Wineries and Vineyards Need Not be Frightened by Bioterrorism Act Rules and Requirements
B. Tasting rooms don’t have to register if they sell food products directly to consumers as their primary function. The FDA definition of “consumers” does not include other businesses. In order to calculate the “primary function” of a business, the test is whether the dollar value in sales of food products sold directly to consumers exceeds the value of sales to all other buyers. In other words, if you’re selling most of your wine directly to consumers out of your tasting room then you are considered a “retail food establishment” and don’t need to register. However, if your tasting room is on-site at the winery, the facility will need to register, since it will be considered a “mixed-use” facility.
4. When do I need to register? If you are required to register you should have done so already. The registration requirements have been in place since 2003. Registration is a fairly straightforward process and can be completed online.
If you are already registered, it’s time to re-register! Registration renewal is required under 21 U.S.C. § 350d(a)(3). Specifically, during the period beginning on October 1 and ending on December 31 of each even-numbered year, each registrant must renew their registration.
5. How do I register? You can mail in the questionnaire, or submit it online. Information on how and when to register can be found through the link above. While you may have read that renewal registrations were not yet open, the FDA site has recently begun accepting renewals.
For assistance with the registration process or with other questions related to winery or grower issues, please contact Dickenson, Peatman & Fogarty at [email protected].