsually 8 14Full flavor or RegularUsually 15 or more

    These ratings were not an accurate indicator of how much tar a smoker might have been exposed to, because people do not smoke cigarettes the same way the machines do and no two people smoke the same way.

    Ultralight and light cigarettes are no safer than full flavor cigarettes. There is no such thing as a safe cigarette (1).

  5. Are machine measured tar yields misleading?

    Yes. The ratings cannot be used to predict how much tar a smoker will actually get because the way the machine smokes a cigarette is not the way a person smokes a cigarette. A rating of 7 milligrams does not mean that you will get only 7 milligrams of tar. You can get just as much tar from a light cigarette as from a full flavor cigarette. It all depends on how you smoke. Taking deeper, longer, and more frequent puffs will lead to greater tar exposure. Also, a smoker s lips or fingers may block the air ventilation holes in the filter, leading to greater tar exposure (7).

  6. Why would someone smoking a light cigarette take bigger puffs than with a regular cigarette?

    Cigarette features that reduce the yield of machine measured tar also reduce the yield of nicotine. Because smokers crave nicotine, they may inhale more deeply take larger, more rapid, or more frequent puffs or smoke extra cigarettes each day to get enough nicotine to satisfy their craving. As a result, smokers end up inhaling more tar, nicotine, and other harmful chemicals than the machine based numbers suggest (1).

    Tobacco industry documents show that companies were aware that smokers of light cigarettes compensated by taking bigger puffs. Industry documents also show that the companies were aware of the difference between machine measured yields of tar and nicotine and what the smoker actually inhaled (8).

  7. How can I get help to quit smoking?

    There are many groups that can help smokers quit

    • Go online to ( ), a Web site created by NCI s Tobacco Control Research Branch, and use the Step by Step Quit Guide.
    • Call NCI s Smoking Quitline at 1 877 44U QUIT (1 877 448 7848) for individualized counseling, printed information, and referrals to other sources.
    • Refer to the NCI fact sheet Where To Get Help When You Decide To Quit Smoking, which is available at on the Internet.