http://www.tobacco.org/newsfeed/org/fda.rss Latest top tobacco news headlines en-us http://www.metrowestdailynews.com/news/x1085184701/No-punishment-for-cigarette-violations-in-Ashland http://tobacco.org/news/333510.html Two local gas stations that sold cigarettes to minors last year faced the Board of Health Tuesday night, but left with virtually no punishment for the violations. That is because the Board of Health only two weeks ago found out that the Marathon Mobil on West Union Street and Shell Station on Union Street sold cigarettes to minors in September. "I just wish we had known in September," Board of Health Chairman Leslie Githens said. The board two weeks ago learned the results of a federal Food and Drug Administration sting operation, members said Tuesday night. As a result, officials missed the 10-day window to fine the gas stations. Metro West Daily News mdnletters@cnc.com Wed, 08 Feb 2012 05:00:00 GMT http://www.examiner.com/public-policy-in-cincinnati/cigarette-makers-intend-to-defy-the-government http://tobacco.org/news/333334.html Apparently, Cigarette makers have told U.S. District Judge Richard Leon they can't be forced to spread the government's anti-smoking advocacy with "massive, shocking, gruesome warnings" on products they legally sell. Since there is so much evidence to support how detrimental cigarettes and cigarettes makers are to society; why is there so much resistance to reduce of remove cigarettes from human consumption? Why all the fuss? Just do it. . . . For all practical purposes it seems that the cigarette makers intend to defy the government and take their products to market at any cost if it means robbing you of your health and/or costing your life. Examiner.com Sun, 05 Feb 2012 05:00:00 GMT http://www.lvrj.com/opinion/what-bill-of-rights-138630639.html http://tobacco.org/news/333184.html The Obama administration was back in court Wednesday, trying to convince a judge that tobacco companies should be required to put large, gruesome, graphic photos on cigarette packs to show that the habit kills smokers and their babies. . . . Mr. Obama once taught constitutional law. But apparently the government he leads can't be bothered by the faded words of dead 18th-century males like Benjamin Franklin and Thomas Jefferson, who sought to protect Americans from the incursions of a tyrannical state. Las Vegas Review-Journal webmaster@reviewjournal.com Fri, 03 Feb 2012 05:00:00 GMT http://www.bloomberg.com/news/2012-02-01/tobacco-companies-ask-judge-to-find-graphic-label-rule-unlawful.html http://tobacco.org/news/333126.html Cigarette makers, including R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., urged a federal judge to overturn a U.S. rule mandating graphic health warnings on cigarette packaging. “The purpose of the warnings is not to inform, but to scare consumers into adopting the government’s course of action,” Noel Francisco, a lawyer for R.J. Reynolds, a unit of Reynolds American Inc. (RAI), told U.S. District Judge Richard Leon today in Washington. The government is using “threats and fear” to motivate people to stop using a lawful product, he said. Bloomberg News tschoenberg@bloomberg.net (Tom Schoenberg) Wed, 01 Feb 2012 05:00:00 GMT http://www.tobacco-on-trial.com/2012/02/02/rjr-v-fda-hearing-feb-1-2012-fda-chooses-to-demur/ http://tobacco.org/news/333113.html Throughout the hearing, the big argument was the Constitutional Issue-the 1st Amendment. Famed 1st Amendment legal scholar Floyd Abrams, who had argued the case for Lorillard in Sept., said FDA not only doesn't address it; but simply states there are no 1st Amendment issues. To use a cigarette pack's label to inform is legitimate, he said. To use it to try to directly persuade, to force a business to ADVOCATE against its product is not, according to the plaintiffs and Judge Leon. Yet there's some room for judgement here, and Judge Leon said several times, "I'm trying to see where the line was crossed-into advocacy." Francisco claimed that the 2009 Institute of Medicine report "Ending the Tobacco Problem: A Blueprint for the Nation" formed the "chief evidentiary basis" for the Family Smoking Prevention and Tobacco Control Act. And the IOM report "says right out: 'The primary object is to discourage' smoking." Francisco said the warning labels are basically anti-tobacco advertising, and their purpose is not to inform, but to scare. Francisco questioned if there were not less restrictive means to achieve the Government's goal, means that were obvious and obtainable. Why, the FDA could use its own new $600 million campaign. "Do they have to use OUR voice?" he asked. He critiqued the warning label requirements for not being "narrowly tailored" Tobacco On Trial Thu, 02 Feb 2012 05:00:00 GMT http://www.mondaq.com/404.asp?404;http://www.mondaq.com:80/unitedstates/x/163290/Healthcare Food Drugs Law/Update on Tobacco Warning Letters&login=true http://tobacco.org/news/333098.html Welcome to the first monthly update on FDA's enforcement over regulated tobacco products. This update will examine trends in Warning Letters, and cover some unique Warning Letters and enforcement actions that have occurred