FDA has posted a draft guidance to help persons submitting applications for new tobacco products understand the premarket tobacco product application process.
The draft guidance addresses questions such as:
• Who may submit a new tobacco product application
• When to submit a new tobacco product application
• What information the FD&C Act requires you to submit in a new tobacco product application
• What information FDA recommends you submit in a new tobacco product application
The public comment period will be open for 90-days from the publication in the Federal Register.
The draft guidance can be found at:
FDA’s Center for Tobacco Products (CTP) will hold a Webinar on Tuesday, Nov. 1 from 2 p.m. to 3 p.m. to discuss this new draft guidance.
For questions regarding the draft guidance, contact the Center for Tobacco Products (CTP) at (877) 287-1373, or by emailing AskCTP@fda.hhs.gov.