Washington- Tough new rules are needed to monitor the sale and use of dietary supplements, the vitamins and herbs now used by about 60 percent of Americans, a government study says.

A draft report of the study by the Department of Health and Human Services inspector general's office said federal regulations now do a poor job of protecting the public from the risks of dietary supplements.

The report said supplements do not undergo premarket safety approval procedures of the Food and Drug Administration, and manufacturers are not required to report adverse health effects experienced by people takein the supplements.

Instead, the report said, the FDA relies on voluntary reports of adverse health effect and "rarely reaches the point of knowing whether taking safety action is warranted" for a dietary supplement.

The study urged regulation requiring supplement manufacturers to register themselves and their products with the FDA and to report any adverse health results to the agency.

A recent FDA study, the report said, estimated that the agency learns of fewer than 1 percent of adverse events involving dietary supplements, even though some, such as ephedrine alkaloids or ginkgo biloba, have been linked to serious side effects.

Often the FDA is unable to determine the ingredients in products mentioned in adverse event reports, because labels are missing from 77 percent of products mentioned in such reports, the study found. Even the city and state where the products were manufactured was missing from 71 percent of the products named in adverse reaction reports.

Source: Detroit Free Press, Associated Press, April 18, 2001, page A8