Under the Food Safety Modernization Act (“FSMA”), which was passed into law in 2011, all food facilities, including those where alcoholic beverages are produced or stored, are required to renew their FDA registrations by December 31, 2014. As we’ve previously blogged about here and here, the FSMA and related FDA laws include alcohol in the definition of “food,” and a “Food Facility” includes any “factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food,” not including restaurants and other retail food establishments. Accordingly, many in the alcohol industry must register with the FDA, including wineries, breweries, distilled spirits plants, alcohol beverage distributors, importers, warehouses, and wholesalers. Note that foreign facilities that produce food or alcoholic beverages sent to the U.S. are among those required to register.
The FSMA requires that all registered food facilities renew their registrations every two years between October 1 and December 31 of every even-numbered year. That means that even if your facility was first registered with the FDA in 2013, or even in early 2014, renewal is required before December 31, 2014. Renewal won’t be required again until October 1 through December 31, 2016.
FDA registration and renewal is a simple process that can be completed online and there is no fee for either the initial registration process or renewal. The FDA does not issue a formal certificate once the process is completed, and instead simply issues a registration number to registered facilities, along with a PIN that all registrants should keep available for the renewal process. Many registrants may have received emails or other correspondence from third parties that may claim to be affiliated with the FDA and that attempt to collect fees for FDA registrations. The FDA has recently warned registrants that it is not affiliated with any third parties, and that registration is always free, so be on the lookout for emails requesting a fee or other information related to FDA registration. More information on FDA registration and renewal can be found here.
Contact one of the attorneys at Strike & Techel if you have any questions about FDA registration or related issues.
Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2014 · All Rights Reserved ·