Tobacco Product Application Resources

CTP Connect

In this issue of CTP Connect, we’re covering several topics about the process for introducing new tobacco products, including new resources to submit PMTA amendments and small business assistance.

Introducing a New Tobacco Product to Market

Before introducing a new tobacco product to the U.S. market, a company must submit a marketing application to the FDA and receive authorization.

These new products and their applications are comprehensively evaluated by FDA scientists, who determine whether or not the application proves the new tobacco product meets the appropriate statutory standards.

There are three pathways to market for new tobacco products:

  • Premarket Tobacco Product Applications (PMTA)
  • Substantial Equivalence (SE)
  • Request Exemption from Demonstrating Substantial Equivalence (EX REQ)

Learn More About the Three Pathways

New Resources to Help Applicants Submit PMTA Amendments

Over the last few years, CTP has received millions of premarket tobacco product applications (PMTAs). As part of the center’s ongoing efforts to assist applicants, and in response to questions we have received, CTP created two new resources to help applicants prepare and submit amendments to their applications:

Read More About PMTAs

Small Business Assistance for Tobacco Product Industry

Do you need help understanding and complying with FDA’s tobacco laws and regulations? Our Office of Small Business Assistance (OSBA) can help.

OSBA welcomes calls and emails from regulated industry, including small tobacco product manufacturers and retailers, as well as from tobacco product consumers and the general public.

Please reach out for technical assistance, help finding the right resources, and the opportunity to communicate your small-business viewpoint to FDA.

Contact the OSBA

In Case You Missed It: Recent CTP News

This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.