Why FDA’s New Registration Requirement is a Victory for America’s Wineries

By Cary Greene

Since FDA’s biennial registration requirement went live on October 22, we’ve been hearing from concerned members asking us whether registration is the first step toward an FDA takeover of wine regulation. The quick answer is no. In fact, the Food Safety Modernization Act (FSMA), the new law that created the biennial registration requirement, goes a long way toward preventing such a takeover.
As we reported last July, the FSMA contains a first of its kind exemption that excludes alcohol beverages from the vast majority of the law’s new food production requirements. The law effectively instructs FDA to keep its hands off of wine regulation.
Federal laws governing wine production were designed to keep tainted products out of the market. If there is a safety problem with a wine, TTB has legal tools to get it off the market. The FSMA was written to give FDA powers that TTB already has. Last year, we argued that including alcohol in the FSMA would undermine a regulatory system with strong safety checks built into it. Giving FDA new power over alcohol would create confusion and business disruption. Congress ultimately agreed with us. The first of its kind exemption is the proof.
The FSMA is a milestone for wineries. It’s the first time federal law governing food and beverage production specifically exempts alcohol beverages. For more than a century, the overlap between federal food and alcohol laws has created confusion. Finally, confusion is giving way to some clarity.
The biennial registration requirement is a modest burden compared to what could have been. There was a real chance wineries could have faced conflicting FDA and TTB safety standards. The exemption prevents this conflict, and creates a powerful and positive precedent that we can turn to in the future.
TTB and FDA will always need to work out their jurisdictional differences. When these differences pop up, WineAmerica will need to ensure that America’s wineries gets heard. At the same time, the FSMA has put us on stronger footing, making it clearer that Congress wants wine regulation in the hands of alcohol beverage regulators, not food and health regulators.
When you register your winery this fall and winter, remember that WineAmerica’s efforts have restricted, not expanded, FDA’s power over your business.