FDA Stalls Again On Menthol

WASHINGTON, July 23, 2013 /PRNewswire-USNewswire/ -- Today's announcement by the U.S. Food and Drug Administration (FDA) that it is seeking additional information regarding the potential regulation of menthol in cigarettes is an unnecessary regulatory step, further delaying action that could save American lives.

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"Two years ago, the FDA's own scientific advisory committee found that removing menthol cigarettes from the marketplace would benefit public health in the United States," said David Dobbins, Chief Operating Officer at Legacy. "The FDA does not need more information on this issue.  It needs to remove menthols from the market."

Today, the FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking "to obtain information on the potential regulation of menthol in cigarettes," requesting feedback on a just-completed internal FDA evaluation of the science related to the impact of menthol cigarettes on the public health, and posing a number of questions regarding the details of a potential tobacco product standard.  This follows a thorough review of the scientific evidence by FDA's independent and expert Tobacco Products Scientific Advisory Committee (TPSAC), which in 2011 definitively concluded, based on an exhaustive review of the scientific evidence, that a ban on menthol cigarettes would benefit the public health. Scientific studies conducted in the two years since TPSAC issued its report, and well known to the FDA, serve to further reinforce its conclusion. 

"The FDA already has ample support for a ban on menthol," added Dobbins. "Conducting its own two-year review of the science was duplicative of the TPSAC report. This additional delay will simply prolong the disease and death caused by menthol cigarettes, with particularly adverse consequences for youth and African-Americans who smoke menthol cigarettes at disproportionately higher rates."

Since the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, Legacy has actively advocated for a ban on menthol cigarettes.  As of 2010, there were more than 20 million menthol smokers in the U.S., accounting for over a third of all smokers. The evidence establishes that menthols are a "starter" product for millions of youth, with the newest and youngest smokers most likely to smoke menthols.  In fact, an astonishing 52 percent of middle school smokers, smoke menthol cigarettes.  The evidence also shows that menthol smokers are significantly less likely to quit smoking even though they make more quit attempts. And based on years of targeted marketing, menthols are smoked at highly disproportionate rates by minority communities.  More than 80 percent of African-American smokers smoke menthol cigarettes.  This is of even more concern since African American communities bear a disproportionate burden of tobacco-related death. While other flavored cigarettes were banned by the law, menthol was exempted and menthol cigarettes remain on the market, despite the mounting evidence showing that a ban would benefit public health.

Growing research not only shows the product's harm to our society, but also the benefit of removing it from the marketplace altogether. One study showed that, conservatively, a menthol ban could prevent more than 300,000 smoking-related premature deaths by 2050, a third of those from the African American community. The European Union (EU) recognized this reality and took an important step this month by banning menthol cigarettes. The slow pace of FDA action will result in more Americans – particularly African Americans and young people – suffering the tremendous harms of cigarette use.

The scientific evidence base supporting such a ban is strong and growing. Legacy was the first public health organization to call for a menthol ban in 2009. On April 12, 2013, Legacy joined 20 other leading national public health organizations in petitioning the FDA to exercise its authority to ban menthols as it has already done with all other flavored cigarettes. Just last month, the EU announced its plan to ban menthol and other flavored cigarettes in its 28 member states.

"While we deplore this further unnecessary delay, Legacy will respond to the FDA's requests for information. We will once again strongly urge the FDA to move expeditiously to implement a ban," said Dobbins.  "It is nothing less than a matter of life and death."


Legacy helps people live longer, healthier lives by building a world where young people reject tobacco and anyone can quit. Legacy's proven-effective and nationally recognized public education programs include truth®, the national youth smoking prevention campaign that has been cited as contributing to significant declines in youth smoking; EX®, an innovative public health program designed to speak to smokers in their own language and change the way they approach quitting; and research initiatives exploring the causes, consequences and approaches to reducing tobacco use. Located in Washington, D.C., the foundation was created as a result of the November 1998 Master Settlement Agreement (MSA) reached between attorneys general from 46 states, five U.S. territories and the tobacco industry. To learn more about Legacy's life-saving programs, visit LegacyForHealth.org.

Follow us on Twitter @legacyforhealth and Facebook www.Facebook.com/Legacy.



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