Dietary supplements (DS) and foods with added dietary ingred., such as vitamins and herbs, are multibillion dollar industries. Past reports on the FDA¿s reg¿n. of these products raised concerns about product safety and the availability of reliable info. Since then, FDA published draft guidance on requirements for reporting adverse events -- which are harmful effects or illnesses -- and Current Good Mfg. Practice reg¿s. for DS. This report examines FDA's: (1) actions to respond to the new serious adverse event reporting require.;(2) ability to identify and act on concerns about the safety of DS, and the safety of foods with added dietary ingred.; and (3) actions to ensure that consumers have useful info. about the safety and efficacy of DS. Illustrations.
FDA is not required to review substances, such as spices and preservatives, added to food that are Generally Recognized as Safe (GRAS) for their intended use. A few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances, including materials manufactured at a tiny scale to take advantage of novel properties. This report reviewed the extent to which: (1) FDA's oversight of new GRAS determinations helps ensure the safety of these substances; (2) FDA ensures the continued safety of current GRAS substances; and (3) FDA's approach to regulating engineered nano-materials in GRAS substances helps ensure the safety of the food supply. Illus.