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”
FDA’s Ingredient Listing Deadline Rapidly Approaching for Manufacturers of E-Vapor, E-Liquid and Other Deemed Tobacco Products
By Azim Chowdhury on
Posted in Deeming Rule, FDA
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…
Revisions to Industry Guidance Regarding FDA Health Document Submission Requirements for Tobacco Products
By Azim Chowdhury on
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…