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Jump to full article: Food and Drug Administration (FDA), 2009-11-13
Author: noon Wednesday November 18, 2009. If there is insufficient
Intro: Chapter IX of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires industry submission of certain information.
Establishment Registration and Product Listing Under section 905 of the act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.
* Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
* The FDA’s eSubmitter tool is designed to facilitate efficient and secure electronic submission of this information and provides automatic acknowledgement of FDA receipt with attached data from FDA to facilitate future submissions. Instructions and helpdesk assistance (esubmitter@fda.hhs.gov or 1-877-FDA-1CTP (1-877-332-1287)) are available. The instructions also address information regarding obtaining a DUNS number.
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