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 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.
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, 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.
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.
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.
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.
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.
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.
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.
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 menthol cigarettes. It also found that Newports, the most popular brand of menthol cigarettes, tended to be cheaper.
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 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.
Aided by army of ‘vapers,’ e-cigarette industry woos and wins europe – nytimes.com
^mov.sq stream coffee and cigarettes (2003) fre…
The signatures had been collected via a website, , which proclaimed itself the voice of the forgotten millions in this debate people who had taken up e cigarettes to stop smoking, and their grateful families.
The website, however, was not quite the grass roots effort it claimed to be. The text of the letter it asked people to sign was drafted by a London lobbyist hired by Totally Wicked, an e cigarette company. The website had been set up by a British woman living in Iceland who had previously worked for the owners of Totally Wicked.
As the headquarters of the European Union, Brussels sets regulatory standards that resonate around the world. It rivals Washington as a focus for corporate lobbying, with an estimated 30,000 professional lobbyists with registered lobbying firms and thousands more who operate beneath the radar.
In this case, a determined lobbying campaign, marrying corporate interests in a fledgling but fast growing industry with voices elicited from the general public, was aimed at a compelling public health issue whether e cigarettes, which deliver nicotine without burning tobacco, should be regulated as medicinal products, just as nicotine patches are.
The stakes were substantial. Although e cigarettes have not been linked to any serious health issues, they have been in widespread use for such a short time that researchers have no basis yet for determining if there are long term risks. The decision by the European Union would set the stage for a debate over the extent of regulation in the United States, where the Food and Drug Administration is soon expected to issue its own rules on nicotine delivery devices. The outcome of the battle in Brussels could go a long way in shaping the competitive landscape of the business in Europe and beyond.
The odds seemed very much against the e cigarette industry. Hostility toward corporate lobbying runs deep in the European Union bureaucracy and legislature. And lawmakers were seemingly on track to categorize e cigarettes as medicinal.
Yet the outcome, driven in large part by the industry s success in mobilizing a wave of support from consumers and using it to apply political pressure to lawmakers, amounted to a big victory for e cigarette sellers, one in which they outgunned not just the tobacco companies but also pharmaceutical companies that make competing products for people trying to stop smoking.
To the delight of companies like Totally Wicked, the European Parliament voted Oct. 8 to scrap proposals by health officials to regulate e cigarettes as a medicinal product, which would have restricted their sale to pharmacies in many countries of the 28 nation bloc and imposed costly certification procedures on producers. The Parliament s decision did not end the argument, but it lifted a big, immediate cloud threatening a business that some Wall Street analysts predict could be bigger than tobacco within a decade.
When the European Commission initially proposed last December that e cigarettes be treated like medicines, the industry immediately realized that we had a very big problem and a big fight ahead, recalled Ray Story, the American president of United Tobacco Vapor Group, an e cigarette company with offices in Atlanta and Amsterdam.
Determined to avoid a precedent that would most likely harden the regulation of e cigarettes far beyond Europe, Mr. Story hired EPPA, an established Brussels lobbying company, and a prominent Belgian law firm, Van Bael & Bellis. They pressed the argument that e cigarettes are not a drug and that any decision to classify them as such would be vigorously challenged in court.