Section 415 of the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) requires facilities that manufacture, process, pack, or store food within the United States to register with the FDA. However, retail food facilities-including restaurants, cafés, cafeterias, fast-food outlets, and food stalls-are explicitly exempt from this FDA food facility registration requirement.
Nevertheless, an exemption from FDA registration does not equate to an exemption from permitting requirements. Container cafés must still apply for a food facility health permit or operating permit from the environmental health department of the relevant state and county. Regulations in Kern County, California, stipulate that operators selling unpackaged food must hold a food safety certification; furthermore, if the business operates as a mobile food facility, it must be affiliated with an approved commissary.
This offers a valuable reference for manufacturing plants: when clients ask, "Is your café FDA-certified?" the correct response is that retail food service facilities do not require FDA registration but do need an operating permit from the local health department. What the factory needs to provide are documents detailing materials and equipment specifications that comply with health department requirements.
