September 7, 2013

Stanton A. Glantz, PhD

FDA should reject Big Tobacco's request to extend the public comment period on menthol

I just learned from one of the Attorneys General that three tobacco companies have requested that the FDA extend the public comment period on menthol, currently scheduled to close September 23, for 60 more days on the grounds that they need more time to respond.

This is ridiculous.  The FDA has been dragging its decision on menthol on for years since the TPSAC report was issued in March 2011, giving the tobacco companies have had plenty of time to think about it and muster their arguments.

This is a delaying tactic, pure and simple.

The FDA needs to deny this request and keep the process moving forward, then act on the science and ban menthol and menthol analogs.



On August 23, sixteen major organizations wrote the FDA urging that the tobacco companies' request to extend the public comment period be denied:
African American Tobacco Control Leadership Council
American Academy of Pediatrics
American Cancer Society – Cancer Action Network
American Heart Association
American Legacy Foundation
American Lung Association
American Public Health Association
Americans for Nonsmokers’ Rights
Asian Pacific Partners for Empowerment, Advocacy and Leadership
Association for the Treatment of Tobacco Use and Dependence
Campaign for Tobacco Free Kids
National African American Tobacco Prevention Network
National Latino Alliance for Health Equity
Partnership for Prevention
Society for Research on Nicotine and Tobacco
Tobacco Control Legal Consortium
The main points in the letter are:
<blockquote;Menthol, as has been shown in both the TPSAC review of the science on menthol in tobacco, as well as in FDA’s own review of the science, is a starter product for youth, increases nicotine dependence, and makes it more difficult to quit using tobacco, particularly for African American smokers. Further, menthol is used at higher rates among youth, African American smokers, as well as other minorities and women.&nbsp; Modeling used in the TPSAC review estimated that from 2010-2050, “9 million people will initiate smoking because of the availability of menthol cigarettes.”&nbsp; Another model, using their most conservative scenario, estimated that if a prohibition on menthol had gone into effect in 2011, over 320,000 deaths would be averted by 2050 – almost a third of them among African Americans. This translates to thousands of people living longer, healthier lives. Any further delay in this process costs lives.
This Advanced Notice of Proposed Rulemaking and the release of the FDA report on the science around menthol in cigarettes are already long-overdue. The FDA’s report has been finished for nearly two years and only recently been released. A 60-day comment period is appropriate and sufficient to provide the information requested. The tobacco industry has vast resources at its disposal, and should not have any problem preparing their responses in the current time frame.
Time is of the essence. The public health threat posed by menthol cigarettes calls for swift and bold action by FDA. Allowing an additional extension at this stage is unacceptable. Lives are at stake – removing menthol from the market as quickly as possible will have a positive impact on people’s lives. A further delay cannot be allowed. [citations deleted]</blockquote;
The full letter is /sites/g/files/tkssra4661/f/u9/letter%20to%20FDA%20opposing%20an%20extension%20of%20ANPRM%20comment%20period%20FINAL%5B1%5D.pdf" target="_blank";here.

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