New Tobacco Chief Promises U.S. Action as Industry Waits

The new health regulator in charge of tobacco said the U.S. Food and Drug Administration will begin to take action soon on major decisions from the effects of menthol to the marketability of newer products. Mitch Zeller, appointed head of the FDA’s Center for Tobacco Products last month, said his first days on the job have been consumed by reviewing the risks of menthol, sifting through industry requests for new product clearances and weighing whether to expand the agency’s authority over e-cigarettes, cigars and other tobacco products. “I know that all interested parties from industry to public health have been waiting for signs of public action,” Zeller said at a conference in Washington today. “I am keenly aware of the level of public frustration.” While Zeller didn’t give specifics on timing, the industry has expected his appointment would hasten agency decisions. “There is going to be a probably more significant or at least a speeding up of some of the activity at the FDA,” Daniel Delen, chief executive officer of Reynolds American Inc. (RAI), the second-largest U.S. seller of tobacco, told analysts yesterday on a conference call. The FDA was given authority over tobacco products through the 2009 Family Smoking Prevention and Tobacco Control Act. The industry, led by companies such as Richmond, Virginia- based Altria Group Inc. (MO) and Winston-Salem, North Carolina-based Reynolds, are awaiting FDA determinations on almost 3,700 requests that products be considered substantially equivalent to older products so they can continue to be sold, Alfred Kevin Altman, a consultant for the Council of Independent Tobacco Manufacturers of America, said at the meeting sponsored by the Food and Drug Law Institute. Marketing Rules New tobacco products marketed after Feb. 15, 2007, must be cleared for sale by the FDA. A tobacco product marketed before March 22, 2011, can continue to be sold if the FDA issues an order that it is substantially equivalent to an older product or one that has been declared substantially equivalent. Zeller blamed some of the delay on incomplete industry submissions while the tobacco industry said the FDA keeps changing what it wants from them. James Swauger, vice president of regulatory oversight at Reynolds American’s R.J. Reynolds Tobacco Co., said he has reworked substantial equivalency submissions three or four times for the FDA. Menthol Risk The FDA also is weighing whether menthol cigarettes are more dangerous than unflavored versions, a determination that could lead to a ban. A panel of outside advisers to the agency determined in a March 2011 report that removing menthol cigarettes from sale in the U.S. would benefit public health. The panel report on the health impact of menthol cigarettes was required by 2009 legislation that gave the agency authority over the tobacco industry. “I’m encouraged by him saying that things will start moving again,” Murray Kessler, the CEO of Lorillard Inc. (LO), which makes the top-selling menthol cigarette Newport, told analysts today on a conference call. Kessler said he plans to meet with Zeller in the next couple of weeks since officials at the Greensboro, North Carolina-based company haven’t met with FDA officials in the last few months. Altria, the parent company of Philip Morris USA and largest seller of tobacco in the U.S., sells menthol cigarettes under the Marlboro, Virginia Slims and Parliament brands, among others. Reynolds American sells the mint-flavored product under its Camel, Salem and Kool brands. Altria also recently began making Marlboro NXT, a cigarette that allows smokers to switch to menthol flavor by crushing a capsule in the filter. Zeller also said he sees an opportunity to create a “comprehensive nicotine policy” at the agency. “I see this as one of the big issues in public health,” he said. He wouldn’t be more specific. The FDA also regulates nicotine replacement therapies, such as GlaxoSmithKline Plc (GSK)’s Nicorette gum, through its drug center, which weighs the safety and effectiveness of products.

Ukip plans to stop benefit claimants buying tobacco and alcohol

Proposals to be announced at conference also include ban on welfare payments to EU or other foreign citizens living in UK Some long-term benefit claimants would be banned from using their benefit cash to buy cigarettes, alcohol or satellite TV subscriptions under proposals due to be presented at the UK Independence party's spring conference on Saturday. The proposed ban on paying for satellite TV comes only a fortnight after it was disclosed that Rupert Murdoch, the chairman and biggest shareholder of News Corp, had met the Ukip leader, Nigel Farage, for the first time, prompting speculation that the Sun may support the party. Ukip's welfare plans also include proposals to stop paying benefits to EU or other foreign citizens living in the UK. Nick Clegg and David Cameron are delivering speeches on immigration either side of the Ukip conference. Ukip's success in the Eastleigh byelection, when it beat the Tories to take second place, prompted all three main parties to re-examine their immigration policies. In his speech on Friday, Clegg signaled he was abandoning the Liberal Democrat 2010 election promise to offer earned amnesty for illegal immigrants who have been in the UK for at least 10 years. He also proposed higher fines for employers taking on illegal immigrants and suggested a repayable immigrant bond. On Monday Cameron will focus on how to reduce EU citizens' access to key benefits, arguing that the generosity of the benefits acts as a draw for EU citizens. He is unable to impose direct border controls because of EU provisions on free movement of labor. The prime minister wants the UK to be seen as one of the toughest states in Europe for new migrants to get access to benefits as part of a drive to reduce the "pull factors" and reassure the public over fears of a surge when restrictions on Bulgarians and Romanians working in Britain are lifted in December. Ministers have been told that any measures will have to apply to all newly arrived EU migrants and cannot be imposed solely on those coming from Romania and Bulgaria. The European commission has, however, advised that it is possible under the EU's free movement directive to impose quite radical restrictions on access to benefits and services once migrants have been in Britain for three months. "The right to move and reside freely comes with certain conditions attached which are laid down in the EU's free movement directive from 2004. EU citizens have a right to come and stay for up to three months with a valid passport or identity card. To stay for longer, they need to be in employment or have sufficient resources and sickness insurance not to be a burden on public funds," said a commission source. Ministers are understood to be looking at introducing a compulsory registration certificate or "residence permit" for EU citizens living in Britain for more than three months. The permit would give them access to health and education service and provide proof of their immigration status for claims for welfare benefits. The cabinet sub-committee chaired by the immigration minister, Mark Harper, has been looking at European benefit systems. In Spain, access to unemployment and other benefits is severely restricted for citizens from other EU countries. The proposed ban on buying alcohol, nicotine or satellite TV comes in a Ukip policy paper suggesting long-term claimants should be given an electronic spending card that would be unusable for these products. The electronic card would not apply to all claimants, but instead "those who have an addiction and those who choose a lifestyle on benefits". Janice Atkinson, the report's author, said: "No one would be stigmatized through an electronic spending card as it would be like using a credit card at the cash desk. There is enormous public support for a card that mirrors the principles of Beveridge. We have gone too far in this country by funding the feckless lifestyle." In a wide-ranging speech on immigration, Clegg admitted his party election policy of earned citizenship for illegal immigrants who had been in the UK for 10 years "was seen by many as a reward for breaking the law". Clegg said he had asked the former local government minister Andrew Stunell to review Liberal Democrat immigration policy, but argued the earned citizenship policy "risked undermining public confidence in the immigration system". He added that confidence in the system was an essential building block of cohesion and tolerance. Lib Dem polling has shown the so-called amnesty was one of the party's most unpopular policies and was seen as a major drag in attracting center-ground voters. Source: http://www.guardian.co.uk/politics/2013/mar/22/ukip-benefits-claimants-tobacco-alcohol