WASHINGTON, June 22 (Reuters) — Makers of vitamins, herbs and other dietary supplements taken by millions of Americans must meet new government standards to show the products are free of contamination and contain exactly what the label says, United States health officials said Friday.
Under the Food and Drug Administration rules, companies in the $18-billion-a-year industry must test the purity, strength and composition of all of their supplements.
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” Andrew von Eschenbach, the commissioner of food and drugs, said in a statement.
Congress gave the agency power to set manufacturing standards for dietary supplements in a 1994 law. The final requirements announced on Friday will not apply to all makers until 2010.
In addition to product testing, the new standards address design and construction of manufacturing plants, record-keeping and handling of consumer complaints.
Inspectors will check manufacturing plants for compliance, F.D.A. officials said. For less serious violations, the agency may ask a company to fix a problem. Bigger problems could lead to product seizures or other action, said Robert Brackett, head of the Center for Food Safety and Applied Nutrition at the agency.
Some supplements have been recalled in the past because they were contaminated with microbes, pesticides or metal, or because they did not contain the ingredients listed.
The drug agency has also warned companies that sold supplements with undeclared drug ingredients for impotence, and others with less-than-advertised levels of vitamins A and C and folic acid.
Senator Richard J. Durbin, Democrat of Illinois, said the manufacturing rule was “better late than never,” but he added that “the requirements do not appear to go as far as they could have.”
Supplements do not have to be proven safe and effective before they can be sold, as medicines do, and the new rules will not change that.
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