The Act requires new drugs to be shown safe before marketing, starting a new system of drug regulation.
Drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them.
Review is created to enhance the safety, effectiveness, and appropriate labeling of drugs sold without prescriptions
Dietary supplements are now considered a food; they no longer have to meet the rigorous drug safety and efficacy requirements of the FD&C Act
Manufacturers are required to report to the FDA any serious adverse effects linked to their dietary supplement.
Manufacturers of dietary supplements are required to test the safety and efficacy of their product before it hits the market.
The FDA receives its first, but certainly not last, report of a death linked to a dietary supplement containing ephedra.
After 150 reported deaths and 800 reported serious adverse effects, the FDA finally gathers sufficient evidence to prove that it presented an unreasonable health risk