Under section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)), a dietary supplement and a
component of a dietary supplement are “foods.” Accordingly, a facility that
manufactures/processes, packs, or holds a dietary supplement or a component of a dietary
supplement is required to register as a food facility unless it qualifies for an exemption from
registration (21 CFR 1.226).
Products marketed as nutritional supplements or feed supplements for animals are considered to
be “foods” or “new animal drugs” depending on the intended use. Facilities
manufacturing/processing, packing, or holding animal food for consumption in the United States
must register.