Recently I spoke with representatives from the Food and Drug
Administration (FDA), and it occurred that there is some
confusion about what “regulation” by the FDA means when it comes
to dietary supplements.  The term “regulate” has various
meanings.    In a general sense, dietary supplements fall under
the purview of the FDA – where there are regulations that
pertain to labeling and “claims.”  However, when it comes to the
measurement of safety and effectiveness – as prescription drugs
must do – it is not the same.  The FDA does not ensure potency,
purity or biologic activity of the ingredients in dietary
supplements.  There is no registration or clearance by the FDA
before a dietary supplement goes on the market.  Structure-
Function Claims These claims describe the structure or function
of the body (i.e., “supports a healthy immune system or cell
function”).  If a company plans on using a structure-function
claim on their dietary supplement, they must notify the FDA
within 60 days of use.  The moment a dieta