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.