FDA on DSHEA
This article was originally published in The Tan Sheet
Executive Summary
Consumers are increasingly looking at scientific data to determine whether a product is safe and effective, making the Dietary Supplement Health & Education Act "a total aberration" since it does not require supplements undergo large-scale clinical trials prior to their marketing, FDA Office of Drug Evaluation I Director Robert Temple, MD, stated at the FDLI educational conference in Washington, D.C. Dec. 16. Attorney Stephen McNamara (Hyman, Phelps & McNamara) disagreed, however, noting science is not always the overriding factor, but that consumer demand itself, a legitimate concern, can dictate policy as well. To illustrate his point, McNamara referred to consumers' desire for diet beverages, which outweighed FDA concerns over the safety of saccharine