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 Since then, FDA published draft guidance on requirements for reporting adverse events -- which are harmful effects or illnesses -- and Current Good Mfg.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.
In 2007, Americans consumed 5 billion pounds of seafood. Most seafood buyers -- importers, distributors, supermarkets, restaurants, and individual consumers -- assume that the seafood they buy is what the seller claims it is. However, this is not always the case. Sometimes seafood products are mislabeled for financial gain -- an activity called seafood fraud. Three federal agencies play key roles in detecting and preventing seafood fraud: Customs and Border Protection, the Nat. Marine Fisheries Service, and the FDA. This report determines: (1) the actions key fed. agencies take to help detect and prevent seafood fraud; and (2) the extent to which these key fed. agencies collaborate with each other to help detect and prevent seafood fraud. Illus.
FDA oversees federal requirements to prohibit false or misleading food labels; the FTC enforces the prohibition against false or misleading advertising. By statute, health claims on food labels must have significant scientific agreement, but in 2002, in response to a court decision, FDA decided to allow qualified health claims with less scientific support. Structure/function claims refer to a food's effect on body structure or function and are also used on food. This study of FDA's implementation of qualified health claims for food examined: (1) the results of FDA's efforts to allow the use of qualified health claims and oversight of these claims; and (2) consumers' understanding of the claims. Charts and tables. This is a print on demand publication.
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.