Report calls for tougher FDA oversight of dietary supplements

Wednesday, April 18th 2001, 12:00 am
By: News On 6

WASHINGTON (AP) _ 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 taking the supplements.

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

The study urged regulations 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, the study found.

``Our evaluation of FDA's dietary supplement adverse event report system leads us to conclude that ... the potential of the system to serve as a consumer safeguard is inherently limited,'' the draft report said. It said the current system ``cannot serve as an adequate safety valve.''

The report said dietary supplements are ``increasingly popular,'' used daily by about six out of 10 Americans.

Dietary supplements include vitamins, minerals, herbs and amino acids. Such supplements can be beneficial, but they can also carry health risks, the report notes. In the past, the FDA has warned about ephedrine, which can cause strokes, and about some herbal products marketed as sleep aids or weight control formulations that caused heart attacks, strokes, even death.

The Council for Responsible Nutrition, a trade organization of dietary supplement manufacturers, said the report was seriously flawed and demanded extensive revision of the draft before the report is made public.

``The report paints a negative picture of the dietary supplement industry, implying that many companies are fly-by-night operations that FDA has difficulty locating,'' said a letter to the inspector general's office from Annette Dickinson, the council's vice president.

Instead, she said, 65 manufacturers known to the agency account for about 75 percent of the dietary supplement products on the market.

Dickinson said the trade group worries about ``the negative view of dietary supplements that we believe pervades the IG's report'' and asked that extensive changes be made before the report is completed.