FDA announces first decisions on new tobacco products through the substantial equivalence pathway
The U.S. Food and Drug Administration (FDA) has authorized the marketing of two new tobacco products from Lorillard, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, as “substantially equivalent” to other products already on the market. The FDA simultaneously denied the marketing of four other products through the substantial equivalence (SE) pathway. FDA also withdrew 136 SE reports at the request of the tobacco manufacturers that submitted them. These decisions are the first of their kind since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products. In a statement, FDA commissioner Margaret A. Hamburg, M.D. said, “Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco.” To read more about the decisions, click here, or click here for a press release from FDA.

Public workshop and request for comments: Electronic submission of tobacco product applications and other information
The Food and Drug Administration, Center for Tobacco Products (CTP) announced a workshop to obtain public input on topics related to the potential electronic submission of tobacco product applications and other information. Information obtained during the workshop may be used to inform the FDA in the development and implementation of standards for an electronic submission to CTP. The workshop will be held July 18, 2013. Submit either electronic or written comments to Docket FDA-2013-N-0602-0001 by August 19, 2013. Click here to learn more about the workshop.

Scientific workshop and request for comments: Tobacco product analysis
The Food and Drug Administration, Center for Tobacco Products (CTP) announced a scientific workshop to obtain input on the chemical analysis of tobacco products. The workshop will examine the chemical testing of tobacco filler and smoke from cigarettes, roll-your-own tobacco, and smokeless tobacco products. The workshop will be held July 30-31, 2013. The registration and oral presentation deadline is July 1, 2013. Requests can be sent here. To learn more about the workshop, click here. FDA has also opened a docket to collect written comments on the topics to be addressed at the meeting. Click here to submit a comment to Docket FDA-2012-N-0212-0009 by September 30, 2013.

Proposed rule and comment opportunity: Requirements for the submission of data needed to calculate user fees for manufacturers and importers of tobacco products
The Food and Drug Administration is collecting electronic or written comments on a proposed rule that will require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Comments on the proposed rule are due August 15, 2013. Electronic comments can be submitted on regulations.gov by searching for Docket ID FDA-2012-N-0920-0001. To read more about the proposed rule, click here.

Opportunity for public comments: Prohibit menthol as a characterizing flavoring of cigarettes and cigarette smoke
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.

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