New Biennial Registration Requirement with the Food & Drug Administration

By Cary Greene
A member winery recently asked about changes in Food & Drug Administration (“FDA”) registration requirements. It’s an important question, and it seemed like a good opportunity to remind all wineries about the new requirements.
Since the Bioterrorism Act of 2002 was passed, the FDA has required wineries to complete a one-time registration as a “food facility.” To FDA’s credit, the guidance for registration is fairly user-friendly, though it inevitably presents its challenges,
With the official passage of the Food Safety Modernization Act (the “FSMA”) back in January, the one-time registration has been modified to a biennial registration. The statute explains that “food facilities” will need to register: “[d]uring the period beginning on October 1 and ending on December 31 of each even-numbered year.” See 21 U.S.C. § 350d(a)(3) (emphasis added).
In all likelihood, starting in October 2012 (and every alternating year following), wineries will have a three-month window to re-register as “food facilities” and satisfy FDA’s new requirement. This may be subject to change as FDA has yet to issue final rules on biennial registration.
As we reported on numerous occasions last year (e.g.,, the original versions of the FSMA contained a variety of onerous requirements (including an annual $500 fee that wineries would have needed to pay to FDA) that WineAmerica played a major role in avoiding. While wineries have ultimately been included in the FSMA’s biennial registration requirement, this is a relatively modest burden compared to the possibility of what could have been. There was a real chance we could have faced conflicting FDA and Alcohol & Tobacco Tax & Trade Bureau (“TTB”) safety standards. This would have been a source of significant business disruption.
Because of WineAmerica’s efforts, in coordination with our industry partners, wineries aren’t stuck in a regulatory morass, TTB remains our primary regulator, and FSMA’s requirements for wineries are straightforward. This was a big victory for the American wine industry, and something that should make you feel good about the investment you’re making as a WineAmerica member.
We’ll keep you updated if FDA publishes new information on the biennial registration requirement.