FDA Registration Information for Winery Agents, Wine Vendors, Wine Producers and Vineyards As of December 13th, 2003, the US FDA is requiring Facility Registration for winery agents, wine vendors and vinyeards. FDA is allowing registrants to submit their registrations on paper by mail or FAX or by CD-ROM. FDA will enter these submissions into its registration system as soon as possible, in the order received. Note that it is NOT required NOR necessary to register through a "for profit" registration agency. Many private organization with deceivingly official names are offering to assist with registration although wine producers should and can self-register directly with the FDA. Read the FDA Notice Regarding Firms Offering Registration Services. If you need further assistance with these forms, please feel free to call us at Vins de Vie 1.509.242.2035 or go directly to the online registration. FDA strongly encourages electronic registration via the Internet, which will be quicker and more convenient than registration by paper or CD-ROM for both facilities and FDA. Go to our FDA Registration Information Page or Bookmark The online registration page at: http://www.cfsan.fda.gov/~furls/ovffreg.html Forms can also be downloaded in .pdf format from the Vins de Vie Downloads Page. Registration by Mail or Fax If, for example, you do not have reasonable access to the Internet, you may submit a paper registration by mail or FAX. You must register using Form 3537. Forms are available for download below: Food Facility Registration Form DHHS/FDA Form No. 3537: (available in fill-in PDF for printing or CD-ROM). Forms for Older Versions of Adobe Acrobat Reader (Version 3.0 and Higher) Registration - DHHS/FDA Form No. 3537: (available in PDF for printing). This PDF version of the form must be used for submission. Help for using PDF files and information on downloading free PDF readers is available at http://www.cfsan.fda.gov/~frf/help2.html. For more information and assistance, you can contact the Law Office of J. Pierce. Sec. 305. Registration of Food Facilities Amends the Act by adding new section 415 to require registration for food facilities. Requires the owner, operator, or agent in charge of a domestic or foreign facility to submit a registration to the Secretary. For a foreign facility, the registration must include the name of the U.S. agent for the facility. The registration shall contain information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category as identified under 21 CFR 170.3. Requires the registrant to notify the Secretary in a timely manner of changes to such information. Requires the Secretary to notify the registrant of receipt of the registration and to assign a registration number to each facility. Requires the Secretary to compile and maintain an up-to-date list of registered facilities. Protects the list and any registration documents from disclosure under Section 552 of Title V, U.S. Code. Defines facility as any factory, warehouse, or establishment of an importer that manufactures, processes, packs, or holds food. Specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer; and fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k). [Note: this covers animal feed and dietary supplement manufacturers.] Limits foreign facilities to those that manufacture, process, pack, or hold food only if food from such facility is exported to the U.S. without further processing or packaging outside the U.S. Amends Section 301 making failure to register a prohibited act. Amends Section 801 to require that an article of food offered for import from an unregistered foreign facility be held at the port of entry until the facility is registered. Authorizes the Secretary to provide for and encourage the use of electronic methods of registration; however, paper registration is allowed. Requires the Secretary to promulgate proposed and final regulations within 18 months of enactment. The requirement takes effect upon the expiration of the 18-month period even if the Secretary does not meet the deadline. Mailing Address for Contacting Regulatory Leads: Food and Drug Administration Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 FDA registration is free for agents, producers and others involved with the manufacture and storage of foodstuffs. This includes all wine related facilities. Go to the Food and Drug administration site for free access to the registration forms. Simply set up your new user account and put in the contact information for your facility and domestic agent. L'enregistrement pour le FDA est libre pour des agents, des producteurs et d'autres impliqu?s de la fabrication et du stockage des produits alimentaires. Ceci inclut tous les producteurs et fournisseurs du vin. Vont l'emplacement FDA pour le libre acc?s aux fiches. Installez simplement votre nouveau compte d'utilisateur et mettez dans l'information de votre domicile et agent domestique.
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Last modified: 02-28-08 By: jpierce