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U.S. Department of Health and Human Services

Tobacco Products

This Week in CTP – March 18, 2014


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.