Modified Risk Tobacco Product Applications Draft Guidance for Industry April 2012
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Tobacco Products
The draft guidance provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through postmarket surveillance and studies.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0071.