http://www.tobacco.org/newsfeed/org/fda.rss Latest top tobacco news headlines en-us http://www.officialwire.com/main.php?action=posted_news&rid=34978&catid=105 http://tobacco.org/news/292926.html LPD Services, a U.K. based lab that is fully accredited has submitted the results of its findings on the Gamucci line of e-cigarettes. As most have suspected, the lab indicated that the electronic cigarette is much safer than traditional tobacco cigarettes. There have been several reports from highly credible labs around the world on the e cigarette. One from South Africa, New Zealand, the U.K. and several others that are high profile in nature and performed by stout anti-smoking advocates that believe in harm reduction. All of these labs came back with the same result: the e cigarette is many times safer than traditional tobacco cigarettes. There seems to be an air of change on the horizon concerning the e cigarette with strong lab results supporting claims of a smarter and safer choice over the tobacco cigarette. Top anti-smoking advocates like Dr Murray Laugesen, who has been the recipient of top awards from the World Health Organization in his fight against the harm of tobacco, supports the e cigarette. Professor Michael Siegel is a doctor also and another strong advocate for harm reduction OfficialWire gaultmarketing@gmail.com (Tiffany Ellis (OfficialWire) ) Sat, 14 Nov 2009 05:00:00 GMT http://jama.ama-assn.org/cgi/content/short/302/19/2078?rss=1 http://tobacco.org/news/292828.html With great fanfare, the US Food and Drug Administration (FDA) on September 22 announced a ban on certain flavored cigarettes that, the agency says, are aimed at enticing children to smoke. "Almost 90% of adult smokers start smoking as teenagers, and these flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA Commissioner Margaret Hamburg, MD, at a press conference announcing the ban. Journal of the American Medical Association Wed, 18 Nov 2009 05:00:00 GMT http://www.marketwire.com/press-release/FdaimportsCom-1077520.html http://tobacco.org/news/292819.html FDAImports.com reports: the U.S. government is a house divided. While some government officials are fighting for greater restrictions on the sale of tobacco products, others are fighting to prevent any more restrictions and balking at the restrictions that other nations have implemented on tobacco sales. Does the right hand know what the left hand is doing? On November 6, FDA posted a special update on its web site, highlighting what its Center for Tobacco Products has done to implement the Family Smoking Prevention and Tobacco Control Act. On the list was the statutory ban on cigarettes containing certain characterizing flavors (other than menthol) that went into effect on September 22, 2009. FDA stated that it is also exploring options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes, in efforts to reduce smoking in America; particularly youth smoking. FDA also established mechanisms for the public to report information about possible violations of the law, and has issued Warning Letters to firms who appear to be in violation of the ban. Meanwhile, at a World Trade Organization meeting last week, U.S. members joined Mexico and 5 other countries in the Committee on Technical Barriers to Trade in opposing Canada's ban on flavored tobacco products. These members voiced concerns that the ban was too restrictive, since it bans all tobacco products with even one of the listed additives, and that it would impact various countries' exports. U.S. Senator Jim Benning (R-KY) is using political means to pressure President Obama to fight the Canadian law -- by placing a hold on the nomination of Miriam Shapiro to be deputy trade representative. Market Wire Canada USA Mon, 16 Nov 2009 05:00:00 GMT http://www.marketwire.com/press-release/FdaimportsCom-1077520.html http://tobacco.org/news/292818.html FDAImports.com reports: the U.S. government is a house divided. While some government officials are fighting for greater restrictions on the sale of tobacco products, others are fighting to prevent any more restrictions and balking at the restrictions that other nations have implemented on tobacco sales. Does the right hand know what the left hand is doing? On November 6, FDA posted a special update on its web site, highlighting what its Center for Tobacco Products has done to implement the Family Smoking Prevention and Tobacco Control Act. On the list was the statutory ban on