The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1] On April
eSubmitter
FDA’s May 8, 2018 Ingredient Listing Deadline Approaching for Large Manufacturers of Deemed Tobacco Products; New FDA eSubmitter Instructions and Ingredient Spreadsheets Now Available
Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the…
FDA’s Ingredient Listing Deadline Rapidly Approaching for Manufacturers of E-Vapor, E-Liquid and Other Deemed Tobacco Products
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
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…