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U.S. Department of Health and Human Services

Tobacco Products

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

 

November 2009

 

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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.  


 

 

 

 

 

Contact FDA

1-877-CTP-1373
1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov

Center for Tobacco Products Food and Drug Administration

9200 Corporate Boulevard

Rockville, MD 20850-3229