in the previous month. As the first post regarding tobacco products, we begin with an alert regarding FDA's issuance of civil money penalty complaints. The update also provides a summary of tobacco related Warning Letters issued by the FDA to date.1 The most significant enforcement event over the last month is the issuance of twenty (20) civil money penalty complaints to retailers by the FDA. . . . Overall, there have been 1,370 Warning Letters issued by the Center for Tobacco Products since the Family Smoking Prevention and Tobacco Control Act was passed in 2009. The majority of Warning Letters were issued as the result of state contract inspections of retailers. The remaining 45 Warning Letters were issued directly by the Center for Tobacco Products to Internet retailers and manufacturers. The most common violation among brick-and-mortar retailers is the sale of a tobacco product to a minor Mondaq unsubscribe@mondaq.com ( Article by Sheppard Mullin Richter & Hampton LLP) Thu, 02 Feb 2012 05:00:00 GMT http://www.tobacco-on-trial.com/2012/01/27/rjr-v-fda-judge-leons-memorandum-opinion-nov-7-2011/ http://tobacco.org/news/333070.html CONCLUSION This case poses a constitutional challenge to a bold new tact by the Congress, and the FDA, in their obvious and continuing efforts to minimize, if not eradicate, tobacco use in the United States. Notwithstanding the potential legal and financial ramifications of this challenge, the Government, for reasons known only to itself, is unwilling to voluntarily stay the effective date of this Rule until the Judicial Branch can appropriately review the constitutionality of the Government's novel -- and costly -- approach to regulating tobacco packaging and advertising. Thus, this Court must -- and will -- act to preserve the status quo until it can evaluate, on the merits (and without incurring irreparable harm to those companies genuinely affected), the constitutionality of the commercial speech that these graphic images compel. Therefore, for all the foregoing reasons, this Court concludes that the plaintiffs have demonstrated: (1) a substantial likelihood of success on the merits; (2) that they will suffer irreparable harm absent injunctive relief; (3) that neither the Government, nor the public, will suffer any comparable injury as a result of the relief sought; and (4) that the public's interest in the protection of its First Amendment rights against unconstitutionally compelled speech will be, in fact, furthered. Accordingly, the plaintiffs' Motion for Preliminary Injunction [Dkt. #11] is GRANTED. An order consistent with this decision is attached herewith. Tobacco On Trial Mon, 07 Nov 2011 05:00:00 GMT http://www.wlf.org/upload/legalstudies/workingpaper/BashamLuikFinalWeb.pdf http://tobacco.org/news/333055.html Key Points in this WORKING PAPER: • Public health officials and activists argue that warnings with alarming language and graphic images are required to effectively “guide” the public toward better consumption decisions. • Graphic health warnings are not grounded in social psychological principles and are not supported by scientific evidence. Properly conducted studies show that such warnings not only are ineffective, but can be counterproductive. • Graphic health warnings are fundamentally at odds with three core democratic values: autonomy, respect, and freedom of expression. Washington Legal Foundation Sun, 01 Jan 2012 05:00:00 GMT http://www.wlf.org/Publishing/publication_detail.asp?id=2289 http://tobacco.org/news/333054.html This LEGAL BACKGROUNDER explores how the present Supreme Court's textual reading of the First Amendment affects pending governmental efforts to compel private party speech with respect to tobacco (Food and Drug Administration regulations requiring new warning labels including specific government-prescribed graphic images) and cell phones . . . the federal government has for decades required Surgeon General warning on cigarettes, drug side-effects warnings in pharmaceutical advertising, and mandated food labeling, including compliance with government-established food standards of identity. The government's justification for these examples of compelled speech is that they convey truthful information in an unbiased format. However, even under Central Hudson, some forms of government-compelled speech cannot survive when they run counter to scientific fact or impose undue, unjustified burdens on speech. . . . The First Amendment's protection of speech appears to be clear, uncontroversial, and absolute: Congress "shall make no law . . . abridging the freedom of speech. . ." The framers of the Constitution provided no modifiers limiting freedom of speech and the word "abridging" means as to rights "to lessen or curtail." . . . Judge Leon had no difficulty concluding that strict scrutiny should apply because the graphic images were better described as "digitally enhanced or manipulated" or "cartoons." He also concluded that the amount of space demanded by FDA was "confiscatory." Judge Leon also rejected as confusing and contradictory FDA's so-called compelling interest. Having concluded that strict scrutiny applied, there is