Regulation of "Nutraceuticals"

TLDR

DSHEA established a regulatory framework that limits health‑claim labeling but does not mandate rigorous safety studies for dietary supplements, creating public health risks and reported adverse effects. The author proposes creating a nutraceutical category for high‑dose supplements and requires pre‑market safety evaluation. The study is conducted in the U.S.

Abstract

The U.S. Congress, in the Dietary Supplement Health and Education Act (DSHEA) established a framework for regulation of dietary supplements by the U.S. Food and Drug Administration. For dietary supplements, the FDA regulates labeling to limit health claims, but is not empowered to insist on rigorous studies establishing safety before marketing (as would be required for drugs or food additives). This creates a substantial potential risk to the health of the public, and serious adverse effects have been reported from some dietary supplements that are currently being marketed. The author recommends that a new category of dietary supplements, called nutraceuticals, be established for supplements to be administered at doses that exceed normal human exposure to these agents in foods. Regulations should require that these nutraceuticals be judged safe before they are marketed.