cigarettes containing certain characterizing flavors (other than menthol) that went into effect on September 22, 2009. FDA stated that it is also exploring options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes, in efforts to reduce smoking in America; particularly youth smoking. FDA also established mechanisms for the public to report information about possible violations of the law, and has issued Warning Letters to firms who appear to be in violation of the ban. Meanwhile, at a World Trade Organization meeting last week, U.S. members joined Mexico and 5 other countries in the Committee on Technical Barriers to Trade in opposing Canada's ban on flavored tobacco products. These members voiced concerns that the ban was too restrictive, since it bans all tobacco products with even one of the listed additives, and that it would impact various countries' exports. U.S. Senator Jim Benning (R-KY) is using political means to pressure President Obama to fight the Canadian law -- by placing a hold on the nomination of Miriam Shapiro to be deputy trade representative. Market Wire Canada USA Mon, 16 Nov 2009 05:00:00 GMT http://www.prnewswire.com/news-releases/physicians-urge-fda-to-justify-condemnation-of-e-cigarettes-70265572.html http://tobacco.org/news/292790.html "We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes," says Joel L. Nitzkin, Chair of the American Association of Public Health Physicians Tobacco Control Task Force in a letter to the FDA. The letter specifically targets the new tobacco legislation that passed through Congress this summer which gives the FDA power to regulate tobacco products in the United States and notes that the success rate of current smokers who attempt to quit by using pharmaceutical aids is as low as 5%. Making smokers more aware of less harmful alternatives, snus and e-cigarettes included, could significantly reduce the amount of smokers who die due to tobacco-related illnesses. "Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products," says the letter. The FDA's study in July found miniscule amounts of carcinogens in a few e-cigarette cartridges, but failed to provide any data on the amount of those same carcinogens in pharmaceutical nicotine products. PR Newswire Tue, 17 Nov 2009 05:00:00 GMT http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/default.htm http://tobacco.org/news/292629.html Chapter IX of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires industry submission of certain information. Establishment Registration and Product Listing Under section 905 of the act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling. * Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments * The FDA’s eSubmitter tool is designed to facilitate efficient and secure electronic submission of this information and provides automatic acknowledgement of FDA receipt with attached data from FDA to facilitate future submissions. Instructions and helpdesk assistance (esubmitter@fda.hhs.gov or 1-877-FDA-1CTP (1-877-332-1287)) are available. The instructions also address information regarding obtaining a DUNS number. Food and Drug Administration esubmitter@fda.hhs.go (noon Wednesday November 18, 2009. If there is insufficient) Fri, 13 Nov 2009 05:00:00 GMT http://www.miamiherald.com/news/miami-dade/story/1327160.html http://tobacco.org/news/292440.html The band of clove smokers is small in South Florida. But as their cloves diminished, stick by stick, worries flared about how this new ban would affect the local culture in a place where partyers can still puff at nightclubs, in a state that has chosen not to levy taxes on tobacco. ``What Hollywood is to actors, Miami is to cigars,'' said William Carroll, manager at Vilar Cigar Shop in South Miami. ``We wonder if its cloves first, then what's next?'' Vilar Cigar smells like roasted coffee and boasts more than 200 types of tobacco. Less than 1 percent of buyers wanted cloves, Carroll said, so it made little difference profit-wise. The shop easily gave them up but remains wary about the future. Signed in June, the Family Smoking Prevention and Tobacco Act gave retailers, manufacturers, and distributors three months to get rid of their flavored cigarettes -- or face warning letters, fines or prosecution. Miami Herald rsamuels@MiamiHerald.com (ROBERT SAMUELS) Wed, 11 Nov 2009 05:00:00 GMT http://www.nbcactionnews.com/content/cfa/story/E-Cigarettes-Under-Fire/HdjNw0EFfUibG7ZzLFFx6A.cspx http://tobacco.org/news/292379.html As more cities ban smoking in restaurants and bars, there is a newer product to the United States that makers claim you can still smoke indoors. It's under fire from cities across the country, the Food and Drug Administration and a metro parent. If you've been to the mall lately, you may have seen a kiosk selling electronic cigarettes. We've found the kiosks at Independence Center and Oak Park mall. If you walk past the kiosk at Oak Park, a salesperson will ask if you smoke. At Smoke51 we were shown a product that closely resembled a real cigarette. It comes with a battery and filter and even comes in flavors. "There's a heating element that steams water, nicotine, and flavor so you're going to see me blow out smoke but it's actually steam or water vapor," the salesman said. There are many questions about how this product is marketed. KSHB-TV NBC 41 /mediacenter/local.aspx?videoid=546274@kshb.dayport.com ( Reported by: Jenn Strathman ) Mon, 09 Nov 2009 05:00:00 GMT http://www.courier-journal.com/article/20091109/NEWS01/911090305/Anti-smoking chief maps new territory http://tobacco.org/news/292351.html Today Dr. Lawrence Deyton, who at 57 still goes by his childhood nickname of "Bopper," is the nation's first anti-smoking czar. He directs a new agency in the federal Food and Drug Administration -- the Center for Tobacco Products -- that is writing rules to govern the previously unregulated tobacco industry. In last week's interview, Deyton twice stressed that he is not an anti-tobacco zealot. "I am not an expert in tobacco," he said. "But I am an expert in public health, and I am an expert in government health programs." And what Deyton promises is "methodical, science-based tobacco regulation." But Deyton already has been greeted with worry from growers in tobacco-producing states like Kentucky, and three lawsuits from the industry challenging the agency's authority to restrict advertising and marketing. The center was created under a sweeping anti-smoking law passed by Congress and signed into law by President Barack Obama on June 22. Its three key goals are to reduce youth smoking rates, which in recent years have leveled off at about 20 percent; to reduce the overall toll of tobacco-related disease, which annually kills more than 400,000 Americans; and to provide the public with information about the ingredients of tobacco products and their health effects. Louisville Courier-Journal jcarroll@courier-journal.com (James R. Carroll ) Mon, 09 Nov 2009 05:00:00 GMT http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm http://tobacco.org/news/292275.html The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites. The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. In addition, FDA requested a written response from each of the companies within 15 days outlining the corrective actions taken. Enforcement of the flavored cigarette ban is FDA’s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking. “FDA takes the enforcement of this flavored cigarette ban seriously,” said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.” . . . Report possible violations of the flavored cigarette ban: www.fda.gov/flavoredtobacco Food and Drug Administration kathleen.quinn@fda.hhs.gov Fri, 06 Nov 2009 05:00:00 GMT http://www.google.com/hostednews/ap/article/ALeqM5jKdYE3UEXb9ZfiXoS43vCQyzBUgAD9BQ6BJG1 http://tobacco.org/news/292260.html The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online. The agency sent letters this week to more than a dozen Web-based companies saying they are violating a new ban and asking the companies to describe in writing what action they have taken to comply. The FDA banned candy-, fruit- and clove-flavored cigarettes in September. Federal health authorities and regulators say those products appeal especially to young people and are thought to attract new smokers. "FDA takes the enforcement of this flavored cigarette ban seriously," Dr. Lawrence R. Deyton, director of FDA's Center for Tobacco Products, said in a statement. "These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use." AP Fri, 06 Nov 2009 05:00:00 GMT http://www.aafp.org/online/en/home/publications/news/news-now/health-of-the-public/20091105fda-tobacc-cmnts.html http://tobacco.org/news/292258.html The AAFP has weighed in with numerous suggestions to a July request from the FDA for public input on how the agency should implement its newfound authority to regulate tobacco. The FDA gained the authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health and reduce tobacco use in minors when President Obama signed the Family Smoking Prevention and Tobacco Control Act in June. In its comments, the AAFP lauded the agency's recent ban on cigarettes with fruit, candy or clove flavoring and suggested the agency go a step further by forcing manufacturers to remove menthol as a flavoring agent. The Academy also recommended that the FDA * ban single sales of little cigars to reduce initiation of smoking among adolescents; * broaden restrictions on misleading information on cigarette packaging; American Family Physician ann@aafp.org (News Staff 11/5/2009 ) Thu, 05 Nov 2009 05:00:00 GMT http://www2.journalnow.com/content/2009/nov/06/rjr-try-falls-short/ http://tobacco.org/news/292226.html R.J. Reynolds Tobacco Co.'s bid to carve out a "free speech" marketing niche for innovative products received a setback yesterday. A U.S. District Court judge denied a motion for a preliminary injunction by Reynolds regarding the Family Smoking Prevention and Tobacco Control Act, which became law in June. Judge Joseph McKinley ruled that "the plaintiffs have little likelihood of success" in challenging the modified-risk tobacco-products provision of the law. A lawsuit was filed Aug. 31 in the Western District of Kentucky against the federal government and the Food and Drug Administration by Reynolds; Conwood Co. LLC, a sister company with Reynolds American Inc.; Lorillard Inc.; Commonwealth Brands Inc.; and two other parties. The companies said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products." . . . However, Adam Spielman, an analyst with Citigroup Global Markets Inc., said he believes that regulation will not undercut Reynolds' smokeless innovations. "The rules on new products do not require sign-off from the FDA if the product is substantially equivalent health-wise to existing products," he said. The decision comes at a time when the National Cancer Institute has provided grants for a new series of medical studies on smokeless-tobacco products, some focused on whether the products provide a less harmful alternative to conventional tobacco products. Winston-Salem Journal rcraver@wsjournal.com ( Richard Craver * Journal Reporter) Fri, 06 Nov 2009 05:00:00 GMT http://www.google.com/hostednews/ap/article/ALeqM5hWkf5Lbl2ri_uUA8hqFO13YMI9_gD9BPKVLG2 http://tobacco.org/news/292225.html A federal judge ruled Thursday that tobacco companies hoping to block new restrictions on their marketing have little chance of succeeding. The companies had asked U.S. District Judge Joseph H. McKinley Jr. to issue a preliminary injunction in a lawsuit they filed in August claiming new tobacco regulations violate their right to free speech. The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. The ruling focused on a narrow portion of the legal challenge dealing with modified-risk tobacco products. AP Thu, 05 Nov 2009 05:00:00 GMT http://www.tobaccofreekids.org/pressoffice/Preliminary_Injunction_11052009.pdf http://tobacco.org/news/292223.html The question before the Court is whether Plaintiffs have met their burden of showing the need for the “extraordinary remedy” of a preliminary injunction against enforcement of the MRTP provision. Tennessee Scrap Recyclers Ass’n v. Bredesen, 556 F.3d 442, 447 (6th Cir. 2009). In determining whether to issue a preliminary injunction, courts consider four factors: (a) whether the movant has a strong likelihood of success on the merits; (b) whether the movant would suffer irreparable injury without the injunction; (c) whether issuance of the injunction would cause substantial harm to others; and (d) whether the public interest would be served by the issuance of the injunction. . . . Assuming that the MRTP provision implicates the First Amendment, it seems likely that its restrictions on speech are constitutionally permissible. . . . In sum, the Court concludes that Plaintiffs have little likelihood of success on the merits of their facial First Amendment challenge to the MRTP provision except on the theory that it operates as a prior restraint on speech and lacks a reasonable time limit for FDA review. . . . Having considered each of the required factors, the Court finds that the “extraordinary remedy” of a preliminary injunction is unwarranted. 29 III. CONCLUSION For the foregoing reasons, Plaintiffs’ motion is DENIED. Campaign for Tobacco-Free Kids Thu, 05 Nov 2009 05:00:00 GMT