More oversight recommended for dietary supplements
■ An advisory committee report calls for scientifically based assessments and even more attention from the FDA in evaluating supplement safety.
By Susan J. Landers — Posted April 26, 2004
Washington -- Additional scrutiny by the Food and Drug Administration of the vast dietary supplement market was recommended in a new federal report which also provided a scientific framework for use in analyzing the safety of supplements.
A science-based assessment process could include checking results of animal tests or information derived from tests on similar substances when human data are unavailable, advised the report, written by members of the Institute of Medicine and the National Research Council.
"Approximately 29,000 dietary supplements are currently available to the American consumer, and while most are safe, questions have been raised about FDA's resources to identify and address the occasional problem products," said Committee Chair Barbara Schneeman, PhD, a professor of nutrition at the University of California, Davis.
The report, "Dietary Supplements: A Framework for Evaluating Safety," also recommended that Congress require supplement manufacturers and distributors to report adverse events to the FDA and that the agency be given more money to oversee the huge industry. Under the 1994 Dietary Supplements Health and Education Act, which covers herbal remedies, botanicals, vitamins and minerals, supplements were to be regulated like foods instead of drugs and to be considered safe unless proven otherwise. They were also not required to be clinically tested before they reached the market.
Although the FDA recently took action to remove the supplements ephedra and androstenedione from the market and has warned dietary supplement manufacturers against making false and misleading claims for weight-loss products, groups, including the AMA, had been seeking such action for several years and believe more may be required.
The report also recommended that physicians and other health care professionals be educated on ways to report health concerns and that supplement labels include the phone number of MedWatch, the FDA's safety information and adverse event reporting program.