Dietary supplements are considered foods and are
subject to requirements of "Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Human Food" (108). These
regulations provide guidelines with regard to maintenance of
buildings and facilities, requirements for food handlers, and
cleanliness of equipment, as well as procedural requirements for
maintaining safety during the production and processing of foods.
This requirement is very similar to the same one used for regular
food handling or labeling.
DSHEA specifically authorizes FDA to establish
dietary supplement GMPs. Recognizing this perceived need, major
industry groups in 1995 jointly prepared extensive revisions to the
food GMPs that address aspects of manufacturing practices used by
the dietary supplement industry. These proposed GMPs for dietary
supplements were submitted to FDA and subsequently published as an
ANPR in the Federal Register (32). The Commission supports these
efforts of FDA and the industry to develop appropriate GMPs for
dietary supplements.
Some Supplement companies choose to voluntarily adhere
to the Pharmaceutical Standards. This is the same standard that is applied
to the production of drugs. There are two significant differences between
these standards: