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F.D.A Takes Steps Toward Ruling on Menthol Cigarettes F.D.A. Closer to Decision About Menthol Cigarettes
(about 4 hours later)
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. WASHINGTON — Moving closer to a decision on whether to ban menthol in cigarettes, the Food and Drug Administration released a scientific review on Tuesday that found the mint flavoring made it easier to start smoking and harder to quit, and solicited public comment on “potential regulation” of menthol flavored 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. These steps pleased smoking opponents who have been calling for F.D.A. action since 2009, when Congress exempted menthol from a ban on flavors in cigarettes, leaving the agency to decide whether its use is 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 black smokers, about four out of five of whom report smoking them, according to federal surveys.
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, 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 F.D.A. to act on menthol in 2011 after a Congressionally mandated committee of outside experts, convened by the agency, found that menthol had a negative effect on public health. The findings by the agency on Tuesday echoed those conclusions, leaving smoking opponents frustrated that it had not clearly signaled an intent to ban menthol.
“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, but he emphasized that they did not foreshadow a ban. The public comment period will be open for 60 days. Mitchell Zeller, the new director of the drug agency’s Center for Tobacco Products, said the steps the agency took Tuesday showed that it was moving forward as fast as it could, 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,” Mr. Zeller said on a conference call with 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.” Lorillard, 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.”
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 nonmenthol cigarettes. The agency did find, however, 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.
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. Mr. Myers said the timing of the announcement was most likely linked to an international trade dispute. The United States has until Wednesday to comply with a World Trade Organization ruling 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.
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. Indonesia, a maker of clove cigarettes, brought the suit. The United States contended that menthol posed a different public health risk, but the trade organization did not accept its argument.
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. Menthol flavoring makes an otherwise harsh cigarette more palatable for young people who are first-time smokers, smoking opponents say. And while smoking rates have been declining across the nation, rates for menthol cigarettes among 18- to 25-year-olds have climbed — to 16 percent in 2010 from 13 percent in 2004, according to a 2011 federal report.
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. Young blacks are particularly vulnerable, smoking opponents say. More than three-quarters of black adolescent and young adult smokers use Newports, a menthol cigarette produced by Lorillard, according to a 2004 study.
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. A 2011 study led by a Stanford University researcher found that stores within walking distance of California high schools attended by large numbers of black students were more likely to advertise for menthol cigarettes. It also found that Newports, the most popular brand of menthol cigarettes, tended to be cheaper.
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. Lorillard disagreed with the conclusion, saying that it marketed its products “uniformly throughout California,” and that retailers themselves set prices.
The issue of race has complicated discussions of menthol, said Valerie Yerger, a researcher at the University of California, San Francisco, who provided testimony to the drug agency and its expert panel in 2010. Several black groups lobbied against a ban on grounds that it would discriminate against blacks, since a larger proportion of them prefer menthol cigarettes.
The racial politics are delicate, experts said, though it is not clear whether they are contributing to the slowness of the regulatory process.
Many smoking opponents seem willing to give Mr. Zeller, a 55-year-old lawyer named in March to lead the F.D.A.’s tobacco unit, the benefit of the doubt. He began his career at the Center for Science in the Public Interest, a consumer health advocacy group, and many smoking opponents see him as a strong public health proponent.
“I’m cautiously optimistic that he’s going to move to meaningful action on menthol,” said Joelle Lester, a Minnesota-based lawyer with the Tobacco Control Legal Consortium, a nonprofit network of legal centers for tobacco control policy.
The F.D.A. also announced that it would conduct a public education campaign focused on young people later this year, and said it was commissioning three new pieces of research related to menthol, including one on genetic differences in taste perceptions that might explain why some racial and ethnic populations are more likely to smoke menthol cigarettes.
“The bottom line is, we need more information,” Mr. Zeller said. “We also need input from the public.”