In its dietary supplement labeling guide, first issued in April 2005, FDA advised that it would not consider the term, “dietary supplement,” alone, to be an appropriately descriptive “statement of identity.” FDA, however, has now reversed course. Revised guidance released last week now provides as follows:
Can the term “dietary supplement” by itself be considered the statement of identity?
Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement.”
The revised guidance also adds the following: “Dietary supplement” may be included as “part of a longer statement of identity (e.g., ‘cod liver oil liquid dietary supplement’).”