no surprise that Judge Leon then concluded that the Final Rule could not stand. FDA's appeal thus will no doubt primarily challenge the application of strict scrutiny. . . . It is difficult, if not impossible, to reconcile the cigarette and cell phone District Court decisions. However, it appears that when the government goes beyond compelled text to compelled graphics, it has crossed an impermissible line. With expedited appeals now pending in both the D.C. and Ninth Circuits, we will likely see important decisions in 2012. Indeed these may well be the most important commercial free speech cases to watch in the near term. Washington Legal Foundation info@wlf.org (Charles M. English) Fri, 13 Jan 2012 05:00:00 GMT http://www.cspnet.com/news/tobacco/articles/rj-reynolds-lawyer-takes-graphic-label-mandate http://tobacco.org/news/333047.html Cigarette makers, including R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., urged a federal judge to overturn a rule mandating graphic health warnings on cigarette packaging, said a Bloomberg report. "The purpose of the warnings is not to inform, but to scare consumers into adopting the government's course of action," Noel Francisco, a lawyer for R.J. Reynolds, a unit of Winston-Salem, N.C.-based Reynolds American Inc., told U.S. District Judge Richard Leon in Washington. The government is using "threats and fear" to motivate people to stop using a lawful product, he said. Leon in November canceled a September 22 deadline for tobacco companies to begin displaying images such as diseased lungs and a cadaver with chest staples on an autopsy table on the top half of the front and back of all cigarette packages. The U.S. Food & Drug Administration (FDA) rule may "unconstitutionally compel speech," the judge said. The government appealed. Leon said yesterday that he will issue a ruling before the U.S. Court of Appeals in Washington hears arguments scheduled for April 10 on his earlier decision. . . . "It's very unusual to sell a product that when used as intended will kill you," Stern said. Francisco countered that under the government's rationale, it would be "factual and uncontroversial" to show a picture of an elderly woman smoking a cigarette with text claiming "115 years old and still smoking." Leon said there's nothing in the record to show that Congress gave "clear, thoughtful analysis" to the First Amendment applications of the law. "Congress did what it did out of some innate sense of 'we can do this'," he said. Convenience Store/Petroleum cspinquire@cspnet.com Wed, 01 Feb 2012 05:00:00 GMT http://www.law360.com/articles/305597/big-tobacco-wants-permanent-ban-on-graphic-fda-labels http://tobacco.org/news/333045.html R.J. Reynolds Tobacco Co. and other tobacco companies asked a Washington federal court Wednesday to make permanent an injunction it granted halting the rollout of graphic warning labels on cigarette packages, with an impending appeal to the D.C. Circuit in mind. U.S. District Judge Richard Leon granted the tobacco makers a temporary victory Nov. 7, issuing a preliminary injunction that blocked the the federal government from rolling out new, graphic cigarette warning labels that include images of a cadaver, a woman weeping and the phrase “Smoking can kill you.” The U.S. Food and Drug Administration appealed that ruling to the D.C. Circuit on Nov. 29. “The court is painfully aware that this is not the last stop on the railroad,” Judge Leon said at the outset of Wednesday's hearing on the parties' cross-motions for summary judgment and the tobacco companies' request for a permanent injunction. R.J. Reynolds attorney Noel Francisco told the court that the U.S. is free to tell its citizens how to live, but cannot force manufacturers of a lawful product to serve as the government's unwilling spokesman in its “paternalistic” mission to prevent consumers from buying that product. “A state's failure to persuade does not allow it to hamstring the opposition,” he said. . . . Judge Leon noted, in response to Francisco's arguments, that the government is not even trying to argue the constitutional standard at issue. “They just act as if it's a fait accompli” that the standard they are advocating is the law, Judge Leon said of the government. . . . DOJ attorney Mark B. Stern, in turn, even questioned whether there was any way at all the government could change Judge Leon's mind about the labels in the wake of his preliminary injunction ruling. “It's no secret that the government wants people to stop smoking,” he said, calling smoking the single greatest health epidemic in the nation. The problem is that there is no way to use cigarettes in a safe, nondeadly way, according to Stern. The government's interest in making consumers aware of that fact “is about as compelling as it gets,” he said. “The point of it is to go, 'This could be you,'” Stern said. Judge Leon expressed little sympathy for the government's position. Law360 Wed, 01 Feb 2012 05:00:00 GMT http://www.cspnet.com/news/tobacco/articles/fifth-series-update-possible-fda-regulation-cigars-and-pipe-tobacco http://tobacco.org/news/333042.html On April 25, 2011, the FDA issued a letter