In the ever-changing regulatory landscape that alcohol manufacturers must navigate, the regulations imposed by the U.S. Food and Drug Administration (FDA) are often overlooked. But breweries, distilleries and wineries must be aware of these regulations, especially the requirement to register with the FDA unless the manufacturers can demonstrate that their business meets two very narrow exemptions. This is key, because, if the alcohol manufacturer is required to register, it is also subject to random, unannounced inspections by the FDA.

Before I get into the details of FDA registrations and inspections for alcohol manufacturers, here is a brief history of how these regulations came to affect the alcohol industry. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) made changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Then, on Oct. 10, 2003, the FDA issued a final rule to implement amendments to the FD&C Act that were enacted under the Bioterrorism Act.