Assessing Supplement Safety — The FDA's Controversial Proposal

Pieter A. Cohen

New England Journal of Medicine · 2012 · 79 citations · 0 references

DOIFull text

Open access

Concepts

Abstract

By law, dietary supplements whose ingredients were not sold in the United States before 1994 require demonstration of a “reasonable expectation of safety” — a currently unenforced requirement. Will the FDA's proposed new guidance in this area be adequate?