FDA Moves To Ensure Safety of Supplements
Saturday, June 23, 2007
For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients, the Food and Drug Administration ordered yesterday.
The FDA said the new mandate is needed to ensure that products are free of contamination and impurities. Last year, the FDA found that some supplements contained undeclared active ingredients that are used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that did not contain the levels of Vitamin C or Vitamin A that were claimed.
If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or seek criminal charges.
Critics complain that the new rule does not go far enough in policing the $22 billion industry.
"Consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports.
Sidney Wolfe, director of health research at the Washington-based group Public Citizen, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.
"You still don't have to show the product is safe. You don't have to prove it works," said Wolfe.
Most companies already test their raw ingredients, said Steve Mister, president and chief executive of the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.
"This raises the bar so that all have to comply," Mister said.
The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. Even the largest of the manufacturers will not have to comply until next June.