First St. John's Wort, Now Sam-E: Is Society as a Whole at Risk without FDA Regulation of Psychiatric Self-Medication?

Abstract

That is precisely what we are doing when we allow persons who are in need of professional psychiatric help to instead stroll down the aisle of their favorite health food store and select a dietary supplement to alleviate their symptoms. The average consumer is not qualified to judge the efficacy, dosage or drug interaction properties of the herb. Persons afflicted with this disease suffer from mood swings, varying from depression to mania. It can be said with substantial certainty that the FDA lost most if not all control over dietary supplements upon passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. The FDA responded to consumer concern by formulating a task force to examine the entire dietary supplement arena. A drug may be derived from a plant, as can a dietary supplement or herbal preparation. The FDA can thus challenge a substance which it believes should be regulated as a food additive but is sold as a dietary supplement. DSHEA forbids the FDA from using its food additive jurisdiction to prohibit the marketing of dietary supplement products. As a result of these findings, the FDA proposed labeling regulations in an attempt to clarify whether existing label statements represent a dietary supplement's affect on the structure and function of the body, or whether they constitute a disease claim.

Keywords: Dietary Supplement Health and Education Act, dietary supplement, FDA, pshyciatric self medication

JEL Classification: I18, K23, K32