Tobacco Articles: org fda

Electronic Cigarettes Are Tobacco Products, States AAPHP

Sat, 13 Mar 2010 05:00:00 GMT

The American Association of Public Health Physicians has petitioned the FDA to change their classification of electronic cigarettes from 'drug-device combination' to 'tobacco product,' stating that the change would promote harm reduction.

POLITO: CDC ignores cold turkey quitters

john@whyquit.com (John R. Polito) — Thu, 11 Mar 2010 05:00:00 GMT

The U.S. Centers for Disease Control (CDC) continues to give millions of cold turkey quitters the cold shoulder despite pleas from tobacco control's leading integrity watchdog, Professor Michael Siegel of Boston University School of Public Health and the former editor of the leading tobacco control journal, Simon Chapman, Professor of Public Health at the University of Sidney. Below is an open letter to the CDC's senior quit smoking scientist from the director of the Internet's leading cold turkey quit smoking forum. . . . Dear Dr. Pechacek, As you know, during 2010 cold turkey will account for more long-term successful quitters than all other quitting methods combined. As senior scientist at the CDC's Office on Smoking and Health (OSH) since 1999, America's lead agency in the war against tobacco induced disease and death, I write imploring OSH to immediately reverse course and end the practice of undermining and discouraging cold turkey quitting attempts, to at last begin supporting their efforts. Dr. Pechacek, OSH is guilty of having taken its eye off the ball. Its mission statement makes it nicotine dependency recovery's integrity guardian, as even the tobacco industry acknowledges that nicotine is the sine qua non of smoking. With due respect, OSH has failed horribly. . . . As the nation's primary tobacco control guardian, it was OSH's duty to investigate, question and expose financial conflicts among "experts" invited to author official U.S. quitting policy. On February 8, 2007, we awoke to front page Wall Street Journal headlines blasting U.S. health officials for allowing pharmaceutical influence to coin policy while undermining cold turkey quitting. . . . Dr. Pechacek, it is OSH's health responsibility to orchestrate creation and deployment of the most effective cold turkey quitting tools smokers have ever seen, including high quality support. While true that roughly 10-12% of unassisted cold turkey quitters currently succeed in quitting for 6 months, how much improvement would be seen if OSH used low cost Internet based programs and existing telephone quit-lines to motivate, educate and support abrupt nicotine cessation? How will it know unless it tries? Sincere regards, John R. Polito

FDA Tobacco Advisory Committee: 6 Jokers In A Stacked Deck: Bad hand dealt to consumers

nycclash@nycclash.com (MrPressRelease.com) — Wed, 10 Mar 2010 05:00:00 GMT

The ostensible point of the FDA's new congressionally-granted powers to regulate tobacco was to responsibly oversee the manufacture, marketing and distribution of tobacco in the name of harm reduction. "But instead," says Audrey Silk, founder of Citizens Lobbying Against Smoker Harassment (C.L.A.S.H.), "the panel they've chosen to accomplish this task seems deliberately selected to steer away from that mission toward another: promoting lucrative substitutions. Far from being composed of objective and cleanly disinterested scientists, the list of participants announced so far has been shown to be deeply biased against tobacco, biased against smokers and neck-deep in pharmaceutical-rooted conflicts of interest." ¶ Jonathan Samet, the Committee's chairman, is director of the Institute for Global Tobacco Control, which is funded by Pfizer and GlaxoSmithKline, manufacturers of nicotine replacement products and quit-smoking drugs. An activist in the stamp-out-tobacco movement since the early 1980's, he's also pursued his studies through the generous funding of anti-tobacco lobby groups and GlaxoSmithKline. ¶ Dr. Neil Benowitz scores a trifecta-- financially beholden to Pfizer, GSK, and Nabi Pharmaceuticals. . . . "You'd think," Silk comments, "they'd want to hear the smokers' perspective and even make use of the smokers' experience in designing their government-approved cigarette." . . . And Dr. Whelan summed it up: "It's hard to imagine a more biased group." . . . "This particular pack of cards," says Silk, "is full of misrepresentative and hurtful jokers. And somebody ought to care."

