Roundup of Recent Tobacco Product Review Actions
Since the start of the year, FDA has issued a number of actions regarding tobacco product marketing applications submitted through one of the three pathways to market a new tobacco product. These actions include:
- Issuing, for the first time ever, four not substantially equivalent (NSE) orders for marketed products
- 13 Refusal to Accept (RTA) letters for Exemption Requests from Substantial Equivalence
- 43 report withdrawals of substantial equivalence (SE) submissions
- 4 Refuse to File (RTF) submissions for Premarket Tobacco Applications (PMTAs)
More information on these actions, and a summary of all the actions FDA has taken, can be found on our tobacco product marketing orders webpage.