Part one of term paper
Some manufacturers are marketing supplements that have substances and effects similar to drugs. The FDA is attempting to impose drug status on these supplements and is being challenged in the courts by supplement manufacturers. In this article, I examine the legal debate surrounding the definition and regulation of substances - whether as a d ...

Part two of term paper
... challenging these attempts. Third, I discuss future litigation and other regulatory actions regarding the drug or dietary supplement debate and its implications for marketers, consumers, and policy makers. Supplements are not required by the FDA to have premarket approval or safety testing, as are necessary for new drugs and food additives. For example, prior to release, a new drug must obtain FDA drug approval through an extensive process that involves preclinical testing on animals, three phas ...