stating its intent to propose regulations on other tobacco products, such as cigars and pipe tobacco. The letter went on to state that these regulations may include company registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products and premarket review requirements for new tobacco products and modified risk tobacco products. Subsequent to the April 2011 announcement by the FDA, industry trade groups representing cigar and pipe tobacco manufacturers have made presentations to FDA staff on the uniqueness of these tobacco products and the agency has not yet issued any proposed regulations for these products. In particular, NATO provided the FDA with recent national survey data, which shows that from 2009 to 2010, pipe tobacco use among youth under the age of 18 declined 30% from .9% of minors to just .6% of minors. This further reduction in pipe tobacco usage demonstrates that the issue of minors using pipe tobacco is almost non-existent. Convenience Store/Petroleum info@natocentral.com ( Thomas A. Briant Executive Director National Association of Tobacco Outlets (NATO)) Tue, 31 Jan 2012 05:00:00 GMT http://www.reuters.com/article/2012/02/02/us-usa-tobacco-labels-idUSTRE81100320120202 http://tobacco.org/news/333031.html Reynolds American Inc's R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC, Commonwealth Brands Inc, which is owned by Britain's Imperial Tobacco Group Plc, and Santa Fe Natural Tobacco Co Inc contend that the FDA rule would force them to engage in anti-smoking advocacy against their own legal products. U.S. District Judge Richard Leon, who last November issued a temporary injunction blocking the rule, said he would issue his final ruling in the case well before April 10. That is the date when the U.S. Appeals Court for the District of Columbia Circuit is scheduled to hear the government's appeal of Leon's injunction. The FDA rule was due to take effect this September. Lawyers said a ruling before April 10 would give appellate judges leeway to rule on the case and the injunction at the same time. In his injunction order, Leon agreed with cigarette makers that the government had failed to show how the graphic images met legal precedents requiring government-imposed labeling to be factual and uncontroversial. Leon cast additional doubt on the legality of the rule on Wednesday by suggesting that Congress had ignored legal precedents protecting commercial speech from government control. "There's nothing on the record to suggest that Congress gave any clear and thoughtful analysis on the First Amendment implications of this," the judge said. Reuters Wed, 01 Feb 2012 05:00:00 GMT http://www.businessweek.com/news/2012-02-01/reynolds-assails-mandate-for-graphic-cigarette-pack-images.html http://tobacco.org/news/333016.html Cigarette makers, including R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co. urged a federal judge to overturn a rule mandating graphic health warnings on cigarette packaging. "The purpose of the warnings is not to inform, but to scare consumers into adopting the government's course of action," Noel Francisco, a lawyer for R.J. Reynolds, a unit of Altria Group Inc., told U.S. District Judge Richard Leon today in Washington. The government is using "threats and fear" to motivate people to stop using a lawful product, he said. Business Week/Bloomberg tschoenberg@bloomberg.net (Tom Schoenberg) Wed, 01 Feb 2012 05:00:00 GMT http://www.google.com/hostednews/ap/article/ALeqM5giYRP95haPMHC8Hhnvz9Py1n3Lfg?docId=a2c311eec5014becb241c45dcba926c2 http://tobacco.org/news/333015.html The U.S. government fought an uphill battle Wednesday to convince a skeptical judge that tobacco companies should be required to put large graphic photos on cigarette packs to show that the habit kills smokers and their babies. Cigarette makers told U.S. District Judge Richard Leon at a hearing that they can't be forced to spread the government's anti-smoking advocacy with "massive, shocking, gruesome warnings" on products they legally sell. Attorneys for the Obama administration countered that the photos of dead and diseased smokers it wants on all cigarette packs are "factually uncontroverted." Leon has already ruled that the cigarette makers are likely to succeed in their lawsuit to stop the requirement, which was supposed to go into effect next year. Leon blocked the rule from taking effect until after the lawsuit is resolved. Leon found in his earlier ruling that the nine graphic images approved by the Food and Drug Administration in June go beyond conveying the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. Leon also ruled the size of the labels suggests they are unconstitutional . . . The judge showed no sign that he was changing his position in favor of the government after the hour-long hearing Wednesday. "It sounds like they are headed to a place where you have to watch a 10-minute video before you can even buy a pack of cigarettes," he said. . . . The Obama administration has appealed Leon's preliminary injunction stopping the rule from taking effect. The U.S. Court of Appeals is scheduled to hear the case April 10. Associated Press Wed, 01 Feb 2012 05:00:00 GMT