Just five days before the September 30, 2017 registration deadline for U.S. manufacturing establishments, on Tuesday, September 26, 2017, the Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, tweeted that due to “website connectivity problems” with the FDA Unified Registration and Listing System (FURLS), FDA would be “implementing a short term extension
Just two weeks before the September 30, 2017 registration deadline for U.S. tobacco product manufacturing establishments, on Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments .See our original Client Alert summarizing the
On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced its new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” that refocuses the Agency’s implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA’s new strategy appears to be moving away from its “one-size-fits-all”
UPDATE – FDA’s Ingredient Listing Deadline For Deemed Products Extended by Six Months
On December 28, 2016, FDA finalized its Guidance for Industry, “Listing of Ingredients in Tobacco Products” which is available here. In the new guidance FDA states that, “considering that some manufacturers of newly deemed products are not familiar with the forms
UPDATE: On December 5, 2016, FDA finalized its Guidance for Industry, “Health Document Submission Requirements for Tobacco Products” which is available here. As noted above, manufacturers and importers of newly deemed tobacco products (such as e-vapor products) that were on the market on the August 8, 2016 effective date of the Deeming Regulation
