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F.D.A. Takes Steps Toward Ruling on Menthol Cigarettes F.D.A Takes Steps Toward Ruling on Menthol Cigarettes
(35 minutes later)
WASHINGTON — The Food and Drug Administration inched closer on Tuesday to a decision on whether to ban menthol in cigarettes, releasing its own scientific review that found the mint flavoring made it easier to start smoking and harder to quit. WASHINGTON — Moving closer to a decision on whether to ban menthol in cigarettes, the Food and Drug Administration on Tuesday released a scientific review that found the mint flavoring made it easier to start smoking and harder to quit, and solicited public comment on "potential regulation” of those products.
The agency also published a notice in the federal register calling for input from the public on the “potential regulation on menthol in cigarettes,” another step in the rulemaking progress that began in 2009 when Congress exempted menthol from a ban on flavors in cigarettes. These steps pleased smoking opponents who have been calling for F.D.A. action ever since 2009 when Congress exempted menthol from a ban on flavors in cigarettes unless the agency decided its use was a danger to public health. Menthol cigarettes account for about a third of all cigarettes sold in the United States and are particularly popular among African-American smokers, about four out of five of whom report smoking them, according to federal surveys.
The move is likely to please smoking opponents, who have been calling for F.D.A. action on menthol cigarettes. They account for about a quarter of all cigarettes smoked in the United States and are particularly popular among African-Americans. Still, the action was only an intermediate step in what advocates say has been a prolonged regulatory process and comes at a time when menthol smoking rates for young adults have been increasing. Many had expected the agency to act on menthol in 2011 after a Congressionally mandated committee of outside experts, convened by the F.D.A., found that menthol had a negative effect on public health. The F.D.A.'s findings on Tuesday echoed those conclusions, leaving smoking opponents frustrated that the agency had not clearly signaled an intent to ban menthol.
Still, it was only an intermediate step in what advocates say has been a prolonged process. Many expected the agency to act on menthol in 2011 after a Congressionally mandated committee of outside experts, convened by the F.D.A., found that menthol had a negative effect on public health.
“This is either a way to take the heat off, or the beginning of a meaningful process,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group. “That’s the book the jury is still out on.”“This is either a way to take the heat off, or the beginning of a meaningful process,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group. “That’s the book the jury is still out on.”
Mitchell Zeller, the new head of the F.D.A.'s Center for Tobacco Products, said the steps the agency took on Tuesday showed it is moving forward as fast as it can. The public comment period will be open for 60 days. Mitchell Zeller, the new head of the F.D.A.'s Center for Tobacco Products, said the steps the agency took on Tuesday showed it is moving forward as fast as it can, but he emphasized that they did not foreshadow a ban. The public comment period will be open for 60 days.
“The F.D.A. is a regulatory agency,” he said on a conference call for journalists. “As a regulatory agency we can only go as far as the regulatory science will take us.”“The F.D.A. is a regulatory agency,” he said on a conference call for journalists. “As a regulatory agency we can only go as far as the regulatory science will take us.”
He added: “The bottom line is, we need more information. We also need input from the public.”He added: “The bottom line is, we need more information. We also need input from the public.”
Mr. Myers said the timing of the announcement was likely linked to an international trade dispute. The United States has until Wednesday to comply with a World Trade Organization ruling. It held that the United States ban on clove cigarettes under the 2009 law violated Indonesia’s trade rights if the United States was not also banning menthol. Indonesia, a maker of clove cigarettes, brought the suit. The United States contended that menthol posed a different public health risk than other flavors, but the W.T.O. did not accept the argument. Lorillard Inc., the biggest manufacturer of menthol cigarettes in the United States, said in a statement that “the best available science demonstrates that menthol cigarettes have the same health effects as nonmenthol cigarettes and should be treated no differently.”
Indeed, the F.D.A.'s review found that menthol cigarettes did not increase the risk of disease compared with smoking cigarettes not flavored with menthol. However, the agency did find that the mint flavoring made people more likely to start smoking, and led to greater dependence on nicotine and decreased rates of quitting, conclusions that opponents of smoking say should spur the agency to action.
Menthol flavoring makes an otherwise harsh cigarette more palatable for young people who are first-time smokers, and so hooks more of them, antismoking advocates say. They say young blacks are particularly vulnerable. More than three quarters of black adolescent and young adult smokers use Newports, a menthol cigarette produced by Lorillard, according to a 2004 study on menthol.
And while smoking rates have been declining across the nation, rates for menthol cigarettes have climbed to 16 percent in 2010 from 13 percent in 2004 among 18 to 25 year olds, according to a 2011 federal report. The report also found that from 2007 to 2010, 52 percent of new smokers (those who smoked their first cigarette in the year before the survey) smoked menthol cigarettes, compared with 42 percent in the period from 2004 to 2006.
Among smokers ages 12 and over, 31 percent who had smoked in the past month reported smoking menthol cigarettes in 2004, 34 percent in 2008 and 38 percent in 2010, according to the Campaign for Tobacco-Free Kids, citing federal data.
Mr. Myers said the timing of the announcement was likely linked to an international trade dispute. The United States has until Wednesday to comply with a World Trade Organization ruling. It held that the American ban on clove cigarettes under the 2009 law violated Indonesia’s trade rights if the United States itself continued to allow the sale of menthol-flavored cigarettes. Indonesia, a maker of clove cigarettes, brought the suit. The United States contended that menthol posed a different public health risk than other flavors, but the W.T.O. did not accept its argument.
The debate over menthol mirrors one in Europe. European Union ministers struck a deal last month that could eventually ban menthol, but the ban would have to first be approved by the European Parliament and national governments would have up to three years to carry it out.