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US FDA Wants Vitamin Manufacturers to Test All Ingredients

ducts before they are distributed.

It also includes requirements for record keeping and handling consumer complaints.

Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, 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, director of Public Citizen's Health Research Group.

Consumers Union, publisher of Consumer Reports, called the rule a good step toward improving consistency in the ingredients that go into supplements.

"However, consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union.

Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop.

Under the old regulations, supplements were governed by the same rules that applied to producing foods, such as cans of soup.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition.


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