Registration And Listing For Owners And Operators Of Domestic Tobacco Product Establishments {FDA 3741}

FDA 3741 - REGISTRATION AND LISTING FOR OWNERS AND OPERATORS OF DOMESTIC TOBACCO PRODUCT ESTABLISHMENTS. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the act) by, among other things, adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Complete this form to register your establishment and submit your product listing to FDA's Center for Tobacco Products. All owners and operators must fulfill the requirements for section 905 of the act. In order to reduce redundant submissions, FDA strongly encourages owners to register and submit product listing information for themselves and on behalf of their operators. Section 905(b) of the act requires that "every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person." Section 905(i)(1) of the act requires that all registrants "shall, at the time of registration . . . file with [FDA] a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution," along with certain accompanying information, such as all labeling. Section 905(i)(3) of the act requires that certain changes in the product list be submitted biannually, once during June and once during December. www.FormsWorkflow.com