Report: Dietary supplement warning system lacking

By Pete Hartogs
CNN Medical Unit

WASHINGTON (CNN) -- The U.S. Food and Drug Administration does not have enough information to adequately protect people who use dietary supplements, a new draft report from the Office of the Inspector General contends.

The report recommends the FDA take a series of steps to fix the problem.

Approximately 60 percent of Americans take some sort of dietary supplement, such as vitamins, minerals, botanicals or amino acids.

The report notes that the FDA does not require reporting of "adverse events" -- illness or injury -- that might be associated with a supplement. Instead, the agency relies on voluntary reports of such events from consumers, health professionals, and manufacturers.

Furthermore, the report contends, the FDA lacks much of the information it would need to analyze such reports, identify areas of concern and take action. Among the problems, it says, are lack of adequate medical and product information, limited information from consumers, and limited ability to analyze trends.

Responding to the report, an FDA spokesperson said, "The agency has a system in place to monitor adverse events and is looking into ways to improve its system."

Under a 1994 law, the FDA regulates dietary supplements as food. Unlike prescription drugs, supplements can reach the market without FDA approval, and it is the FDA's responsibility to prove questionable supplements unsafe, not the manufacturer's responsibility to prove them safe.

Since 1994 the FDA has required notification from supplement manufacturers 75 days before marketing new ingredients, but the inspector general's report called that step only "minimally effective" in protecting consumers because so few ingredients have been defined as new.

The report also is critical of labeling of supplements, pointing out that ingredients can be listed under a variety of names, some of which would not immediately be familiar to a consumer.

For instance, the report found ephedrine alkaloids, which act as stimulants, are listed under at least 25 names, including ma huang, ephedra, Chinese joint-fir, bitter orange, country mallow and Brigham's tea.

The inspector general's office found 31 actions taken by the FDA between January 1994 and June 2000 as a result of "adverse event" reports. Of those, half involved voluntary product recalls, while the others involved lesser actions, such as issuing a consumer warning in the form of a press release or discussion papers.

The inspector general's report recommends the FDA:

-- Require manufacturers to report adverse events to the FDA.

--Notify manufacturers when the FDA receives a report.

--Develop a computer database to track and analyze the reports.

--Disclose more useful information to the public about dietary supplements' adverse events.

--Require manufacturers to register themselves and their products with FDA.

--Tell manufacturers what type of safety information they should include in the 75-day pre-market notifications of new ingredients.

--Collaborate with the National Institutes of Health in setting a research agenda addressing safety issues.

--Assist manufacturers and the United States Pharmacopeia, a non-profit organization that sets prescription drug standards, in standardizing dietary supplement ingredients.

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