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Tobacco Products

Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act

November 2009

This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA’s current thinking regarding the appropriate preliminary timetable for its review of applications for Modified Risk Tobacco Products (MRTP) under section 911 of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). For the reasons discussed below, pending further guidance or rulemaking, FDA intends to issue a decision on an MRTP application within 360 days of its receipt by FDA.

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For General Inquiries:

Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002

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