Contrary to advertiser claims that e cigarettes can help consumers stop smoking conventional cigarettes, teenagers who used e cigarettes and conventional cigarettes were much less likely to have abstained from cigarettes in the past 30 days, 6 months, or year. At the same time, they were more likely to be planning to quit smoking in the next year than smokers who did not use e cigarettes.

The study s cross sectional nature didn t allow the researchers to identify whether most youths initiated with conventional cigarettes or e cigarettes. But the authors noted that about 20 percent of middle school students and about 7 percent of high school students who had ever used e cigarettes had never smoked regular cigarettes meaning that some kids are introduced to the addictive drug nicotine through e cigarettes, the authors said.

It looks to me like the wild west marketing of e cigarettes is not only encouraging youth to smoke them, but also it is promoting regular cigarette smoking among youth, said senior author Stanton A. Glantz, PhD, UCSF professor of medicine and director of the Center for Tobacco Control Research and Education.

Study of E Cigarette Use Progresses

The new results are consistent with a similar study of 75,000 Korean adolescents published last year by UCSF researchers, which also found that adolescents who used e cigarettes were less likely to have stopped smoking conventional cigarettes.

In combination, the two studies suggest that e cigarettes may contribute to nicotine addiction and are unlikely to discourage conventional cigarette smoking among youths, said the scientists.

The federal Centers for Disease Control and Prevention reported last year that the majority of adolescents who have ever smoked e cigarettes also have smoked regular cigarettes. An estimated 1.78 million U.S. students have used the devices as of 2012, the CDC reported.

The research was funded by the National Cancer Institute (grants CA 113710 and CA 060121).

The Center for Tobacco Control Research and Education specializes in tobacco control research focused on policy change, smoking cessation, nicotine addiction, health disparities in smoking, novel tobacco devices and tobacco marketing. It also houses the Legacy Tobacco Documents Library, a rich resource of previously confidential tobacco industry documents.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care. It includes top ranked graduate schools of dentistry, medicine, nursing and pharmacy, a graduate division with nationally renowned programs in basic biomedical, translational and population sciences, as well as a preeminent biomedical research enterprise and two top ranked hospitals, UCSF Medical Center and UCSF Benioff Children s Hospital.

Fda proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes

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FDA NEWS RELEASE

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For Immediate Release April 24, 2014
Media Inquiries Jenny Haliski, 301 796 0776,
Consumer Inquiries 888 INFO FDA

FDA proposes to extend its tobacco authority to additional tobacco products, including e cigarettes

As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency s tobacco authority to cover additional tobacco products.

Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco.

“This proposed rule is the latest step in our efforts to make the next generation tobacco free,” said HHS Secretary Kathleen Sebelius.

Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements

  • Register with the FDA and report product and ingredient listings
  • Only market new tobacco products after FDA review
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole and
  • Not distribute free samples.

In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products

  • Minimum age and identification restrictions to prevent sales to underage youth
  • Requirements to include health warnings and
  • Prohibition of vending machine sales, unless in a facility that never admits youth.

“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”

“Tobacco related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health related claims.”

The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.

Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA s existing drug and device authorities in the Food, Drug &Cosmetic Act.

The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including

  • The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
  • The FDA seeks answers to the many public health questions posed by products, such as e cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.

For more information

  • Proposed rule Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming)
  • FDA Extending Authorities to Additional Tobacco Products
  • Consumer Update Recognize Tobacco in Its Many Forms
  • FDA Voice Blog Proposed Rule Would Expand FDA s Tobacco Control Authority
  • En Espanol La FDA propone ampliar su autoridad para regular otros productos de tabaco, incluyendo los cigarros electr&oacute nicos

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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