Reclassify Nicotine Vaporizers (E-cigarettes) from "Drug-Device Combination" to "Tobacco Product" : Docket ID: FDA-2010-P-0095

Tue, 23 Feb 2010 05:00:00 GMT

American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition OTHER Tobacco Control Task Force, American Assn. FDA-2010-P-0095-0001 02/23/10 Acknowledgement Letter to American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) OTHER

Tobacco Legislative Roundup : Regulatory threats "slowly moving toward prohibition": NATO

cspinquire@cspnet.com (Samantha Oller) — Fri, 05 Mar 2010 05:00:00 GMT

In the first of a series of webcasts, the National Association of Tobacco Outlets Inc. (NATO) provided members with an update this past week on tobacco legislation and litigation, led by executive director Thomas Briant. With the Food & Drug Administration's (FDA) Center for Tobacco Products finalizing its approach to tobacco oversight, regulatory matters dominated the event. They included: Self-service displays. While "adult-only" retail stores are currently exempt from an FDA rule that prohibits the use of self-service cigarette, roll-your-own and smokeless tobacco displays, FDA may be revising that law to revoke the exemption. (The law does not apply to pipe tobacco or cigars.) . . . While most of these regulatory threats have not yet wended their way through completion, they suggest that federal and state governments, and anti-smoking advocates are "slowly moving toward prohibition, one step at a time," in effect making it so difficult to sell tobacco that that retailers will decide it is not worth the trouble," argued Briant. "It's time to be vigilant and respond."

Debate continues over e-cigarettes

webmaster@jcfloridan.com (DEBORAH BUCKHALTER Floridan Staff Writer ) — Sun, 07 Mar 2010 05:00:00 GMT

As the debate over the electronic cigarette continues , the device has found at least three true believers in Jackson County. Mildred “Mikay” Barrentine, 30, along with Pat Manning, 37, and 45-year-old Linda Lockwood, the latter two of Altha, are enthusiastic about the e-cigarette. All three are long-time heavy smokers who have given up traditional cigarettes in favor of “vaping,” users’ common term for this alternative to smoking. Although e-cigarettes are not marketed or proven in studies as a smoke cessation device, all three say it has worked for them. They breathe better and cough less. They also food tastes better, and they can smell it better, too, because they are no longer using tobacco with tar and the hundreds of chemicals contained in regular cigarettes. . . . As for the chemicals found in the FDA’s limited testing, the women say traditional cigarettes have those chemicals and a host more. E-cigarettes, they say, are infinitely safer than regular cigarettes, and should be left available for those who want a less dangerous puff. All three said they’d most likely go back to regular cigarettes if e-cigarettes are pulled from the market.

Lorillard Tobacco Company Statement on FDA's Announcement of Tobacco Products Scientific Advisory Committee Membership

Tue, 02 Mar 2010 05:00:00 GMT

"Ever since Congress, in a carefully constructed bill, authorized the FDA to regulate cigarettes and other tobacco products, we have been anticipating the appointment of this panel. "While the scientific advisory committee will be looking at many aspects of regulation, one major challenge will be for committee members to remain focused on an objective analysis of the science surrounding menthol. "We remain confident that a serious examination of menthol science will show no differing health risk as compared to non-menthol products and a comparable cessation rate. We look forward to a fair hearing grounded in good science that advances public policy."

FDA names tobacco scientific advisory panel

Tue, 02 Mar 2010 05:00:00 GMT

The Food and Drug Administration yesterday named nine members to a scientific panel that will advise the federal agency on regulation of tobacco products. Issues such as nicotine content, reduced-risk products and the health effects of menthol cigarettes will go before the Tobacco Products Scientific Advisory Committee, which includes some of the nation's top experts on tobacco, nicotine and addiction, and some long-time tobacco-control advocates. The advisory panel, "has enormous responsibility to advise the FDA on a broad range of scientific issues," said Matthew Myers, president of the Campaign for Tobacco-Free Kids. Seven of the members are medical doctors or health professionals, one represents state governments and one the general public. The group will hold public meetings at least four times a year. . . . The advisory group also will have three non-voting members, including one member from the tobacco manufacturing industry, one member representing tobacco growers, and one representative from the small business manufacturing industry. Those members were not named yesterday, and the FDA said in a statement that "selection of the three non-voting members representing industry interests is ongoing."

FDA panel to target menthol cigarettes

Mon, 01 Mar 2010 05:00:00 GMT

A U.S. scientific panel this month will weigh the controversial role of popular menthol flavoring in cigarettes in the first public meeting on tobacco products since a new law granted regulators power over the industry last year. Over two days, the Food and Drug Administration's panel of outside experts will look at the health impact of the mint-like additive on smoker's use as well as addiction and health, with another meeting set later this year, the FDA said on Monday. The panel's findings and any possible regulatory action against menthol could be a potential blow to Lorillard, the nation's third-largest cigarette company and maker of the top-selling menthol brand, Newport. "It's the beginning of a long, slow funeral procession for menthol," said healthcare analyst Ira Loss of Washington Analysis Corp.

U.S. FDA advisory meetings through April 7

Mon, 01 Mar 2010 05:00:00 GMT

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE DATE: March 30-31, 0830/1230 LOCATION: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW, Washington CONTACT: Cristi Stark, 240-276-3992 On March 30, the committee will cover receive presentations on the background and overview of the FDA Center for Tobacco Products, the Family Smoking Prevention and Tobacco Control Act and the Tobacco Products Scientific Advisory Committee.

