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4/5/2004

Panel Advises FDA on Oversight of Supplements

Kate Traynor

An expert scientific panel concluded last week that the Food and Drug Administration (FDA) needs better adverse-event data on dietary supplements to protect the public from problems associated with the products' use.

In a 370-page report commissioned by FDA, a committee of the Institute of Medicine and the National Research Council describes a process for the regulatory agency to evaluate the safety of dietary supplements and take action if evidence shows that a product poses a health risk for consumers.

The report also calls for additional funding for FDA to improve its oversight of the dietary supplement industry.

Committee Chair Barbara O. Schneeman, associate vice provost of the University of California at Davis, said during an April 1 press conference that the group's recommendations work "within the parameters of the current law governing how dietary supplements are regulated." But Schneeman described a major limitation in the law: "Currently, supplement manufacturers and distributors are not required to notify [FDA] about health problems that they discover related to the use of their products," she said. "The law should be modified to require such reporting."

FDA's authority to regulate dietary supplements is governed by the Dietary Supplement Health and Education Act of 1994, or DSHEA. The law treats most dietary supplements as safe unless proved otherwise and leaves the burden of such proof on FDA, not the manufacturer.

A recent article in Consumer Reports describes FDA as "hamstrung" by DSHEA because the law "denies the agency all but the sketchiest information about the safety record of most" dietary supplements.

Schneeman likewise noted that "the constraints imposed by some aspects of DSHEA limit [FDA's] ability" to evaluate supplements "as effectively and as efficiently as possible."

The Consumer Reports article briefly chronicles FDA's attempts since 1997 to regulate products containing ephedrine alkaloids, a ban on which is effective next week. FDA last month banned the distribution of dietary supplements containing androstenedione and declared that all such products on the market are considered adulterated until proved otherwise.

DSHEA offers FDA stronger justification to act against products introduced after 1994, like androstenedione, than against older products, which the law deems safe because of their long history of use.

Schneeman's committee concluded that most of the approximately 29,000 dietary supplement products sold in this country "are probably safe." She said that the committee's job was "to develop a framework that will specifically help FDA look at the science, look at the evidence, to decide when something does pose a significant risk" to consumers.

According to the report, the committee's "framework" for FDA involves three main steps: the detection of a signal that might indicate a problem with a supplement, evaluation of that signal, and an "integrative evaluation" of supplements that may pose a problem. The evaluation involves gathering data on risks and preparing a "safety monograph" to describe the risks. Products that are then determined to pose an unreasonable risk to consumers' health would be "strong candidates for regulation" by FDA.

In the committee's opinion, Schneeman said, the "unreasonable risk" rationale "does not require the same level of definitive proof that would be needed to document actual harm" to consumers.

For example, she said, some evidence about the risks of supplements could be gathered "from animal sources, tests done in laboratories, or toxicity" studies.

"Some of these types of data may be sufficient, by themselves, for the FDA to determine that a supplement ingredient poses an unreasonable risk," Schneeman said. But the committee emphasized that an "integrative" approach involving a variety of available data about supplement ingredients would normally provide the basis for regulatory action.

Two bills related to the regulation of dietary supplements have been introduced in the House of Representatives, and two are before the Senate.

Senate bill 1538, the DSHEA Full Implement and Enforcement Act of 2003, would ensure that enough money is set aside to allow FDA to fully implement all of the provisions of DSHEA but does not alter the language of the act.

The other bills—Senate bill 772 and House of Representatives bills 774 and 3377—seek to modify DSHEA. All three bills would require manufacturers to report adverse events related to supplement use to the Department of Health and Human Services (HHS) and increase the authority of the HHS secretary to take action against supplement manufacturers.