Since the start of 2014, the FDA Center for Tobacco Products (CTP) has issued four Not Substantially Equivalent (NSE) Orders, 13 Refusals to Accept Exemptions from Substantial Equivalence (SE), four Refusals to File (RTF) submissions for Premarket Tobacco Applications (PMTAs), and 43 Withdrawals of SE Reports.
The four NSE Orders were issued due to lack of full identification and characteristics of new and predicate products, lack of scientific evidence and rationale for why differences between the new and predicate products do not cause different issues of public health, lack of an adequate summary of health information, lack of statement regarding compliance with section 907 of the FD&C Act, and lack of evidence to establish grandfathered status of the predicate product(s).
The reasons for the RTFs include missing information such as reports of investigations regarding health risks; full statement of components, ingredients, additives and properties of the tobacco products; full description of methods used in manufacturing, processing and packing the tobacco products; and specimens of proposed labeling. Additional information can be found on the FDA’s tobacco product marketing orders webpage.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders practice partner, at 804.697.1420 or by email.