FDA is extending deadline for ENDS Ingredient Listing submissions – PMTA
FDA is extending deadline for ENDS Ingredient Listing submissions – PMTA
FDA is extending the compliance deadline to submit ingredient listings for deemed tobacco products by six months due to technical issues users encountered with eSubmitter. FDA is extending this compliance deadline to provide manufacturers with additional time to submit the ingredient listing information required under Section 905 of the FD&C Act.
FDA does not intend to enforce the submission requirement for deemed tobacco products that were on the market as of Aug. 8, 2016, until May 8, 2018 (or November 8, 2018 for small-scale manufacturers). These extended dates now apply to all manufacturers and importers, including those in an area impacted by recent natural disasters. Deemed tobacco products entering the market after Aug. 8, 2016, must submit the ingredient information at least 90 days before the product is introduced to interstate commerce. FDA encourages manufacturers to start the process as early as possible.
For Guidance to Industry on Ingredient Listing, click here
For more information, please contact the FDA at SmallBiz.Tobacco@fda.hhs.