FDA Tobacco Panel Includes Members With Quit-Smoking Ties

TBD@wsj.com (DAVID KESMODEL AND JARED A. FAVOLE) — Mon, 01 Mar 2010 05:00:00 GMT

The Food and Drug Administration on Monday named at least two scientists with ties to pharmaceutical companies that market stop-smoking medicine to a scientific panel that will help it regulate the tobacco industry. Jack Henningfield, a vice president of research and health policy with Pinney Associates, a consulting firm whose clients include GlaxoSmithKline PLC, will be part of a committee of 12 people that will provide advice, information and recommendations to the FDA on a wide range of tobacco issues. Mr. Henningfield will be one of nine voting members. The three nonvoting members, which will come from the tobacco industry, haven't been named. At least one other member of the panel has had ties to the pharmaceutical industry. Neal L. Benowitz, a professor of medicine at the University of California, San Francisco, has served as a consultant to GlaxoSmithKline and Pfizer Inc. He also will be a voting member of the panel. The selections raise questions about whether the members would have a conflict of interest on topics such as whether to approve a low-carcinogen smokeless tobacco product as a safer alternative to cigarettes. Such products compete for smokers' dollars against smoking-cessation aids such as the Nicorette gum marketed in the U.S. by GlaxoSmithKline. . . . Maura Payne, a spokeswoman for Reynolds American Inc., the second-largest cigarette maker in the U.S., said it looks forward to working with the new panel "to help set a scientifically based regulatory structure for the tobacco industry."

Overview and General Information on Advisory Committee Membership

Thu, 18 Jun 2009 04:00:00 GMT

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations of individuals to serve as members of its advisory committees. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, we encourage nominations for qualified candidates from these groups.

Roster of the Tobacco Products Scientific Advisory Committee

Cristi.Stark@fda.hhs.gov — Mon, 01 Mar 2010 05:00:00 GMT

Chair Jonathan M. Samet, M.D., M.S. . . . Acting Executive Secretary Cristi L. Stark, M.S. Center for Tobacco Products . . . Members Neal L. Benowitz, M.D. . . . Mark Stuart Clanton, M.D., M.P.H. . . . Gregory Niles Connolly, D.M.D., M.P.H. . . . ** Karen L. DeLeeuw, M.S.W. . . . Dorothy K. Hatsukami, Ph.D. . . . * Patricia Nez Henderson, M.P.H. . . . Jack E. Henningfield, Ph.D. . . . Melanie Wakefield, Ph.D.

Dispatch: PLoS and NYT vs. Money; FDA vs. Flavor; Hype(r)tension: Facts & Fears

Tue, 23 Feb 2010 05:00:00 GMT

Medical Journal Gives Up on Evaluating Science Today the editorial staff of PLoS Medicine, a peer reviewed, open access journal published by the Public Library of Science, declared, "While we continue to be interested in analyses of ways of reducing tobacco use, we will no longer be considering papers where support, in whole or in part, for the study or the researchers comes from a tobacco company." . . . "It's true that tobacco companies knowingly deceived their customers for many years," says ACSH's Dr. Gilbert Ross. "We can name a few activist groups funded by other interests that have also distorted science to suit their agenda. Still, it's the twenty-first century now, and there are many tobacco products - be they smokeless tobacco or lozenges - that may be used to help people quit smoking. Who but the tobacco industry that produces these alternatives is going to fund research concerning their safety and efficacy? And while smoking is decidedly bad for anyone's health, are the PLoS editors going to ban research supported by other disfavored industries - beverages, pharmaceuticals, who knows what others? - in the near future?"

The tobacco company Star Scientific Inc. filed an application with the FDA to allow its dissolvable tobacco "lozenge" to be certified as less harmful than traditional forms of tobacco. . . . The requirement to prove that it's good for the overall health of the country is a poison pill for the approval process, since doing so would have to be based on assumptions that are impossible to make. We hope the FDA approves it, but it is perhaps ironic that one of the brands seeking approval is called 'Stonewall,' because that may be what the FDA does to them and, sadly, to cigarette smokers looking for a less harmful alternative." "It's also significant that the lozenge is wintergreen flavor," says Dr. Ross. "Opponents will say that they will attract young people, despite the overwhelming evidence to indicate that these products are not a gateway to cigarettes. The default legislative mechanism is always against anything related to tobacco."

Establishment of the Tobacco Products Scientific Advisory Committee (PDF)

Wed, 26 Aug 2009 04:00:00 GMT

ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and non-voting membership on this committee. This document also amends the agency’s regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency’s list of standing advisory committees.