FDA Announcements

FDA releases report from independent evaluation of menthol as a cigarette flavor, invites public comments
The U.S. Food and Drug Administration has released a much-anticipated independent report that summarizes the research on the public health effects of menthol being used as a characterizing flavor in cigarettes. The agency also issued an Advance Notice of Proposed Rulemaking (ANPRM) to collect information from the public to help the agency make informed decisions about menthol in cigarettes. Click here to read FDA's press release, or click here for the report, "Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes." Comments may be submitted online or in writing in response to the ANPRM under Docket #FDA-2013-N-0521 until September 23, 2013; click here to view the ANPRM and submit a comment. Public health groups responded to the release of the report by calling on the agency to take swift action to remove menthol products from the market based on the conclusions in the report that menthol flavoring is associated with increased smoking initiation, greater progression toward addiction, and decreased success in quitting smoking. Click here for a joint statement from the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids.

Opportunity for public comments: Prohibit menthol as a characterizing flavoring of cigarettes and cigarette smoke
Earlier this year, the Tobacco Control Legal Consortium and eighteen other leading public health groups filed a formal Citizen Petition urging the Food and Drug Administration (FDA) to prohibit menthol as a flavor in cigarettes, and in response, the FDA opened a docket to collect comments from the public on this topic. Click here to visit the Legal Consortium’s FDA Action Center to learn more about this issue and other opportunities to guide FDA’s regulation of tobacco. Click here to read highlights from the Citizen Petition. Click here to submit a comment in response to Docket FDA-2013-P-0435. At this time, there is no deadline for submitting comments. FDA will issue further guidance on whether comments on this docket will be included as part of the official record on menthol under the new Advance Notice of Proposed Rulemaking.

Scientific workshop and request for comments: Tobacco product analysis
The Food and Drug Administration, Center for Tobacco Products (CTP) is hosting a scientific workshop to obtain input on the chemical analysis of tobacco products on July 30-31, 2013, and the agency has also opened a docket to collect written comments on the topics to be addressed at the meeting. The workshop and docket have been set up to collect information to guide rules about the chemical testing of tobacco filler and smoke from cigarettes, roll-your-own tobacco, and smokeless tobacco products. To learn more about the workshop, click here. Click here to submit a comment to Docket FDA-2012-N-0212-0009 by September 30, 2013.

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