WASHINGTON--A 14 percent budget increase for the Food and Drug Adminstration (FDA), which would have earmarked $2.5 million and two employees to the agency's adverse events office for dietary supplements, was cut by the Senate Subcommittee on Agriculture, Rural Development and by the FDA in a cost-cutting measure. As a result of its budget shortfall, FDA has stopped tracking cases in which herbal remedies have been linked to illness or death. Until 16 months ago, FDA had logged 2,621 "adverse reactions," which included 184 deaths it claimed were caused by dietary supplements.
"There is a need to responsibly monitor this because of the herbs involved," said Marc Ullman, a partner in the New York-based firm Ullman, Shapiro & Ullman. "There is a potential for drug interactions and adverse reactions."
The monitoring system was established to record cases where doctors or manufacturers noted that a connection between a health problem and an herbal product may exist. "That means anyone can report an adverse reaction," said Rob McCaleb, president of the Herb Research Foundation, one of the industry's nonprofit organizations. "There is no scientific follow-up by doctors or toxicologists to determine whether there was anything wrong with the supplement or if the supplement was even a causative factor."
Industry members say FDA's reports of deaths associated with dietary supplements are skewed and most likely many deaths were caused by unrelated events. FDA acknowledges in disclaimers that reported reactions may not have been caused by the product it lists.
Email this article
Add a comment
Printer version
Order reprints
RSS Feed
Bookmark article