Pharmanex, Inc. v. Shalala: A Wake Up Call for Congress and a Not So Bitter Pill for the FDA

In 1994, Congress, through specific legislation, enacted the Dietary Supplement Health and Education Act (DSHEA) for the Federal Food and Drug Administration (FDA) to regulate dietary supplements which has seemingly puzzled food and drug practitioners for years. FDA officials and critics have debated back and forth over whether dietary supplements constitute food or drugs and the proper procedure for regulating these products. Now, the DSHEA guides the regulation of dietary supplements, yet controversy still remains over exactly how a dietary supplement should be regulated and the exact criteria for defining a dietary supplement.