FDA Issues New Dietary Supplement Safety Rules

They're meant to keep products contaminant-free, but critics say more oversight is needed.

By Steven Reinberg
HealthDay Reporter
Friday, June 22, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

FRIDAY, June 22 (HealthDay News) -- After years of pressure from consumer advocates to do so, the U.S. Food and Drug Administration announced Friday that it was tightening up its oversight of dietary supplements.

Firms that make vitamins, herbals and other supplements must now test their products to ensure they aren't contaminated and must include the ingredients listed on the label, FDA officials said.

"This is a critical component of FDA's implementation of the Dietary Supplement Health and Education (DSHEA) act that was passed by congress in 1994," Robert E. Brackett, director of the FDA's Center for Food Safety and Applied Nutrition, said during a late morning teleconference.

Under the act, manufacturers are responsible for making sure that their claims about their products are substantiated by adequate evidence, Brackett said. "This is to show the claims are truthful and not misleading," he added.

The move comes on the heels of recent scandals centered on adulterated supplements. Last year, the FDA discovered that some supplements contained undeclared active ingredients found in prescription erectile dysfunction drugs, according to the Associated Press. In other cases, supplements were found to have lower levels of vitamins A or C than what was claimed on the label.

In the past, critics have slammed the FDA's approach to supplements as woefully ineffective. Since dietary supplements are considered food supplements and not drugs, they do not fall under the stricter FDA guidelines for drug safety and efficacy -- even though many people use them like drugs, or instead of drugs, to stave off or treat illness, with sometimes deadly consequences.

Consumer groups described the FDA's new efforts to rein in the $22 billion supplements industry as too little, too late.

Friday's move "not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective -- a critical necessity," Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, said in a statement. Wolfe noted that, under the new rule, large manufacturers have a year to comply, and smaller firms have been given a three-year window.