FDA Releases New Resources for Tobacco Product Applicants

On Sept. 7, the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) launched new resources to help applicants navigate the FDA tobacco product application process. Specifically, the CTP is offering a new webpage with more in-depth information on how to complete the three required premarket tobacco product application (PMTA) forms to submit and amend pending applications.

Over the last few years, the CTP has received more than 26 million PMTAs and made determinations on 99% of those applications. Based on this experience and communications with applicants, the CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future as part of the CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation. These latest resources build on tips the CTP provided earlier this year for applicants preparing amendments to pending PMTAs.